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Global Service Providers Guide 2012 A guide to chemicals management and control services

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Contact information Tel. +358 (0) 9 412 3055 Fax: +358 (0) 9 412 3049 Sales: sales@reachlaw.fi Global customer care: info@reachlaw.fi

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Chemical Watch | Global Service Providers Guide 2012


foreword Welcome to Chemical Watch’s second global service providers guide and directory. This edition follows the successful inaugural guide in 2011, and the growing need of our readers for information about the breadth and depth of the service provision for REACH, GHS and other chemicals management activities globally. The guide is in three parts. The editorial is based on a survey of some 277 respondents based in client companies across the world looking back at changes in 2011 and predictions for the year ahead. The guide represents a snapshot of the current state of play but in analysing the survey data our author Cynthia Challener once again conducted numerous interviews with providers and clients to obtain an understanding of what they think current and future trends are, resulting in some important insights. The core body of the guide comprises the corporate profiles of 106 global service providers, including consultants, lawyers, laboratories, information providers, IT solutions and training companies – almost 60 organisations have opted for two-page spreads, while almost 50 have quarter-page niche profiles. Each profile presents

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

About Chemical Watch Chemical Watch publishes news and intelligence to help companies 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. Our services include:

News Daily news and weekly news alerts covering REACH, GHS and other global chemical regulations, policy and implementation as well as industry initatives, NGO viewpoints and emerging science. Our news is organised by region/country and also contains a risk assessment channel

Chemical Watch European Business Briefing Monthly pdf newsletter containing in-depth analysis of regulatory and other drivers of sound chemicals management, with case-studies of company practice and expert contributions chemicalwatch.com/issue

Webinars and workshops A series of Chemical Watch webinars and workshops to complement our editorial coverage offering expert insight into the specifics of chemical regulations chemicalwatch.com/events_webinars

chemicalwatch.com/news Managing CLP Compliance – The Essentials for Business Packed with case studies, this report offers a step-by-step guide to CLP compliance chemicalwatch.com/reach_clp

REACH consortia Database of more than 200 REACH consortia. Search by substance or CAS or EC number chemicalwatch.com/REACH_consortia

Jobs Vacancies worldwide for chemical regulatory specialists, toxicologists and other professionals working with chemicals chemicalwatch.com/jobs

Forum Discussion forum for the Chemical Watch community to inform each other, ask questions and debate the issues of the day

Events database Extensive database of hundreds of events worldwide for those engaged in chemicals management

Global Service Providers Guide The guide is also updated regularly online. To take an entry, contact June Meagher at june@chemicalwatch.com

forum.chemicalwatch.com

chemicalwatch.com/events

chemicalwatch.com/REACH_services

Chemical Watch | Global Service Providers Guide 2012

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CS REGULATORY LTD YOUR PARTNER FOR GLOBAL REGULATORY COMPLIANCE

REACH registration in Europe Worldwide notification of chemicals Representation of clients within Europe Data waiving Data management services Chemical Safety Assessment Production of chemical safety documents Liaison with authorities and product defence Technical Consultancy CLP Documentation

www.csregulatory.com

FS 553614

CS Regulatory Ltd. An ISO 9001:2008 Accredited Company.


contents Chemical service providers editorial..... 5 Profiles........................................28 24-7 Response...................................... 28 3E Company......................................... 30 ACTA..................................................... 32 APC....................................................... 34 Apeiron-Team........................................ 36 ARCADIS............................................... 38 ARCHE.................................................. 40 ATOUT REACH...................................... 42 B-Lands Consulting.............................. 44 bibra toxicology advice & consulting... 46 Bioagri................................................... 48 Brixham Environmental Laboratory...... 50 Bureau Veritas....................................... 52 Cardno ENTRIX..................................... 54 CEHTRA................................................ 56 Centro Reach........................................ 58 ChemADVISOR..................................... 60 Chemservice......................................... 62 ChemService Srl Controlli e Ricerche.. 64 Chilworth – a DEKRA Company........... 66 Compliance Services International...... 68 CRAD.................................................... 70 CS Regulatory Ltd................................. 72 Dr. KNOELL CONSULT......................... 74 EBRC Consulting.................................. 76 EcoMundo............................................. 78 ECOonline............................................. 80 elc group............................................... 82 ENVIRON.............................................. 84 ERM....................................................... 86 Exponent International Limited............. 88 H2 Compliance..................................... 90 Harlan Laboratories.............................. 92 ICF International.................................... 94 International Cosmetics & Chemical Services Ltd.......................................... 96

Intertek.................................................. 98 JSC International................................. 100 KFT Chemieservice............................ 102 LAUS................................................... 104 LSR Associates................................... 106 Mercer................................................. 108 NOTOX................................................ 110 Polgar ACRO....................................... 112 PwC..................................................... 114 REACh ChemAdvice GmbH............... 116 REACH mastery.................................. 118 ReachCentrum.................................... 120 REACHLaw.......................................... 122 Risk & Policy Analysts (RPA)............... 124 Royal Haskoning................................. 126 SCC..................................................... 128 Science & Environnement................... 130 Smithers Viscient................................ 132 SSS (Europe) AB................................. 134 TNO Triskelion..................................... 136 ToxMinds............................................. 138 Wildlife International Ltd..................... 140 WTConsulting...................................... 142

Niche firm profiles........................ 146 AG-HERA............................................ 146 Alemare Solutions............................... 146 ALTox................................................... 146 AW-ChemAdvice................................. 146 Caleb Management Services............. 147 CFCS................................................... 147 ChemRisk............................................ 147 ChemSW............................................. 147 CJV Consulting Limited...................... 148 Compliance & Risks............................ 148 CONUSBAT......................................... 148 Crowell & Moring................................. 148 Danger And Safety Srl ....................... 149 Profile production Nick Hazlewood, nick@chemicalwatch.com

The Global Service Providers Guide 2012 is compiled and published by CW Research Ltd, publishers of the Chemical Watch news service and other information products for chemical regulatory experts worldwide. CW Research Ltd, 140B Longden Coleham, Shrewsbury SY3 7DN, UK Tel: +44 (0)1743 818 101 Fax: +44 (0)1743 818 121 email: cw.enquiries@chemicalwatch.com www.chemicalwatch.com Editor Mamta Patel, mamta@chemicalwatch.com Contributing Editor Cynthia Challener, cynthia@chemicalwatch.com

Head of Sales and Marketing June Meagher, june@chemicalwatch.com Sales Executives Will Marner, will@chemicalwatch.com Lotte Spencer, lotte@chemicalwatch.com Matt Rothwell, matt@chemicalwatch.com Business Development Director Stuart Foxon, stuart@chemicalwatch.com Managing Director Julian Rose, julian@chemicalwatch.com Distribution policy Copying of this document including electronic circulation is not permitted without consent of the publisher.

Chemical Watch | Global Service Providers Guide 2012

Dr Mach.............................................. 149 Ecotox Services International............. 149 EggCentris.......................................... 149 ETC...................................................... 150 Exitss................................................... 150 FinnREACH......................................... 150 FoBiG.................................................. 150 Global MSDS....................................... 151 IGCON................................................ 151 Jongerius Consult BV......................... 151 JRF Global.......................................... 151 Linmark Consulting............................. 152 LKC Switzerland Ltd............................ 152 MSDS Europe..................................... 152 Peter Fisk Associates.......................... 152 REACH Delivery.................................. 153 REACH Global Services..................... 153 Reach Only Representative Ltd.......... 153 Reach Registration Services Ltd........ 153 REACHReady...................................... 154 REACHsuite......................................... 154 REACHWise........................................ 154 Regulatory Services International...... 154 SciVera................................................ 155 Sitmae REACH Services BV............... 155 Steptoe & Johnson LLP...................... 155 Stewardship Solutions Ltd.................. 155 Tenviro................................................. 156 The Wercs........................................... 156 Tox Focus LLC..................................... 156 toXcel International Ltd....................... 156 Toxikon................................................. 157 Verdant Law PLLC............................... 157 wca environment................................. 157 Wilmer Tox Consulting......................... 157

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

Disclaimer While Chemical Watch takes every effort to ensure the accuracy of this guide, we cannot take responsibility for any adverse consequences arising from actions taken in response to our content and we recommend that readers take appropriate professional advice. Designed and typeset by Ministry of Design, Bath, UK www.ministryofdesign.co.uk Printed by The Complete Product Company, Malmesbury. Printed on 9 Lives 80 recycled stock. First published 2012 Copyright and Database Rights © 2012 CW Research Ltd. All rights reserved

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Chemical service providers After completion of the 2010 registration deadline for the EU’s REACH Regulation, activity in the chemicals management and control sector seemed to quieten a little in early 2011 as companies took time to recover from the efforts for the 2010 registrations and worked to get reorganised and prepared for the 2013 deadline. But the slack has since been compensated for by new chemicals control legislation in other nations, implementation requirements for the UN globally harmonised system of classification and labelling of chemicals (GHS) and changes in sector-specific regulations (eg nanomaterials, biocides, crop protection products, cosmetics, food contact materials, veterinary and human medicines, etc). By the end of 2011, many chemical manufacturers and downstream users were also beginning to take action with respect to the 31 May 2013 REACH registration deadline for lower volume chemicals. This resulted in most service providers experiencing a modest increase in business in 2011, and many made preparations for an anticipated year of significant growth in 2012. To learn in more detail how users and providers of chemicals management and control services view the sector – from their level of satisfaction to expectations for use of different types of services – Chemical Watch conducted the second annual survey of its unique member community. Over 270 respondents shared their thoughts on the services they rely on the most and the level of outsourcing they anticipate in the future. The results, including comparisons where possible with the data gathered from the first survey, are presented below along with a discussion of the major trends and issues facing the chemicals management and control activities.

An introduction to chemical service providers Chemicals management and control efforts span a wide range of activities that impact all aspects of a company’s operations. Even large organisations that have their own environmental, health and safety and product stewardship departments often turn to service providers for strategic advice, independent administrative assistance, scientific and legal expertise, laboratory capabilities and software and information management tools. Smaller firms that lack the resources for in-house staff rely heavily on service providers for all of the above, as well as development and implementation of required programmes and activities. Our survey captured the following types of services offered by companies, many of whom offer multiple services, not least through networks as discussed later in this section: OO consultancy/advisory OO representation/management OO legal OO laboratory and technical

Chemical Watch | Global Service Providers Guide 2012

information providers software/IT See the A-Z Listing at the back of the guide for details of what services are offered by more than 200 service providers. The basic make-up of the chemicals management and control service provider sector has remained relatively stable in recent years, but new developments in various regions of the world are beginning to have an impact. The majority of service providers are currently located in Europe or the US, but the increasing implementation of chemicals management and control regulations in other countries, such as China, South Korea, Malaysia, Turkey and Russia, has created a demand for service providers with expertise in these new regimes. In fact, several respondents to the Chemical Watch survey indicated that they were specifically looking for service providers with global expertise and insight. The market has responded, with regional domestic firms establishing a presence and a growing number of westernbased providers adding on-site staff and/or partnering with local experts. Networking among smaller providers with different core areas of expertise has also grown within the mature markets. By forming such relationships, these providers believe they can continue to offer the flexibility and responsiveness of a small company, combined with the full breadth of capabilities that would traditionally only be found in a much larger organisation. “There is no one service provider organisation that can deliver every aspect of a customer’s REACH requirements. Therefore, there is a distinct advantage in having a formal network of high quality, complementary service providers united by working to the same set of rules and the same set of goals through a common IT platform,” comments Malcolm Pollard, CEO of Baytouch and REACHsuite. The chemicals sector, which includes manufacturers of basic/commodity chemicals, fine and speciality chemicals, crop protection products and pharmaceuticals is the largest purchaser of services. Manufacturing is the second most important customer segment, and includes automotive, aerospace, electronics, appliances and similar products. However, consumer products and the retailers that sell them are also increasingly turning to service providers for assistance with regulatory compliance, particularly in Europe due to the REACH Regulation, which covers substances in articles, and in other parts of the world, where REACH-like regulations are being adopted. It is difficult to make direct year-on-year comparisons as the number of respondents varies and does not cover the entire market place but 151 purchasers of services who responded to this question each invested on average, at a company level, approximately €9.3m on outsourced services, which equates to a total yearly expenditure of €1.410bn. Importantly, and similar to last year (38%), these external efforts accounted for only 37% of the work completed by respondent companies, with the majority actually carried out by in-house teams (Figure 1). OO OO

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Chemical service providers

Overview


Figure 1

Figure 3

Percentage of chemical management work performed by inhouse teams at survey participant firms

Effect of strategy and organisational changes on use of external service providers Less work from service providers 13%

Chemical service providers

0 - 20% 12%

No change 31%

20 - 40% 12%

80 - 100% 36%

40 - 60% 15%

More work from service providers 56%

60 - 80% 25%

The growing complexity of global chemicals management and control requirements has had both direct and indirect impacts on the growth of the service providers sector. Clearly, demand for services has increased as a broader array of companies has turned to outside support for assistance with compliance efforts. Divergent company strategies have been implemented in response, and in turn, the organisational structures required to support those strategies, are also emerging. Overall, 42% of respondents indicated their activities are fully integrated, while just 10% have separate compliance divisions, and the remainder are integrated to some degree. Some firms have more fully integrated their chemicals management and control activities throughout their business operations over the last five years, while others have strengthened their compliance divisions (Figure 2). Figure 2

Figure 4

Integration changes over the last five years Move towards general management 27%

The money spent on external providers was most often invested for the retention of laboratory services (32.7%), followed by consultancy work (23.7%), IT and software support (12.8%), information management (8.2%) and legal assistance (8.1%). This line-up is quite different from that in 2010 when our respondents suggested that consultancy work (30%) and representation/management services (18%) were in greatest demand (Figure 4). This shift is not surprising given the need for laboratory services to meet data requirements for the upcoming May 2013 REACH registration deadline. “Ecotoxicological testing, in particular, was in greatest demand in 2011 due to requirements for REACH. We fortunately had the flexibility to allocate technical staff to these lab activities in order to meet this increased need in the marketplace,� says Carlotta Casalegno in the regulatory and development business of ChemService srl Controlli e Ricerche.

Changes in the proportion of spending on provider service types 100%

Remained the same 43%

90% 80% 70% 60% 50% 40%

Move towards separate compliance divisions 30%

30% 20% 10%

Regardless of whether they have shifted to a more integrated or separated approach, the change in strategy and organisational structure has often led to an increased need for external support from service providers (Figure 3).

0% 2010 Other services

Laboratory

Training

Legal

Information

Representation & management Consultancy

IT & software

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2011

Chemical Watch | Global Service Providers Guide 2012


Respondents use chemicals management and control services most often on an occasional basis, with 11% or less preferring to retain services on a permanent basis (Figure 5). Consultancy/advisory, laboratory and information services were the three service types that were most likely to be permanently or frequently retained.

100% 90%

19%

11%

32%

50%

46%

13%

38%

71%

30%

Legal services

20%

17%

52%

10%

Laboratory 11%

31%

0%

34%

IT & software solutions 16%

39%

Information services 10%

72%

40%

Representation & management

Chemical service providers

60%

Consultancy/advisory

9%

9%

70%

Frequency of service retention

4%

Change in overall satisfaction levels

80%

Figure 5

7%

Figure 6

23%

16% 2010

6% 2011

Very dissatisfied

Satisfied

Dissatisfied

Very satisfied

Neither satisfied nor dissatisfied

36%

Training 5%

20%

48%

Other services 1% 1% 0%

6% % of participants

Permanent

Frequent

100%

Occasional

Customer satisfaction levels The success of any industry depends on its ability to provide products and services that meet the needs of the marketplace – in other words, that provide value as perceived by its customers. Of concern then, is that Chemical Watch survey respondents indicated that their overall level of satisfaction with the services they receive is lower, down from 88% at the time of last year’s survey, to 77% currently (Figure 6). Case study

DR. KNOELL CONSULT: Application of a category approach to avoid expensive and time consuming animal testing Problem: A consortium realised that there were several data-gaps within a group of 20 substances, which could cause high costs for animal testing and a considerable delay in dossier preparation. Solution: DR. KNOELL CONSULT began by first of all preparing a full data-set of physico-chemical parameters for all the substances in question. Based on this, it was subsequently possible for their experts to establish a well-founded registration strategy leading to a comprehensive category approach. As a result, all data-gaps could be filled by read-across within this category, saving time and money. It was not necessary to perform animal tests nor to propose them.

Chemical Watch | Global Service Providers Guide 2012

The drop in satisfaction is due to a decrease in very satisfied participants. Two particular areas of dissatisfaction are pricing and the quality of the briefs that respondents have received. Specifically, in 2011, just 47% of participants felt that their service providers were providing value for money, down from 64% in last year’s survey. Regarding the quality of briefs, while 83% of participants were happy with the briefs they received in 2010, only 72% found them to be satisfactory in 2011. Finally, just 41% of this year’s survey participants are satisfied with the prices charged by their service providers, compared with 48% last year (Figure 7). Case study

Compliance Services International (CSI): Building a long-term relationship to ensure business continuity Problem: Two EU affiliates of a US-based parent company needed a third party representative prior to the 2008 REACH preregistration phase for dealing with nearly 30 substances. Solution: CSI worked closely with the clients’ EU and US staff to produce a viable REACH strategy that involved pre-registration, preSief and Sief communications, survey responses and consortium communication, accessing required data, and creating and submitting IUCLID format dossiers. As a result of CSI’s efforts and the client’s adoption of a highly proactive approach, registration of all substances under the 31 May 2013 deadline should be complete in Q2 of 2012, and all those with a 2018 deadline should be complete by Q1 2013. Such early registration will allow promotion of the client’s product components as REACH Registered and gain the commercial advantage in advance of the registration deadlines.

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a further 51% said they would possibly change. Both of these figures are up slightly from last year (Figure 8).

Figure 7 Satisfaction of survey participants with specific service aspects

Figure 8

Availability

Interest level in changing suppliers

70%

100%

74%

90% 80%

70%

70%

81%

60%

Experience/knowledge in all countries in which you operate 50%

50%

56%

40%

Offering flexibility

30%

53%

10%

Adding value on top of agreed deliverables

10%

6%

0%

49%

2010

44%

No

Technical knowledge 75% 82% Providing value for money 47% 64% Price of service 41% 48% Delivering on schedule 63% 72% Meeting your brief 72% 83% % of participants 2011

51%

48%

20%

67%

0%

39%

46%

Chemical service providers

Personal relationship

100%

2010

This decline in satisfaction levels should be a warning to service providers. The expected continued growth of the chemicals management and control service provider market does not guarantee success to anyone that offers services. “Companies learned in the run-up to the 2010 REACH deadline the types of problems they can encounter: delays, lack of transparency, lack of expertise, etc.” states Christelle Henry, a REACH representative with ATOUT REACH. “Many clients understand REACH now and cannot work anymore with someone who thinks that he knows better. REACH is complex, and often service providers and clients need to discuss the technical points in order to decide together what needs to be done.” In fact, a number of respondents to the Chemical Watch survey indicated that they were considering a change in service providers: 9% said they had plans to change, while

Chemical Watch | Global Service Providers Guide 2012

Possibly

2011 Yes

Several specific reasons were given for the possible change, and many related to cost and quality of the service provided. It must be noted, however, that a need for services on a global basis was also a frequently mentioned explanation. “There remains a wide range of service providers and capability in the market,” admits Sue Bullock, a principal at ENVIRON. “It’s often a challenge for companies, particularly those new to the chemicals management and control market, to differentiate between the capabilities of different service providers.” Reasons cited for changing service providers: OO provider not keeping up with regulatory information and requirements OO lab services that promise delivery and then don’t – poor service OO poor follow-up of outstanding actions OO cost and quality of service OO competitive tender for some work OO lower price or better value OO small charges for everything OO business expanding to different regions OO inadequate knowledge of global chemical regulatory compliance topics and limited availability of solutions OO broader database availability OO high turnover means constant loss of experience in suppliers. As a result need to broaden the base of companies which can supply services. OO keeping up with technology Of course, our figures show the majority of the survey participants were happy with the chemicals management and control services they received. And there are good reasons not to change, even if a user of these services is not wholly satisfied. Some companies are concerned about the know-how loss when switching service providers and prefer to assure the continuity of projects. Others aim to build long-term partnerships with their suppliers, and also feel that changing providers would cause unnecessary extra work and bear unwarranted risks. “Much of the business in our core industry sectors is repeat business

Page 9


Chemical service providers

from satisfied customers, while new business often comes through personal recommendations to others from these existing clients,” confirms Warren Scott, senior consultant and REACH programme coordinator with Compliance Services International (CSI). Chemicals management and control service provision, in fact, is a business based largely on trust. Relationships are critical. For customers of these services, being able to rely on adherence to project protocols is a top priority, according to Chemical Watch survey respondents. Regular face-to-face meetings and building long-term relationships are also very important (Figure 9).

Science & Environnement. “They also need to feel that their service providers are part of a team,” he notes. In fact, clients seem to be focusing on personal recommendations for choosing their service providers, according to Paul Thomas, director at CEHTRA. He also agrees that credibility and quality seem to be high on the list for return clients and new clients recommended by existing clients. Figure 10 Most important service provider choice factors Expertise of key staff 79%

Figure 9

Proven experience on similar projects

Most important relationship factors

71%

Strict adherence to project protocols

In-depth knowledge of country specific regulations 46%

58% Comprehensiveness/accuracy of proposal

Regular face-to-face meetings -

52%

37%

Availability

Building long-term relationships with individual staff 34%

41% Ability to operate on a global scale

Use of penalty clauses

40%

29%

Appropriate accreditation/certification

Paying more to get better value

34%

25%

Contract price

Service level agreements in place

34%

24%

Independence of supplier organisation

Suppliers keeping costs as low as possible

21%

20%

ISO9001 or equivalent (quality management)

Regularly reviewing (and at times changing) suppliers

20%

9%

ISO14001 or equivalent (environmental management)

10%

Recommendation from peers

20%

Other

18% 0%

10%

20%

30%

40%

50%

Inhouse equipment/software

% of participants

Before these issues can even be considered, however, service providers must earn the right to have the opportunity to build trust and develop relationships. They must meet a minimum set of expectations, the most important of which are demonstration of their expertise and proof of performance on similar projects, according to survey participants. Other key factors considered during the selection process for service providers include knowledge of regulations (increasingly on a global scale), proposal quality, availability, certifications and price (Figure 10). “There is a minimum set of criteria that service providers must meet; they must have excellent technical expertise, credibility, trustworthiness and integrity. Beyond that there are qualities that can differentiate suppliers. Flexibility, the ability to establish an easy working relationship, and the willingness to really listen to clients’ needs can provide a competitive advantage,” notes Grant Kinsman, CEO of H2 Compliance. “Clients want expertise and commitment, and to feel confident that the service provider can and will do more than just the minimum,” agrees Erwan Saouter, director of

Page 10

15% Proximity to your office 6% Large size of supplier organisation 6% Other 20% 0%

20%

40%

60%

80%

100%

% of participants

Chemical Watch | Global Service Providers Guide 2012


CEHTRA: Contesting technically flawed studies Problem: During 2011 a client passed us a set of studies which included one chronic ecotoxicology test which would have resulted in a serious classification and labelling issue as well as an extremely low PNEC in the risk assessment, seriously limiting the European manufacturing tonnage of this substance. Solution: CEHTRA ecotoxicologists undertook an in depth evaluation of the relevant data and analogues and pinpointed a series of flaws in the methodology used in the study. The issues were not clear from an initial reading of the report that superficially appeared to be a Klimisch 1 study. However, further to a critical review of the raw data on the test replicate parameters and statistical analysis used in the study, a position paper was prepared and submitted. The laboratory performing the study agreed to invalidate the existing study and re-perform it for free for the client.

The past year: Looking back at chemicals management and control service provision in 2011 Rapid expansion of the global regulatory landscape continued to have an impact on the chemicals management and control services market in 2011. Unlike the previous year, however, which was dominated by the need to meet the first REACH registration deadline, 2011 was a year of more varied activities, with REACH requirements only partially responsible for the increasing demand for services. Materials and market-oriented legislation, the impact of GHS implementation, and new chemicals control programmes in several countries around the world caught the attention of companies involved in the production, distribution or sale of chemicals – in addition to ongoing CLP and REACH requirements. Estimating the actual growth rate of the service provider market is challenging because there are many different types of service providers, and potentially different levels of demand between and within each category. In 2011, therefore, some providers, such as Bureau Veritas and Borenius, found that REACH was less important to their businesses, while more traditional hygiene and environmental services were profitable. Others, like ReachCentrum, continued to see a growing demand for REACH-related activities, including support of lead registrants and Sief leadership teams. Meanwhile, providers with expertise in plant protection products, biocides and cosmetics-related regulations, such as Exponent International, seemed to experience a significant rise in interest for support. Those that have worked to stay on top of the somewhat nebulous nanomaterial and endocrine disruptor fields, like Steptoe & Johnson, are also attracting inquiries, given that recent decisions could lead to additional regulatory requirements for products containing substances that fall under these classifications. In three areas – laboratory testing, information and data provision and software systems – the growing complexity of

Chemical Watch | Global Service Providers Guide 2012

global chemical regulations appears to have benefited all players. Many companies are now building on relationships they formed with their service providers at the cutting edge of REACH implementation. “Many of our clients used us in 2011 because they were generally pleased with the way we had worked with them in 2010,” notes Mr Thomas of CEHTRA. Even so, his company took time last year to identify areas where they could improve, and implemented changes to address them. Despite companies favouring to keep much of their compliance work in-house, there was sufficient demand for external expertise to warrant several providers increasing their staff numbers. Firms including Sustchem Engineering, toXcel International, Steptoe & Johnson, LAUS, Chemservice, CS Regulatory, DR. KNOELL CONSULT and ENVIRON, among others, added staff as new growth was considered sustainable. Some providers believe that the increasing number and complexity of the regulations that companies must comply with is driving an interest in providers that offer specialised services. Others disagree, however, believing that it is necessary to offer both breadth and depth. “Companies that provided a full range of services combined with indepth expertise and the necessary capacities succeeded the most,” says Michael Cleuvers, head of the industrial chemicals regulatory affairs business unit with DR. KNOELL CONSULT. Dieter Drohmann, managing director of Chemservice GmbH adds that competence in different regions (eg EU, Americas, Asia) is necessary in addition to the ability to offer a broad service range. Firms that have direct chemical experience, strong technical capabilities and understand the global requirements and that can provide centralised solutions also have an advantage, according to John E Phillips, vice president and technical director – product safety and compliance with Cardno ENTRIX. But Chris Eacott of Stewardship Solutions echoes the view that smaller companies can offer more flexible services through their ability to network. “Smaller consultancies are not tied to using in-house resources, with the potential limitation in choice and quality that this expectation can bring,” he argues. “By operating through networks of associates, smaller consultancies can often bring the best of several alternative options to bear on particular problems.” Several firms are also forming partnerships to ensure that they can provide assistance to customers on a global basis. Despite the continued growth of the market, a certain amount of consolidation is predicted. “There has been a dramatic increase in the number of providers in recent years as new entrants to the market, from smaller consultancies right through to larger organisations that have looked to capitalise on REACH. While this situation allows for a more competitive marketplace for our customers, it has also meant that the advice provided by less experienced service providers has led to issues for certain REACH registrants,” according to Steven Green, director of CS Regulatory. “As a result, we expect that over the next few years, there will likely be a reduction in the number of service providers, particularly those who cannot demonstrate significant expertise in the areas in which they are said to specialise.”

Page 11

Chemical service providers

Case study


Provider of Global Product Stewardship Services

OneÊPlanet.ÊOneÊCompany.ÊERMÊÊÊwww.erm.com

REACHÊ&ÊCLP/GHS Food/FoodÊContactÊ/ÊBiocides Toxicology,ÊEcotoxicologyÊandÊRiskÊAssessment EmergingÊChemicalÊControlÊLawsÊaroundÊtheÊWorld LifeÊCycleÊAssessmentÊ&ÊSustainability DownstreamÊProductÊLegislationÊ ComplianceÊAssessmentÊ

Delivering sustainable solutions in a more competitive world.


CS Regulatory: Applying alternative tox assessment methodologies Problem: A company needed to register a range of similar products for which existing NONS Base Set information was available. For registration under REACH this looked like it would require a reproductive toxicology test. Solution: CS Regulatory used available data on analogues and appropriate literature and QSAR data to group the chemicals, demonstrate a common metabolite for all of them and extrapolate the predicted results. This approach was accepted by the regulatory body. The company avoided nine separate OECD 421 screening studies at a savings of €640,000, and numerous animals were saved as a result of the application of a suitable alternative methodology allowable under REACH. Below we take a look at the key areas in which companies are seeking support and a discussion of how well these are served by service providers.

REACH While the first big deadline for REACH came and went in 2010, service providers still kept busy in 2011 addressing a mixture of REACH issues ranging from those related to the first registrations to those associated with the 2013 deadline. OO During the first part of 2011, ECHA received nearly 600 updates per month to previously submitted registration dossiers. OO Downstream user (DU) obligations and the requirements of exposure scenarios and extended safety data sheets (eSDSs) were key issues during 2011. The late availability of ECHA’s Chesar tool for deriving exposure scenarios led to the use of a number of different formats, leading to significant confusion. The complexities of formulations were also of particular note. OO Compliance with REACH communications requirements for SVHCs contained in articles (finished goods) was a real challenge, particularly given the short consultation period of 45 days. ECHA’s review of dossiers from the 2010 registrations took place more quickly than the market expected and updates were requested with very short turnaround times, according to Peter Godfrey, REACH business manager for Cambridge Environmental Assessments. OO The poor quality of some of the dossiers being submitted under REACH has been raised as a concern by ECHA and others, and is likely to be a growing issue. OO ECHA questioned the validity of some read-across cases but ECHA demonstrated a clear resolve to address unsupported and poorly substantiated claims for read-across and non-default assessment factors, which provided a few headaches for industry but were often justified. OO The dissemination of REACH-registered dossiers on ECHA’s website has allowed interested organisations/ companies/individuals to learn far more about the substances that have been registered then was previously possible. OO Industry adopted a varied attitude to the definition of intermediates clarified at the last minute by ECHA,

Chemical Watch | Global Service Providers Guide 2012

OO

OO

OO

with some taking a “wait and see” attitude while others wanted to be more proactive. Sief members came forward with study information that had not been made available during the dossier preparation phase in 2010. Lead registrants had to decide how and if they should include the information into existing dossiers. Supply-chain communication is still a big issue. It is very difficult to identify all of the players due to the complex inter-relationships between manufacturers, suppliers and distributors. 2013 REACH registration dossier work began for chemical companies working to register substances in advance of the deadline. Case study

REACHReady: Training and advice for longdistance REACH compliance Problem: A niche manufacturer of complex dyes manufactures its products in both the US and the EU, but its regulatory expertise is located in the US, with only one person in Europe. They needed advice on how to tackle REACH. Solution: REACHReady briefed senior executives and trained the regulatory team in the US on the technical details of REACH. Practical advice was also provided on working with EU institutions and in multilingual meetings with different operational norms and behaviours. Practical exercises, including role playing of Sief participation, were incorporated into the training. As a result of the training, the dye manufacturer developed internal procedures for handling registrations, and with some further assistance from the REACHReady Helpdesk, was able to make successful submissions for the 2010 deadline.

GHS including CLP Implementation of the GHS in countries around the world, such as in China with Decree 591, continues to pose challenges to global organisations that must comply with the various legislative and regulatory interpretations being implemented in each country. Service providers are finding, however, that many clients don’t realise the implications of this variability. ”The biggest issue we see with GHS is that many people don’t understand the difference between GHS and the EU CLP, and how other country harmonisations with GHS will end up with regulations that are different in some details compared to the EU CLP programme,” remarks Desmond Waight of DanGoods Training and Consultancy. He adds that many also do not recognise how the GHS interacts with transport requirements. Training will be the key for overcoming this lack of understanding. The wide difference in requirements from nation to nation has also meant an increased need for local support with respect to GHS compliance. Companies struggled with putting in place the necessary software to ensure compliance with GHS/CLP requirements. According to Ned Mataraso, marketing administrator with The Wercs, “They were not aware of how long it may take in order to implement software changes or to add the ability to create compliant documents. Companies resolved the issue by either moving to a new software platform that allowed them to implement the necessary changes or by adding functionality to existing

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Chemical service providers

Case study


ARCADIS is an international company providing consultancy, design, engineering and management services in infrastructure, water, environment and buildings. We are assisting companies worldwide in the field of product stewardship, including the Biocidal Products Directive, GHS/CLP and REACH.

Our services focus on, but are not limited to Strategic advice o development of compliance strategies; o compliance audits; o employee training.

Management support o o o o o

portfolio management and SIEF communication; eSDS compliance check; study monitoring; general and financial consortium management; data and cost sharing.

Technical support o o o o

hazard, exposure and risk assessment of chemicals; development of chemical safety reports for registration dossiers; preparation of biocide product dossiers; preparation of dossiers for restriction or authorisation under REACH, including socio-economic analysis; o classification of chemicals and waste according to GHS/CLP.

Creating balance More information? http://www.arcadis.com/Global_Product_Stewardship.aspx or contact: REACH@arcadisbelgium.be


Case study

H2 Compliance: Maintaining market access with effective product stewardship programmes Problem: A global blue chip company needed a product stewardship programme to help ensure development of appropriate procedures and practices. Solution: H2 Compliance provided the tools, structure and strategies for a robust and cost effective product stewardship programme that has become strongly integrated into the operations of the company and extended to include the supply chain. The result: no market access issues since the programme has been implemented.

Non-REACH chemical notification legislation The introduction/expansion of REACH-like regulations in many other countries, and particularly in Asia, continued to have an impact on chemicals management and control service provision in 2011. While many of these regulations are based on REACH, they often have many points of differentiation from the EU regime, and thus add further compliance burdens to chemical manufacturers and their customers. Key developments in 2011 included: OO the registration deadline for Turkey’s chemicals notification regulation drove a lot of activity in the first part of 2011 OO China revised its registration scheme to create Decree 7 on the Measures on Environmental Administration of New Chemical Substances OO Taiwan pursued its new scheme for existing chemical substance nomination (ECN) and plans for new chemical notification (NCN) OO Serbia also enacted a chemicals management and control system in 2011 OO Malaysia now has an Environmentally Hazardous Substances Notification and Registration (EHSNR) Scheme OO Japan and South Korea have also moved forward with major reforms to their chemicals management laws. The regulatory agencies in these countries – and others like China – are now facing the significant issues that come with implementation of such complex legislation OO TSCA reform was held up in 2011 due to political gridlock, and any further movement will not be likely in 2012 due to the fact that 2012 is an election year OO in the US, the new Chemical Data Reporting Rule (formerly the Inventory Update rule), which determines what and how exposure-related information on chemicals is collected, was adopted with implementation beginning in 2012

Chemical Watch | Global Service Providers Guide 2012

OO

California introduced a new draft version of its Safer Consumer Products Regulations in October 2011 for the identification of hazardous substances, the analysis of alternatives and the possibility of substitution, risk management, or information dissemination.

Sector-specific legislation It seems that 2011 was a year of heightened activity for sector-specific regulations: OO in Europe, a Biocidal Products Regulation was negotiated and aimed at enhancing the efficiency of product authorisations compared to the previous regime OO the European Commission published its regulatory definition of nanomaterials in October 2011. The definition will be used in legislation applying directly to all producers of products containing nanomaterials, and industry groups predict that it will cover many more substances than are currently considered as nanomaterials, many of which do not have nanospecific information available. The definition has raised significant questions as to how nanomaterials will fit into REACH. OO new regulations in Europe on food contact materials have driven some demand for support services OO the new Cosmetics Regulation that will come into force in Europe in 2013 drove a lot of business for providers offering services to this market OO the regulatory framework for cosmetics in China remains complex and frustrating for businesses, despite significant changes in recent years intended to bring it closer to those in the EU and the US OO the new EU Toy Safety Directive (2009/48/EC) was a source of business for several service providers in 2011 OO demand for services in the plant protection/crop protection products area remained strong in 2011 OO legislation attempting to manage the risks of endocrine disrupting chemicals has been passed in Canada, and the debate continues in Europe and the US OO children’s product regulations were adopted in several US states, including Maine and Washington, and have created a demand for consultancy and advisory services. There has been, in fact, a significant increase in activity at the state level in the US with regard to chemicals management and control. Case study

FoBIG: Saving money with read-across evaluations Problem: A company discovered that it was missing a pre-natal development toxicity study and a two-generation study for a phasein substance. Solution: FoBIG proposed and developed a strategy to use available data for the two main metabolites of the submission substance. These data were older, but it was shown that, in a weight-of-evidence approach, taking evidence from several studies together was sufficient to achieve a sound evaluation of the hazard (classification) and risk. Documentation and explanation of the readacross approach was provided. As a result, the company invested approximately €20,000 in the read-across approach compared to approximately €300,000 for new testing.

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Chemical service providers

platforms.” Another difficult challenge was the need to provide eSDSs in multiple languages. Service providers with the ability to offer effective training programmes and support targeted around the various local regulatory interpretations of the GHS were most successful in 2011. REACH24H, located in China for example, reports a growing demand for training on compliance issues with Chinese GHS (and other) regulations.


Case study

Chemical service providers

toXcel: Advising on product safety Problem: In late 2011, due to a change in supplier, a manufacturer and distributor of men’s and women’s apparel discovered that a strip of material on a line of apparel contained elevated levels of phthalates. The problem was detected in a routine chemical analysis completed by the manufacturer that is performed on samples of apparel in the country of origin prior to shipment. The particular phthalates detected in this material are listed as substances of concern by a number of international regulatory authorities. A large shipment of this apparel to North America was being held up pending resolution of the safety of the items for consumer use. Solution: toXcel organised a strategy for addressing this problem and developed an exposure assessment method. The articles were tested for actual emissions in an environmentally-controlled test chamber by a certified testing laboratory and the approved exposure models were used to quantify the inhalation and dermal exposures for scenarios involving wearing of the apparel. toXcel successfully demonstrated that the total absorbed doses of phthalates were below the regulatory levels of concern. As a consequence, a shipment of apparel worth $1.75m was able to be released, and the products arrived at stores in the US in time for critical Christmas holiday sales. A voluntary recall and destruction of product was averted by this timely solution to the problem. The general principles used in the exposure modeling and risk assessment have been used successfully for a number of EU clients who manufacture products that are exported to other countries.

Key legal cases There remains little movement in court cases being brought against the European Chemicals Agency (ECHA), the European Commission, and/or individual Member States due to the expense of such action and the uncertainty of the outcome. “In several data compensation related matters, ECHA was of limited assistance,” says Lynn L Bergeson of Bergeson & Campbell, a member of the ACTA Group EU. “We continue to assist our clients in gauging the cost versus the benefit of initiating any such action,” she adds. REACH-related court cases that were decided in 2011 could have wide-ranging impacts on compliance activities for chemical manufacturers and downstream users. OO In 2011, the European Court dismissed four cases challenging the inclusion of substances on the REACH candidate list, suggesting that it will be very hard for chemical companies to fight these decisions and confirming how short the time for bringing a case actually is. OO In case T-262/10, the European General Court did annul a European Commission decision not to include a substance in a positive list of additives for use in plastic food contact materials. The EC decision was based on the fact that the company originally seeking authorisation had withdrawn its application. Steptoe & Johnson identified this decision as a clear breach of procedural law, and the court confirmed this assessment. Importantly, the court found that the earlier decision was a “regulatory act” (as defined in case T-18/10), and thus could be challenged based

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OO

OO

on the more favourable (to applicants) standing rules introduced by the Lisbon Treaty. The NGO ClientEarth started a legal case against ECHA following its rejection of a request for access to documents regarding company names and tonnages. ACTA Group EU is currently assisting in a case against the Commission pertaining to its failure to follow proper procedures prior to issuing use restrictions against specific substances. The case was filed in 2011, and a response to the Commission’s defence is due in early 2012. Potential implications would be for the restrictions to be overturned while also setting a precedent that the Commission and ECHA must follow their own procedures, including performing a risk assessment on a per substance and use basis, as well as notification to the World Trade Organization (WTO), prior to issuing such restrictions.

Tax issues Ingrid Sekki, manager for Latin America at REACHLaw, gives two examples of issues that companies managed with the help of their service providers in 2011: dealing with potential double taxation with regards to OR services and deciding whether it was more tax efficient to designate EU subsidiaries as ORs or importers.

Software and information Rapid expansion of the global regulatory landscape is driving significant corporate interest in IT solutions that support enterprise-level strategies for compliance and sustainability. “Companies are looking to consolidate their systems in order to reduce the complexity and risks associated with compliance reporting,” remarks Francis Trudeau, senior product manager for product stewardship solutions with IHS. Case study

Baytouch: Supporting effective communication and provider alliances Problem: Providing the vast array of services needed today is not practical for one firm. Alliances between organisations and service providers with varying expertise and complementary skills are necessary to meet expanding client requirements. An effective IT solution is needed to enable all of these independent firms to operate cohesively with the same set of data. Solution: Baytouch’s REACHsuite IT solution encompasses sophisticated Sief management and communications along with all of the integrated project controls, document storage facilities and contract management, making the registration process much swifter with less risk and lower administrative overhead. Caleb Management Services uses REACHsuite to give consistent project and communication tools to manage a range of consortia such as Fatty Acids, ATC (Additives Technical Committee), ABC ( Alkanolamine Borates Consortium), and more recently ERGTC (European REACH Grease Thickeners Consortium). Companies thinking more strategically also started implementing not just chemical management systems in 2011, but systems with robust supplier management automation, according to market analyst Kathleen M Hurley with Actio Corporation. “Automated data capture, supplier query, customer communication and data management are the basis for leaner operations, BOM management,

Chemical Watch | Global Service Providers Guide 2012


Laboratory testing Many of the lower tonnage chemicals affected by the 2013 REACH deadline have very limited ecotoxicity data available so it is not surprising that testing laboratories saw increased demand for ecotox services in 2011. In general, the companies starting these studies so far in advance of the deadline were those that had the experience of the 2010 registration process. Testing services were also in demand by companies gathering information for sector-specific regulations (cosmetics, biocides, crop protection products, pharmaceuticals, etc), and as a result of the ongoing requirements associated with other conventional EH&S related activities. Outside of the EU and the US, recent major environmental protection issues, such as the battery manufacturing pollution and lead poisoning cases in China, the plasticiser concerns in the US, Europe, Taiwan and other countries, and the nuclear disaster in Japan, are also contributing to public concerns about product safety and leading to an increased desire and expectation for some sort of certification, according to Nathan Chen, deputy general manager of REACH24H. Larger, well recognised firms are said to be significantly benefiting as a result.

How to get the most from your service provider The customer is always right, but we thought it might be instructive to ask service providers responding to our survey what they feel constitute good and bad clients. The resulting wishlist will prove useful in forging more productive business relationships. According to our survey participants, the best clients: OO recognise the critical importance of EH&S regulatory compliance, and the impact that EH&S initiatives can have on other corporate initiatives OO do not unnecessarily demand urgency, are realistic when defining actual deadlines, and are willing to ask questions OO are innovative and thriving organisations committed to maintaining compliance in their operations and supply chains OO clearly and promptly communicate with service providers about any need or on-going change and recognise the fundamental importance of providing complete information OO understand that you can’t do REACH on the cheap. They work in a trusting partnership recognising that very often a bit more time and effort invested helps them to save money in the long run OO use a consultant as an extended part of the company OO appoint an internal knowledgeable person who is the direct contact for the consultant, and who is responsible for internal communication within the client organisation and for putting the required information together OO communicate well, are open about their needs, expectations and limitations, even when these change, and anticipate requirements far enough in advance to facilitate planning and scheduling OO include the service provider in the overall strategy and planning process for their registration activities, regardless of industry sector OO see business opportunities in the regulations and take a proactive attitude. OO are dedicated to ensuring compliance and minimising liability in a competitive market place while also appreciating the complexity of global chemical programme requirements along with the nuances, technicalities, and business challenges of bringing new products to market and maintaining compliance.

Case study

Stewardship Solutions: Maintaining continuity of business despite late pre-registration Problem: During a 2011 due diligence audit of its French distributor, a US company learned that no pre-registrations for many of the company’s substances that were sold into the EU market at volumes above the 1 tpa threshold had been submitted by an only representative or the distributor. Solution: Following a rapid consultation with the UK REACH authorities, it was decided that Stewardship Solutions could become a first-time importer by assuming full only representative responsibilities on behalf of the US company. The necessary steps for Stewardship Solutions to become the only representative were taken within a very short period of time, and continuity of business to the EU was subsequently assured, to the great relief of all concerned.

Chemical Watch | Global Service Providers Guide 2012

The year ahead: Expectations for chemicals management and control service provision in the future Demand for all aspects of services related to REACH registrations – OR and Sief management support, dossier preparation, laboratory testing, data analysis, etc – has not only carried over but is growing in the first part of 2012. At the same time, the expansion in global regulatory requirement and product and market-specific legislation will continue to provide business for service providers with the right sets of skills and abilities and levels of expertise and experience. Overall, 2012 is predicted to be a year of

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risk management, better public perception, higher quality products and less reporting trouble as documentation of chemical use becomes increasingly public.” The most challenging area for software suppliers in 2011 was in the area of eSDS preparation and integration across functional modules. “Our clients now want everything in the same place and easily accessible, including emails, documents, test data, CSRs, SDS, and so on, for stewardship reasons and to reduce administrative overhead,” comments Baytouch’s Mr Pollard. As for information providers, successful companies brought to the market scalability, breadth, and accurate data within comprehensive and timely solutions – all in the framework of a truly global platform, according to Robert S Christie, CEO and president of 3E Company. His company saw its growth in 2011 come from an increasingly international footprint with data employed through an expanding range of compliance and business processes, along with a heightened attention to stricter regulations requiring data and support.


Chemical service providers

strong growth for the chemicals management and control service providers market. Given the approach of the second major REACH deadline, it is not surprising that most service providers expect REACH to be the major regulatory driver for the provision of services in 2012. In fact, an overwhelming 92% of survey participants still identified REACH as the global driver. “There is a sense among many in the business of helping companies with their substance registrations that there still appears to be a general lack of awareness of what resources are needed and the timescales involved in making a successful and timely registration,” says Philip Copestake, a senior toxicologist with bibra toxicology advice & consulting. Figure 11 Leading regulatory drivers REACH 94% GHS 51% CLP 49% China Decree 7 42% Global chemical notifications 42% TSCA 29% EU biocidal products Directive

Case study

24%

3E Company: Integrating EH&S and product stewardship

Dangerous Substances and Preparations Directives 23% Nanomaterials regulations

Problem: Plastic products producer Spartech Corporation needed an information management system that would allow data sharing through integrated vendor material safety data sheet (MSDS) management with MSDS authoring in order to streamline the development of hazard communication documentation and management of vendor sourced raw material MSDSs and promote compliance. Solution: 3E Integrated MSDS Data for MSDgen solution provided Spartech with the combined EH&S and product stewardship ‘one stop shop’ solution they desired. Supplier MSDSs and raw material data used in Spartech products is updated and imported into the MSDgen authoring platform on a regular basis, and key property information is extracted and used for the development of productlevel hazard communication documentation. The resulting increase in productivity and increased confidence in regulatory compliance has been invaluable to Spartech, according to Spartech’s corporate product stewardship manager Bernard C Henn.

17% EU cosmetics Directive 10% International Carriage of Dangerous Goods by Road (ADR) 10% Agrochemical registrations 8% International Maritime Dangerous Goods (IMDG) Code 6% China cosmetics regulations 5% Veterinary Medicinal Products Directive 3% Other 8% 0%

20%

40%

of particular concern, as is the impact of the increasing complexity of global regulations and the continuing pressure to avoid delays to market for a more diverse product range. Revisions to the RoHS Directive in Europe, pharmaceutical regulations around the world and activities in California were also specifically noted by survey respondents. “There has been an increase in the market due to adoption of new national chemical regulations in many different countries along with the alignment of their current GHS legislation with the UN GHS, and we believe that this trend will continue as a growing number of countries take these steps,” notes Ms Sekki. “We agree, and are expecting a surge in 2012 due to the continued requirements coming from emerging markets, as well as deadlines approaching for various European legislations,” comments Marc Thouin, vice president of regulatory services for Intertek. “The trend for companies is to rely on service providers with a global coverage; that is in all markets and all geographies where such legislation is implemented and enforced.” Service providers responding to our survey also point to several other non-regulatory drivers that have brought clients to them. Chief among them are government policy, increased outsourcing of business support functions by client organisations and general economic growth (Figure 12). Specifically mentioned reasons included growth in the Asian economy and the globalisation of businesses in general. A greater need to understand what materials are involved in a company’s entire supply chain and how to pursue business continuity in the face of the removal of essential substances from the market were also highlighted.

60%

80%

100%

% of participants

The next important drivers identified by Chemical Watch survey participants included the GHS, the EU CLP Regulation, other global chemical notifications and China’s notification and registration rules for new substances (Figure 11). The regulations in Japan, Korea and Taiwan are

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Chemical Watch | Global Service Providers Guide 2012


The impact of the 2013 deadline will affect a set of new companies – generally SMEs – which will need extensive assistance as they typically do not have inhouse resources. “SMEs need help in interpreting REACH requirements, and while ECHA has been constructive in providing guidance to companies, their response time can be frustratingly long, so companies often turn to service providers to fill the gap,” says Arnold van der Wielen, a consultant at AW-ChemAdvice.

Figure 12 Leading non-regulatory drivers Governmental policies/spending 51% Outsourcing of business support functions (by client organisations)

Chemical service providers

44% Economic growth

GHS including CLP

41% Customer pressure 27% Non-statutory ‘voluntary’ corporate initiatives/CSR 24% Increased commercialisation/better management of service provider business 22% NGO pressure 18% Downsizing of inhouse chemical management and control teams 16% Other 6% 0%

20%

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% of participants

Regarding outsourcing, Ms Bergeson believes that in the current market place, there is an increase in the need for service provider support as companies continue to scale back internal operations. The reasons can be many, but generally have to do with a lack of expertise in-house, or a lack of the level of resources needed to work – often to tight deadlines – on dossier preparation such as that required under REACH. CEHTRA’s clients, for example, have strong product stewardship and regulatory teams, but few have groups of (eco)toxicologists able to reach the level of operating capacity required to absorb the upcoming regulatory peaks, according to one of the company’s director’s Paul Thomas.

REACH With respect to ongoing REACH requirements, dealing with eSDSs and exposure scenarios will continue to be major issues in 2012. The scaling of exposure scenarios is a particular concern highlighted by Ineke Gubbels, director of IGCON. “I think that companies are severely underestimating the extensive knowledge of exposure assessment methods that will be necessary for completing the scaling process.” Companies will also be dealing with ECHA’s feedback on their registration dossiers and will need to respond to its questions concerning testing strategies. Authorisation of substance uses will also be a much more prominent issue in 2012, along with the development of socio-economic analysis (SEA) expertise. The beginning of Member States’ substance evaluation processes will also bring challenges, reminds Vincent Navez, a senior legal advisor with ReachCentrum.

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Countries are continuing to adopt GHS-compliant regulations as well as updating those already in place, meaning a continuation of the compliance monitoring headache already experienced by many firms. US plans to implement the GHS are currently attracting most attention. The Occupational Safety and Health Administration (OSHA) submitted its final rule to the Office of Management and Budget (OMB) in October 2011 for review. In January 2012, OMB requested a 30 day extension. The final rule is expected in February 2012. Based on the proposed rule, both pure compounds and mixtures will need to be addressed simultaneously in an 18-month period, according to Julian Reddy, head of REACH and chemical notification services with Exponent International. “The revision will have far-reaching implications for material safety data sheet (MSDS) and label authoring, publishing, distribution, and management,” feels 3E’s Mr Christie. “The proposal also includes revised criteria for the classification of hazardous chemicals, as well as changes to definitions and terms used in the standards, and new training requirements for employees. As a result of the alignment, companies will face many challenges, including re-evaluating how their substances and mixtures are classified, re-issuing MSDSs and labels, and training staff as appropriate.” Furthermore, different agencies within the US are likely to adopt different versions and thus have different requirements under the GHS regulations, further complicating compliance. The EU CLP Regulation continue to present challenges as well. Many companies have not realised how much time it takes to implement software changes or add the ability to create compliant documents, according to Mr Mataraso. In 2012, the change in mixture labelling from the Dangerous Products Directive (DPD) to CLP will be an issue for many companies, as will the implementation of the second adaptation to technical progress (ATP) of the CLP Regulation and changes to the irritancy and environmental classification requirements.

Other global regulations Major changes to regulations in countries outside of the EU are also anticipated in 2012, with many of them in Asia. “Countries with chemicals control legislation will strengthen their laws, and countries with no legislation will implement new ones,” states Mr Drohmann of Chemservice. In particular, he notes the continuation of GHS implementation and further implementation of REACH-like chemicals control regulations. “We can expect changes to the regulatory landscape in the Far East as legislation develops and evolves into practical systems for use,” remarks CS Regulatory’s Steven Green. The ‘new’ South Korean legislation that was proposed in 2011, for example, is similar in many ways

Chemical Watch | Global Service Providers Guide 2012


Case study

REACH24H: Navigating through China’s new chemical notification law Problem: A non-Chinese cosmetic manufacturer had a plant extract that could not be separated from the ethanol solvent in which it is sold. The testing results, therefore, did not demonstrate the desired properties because the concentration of the substance of interest was too low to be effectively evaluated using standard testing methods. Solution: REACH24H first determined that purification was indeed impossible. The cosmetic company thus issued a prudent self-statement attached with justification materials. The laboratory was also asked to issue an expert statement in line with the requirements of the regulation indicating that testing on the solution was not possible. A dossier was submitted to the CRC with a self-statement, a representative agent statement and an ecotoxicological test report on the product in solvent. The notification dossier is presently under review by the CRC expert committee At least in the US, there isn’t much activity expected in the way of Toxic Substances Control Act (TSCA) reform in 2012. “Given budgetary constraints and other fiscal issues that impact US priorities, we do not anticipate much, if any, progress,” notes Ms Bergeson. However, she predicts increased action on endocrine disruptors and computational toxicology in the coming year, and continued increased use of existing TSCA authority to achieve enhanced chemical management goals. Many are also keeping an eye on the decisions that ECHA makes with regard to thresholds and principles in its review of dossiers from 2010 REACH registrations. There is hope that the same data can be used for compliance requirements in different countries. This hope has some basis, as the EU contributes to the OECD’s testing programmes, which are used to develop test guidelines.

Sector-specific issues Companies will be facing more sector-specific regulatory changes in different jurisdictions. “Many of these issues were simmering through 2011 and are starting to bubble at the surface,” comments ENVIRON’s Ms Bullock. In particular, she points to emergent testing Chemical Watch | Global Service Providers Guide 2012

strategies for endocrine disruption, deadlines for biocidal product registration and increased focus on exposure to substances in foods and the environment. Others include cosmetics and nanomaterials regulations. New requirements under the EU 2009 cosmetic products Regulation come into force in July 2013 including several significant differences relating to notification, roles and responsibilities, nanomaterials, safety assessments and assessors, the reporting of serious undesirable effects (SUEs) and claims. The cosmetics dossiers issue has become enormous over the last few months for CEHTRA – so much so that the firm had to recruit new staff specifically to work on it. Cosmetics is also a growth area for H2 Compliance, according to Mr Kinsman. “Cosmetics producers are looking for additional expertise in the compliance area as they become more aware of the requirements of REACH and the new regulation,” he observes. Case study

ChemService Controlli e Ricerche: Rapid chemical equivalence dossier preparation Problem: In mid 2010, Finchimica, an SME manufacturer of crop protection products, wanted to submit to the UK Chemicals Regulation Directorate (CRD) a chemical equivalence dossier for Pendimethalin technical, a broad spectrum herbicide included in Annex I of Directive 91/414/EEC whose data protection period has just expired. Timing was crucial in order to be the first approved source and gain immediate market share. Solution: In just three months, ChemService Controlli e Ricerche performed a preliminary screening of the different qualities of Pendimethalin manufactured by Finchimica, identified the level of quality needed in order to match the technical product registered, performed a Five Batch Analysis on Pendimethalin of said quality and submitted the relevant chemical equivalence dossier to CRD using the fast track option. Non-testing data (QSAR and in vitro) were included in the dossier in order to support the toxicological equivalence of Finchimica’s product with the registered source. The dossier was accepted by CRD in December 2010, and Finchimica became the first approved source of Technical Pendimethalin in Europe after the originator. Companies will also need to take stock of how the recently agreed EU Biocidal Products Regulation will affect them. CEHTRA’s Mr Thomas believes that the increase in testing required for biocidal products and other regulations will have an impact on companies looking to complete study packages under REACH. Nanomaterials also attracted a lot of attention in 2011, particularly following publication of the European Commission’s regulatory definition. “This definition implies that a lot more substances will be regarded as nanomaterials than previously expected,” states Hiram Moerman, managing director of Apeiron-Team. “In addition, the concept is still so broad that it will take some time before the authorities and companies really understand how to deal with these kinds of substances. There will, therefore, be a considerable number of companies facing the difficulties associated with dossier preparation for such materials,” he adds. Endocrine disruptors are less known to the general public than nanomaterials, but there is probably more scientific proof available of the risk the use of such substances causes, Mr Moerman says. Phthalate plasticisers, organotin antifoulants, alkylphenol surfactants,

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to REACH, and could be enforced beginning in 2013 or 2014 (although there could be delays), so companies must be working towards compliance in 2012. The Malaysian inventory and Russian registrations will become more important as well. The implementation of the chemical substance notification regulations and GHS in China have progressed, and companies now need to ensure that they are in compliance for introducing new products to the Chinese market, according to Mr Chen of REACH24H. China is providing a significant challenge to industry, though, because although the new guidelines were implemented in October 2010, certain key documents weren’t available, in particular how the newly required risk assessments should be performed. “As a result,” says Exponent’s Mr Reddy, “the Chinese chemical notifications have almost been left in a state of limbo. Draft risk assessment guidance was issued towards the end of 2011, but as far as we are aware, it has not been finalised, and only recently have the first full notifications submitted under the new guidelines been accepted by the authorities.”


GLOBAL INSIGHT: Stay ahead of the game on chemicals management and control

16-Jan-2012 6RXWK.RUHDSODQQLQJWROLPLW¿YHFKHPLFDOVLQFKLOGUHQ¶VSURGXFWV Annual policy report outlines MoE work on ‘Korea REACH’, children’s products and building materials Read article 12-Jan-2012 (8&RPPLVVLRQVHWWRSHUPLW25DXWKRULVDWLRQXQGHU5($&+ ECHA to analyse implications of decision before updating information for applicants Read article 06 Jan 2012 ,QGLDVHWWRLVVXHUXOHVWRLPSOHPHQW*+6ZLWKLQDPRQWK Industry expects radical revision of laws on handling and storage of hazardous chemicals Read article

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Laboratory testing Many service providers are seriously concerned that laboratory testing capacity will be insufficient to meet demand in 2012 given the confluence of REACH registration and sector-specific regulatory requirements. As a result, the use of alternatives (in vitro testing, read across/QSAR) will assume even greater importance for the next REACH deadlines. Case study

Chris Braun Consultancy: Using epidemiology expertise to reduce testing needs Problem: A company had budgeted for full reproductive toxicity and carcinogenicity testing of a substance covered under REACH, but needed assistance in managing the studies. Solution: Chris Braun Consultancy, using its expertise in epidemiology, determined that, based on a review of the available literature, the testing was not necessary. As a result, the company saved nearly €1.8m. ECHA’s decisions on 2010 dossiers and test proposals will be a crucial influence on this demand. The fact that there are more substances covered by the second REACH deadline in 2013 and that these generally have less available data are also key factors. Higher tier studies from 2010 dossiers are now slowly being accepted by ECHA following consultation, so these are taking up lab capacity that will be required for studies identified in the data gap for 2013 substances, according to Mr Green at CS Regulatory. Particular tests that providers are expecting to be in increasing demand include Annex VII phys-chem tests, ecotoxicity-related tests and ATEX/DSEAR tests for explosive substances.

Downstream user/communication issues Downstream users are facing several big issues in 2012. Supply chain communications, from eSDSs to communicating the presence of SVHCs in articles and preparations (all the way to the retail level), continue to present important challenges throughout industry. While many downstream users are aware of REACH and CLP, they often are not always sure of the requirements for compliance. Others are aware of the legislation but choose to do nothing until forced to take action, preferring to believe that enforcement will not be that strict, especially when related to the exposure scenarios, according to IGCON director Ineke Gubbels. In addition, the requirements for articles containing SVHCs seem to be less well recognised. “Communications issues associated with chemicals management and control regulations are an ongoing issue,” remarks Mr Green. “Interpretation of the legislation by various actors is an ongoing process, and learning curves can be reasonably steep, dependent on the

Chemical Watch | Global Service Providers Guide 2012

geographical location of interest for compliance.” The inability of downstream users to find out how their suppliers are doing in terms of the registration of substances for the 2013 REACH deadline may also be a problem for many companies in 2012. Software solutions and regulatory content have helped to address some of these issues, such as eSDSs. In 2012, according to Mr Trudeau of IHS, software vendors are providing systems to help with the development of specific exposure scenarios for mixtures. “Software solutions for managing exposure scenarios are developing and will be of interest to many companies, as eSDSs work their way down the supply chain,” agrees Denehurst’s Gill Pagliuca. “The next hurdle will be the eSDS for mixtures,” adds Peter Douben, director of REACHWise, “Helping companies understand the issue and providing solutions that are in line with ECHA guidance is proving a challenge, but do-able.” Case study

REACHWise: Resolving REACH non-compliance issues Problem: After internal changes in management, an importer of products into the EU realised that certain ingredients were not preregistered for REACH. Solution: REACHWise notified the competent authorities when this case of non-compliance became apparent, indicating that the issue was identified following internal changes within the company. The authorities accepted the rationale and agreed to a timetable for completion of the necessary registrations in 2011.

Training opportunities With so many new requirements being phased in over the coming years, there has been an increased demand for training services. SMEs are looking for training on the requirements for REACH registration of their substances and the use of the IUCLID-5 and Chesar IT programmes. Companies like ReachCentrum are responding with webinars, virtual training and e-learning solutions along with more conventional face-to-face offerings. Downstream users are another larger group that are looking for training. This group has the least awareness at present and can thus benefit the most, according to a spokesperson from Bureau Veritas. Separately, REACHReady is meeting this need with courses covering how to write and read exposure scenarios. Case study

ReachCentrum: Offering REACH awareness boot camp and IUCLID5 training courses Problem: Companies new to REACH need assistance with understanding the regulations, determining requirements and learning use IUCLID5. Solution: ReachCentrum created a REACH awareness boot camp in 2011, a five-day course covering REACH fundamentals that includes assistance with visualisation of a project plan and the use of IUCLID5 for creating substance datasets. The companies attending the boot camps were better prepared to manage themselves internally and could communicate effectively within the Sief. Furthermore, each course includes the creation of a dossier in IUCLID ready to send to ECHA. It is possible for some companies to submit dossiers at the end of the training session.

Page 23

Chemical service providers

some pesticides, and phytoestrogens, among others, have been identified as possible endocrine disruptors. Organotin compounds, which exhibited this effect, have already been eliminated from marine paints and coatings. Attention to endocrine disruptors is expected to increase in 2012. Other activities of note include the revision of the 2001 EU General Product Safety Directive (GPSD) and environmental risk assessment requests driven by the human and veterinary drugs regulation in Europe.


Chemical service providers

Software /information solutions Given all of the various requirements for REACH, the many international implementations, the numerous country chemicals management and control regulations and the growing array of market-specific legislation, companies need to ensure that they have a sophisticated approach to data management in place to track tonnages of substances manufactured and imported, coverage by ORs, substance classifications, registered uses, safety data sheets and other product information. The market for software systems is therefore expected to be strong in 2012. As more jurisdictions address complex regulations such as REACH, CLP and GHS, this trend will continue to drive increased interest in implementing IT solutions that can streamline business processes around chemical lifecycle management, as well as the full spectrum of environmental, health safety, operational risk and other enterprise sustainability business challenges, according to Mr Trudeau. “Fortunately, initiatives are already underway to help with distributing exposure scenario information from business to business and to make that information easier to understand and communicable via standard phrases. These endeavours are expected to mature and progress in 2012,” he says. An example is the ESCom (Exposure Scenario Communication) project under the auspices of the European Chemical Industry Council (Cefic), with the dual objectives of providing a library of ES phrases and an electronic data exchange mechanism for exposure scenarios in line with the Chesar system. A group of IT companies provides one third of the resources, and Cefic and Downstream Users of Chemicals Coordination (DUCC) provide the remainder. “Access to accurate and reliable product and regulatory data will remain critical, as will the ability to aggregate this data from disparate sources and deliver solutions that help companies manage both business and compliance processes,” adds 3E’s Mr Christie. Case study

thus some are focusing more on cost control rather than on implementing a quality, long-term strategy, with reduction in budgets for sustainability programmes. Service providers therefore need to be sensitive to this issue and seek ways to validate their costs or reduce costs where possible, assesses Ruud Overbeek, vice president of global health, environmental and regulatory services with Intertek. Indeed, according to our survey, 52% of respondents indicated that they would increase the use of in-house staff in the next 12 months, and 69% would do so over the next five years (Figure 13). “We are seeing companies preparing for REACH registration in 2013 and beyond looking to carry out more of the work themselves with expert support to guide them where necessary, rather than looking for consultants to offer a complete management solution,” notes Ms Pagliuca. Figure 13 Anticipated future need for in-house staff 1%

Next 12 months 5%

46%

47%

1% 1%

Next 5 years 15%

25%

54%

0%

100%

% of participants

Increase significantly Decrease

5%

Increase

Static

Decrease significantly

These results may very well reflect the overall growth in the market, and not any particular move away from outsourcing. This assumption is supported by the responses of survey participants regarding their planned increases in the use of external services. Nearly the same number are considering an increase in outsourcing (49%) in the next 12 months and the coming five years (62%) as are expecting to increase internal investments (Figure 14).

IHS: Solving hazard communications dilemmas Problem: A leading specialty chemical company was seeking a solution to help its senior decision makers address multiple enterprise sustainability management (ESM) business challenges around proliferating regulatory requirements – including the need to streamline production of hazard communication documents in multiple languages and prevent the loss of valuable operational knowledge because of staff retirements. Solution: IHS provided its IHS Product Stewardship Solution – including software, managed regulatory content and expertise – to address its strategic ESM issues and increase operating efficiency in the process. IHS supports SDS production and provides regulatory content and software that streamlines data management processes for hazard communication documentation and addresses country- region-, industry- or jurisdiction-specific regulations. As a result, the company now manages product stewardship and compliance as part of a unified strategy for enterprise sustainability management.

Implications for service provision Companies in North America and the EU are faced with a much more competitive and consolidated market today, and

Page 24

Figure 14 Anticipated future need for external services 1%

Next 12 months 7%

42%

48%

1%

Next 5 years 14%

48%

0%

24%

Increase significantly

Increase

13% 100%

% of participants

Decrease

2%

Static

Decrease significantly

Given this situation, reputation, quality of work, expertise, cost, capacity and flexibility to be able to handle exactly what the client asks for and ability to deliver within budget and timescales are increasingly important factors for clients, along with the ability to establish personal relationships, adds Mr Reddy. Survey participants were also asked about future demand for the various types of

Chemical Watch | Global Service Providers Guide 2012


Figure 15 Anticipated need for external sector services in the next 12 months Consultancy/advisory 7%

39%

53% Representation & management

6%

62%

31% Legal services

7%

58%

35% Laboratory

7%

46%

47% IT & software

11%

40%

49% Information

11%

39%

50% Training

10%

51%

39% Other(s)

15%

69%

15% 0%

100%

% of participants Increase

Static

Decrease

Figure 16 Anticipated need for external sector services in the next five years Consultancy/advisory 31%

58%

12%

Representation & management 10%

53%

37% Legal services

8%

50%

42% Laboratory 53%

37%

10%

53%

37%

10%

IT & software

IT solutions will indeed play a critical role. “Information management systems and software technology are currently undergoing major revisions to keep up with the changing regulatory demands. We are hopeful that new viable options will be made available in early 2012,” observes Ms Bergeson. That is particularly true as regulatory obligations and supply chain pressure extend to more medium- and small-sized companies. “The issues around chemical management are increasingly complex, as regulation and public awareness increases and penalties for non-compliance or unsafe use rise. Successful chemical management strategies evolve and involve commercial, technical and strategic elements cutting across many disciplines,” asserts Ms Bullock. And for companies big and small, regardless of their commitment to regulatory compliance, it may be difficult later in 2012 to obtain the necessary laboratory tests, as laboratory capacity is likely to be filled. “We’ll see continued expansion of the chemicals management and control services market in 2012. But 2013 is when things will really pick up for companies selling environmental regulatory compliance technology,” asserts Actio Corporation’s Ms Hurley. “By 2013, companies lagging and waiting until the last minute will have to get their chemical data organised. There is the big 2013 REACH deadline, GHS will have teeth in the US by then, and significant TSCA updates are likely.” Over the next five years, clients anticipate that supply chain communications (and also supporting IT systems), regulatory/policy tracking and regulatory interpretation will show the highest levels of growth, with over 70% saying their needs will increase in each area (Figure 17). Partnerships between service providers and clients will become ever more crucial during these next five years. “Successful partnerships go far beyond the purchase of a point solution. Today, clients can gain much greater value by sharing with service providers their standard operating procedures, operational workflows and process, and strategic goals. The best of the service providers, in turn, offer innovative solutions that are designed to fundamentally transform the way clients conduct their business processes and deliver tangible benefits throughout the organisation. These benefits include streamlining operations, improving corporate efficiency, cutting costs, meeting compliance objectives and optimising human and capital resources,” states Mr Trudeau. The goal in the end, and one that Apeiron-Team’s Mr Moerman hopes will begin to be achieved beginning in 2012, is the recognition by manufacturers and downstream users that REACH is not just about registration and simply a legal requirement, but it has as its true intent the safe use of chemicals, and if safe use cannot be guaranteed, the elimination of those products that contain them.

Information 6%

33%

62% Training 33%

54%

13%

Other(s) 83%

8%

% of participants

100%

8% 0% Increase

Static

Decrease

Chemical Watch | Global Service Providers Guide 2012

Page 25

Chemical service providers

services available. In the next 12 months and five years, consultancy/advisory, information, IT and software and laboratory services will be most in demand (Figure 15 and 16). Given the above discussion, these results are no surprise.


Figure 17 Anticipated need for specific external sector services over the next five years Supply chain communications

73%

Guidance on regulation interpretation

71%

Product compliance

67%

Chemical service providers

Environmental risk assessment Consultancy/ advisory

27%

6% 5%

55%

SVHC advisory services

53%

44%

4%

Corporate strategy/strategic planning

51%

45%

4%

Testing strategies

50%

40%

11%

Assessment of data quality

49%

43%

8% 5%

57%

9%

29%

61%

10%

36%

54%

GHS notification

9%

36%

39%

Registration services

10%

46%

44%

Management (Sief and consortium etc)

39%

48%

12%

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

37%

53%

10%

CLP notification

36%

Business process outsourcing (BPO)

Information

Laboratory

28%

46%

17%

66%

7%

Regulatory/policy tracking

71%

Chemical hazard database

69%

27%

4%

(Material) safety data sheets

68%

27%

4%

26%

2%

Managed regulatory content

56%

42%

2%

Ecotoxicology

58%

36%

5%

Human health toxicology

56%

Exposure testing

56%

Physical & analytical chemistry

53%

42%

5%

SVHC testing

52%

42%

6%

Environmental fate & degradation

52%

41%

6%

48%

4%

Environmental monitoring

7%

37%

4%

40%

48%

Supply chain management/ communications systems

71%

25%

4%

Regulatory information management

68%

29%

3%

33%

2%

(Material) safety data sheet systems

65%

Substance inventory management systems

62%

EH&S solutions

34%

Training courses/webinars

9%

59%

7%

38% 0% Increase

6%

48%

42%

Insurance

9%

66% 46%

Legal representatve

8%

47%

25%

Lobbying/advocacy

6%

33%

45%

CPD/CES certified training

Other

54%

61%

Bespoke/inhouse training

Training

2%

52%

37%

Laboratory information management solutions

4%

34%

46%

Consortia/registration management solutions

Page 26

8%

Registration strategies

Dossier preparation & safety assessment, including CSA/ CSR

IT solutions

6%

20%

34%

61%

Chemical transport and warehousing advice

Representation & management

21%

53%

5%

59%

4%

% of participants Static

100%

Decrease

Chemical Watch | Global Service Providers Guide 2012


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SERVICE AREA BREAKDOWN Other 20%

Consultancy/ advisory 20%

PROFILE: 24-7 Response

CONTACTS Website

www.24-7response.org

E-mail

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

OAMPS

Locations

UK based, Worldwide work

Founded

2011

Information 20%

SERVICES PROVIDED Chemical and hazmat emergency line for hazchem placards

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

2010/11

Turnover, group

<£100,000

Turnover, chemical service provision

<£100,000

No of offices No of countries represented

1 All

Staff, group

10-100

Staff, chemical service provision

10-100

Page 28

Representation & management 20%

Training 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.. 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. REACH consultancy compliance help and advice With an in-depth understanding of the regulations that apply to the transport and supply of chemicals, our consultants can help companies to comply with REACH, CLP/GHS, IATA, ADR, lithium battery transport and other international regulations. 24-7 Response offer a number of services based around REACH, the key services include: OO REACH impact assessments OO REACH dossier preparation OO REACH Sief representation OO REACH third party and only representative services 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 offer a checking service.

Chemical Watch | Global Service Providers Guide 2012


TESTIMONIALS

We can help you to manage the classification, labelling and notification processes associated with CLP.

“When a sub contractor caused a major fire at our depot, OAMPS were on site within hours managing the incident and liaising with the relevant emergency services on our behalf. We had never used the emergency response provided by OAMPS before and we are pleased in our hour of need it lived up to our expectations.” – Robert Oakley, Eco Oils. “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 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

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 SQA accredited DGSA training courses. Our principal consultant is a founder member of the recently formed association for DGSAs, the British Association of Dangerous Goods Professionals (BADGP) www.badgp.org Chemical incident management and clean up Incident management response: situations often occur when the presence of an expert on the scene is required, 24-7 Response can contact an on-call OHES incident manager and arrange for them to attend the scene. Many of our staff are former employees of the Environment Agency – experienced in providing on-site assistance to help minimise the impact of a spill. Fuel, chemicals and hazmat Clean-up: 24-7 Response also have direct access to a nationwide network of UK spill accredited chemical and fuel clean up contractors. Should the need arise, our incident advisors can mobilise a rapid response team from a local specialist clean-up company. 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: in their daily work, many people use or handle hazardous goods. Our chemical hazard awareness course will give them an insight on label interpretation, safe handling and incident management. Additional modules, such as practical spill response can be added, if required. CLP (classification, labelling and packaging) training for suppliers of chemicals who need to generate, 24-7 Response can train staff to classify products correctly and ensure that they have the necessary information to generate safety data sheets (SDS) and product labels to comply with the latest CLP/GHS. Lithium battery safety and legislation training: recent changes to legislation have placed many new restrictions on the transport and supply of lithium metal, lithium-ion and lithium polymer cells and batteries. Our course not only clarifies what the legislation means to those involved, it also gives delegates an understanding of what the hazards and are why the legislation is necessary. DGSA training: for many years our sister company, PTF Training has been running SQA (Scottish Qualifications Authority) accredited DGSA courses.

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 whilst 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. She holds the NEBOSH general certificate and is currently working towards her NEBOSH health and safety diploma. 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 over ten 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.

PARTNERS Westfarmers, OAMPS, OHES, PTF Training, PTF Consultancy

Chemical Watch | Global Service Providers Guide 2012

Page 29

PROFILE: 24-7 Response

CLP and CLP notifications


GLOBAL OFFICES

PROFILE: 3E Company

CONTACTS Website

www.3ecompany.com

E-mail

info@3ecompany.com

Head office

3207 Grey Hawk Court, Suite 200, Carlsbad, CA 92010, USA

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

Tel/ Fax

+1 760 602 8700/ +1 760 930 6662

Regulatory data access and delivery – decision support

Directors

Robert S Christie, President and CEO Leo Oves, Vice President, Research and Development Jeffrey Starr, Vice President, Marketing Greg Merwin, Vice President, North American Sales Andrea Verspay, Vice President, European Sales Alan Goodman, Director, Asia and Latin America Sales Alex Ortiz, Vice President, Ariel US Operations

Ownership

Owned by public company, Verisk Analytics

Locations

US, Canada, Europe, Asia

Founded

1988

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® EHS management – integrated chemical, regulatory, toxicity and eco-toxicity data, vendor MSDS data, expert rules, multilingual phrases, document and label templates, and data loading tools for managing EH&S compliance activities in SAP EHS management

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

 2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

6

No of countries represented

-

Staff, group

-

Staff, chemical service provision

-

Professional services 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 of GHS has on their business TSCA – services range from fully outsourcing TSCA compliance to project-based, function-specific areas C&L notification – assists manufacturers and importers with CLP classification and subsequent ECHA notification under the European Union’s CLP (classification, labelling and packaging) Regulation European product registration – 3E can determine which products need to be registered, perform the registration process, the maintenance of the registration and any necessary updates to MSDSs and labels DGSA (dangerous goods safety adviser) – 3E can serve as a company’s DGSA EH&S supply chain data and sustainability tools

SERVICE AREA BREAKDOWN

IT & software 10%

MSDgen ® MSDS Authoring Software – an enterprise software solution suite designed for companies’ in-house EH&S staff MSDS authoring services – provides outsourced or co-sourced assistance with authoring MSDSs via 3E’s own fully-dedicated, in-house staff of highly qualified, multi-lingual authors MSDS distribution – facilitates the dissemination of MSDSs through multiple channels, including web hosting, or a scheduled delivery via fax, email, or post

3E Online Supplier Portal – facilitates efficient supply chain communication by offering a streamlined process for users to obtain EH&S and regulatory information from their suppliers 3E Green Product Analyser – provides powerful regulatory and toxicology analysis of products

Consultancy/ Other advisory 5% 5%

MSDS management and workplace safety Information 80%

Page 30

MSDS Management: a variety of products and services for the management of vendor supplier MSDSs Transportation: 24-7-365 global hotline access for guidance and classification of shipping hazardous materials for any mode Emergency response: 24-7-365 emergency response to spills, ingestions or exposures, or for dispatching emergency responders to an incident Regulatory reporting: outsourced services for researching, identifying analysing, tracking, completing and submitting required disclosures, permits and reports Chemical Watch | Global Service Providers Guide 2012


CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

Company founded; pioneered MSDS management services business

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

2002 -11

Six-time winner Environmental Business Journal Business Achievement awards. Winner of four Occupational Health and Safety product of the year awards. Nine-time winner Commitment to Worker Safety awards from Compliance Magazine.

ACCREDITATIONS CHMM, CSP, DGSA, CPEA, CSBA, REA, IATA, more PARTNERS SAP, Japan Chemical Daily, ChemSW, SciQuest, Kelaroo, Waste Management, Source 44, RegScan, Redstone, SOCMA ChemStewards CLIENTS Perstorp, Brenntag, Shell Oil, GrafTech International, Eastman Chemical, Sumitomo Chemical, Cabot Microelectronics, Menasha Corp, Costco Wholesale, Southwest Airlines, DTE Energy, Cabela's, Bostik, Momentive Performance Materials, Novelis, JM Huber, Supreme Chemicals, AMCOL International TESTIMONIALS “WebInsight has changed the way our team works by making us more efficient… we have been continuously impressed by the depth and breadth of the Ariel regulatory data and content… Our team has also found great value in the information and guidance that 3E Company provides. The topics and coverage are always extremely timely and relevant to our business.” – Perstorp “With GHS and REACH looming, we knew that our MSDS processes had to be improved and tightened up. MSDgen gave us the platform to not only improve the quality of our MSDS data, but also to manage the process of generating and distributing MSDSs.” – AMCOL International “Both services (MSDS authoring and MSDS distribution) have a wide range of strong technical resources behind them and we’re confident that we’re providing our employees and customers with the most accurate MSDSs in a timely manner. Employee and customer feedback has been extremely positive.” – Novelis CASE STUDY 1: Brenntag utilises 3E’s SAP EHS Solutions to distribute and deliver optimised global HSE programme Industry: chemical distribution Challenge: “To ensure the company has the most accurate and comprehensive regulatory data available, as ever changing regulations, initiatives and directives emerge from regulatory and governing bodies on national, state and local levels.” Solution: Ariel Solutions for use with SAP® EHS Management Results: “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. We were also strongly impressed with ADM-EHSAP’s ability to seamlessly load this information

Chemical Watch | Global Service Providers Guide 2012

into our existing SAP EHSM system… Adopting 3E Company’s Ariel content and tools for SAP EHSM has brought our ability to manage compliance information for the myriad of environmental regulations impacting our business to a whole new level. Since partnering with 3E, our compliance efforts have been streamlined, which translates to increased productivity and focus on the more strategic aspects of compliance management.” CASE STUDY 2: JM Huber Corporation relies on 3E Company to author compliant multiple-language MSDSs Industry: manufacturer of engineered materials, natural resources and technology-based services to customers spanning many industries, from paper and energy to plastics and construction. Challenge: keeping up with constantly-changing regulations in multiple countries; producing locally compliant hazard communication in the multiple languages Solutions: MSDS authoring services, Emergency Response, 3E MSDS On Demand® Results: JM Huber has experienced improved liability and risk management, heightened cost efficiency and control and increased productivity. “Using 3E’s Authoring service saves us so much time. Every time one of our SDSs is changed, all of the corresponding sheets need to be revised as well – in several different languages. Being able to outsource that stress and burden is a tremendous relief. We have been very happy with the service and the quality of the work that our 3E team provides.” STAFF SELECTION Sookie Hong – Senior Regulatory Research Analyst Hong is responsible for researching, analysing and monitoring overall chemical and other EH&S related governmental legislation and regulations of the Asia Pacific region. She has nearly 15 years of regulatory expertise focusing on the Asia-Pacific region, including work in Japan, Hong Kong and the US. Hong holds an MA in international affairs, Asia political economy from American University in Washington DC, and graduate certificate of East Asian studies from Harvard University. She is fluent in Korean, Japanese, English, and highly proficient in Mandarin (including professional reading skills in both simplified and traditional Chinese). Yasmin Chen, Manager Authoring Operations, Europe Chen is manager for 3E’s Copenhagen Authoring Operation, as well as a senior MSDS author and regulatory consultant. She is responsible for the day-to-day management of services offered in the area of global MSDS authoring and label preparation and consulting in the area of chemical management and EH&S in general. Chen has over 25 years’ experience working with chemical products in research & development from chemical industries and institutes in China and Denmark as well as more then a decade of experience in the areas of hazard communication and regulatory compliance worldwide. Yasmin holds a PhD in chemistry from Copenhagen University, Denmark, an MS in chemistry from Beijing Institute of Chemistry, Chinese Academic Science and a BS in chemistry from The China University of Science and Technology. Yasmin relocated to Denmark from Beijing, China in 1989. She is fluent in English, Danish and a native Chinese speaker. In addition, she reads and understands Norwegian and Swedish. Bonita Reynolds – Senior MSDS Author/ Regulatory Specialist Reynolds has been with 3E since 2008. She has been heavily involved with TSCA compliance for the last 14 years of her 24 year regulatory professional career. In addition she has experience from the foods, drugs and cosmetics industry. Reynolds has managed the role of TCSA coordinator for major chemical companies where she worked with writing and maintaining TSCA compliance programmes, training, auditing, day to day compliance, product reviews, inventory status and exemptions, new chemical submissions, technical contact with EPA and customer notifications.

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PROFILE: 3E Company

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


GLOBAL OFFICES The Acta Group LLC Bergeson & Campbell PC; and B&C Consortia Management LLC 2200 Pennsylvania Avenue, NW Suite 100W Washington, DC 20037-1701

PROFILE: ACTA

CONTACTS Website

www.actagroup.com

E-mail

lmacdougall@actagroup.com

Head office

23 New Mount Street, Manchester, M4 4DE, UK

Tel

+44 (0)1612127405

Contact

lbergeson@actagroup.com

Directors

Lynn L Bergeson and Lisa M Campbell

Ownership

Private company, affiliated with: The Acta Group LLC The Acta Group China LLC Bergeson & Campbell PC B&C Consortia Management LLC

Locations

US, UK and China

Founded

2004

SERVICES PROVIDED General consulting services We represent and counsel individuals, business entities, trade associations, and industry associations. Our fundamental goals are to solve our clientsâ&#x20AC;&#x2122; existing problems and to minimise future difficulties. We take a multi-disciplinary approach in assisting our clients. Attention must be paid to the interplay of all branches of government and interest groups. Our capabilities, borne of site- and issue-specific experience, combined with our national and international view on policy and regulatory developments, position us to handle all these tasks with judgment, creativity, and efficiency. Global product registration and agent services (only representative services)

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

2010/11

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%

Representation & management 20%

IT & software 5% Information 10%

Page 32

Regulatory chemical product notification, registration, and technical defence under the framework of global chemical programs. Acta, Acta EU, and Acta China concentrate on obtaining, maintaining, and supporting product approvals and efficiently overcoming commercial or regulatory impediments to the successful and profitable marketing of approved products. The multi-disciplinary skills offered by Acta, Acta EU, and Acta China professionals are essential to obtaining cost-effective and timely product approval. Jurisdictions we are active in are: North and South America, European Union, Switzerland, Turkey, and Pacific Rim. Data compensation support services and trade infringement/ competition issues Acta EU and its affiliates are engaged in numerous data compensation and competition-related issues at the global level. Activities range from supporting, evaluating, preparing, and managing data cost on behalf of the data owner as well as for those entities seeking data access. As a result of recent activities in association with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation, many clients continue to evaluate and pursue competition-related issues. We are actively engaged in data compensation and competition-related disputes. Technical document preparation activities Undertaking the appropriate document preparation and coordination to support a registration and post registration activities, ie chemical substance dossier preparation, exposure assessments, hazard assessments, specific effect analysis and assessments, petitions, response to comment documents, inquiries, and safety data sheet (SDS) preparation. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1998

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

2000

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

2004

The Acta Group LLC establishes an international consulting affiliate, The Acta Group EU Ltd in the UK

2010

Bergeson & Campbell PC establishes a consulting affiliate, B&C Consortia Management LLC in Washington DC, USA

2011

The Acta Group LLC establishes an international consulting affiliate, The Acta Group China LLC

Chemical Watch | Global Service Providers Guide 2012


ACCREDITATIONS

STAFF SELECTION

Occupational Health and Safety Assessment Series 18001; International Organisation for Standardisation (ISO) 9001; ISO 14000

Lynn L Bergeson – Principal/Director

B&C Consortia Management LLC CLIENTS Acta EU’s clients are involved in many businesses, including basic, specialty, agricultural, and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; 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 ECHA appeal Provided strategic technical support to our European legal counsel, Field Fisher Waterhouse, in the first successful appeal under the REACH legislation. It is important to note that at the time of the appeal, the technical completeness check (TCC) tool was not available. ECHA rejected the dossier based on the premise of incompleteness. A successful appeal was performed without the need to petition ECHA further. The substance was granted registration, a registration number assigned, and appeal fees returned. CASE STUDY 2: Data compensation issue Prepared strategic counselling and documentation to support and submit data compensation dispute/appeal under the REACH legislation. Reviewed and issued response to ECHA’s position on the data sharing dispute. Initiated documentation to support a petition for competition law infringement in association with conduct under the framework of REACH. Our work in this area builds upon our significant and extensive data compensation work in the US under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In other roles, we perform analysis of data valuation in association with the data rights to be granted.

Leslie Scott MacDougall – Director of Regulatory Affairs Ms MacDougall has more than two decades experience in various chemical-related matters. She spent a significant portion of her career as a programme manager for the US EPA. In her current role, Ms MacDougall is the managing director for Acta EU with emphasis on global product registration support activities. She is a key technical advisor to legal staff in support of international litigation matters (ie appeals, data compensation issues) and international chemical legislation developments. Ruth C Downes – Regulatory Specialist Ms Downes specialises in REACH registrations and worldwide notifications. Ms Downes is experienced in performing REACH-related submissions as well as document preparation to support international registration activities. Ms Downes has strong links with national competent authorities and communicates with competent authorities frequently. She participates in substance information exchange forums (Sief) and consortia supporting registration activities. Andrew Bourne – Regulatory Specialist Mr Bourne has significant experience in regulatory and chemical management matters. Previously, Mr Bourne worked for Exponent International Ltd (Exponent) as a Regulatory Affairs Specialist where he was a liaison for Sief members, steering groups, and downstream users for the compilation of substance identification and available substance data and risk management information for the REACH phase-in 2010 deadlines. In addition, Mr Bourne produced several chemical safety reports (CSR) for Annex IX and X registrations and assisted in biocides and plant protection registrations.

CASE STUDY 3: Import tolerance Provided strategic regulatory counselling on development of import tolerances/exemption from tolerances for raw and/or processed agricultural goods exported from Europe into the US that have been treated with pesticides that are not registered in the US under FIFRA and can be expected to have residues. Worked extensively with US Environmental Protection Agency (EPA) and US Food and Drug Administration (FDA) staff to bring cases to successful resolution. In addition, worked extensively with enforcement personnel in cases where commodities have been inadvertently imported bearing residues of unregistered pesticides and resolved matters successfully.

Chemical Watch | Global Service Providers Guide 2012

Page 33

PROFILE: ACTA

PARTNERS

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


GLOBAL OFFICES Agents in Japan, plus a consultant network covering Europe, Middle East, Africa, Asia, Australasia SERVICES PROVIDED Regulatory dossier services

PROFILE: APC

CONTACTS

Data gap analysis, drafting of data waivers, data extrapolation, risk assessments, dossier preparation, placement and monitoring of studies, including efficacy development programmes.

Website

www.apc.eu.com

E-mail

info@apc.eu.com

Head office

Unit 3, Cromwell Business Park, York Road, Wetherby, LS22 7SU, UK

Tel

+44 (0)1937 547962

Contact

Jeff Old

Directors

Steve Shires, Saul Shires, Daniel Shires, Jeff Old – Operations Director, Chris O’Hara – Director of Regulatory Affairs

Ownership

Private

Locations

UK (Wetherby and Ringwood), France, Spain and Poland

Founded

2001

Plant protection products

OVERVIEW Established in 2001 by Dr Steve Shires to satisfy a market need for a co-ordinated network of scientific consultants. APC has steadily grown to have offices in the UK, France, Spain and Poland, as well as a global network of consultants covering more than 40 countries. APC’s experienced team of chemists, agronomists, toxicologists and environmental experts can address a broad range of regulatory challenges. Working together with our network of local experts whose knowledge and contacts within various ministries around the world enables APC to design bespoke regulatory solutions for our clients’ needs. As a result of the global reach of the APC network, APC can provide sound regulatory and technical support for biocides (98/8), plant protection products (1107/2009), biopesticide and general chemicals (REACH). Dedicated APC project managers are assigned to each client from the beginning. They become the focal point for communications, providing the client with valuable strategic advice and timely support throughout each project to submission and during evaluation to approval. VITAL STATISTICS

2010/11

Turnover, group

€4m

Turnover, chemical service provision

-

No of offices

5

No of countries represented

>40

Staff, group

26

Staff, chemical service provision

-

Our staff at APC have extensive experience in the preparation and submission of dRRs in the support of zonal authorisations. APC has provided support to our clients for various regulatory projects including data matching, technical equivalence, support through to Annex I inclusion, Annex I renewal (AIR) and dRR Zonal dossiers. Many of these projects required an innovative and bespoke approach to the preparation of higher tier risk assessments. APC can provide market reviews and literature reviews for potential new products and has considerable experience in obtaining international registrations outside EU including Africa, Asia and CIS countries. APC has successfully managed ten Annex II data matching programmes for protected study dossiers and gained Annex I listing for several novel active substances. We have supported numerous actives through the EU review process, including two bio-pesticides and managed and submitted >200 Annex III dossiers with another 50 applications mutual recognitions APC’s particular strength is in the use of our local consultant network to provide regulatory support for our customers, from the drafting of MSDS and labels in the local language through to in-person negotiation with the regulatory authorities. Biocides APC’s team of experts has experience in the submission and support of Annex I dossiers in support of various PT groups, including higher tier environmental and non-dietary human risk assessments. In addition, APC’s network of consultants can complete, submit and notarise national applications forms for our clients in support of applications in the transitional period before Annex I inclusion comes into force. Biopesticides Through our consultant network, APC has expertise in the submission of four Annex I dossiers in support of a biopesticide. REACH and GHS APC provide a range of services from third party/only representation to dossier preparation and risk assessment for CSRs. Our experts have experience of various exposure modelling tools required for CSRs, including ECETOC TRA, ART, Stoffenmanager, EUSES, ConsExpo, BEAT etc. APC can prepare CLP/GHS proposals for MSDSs and dossiers. Training APC runs training events in ecotox, biopesticides and new EU pesticide regulations

SERVICE AREA BREAKDOWN Training 2%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS Consultancy/ advisory 98%

2001

Company registered in England

2005

French office opened

2008

UK Wetherby office opened

2009

Polish office opened

2010

UK Ringwood office opened

ACCREDITATIONS None Required

Page 34

Chemical Watch | Global Service Providers Guide 2012


PARTNERS

STAFF SELECTION

Triveritas – veterinary medicine specialist

Steve Shires – Managing Director

Our current client data base has more than 100 clients from various industry sectors and disciplines CASE STUDY 1: European plant protection product support at STEP 2 APC performed a preliminary bird and mammal risk assessment according to the EFSA Guidance (2009) for a fungicide used on a variety of crops. The critical uses of the product were discussed by ecotoxicology and efficacy experts to ensure that uses were supportable in terms of application rates, numbers of applications and timings (BBCH stages. The efficacy and residues trials programme was tailored to support the revised rates and timings with the aim of supporting the maximum number of crops at re-registration. Separate member state (MS) draft registration reports (dRR) were found to be appropriate for the Central zone as the target MS had different crop groups and environmental fate modelling requirements. On the other hand a zonal dRR was found to be appropriate for the Southern zone where there was overlap of uses and environmental fate modelling. Where necessary MS specific environmental requirements (eg UK spray drift PECsw or relevant FOCUSsw scenarios) were detailed and appropriate environmental mitigation specified. CASE STUDY 2: Annex II equivalence at Step 1 One of the Annex II data matching programmes for protected study dossiers that APC managed was for an insecticide with many complex metabolites and some very challenging environmental issues. In this project we were able to save our client >€1m of studies by drafting skilful waiver arguments and having detailed negotiations with the EU RMS. Despite the many technical challenges APC was then able to meet the tight Step 1 submission deadline and get a positive evaluation from the RMS. Finally, APC lead the successful negotiations for access to protected vertebrate studies with the primary data holder. Our client was therefore able to maintain all of their existing national registrations at a cost well below what was initially expected. CASE STUDY 3: Out of season trials Using our large network of consultants, APC was able to organise out of season trials in South Africa, Australia and New Zealand in order to speed up the acquisition of data needed to confirm the performance of a new formulation. Our field efficacy experts were then able to justify the inclusion of this data as supporting evidence showing comparability with EU conditions where appropriate. This initiative resulted in a registration being obtained one year earlier than first anticipated. CASE STUDY 4: REACH registration non-phase-in substance APC have assisted a PPP manufacture with their REACH preparations by undertaking a full analysis of their marketed products and undertaking REACH registration procedures for the relevant substances. Within this, APC identified the requirement to register non-phase-in substances with ECHA, and took the relevant action to achieve this, filing enquiry dossiers with ECHA, and then using the results of this, and our in house expertise, to undertake a data gap analysis. We then oversaw the completion of any data gaps by overseeing data access agreements with previous registrants, or by constructing expert data waiving arguments for submission to ECHA. This led to a full REACH registration for the substances in question, achieved in early 2010

Chemical Watch | Global Service Providers Guide 2012

Steve Shires started his career in the plant protection business at Shell Research in 1977, where he was a founder member of the environmental biology group. Following seven years leading ecotoxicology projects on pesticides, he spent a further four years in Shell managing development and registration in the Far East and Australia. In 1988 Steve moved to FMC as the registration manager for Europe Middle East and Africa (EMEA) and then moved to become director of development and regulatory affairs. In 2001 he started Agchem Project Consulting Ltd (APC), with a vision of making it a truly international consultancy offering a full range of services at national as well as central EU level. In his current role as managing director of APC Steve is responsible for providing overall company management plus guidance in both technical and business strategic issues. Jeff Old – Operations Director Jeff Old started his career in 1984 as a field trials officer in the herbicide group of Agrisearch UK conducting and arranging small plot field trials. He developed this group becoming manager in 1988 and continued until changing his role within the company in 1991 to become production control manager responsible for the scheduling and management of the workload in the field teams. In 1993 he joined Inveresk Research to set up their field trials department conducting field trials for all pesticides growing and developing this team to 27 staff and attained GEP and GLP in Spain, Italy, France, Poland and UK. In 2010 he joined APC as operations director with responsibility for the day to day running of the company, project scheduling, resourcing of dossier submissions, financial aspects of the company. Chris O’Hara – Director of Regulatory Affairs Prior to joining APC, Chris O’Hara was the head of the Human Health Group at a major consultancy co-ordinating the preparation of dossiers/ risk assessments and the management of resource allocation. Chris O’Hara, director of regulatory affairs has 18 years of regulatory experience with plant protection products, biocides (various PT groups) and CSRs for REACH gained from working at a contract research organisation and at a major consultancy. He has a comprehensive working knowledge of EU regulatory evaluation procedures and risk assessment methods, including relevant guidelines and EC directives as they pertain to existing and new active substances. Graham Poulton – Field Development Manager Graham began his career at HLS, where he gained valuable practical experience in both laboratory and field activities. Having reached the role of efficacy specialist, Graham then joined APC in 2008 as field development specialist and then manager with responsibilities for a team of nine. Graham provides support on all topics coming under either GEP field trials or product development. He takes a lead on developing business strategy in these areas in response to changes in the regulatory environment.

Page 35

PROFILE: APC

CLIENTS


SERVICES PROVIDED Scientific services Product definition and chemical substance identification; CLP notification dossiers; classification of substances and mixtures; representation of our clients in consortia; REACH registration and notification dossiers (study monitoring and hazard assessment; data gap analysis and setup of testing strategies; derivation of threshold values; alternative testing methods; development of exposure scenarios and risk assessment; PBT [persistent, bio-accumulative and toxic] assessments).

PROFILE: Apeiron-Team

CONTACTS Website

www.apeiron-team.eu

E-mail

info@apeiron-team.eu

Head office

Pluyseghemstraat 69

 

2550 Kontich

 

Belgium

Support in REACH (including requirements for nanomaterials), REACHlike legislations, CLP, RoHS, Food Contact, Biocides Regulation: from referral to information sources to assistance in interpretation of legal texts.

Tel

+32 3 808 20 69

Industrial services

Contact

Elke Van Asbroeck

Directors

Elke Van Asbroeck

 

Hiram Moerman

Ownership

Private company

Locations

Kontich, Belgium

Founded

2009

Regulatory services

Tailor-made advice for a cost efficient implementation of regulations, taking into account the global business strategy and required flexibility of our clients; assistance in development of chemicals management system and product stewardship programme; writing of position papers and communication with authorities; SVHC (substances of very high concern) tracking; audit programme: compliance audit, system audit; supply chain audit; project audit; due diligence audit; 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

2010/11

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%

Other 5%

Information 10% Representation & management 10%

Page 36

Consultancy/ advisory 60%

Project management and training Consortium management; pro-active project management with focus on in-time and in-budget delivery supported by state of the art IT tools. Apeiron-Team organises workshops on various aspects of the REACH implementation process. Upon request, tailor-made in-house trainings are developed. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Start of Apeiron-Team NV

2010

Management of consortium of a highly specialised chemical

2010

Move to the new location in Kontich

2010

REACH training for Belgian federation of chemical industry

2010

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

2010

Successful registration of more than 100 substances for REACH

2011

Workshops on development of threshold values, on interpretation of extended SDS and on default values used in exposure models

2011

Generation of safety data sheets with exposure scenarios based on chemical safety reports

2011

Extension of client portfolio in food and pharma industry

2011

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

2011

Expansion of services and experience in REACH-like legislation, global SDS requirements and chemicals management

2011

Development of company specific DU-CSRs (downstream user chemical safety reports)

2011

Writing of position papers regarding certain substances exempt under REACH

2011

Development of compliance check tool for extended safety data sheets

2011

Invited speaker at Sustainable Chemistry Summit in Canada: Toxics Reductions – What’s Next? The EU Perspective: REACH Chemical Watch | Global Service Providers Guide 2012


OO OO OO

Certified toxicologists Environmental advisor (Milieu coordinator) Strategic advisor SME

PARTNERS OO OO OO OO

ProMil CjConsult Burgess Regulatory Services Ltd Jongerius Consult

CLIENTS Our references are situated in several industries and their entire supply chain from manufacture to recycle: OO chemical industry: petrochemical, fine chemicals, toll manufacturing OO food industry OO polymer industry OO refinery OO tyre industry OO pharma Industry TESTIMONIALS "Our experts, together with the experienced Apeiron-Team, successfully implemented the complex EU regulations REACH and CLP. We appreciate the know-how exchange and professionalism on both sides” Borealis "Apeiron-Team is a no-nonsense company delivering their services on time, in full and in budget" Monument Chemical CASE STUDY 1: REACH dossier preparation To support the registration of a high volume rubber chemical, Apeiron-Team has built for this substance the complete REACH dossier and prepared the registration for the lead registrant. The multi-constituent substance was evaluated by Apeiron-Team in all relevant physico-chemical and toxicological aspects both human and environmental. Exposure was assessed for all stages of the lifecycle including the waste stage. Apeiron-Team also provided the CLP classification and composed the eSDS, including the annex. Within the consortium Apeiron-Team provided the cost evaluation of the studies and has set up the cost-sharing model for the consortium and Sief members.

CASE STUDY 4: Development of a compliance check tool for incoming extended safety data sheets For a company dealing with an extensive incoming product portfolio, Apeiron-Team developed a compliance check tool for incoming (extended) safety data sheets. The goal of the tool was to cover legal obligations at different levels: in the first instance, for each product should be documented whether an SDS is required and if so, when it was received and whether it conforms to the legal requirements. On a second level, the tool had to allow the assessment and documentation of compliance with the exposure scenarios. In case follow-up is needed as a result from this compliance check, this can also be tracked and documented by means of the tool. CASE STUDY 5: Strategic approach for authorisation and restriction The REACH restriction and authorisation process is complex but business critical. Apeiron-Team developed for a global article manufacturer a strategic approach to deal with these challenges. Substance specific timelines were developed to allow the company to participate in the authorisation process either directly or via their supply chain. The strategic plan was aligned with process development and R&D planning to ensure efficient and effective use of these resources to assure business continuity at long term. STAFF SELECTION Elke Van Asbroeck – Managing Director OO OO OO OO OO OO

Hiram Moerman – Managing Director OO OO OO OO OO OO

CASE STUDY 2: Development of downstream user chemical safety report A large chemical company using several substances at ten different sites throughout Europe discovered that compliance with the relevant exposure scenarios in the received SDS could not be confirmed for all sites. Instead of looking for site-specific solutions for each of the non-compliant plants it was decided to develop downstream user chemical safety reports (DUCSR) that covered all separate sites. Exposure scenarios were developed that took into account company-specific data, starting from the worstcase plant, ultimately guaranteeing compliance. The company now only needs to verify compliance with its own DU-CSR in case of changes of circumstances and thus has become independent of the SDS sent by its suppliers. CASE STUDY 3: Strategic advice to align REACH registrations with the business objectives Although REACH registration is a scientific exercise involving a lot of communication throughout the supply chain, REACH is also very much a business driven effort. Apeiron-Team has helped several multinationals to develop their REACH registration strategy taking into account the markets and import/export strategies the business had already in place. In addition, where warranted position papers were written in order to defend the exemption status for specific substances under REACH. By doing so, a cost effective registration strategy could be developed avoiding unnecessary registration cost while securing optimal business continuity and flexibility. Chemical Watch | Global Service Providers Guide 2012

ir (Bio-)chemical engineer polymer chemistry/ waste cost-efficient regulation implementation auditing/ GPS supply chain communication (eg SVHC) import/ export strategy ir chemical engineer specialised in process chemistry product stewardship and GPS auditing regulatory IT systems (eg IUCLID, CSI tools) consortium/ project management

Dr An Jamers – Scientific Advisor OO OO OO OO OO OO

PhD ecotoxicology registration/notification dossiers Sief/consortium representation PBT assessments product stewardship and GPS global SDS requirements

Dr Katrien Monsieurs – Scientific Advisor OO OO OO OO OO OO

PhD organic chemistry specialised in organic synthesis substance identification classification and labelling knowledge in human toxicology REACH and CLP training

Dr Tine Vandenbrouck – Scientific Advisor OO OO OO OO OO OO

PhD ecotoxicology specialised in mixture effects hazard and exposure assessments registration/notification dossiers eSDS generation/scaling tools ERT certified toxicologist

Page 37

PROFILE: Apeiron-Team

ACCREDITATIONS


GLOBAL OFFICES Our 300 offices around the world provide global support. Centres of excellence for our product stewardship services are located in both Europe and the US. For Europe, contact ARCADIS Belgium: Citylink, Posthofbrug 12, 2600 Antwerpen-Berchem, Belgium. Contact: Alain Vassart, 0032 3 328 62 48, a.vassart@arcadisbelgium.be For the US, contact: ARCADIS US: 4665 Cornell Road, Suite 350, Cincinnati, Ohio 45241, USA. Contact: Michelle Langefeld, 001 513 860 8700, michelle.langefeld@arcadis-us.com

PROFILE: ARCADIS

CONTACTS Website

www.arcadis.com/Global_Product_Stewardship.aspx

E-mail

reach@arcadisbelgium.be AUSInternet@arcadis-us.com

Head office

Gustav Mahlerplein 97-103, 1082 MS Amsterdam

SERVICES PROVIDED

 

PO Box 7895, 1008 AB Amsterdam, The Netherlands

Tel/ Fax

+31 020 2011011/ +31 20 2011 002

Contact

Alain Vassart (Europe), Michelle Langefeld (US)

Directors

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

Ownership

Public company

Locations

300+

Founded

1888

In order to produce exceptional value for our clients, employees and shareholders, we organise our services into four main business lines, each with its own area of strength and strategies: infrastructure, water, environment and buildings. These segments are naturally woven together, inspiring us to work across disciplines and geographies to deliver exceptional solutions to complex issues. One of the services in the business line environment is global product stewardship (GPS), as highlighted below. In this team, we focus mainly on regulatory compliance for chemicals, biocides and waste. REACH from A to Z

OVERVIEW ARCADIS is an international company providing consultancy, design, engineering and management services in infrastructure, water, environment and buildings. We enhance mobility, sustainability and quality of life by creating balance in the built and natural environments. ARCADIS develops, designs, implements, maintains and operates projects for companies and governments. With more than 19,000 employees and €3.2bn in revenues, the company has an extensive international network supported by strong local market positions. VITAL STATISTICS

2010/11

Turnover, group

€2.3bn

Turnover, chemical service provision

€5m

No of offices

324

No of countries represented

20

Staff, group

19,000+

Staff, chemical service provision

42

SERVICE AREA BREAKDOWN IT & software 5% Laboratory 5% Information 10%

Representation & management 25%

Page 38

The mission of our GPS team is to enable our clients to efficiently manufacture and market their products, and to manage their supply chains in a safe, responsible, and globally compliant manner. The major focus is currently on REACH and CLP/GHS in all its aspects: we provide scientific and management support, combined with strategic advice, resulting in regulatory compliance in the most efficient way. ARCADIS performs risk assessments, prepares chemical safety reports, derives classifications and labelling, supports communication in the supply chain and evaluates extended safety data sheets. The team 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. Restriction and authorisation under REACH Thanks to its extended internal network of expertise, both in industrial uses of chemicals as well as in regulatory affairs and economics, ARCADIS is uniquely placed to prepare application dossiers for restriction or authorisation under REACH, including data collection and socio-economic analysis. The scope of work performed by ARCADIS covers all stages needed for such a process from the IUCLID file to the management of industrial consortia specifically created for this purpose. Biocidal product authorisation

Training 5% Consultancy/ advisory 50%

The Biocidal Product Directive (BPD 98/8/EC) aims to harmonise the European market for biocidal products and their active substances. On top of that, it intends to provide a high level of protection for humans, animals and the environment. It is anticipated that an update of the Directive, as a regulation, will enter into force on 1 January 2013. Being compliant with this Directive is the legal prerequisite that allows marketing of your biocidal products in Europe. It is a time consuming and costly process demanding various expertises. ARCADIS can provide regulatory and/or technical support in the complex process of getting your biocidal products authorised.

Chemical Watch | Global Service Providers Guide 2012


STAFF SELECTION

1888

Parent company Heidemij formed in the Netherlands

Ranulfo Lemus-Olalde ScD – Human Health Toxicologist

1993

Geraghty & Miller merges with Heidemij

1998

Global company becomes ARCADIS

2002

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

2005

ARCADIS merges with BBL

2006

ARCADIS Belgium is established as a second GPS centre of excellence

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

2010

ARCADIS manages several REACH consortia and supports clients in about 100 REACH registration dossiers

2011

ARCADIS further innovates to face regulatory challenges like the authorisation process, REACH enforcement, Biocides Regulation, and others

2011

ARCADIS is engaged by several multinational companies as their key service provider for developing and implementing their REACH compliance strategy

ACCREDITATIONS European registered toxicologists (EuroTox); European registered chemists; diplomat of the American Board of Toxicology. CLIENTS ARCADIS works for multinational clients around the world. We have built sound relationships with clients in following market sectors: chemical production, pharmaceuticals, automotive, rare earth compounds, consumer goods, oil and gas, governments and policy-makers, and others. CASE STUDY 1: Product stewardship services for a home and personal care product producer ARCADIS supports a multinational company with its REACH registration programme. In addition to REACH support, ARCADIS has been providing general regulatory and product safety services to multiple businesses within the company. Key activities include human and environmental safety assessments, updating product material safety data sheets, US TSCA import/export review, scientific manuscript preparation, developing website content, support for green certification, and global product registrations.

Hans Cardinaals – Chemist and Risk Assessor Hans Cardinaals holds a BSc in analytical chemistry and an MSc in human nutrition. He gained significant experience in performing and evaluating physical chemical properties of substances by managing the chemistry department of a contract research organisation for seven years. Over the last 15 years, he has been a regulatory specialist contributing to the preparation of dossiers for different regulatory frameworks (including plant protection products, biocides and industrial chemicals). Nele Deleebeeck PhD – Ecotoxicologist Dr Deleebeeck holds the academic degrees of MSc in biology, MSc in environmental sciences and technologies, and a PhD in applied bioengineering sciences. She has worked for academics, industry, the Belgian government and consultancy. She has more than ten years’ experience in environmental risk assessment and this for a wide variety of chemicals, with her main specialty being metals and metalloids. Kate Sellers, PE – Environmental Engineer Kate Sellers edited and co-wrote Nanotechnology and the Environment (2008) which explores the implications of this new technology. She has presented seminars and short courses to professional societies and multinational clients, and has advised clients on issues ranging from the consequences of nanoparticle exposure to the nuances of regulatory registration. She holds a BS in chemistry, a MS in environmental engineering.

CASE STUDY 2: Exemption dossiers under REACH Certain substances are exempt from registration under REACH, either because they are listed in Annex V or because they are recovered from waste under specific conditions (Art 2.7 d). For both cases, ARCADIS is preparing exemption dossiers which need to be made available to competent authorities on demand. In addition, the classification of very complex industrial streams of recovered products and mixtures are updated and adapted to the new CLP Regulation. CASE STUDY 3: REACH consortia management ARCADIS is currently consortium manager for several international REACH consortia. This includes coordination and follow-up of the REACH registration project, budget and cost tracking, cost sharing among members and communication with stakeholders. Besides management support, ARCADIS is also involved in preparing registration dossiers, developing read-across approaches and intelligent testing strategies and monitoring of studies. The consortia are supported by a team of project managers and experts in chemistry, toxicology and ecotoxicology.

Chemical Watch | Global Service Providers Guide 2012

Page 39

PROFILE: ARCADIS

CORPORATE DEVELOPMENTS & ACHIEVEMENTS


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

PROFILE: ARCHE

CONTACTS Website

www.arche-consulting.be

E-mail

info@arche-consulting.be

Head office

Stapelplein 70, box 104

 

9000 Gent

 

Belgium

Tel

+32 9 265 87 58

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 and (g) REACH dossier submission, updating and follow-up.

Contact

Marnix Vangheluwe

Classification of substances and complex mixtures under CLP/GHS

Directors

Marnix Vangheluwe

 

Patrick Van Sprang

Ownership

Private company

Locations

Gent and Leuven, Belgium

Founded

2009

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

OVERVIEW ARCHE was founded in 2009 by key experts from EURAS who hold a unique track record (15 years) in the field of environmental toxicology, exposure modelling and the preparation of risk assessment dossiers in general. One of the key areas of expertise is the preparation of REACH-related risk assessments and full dossiers for inorganic substances such as metals, alloys, slags etc and, as such, the ARCHE experts have been involved in the preparation of many guidance documents on these topics. Other key services include the classification of substances and complex mixtures (GHS/CLP), setting and/or evaluation of (site-specific) environmental quality standards, and the assessment of pharmaceuticals in the environment, plant protection products and biocidal products. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

2

No of countries represented

1

Staff, group

12

Staff, chemical service provision

12

SERVICE AREA BREAKDOWN IT & Training software 5% 5%

Water Framework Directive (WFD) and Environmental Quality Standard (EQS) Directive The WFD and EQS Regulations directly impact the operation of industrial sites; one of its goals is to assess/protect the chemical status of water bodies (eg impact of effluents). ARCHE provides tailor-made plans to increase the realism of the compliance assessment: (a) translation of generic EQS (b) derivation of site-specific EQS using bioavailability/ background corrections (c) implementation of probabilistic techniques covering temporal variations (d) development and management of full-scale monitoring programmes (biological and physicochemical characterisation) (e) modelling and risk/exposure assessment of the effluent mixing zone. 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 the active substances and products (b) identification of data gaps and design of higher-tier studies (c) exposure modelling (FOCUS suite of models, EUSES, USES, 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. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

Foundation of ARCHE (staff: five people)

2010

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

PARTNERS Consultancy/ advisory 90%

Page 40

EBRC Consulting GmbH, Hannover PietConsulting

Chemical Watch | Global Service Providers Guide 2012


Industrial clients and consortia related to the following chemical substances: OO metals including: Cu, Ni, Mo, Pb, Zn, Hg, V, Co, Fe, Se, Sr, Mg, Bi, Te, Ti OO organic compounds: chlorinated flame retardants, organic acids, plasticisers, amines, biocides, pesticides OO complex materials: Cu slags, Ti slags OO other inorganic substances: Ca, B, NaOH, KOH, sulphur dioxiderelated substances (SO2, sulphites, thiosulphates, dithionites), lime, nitric acid, phosphoric acid TESTIMONIALS “IMOA has worked for the last five years with the environmental scientists working at ARCHE, and they have proved for IMOA/MoCon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects, and data interpretation. ARCHE worked with numerous metal consortia for REACH, and is widely recognised by the metals industry as the experts in their field” − Sandra Carey, International Molybdenum Association CASE STUDY 1: REACH 2010 chemical safety reports for metals and metals compounds The people currently working at ARCHE assisted several metal consortia in their REACH dossier preparation and chemical safety report generation for their metals and metal compounds that had to be registered by 1 December 2010. Data gap analysis with regard to the tonnage-specific REACH information requirements on physicochemical and (eco)toxicological properties were conducted, and where needed testing programmes were designed and managed. The collected and/or generated data formed the basis of the environmental effects assessments that were performed. The outcome of this work was combined with the results of the exposure assessment and relevant exposure scenarios that were also generated by the experts working at ARCHE. These risk characterisation exercises provided the operational conditions under which safe use of metals and metal compounds could be ensured for men and environment. In addition, all information that was used in the CSR was entered into the ECHA data information format (IUCLID). CASE STUDY 2: MeClas – metals classification tool Most complex materials in the metals sector contain a spectrum of different metals (compounds) and minerals, which therefore requires extensive physico-chemical, toxicity and ecotoxicity reference data sets. The MeClas tool offers a unique web-enabled classification tool that is always updated to the latest classification rules. The tool comprises several tiers, aimed at the progressive refinement of classification through recognition of speciation, specific mineral content and the availability of test data on the complex material in question. A licence is needed in order to use the tool (register and obtaining a login account at www.meclas.eu in order to access the MeClas tool and all supporting information). The MeClas tool has been developed jointly by EUROMETAUX and ARCHE based on initial developments in collaboration with the European Copper Institute, ICMM and Euromines.

Chemical Watch | Global Service Providers Guide 2012

CASE STUDY 3: Environmental risk assessment of a biocidal product for milk extraction systems Our experts compared two environmental risk assessment methods for a disinfectant for milk extraction systems: 1) the emission scenario document for biocides (ESD) based on local consumption estimates on a typical dairy farm, and 2) EUSES based on local consumption estimates extrapolated from EU/regional tonnage. For the ESD, formulae and default values were implemented into an Excel worksheet. In EUSES (2.1), scenario 2.5.1 was used; currently there is no scenario available for the product type in question and this scenario was the most appropriate alternative. It was concluded that an ESD calculation is useful for a basic evaluation. However, the formulae appear to be very sensitive to degradation rates in soil and slurry. Although a specific exposure scenario for PT3/PT4 biocides is not yet available, EUSES is preferred due to the more refined fate calculations, the fact that it takes into account a great number of characteristics of substances and that the outcomes of EUSES are far more extended than with an ESD calculation. The results of this study were published at the SETAC Special Science Symposium in October 2011. STAFF SELECTION Patrick Van Sprang − Managing Director ARCHE Patrick Van Sprang graduated as master of science in engineering (environmental technology) at Ghent University (1988). At Ghent University (1994-2000) he was responsible for the research group aquatic ecotoxicology. He was co-founder of EURAS, a consultancy company specialising in environmental risk assessment. Patrick Van Sprang is the main author of the environmental part of several risk assessments (eg Cu, Ni, Pb) and contributed to the metal risk assessment guidance document (MERAG). Marnix Vangheluwe − Managing Director ARCHE Marnix Vangheluwe graduated as master of science in engineering (biochemistry) at Hogeschool Gent (1989). In 1991 he obtained a master in environmental sanitation (Ghent University). At Ghent University (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. 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.

Page 41

PROFILE: ARCHE

CLIENTS


GLOBAL OFFICES France SERVICES PROVIDED Registration The services we offer include: OO registration strategy OO pre-Sief discussions on sameness, level of involvement in the Siefs OO intelligent testing strategies OO estimation of direct and indirect costs OO communication within the supply chain OO preparation and submission of Registration dossier for REACH via IUCLID 5 and REACH IT

PROFILE: ATOUT REACH

CONTACTS Website

www.atoutreach.fr

E-mail

info@atoutreach.fr

Head office

LE DIAMANT A - 14 rue de la République, F – 92800 PUTEAUX, France

Tel

+33 146531120

Contact

Nadine Mulot/ Christelle Henry

Directors

Philippe Prudhon

Locations

France

Ownership

Private

Founded

2007

Sief/consortia management OO OO

OO OO OO

OVERVIEW Created in June 2007 through an initiative of the French Chemical Industries Association (UIC – Union des Industries Chimiques), ATOUT REACH helps companies (manufacturers, importers, downstream users) right throughout the value chain to prepare and implement REACH and CLP regulations. Our methods are many faceted including in-company training courses, webinars, dedicated consultancies tailored to the client. Our specific structure allows us to be very reactive to our clients’ needs: they first asked for training at the beginning of our activity in 2007. The years 2008 and 2009 were dedicated to a strategic approach and chemical inventories. In 2010 we produced many registration dossiers for clients as lead registrants, but most of them were members of joint submissions. We also have presented approximately 25 webinars for SMEs to help them deal with all REACH processes. In 2011 we were regularly asked for SDS authoring, so we developed a special partnership with SELERANT in order to use their IT system EUSHEET (EUSHEET is a software that allows the creation of safety data sheets in 26 languages). 2012 is again dedicated to the registration of our clients. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

3

Staff, group

5

Staff, chemical service provision

3

SERVICE AREA BREAKDOWN

Classification and labelling ATOUT REACH offers expertise on CLP regulation for substances and mixtures. We also work on the notification process: direct, bulk or IUCLID. SDS authoring Using our partner tool EUSHEET from SELERANT, we offer our clients the possibility of being able to build their SDS, including the calculation of the classification and translation of all SDS. Training We offer companies up to date training, and internships, with partners or with ourselves. We are experts in training and advising on REACH, CLP, IUCLID, the role of downstream users, and SDS. Ask for a specific course and we will build the programme to suit you and your company. OR services We offer the only representative services to non EU companies. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Company starts

2008

Partnership for IUCLID

2010

New service as OR

2011

Partnership for SDS with SELERANT EUSHEET

ACCREDITATIONS We are a member of ORO, the Only Representative Organisation in Brussels and comply with the quality exigencies of ORO. PARTNER OO

Training 30%

Representation & management 20%

Special assistance for SMEs in their role of lead registrants Sief/consortia agreements review or redaction with specialists lawyers advices Sief/consortia management Discussions within the Sief: surveys, discussions organisation, Tools for web conferences

Selerant, Mulon Conseil

CLIENTS Consultancy/ advisory 50%

Our clients range from SMEs in the chemical industry to luxury multinational companies, formulators, and companies in the aeronautics and cosmetics industries (especially on natural substances issues thanks to our partner Mulon Conseil). We do not disclose our customers’ names publicly, but we will provide reference names and testimonials upon request. TESTIMONIALS We handled more than 80 registration dossiers in 2010. We are happy to provide testimonials upon request.

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Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 1: REACH 2010 – Sief management and registration dossier ATOUT REACH was asked in 2010 to prepare the registration dossier for a substance. The Sief participants were not from the chemical industry and, as a result it was an even more complex task than usual, as we also had to help them understand why they had to be REACH compliant and what they had to do to achieve it. Nevertheless with our expertise the dossier was prepared and submitted on time, and the clients were satisfied. CASE STUDY 2: REACH training

PROFILE: ATOUT REACH

ATOUT REACH was responsible for training a large chemical company. Several sessions were organised for the technical teams in the different arms of the company and the tools were prepared together with the REACH coordinator. ATOUT REACH also works for a luxury goods company as facilitator for its REACH working group. The meetings, organised three times a year, where ATOUT REACH: OO presents the regulatory news OO answers brands’ specific questions about REACH or CLP compliance OO participates in the website organisation and redaction OO gives advice on letters to be sent to suppliers and/or clients. CASE STUDY 3: REACH compliance strategy Our client’s product is a non phase-in UVCB, at the moment used only for research and development purposes. The blocking point was to choose between the inquiry process and the feasibility of registration in a similar EINECS. Together we worked out and defined their strategy which included: OO PPORD notification OO substance characterisation as UVCB OO classification and assistance for SDS authoring OO contacts with existing consortia for read across and category approach OO assistance for lead registrant responsibilities CASE STUDY 4: REACH training For a chemical industry client, we are in charge of their safety data sheets. This involves: OO information research on substances and classification determination OO classification of five mixtures OO SDS model for the company OO SDS for mixtures OO translation in 23 languages STAFF SELECTION Nadine Mulot Expert consultant REACH/CLP/SDS, with 20 years’ experience. Nadine is a biotechnological engineer, who worked for ten years with aromatics legislation (MANE, FEDAROM – national aromatics federation), and as a general secretary for UIC (Union des Industries Chimiques) Dr Christelle Henry Expert consultant on REACH, with 15 years’ experience. Christelle has a PhD in environmental chemistry – chemical engineer. She has been involved in working with REACH for eight years, firstly to help SMEs understand its impact, then with ATOUT REACH where she is lead registrant for a customer for 2013

Chemical Watch | Global Service Providers Guide 2012

Page 43


SERVICES PROVIDED REACH compliance OO

OO

PROFILE: B-Lands Consulting

CONTACTS Web site

www.reachteam.eu

E-mail

services@reachteam.eu

Head office

5 Place Robert Schuman, BP1516, Grenoble

 

France

Tel

+33 476 295 867

Fax

+33 476 295 870

Contact

Dr Michael J Kilner (UK)

OO

OO

OO

OO

CLP/GHS notification OO

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

Private company

Locations

Grenoble, France

 

Beijing, China

Founded

2007

OO

OO

OO

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

OO OO OO

OO OO

OO

2010

Turnover, group

-

Turnover, chemical service provision

-

No of offices

3

No of countries represented

>40

Staff, group

18

Staff, chemical service provision

18

GLOBAL OFFICES B-Lands Consulting, 5 Place Robert Schuman, BP1516, Grenoble, France Chemken Consultancy, 2nd Floor, 6 London Street, London, W2 1HR, UK B-Lands Beijing,YiZhuang Business Development Area, 100176, Beijing, China SERVICE AREA BREAKDOWN Other 8%

Consultancy/ advisory 30%

IT & software 15%

Information 10%

Page 44

Safety evaluation for cosmetics and fragrances Generation of ingredient dossiers and submission to SCCP Generation and update of cosmetic product safety reports and product information files Monitoring of toxicological studies required for dossiers Reviewing labelling of cosmetics for compliance with EU requirements General regulatory support for cosmetic products

EU biocidal products registration OO

VITAL STATISTICS

Laboratory 2%

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

EU cosmetic products compliance

OVERVIEW

Training 5%

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

OO

OO

OO

OO OO

Identification of biocidal products and their uses Generation and submission of inclusion dossiers for active substances in Annexes I or IA Generation and submission of authorisation dossiers (first authorisation, mutual recognition) Study monitoring in required areas (toxicology, ecotoxicology, environment, residues, efficacy…) Coordination of task forces or consortia General regulatory support for biocidal products

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

B-Lands first premises opens in Grenoble, France

2007

B-Lands launches QuickREACH, automated preregistration tool

2008

B-Lands launches REACHChecker, instant online REACH verifications

2008

B-Lands second premises opens in Beijing, China

2008

Over 17,000 pre-registrations completed

2009

B-Lands launches biocides, cosmetics compliance services

2010

220 full registration dossiers submitted

2011

Ongoing CLP notifications

2011

Registration for late comer companies who missed the 2010 deadline

Admin/ management 30%

Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 4: Assistance with China REACH registration

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

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

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

Chemical Watch | Global Service Providers Guide 2012

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

Page 45

PROFILE: B-Lands Consulting

PARTNERS


PROFILE: bibra toxicology advice & consulting

SERVICE AREA BREAKDOWN IT & Training software 2% Information 3%

7% Representation & management 12%

CONTACTS Website

www.bibra-information.co.uk

E-mail

info@bibratoxadvice.co.uk

Head office

Cantium House, Railway Approach, Wallington, Surrey, SM6 0DZ, UK

Tel

+44 (0)20 8544 4150

Fax

+44 (0)20 8544 4151

Contact

Peter Watts

Directors    

James Hopkins, Managing Director

Ownership

Private company

Locations

United Kingdom

Founded

1960, acquired by current management 2005

Consultancy/ advisory 76%

GLOBAL OFFICES London

Peter Watts, Director of Toxicology Graham Hunt, Commercial Director

OVERVIEW bibra toxicology advice & consulting, an amalgamation of two sister companies – Toxicology Advice & Consulting Ltd and Bibra Information Services Ltd – is one of the most experienced and successful chemical hazard and risk assessment organisations in Europe. We combine the skills and expertise of a large team of highly experienced and outstandingly qualified toxicologists with the finest, independently owned toxicological databank in the world; this unique combination of worldclass expertise and consulting skills with an outstanding information system means we can provide superior quality solutions to virtually all the problems faced, both by toxicologists and related company managers, in 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, including industrial chemicals, plant protection products and biocides. We have built an enviable reputation for our ability to handle large, as well as small projects, and to deliver high quality consulting and information services to tight deadlines. We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with all their REACH regulatory responsibilities. We helped industry successfully register a large number of substances for the first REACH deadline (in 2010) and continue to support companies with their REACH obligations for the 2013 and 2018 deadlines. VITAL STATISTICS

2010/11

Turnover, group

£1.2m

Turnover, chemical service provision

£1.2m

No of offices

1

No of countries represented

1

Staff, group

15

Staff, chemical service provision

13

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. Human health hazard and risk assessment The bibra team of toxicologists has worked together over many years, providing robust human health hazard and risk assessments for a diverse range of clients. Tailoring our output to suit the specific requirements of the client, we have worked with companies from the industrial chemicals, agrochemicals, biocides, food and food contact, consumer products and pharmaceutical sectors, as well as a number of international governments and respected NGOs. Our skill sets are very well matched to current requirements for toxicological hazard and risk assessment under REACH and other regulatory chemical control activities. Data searching, gap analysis and development of testing strategies We perform data searches as required under REACH. Retrieved information can be quickly assessed for relevance and reliability to satisfy tonnage-relevant data requirements. Additional testing can be minimised by expertly exploring opportunities for data waiving, read-across and taking weight-of-evidence approaches to fill data gaps. If further testing is deemed necessary we advise on testing strategies to minimise both the use of animals/overall costs to the client, while maintaining scientific integrity. We assess the impact of the results of new tests conducted and provide ongoing expert guidance on what is really needed. Extensive in-house toxicological database and databank For more than 50 years, bibra toxicology advice & consulting has been scrutinising emerging toxicological literature, expert reviews or pronouncements, and indexing these in a systematic endpoint and chemical-specific way. Much of this scientific literature is held in-house in our technical library and quickly accessed using its associated database, TRACE. This unrivalled resource (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

Page 46

1960

Formation of BIBRA

1960

Establishment of Toxicology Information and Advisory Department

Chemical Watch | Global Service Providers Guide 2012


Began to build the technical library

CASE STUDY 2: Urgent request for help with chemical safety report

1987

TRACE, a database designed to source data, from the tech library (databank), was developed

2000

TRACE, and associated databank, independently assessed as the finest toxicological data source of its type, worldwide

2003/5

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

2005

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

2010

Relocated to new, larger offices in Wallington, Surrey

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.

ACCREDITATIONS Our senior toxicologists are all Society of Biology/British Toxicology Society and EUROTOX registered toxicologists. We are a REACHReady Approved Supplier PARTNERS TSGE Enviresearch Ltd Linmark Consulting Gmbh wca environment Ltd Campden BRI group Leatherhead Food Research 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 OO Environment Agency (UK) OO Health Canada OO International Programme on Chemical Safety OO World Health Organization OO Groupe Danone OO Infineum UK Ltd OO Innospec Active Chemicals OO IRSST (Canada) OO Johnson Matthey plc TESTIMONIALS “Reliable, responsive and adept at applying their toxicology expertise to REACH, our experience of working with bibra has been very positive” – Infineum UK Ltd "In my opinion the toxicologists at bibra/toxicology advice & consulting are able to provide a very high-quality service by applying a combination of many years of experience and a high level of efficiency, in relation to scientific toxicological literature reviews and risk assessment" – Marc Baril PhD, Conseiller scientifique, IRSST CASE STUDY 1: Complex REACH submission involving a large category of substances bibra toxicology advice & consulting has been working on a number of REACH submissions that involve large categories of substances. In one case, we are supporting a consortium of companies with all the mammalian toxicology aspects of their regulatory obligations for a group of more than 70 related metal compounds. The work has involved the evaluation of a large number of proprietary studies and published literature, drafting of endpoint study records (ESRs) in IUCLID 5, assessment of Annex III compliance, complex data-gap analyses and advice on possibilities for read-across and weight-of-evidence approaches, and the development of an appropriate integrated testing strategy, to minimise the amount of animal testing required. Chemical Watch | Global Service Providers Guide 2012

CASE STUDY 3: Provision of alerting service to keep industry upto-date on emerging issues bibra toxicology advice & consulting was asked by an industry sector group to provide an ongoing service to track the emerging toxicological literature on a range of chemicals of particular interest to their members. Using a range of carefully tailored search and alerting strategies (SDI – selective dissemination of information), the bibra team receives daily notification of newly published or pre-published papers, abstracts or comment and alerts the sector group members to keep them abreast of the scientific literature and developing areas of possible concern. The service allows the industry to successfully foresee and manage arising issues in a co-ordinated and proactive way. STAFF SELECTION James Hopkins – Managing Director James was a senior toxicologist of high repute at BIBRA before leading the management buyout in 2003. The new company, bibra toxicology advice & consulting, has performed impressively under James's guidance, reporting record results in 2010/11. 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 team of toxicologists to support a number of client companies and consortia with their registration submissions. The rest of the team We have another ten highly-competent toxicologists, all of whom are professionally qualified (the majority are SB/BTS and EUROTOX registered toxicologists) and, barring our graduate trainee, range in practical experience from nine to 35 years. All are extremely skilled in chemical hazard and risk assessment and have been heavily involved in REACH-related work during the past three to four years.

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PROFILE: bibra toxicology advice & consulting

1961


SERVICE AREA BREAKDOWN Other 5%

PROFILE: Bioagri

CONTACTS

Consultancy/ advisory 20%

Laboratory 75%

Website

www.bioagri.com.br

E-mail

jlgarrigue@bioagri.fr

Head office

Rodovia SP 127 km 24, 13412-000 Piracicaba SP, Brazil

Tel

+ 55 19 3429 7700

Fax

+ 55 19 3429 7713

GLOBAL OFFICES

Contact

Dr Jean-Luc Garrigue

Directors

Dr Alvaro Vargas

 

Dr Roberto Bonetti

Headquarters Mérieux NutriSciences: Chicago, USA Headquarters Bioagri Laboratorios: Piracicaba, Brazil Sales Offices: Piracicaba (Brazil), Lyon (France), Shengai (China)

 

Dr Paulo Silva

 

Edivan Tonhi

SERVICES PROVIDED Toxicology

Celso Zaccaria Ownership

Mérieux Nutrisciences

Locations

Brazil, France, China

Founded

1991

OVERVIEW Bioagri is Latin America's leading pre-clinical contract research organisation (>1000 employees) serving the chemical, cosmetic, food, pharmaceutical and crop protection industries worldwide. Services encompass toxicity, physicochemistry, ecotoxicity, analytical and microbiological studies, and residues analysis under applicable regulatory guidelines. Laboratories are OECD, GLP-certified, accredited by AAALAC International and employ the most current equipment and technologies. Bioagri, within its parent company Mérieux NutriSciences, has the ambition to become the partner of choice of chemical industry leaders, as in addition to expertise in toxicology, its unique strengths are indeed: OO reactivity, very short decision-making centres (in Brazil, but also in France or China if necessary), OO international locations throughout Mérieux NutriSciences, able to facilitate the local coordination of projects on the spot OO integrity, scientific quality and accountability, pivotal values of Mérieux Nutrisciences for three generations, OO extreme flexibility of our project management dedicated to studies (versus cost structure) OO global network and innovative services with access to key opinion leaders (eg China, Brazil, USA, Europe) Overall, Bioagri offers to chemical, cosmetic, food, pharmaceutical or crop protection industry one of the most performing solution, with high quality standards at competitive cost for a large range of CRO services within undisputed financial robustness and international footprint. VITAL STATISTICS

2010/11

Turnover, group

US $57m

Turnover, chemical service provision

US $11m

No of offices No of countries represented Staff, group Staff, chemical service provision

Page 48

16 3 1005 250

Performs all classical acute to long-term toxicity studies in rodents, rabbits, guinea pigs and dogs, by oral, dermal, inhalation or intraperitoneal route, under supervision of an animal welfare ethical committee OO acute oral, dermal or inhalation toxicity OO acute dermal or eye irritation study OO skin sensitisation (llna, mk,bu) OO repeated dose (7-d, 14-d, 28-d, 90-d) oral or dermal toxicity OO in vivo kinetics and metabolism (ADME) (single or repeated dose for one radio-labelled substance) OO genetic toxicity (Ames test, in vivo micronucleus test) OO fertility and early embryonic development to implementation OO embryo-foetal developmental toxicity OO one or two-generation reproduction toxicity OO reproduction and developmental toxicity screening OO combined repeated dose toxicity study with the reproduction / development toxicity screening OO carcinogenicity OO combined chronic toxicity and carcinogenicity 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 biodegradability OO inherent biodegradability (aerobic) OO acute immobilisation (daphnia magna) OO algea growth inhibition (pseudokirchneriella subcapitata) OO activated sludge respiration inhibition OO soil microrganisms (nitrogen test) OO earthworm acute or reproduction toxicity (eisenia foetida) ) OO daphnia magna reproduction – 21 days 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 OO adsorption/ desorption

Chemical Watch | Global Service Providers Guide 2012


Analytical chemistry

CLIENTS

The largest number of high end chemistry equipment offering flexibility and shorter detection limits: OO ICP-MS (n = 2) OO ICP-OES (3) OO atomic fluorescence (2) OO GC-MS/MS  (40) OO LC-MS/MS (12 ) OO HPLC (80)

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

Performs qualitative/quantitative assays of the active ingredients and impurities and metabolite identification (degradation in water, soil and biological matrices).

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

Radiochemistry

CASE STUDY 2:

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

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

Microbiology Evaluates bactericidal / fungicidal properties of biocides; conducts 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. Pesticide residues Analysis of herbicide and pesticide residues in samples from field trials. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1991

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

2000

Bioagri is the first Latin America lab to be accredited for good laboratory practices (GLP) in 2000 by INMETRO (Brazil) and 2002 by OECD (Netherlands).

2009

Bioagri is the leading private CRO in Latin America, with 25,000m2 laboratory space, and more than 850 collaborators, including scientists qualified in toxicology, analytical chemistry, physicochemistry, mass spectrometry and microbiology.

2010

Bioagri is the first Latin America lab to be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

2010

Bioagri is part of Mérieux NutriSciences Corporation, With more than 40 years of experience and part of Institut Mérieux, Mérieux NutriSciences helps advance science and solutions for food safety, quality and nutrition with 4,000 professionals in 16 countries. This collaboration increases financial robustness and provides Bioagri’s clients with the highest levels of quality, customer service and worldwide technical support.

2011

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

CASE STUDY 3: Thousands of GLP pre-clinical safety studies have been conducted in developmental toxicity or systemic toxicity studies for pharmaceutical, chemical or cosmetic ingredients for worldwide companies, matching sponsor’s expectations in >95% as far as time schedule or scientific quality was concerned. STAFF SELECTION Our technical staff include about 300 hundred dedicated and professionally trained scientists qualified in mammalian toxicology (including VetD, MD, PhD, Eurotox toxicologist, experts in immunotoxicology), ecotoxicology, analytical chemistry, physicochemistry, mass spectrometry and microbiology among others. Bioagri’s testing services are reliable, timely, accurate and cost-effective. Tailormade custom services are provided to meet all of our clients’ needs.

ACCREDITATIONS GLP, OECD, AAALAC, INMETRO, ISO-17025 PARTNERS Silliker (food safety), Biofortis (CRO and R&D in nutrition) (sister companies of Bioagri within Merieux Nutrisciences) Many European partners in regulatory and toxicology expertise, working with Bioagri under confidential agreement.

Chemical Watch | Global Service Providers Guide 2012

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PROFILE: Bioagri

Mass spectrometry

CASE STUDY 1:


PROFILE: Brixham Environmental Laborator y

Industrial chemicals (REACH)

Website

www.brixham-lab.com

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

E-mail

infomaster.brixham@astrazeneca.com

Plant protection products

Head office

Freshwater Quarry, Brixham, Devon, UK

Tel

+44 (0)1803 884400

Fax

+44 (0)1803 882974

Contact

Enquiry co-ordinator

Brixham Environmental Laboratory has worked extensively for the plant protection products industry for more than 30 years, generating both ecotoxicological and environmental fate data. As well as working directly with agrochemical companies, the laboratory also works on behalf of consultancies who are preparing registration or re-registration submissions.

Ownership

AstraZeneca UK Ltd (parent company)

Biocidal products

Locations

Brixham, Devon, England

Founded

1948

CONTACTS

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

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

1

Staff, group

83

Staff, chemical service provision

83

SERVICE AREA BREAKDOWN

Brixham Environmental Laboratory is experienced in designing the appropriate testing strategy for a particular biocidal product and in agreeing that strategy with the regulatory authorities. We are able to deliver all studies required for the environmental component of the submission, including various studies listed on the Directive. Veterinary medicines Directive 2001/82/EC, as amended by Directive 2004/28/EC on the community code relating to veterinary medicinal products, includes provision for an assessment of environmental risk. Brixham Environmental Laboratory can provide the Phase I assessment and all of the Phase II testing. Human pharmaceuticals An environmental risk assessment (ERA) is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure. We can provide all phases of the risk assessment. Pharmaceuticals are unique in that the ERA takes place towards the end of a development process that will have already included a great deal of in vitro and in vivo testing of efficacy, safety, metabolism and pharmacokinetics. Brixham Environmental Laboratory has experience of interpreting these data and using them to design an intelligent environmental testing strategy. Research and development Solution driven, we work at the forefront of environmental research often acting as a central hub on cross disciplinary collaborations with a range of research institutes, funding bodies, industrial and academic partners, ensuring realism and a pragmatic application of science. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1948

Established as a marine research station for ICI Paints

1960s -70s

Environmental science began to dominate the laboratory's function

1979

First environmental laboratory to be OECD GLP compliant in Europe

1980s

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

1993

The laboratory transferred to Zeneca Limited following the demerger of ICI

SERVICES PROVIDED

1999

The laboratory became part of AstraZeneca Pharmaceuticals

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

2007

ÂŁ12m laboratory refurbishment and expansion to include state of the art facilities

2011

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

Consultancy/ advisory 20% Representation & management 5% Information 5% Laboratory 70%

Page 50

Chemical Watch | Global Service Providers Guide 2012


BEL continues to work at the forefront of environmental science, with a large publication output every year. Our expertise and testing helps to produce guidelines such as OECD, ISO, ECHA and many more. We continue to provide ecotoxicology and environmental fate testing for a very wide variety of compounds. More than 30 successful ERA submissions conducted since EMA guidelines published in 2006 Please refer to our website for our latest news, achievements and publications

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

ACCREDITATIONS

Dr Jason Snape − Environmental Foresight Business Manager

Good Laboratory Practice (GLP)

Jason is an environmental microbiologist and biochemist with 18 years' laboratory and field experience in the biodegradation and persistence of chemical products in the environment. He uses this extensive empirical experience at the interface between science and science-based policy and the development of pragmatic environmental regulations for exposure and persistence assessment. Jason is actively involved in chairing/cochairing committees, task forces and working groups. His expertise has also provided many published papers.

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

Chemical Watch | Global Service Providers Guide 2012

Dr Paul McCormack – LC/MS and MSn Specialist, Chemistry Paul has over 12 years’ experience in liquid chromatography and multistage mass spectrometry (LC/MSn). His experience includes the detection, separation, characterisation and identification of iron complexes in seawater and oilfield chemicals in crude oil and produced waters. He joined Brixham in 2005 as a consultant providing specialist knowledge of data interpretation using MSn. He has been involved with a number of research projects as well as continuing to provide technical expertise in developing LC/MSn methodology for the identification of transformation products in aquatic, soil and sediment systems. Recent research includes monitoring of active pharmaceutical ingredients for a number of AstraZeneca manufacturing sites worldwide to help develop environmental quality standards and bioanalysis of the endocrine disruptor Bisphenol-A that has been linked to human health effects. Dr Gary Roberts − Senior SHE Specialist, Environmental Fate Gary is a specialist in studying the environmental fate of biologically active chemicals. Gary’s research interests include the biodegradability of volatile, poorly water-soluble substances; the partitioning of pharmaceuticals in biosolids, soil and sediment; and the anaerobic degradation of pharmaceuticals. Gary chaired the organising committee for the ECETOC workshop: Significance of bound residues in environmental risk assessment, and currently chairs the ECETOC taskforce on this topic. He is actively involved in projects both within AstraZeneca and in collaboration with other industry and academic partners Martin Vaughan − Ecotoxicologist/Study Director Study director with 20 years of experience of ecotoxicology and environmental research techniques in GLP accredited laboratories. Ecotoxicology expertise in the aquatic, sediment and terrestrial compartments and the risk assessment of chemicals in the environment. Experience of testing with various species including fish, invertebrates, algae, macrophytes and mesocosm studies and analysing the results generated from such tests. Specific expertise in the bioaccumulation of chemicals in the environment. Active contributor to international working groups such as OECD and ILSI HESI bioaccumulation groups. Other staff BEL currently employs 83 people, from all over the world with a wide range of professional qualifications. These include internationally acclaimed scientists with doctorates and established publication records as well as individuals with professional business and management qualifications. Our specialised scientists cover a wide range of disciplines including ecotoxicology, analytical chemistry, environmental fate and environmental risk assessment, etc. 

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PROFILE: Brixham Environmental Laborator y

1948 -2012


GLOBAL OFFICES Global geographical coverage (900 offices + 330 labs in 140 countries) across OO Americas OO Europe OO Middle East, India, Russia and Africa OO Asia-Pacific SERVICES PROVIDED

PROFILE: Bureau Veritas

CONTACTS Website

www.bureauveritas.com

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

E-mail

hse@bureauveritas.com

REACH assistance

Head office

67/71 Boulevard du Château, 92578 Neuilly/ Seine, France

Tel/ Fax

+33 1 5524 7000/ +33 1 5524 7001

Contact

Philippe Lafont, HSE Services Dr Marie-Laure Héraud, Chemical SGP Mgr

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

Directors

Franck Piedelièvre, CEO

MSDS Management – REACH/CLP context

 

Philippe Donche-Gay, COO

 

Sami Badarani, CFO

Ownership

Listed private company (Paris Stock Market)

Locations

Global geographical coverage (140 countries)

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

Founded

1828

Occupational hygiene and chemical workers exposure

OVERVIEW Bureau Veritas is a world leader in conformity assessment and certification services. We help our clients to improve their performances by offering services and innovative solutions in order to ensure that their products, infrastructure and processes meet standards and regulations in terms of quality, health and safety, environmental protection and social responsibility. Bureau Veritas is recognised and accredited by major national and international organisations. From a global standpoint, Bureau Veritas services are related to: OO marine: ships and equipment classification OO industry: conformity assessment of industrial assets OO in-service inspection and verification of facilities OO construction verification in buildings, infrastructures OO certification of QHSE management systems and specific schemes OO commodities inspection and testing of raw materials OO consumer products and goods testing and certification OO government services and international trade services

Operations in industry

1929

Operations in construction

1984

Operations in government services, international trade

1988

Operations in certification

900 offices + 330 labs

Since 1993

Deployment on all continents

140

2007

Bureau Veritas listed on stock market (Paris)

48,000 employees

2008

Mining platform

200+ employees

2010

Commodities platform

€3.15bn

Turnover, chemical service provision

€15m

No of countries represented

ACCREDITATIONS

CHEMICAL SERVICES AREA BREAKDOWN Training 15%

Consultancy/ advisory 20%

IT & software 10% Laboratory 5% Information 10%

Page 52

CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1910

Turnover, group

Staff, chemical service provision

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

2010/11

Staff, group

Dangerous goods safety advisory (DGSA)

1828

VITAL STATISTICS

No of offices

Bureau Veritas delivers chemical risk prevention services, such as employee monitoring, and exposure mitigation recommendations, according to specific regulations (EU/US), to assist in setting a global approach to chemical risk management.

Representation & management 40%

Selected credentials: OO group certified against ISO 9001 for all activities and almost all locations OO accreditations for certification, inspection, testing and training services by many organisations (UKAS and IRCA in the United Kingdom, ANAB in the United States, JASANZ in Australia and New Zealand, INMETRO in Brazil etc) OO notification for European directives including pressure equipment, machinery, electrical and electronic appliances, lifts, construction products and personal protective equipment OO laboratory accreditations in 20 countries, delivered by bodies such as HOKLAS, A2LA, UKAS and COFRAC OO notified body for European directives covering electrical products and toys. Chemical Watch | Global Service Providers Guide 2012


PARTNERS

STAFF SELECTION

To offer full REACH testing capabilities, Bureau Veritas has developed partnerships with external laboratories.

Dr Gautier Vincent – Senior Toxicologist, Practice Leader

400,000 clients in various markets (aeronautics – agriculture – automotive – construction and real estate – consumer products – food – governments and public organisations – industrial equipment – international trade – IT, telecoms and electronics – maritime industry – mines and minerals – oil and gas – power and utilities – process Industries – chemical industries and chemistries – retail – services – transport and infrastructures) CASE STUDY 1: During the first REACH registration period, Bureau Veritas gained experience with the registration of not only usual substances but also very specific substances such as unstable, reactive or inorganic substances. Indeed the exemptions or adaptations foreseen in column 2 of appendices VII to X and the tools for the health and environmental assessment are not always adapted or relevant for these kind of substances. Thus, to implement the integrated testing strategy, OECD guidelines were considered and adapted protocols were developed in collaboration with laboratories. For the CSA (environmental assessment), a Tier 2 with the use of reliable and representative data from measurement campaigns was sometimes necessary to justify the risk control. CASE STUDY 2: A leading computer industry hardware manufacturer selected Bureau Veritas as its worldwide HSE compliance partner to deliver health, safety and environmental support, as required for manufacturing and administrative sites globally. As major users of chemical materials and products in the manufacture of numerous articles, Bureau Veritas supports all client requirements in meeting its HSE compliance obligations, including the range of chemical management obligations in the UK and Europe associated with REACH, GHS and chemical safety. Service aspects include: OO chemical classification OO chemical risk assessment OO chemical exposure assessment and control OO design and delivery of technical training including for chemical hazards and control OO statutory safety compliance assessments and audits CASE STUDY 3: For the benefit of a chemical products processing company that wished to sell chemicals/chemical products at the European marketplace level, Bureau Veritas has acted as an independent third party handling confidential information from sub-suppliers. On this basis, Bureau Veritas has taken care of client labelling, classification, notification to authorities issues, and managed their safety data sheets (SDS) in various languages. In real terms the company has called Bureau Veritas to ensure that regulation, documentation and other related procedures in this very chemical area were met so that the company can focus on their core business.

Chemical Watch | Global Service Providers Guide 2012

Simon Hodge – Chemical Practice Leader Simon holds a masters degree in environmental science, backed up by 30 years’ experience delivering health, safety and environmental scientific support to clients spanning a wide range of industrial and commercial sectors. He specialises in hazardous material and chemical risk assessment, management, exposure and control and has led the Bureau Veritas UK chemical management service for the past ten years, developing a range of chemical assessment and consultancy services to assist clients in achieving compliance with regulation. Jan Henriksen – Chemical Safety Operation Manager Jan has regulatory, commercial and research experience worldwide spanning more than 26 years. He has worked with risk assessment and dangerous goods related services in a wide selection of industries, spanning from automotive to offshore production and has, based on this experience, developed Bureau Veritas’s dangerous goods safety advisory concept. Working worldwide with focus on implementation of the concept in international companies, he has gained a deep understanding for the logistic and commercial problems that need to be overcome, to be able to move chemicals nationally and internationally. To support the logistic tasks in relation to dangerous goods, he is also the product manager for the unique internet based software solution “DGdoc.net”, that can ensure legal performance when delivering documentation for transport. Cathy Alvarez – Senior Ecotoxicologist Cathy is an ecotoxicologist who has seven years’ experience in regulatory ecotoxicology and environmental risk assessment. She worked within the French Competent Authorities, in charge of the risk assessment of new and existing substances and the technical instruction of substances registration dossiers. She was also an active member of the European Stakeholder Experts Group in charge of the development of the CSA/ CSR guidance. Melodie Caraty – Socio-Economic and Sustainability Analyst Melodie is a socio-economic analyst. She is in charge of developing socio-economic analysis in the frame of REACH authorisation dossiers, especially through a cost-benefit approach. She has previously worked on environmental questions for international institutions (World Bank, UNEP, WTO etc) and on economic and social issues on the West Bank. Joseph J Fater, CIH – Industrial Hygiene Practice Leader Joe has more than 35 years’ experience in industrial hygiene consulting and health, safety and environmental (HSE) auditing, with an emphasis on chemical exposures and industrial operations. He is the Bureau Veritas US National Practice Leader for industrial hygiene services and also provides litigation support services and represents clients during contested occupational safety and health administration (OSHA) citations.

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PROFILE: Bureau Veritas

CLIENTS

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


GLOBAL OFFICES Cardno ENTRIX and Cardno Ltd have offices in the US, Australia, Europe, UK, Canada, New Zealand, South America, Indonesia, and United Arab Emirates SERVICES PROVIDED

PROFILE: Cardno ENTRIX

CONTACTS

Product stewardship and compliance programme design

Website

www.cardnoentrix.com

E-mail

John.Phillips@cardno.com

Head office

4520 East Ashman Road, Midland, MI 48642, US

Tel

+1 517 347 7693

Fax

+1 517 281 1435

Contact

John Phillips

Directors

Todd Williams, President

 

John Phillips, Vice President and Technical Director

 

Rich Hubner, Senior Consultant

 

Paul Mehrle, Senior Principal

Ownership

Cardno Ltd (parent company)

Locations

United States, South America, Canada

Founded

1984

Cardno ENTRIX can provide all the strategic and tactical advice required to establish a comprehensive global product stewardship and regulatory compliance program. Our services include: OO development of an overall product stewardship and regulatory compliance strategy that meets both corporate and business unit objectives OO design of tactical plans to achieve strategic objectives and meet global regulatory requirements OO integration of product stewardship and compliance into business plans OO identification of product information gaps OO design and oversight of toxicology and environmental testing plans to fill information gaps OO interpretation of test results OO advocacy with government agencies OO evaluation (audits) of supply chain risk management strategies. Product safety assessments

OVERVIEW Cardno ENTRIX is widely considered a premier human health, environmental, and natural resource management consulting firm for its strategic planning and innovative approaches in conducting risk assessments, cost-effectively managing environmental liabilities, and providing sustainable business solutions for global clients. Our integrated team of human health toxicologists, ecotoxicologists, environmental fate chemists, industrial hygienists, regulatory toxicologists and economists have worked successfully with private clients in the petrochemical, chemical and consumer product industries to develop global stewardship and compliance programmes, manage critical issues and meet REACH, TSCA, FIFRA and other chemical regulatory requirements.

Cardno ENTRIX is widely considered a premier human health and environmental consulting firm for conducting science-based risk or safety assessments and providing sustainable business solutions for global clients. Our services includes: OO product safety assessments of chemicals and consumer products OO US TSCA compliance OO chemical safety assessments for REACH registration OO safety and socioeconomic impact assessments for REACH authorisation OO development of science-base green chemistry strategies and programmes OO endocrine disruptor screening and assessments. Green chemistry evaluations

VITAL STATISTICS Turnover, group

n/a

Turnover, chemical service provision

n/a

No of offices

40

No of countries represented

3

Staff, group

1200

Staff, chemical service provision

50

SERVICE AREA BREAKDOWN Consultancy/ advisory 100%

Page 54

Cardno ENTRIX experts can help clients understand the regulatory processes being proposed for “green chemistry” and develop a system to meet their specific needs. Green chemistry initiatives typically require very diverse technical and business solutions. Cardno ENTRIX scientists and regulatory experts have developed green chemistry ranking systems that are: OO credible in terms of criteria and rational OO transparent, standardised and easy to explain OO based on scientifically valid principles OO globally applicable, incorporating a variety of international, regional, federal and state regulatory criteria OO quantitative in relative ranking OO supports research and development of new products. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1984

ENTRIX founded

2009

expanded product safety and compliance practice

2010

merged with Cardno Ltd

2011

#1 ranking on Zweig Hot Firm List

2011

#6 ranking on ENR Top Environmental Sciences firm

Chemical Watch | Global Service Providers Guide 2012


OO OO OO OO OO OO OO OO

Chemical manufacturers Speciality chemical firms Agrochemical firms Energy firms Petrochemical firms Silicone chemical producers US and European trade associations Law firms

TESTIMONIALS Client quote “As we transitioned into our own company, the Armored AutoGroup needed to develop a plan to outsource most of its product stewardship and compliance work. We got a recommendation that Cardno ENTRIX could help us with a transition plan and were also able to help us with our international compliance needs. We found that the team at Cardno ENTRIX were very knowledgeable and efficient and were able to assist us in some immediate needs while we were working on the transition plan.” CASE STUDY 1: Human health and environmental exposure assessments for REACH registration of major surfactant categories Summary Cardno ENTRIX conducted human health and environmental exposure assessments for REACH registration of two major surfactant categories. This work was conducted for a consortium including some of the highest profile global manufactures of cleaning products and their chemical components. The client supplied Cardno ENTRIX with IUCLID information for the surfactants being registered. Cardno ENTRIX worked hand-inhand with consortium member technical staff, and conducted human health and environmental risk assessments for approximately 40 different use scenarios using ECETOC TRA and CONSEXPO. PNECs, DNELs and DMELs have also been established for clients CASE STUDY 2: Hydraulic fracturing fluids green ranking project Summary Cardno ENTRIX was hired to develop a prototype "green" ranking system for a major oilfield services company. The prototype developed was quantitative in nature to allow for relative "green" product development of “fracking” fluids and marketing decisions. This science-based system is consistent with regulatory schemes, like globally harmonised system for hazard classification (GHS), and separately ranks three sets of criteria (human health, environmental, and physical impacts). The ranking can be provided for individual chemicals or chemical mixture. It also provides context and risk-based prioritisation through the use of relative ranking scale. STAFF SELECTION John Phillips – Vice President and Technical Director Global Product Safety and Compliance Practice Mr Phillips is vice president and technical director of the firm’s global Product Safety and Compliance practice. In this capacity, he provides clients with innovative strategies and systematic solutions that identify and resolve critical environmental, health and regulatory issues. He brings a wealth of experience in issues management, regulatory toxicology, and product stewardship to his work. This expertise stems from more than 30 years of experience with a major multinational chemical company, where he served as the global director of Environmental, Health and Safety responsible for global chemical policy (such as SAICM, REACH, TSCA, and the California Green Chemistry Initiative) and advancing product stewardship programmes across the chemical industry. John was a member of the Business and Industry Advisory Council to the OECD, a member of the industry delegation to the United Nations Environmental Program and co-led the development of the Global Product Strategy at the International Council of Chemical Associations. Chemical Watch | Global Service Providers Guide 2012

Rich Hubner – Senior Consultant Mr Hubner leads the product safety and compliance practice in the Washington, DC area. He is a well respected public health expert and risk analyst with more than two decades of experience in the fields of strategic risk management, toxicology, human health risk assessment, product stewardship, industrial hygiene, risk communication, and regulatory affairs. He consults with clients in a range of product safety and compliance matters, including product registration, product stewardship and regulatory advocacy. Rich is versed in national, state and international regulatory arenas, having worked extensively with regulatory agencies and in helping private sector clients navigate complicated issues. Christina Clements – Senior Staff Scientist Ms Clements is a senior staff scientist with nearly 20 years’ experience at a major multinational chemical company in toxicology and regulatory compliance, hazard communication, and environmental health and safety. As a six-sigma black belt, her efforts related to chemical regulatory compliance led to the establishment of global business rules for the creation of safety data sheets, which helped improve performance by highlighting areas of non-compliance or deviation. Christina also developed and provided training on Trade Secret compliance, as well as corporate hazard communication reporting. She is extremely knowledgeable in the varying national requirements of different regions around the world, and is well-versed in the specific requirements and legislation of OSHA, ANSI, REACH, and the GHS for hazard classification and communication. Kent Washburn – Senior Consultant Dr Kenneth Washburn is a senior consultant and a highly regarded product safety expert with extensive experience across the petroleum, specialty chemical and contract research industries. He is a diplomat of the American Board of Toxicology and brings a wealth of experience in product stewardship, regulatory affairs, hazard communication and litigation support to Cardno ENTRIX clients. Dr Washburn spent six years working as a senior product safety and toxicology professional at an international chemical firm. In this capacity, he was a lead member of the team responsible for the optimisation and implementation of corporate product stewardship programmes across diverse business units as well the lead toxicologist responsible for managing mammalian toxicology and environmental toxicology testing used to support product registration, environmental permitting, hazard communications, and litigation support efforts. Denise Kay – Senior Consultant Dr Kay is a senior consultant with a unique interdisciplinary base in ecology, ecotoxicology and microbiology that provides an insightful perspective on environmental fate, transport, bioavailability and bioaccumulation of chemicals. Dr Kay’s expertise includes design, management and interpretation of toxicity data for use in risk assessments, and planning and conducting screening level and baseline ecological risk assessments on a variety of chemicals. In addition, she has extensive knowledge and experience in chemical partitioning, sorption reversibility, bioavailability and environmental fate of chemicals. Dr Kay is an experienced manager of projects related to chemical product compliance and ecological risk assessments. Support team Cardno ENTRIX has experienced staff scientists in the fields of ecotoxicology, human health toxicology, chemistry, industrial hygiene, regulatory toxicology, and resource economists. Our depth of personnel and experienced staff support our senior professionals in performance of technical work and project management as well as providing costeffective deliverables to clients.

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PROFILE: Cardno ENTRIX

CLIENTS


GLOBAL OFFICES CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, France CEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, Belgium CEHTRA UK – 6th Floor City Gate East, Toll House Hill, Nottingham, NG1 5FS, UK CEHTRA India – 2A Vandana Building, 11 Tolstoy Marg, New Delhi-110001, India CEHTRA NA – 24 Ivy Lea Crescent, Toronto, Canada CEHTRA NL – Zonnemare 12, 4571 CX Axel, The Netherlands

PROFILE: CEHTRA

CONTACTS Website

www.cehtra.com

E-mail

cehtra@cehtra.fr

Head office

43-45, rue Laroque, 33560 Saint-Eulalie, France

SERVICES PROVIDED

Tel

+33 5575610

Regulatory dossier services

Fax

+33 5575620

Contact

Paul Thomas

Directors

Pierre-Gérard Pontal, President

 

Michel Guilhem, CEO

 

Philippe Adrian, Director CEHTRA Europe

 

Paul Thomas, Director CEHTRA Lyon

CEHTRA provides clients with bespoke services for the production of regulatory dossiers, be that in the field of general chemicals, cosmetics, biocides, pesticides or pharmaceuticals. We have all the competencies inhouse to do all or any part of a project. 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).

Peter Jenkinson, Director CEHTRA UK

Industrial hygiene and worker exposure studies

Jason Nugent, Director CEHTRA North America

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

Nathalie Ledirac, R&D Director

Marc Aerssens, Director CEHTRA Netherlands Ownership

Private company

Locations

Bordeaux FR, Brussels BE, Lyon FR, Nottingham UK, Delhi IN, Toronto CA, Axel NL

Founded

2001

Consortium and Sief management

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

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

7

No of countries represented

6

We offer a complete service that can either be used as a stand-alone or may be combined with the technical services provided by CEHTRA. We make sure that the milestones and deadlines of your project are met while ensuring the spirit of fairness and transparency, at the same time maintaining strict confidentiality for those areas that matter for your business. We can help you with the preparation of consortium agreements, maintaining contact lists, archiving, billing and all the aspects required for effectively running consortia and Siefs. Expert services

 

Our experts have been successful in proposing and supporting complex issues for CMR classifications, modifying acceptable exposure limits and other critical substance-related end-points at member state or EU level. We have also successfully used our knowledge in clinical toxicology and epidemiology to support several of our clients in court cases.

Staff, group

50

REACH OR Services

Staff, chemical service provision

40

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

SERVICE AREA BREAKDOWN

Authorisation Services

Training IT & 2% Other software 2% Legal 4% 2% Information 5%

CEHTRA has teamed up with other recognised experts in the field of authorisation and created a joint venture, ChemAdvocacy, to provide a full service including socio-economic analysis. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Representation & management 10% Consultancy/ advisory 75%

Page 56

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 offices in Canada and The Netherlands

2012

Opening of ChemAdvocacy

Chemical Watch | Global Service Providers Guide 2012


ACCREDITATIONS

Peter Jenkinson PhD, GT − Director and Manager of UK Office

Number of European registered toxicologists (ERT) and other certificates: OO 5 ERTs OO 1 IOB/UKEMS GT OO 2 Chartered chemists (MRSC) OO 1 CIH (industrial hygiene)

Peter Jenkinson has a PhD in reproductive toxicology and 30 years' experience in the CRO industry specialising in genetic toxicology. Latterly he was the director of the Chemical Business Unit at Harlan Laboratories with a primary role of developing the REACH services of the company. In March 2010 he joined CEHTRA to open the UK office and has provided expert toxicology advice, particularly for study monitoring and data interpretation.

LTS REACH OR, ChemService GmbH, ecoonline, Chris Braun Consultancy CLIENTS Chemical companies, flavours and fragrances, plant protection industry, biocides, veterinary products, pharmaceuticals, cosmetic companies 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: REACH dossier rescue Late summer 2010, CEHTRA was asked to help on a problematic incomplete and flawed R50/53 dossier. Issues: OO environmental and HH studies of limited value OO re-work needed for environmental ES OO failed consumer and environment RCR CEHTRA response: OO total review of available studies, WOE approach, July OO short-term Ecotox. study performed to declassify, Aug OO all ES completely re-worked and taken to Tier 2, Aug/Sept OO dossier compiled, draft CSR sent early Sept OO consortium comments addressed, submitted end Sept. CASE STUDY 2: Declassification of a carbamate insecticide Based on sparse findings in the toxicology dossier and an open literature publication, the substance was proposed to be classified as R60, R62, R63, R64. The toxicology data were reviewed and a position paper written to demonstrate the lack of relevance of the finding for reproductive toxicity. An ad-hoc study was designed and conducted which demonstrated that the alleged findings in the publication were flawed. Our expert had face-to-face or telephone discussion with several MS experts from the C&L commission. Our expert attended the C&L meeting at ISPRA to present the case and answer to expert questions. At the end of the meeting, all R6X classifications were cleared. STAFF SELECTION Paul Thomas PhD, ERT − Director and Manager of Lyon Office Paul Thomas has a PhD in aquatic ecotoxicology and 16 years' experience with industrial chemicals, agrochemicals and biocides. He joined CEHTRA in 2008 as director of CEHTRA Lyon specialising in REACH-related services and is manager of the CEHTRA ecotoxicology team. Paul has contributed strongly to numerous successful registrations including several fragrance molecules.

Chemical Watch | Global Service Providers Guide 2012

Philippe Adrian PhD − General 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 Agrochemie and FMC. In 2001 he created CEHTRA with Pierre-Gerard Pontal and manages the environmental fate team and has developed modelling expertise for pesticides according to current models as well as biocides using relevant TGDs. Pierre-Gérard Pontal MD, ERT− President of CEHTRA Pierre-Gérard Pontal is a medical doctor and has 26 years of experience with industrial chemicals, agrochemicals and biocides. He has worked for Rhone-Poulenc Chimie and Aventis cropscience in the product safety and risk assessment group. He has been a member of numerous task forces such as ECPA, ECETOC and UIPP and since 1994 a member of the EUROPOEM group. He is a recognised expert for operator exposure, having conducted more than 20 worker exposure studies. Michel Guilhem MSc – CEO Michel has three master’s degrees in chemical, environmental and safety engineering and 30 years of experience, from R&D and regulatory affairs project management at Dow Chemical to management positions in worldclass consultancies (ERM, ENVIRON) and in the pharmaceutical industry EHS services (Janssen-Cilag). He joined CEHTRA in 2009 and, beyond his key management responsibilities, he is in charge of expology and occupational health services. Nathalie Ledirac PhD, ERT – R&D Director Nathalie has a PhD in cellular and molecular aspect of biology and 12 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). Jason Nugent MSc – Director 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. Marc Aerssens PhD – Director CEHTRA NL Marc has a master’s degree in organic chemistry with, and 12 years of experience in, the registration of industrial chemicals, pesticides and biocides and has held senior management positions in industry (ICL-IP) and regulatory consultancy (Rivendell International). Prior to working in regulatory affairs he gained 13 years of experience in the manufacturing of chemicals (ICL-IP). He joined CEHTRA in 2011 and provides key services with regards to consortium management.

Page 57

PROFILE: CEHTRA

PARTNERS


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

E-mail

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, IUCLID5 compilation and registration submission, letter of access management, Sief management and late preregistrations. 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. Other chemical regulatory needs

OVERVIEW Centro Reach was founded on 20 February 2007 on the initiative of Federchimica and Assolombarda. Federchimica, the Italian Chemical Industry Association, controls 53.3 % of the capital stock, the remaining part is held by ten other industrial associations. The company mission is to provide professional consultancy support to chemical industry firms and downstream users, helping them meet the REACH, CLP and other Regulations concerned with the management of chemicals and safety in the workplace. Centro Reach assists chemical manufacturers and importers in the dossier preparation for substance registration either on an individual basis or in consortia and has participated or is particpating 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

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 2007-2011 more than 2,000 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 cooperation agreements Involvement in more than 15 national and EU consortia Intensive training activities involving almost 500 professionals, both in-house and in-company courses

2010

Individual registrations for 95 companies successfully submitted. Management and involvement in 20 consortia 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. Cooperation with Reach Global Services ( RGS ) for substance notifications of Italian companies in Turkey

2010/11

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 Other 5% Training 20%

Legal 5% Information 5% Representation & management 10%

Page 58

Consultancy/ advisory 55%

Chemical Watch | Global Service Providers Guide 2012


ACCREDITATIONS

STAFF SELECTION

ISO 9001 certification under progress

Bruno Brianzoli – Coordinator

Reach Centrum, Certiquality, Mario Negri Institute, Assoservizi, Intertek, DGM Italia, Field Fisher Waterhouse, PriceWaterhouseCoopers, Lenviros, ARPA Em Romagna, others CLIENTS Mainly SMEs but also companies like MAPEI, BASF Italia, Bracco, Polynt, Clariant Italia, DSM Italia, Polimeri Europa, others as well as non-Italian customers CASE STUDY 1: EU Project ORCHESTRA Centro Reach is working in partnership with the M Negri Institute and other Italian and European subjects in the European Union's Seventh Framework Programme “Organising dissemination on results of projects on chemical evaluation, spreading techniques for risk assessment (ORCHESTRA)". Non testing methods (NTM) such as in-silico methods will be very important to 2018 registrations, which will see mostly SMEs involved in the registration of more than 20,000 substances. ORCHESTRA addresses the strategic questions concerned with a broad, systematic dissemination and exploitation of the research 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 will be concluded at the end of 2012. further information can be found on the ORCHESTRA dedicated website CASE STUDY 2: Titaniumdioxide ( TiO2 ) study in nanosize under REACH Centro Reach in cooperation with ARPA E Romagna has simulated a IUCLID 5 dossier for a volume up to ten tons/year covering the 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.

Chemical Watch | Global Service Providers Guide 2012

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 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 250 in-company activities and visits.

Page 59

PROFILE: Centro Reach

PARTNERS


SERVICES PROVIDED Regulatory consulting (M)SDS authoring Label statement creation GHS classification REACH only representative service and support CLP classification and notification Global product registration support Transportation classification EHS&T compliance managed services

PROFILE: ChemADVISOR

CONTACTS Website

www.chemadvisor.com

E-mail

info@chemadvisor.com

Head office

811 Camp Horne Road, Suite 220, Pittsburgh, Pennsylvania 15237, USA

Tel

+1 412 847 2000

Fax

+1 412 847 2010

Contact

Matthew Kaus, Nathan Peters, Janet Neal

Directors

Andrew Dsida, President

 

Darlene Susa-Anderson, COO and VP EH&S

Ownership

Private Company

Locations

US, Belgium

Founded

1986

Regulatory training Hazard communication Globally Harmonised System REACH Country specific training: OO China OO US OO Japan OO Korea OO Canada Custom designed courses that address your specific regulatory issues Regulatory databases

OVERVIEW

LOLI database Transportation advisor database ChemADVISOR online OHS pure substance database EHS&T data elements LOLI-SAP EHS&T compliance suite

Since 1986, ChemADVISOR, Inc has been the chemical industry’s indispensable source of environmental health safety and transportation information. Specialising in providing regulatory consulting services, products and training, ChemADVISOR has a solution ready to meet your compliance needs. Our LOLI database is the largest and most comprehensive regulatory database available, providing a single source of world-wide regulatory information at your fingertips VITAL STATISTICS

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

3

No of countries represented

Global

Staff, group

70

Staff, chemical service provision

60

SERVICE AREA BREAKDOWN Training 5% IT & software 15%

Information 40%

GLOBAL OFFICES United States, Belgium

Consultancy/ advisory 30%

Representation & management 10%

1986

Company founded

1988

LOLI database developed

2001

Transportation advisor database developed

2004

Belgian office opened

2004

SAP solution developed

2005

LOLI database grows to 1,000 lists

2008

REACH services offered

2008

ChemADVISOR purchases OHS

2010

LOLI database reaches over 3,000 lists from 100 countries

2011

ChemADVISOR Online replaces LOLI-On-Line

2012

LOLI database reaches 4,000 lists from 107 countries

PARTNERS Wercs, BNA, ICC, the Compliance Center, Dialog, Enablon, Formulator, ISRI, JCDB, Lisam, Locus, Hazox, Right Answer, Safetec, Selerant, Sitehawk CLIENTS ChemADVISOR’s customers are manufacturers and distributors who are seeking best in class support for their chemical regulatory compliance efforts. We provide support to organisations who manufacture bulk chemicals, specialty chemicals, pharmaceuticals, cosmetics, petrochemicals, food products, consumer products and manufacturing. CASE STUDY 1: LORD Corporation LORD Corporation is a user of the SAP EH&S module. ChemADVISOR successfully converted their data provider from a third party source to ChemADVISOR’s LOLI-SAP Solution.

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Chemical Watch | Global Service Providers Guide 2012


Jennifer Mahoney – EHS Consulting Services Team Leader

ChemADVISOR manages the (M)SDS authoring, maintenance and distribution processes for many of our clients, using a variety of both ChemADVISOR and third party software, as dictated by the needs of the client.

Jennifer L Mahoney has worked at ChemADVISOR, Inc since August 2004, and is currently team leader, Consulting Servces. In this role, Ms Mahoney is responsible for the team of experts creating and maintaining material safety data sheets and label documents, and providing global regulatory compliance assistance for ChemADVISOR’s clients. She is also involved with the development and testing of ChemADVISOR’s (M)SDS authoring software system, ChemSDS+, and she provides customer training and technical support for this product. In addition to ChemSDS+, Ms Mahoney and her team are trained in a number of authoring platforms including SAP EHS, WERCs, and Intelligent Authoring. Ms Mahoney also serves as an instructor for a variety of ChemADVISOR’s training courses including those on globally harmonised system (GHS) and EU classification and labelling. Ms Mahoney graduated with a BSc honours degree from Walsh University with a double major in chemistry and biology. Her previous work experience includes time in R&D and quality assurance for a large specialty chemicals manufacturer. She is a member of the American Chemical Society (ACS) and the American Conference of Governmental Industrial Hygienists (ACGIH), and is chair of the Professional Development Committee of the Society for Chemical Hazard Communication (SCHC).

CASE STUDY 3: Product registrations ChemADVISOR has assisted our clients in performing product registrations around the world, from the general identification of country specific requirements, to the hands-on guidance in submitting the required documents. STAFF SELECTION Darlene Susa Anderson – Chief Operating Officer and Vice President of Environmental Health and Safety Darlene Susa-Anderson is vice president, EHS Services at ChemADVISOR, Inc. She received her MS degree in pharmacologytoxicology from Duquesne University and her MS degree in information science from the University of Pittsburgh. Darlene received her BA degree from Carlow College, Pittsburgh, where she graduated Summa cum Laude with a double major in biology and mathematics. Darlene's 25+ years of experience include employment at the former Gulf Oil Corporation, Koppers Company, Calgon Corporation, and Fisher Scientific. Darlene's immediate past position prior to employment at ChemADVISOR was director of Regulatory Affairs and Quality Assurance at Fisher Scientific. Ms Susa-Anderson co-chaired the Chemical Manufacturers Association (now known as the American Chemistry Council) Labelling work group to revise the ANSI Standard for Industrial Chemicals – Industrial Labelling (ANSI Z1291-1999) and was a member of the work group that revised the 1994 edition of this same standard. She also was a member of the work group that revised the ANSI Standard for Industrial Chemicals – (M)SDS Preparation (ANSI Z4001-1998). Ms Susa-Anderson served as program co-chair for the Society for Chemical Hazard Communication (SCHC) and is currently in her second two year term on its board of directors where she is currently serving as chairperson. Wolfgang Urhahn – REACH Services Team Leader Wolfgang Urhahn is a regulatory compliance specialist with ChemADVISOR, Inc at the company's headquarters in Pittsburgh, Pennsylvania since 2008. As a member of ChemADVISOR's regulatory database team, Mr Urhahn tracks and maintains regulatory information concerning the European Union (EU) and Germany. He is also member of ChemADVISOR's REACH team and serves as an instructor for the company's REACH training courses. Mr Urhahn has 20 years of professional experience, primarily in research and product development and EHS services. This includes five years in the pharmaceutical industry, one year at 3M Europe Laboratories, and more than 12 years with the Henkel Corporation as an EHS manager for product safety in the EMEA region. In addition, he served in several working groups regarding REACH and hazard communication on a national and EU level. Wolfgang's immediate past position prior to employment at ChemADVISOR was head of Regulatory Affairs and Product Safety EMEA at Henkel Headquarters, Division of Consumer and Construction Adhesives, in Düsseldorf, Germany. He graduated from the technical college associated with the RWTH University Aachen in Germany with a four-years degree in technical chemistry and environmental science. He is a native German speaker, but is also fluent in English.

Chemical Watch | Global Service Providers Guide 2012

John Kowalski – US Regulatory Expert John J Kowalski is a certified hazardous materials manager (CHMM) with a diverse and extensive background in the areas of environment, health and safety (EHS) and chemical regulatory compliance. He has more than 25 years of professional experience, primarily in the manufacturing sector. This includes more than ten years with the Coatings and Resins Group of PPG Industries and five years with the former Calgon Corporation, which is now a part of Nalco Company. Mr Kowalski has worked as a senior regulatory specialist for ChemADVISOR, Inc since 2004. His duties there include maintenance of a chemical regulatory database, development and presentation of training courses, and consulting. He also assists with sales and marketing efforts on an as-needed basis. Mr Kowalski received his BSc degree in chemistry from Duquesne University. He is a member of the Alliance of Hazardous Materials Professionals (AHMP) and former president of the Three Rivers Chapter Caroline Miller – Global Hazard Communication Expert Caroline W Miller is a hazard communication specialist at ChemADVISOR, Inc, where she is responsible for authoring and reviewing material safety data sheets and Globally Harmonised System (GHS) classifications and for preparing documentation for the SAP EH&S expert rules. She is also an instructor for ChemADVISOR's material safety data sheet (M)SDS authoring, SAP EH&S (M)SDS authoring, and Control Banding courses. Ms Miller holds a BSc degree in industrial hygiene from Clarkson University and an MSc degree in engineering management from Syracuse University. She is a certified industrial hygienist (CIH) and a certified safety professional (CSP). Previously, Ms Miller was an environmental, health and safety (EH&S) consultant for manufacturing, service, and construction industries for eight years. In this capacity, she was responsible for auditing, monitoring, preparing plans and reports, and training. Additionally, Ms Miller worked for a pharmaceutical company in their corporate EH&S department for ten years. In this capacity, she supported health and safety programmes at various facilities, maintained injury/ illness and hazardous materials databases, and conducted regulatory reviews.

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PROFILE: ChemADVISOR

CASE STUDY 2: (M)SDS authoring


GLOBAL OFFICES

Website

www.chemservice-group.com

Chemservice GmbH, Worms, Germany Chemservice SA, Grevenmacher, Luxembourg Chemservice Asia Co Ltd, Seoul, Korea Chemservice Ltd Sti, Bodrum/Mugla, Turkey Chemservice EHNS GmbH, Worms, Germany Consortia Management GmbH, Worms, Germany ChemCehtra S.A.S., Bordeaux, France

E-mail

info@chemservice-group.com

Head office

Chemservice GmbH

SERVICES PROVIDED

 

Von-Steuben-Str. 13

 

D-67549 Worms, Germany

Tel

+49 (0)6241 95480 0

Fax

+49 (0)6241 95480 25

Contact

Karl-Heinz Reis

Directors

Dr Dieter Drohmann, Managing Director

Ownership

Privately owned group of companies

Locations

Germany, Luxembourg, Korea, Turkey, France

Founded

2007

PROFILE: Chemservice

CONTACTS

Global regulatory affairs consulting Chemservice provides a broad range of services designed to assist clients in preparing for and in complying with international and national chemical control legislation. The application range for chemistry is extensive. Therefore, chemical control legislation is comprehensive in order to assure product safety, producer liability and consumer and environmental protection to regulate the marketing of chemical substances. Beside inventory notifications we conduct registrations of biocides, plant protection products, cosmetics, and compile dossiers for food contact clearances and food and feed additive petitions. REACH and GHS/CLP

OVERVIEW The Chemservice vision is to be the leading global regulatory affairs consulting company by supporting our clients around the world in gaining competitive advantage through the regulatory process. In-depth experience in regulatory affairs and international chemical control legislation, toxicology, risk assessments and environmental sciences. Our substantial network in and knowledge of industry, academia, regulatory bodies and governments will be beneficial in solving regulatory issues. Different in-house disciplines (chemists, chemical engineers, toxicologists, env scientists, agronomists, biologists, veterinarian, regulatory specialists etc) enables broad issue addressing. VITAL STATISTICS

7 5

Only representative and third party representative

Turnover, group

ca €3m

Turnover, chemical service provision

ca €3m

No of countries represented Staff, group

26

Staff, chemical service provision

24

SERVICE AREA BREAKDOWN Other Training 5% 5% IT & software 10% Information 15%

Representation & management 20%

Page 62

Consultancy/ advisory 45%

Consortia, Sief and letter of access management Independent secretariat, trustee and accounting services to REACH consortia and Siefs in order to enable the chemical industry and its value chain to fulfil their registration obligations according to the REACH Regulation. The automated online letter-of-access tool provides an efficient LoA management for Sief members to acquire access rights for a specific substance for the submission of the joint REACH dossiers. Moreover, it will help to reduce resources at lead registrant and consortia level and offers professional accounting support – including trustee account management.

2010/11

No of offices

We provide our clients with strategic and technical support to be prepared for REACH and GHS/CLP. The technical support includes, for example, data gap analysis, registration cost evaluation, testing strategy proposals, placing/monitoring/reviewing of studies, pre-registrations and registrations, dossier preparation, compilation of chemical safety reports, exposure, hazard and risk assessments, PBT/vPvB evaluation and support on authorisation, REACH-IT and IUCLID5 assistance, CLP notification, safety data sheet and label creation.

We act for manufacturers outside the EU as only representative and cover fully the registration and pre-registration obligations. The importers of that non-EU manufacturer would no longer have duties as importers, but will be regarded as downstream users. Only one registration is needed by the only representative. Moreover, we act as only representative for non-EU manufacturers of articles, which intentionally release substances and we act as third party representative (of a Community Entity) according to REACH Article 4. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Start-up in Luxembourg

2008

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 in Quarter 1, Office opening in USA in Quarter 2

Chemical Watch | Global Service Providers Guide 2012


ACCREDITATIONS

STAFF SELECTION

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

Dr Dieter Drohmann – Managing Director

PARTNERS

OO

CLIENTS Consultant for the chemical industry and its value chain, including OEMs. Our clients range from multinational chemical companies to SMEs, formulators, traders, retailers and OEMs. We do not disclose our customers publicly, but provide reference names and testimonials upon request. TESTIMONIALS Persons who request testimonials or references will be provided with them upon individual request. CASE STUDY 1: Global inventory strategy and registration We have significant experience in global inventory registrations and conducted ca 100 notifications to the Turkish inventory and 300 nominations to the inventory in Taiwan. For one client we supplied a global inventory strategy for a new polymer, and for multiple clients we conducted notifications to chemical inventories like Australia (AICS), Canada (DSL), China (IECSC), Korea (ECL), New Zealand (NZIOC), Philippines (PICCS) and USA (TSCA). CASE STUDY 2: REACH-Code-Model REACH does not distinguish between direct and indirect imports into the EU. Therefore, non-EU business followed by export to EU is more complicated – in particular if several non-EU steps along the supply chain are involved and substances have been formulated into preparations with confidential composition. In a multi-level non-EU supply chain the manufacturer of a substance usually does not know through which channels, in which products and finally how much volume of his substances is being imported into the EU. It is an essential business secret (CBI) of traders or formulators what the components of their products and who their suppliers and customers are. Neither the nonEU manufacturer (represented by the OR) nor the importer can fulfil their obligations without disclosing CBI and potentially leading to loss of business. Chemservice has developed a software based solution to track indirect EU export and many companies with multi-step non-EU supply chains have signed up to this system already. This software can be used as well by only representatives to track their volumes and importers and is commercially available.

OO

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

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

PhD in chemistry >10 years of experience in GLP and GMP quality assurance in the field of pharmacology and plant protection products, and nanoparticles

Dr Günter Spang – Senior Regulatory Affairs Advisor OO OO

PhD in agronomy >15 years of experience in regulatory affairs consulting, including risk assessments and dossier preparation

Natalia Jansen-Bouriatchenko – Regulatory Affairs Advisor OO OO

master in biochemistry >15 years of experience in analytical and ecological chemistry, ecotoxicology and toxicology

Karl-Heinz Reis – Senior Regulatory Affairs Advisor OO OO

master in biology >20 years of experience in the field of risk assessments, PBT assessments and CRO study director

Thomas Schaefer – Manager Data and System Services OO OO

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

Yong Jiang – Regulatory Affairs Advisor OO OO

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

Ah-Reum Seo – Regulatory Affairs Advisor OO OO

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

CASE STUDY 3: REACH dossier work Chemservice has experience with ca 120 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 and chemical safety reports and extended safety data sheets were successfully completed. Furthermore, we have acted on behalf of our clients in more than 350 CLP-notifications.

Chemical Watch | Global Service Providers Guide 2012

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PROFILE: Chemservice

Our partner companies can be viewed on our website.

OO


SERVICES PROVIDED

PROFILE: ChemService Srl Controlli e Ricerche

REACH

CONTACTS Website

www.chemservice.it

E-mail

c.marchiori@chemservice.it

Head office

Via Fratelli Beltrami 15, 20026 Novate Milanese (MI), Italy

Tel

+39 2 3569961

Fax

+39 2 38201446

Contact

Cristina Marchiori

Directors

Giacomo Ravetta, Managing Director

Ownership

Private company Novate Milanese (MI), Italy

Founded

1992

Plant protection products (PPPs) and biocides Preparation and submission of dossiers for authorisation of active substances and for registration of formulated products. Technical equivalence of active substances. Development of regulatory strategies. Literature searches, data gap analysis, robust study summaries. Exposure assessment (human, environment) and efficacy assessment (scientific monitoring of efficacy trials and preparation of biological assessment dossiers-BAD-for PPP). Human (operator, worker, bystander, consumer) and environmental risk assessment, e-fate modelling (eg FOCUS model for PPP). Scientific monitoring of sub-contracted studies, consultancy for non-standard studies (operator exposure, radio-labelled material). Use of IUCLID (for PPP), CADDY (for biocides). Follow-up with authorities.

Affiliated with FINAGRO SPA – IPICI GROUP Locations

Preparation of registration dossiers (lead/joint submissions), data gap analysis, review and analysis of physico-chemical, environmental fate, ecotoxicology and toxicological data. CSA/CSR preparation (Chesar), human and environmental exposure scenarios and risk assessment. Use of alternative strategies as read across/category approach and use of QSARs (eg OECD Toolbox, CAESAR, ToxTree, Lazar, EPI Suite). IUCLID 5 file preparation and submission to ECHA. Contacts with ECHA during pre/post (follow-up) dossiers submission.

OVERVIEW ChemService Srl Controlli e Ricerche is a contract research organisation (CRO) providing GLP testing and regulatory services for the plant protection, biocidal, veterinary, industrial chemical and consumer product industries. Our mission is to provide our clients smart solutions for regulatory and testing issues through our long lasting experience in the fields of analytical chemistry, physico-chemistry and ecotoxicology, coupled with an extensive expertise in preparation and submission of registration dossiers. ChemService Srl Controlli e Ricerche collaborates with EU authorities, being selected by the EU in 2008 (EuropeAid/123060/D/SUP/RO) for building an ecotoxicological laboratory in Romania and by EFSA in 2009-2010 for the assistance to the EFSA scientific units on toxicology and ecotoxicology.

Analytical methods development and validations, physicochemistry, ecotoxicology and biodegradability testing Testing services for a broad range of substances including development and validation of analytical methods, physico-chemical testing in accordance with most commonly accepted guidelines (eg OECD, CIPAC methods), short and long term ecotoxicological testing on aquatic (alga, daphnia, fish, activated sludge) and terrestrial organisms (earthworms), soil microorganisms (OECD 216, 217), aquatic plants (lemna sp). Biodegradability testing (OECD 301). CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

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

2010/11

1992

Achievement of ISO/IEC 17025 accreditation

Turnover, group

€5m

1995

Achievement of OECD GLP compliance

Turnover, chemical service provision

€5m

2003

Beginning of regulatory services (Dossier department)

No of offices

1

2004

No of countries represented

1

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

20082010

Collaboration with EFSA and EU authorities

2011

Improvement of REACH services through partnership with academic experts.

VITAL STATISTICS

Staff, group

50

Staff, chemical service provision

45

SERVICE AREA BREAKDOWN

ACCREDITATIONS

Training 5%

Good Laboratory Practice (GLP) and ISO/IEC 17025:2005 Consultancy/ advisory 40%

Laboratory 55%

PARTNERS With the aim of improving the quality of REACH services, ChemService Srl Controlli e Ricerche developed a partnership with MELETE Srl, spin-off of the University of Milan (Italy) and the University of Insubria (Varese, Italy) where several chemistry, toxicology and ecotoxicology experts from academia are involved. The specific target of the venture is to handle complex and nonstandard issues related to chemical, occupational and environmental risk and, in general, to advise companies on REACH requirements.

GLOBAL OFFICES

CLIENTS

ChemService Srl Controlli e Ricerche – Via Fratelli Beltrami 15 20026 Novate Milanese (MI), Italy

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

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Chemical Watch | Global Service Providers Guide 2012


STAFF SELECTION

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

Giacomo Ravetta – Managing Director

CASE STUDY 1: Inclusion of sulphur in Annex I (91/414/EEC) ChemService successfully stewarded a fourth list substance, sulphur, onto Annex I inclusion in 2010 after several years of work. Sulphur is a widespread substance that has been used in agriculture for a long time; nevertheless, the high volume used in the field and the difficulty in distinguishing the natural background level in the environment, gave rise to the request for non-standard studies, such as field operator exposure study and tests on sediment – dwelling organisms with radiolabelled material. Sulphur is a product broadly used in Europe; as a consequence, several different companies were interested in supporting it in the EU review process. Therefore, ChemService put together a task force of 12 companies from all over the world, which was headed by an Italian company and managed from ChemService across the revision process. The technical and management experience of ChemService in coordinating different facilities and the need of the task force members for a common goal was crucial to the success of the project. CASE STUDY 2: Successful chemical equivalence dossier for an Annex I listed agrochemical Finchimica, a SME manufacturer of agrochemicals, decided in mid 2010 to submit to the UK chemicals regulation directorate (CRD) a chemical equivalence dossier for Pendimethalin technical, a selective herbicide included in Annex I of Directive 91/414/EEC whose data protection period was just expired. Timing was crucial in order to be the first of the newcomers and gain immediate market shares. In a three months timeframe, ChemService performed a preliminary screening of the different qualities of Pendimethalin manufactured by Finchimica, identified the level of quality needed in order to match the technical product registered, performed a five batch analysis on Pendimethalin of said quality and submitted the relevant chemical equivalence dossier to CRD using the fast track option. Non testing data (QSAR and in vitro) were included in the dossier in order to support the toxicological equivalence of Finchimica’s towards registered source. The dossier was accepted by CRD in December 2010 and Finchimica became the first approved source of Technical Pendimethalin in Europe after the originator. CASE STUDY 3: Assistance to the EFSA scientific units on toxicology and ecotoxicology In May 2009 ChemService Srl Controlli e Ricerche became part of a panel of experts selected by EFSA for assisting EFSA’s scientific units on toxicology and ecotoxicology (Multiple Framework Service Contract CT/ EFSA/AMU/2009/07, budget available 1,000,000 €) and in the same year was awarded a specific contract (n PPR/01 implementing Framework Contract CT/EFSA/AMU/2009/07-Lot 2, value of the assignment: 83,000 €) for the data entry of pesticide ecotoxicology Tier 1 study endpoints in a IUCLID database. In view of this valuable piece of work, conducted in 2010, ChemService Srl Controlli e Ricerche was again selected by EFSA (CFT/EFSA/PPR/2010/03, Open call, value of the assignment: 139,000 €) for the completion of data entry of pesticide ecotoxicology Tier 1 study endpoints in the database.

Chemical Watch | Global Service Providers Guide 2012

Masters degree in industrial chemistry, 20+ years’ experience in project management in the EU and abroad (China, India, USA), as head of R&D teams for the development of agrochemicals products. He developed a broad network in the global community of chemicals production and legislations and he has a strong focus on customers’ business. Since 2009 he has been managing director of Chemservice Srl Controlli e Ricerche where he has brought his sound management and business oriented background. Dr Valeria Croce – Head of Regulatory Services Masters degree in biology and PhD in environmental sciences, ten years’ experience in the fields of regulatory services, ecotoxicology and environmental risk assessment. Currently head of the Dossier department she coordinates a highly skilled team of six regulatory experts plus a senior scientific consultant, covering a broad range of expertise: chemistry, agronomy, biology (toxicology/ecotoxicology), e-fate modelling, environmental sciences. Since 2008 she has been involved, as an ecotoxicology and regulatory expert, in EU and EFSA projects. Chiara Neri – Head of Ecotoxicological Testing Unit Masters degree in biology, with a specialisation in ecotoxicology, and holder of a European scholarship from 2004 to 2006 “Comparative Research of Endocrine disrupters project”. In 2006 she joined ChemService Srl as study director for algae, daphnia, fish, sludge and heartworms GLP studies. Currently head of Ecotoxicological Testing unit she coordinates a team of five ecotox experts, supported by a senior scientific consultant. Since 2008 she has been involved, as an ecotoxicology expert, in EU and EFSA projects. Stefano Garofani – Head of Analytical Studies Unit Masters degree in chemistry, 20+ years’ experience in development and validation of analytical methods, GLP physico-chemical studies, residue and five batch analysis. His highly skilled group of chemists conducted more than 2,500 GLP analytical studies from 2005-2010 (600+ in 2011). Dr Carlotta Casalegno – Head of Regulatory and Development Masters degree in biology and PhD in naturalistic and environmental sciences, from 2000 to 2005 she was involved in basic environmental research and EU projects management. In 2006 she joined ChemService Srl Regulatory Services, dealing with toxicology and human exposure and risk assessment for PPPs, biocides and REACH registration dossiers. In 2010 she worked for an international ONG (ECEAE-BUAV) commenting on testing proposals for REACH Annex IX and X substances and was appointed as ONG representative to support the use of alternatives during ECHA committee (RAC, MSC) meetings in Helsinki. She came back to ChemService in 2011 as head of Regulatory and Development.

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PROFILE: ChemService Srl Controlli e Ricerche

TESTIMONIALS


GLOBAL OFFICES

PROFILE: Chilworth – a DEKRA Company

DEKRA Industrial GmbH Handwerkstr. 15 D-70565 Stuttgart Germany CONTACTS

SERVICES PROVIDED www.chilworth.co.uk

Website

OO OO

process safety consultancy dust, fire and explosion protection chemical reaction hazards material testing laboratory testing regulatory testing process safety training

E-mail

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

OO

Contact

Dr David Firth, Mr Daniel Baker, Mr Mike Weaver

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Directors

DEKRA Explosion & Process Safety Business Line

1986

Foundation of Chilworth Technology Ltd

Ownership

Wholly owned subsidiary of DEKRA SE

1991

Chilworth Technology Inc established in USA

Locations

UK, USA, India, Germany, France, Spain, Benelux, Scandinavia, Eastern Europe, Japan, Brazil, Northern and Southern Africa, Israel, Japan and China

1995

Received Good Laboratory Practice accreditation

2001

IChemE safety and environmental awards winner

2003

Chilworth goes global; capabilities established in France, Italy and India

OVERVIEW

2008

Chilworth acquires Spanish facility

Chilworth – a DEKRA company is the UK’s leading provider of expert knowledge and quality test data in the field of process safety. With an international consulting base, we employ doctorate engineering and scientific staff along with consultant engineers, scientists and technicians. Our GLP/ ISO17025 compliant laboratories offer industrial explosion hazard testing, chemical reaction hazards evaluation and electrostatic testing, as well as a full range of regulatory testing services for REACH, SDS, CLP, UN and other transport applications. Our electrostatic services cover profiling of powders, films and liquids for both production handling problems and electrostatic ignition hazards. DEKRA fulfils the only representative position for several companies based outside the EU, assisting with portfolio optimisation, representing the company in consortia, performing testing and preparing registration dossiers. We have unrivalled expertise in process safety, laboratory testing, consulting, training and instruments with a truly global perspective. Wherever you are, we are close at hand!

2009

Acquisition of JCI, the UK’s electrostatic measurement experts

2011

Wholly acquired by DEKRA, Europe’s leading safety provider

VITAL STATISTICS

2010/11

Turnover, group

€1.8bn

Turnover, chemical service provision

€495m

No of offices

30+

No of countries represented

80+

Staff, group

25,000

Staff, chemical service provision

500+

SERVICE AREA BREAKDOWN

Training 5%

Laboratory 50%

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Other 10%

OO OO OO

1925 (DEKRA)

Founded

OO

Consultancy/ advisory 30%

Representation & management 5%

ACCREDITATIONS Good Laboratory Practice (UK); ISO 17025 (US) CLIENTS Chilworth – a DEKRA company 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 organisations operating in the petrochemical, chemical, pharmaceutical, food, drink, paper and packaging, plastics and rubber, agrochemical, automotive and aerospace and power generation sectors. TESTIMONIALS Testimonials can be provided on request. CASE STUDY 1: Working closely with a global supplier of metals and minerals, Chilworth – a DEKRA company devised and delivered a comprehensive testing programme for CLP registration of a range of products and formulations. CASE STUDY 2: Supporting a global manufacturer and marketer of differentiated chemicals, Chilworth – a DEKRA company has tailored an extensive portfolio of tests of a diverse selection of materials under both REACH and CLP criteria. CASE STUDY 3: Cooperating with a number of service providers from Europe to the Far East, Chilworth – a DEKRA company has carried out a range of physicochemical properties testing for REACH registration of products across a broad range of applications, whilst acting as study managers for a range of toxicology and exotoxicology test programmes.

Chemical Watch | Global Service Providers Guide 2012


STAFF SELECTION Dr Stephen Rowe – Managing Director

PROFILE: Chilworth – a DEKRA Company

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 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 Michael Weaver – Principal Specialist Process Safety Principal specialist process safety – bringing more than two decades of testing and consultancy experience to the team – Mike is particularly involved in devising and managing regulatory testing programmes for our customers across the full range of services as well as gas / vapour and dust explosions. Mr Daniel Baker – Safety Testing Specialist Safety testing specialist – responsible for the management of our laboratories – Daniel has more than a decade of experience in testing and project management and brings a wealth of knowledge on regulatory test requirements. As a qualified DGSA, he provides guidance on the implication of results on classification of products. Dr Andrew Starkie – Principal Process Safety Specialist Principal process safety specialist – managing our GLP programme and with over a quarter of a century of experience in the sphere of process safety testing and consultancy – Andy has particular expertise in the handling and testing of hazardous and sensitive materials and chemical reaction hazards. Mr Jochen Dettke – Head of REACH RegistrationTeam in Germany An expert at DEKRA Industrial GmbH – based in Stuttgart, – Jochen heads up the REACH registration team in Germany, providing consultancy and testing advice from portfolio optimisation, through data acquisition and into dossier preparation.

Chemical Watch | Global Service Providers Guide 2012

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SERVICES PROVIDED

PROFILE: Compliance Services International

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

CONTACTS Website

www.complianceservices.com

E-mail

info@complianceservices.com

Head office

7501 Bridgeport Way West, Lakewood, WA 98499-2423, USA

Tel

+1 253 473 9007

Fax

+1 253 473 2044

Contact

Bernalyn McGaughey

Directors

Bernalyn McGaughey, President and CEO

Ownership

State of Washington, USA

Locations

USA, France and UK

Founded

1988

Hazard, exposure and risk assessment Physico-chemical, human health and environmental hazard assessment, exposure assessment and risk characterisation and reporting (eg chemical safety assessments/chemical safety reports). Use of exposure modelling tools, eg ECETOC TRA, EUSES, OECD ESDs, ART model, ConsExpo etc. Only representative/third party representative Only representative services for non-EU companies which (under REACH) cannot directly pre-register/register the substances that are exported to the EU. Third party representative services for companies not wishing to disclose their interest in a particular substance for reasons of commercial confidentiality. Consortia/task force management

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

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

9

No of countries represented

3

Scientific, technical and administrative support for consortia/task forces, including all aspects of communication and coordination. Due diligence Regulatory due diligence associated with mergers and acquisitions. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1988

CSI formed in Washington State, USA.

1990s

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

1990s

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

2000

CSI-Europe launched .

2010

Winner – AGROW award for best supporting role.

2011

Shortlisted – AGROW award for best supporting role.

Staff, group

23

ACCREDITATIONS

Staff, chemical service provision

16

Winner – 2010 AGROW award for best supporting role Shortlisted – 2011 AGROW award for best supporting role European registered toxicologist on staff

SERVICE AREA BREAKDOWN

PARTNERS

IT & Legal software 5% Laboratory 5% 5% Information 5% Representation & management 5%

CSI operates independently and has no formal partners, but utilises a network of contract research organisations, legal companies and specialist providers as appropriate to supplement our consultancy services. CLIENTS Consultancy/ advisory 75%

Client names remain confidential, however CSI works with a wide variety of clients from multinationals to family-owned businesses based in our domestic EU and USA markets and throughout the world. TESTIMONIALS

GLOBAL OFFICES CSI-Europe, Pentlands Science Park, Penicuik, Nr Edinburgh, EH26 0PZ, United Kingdom CSI-Europe (France), Domaine de Marsange, Bât A3, 130 Chemin de Morgiou, 13009 Marseille, France CSI Head Office, 7501 Bridgeport Way West, Lakewood, WA 984992423, USA US regional offices in Washington, Massachusetts, Maryland, Texas, North Carolina and Missouri

Page 68

On request we would be happy to supply contact details for existing CSI clients willing to provide references on our behalf. CASE STUDY 1: REACH only representative services Utilising our US and EU office locations Compliance Services International (CSI) provides a comprehensive only representative service for multiple non-EU companies seeking full REACH compliance. Services provided include pre-registration, late pre-registration (under REACH Article 28.6), Sief and consortia communication, and development and submission of IUCLID format dossiers resulting in successful substance registrations.

Chemical Watch | Global Service Providers Guide 2012


Shirley Hudson – Principal Consultant

Compliance Services International (CSI) successfully provided chemical registration services, including consortium management and Sief communications, study monitoring and registration dossier preparation, for a substance subject to the first REACH registration deadline on behalf of the Organotitanates and Zirconates consortium.

Shirley is a mammalian toxicologist with more than 25 years’ experience in contract research and consulting organisations, focusing on regulatory compliance of toxicology studies, data gap analysis, and quality checks of toxicological data packages. At CSI, Shirley prepares registration dossiers and risk assessments and provides expert toxicological support for plant protection products, chemicals and biocides. Shirley has successfully prepared and submitted REACH substance and intermediate dossiers for the 2010 deadline.

CASE STUDY 3: Biocidal Products Directive Compliance Services International (CSI) stewarded the first new active ingredient onto Annex I of the Biocidal Products Directive and has attained mutual recognition of biocidal products containing the active ingredient throughout Europe. CASE STUDY 4: Biocidal Products Directive Compliance Services International (CSI) has been instrumental in obtaining the first frame formulation approval for a new active substance in the UK with mutual recognition of the frame formulation and associated biocidal products currently on-going in several member states. CASE STUDY 5: Plant Protection Products Directive Compliance Services International (CSI) stewarded two existing plant oil-based active ingredients onto Annex I of the Plant Protection Products Directive (PPPD). CASE STUDY 6: Plant Protection Product Literature Search Compliance Services International (CSI) has recently performed literature searching activities in support of a PPPD Annex I renewal submission using Dialog (on-line information service providing potential access to over 600 databases). These activities included development of search strategies, review of output files and record keeping in accordance with EFSA Guidance.

Alison Strutt – Principal Consultant Alison has over 20 years’ experience in toxicology and regulatory affairs gained in contract research, industry and consulting. As a European registered toxicologist, she provides specialised toxicology support including preparation of toxicological dossiers, human health risk assessments and participation in expert toxicology groups. Alison speaks fluent French and German. Gwen Fraser – Senior Consultant Gwen is a biological sciences graduate with more than 15 years’ experience whose regulatory knowledge is supported by extensive contract research experience in analytical chemistry support for plant protection product and animal health product development. At CSI, Gwen has been extensively involved in preparation and submission of registration dossiers for the Biocidal Products Directive and the REACH and Plant Protection Products Regulations. Gwen is CSI’s representative member of the Chemical Hazards Communication Society (CHCS). Lorna Phillips – Senior Consultant

STAFF SELECTION

Lorna is a graduate scientist with more than 20 years’ contract research and consulting experience, including seven years in regulatory study Quality Assurance. At CSI Lorna is involved in dossier preparation for biocidal product active substances and products, plant protection products, and in CSA/CSR preparation for REACH. Lorna is also actively involved in providing independent quality assurance consultancy support to clients.

Bernalyn McGaughey – President/CEO

Jeff Giddings – Principal Consultant

Bernalyn has more than 30 years’ of data evaluation, chemical research, study monitoring, and project management experience in the properties, use, toxicology, and environmental fate of pesticides and other chemicals. Her activities have included original and regulatory research, report design and composition, and international technical assistance on toxicology investigations and risk assessments. She has been manager of the FIFRA Endangered Species Task Force for more than 13 years.

Jeff has more than 30 years’ experience in research, testing, and consulting in environmental toxicology and ecological risk assessment in North America and Europe. Jeff directs CSI’s ecological risk assessment programme and has extensive publications and presentations in the field of environmental toxicology. Since 1994, Jeff has specialised in ecological risk assessment and endangered species analysis of pesticides.

Frank Galloway – Manager, CSI-Europe/Principal Consultant Frank has regulatory, commercial and research experience spanning more than 30 years. He has worked extensively with consortia and task forces supporting existing crop protection and biocidal product active substances and industrial chemicals. As a past regulator with the former UK Pesticides Safety Directorate, Frank conducted operator, consumer and environmental risk assessments for agricultural pesticides and prepared recommendations for consideration by government departments. Alison McGuire – Deputy Manager, CSI-Europe/Principal Consultant Alison has extensive regulatory and research experience spanning more than 20 years. Alison performs exposure and risk assessments for biocides, industrial chemicals and pharmaceuticals, and is actively involved in the technical aspects of REACH, in addition to working on biocide dossiers. Alison is an experienced analytical chemist and prior to joining CSI spent seven years managing and developing residue chemistry services at a major contract research organisation. Warren Scott – REACH Programme Coordinator/Senior Consultant Warren has more than 20 years’ experience in laboratory contract research studies and business development for contract research organisations. He serves as CSI’s REACH programme coordinator and has accumulated considerable REACH experience fronting CSI’s activities as an only representative, third party representative and consortium secretariat.

Chemical Watch | Global Service Providers Guide 2012

Page 69

PROFILE: Compliance Services International

CASE STUDY 2: REACH consortium services


SERVICES PROVIDED General consulting services Our team’s expertise on Turkish, EU and global chemical regulations lets our clients have a focused insight into Turkish chemical regulations and helps them solve their problems with work and cost efficient compliance solutions for marketing products in Turkey. Also our regulatory follow up service lets companies be aware of future regulations and enables them to plan their strategy at the earliest moment possible. We also provide REACH compliance services for non-EU companies especially in Turkey and close regions such as MENA, with our capacity enriched by our strategic partners expertise.

PROFILE: CRAD

CONTACTS Website

www.crad.com.tr

E-mail

info@crad.com.tr

Head office

CRAD Ltd Sti, Atakent Mh.Turkler Cd.Gokturk Sk.No:8 Umraniye, Istanbul, Turkey

Tel/ Fax

+90 216 335 4600/ +90 216 335 4606

Contact

Melih Babayigit

Directors

Melih Babayigit, Managing Director

Ownership

Private company

Locations

Turkey

Founded

2008

Notification, registration and legal representative services We represent companies fully on notifications and product registrations in Turkey. Our service means the global chemical industry is free to communicate CBI covered by a NDA, and have the comfort of keeping their CBI and strategic data undisclosed to their commercial agents. Another advantage of our representation service is that it allows the freedom of changing the commercial supply chain, without being restricted by registration ownership of the former commercial agent.  Biocidal/ cosmetic/ detergent product registration services

OVERVIEW CRAD is the leading consultant company in Turkey, providing regulatory compliance consultancy for the global chemical industry. With a well equipped team of consultants and with their knowledge of local regulations as well as of global and EU chemical products regulations, CRAD is capable of providing services within a wide context. Our multidisciplinary service portfolio allows our client to have a better understanding of the compliance process, with similarities and differences between regulations to cope with. Thanks to our strategic partners around the globe CRAD is also capable of providing its clients global information with a local twist. With our awareness about our responsibility to both the human and environment aspects, we not only serve our clients but also keep an eye on our responsibilities towards the welfare of humankind and environment, particularly within the scope of our services. Aiming to be a one-stop compliance solution centre, we always aim to enlarge our portfolio of services. A team of hazard communication experts serves our clients in SDS and label compliance for products placed on the market in Turkey and the EU. VITAL STATISTICS

2010/11

Turnover, group

>€1m

Turnover, chemical service provision

>€1m

No of offices

1

No of countries represented

12

Staff, group

12

Staff, chemical service provision

10

SERVICE AREA BREAKDOWN Training 10%

IT & software 25%

Information 5%

Page 70

With extensive communication capabilities with relevant Turkish authorities, we serve our clients with the best level of information and most efficient approach related to several product registration schemes such as biocidal products, plant protection products, cosmetic, household products etc. With our capacity and experience on dossier compilation and registration we provide a result-oriented service for our clients. Also representing companies in means of registration keeps manufacturers away from the CBI concerns. Label compliance and (M)SDS authoring services Turkish SDS provisions requires MSDSs to be authored by a locally certified personnel to author the SDS in compliance with the regulation and represent his certification when required by the authority. A compliant SDS and label are also one of the main components of a product registration dossier. CRAD’s team of experts in the field of classification and hazard communication provides you the SDS and label compliance and defends your cause to the authority when a case of dispute arises With our follow up service we also provide updated SDSs when the related regulations requires an obligatory revision. Classification, SDS and chemical inventory software tools Thanks to our strategic partner Safeware Quasar’s expertise on regulatory compliance IT solutions and our in-house IT capabilities we provide “plug and play’’ and bespoke IT solutions for the chemical industry. Regulatory compliance training and bespoke training Whenever your team needs a focused insight into the Turkish regulations on chemicals, we are ready to provide a webinar for your regulatory team or an in-house training course for your team members located in Turkey with our key staff who are recognised as key speakers at international regulatory events. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Consultancy/ advisory 60%

2007

CRAD established

2008

Strategic partnership agreement signed with CEA

2008

CRAD staff certified SDS author by TSE

2008

Distribution agreement with Safeware Quasar

2008

Market leader in REACH compliance services in Turkey

2009

In-house training class for 20 became available

2009

Over 50 class and bespoke training sessions had been organised

2009

CRAD has been accredited to official REACH group of MoEF Chemical Watch | Global Service Providers Guide 2012


2009

CRAD launched services for Turkish regulatory compliance

STAFF SELECTION

2010

CRAD joined the GCC Network

Melih Babayigit – General Director

2010

CRAD serves global chemical industry through strategic partners located in the USA, EU, Korea, Japan, China, UAE, Russia for Turkish regulatory compliance

2011

Turkish SDS authored by CRAD exceeded 5,000 More than 2,000 substances notified to the Turkish Inventory representing over 100 global chemical companies.

Babayigit has 15 years of experience in the chemical industry and for the last five years he has been particularly focused on global and emerging regulations on chemicals. He has been one of the leading key experts in Turkey in the field of hazard communication and product compliance. He is an appointed consultant to the competent authorities for PPP and biocidal product registrations schemes. He is regularly published in industry magazines including Chemical Watch and is a highly sought-after speaker at regulatory events. He is a member of CHCS and a certified SDS author.

Certified to author SDS (TSE) Turquality certified consultant Member of REACH discussion group at Turkish competent authority

Bulent Özdemir – MSDS Author and Classification Expert

Due to our confidentiality agreements and the nature our business, CRAD does not release the identity of its customers. We do serve from SMEs to globally well know, NYSE listed, chemical enterprises.

Bulent Özdemir holds the academic degree of MSc in biology. He has more than ten years’ experience in the chemical industry. After joining the CRAD team he has focused on risk assessment and hazard communication about chemicals. Mr Özdemir serves as an expert in the classification of chemicals, and the generation of material safety data sheets (MSDS) with multidisciplinary approach.

TESTIMONIALS

Gurhan Varlık – Regulatory specialist

CLIENTS

References can be provided upon request as far as our agreements with our clients permits. PARTNERS Cambridge Environmental Assessments / ADAS UK Safeware Quasar Ltd UK Repre Ltd Japan KIST Europe Korea Member of the GCC-Network/ Member of CHCS Full list of our strategic partners can be found on our website. CASE STUDY 1: Turkish chemical inventory notification With a regulation published in 2009, Turkey implemented an inventory notification scheme. At the very earliest phase of the implementation there were no options given for global chemical suppliers to notify through a representative in order to prevent CBI concerns and workload to their local clients. CRAD advised the competent authority of this need and shared the concerns of the global industry with them. This lead to a corrigendum to the regulation, providing an option for exporters to Turkey to notify substances that they export. The CRAD team has concluded more than 2,000 notifications, representing over 100 companies including major global actors in the industry.

Mr. Varlık who holds a degree of MBA( Economics) has spent ten years in the chemical industry. With his focused role on chemical regulations worldwide, he has spent a long time on product compliance in several markets. At the time when the REACH Regulation was being drafted, he dedicated himself to getting a better understanding of the Regulation within the Turkish industry. Now he is supporting a huge number of companies in every aspect of REACH, from registration to SDS requirements. The rest of the CRAD team In order to provide multidisciplinary services to our clients we also have another seven competent experts with academic and industrial experience and experience in several fields such as Ms Esra Ozdemir (MSc environmental engineering), Ms Hande Erensoy (MSc chemistry) with a range of experience from two to eight years.

CASE STUDY 2: Registering products with an appointed representative A biocidal product producer based in the EU was having problems registering and marketing their biocidal products in Turkey, due to their former sales agent’s using their formula and trade name for registering the product. As the regulation doesn’t allow a second product to be registered with the same trade name, that former registration was preventing our client registering and marketing their product in Turkey. We applied to the competent authority about the case and proposed that they ask for an appointment letter to be confirmed by Turkish consulates at the registered locations of the manufacturer, to prevent such dispute cases. The competent authority accepted our proposal for general implementation principle. and we successfully registered our client’s products as a representative independent from the supply chain. Unauthorised registrations of the former registrant was rejected.

Chemical Watch | Global Service Providers Guide 2012

Page 71

PROFILE: CRAD

ACCREDITATIONS


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

PROFILE: CS Regulator y Ltd

CONTACTS Website

www.csregulatory.com

E-mail

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 Staff at CS Regulatory are experts 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.

OVERVIEW CS Regulatory Ltd is an independent, privately owned organisation accredited to ISO 9001:2008 successfully providing regulatory assistance to suppliers of industrial chemicals throughout the world. Staff at CS Regulatory offer a combined experience of more than 40 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

2010/11

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%

Training 5%

Representation & management 20% Consultancy/ advisory 65%

GLOBAL OFFICES Not applicable. CS Regulatory has a global network of independent expert consultants for global regulatory compliance.

Page 72

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; read-across and grouping of chemicals; provision of expert reports for data-waiving. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

CS Regulatory established as an LLP

2007

Established a global network of expert regulatory consultants

2008

Incorporated as a private limited company

2009

Established the preferred partner agreement with LAB Research Inc

2009

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

ACCREDITATIONS ISO 9001:2008 PARTNERS CiTox LAB preferred partner

Chemical Watch | Global Service Providers Guide 2012


CLIENTS

STAFF SELECTION

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 international blue chip companies and household names, as well as small and medium enterprises with their regulatory requirements.

Steven Green − Director

Specific references can be provided to potential clients upon request CASE STUDY 1: REACH registration and the use of QSAR to replace testing In early 2010 CS Regulatory was approached by a client with a series of related UVCB substances that were produced, supplied and used in the presence of a carrier solvent essential to maintain the structure and substance integrity. The substance had previously been reviewed by a consortium appointed consultant that had determined an absence of physico-chemical study endpoints and advised a test package on each substance in the range. Due to the extensive experience of CS Regulatory's staff, we very quickly determined that any of the physicochemical tests would be technically unfeasible and/or meaningless due to the effects of the solvent. Working with the client's process chemists, CS Regulatory was able to prepare a detailed justification for waiving physico-chemical study data along with preparing QSAR for many of the environmentally significant endpoints by assessing multiple variations of each of the UVCB structures to prepare a weight of evidence for the purposes of risk assessment. With the IUCLID 5 registration dossiers prepared by CS Regulatory incorporating this strategy, the client successfully completed the lead registration for the 2010 deadline for all the substances including the waivers and QSAR endpoints and saved almost €1m of testing costs. CASE STUDY 2: REACH and CLP compliance audits A number of clients positioned mid-way in the supply chain as importers of products and/or suppliers of formulated products. In seeking to ensure compliance with all EU regulations, CS Regulatory was employed to assess the chemical substances and products and articles from upstream 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.

Craig Deegan − Director Mr Deegan has been working in the field of international regulatory affairs and health, safety and environmental consultancy for 17 years, incorporating development of testing strategies based on risk hierarchy, evaluation and interpretation of client specific requirements to ensure best value for clients with an interest in REACH. With detailed experience of the practical application of risk management, Mr Deegan offers experience and knowledge that many regulatory consultancies lack. Tracey Thomas – Regulatory Affairs Officer Ms Thomas has been working in the field of health and medical consultancy for 13 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 nine 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.

CASE STUDY 3: Global registration CS Regulatory was employed to undertake the global registration of a new (REACH non phase-in) substance. Working with its global network of regulatory consultants, CS Regulatory completed the appropriate inquiry process in the EU and due procedures in other jurisdictions and then designed a single testing package to meet the data requirements in the EU, Australia, Japan, Canada, Korea and Philippines with only minimal repetition of data for the purpose of compliance in each jurisdiction. Where most appropriate, data was acquired by testing at a suitable facility within a national regulatory jurisdiction. CS Regulatory, in conjunction with its network of global expert partners, then successfully completed registration of the substance to each jurisdiction to allow supply to commence.

Chemical Watch | Global Service Providers Guide 2012

Page 73

PROFILE: CS Regulator y Ltd

TESTIMONIALS

Over a period of 19 years, Mr Green has successfully completed chemical registration submissions throughout the world, having negotiated with many regulatory authorities including EU member state authorities, NICNAS, JMETI, MHLW, JMAFF, KMoL and CRC SEPA. Mr Green is 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.


GLOBAL OFFICES DR. KNOELL CONSULT GmbH, Mannheim, Germany DR. KNOELL CONSULT GmbH, Leverkusen, Germany DR. KNOELL CONSULT GmbH, Wageningen, The Netherlands DR. KNOELL CONSULT Ltd, Cardiff, United Kingdom DR. KNOELL CONSULT Shanghai Ltd, Pudong, Shanghai, China DR. KNOELL CONSULT Schweiz GmbH, Basel, Switzerland FORIM GmbH, Mannheim, Germany Cyton Biosciences Ltd, Bristol, United Kingdom KNOELL ACADEMY GmbH, Mannheim, Germany

PROFILE: DR. KNOELL CONSULT

CONTACTS Website

www.knoellconsult.com

E-mail

info@knoellconsult.com

Head office

Dynamostraße 19

 

68165 Mannheim

 

Germany

Tel

+49 (0)621718858-0

Fax

+49 (0)621718858-100

Contact

Dr Michael Cleuvers

Directors

Dr Hans-Emil Knoell, Managing Director

SERVICES PROVIDED Registration of industrial and specialty chemicals

Dr Runar Eberhardt, Managing Director

Strategic advice and consulting, literature search, data evaluation, data gap analysis, study monitoring. Testing and registration strategies, in silico methods (QSAR), read-across and waiving strategies. Dossier preparation, eg IUCLID5-files for REACH, hazard and risk assessment, exposure modelling, extended safety data sheets. Post submission support, communication with authorities, OR- and TPRservices, full consortia management.

Ownership

Private company, majority-owned by Dr Knoell

Registration of agrochemicals and biocides

Locations

Germany, UK, Switzerland, China, Netherlands

Founded

1996

Strategic advice and consulting, literature research, data evaluation, data gap analysis, 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.

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

Human pharmaceuticals, medical devices, cosmetics

Turnover, group

> €20m

Non-clinical/ pre-clinical services (study management, toxicology, pharmacology, metabolism, pharmacikinetics, bioanalysis, biosafety testing). Clinical services (design, initiation and management of phase I, II and IV clinical trials and PASS), medical writing (eg expert opinions, study reports). Pre- and post-marketing pharmakovigilance, PSUR, summary of product characteristics (Core SmPC), summary bridging reports (SBR) and post authorisation safety studies (PASS), classification of medical devices, CE-marking, authorisation of cosmetics (INCI-listing, labelling etc), food and food additives.

Turnover, chemical service provision

> €20m

Animal health (veterinary drugs, feed additives)

VITAL STATISTICS

2010/11

No of offices

10

No of countries represented

5

Staff, group

250

Staff, chemical service provision

230

SERVICE AREA BREAKDOWN Training 5% Information 8%

Representation & management 25%

Page 74

Strategic advice, project management, auditing, managing and writing of registration submissions, expert reports, successful marketing authorisations. All routes, all therapies, all species. Management of pharmacological, toxicological, residues and ecotoxicological studies for feed additives. Management of pre-clinical and clinical studies for feed additives, several services for vaccines and neutraceuticals. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Consultancy/ advisory 63%

1996

Foundation, Mannheim, Germany

2002

Office in Leverkusen, Germany

2007

Foundation of DR. KNOELL CONSULT Switzerland GmbH, Basel

2007

Foundation of FORIM GmbH, Mannheim

2009

Set up of KNOELL ACADEMY for training and in-house seminars covering all our fields of expertise

2009

Set up of DR. KNOELL CONSULT Ltd in Cardiff, UK

2009

KNOELL contributed to more than 100 dossiers for plant protection products

2010

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

Chemical Watch | Global Service Providers Guide 2012


2010

Opening of a new office in Wageningen (NL)

STAFF SELECTION

2010

Acquisition of Cyton Biosciences Ltd, Bristol, UK

Toxicology

2010

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

> 30 toxicologists

2010

Set up of DR. KNOELL CONSULT Shanghai Ltd in China

2010

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

12 specialists

2010

KNOELL GROUP has been appointed as institution for the training of experts in toxicology

Cefic – partner

Ecotoxicology > 30 ecotoxicologists Dietary safety >15 specialists Product safety specialists for MSDS preparation > 15 specialists

PARTNERS

Global regulatory affairs chemicals

SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres International, Ruio Technology, Tier3 soloutions, Doruksistem

> 10 specialists

CLIENTS

Eight consortium managers

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

Residues and metabolism

TESTIMONIALS

> 12 specialists

Consortium management, OR, TPR

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

Environmental fate and risk assessment

CASE STUDY 1: REACH: consortium management and dossier preparation

Human pharmaceutical experts

As one example of our performance, DR. KNOELL CONSULT has managed a huge consortium covering 370 substances in 10 subcategories and submitted 55 successful registrations for this consortium in 2010 and more than 120 are expected for 2013. To achieve this, we established a team of about 30 scientists dedicated to this project (chemists, toxicologists, ecotoxicologists, QSAR-specialists) who prepared the entire testing and registration strategy, including category and analogue approach, QSARs and exposure based waiving. CASE STUDY 2: Agrochemicals DR. KNOELL CONSULT successfully submitted a number of AIR-I (Annex-I renewal procedure) dossier for global R&D companies. The projects were well recognised by the authorities, in particular bearing in mind that neither industry nor authorities had experience with such projects. More than 30 people based all over the world were involved in this project. CASE STUDY 3: Biocides Biocidal product registration in Spain: the Spanish Ministry of Environment informed us that “our dossier for a wood-preservative was the best organised and well-done dossier in comparison with the rest of dossiers received from other companies.”

Chemical Watch | Global Service Providers Guide 2012

PROFILE: DR. KNOELL CONSULT

ACCREDITATIONS

Regulatory affairs agrochemicals/biocides

> 40 specialists Efficacy, biological dossiers > 12 specialists Ten Vet pharmaceutical experts 20 Selected staff Dr Michael Cleuvers – Head of Industrial Chemicals, Global Regulatory Affairs Torsten Hauck – Head of Agrochemicals and Biocides, Human and Environmental Safety, Environmental Risk Assessment Dr Volker Mostert – Head of Agrochemicals and Biocides, Regulatory Affairs Dr Marika Suhm-Tintelnot – Head of Industrial Chemicals, Human and Environmental Safety Dr Elisabeth Wekel – Head of Industrial Chemicals, Customised Projects Dr Iain A MacKinnon – Managing Director, DR. KNOELL CONSULT Ltd Dr Jan Tuinstra – Senior Expert REACH, Wageningen office Conrad Scheidegger – Senior Expert REACH, DR. KNOELL CONSULT Schweiz GmbH

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GLOBAL OFFICES EBRC Consulting GmbH Raffaelstr 4 30177 Hannover Germany SERVICES PROVIDED Industrial Chemicals – REACH

PROFILE: EBRC Consulting

CONTACTS Website

www.ebrc.de

E-mail

info@ebrc.de

Head office

Raffaelstr 4

 

30177 Hannover

 

Germany

Tel

+49 511 898389 0

Fax

+49 511 898389 10

Contact

Dr Rüdiger Battersby

Directors

Dr Rüdiger Battersby

Ownership

Privately owned

Locations

Germany

Founded

1993

EBRC offers comprehensive scientific, regulatory and administrative support on industrial chemicals, including: OO data gathering, literature searches and evaluation OO data-gap analysis, closing of data-gaps and study monitoring OO chemical safety assessment (CSA) and report (CSR) OO PBT and vPvB assessment OO technical dossier (IUCLID 5) OO identification of known uses OO development of exposure scenarios for HH and ENV OO risk characterisation OO classification and labelling OO safety data sheets OO consortium and SIEF management Agrochemicals

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

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

1

Staff, group

50

Staff, chemical service provision

30

SERVICE AREA BREAKDOWN

Annex I inclusion and national registration. EU notification of active substances currently regulated under regulation (EG) 1107/2009 (previously: Directive 91/414/EEC): OO support of existing substances in the context of the EU Review Programme OO support of new active substances OO completeness checks, validation of existing studies, literature surveys, full dossier preparation including risk assessments, submission and defence of dossiers in the review and evaluation process Product registration dossiers for national authorisations (pre- and post Annex I listing) in EU member states including and zonal dossiers: OO AIII dossiers (dRRs) for registration and re-registration of plant protection products, label extensions and formulation changes OO our services include the compilation of all required documents, the conduct of exposure and risk assessments, advice in closing data gaps, the supervision of experimental studies as well as the submission of the application to competent authorities and attendant contacts/ services during the registration process. OO previous experience includes herbicides, fungicides, insecticides, rodenticides and nematicides. Biocides

Training IT & 5% software 5% Representation & management 15% Consultancy/ advisory 75%

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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 a.s.) OO biocidal products (registration/authorisation in EU member states) OO task force/consortia management OO evaluation of substances – as specified for industrial chemicals and agrochemicals above

Chemical Watch | Global Service Providers Guide 2012


STAFF SELECTION

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 OO Bayesian approaches for (occupational) exposure assessments

Rüdiger Battersby – Director

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 OO provision of web-interfaces for data-entry and analysis CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1993

Foundation of EBRC (initial staffing: six people)

2012

Continual growth, leading to a current staff count of 50

PARTNERS ARCHE, Belgium CLIENTS A wide range of companies producing agrochemical, biocidal and industrial chemical substances and formulations 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 aims at providing a first tier screening tool for occupational inhalation and dermal exposure to metals and inorganic substances. CASE STUDY 2: HERAG (Health Risk Assessment Guidance) With its extensive background in metals risk assessments, EBRC was contracted from 2005-2007 by the European Metals Industry to compile a guidance document for the human health risk assessment of metals and inorganic metal compounds. The HERAG documents provide guidance 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. CASE STUDY 3: Development of standard handling frequencies of rodenticide baits 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 2012

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 EBRCs 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, and of the German Committee on Hazardous Substances, Subcommittee UAIII, Metals Working Group (AGS, Ausschuss für Gefahrstoffe - UAIII, AK Metalle). Arne Burzlaff – Senior Registration Manager Industrial Chemicals Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in technical chemistry/biotechnology (2005). He worked for the German Federal Institute for occupational safety and health, Division for Chemicals and Biocides Regulation (2005-2007) on dossier evaluation for biocides, collaboration in EU working groups and scoping issues on borderline cases among legal frameworks. Since 2007 he has been working at EBRC as senior scientist/toxicologist. In this position he has been compiling REACH registration dossiers, with a focus on human health hazard assessment and risk characterisation, and initiation and monitoring of experimental studies on industrial chemicals. Andreas Büsing – Senior Registration Manager Agrochemicals Andreas Büsing graduated as a biochemist at the University of Hannover (1984). After years of experiences in biochemical analytics with specific emphasis on the development and validation of immunoassays, he is working at EBRC as registration manager for agrochemicals since 1999. His main responsibilities at EBRC include the co-ordination and supervision of registration dossiers under Directive 91/414/EEC and subsequent regulations, with focus on ecotoxicological risk assessments, data gap analysis and monitoring of experimental studies on active substances and plant protection products. Thomas Sendor – Senior Registration Manager Biocides Dr Thomas Sendor graduated as a biologist (1998) and obtained a PhD in biology/animal ecology (2002). Since 2002 he has been working at EBRC as registration manager for biocides. In this position he has been compiling dossiers in support of inclusion of active substances in Annex I of Directive 98/8/EC, with a focus on human and environmental exposure assessments and risk characterisations, and initiation and monitoring of experimental studies on active substances and biocidal products. Daniel Vetter – Senior Consultant Special Services Daniel Vetter graduated as Dipl-Ing agr at University of Hannover (2003). His main responsibilities at EBRC include the development and implementation of novel statistical techniques in human health risk assessments. He developed MEASE, an assessment tool for 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

Special services


SERVICES PROVIDED REACH registration and authorisation dossier This is the core activity of EcoMundo, we have dedicated teams with REACH managers, toxicologists and ecotoxicologists, who provide several services: OO Sief/consortium manager: formation of Sief and consortium, assistance to the LR, collection of data, registration strategy, constitution of joint and individual dossiers and chemical safety report. Full management up to 2018 OO building of individual dossier: representation of the registrant to the Sief/consortium, purchase of the letter of access, constitution of the individual dossier in IUCLID 5.2 format, chemical safety report OO authorisation dossier: definition of the process, building of exposure scenarios, analytical identification of SVHC, chemical safety assessment and dossier submission.

PROFILE: EcoMundo

CONTACTS Websites

www.ecomundo.eu www.reach-factory.eu

E-mail

contact@ecomundo.eu

Head office

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

Tel/ Fax

+33 (0)1 83 64 20 53/ +33 (0)1 34 29 60 35

Contact

Pierre Garçon

Directors

Pierre Garçon, Founder and President

 

Jean-Raphaël Miron, Associate

Ownership

Private company

Locations

Issy-les-Moulineaux (France), Brussels (Belgium)

Founded

September 2007

CLP compliance EcoMundo offers a two-step process: OO classification of substances and mixtures: data generation and reclassification if necessary OO CLP notification of substances: creation of the notification dossier in XML or IUCLID format and submission to the classification and labelling inventory of ECHA.

OVERVIEW

SDS creation and management

EcoMundo is a consulting firm dedicated to compliance with chemicals regulations. Staff skills are mainly chemical engineering, toxicology and ecotoxicology, materials engineering, ecodesign and IT. Based in France, with a representative office in Brussels, the firm generates half of its turnover abroad. Our main activity is the preparation of technical dossiers under REACH. We act as only representative for exporters to the EU and manage several Siefs and consortia. Other services include authorisation dossier, CLP compliance, safety data sheets management and SVHC traceability in the supply chain. We have designed the web platform REACH Factory to ensure industrials can do safe business by meeting their regulatory obligations. EcoMundo is an affiliate member of MMTA and SOCMA. We have established a solid network of relations with large international federations and official representations. EcoMundo publishes two newsletters: The Molecule and The Nano Molecule covering topics such as REACH, ecodesign, cosmetics, nanomaterials etc.

EcoMundo offers complementary services: update of SDS to a REACH and CLP compliant format, creation of extended SDS based on expert assessment and official translation into any European language.

VITAL STATISTICS

2010/11

Turnover, group

€1.3m

Turnover, chemical service provision

€1.3m

No of offices

2

No of countries represented

2

Staff, group

31

Staff, chemical service provision

31

SERVICE AREA BREAKDOWN Training 4%

Consultancy/ advisory 42%

IT & software 42%

Information 6%

Representation & management 6%

SVHC management EcoMundo helps downstream users detect possible SVHC in their products through efficient communication with their suppliers, inform their clients if necessary, anticipate substances that are most likely to be added to the candidate list, and substitute SVHC by less hazardous substances. Web platform REACH Factory EcoMundo has developed a web platform composed of six modules : OO MAT Factory for a complete inventory of substances, materials and global regulations OO USE-CASE Factory for the collection of use cases in the supply chain OO CLP Factory for the classification and notification of substances and mixtures OO SVHC Factory for the traceability of very hazardous substances OO SDS Factory for the creation and management of safety data sheets. OO SAFE Factory for the management of workers exposure and safety. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2007

Creation of EcoMundo by Pierre Garçon, founder and president, after two European research projects

2008

EcoMundo develops high quality services to assist companies with REACH registration and opens a second office in Brussels

2009

Diversification of services with the launch of web-based tools coupled with a dedicated expertise: REACH communication, SVHC management, SDS updates and CLP compliance

2010

EcoMundo realises 80 % of its turnover abroad

2010

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

2011

Anticipating the REACH registration of nanomaterials, EcoMundo develops technological partnerships and publishes a dedicated newsletter: the Nano Molecule

2012

EcoMundo officially launches REACH Factory, a web platform made of six modules to make REACH compliance process easier for industrials

2012

EcoMundo opens up to the North American market with a US REACH Road Show in partnership with SOCMA and the US Department of Commerce

GLOBAL OFFICES Brussels Office (Belgium), at Beci – Brussels Enterprises Commerce and Industry, 500 Avenue Louise, 1050 Brussels, Belgium

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Chemical Watch | Global Service Providers Guide 2012


OO OO OO OO

OO

OO

member of Minor Metals Trade Association in the UK (MMTA) partnership with CETIM, the technical centre for the mechanical industry liaised with the CRIQ, industrial research centre from Québec in Canada member of the US Society of Chemicals Manufacturers and Affiliates (SOCMA) premium partner of the French cluster ECOTOX to become the largest research centre on ecotoxicology in Europe partnership with the French national centre for industrial risks (CNRI)

CLIENTS Our clients are SMEs and large industrial groups and come from various industries : cosmetics, pharmaceuticals, electronics, manufacturing, aerospace, etc. Clients include: L'Oréal, Sanofi-Aventis, Chemtura, Novasep, Schneider Electric, Hager Group, Steelinvest, Fosbel Ceramic Technologies, Vishay, Anhybel, Steelcase, Glass Service, Lisi Aerospace, Plastic Omnium TESTIMONIALS "From the day we started our collaboration, EcoMundo took care of absolutely everything and we were very happy with the minimum involvement that was necessary from our side. All REACH registration dossiers were successfully drafted, respecting all deadlines and without any hidden costs" − Steelinvest "The expertise and constant effort shown in completing our submissions were extremely timely and without flaw" − Fosbel Ceramic Technologies CASE STUDY 1: Building of REACH Authorisation dossiers Authorisations apply to substances of very high concern (SVHC) included in Annex XIV of REACH, with no tonnage limit for the authorisation requirement. As an identified technical expert, EcoMundo had the chance to constitute one of the first authorisation dossiers. This required collaboration with ECHA to clarify some requirements and this teamwork benefited both ECHA and industry regarding the understanding of the authorisation process. The product used consisted of fibre fabrics carrying a polymide resin containing the SVHC, which was cut in pieces and folded into moulds. The moulded parts were heated to induce complete polymerisation of the SVHC, which resulted into the desired rigid shapes. There was discussion between the non EU supplier saying that the product was an article and no authorisation was necessary and our client who considered it as a preparation in a carrier, in which case an authorisation was required. EcoMundo collected the arguments, and our conclusion supported our client. First, the design of the tissue was equally relevant for the processing of the article as the presence of the SVHC, necessary for polymerisation. Second, the SVHC could not be easily or readily removed from the products and we defined the product as semi-finished further processed to a final article. Further, the properties of the final article depended not on the fibre tissue used but mainly on the type of polymer formed. Since heating was applied up to temperatures above 300 ºC, the process could not be defined as “light”. According to the decision tree in the guidance for authorisation, the product was therefore not an article and authorisation was required. CASE STUDY 2: Creation and management of REACH consortia In the context of REACH registration, numerous families of substances often end up being ignored by large consortia for economic reasons. Solicited by several industrials, EcoMundo created the Lead Across Platform (LAP) as well as the Nickel Across Platform (NAP) both aiming to assist companies with the REACH registration of lead and nickel compounds. As all lead compounds and some nickel compounds are classified CMR category 1 or 2, they had to be registered in 2010. EcoMundo managed the relevant Siefs and drafted the associated REACH technical registration dossiers for ten substances and as many companies. Sharing of data and read-across strategies were optimised in collaboration with both the lead REACH consortium and the Nickel Institute. Finally, EcoMundo has been entrusted by metal industry leaders to handle the administrative and technical operation of the SIEFs up to 2018.

Chemical Watch | Global Service Providers Guide 2012

CASE STUDY 3: Development of the MAT Factory web platform Facing the growing challenge of managing substances and materials in various regulatory environments, industrials need a unique and complete database to ensure efficient chemicals management. To assist, EcoMundo has developed webplatforms on the basis of two European research projects (EDIT in 2001 and ECODIS in 2003) on the traceability of hazardous substances in the automotive sector. The outcome of these projects is the web tool MAT Factory, one of the six modules of the web platform REACH Factory. MAT Factory is a customizable inventory of substances, mixtures and regulations throughout the world. It contains more than 100,000 substances and materials with information such as classification, uses or international regulations. EcoMundo is strongly attached to the continuous enrichment and update of MAT Factory database with new data on physico-chemical, mechanical, environmental, toxicological, and ecotoxicological properties of materials.We work closely with various partners to integrate new data into MAT Factory, one of them is the Technical Centre for the Mechanical Industry (CETIM). STAFF SELECTION Pierre Garçon – Founder and President Before creating EcoMundo, Pierre Garçon held senior positions in software publishing companies and founded the West Valley Company which was successfully introduced on the free stock market in France. He directed multidisciplinary teams in large European research projects. Today as president of EcoMundo, Pierre Garçon focuses on building international partnerships in North America, Eastern Europe and India. Jean-Raphaël Miron – Technical Director As a senior consultant, Jean-Raphaël Miron has been involved in ecodesign and multimedia IT development for more than 15 years. Today he supervises the information technology team at EcoMundo and ensures the development of web-based platforms and software specifically conceived for clients. Rinus Bogers – PhD Environmental Sciences A member of Eurotox for over ten years, Dr Rinus Bogers has more than 20 years of research experience in environmental toxicology and risk assessment. Today he manages EcoMundo’s team of experts in toxicology and ecotoxicology, in charge of the entire REACH registration process: registration strategies, read-across proposals, exposure and risk assessment, chemical safety reports management etc. Olivier Le Curieux – PhD Toxicologist and Ecotoxicologist After a three-year mandate as RAC (Risk Assessment Committee) expert member within ECHA, Olivier is now working at EcoMundo as senior REACH manager. Olivier brings in his expertise especially on the building of REACH authorisation dossiers, for which he is recognised as one of Europe’s top specialists. Olivier has also worked four years as scientific project manager for the evaluation of risk assessment dossiers in the framework of REACH and CLP at ANSES, the French Agency for Food, Environmental and Occupational Health and Safety.

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PROFILE: EcoMundo

PARTNERS


SERVICE AREA BREAKDOWN Training 10%

Representation & management 20%

PROFILE: ECOonline

CONTACTS Website

www.ecoonline.com

E-mail

lgp@ecoonline.com

Head office

Trudvangveien 77, N-3117 Toensberg, Norway

Tel/ Fax

+47 33 01 68 00/ +47 33 01 68 01

Contact

Mr Luis G Paulsen

GLOBAL OFFICES

Directors

Mr Øyvind Thorsen, CEO

 

Mr Kjell Hamnes, CTO

 

Ms Martina Johnson, VP Product Management

 

Mr Luis G Paulsen, VP International Sales

Norway Sweden Finland Switzerland

Ownership

Privately held, employees

Locations

Norway, Sweden, Finland, Switzerland

Founded

2000

IT & software 70%

SERVICES PROVIDED Supply chain communication SDS authoring SDS distribution

OVERVIEW ECOonline is one of the most widely used platforms for SDS authoring, distribution, communication and management in Northern Europe with nearly 3,000 enterprises connected online. The platform is ideal for companies in most industries, and it is the perfect solution for supply chains and industry bodies seeking low cost and efficient SDS exchange for members. All parts of the platform are offered online (Cloud, SaaS, ASP), so no installations are required. A common web browser and internet connection are the only requirements. Integration to ERP can be made easily. At the core of the platform is an SDS database which connects suppliers and downstream users online, reducing time and costs involved in nearly all aspects of handling SDSs and managing substance inventories. Flexibility and speed is radically increased, as downstream and end users can access and pull all data from the SDS without having to reenter them, utilise data for analysis, reporting and management, and can communicate efficiently up and downstream. Originating in the internet hotspot of Scandinavia, ECOonline has pioneered the SDS industry, and continuously improved the platform to make it the most widely used. Available in 23 languages, it is designed to meet your requirements for the REACH area. Our aim is to become the most preferred platform for SDS communication and management in Europe, working with leading consultants and members of industry. A team of 60 employees, and a network of highly qualified consulting partners, are ready to give a demonstration of the applications and benefits. VITAL STATISTICS Turnover, group

2010/11 €6m

Turnover, chemical service provision

-

No of offices

5

No of countries represented

6

Staff, group Staff, chemical service provision

60 -

SDS database SDS substance inventory management Workplace risk assessment Employee exposure tracking and storing Up and downstream reporting CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2000

Founded by Mr Kjell Hamnes, long time industry professional with a vision to create the first and most widely used online platform for SDS communication. HQ in Tønsberg, Norway

2001

Launched the first online platform for SDS communication

2007

Opened office in Gothenburg, Sweden

2011

Opened Office in Helsinki, Finland

2011

The 11th year of consecutive growth,by number of connected enterprises, partners, employees, as well as revenue

2012

We welcome new customers, consultants, partners, and industry associations to explore the benefits of connecting to the ECOonline platform

PARTNERS ECOonline works closely with local, regional and international consulting partners in the areas of SDS authoring, substance inventory management, risk assessment, dossier preparations, authority notification, and occupational health. Please contact Mr Luis G Paulsen if you would like to learn more about opportunities of working together with ECOonline. CLIENTS Small and large, public and private, multinationals and locals, our clients represent most segments and industries. We would love to list them all, but with close to 3,000 of them we rather thank them for their long term loyalty and hope to see more joining our community of connected members. TESTIMONIALS Please contact us for testimonials. We’d be happy to provide you with some that are relevant to your needs and your industry!

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Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 1: Automotive OO OO

50% of auto dealers in Norway are connected to the platforn dealers and repair workshops get their SDS directly in their inventories, and reduce time spent on managing inventory and performing relevant tasks.

CASE STUDY 2: Diagnostics manufacturer, and their suppliers of laboratory products

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

PROFILE: ECOonline

OO

CASE STUDY 3: Universities, hospitals, municipalities, public institutions OO OO

OO

OO OO

OO

all 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

STAFF SELECTION Mr Kjell Hamnes – Norway, International Kjell is the founder and head of product development at ECOonline. He has pioneered the development of electronic tools for SDS authoring and management in Northern Europe, and is a widely used resource by industry and authorities on the issues of legislation and compliance. Ms Martina Jonsson – Sweden, International Martina is product manager at ECOonline, and a key figure in Sweden on the issue of REACH and SDS management. Ms Tanja Virtanen-Leppä – Finland, International Tanja is head of training and product in Finland, and she has extensive background EHS from large enterprises. Mr Luis G Paulsen – International Luis is responsible for international sales and operations, and works closely with consultants and partners to ECOonline. Mr Øyvind Thorsen – Head office Øyvind is the CEO of ECOonline.

Chemical Watch | Global Service Providers Guide 2012

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GLOBAL OFFICES United Kingdom, Czech Republic, India and Romania SERVICES PROVIDED REACH consulting elc group REACH advisory services are commercially and technically enabled to undertake any complex regulatory challenge. OO assessment of REACH on business (obligations, benefits of investment towards registration, market analysis) OO project strategies (identifying cost effective registration process and estimating time to complete the project) OO examining other regulatory requirements OO communication on hazards, usage of substances along the supply chain (manufacture, importer and downstream user) OO impact of regulation (methods of production, substance use as an intermediate, guidance on exemptions)

PROFILE: elc group

CONTACTS Website

www.elc-group.com

E-mail

ajain@elc-group.com, jsardhara@elc-group.com

Head office

elc group, Regus House, 1010 Cambourne Business Park, Cambourne, Cambridge CB23 6DP, UK

Tel

+44 (0)1223 969 820, +420 22 491 0000

Fax

+420 22 491 0671

Contact

Akhil Jain, Jastin Sardhara

Directors

Marco Rubinstein

 

Akhil Jain

Ownership

Private company

Locations

United Kingdom, Czech Republic, India, Romania, (proposed in Singapore)

CLP Regulation OO OO

OO

2004

Founded

OO

OVERVIEW

OO

elc group is a leading global services organisation that helps clients expedite time-to-market through our services. These include a broad range of development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialisation services. elc group delivers its customised solutions through its four core business segments: OO EU REACH Regulation services OO regulatory affairs services OO medical devices OO corporate languages solutions (translations, design, DTP, localisation)

OO

SVHC services OO OO OO

OO

2010/11

Turnover, group

€5m

Turnover, chemical service provision

€2m

No of offices

4

No of countries represented

35

Staff, group

60

Staff, chemical service provision

20

SERVICE AREA BREAKDOWN

OO OO OO

dossier compilation using latest IUCLID version, exposure scenarios and risk and hazard assessment strategies on data gap analysis (Annex VII to XI of REACH), data evaluation and testing requirements QSAR, read-across and waiving strategies communication with data holders and authorities only representative and third party representative services

Sief/consortium management OO

OO

Sief and consortium formation, assistance to the LR, structuring of joint and individual dossiers and chemical safety report post submission of lead dossier support for letters of access, administrative and cost sharing tasks between registrants

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

IT & Training software 3% Laboratory 2% 5% Information 5% Consultancy/ advisory 45% Representation & management 40%

notification of SVHC in articles authorisation of substances in (Annex XIV of the REACH Regulation) SVHC testing and assessment

REACH registration

OO

VITAL STATISTICS

classification and labelling of substance and preparations notification of substances to classification and labelling (C&L) inventory preparation of safety data sheet (SDS) and extended safety data sheet (eSDS) review current SDS and labels for REACH compliance modifying and classifying existing SDS to comply with REACH and CLP identifying additional information as per regulatory requirements

2004

Company established in Prague, Czech Republic

2007

Started offering complete REACH solutions

2008

Opened office at Ahmedabad in India

2010

Exceptionally talented project management, technical and marketing team built and started operations in Romania

2011

Registered office set up in Cambridge, UK

2012

Proposed new offices in Mumbai and Singapore

ACCREDITATIONS Active member of various chemical consortium. PARTNERS elc has global presence through our certified partners in different countries on legal matters and laboratory and training services.

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CLIENTS

STAFF SELECTION

Our clients range from multinational chemical companies to SMEs. We do not disclose our customers identity as per the terms agreed upon by the parties.

Our global staff is highly competent and have long experience in research, risk management measures, analysis of wide range of substances used in chemicals and pharmaceutical industries. Our key members are enabled to undertake any global regulatory challenges.

TESTIMONIALS

PROFILE: elc group

"We selected elc group as we needed a complete REACH service provider, we missed the pre-registration period and elc ensured that our EU exports remained undisrupted, made a timely inquiry to ECHA and successfully registered a substance. Their services are straightforward, no hidden charges, project estimates are very close to actual and keep you within your financial goals." "We have been using elc’s REACH services since 2008 and are very pleased with the technical support they have provided for registering some complex mixtures. They have very friendly staff, always ready to go an extra mile in order to get the job done beforehand. There has never been any concern and we look forward to continuing availing ourselves of their services in future." "elc is of great help to SMEs like us with financial limitations who practically find it difficult to survive in the European market. Their cost effective REACH advisory services are outstanding, they just deliver what they promise. I am very pleased that I made a right decision by appointing them as our only representative.” CASE STUDY 1: REACH inquiry dossier for leading Russian manufacturer Just before 2010 deadline, elc was approached to identify the repetitive failures on an inquiry submitted by previous only representative. Challenges: OO substance identification and sameness OO data gap analysis, additional analytical tests requirement. OO compilation of a dossier in IUCLID as per results of available tests elc ensured that consistency was met while managing concentration ranges of substance purity, impurities with the test results which are common reasons for an inquiry failure. elc also responded that there are requirements of optical activity tests for that particular substance along with a justification to other mandatory requirements. In just two months the final dossier was successfully submitted, long before the final date for submission and the substance was successfully registered. CASE STUDY 2: Global MSDS commission from leading Turkish manufacturer A US company – manufacturer and supplier of chemicals for multiple industries, including water treatment, personal care, intermediates, pigments, electronic etchants, petrochemical, pharmaceutical and chemical-intermediates – appointed elc group to fulfil regional regulatory MSDS requirements for products shipped in the US, Canada, India, China, Turkey, Israel, Russia, Ukraine and throughout the EU. Our fully equipped MSDS software ensured that MSDS were globally compliant with regulatory and language requirements for each country where the client has a presence. The database is regularly reviewed to update any global regulatory changes ensuring 24x7 compliance solutions for our customers worldwide. CASE STUDY 3: Classification and labelling for leading Indian manufacturer In order to meet global compliance requirements elc group has made classification and labelling recommendations for several EU and non EU companies. ECHA updated C&L inventory but still there were large number of substances and formulations for which self-classification was required as per CLP guidelines. elc made several such classification recommendations based on the available data, substance hazards, and literature searches to chemical companies worldwide.

Chemical Watch | Global Service Providers Guide 2012

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

PROFILE: ENVIRON

CONTACTS

REACH, CLP and parallel European chemical regulation (biocides, plant protection products, cosmetics, food contact materials)

Website

www.environcorp.com

E-mail

sbullock@environcorp.com

Head office

5 Stratford Place, London, W1C 1AX, UK

Tel/ Fax

+44 20 7478 9800/ +44 20 7478 9801

Contact

Sue Bullock

Directors

137 partners worldwide, including

 

Jose Fernandez (F), President Europe

 

Sue Bullock (UK), Aidan Turnbull (UK)

 

Henk Verhaar (NL), Martina Vosteen (DL)

ENVIRON has 30 years of experience developing and supporting product regulatory compliance strategies and preparing robust technical dossiers and risk assessments/ CSRs for substances in industrial, agricultural, biocidal and consumer applications. We balance clients’ technical, regulatory and commercial interests through sound science; clients regularly entrust our multi-disciplinary team with their most recalcitrant and critical problems. We provide scientific and regulatory support for SVHC, from the initial proposal for inclusion on the Candidate List to Authorisation, including business impact assessment, socio-economic analysis and substitute assessment. We advise on communication with ECHA and MSCA, and development of policy, regulation and guidance. We also audit product regulatory compliance systems and support supply chain management. ENVIRON also acts as consortium manager and only representative, and is independent from testing facilities.

Joseph Rodricks (US) Ownership

Private limited company

Locations

Over 80 offices worldwide

Founded

1982

Global chemical notifications and regulatory compliance support

OVERVIEW An international health, environmental, safety and sustainability consultancy, ENVIRON works with clients to resolve their most demanding environmental and human health issues. Our global product safety and regulatory compliance team helps companies gain regulatory approval for products to comply with chemical regulations around the world. Beyond this, we assist industry leaders and innovators alike to provide effective product stewardship programmes to manage risk, reduce liability and enhance support from stakeholders. Striving always to be at the leading edge of science, we deliver thoughtful and innovative solutions in product safety. Clients around the world benefit from our unique ability to bring clarity to issues at the intersection of science, business and policy. We provide a single point of support for chemical regulation and risk management. VITAL STATISTICS

2010/11

Turnover, group (2010)

€177m

Turnover, chemical service provision

-

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, Switzerland, Taiwan, Turkey, and the US. Product stewardship and troubleshooting Our breadth and depth of expertise in toxicology (plus expertise in toxicokinetic modelling); epidemiology; exposure modelling, measurement and reconstruction; risk assessment and mitigation; ecotoxicology, environmental fate, regulatory affairs, chemistry, occupational health, supply chain issues; product vigilance and advocacy means we are ideally placed to advise clients on problems – from in depth assessment of animal and human evidence for health effects to concerns regarding measured exposure levels of substances in humans and the environment and managing supply chain issues. We couple internationally recognised expertise and reputation as leader in risk management with client-focused solutions.

No of offices

87

BOMCheck

No of countries represented

18

Substances declarations web database for REACH, RoHS, batteries and packaging compliance to facilitate supply chain management.

Staff, group

1,300

Staff, chemical service provision

50

SERVICE AREA BREAKDOWN Laboratory 5% Representation & management 10%

Consultancy/ advisory 85%

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CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1982

Founded in Washington, DC, USA

1996

Acquired UK consultancy EAG

2000

Opened offices in Italy, France, Germany and Finland

2001

Opened offices in Australia, China, Malaysia and Singapore

2003

Merged with AEI to bring full range of services in occupational health, environmental health and injury and disability research

2005

Merged with ADVENT Group, increasing range of technical services related to water management

2007

Acquired Boelter Associates; the largest single acquisition in the firm's history.

2008

Acquired Gustitus Group.

2009

Acquired Arquipélago in Brazil

Chemical Watch | Global Service Providers Guide 2012


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

2011

American Academy of Environmental Engineers 2011 Excellence in Environmental Engineering Competition: Grand Prize, Research

2012

Opened first African office in Johannesburg

CLIENTS Clients in the following industries: industrial and specialty chemicals, petrochemicals, agrochemicals, food and food packaging, cosmetics, medical devices, electronics, manufacturing TESTIMONIALS “We are working with ENVIRON in a constructive and successful manner on various REACH projects, covering the entire processes (ie preparation of technical dossiers, exposure estimation and hazard and risk assessment)” – Dr Hans Certa, manager Global Product Safety, SASOL. “ENVIRON has rapidly integrated into our global REACH team to add excellent technical expertise, and provide timely REACH knowledge for registration, CLP and Sief management. ENVIRON is very well organised 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 CASE STUDY 1: REACH dossier and CSR for a group of SVHCs ENVIRON prepared REACH dossiers and CSRs for a group of high profile hazardous organic substances with potential endocrine disrupting properties and a wide use pattern. ENVIRON provided robust and comprehensive dossiers while balancing the effort associated with registration through use of read-across, weight-of-evidence, QSAR and waiving (including exposurebased waivers). ENVIRON developed and implemented original methods to refine chemical fate and exposure parameters (eg dermal penetration, biotic degradation, dissociation coefficient). CSAs were prepared using EUSES, ECETOC TRA and CHESAR based on carefully defined exposure scenarios developed with regard to available exposure data and information from downstream users. The CSRs were developed to be accessible and useful to both registrants and their customers alike.

CASE STUDY 4: Regulatory action related to product contamination Our client, a food packaging producer, faced possible regulatory action associated with residual levels of a contaminant (a potential carcinogen) in a key product. Using an integrated approach – involving expert determination of a safe intake level (DNEL), analysis of available exposure information and development of refined exposure models – we demonstrated that consumer exposure to the contaminant from handling the packaging and ingesting the packaged foods were within safe levels. Through partnership with our client and thoughtful evaluation of the problem, we provided a robust and defensible approach that informed important strategic decisions for the business, including product viability, consumer perception and communications, as well as supporting product regulatory notifications CASE STUDY 5: Review proposed carcinogenicity classification An industry association asked ENVIRON to review all available evidence for the carcinogenicity of a product in order to comment on the basis and technical merits of proposals to classify the substance as a carcinogen. STAFF SELECTION Sue Bullock – Principal, Product Safety and Regulatory Compliance Leading ENVIRON's product safety and regulatory compliance services for 20 years, Sue has provided strategic, regulatory and technical assistance to industry relating to presence of chemicals in the environment, the workplace and consumer products. She has an extensive knowledge of REACH and helps companies around the world comply with global chemical regulations, assess and manage health and commercial risks, manage liability and deliver effective product stewardship across the supply chain. Dr Henk Verhaar – Principal, Chemist and Ecotoxicologist Twenty years' experience in modelling the fate of chemicals in the environment and assessing and predicting their ecotoxicity. His work on predictive aquatic toxicology has been widely used in Europe and the US during the development of hazard assessment models for chemicals in the aquatic environment. His fields of expertise also include derivation of safe exposure levels and environmental statistics. Dr Verhaar has extensive experience as a troubleshooter on chemical and ecotoxicological matters. Dr Martina Vosteen – Principal, Chemist and Product Safety Dr Vosteen has more than ten years of experience as a consulting chemist, including coordination and management of hundreds of risk assessments regarding product and environmental liability (financial losses) particularly for the chemical, pharmaceutical, medical devices and food industries. She has acted as technical/scientific expert in several product liability cases and advises the industry in relation to REACH and other product regulatory relations (cosmetics, pesticides, etc).

CASE STUDY 2: Global regulatory approval – new consumer product

Dr Joe Rodricks – Principal, Toxicologist

ENVIRON evaluated regulatory obligations in more than 50 counties – considering chemical notification, packaging and labelling requirements – for a company wishing to market a product globally. The review allowed identification of key market opportunities. ENVIRON then prepared notifications for priority countries, including identification and management of local representative to file documents, as needed.

An internationally recognised expert in the field of toxicology and risk analysis and their uses in chemical regulation, management and stewardship. Since 1980 he has consulted for hundreds of manufacturers, for government agencies and for the World Health Organisation. He has served on 15 boards and committees of the National Academy of Sciences and the Institute of Medicine.

CASE STUDY 3: Exposure data drives regulatory scrutiny Biomonitoring studies have reported detectable levels of perfluorooctanoate (PFO) in the blood of the general population. A multinational company asked ENVIRON to evaluate the contribution of exposure to perfluorooctanoate (PFO) from certain consumer articles (eg treated carpets, clothing, upholstery and cookware) to total PFO exposure. Based on an analysis of data generated to support the exposure assessment, ENVIRON quantified the magnitude of potential PFO exposure for consumers of these products in the home, in school or at work and derived toxicity criteria. We concluded that exposure to these products in the consumer environment is not expected to contribute appreciably to PFO levels in the blood of the general population, or to cause adverse human health effects. Chemical Watch | Global Service Providers Guide 2012

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PROFILE: ENVIRON

2010


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 Classification, labelling and packaging (CLP/GHS)

PROFILE: ERM

CONTACTS Website

www.erm.com

Classification support, safety data sheet (SDS) and label authoring SDS and label review and improvement

E-mail

rudolf.wilden@erm.com

Emerging chemical control laws around the world

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 (USA), Simon Aumonier (UK), Kathleen Goossens (Belgium), Dirk Nuyens (France), Rudolf Wilden (Germany)

New chemical notification, tracking of emerging legislation bans/ restrictions Downstream product legislation, eg food/food contact, biocides OO OO OO OO

food contact notifications compliance with country-specific legislation FIFRA / BPD support national registrations local / regional registration labelling and claims support

Ownership

Private Limited Company

Locations

140

OO

Founded

1971

Lifecycle assessment and sustainability

OO

OO

OVERVIEW

OO

Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management and technical consulting services, with considerable experience in providing global product stewardship (GPS) services. With global product stewardship positioned as a strategic growth initiative within the firm, ERM offers integrated product service across all divisions within the company. VITAL STATISTICS

2010/11

OO OO OO OO OO OO

carbon foot printing and emission inventories lifecycle management (LCM) also to ISO14040 input/output as well as eco-efficiency analysis supply chain management and carbon reduction advice design for environment (DfE) environmental product declarations (EPDs) lifecycle analysis (LCA) sustainable business strategy

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

$483m

2010

ERM hosts the first ChemicalsForum Europe together with Trasys

Turnover, chemical service provision

$8m

2010

No of offices

140

Preparation of more than 100 REACH registration dossiers and compilation of the first socio-economic analysis according to ECHA standards

2011

ERM supports clients with evolving product legislation such as those in Turkey, China, Korea, Japan, Brazil

2011

ERM brings on board the product stewardship team around Sal Giolando

Turnover, group

No of countries represented

40

Staff, group

> 4,000

Staff, chemical service provision

>50

SERVICE AREA BREAKDOWN

ACCREDITATIONS

Training 10%

ISO 9001 & ISO 14001

Representation & management 20%

PARTNERS Partner of Cefic CEHTRA Consultancy/ advisory 70%

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. 

GLOBAL OFFICES

TESTIMONIALS

We support our clients in all countries globally.

"We have been working with the ERM team on REACH for a number of years now, and there are very good reasons to continue and expand this collaboration. Both on practical, communicative and technical-scientific levels ERM has provided us with active, solid and high-quality support for MSD's REACH programme. We are pleased to observe that our collaboration has turned into a true partnership." – Frits Wielaard, REACH programme manager, Merck Sharp & Dohme “ERM have provided support and advice for us throughout the preregistration and registration phase of REACH and have always been totally professional, flexible and quick to respond to our needs. They provide an excellent service and we look forward to continuing our partnership with them in the years to come.” – Steve Williams, Regulatory  Manager Europe, Knauf Insulation

SERVICES PROVIDED Registration, evaluation and authorisation of chemicals (REACH) OO OO OO OO OO OO OO OO OO

socio-economic analyses REACH training/ REACH impact assessments preparation of lead and member registration dossiers preparation of application for authorisation chemical safety assessments CLP notifications Sief management REACH compliance assessments REACH implementation workshops (management systems)

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Chemical Watch | Global Service Providers Guide 2012


“ERM has been Momentive’s partner in the implementation of REACH since the beginning and has always provided the expert support we needed through the different stages of the project.” – Ralf Maecker, Momentive Performance Materials

Dr Dave Best – Technical Director

CASE STUDY 1: Supporting the REACH team of Momentive Performance Materials (MPM)

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 Randy Shuler – Senior Toxicologist Diplomate, American Board of Toxicology Inc, 1996-present, with more than 18 years of experience in toxicology, environmental science and consulting. Randy has evaluated toxicology and epidemiology data, and has provided litigation support in toxic tort and environmental litigation cases. Kathleen Goossens – Principal Partner 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 Dirk Nuyens – Principal Partner

CASE STUDY 2: Supporting a multinational pharmaceutical company’s new chemical registration in China

Has 20 years’ consulting experience in the fields of EHS compliance, REACH and risk assessment.

An ERM client needed to register a new chemical product with high toxicity (eg fish LC50(96h) < 10 μg/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 can 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.

Alain Renard – Project Manager

STAFF SELECTION ERM’s Global Product Stewardship TEAM (GPS) ERM has more than 50 professionals with extensive specific GPS experience located at various offices world wide. 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 – Head of EU REACH Team 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 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 Simon Aumonier – Head of the Sustainable Product Support Team Twenty years of experience in supporting the strategic decisions of government and business, employing a toolkit that includes cost effectiveness and cost benefit analysis, risk assessment, lifecycle assessment, carbon footprinting, decision analysis techniques and facilitation.

Chemical Watch | Global Service Providers Guide 2012

Experienced manager of four REACH consortia. As a former manager of the Cefic Authorisation/Restriction working group, Alain developed an extensive network with authorities and in-depth knowledge of the authorisation process. Dr Eckhard Schäfer PhD in chemistry, with more than 20 years’ experience in chemical risk assessment and preparation and implementation of safety plans. Health and safety advisor of the Hoechst Corporation between 1986 and 1994. Dr Elsie Millano BSc in chemical eng and PhD in civil eng. environmental area. Supporting the REACH team in the review and preparation of CSRs and safety data sheets, and review of robust study summaries. Over 25 years of environmental consulting experience in human health risk assessments, including exposure assessments, fate and transport evaluations, and risk calculations. Extensive expertise in contaminated site closures based on controlling exposures. Carolyn Hammer – Senior Ecotoxicologist 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. Dianne Green – Senior Project Manager 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. Dr Jeff Eberhard – Senior Project Manager Over 25 years of relevant expertise in both industry and consulting, focusing on bringing highly regulated products to market with a strong focus on providing technical excellence in human and environmental health and risk assessment. Donna Morrall – Senior Project Manager 20 years of relevant expertise in both industry and consulting with a strong focus on risk assessment, data analysis and computational modelling.

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PROFILE: ERM

MPM required support for its REACH team using ERM’s REACH expertise, including toxicologists, ecotoxicologists and chemists. The ERM REACH project team was fully integrated into the MPM team and early identification and discussions of issues encountered provided timely resolution of such. Benefits and value OO 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 cooperation OO cooperation of the team with a view beyond registration (eg on health and safety management) helped solving upcoming issues OO lessons learned during the first registration phase will inform and streamline future REACH management

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.


SERVICES PROVIDED

PROFILE: Exponent International Limited

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. We can also place and monitor studies, prepare and submit registration dossiers and chemical safety reports and provide post-submission support during evaluation and authorisation phases. Exponent has significant experience in programme and project management and Sief and consortia management and we can also act as your only representative or third party representative.

CONTACTS Website

www.exponent.com

E-mail

jreddy@uk.exponent.com

Head office The Lenz, Hornbeam Business Park, Harrogate, North Yorkshire, HG2 8RE, UK Tel

+44 (0)1332 868000

Fax

+44 (0)1332 868099

Contact

Julian Reddy

Ownership

Wholly owned subsidiary of Exponent Inc.

Locations

Derby, UK; Basel, Switzerland

Founded

2002

Preparation of REACH registration dossiers and chemical safety reports

OVERVIEW Exponent Inc is one of the world's largest regulatory, engineering and scientific consultancies providing innovative solutions to complex technical problems. Exponent International Limited is a wholly owned subsidiary of Exponent Inc and is the European arm of the Chemical Regulation and Food Safety practice with offices in Harrogate and Derby in the UK and Basel in Switzerland. Exponent combines unparalled technical expertise with the ability to focus this knowledge to meet our client's needs within short timeframes. Our ability to create multidisciplinary teams of scientists, regulatory consultants and project managers means that we can either perform in-depth scientific research and analysis or very rapid-response evaluations to provide our clients with the critical information that they need to make day-to-day strategic decisions. VITAL STATISTICS

2010/11

Turnover, group

US$7m

Turnover, chemical service provision

US$3m

No of offices

3

No of countries represented

35

Staff, group

45

Staff, chemical service provision

25

SERVICE AREA BREAKDOWN Training Other 2% 3% Information 5%

Exponent has prepared in excess of 50 complete lead registrations for phase-in substances. We can complete all aspects of the process such as data evaluation and data gap analysis, determination of substance identification, use of intelligent strategies to address data gaps and study placement and monitoring. We can complete all of the IUCLID 5 dossier and the chemical safety report including exposure assessments, using ECETOC TRA and higher tier models if necessary, and risk characterisation. Once the assessments have been completed we can produce the final exposure scenario and extended safety data sheets. Global chemical notifications Our consultants have considerable experience in compiling and submitting chemical notifications worldwide; utilising our team of consultants we are capable of preparing and submitting chemical notifications to all countries that have a relevant scheme. We can prepare and submit dossiers for Australian, Canadian, New Zealand and Swiss registrations and use our Swiss office to act as a sole representative. We have a network of local agents to help with the preparation and submission of regulatory documentation in China, Japan, Korea, Philippines, Taiwan and Turkey and can utilise the experience of our US colleagues for TSCA notifications. Other regulatory regimes Exponent's consultants have significant experience in assisting clients with EU agrochemical, biocide and food regulatory requirements. For agrochemicals and biocides we can assist with regulatory strategy, data gap analysis, study monitoring, risk assessments and completion of active substance and product registration dossiers. This includes in-depth support such as managing compounds to Annex I inclusion. For clients in the food industry we can develop strategies for technical and regulatory challenges, develop food safety systems and help meet regulatory requirements for food additives, contact materials, novel foods and health claims. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Representation & management 25% Consultancy/ advisory 65%

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

GLOBAL OFFICES

ACCREDITATIONS

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

ISO 9001 accreditation

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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.

Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 3: REACH Support for the 2013 Deadline

Exponent Inc has worked with over 5,000 clients and Exponent International has undertaken work for over 350 clients globally. Exponent has provided regulatory support to a range of companies across many industries; companies ranging from SMEs working in one industry to global companies conducting business in a number of industries including industrial chemical, speciality and fine chemical, petrochemical, agrochemical, cleaning and maintenance products, metals, organometallics and plastics.

Exponent provides full assistance for a fine chemical manufacturer in meeting their REACH requirements for the May 2013 deadline. The company is a lead registrant for eight substances and we have worked with them to identify gaps in the available data, managed the testing programme that was placed with a global CRO, produced substance identity profiles and we are currently in the process of completing the dossiers for these eight substances. Future work will include the completion of 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 timescales, use what we have learnt from one substance to help with others where possible and provide our client with confidence that they will meet their REACH obligations ahead of the 2013 deadline.

TESTIMONIALS "Exponent International has consistently provided high-quality REACH and biocides services and support to our company for over five years. They produce work of the highest quality at competitive prices and are always prepared to go that bit further to ensure that they can deliver what we need within challenging deadlines. Their excellent technical knowledge and abilities mean that they are always the company we go to when we need help in these areas" − Regulatory Affairs Manager, global cleaning and maintenance products manufacturer CASE STUDY 1: Provision of technical support to an organometallic consortium Since 2009, Exponent has provided technical support to a consortium of organometallic substance manufacturers. Exponent performed the technical work required for the 16 substances that needed to be registered in 2010 and continues to provide support for the substances to be registered in 2013. The 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 have been and are still responsible for the production of the registration dossiers in IUCLID 5 including appropriate data waivers and testing proposals and for the production of chemical safety reports (CSRs). To complete the CSRs Exponent have 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, but pragmatic, solutions have been necessary to demonstrate safe use. Exponent's technical capabilities and support ensured that all 2010 consortium substances were registered ahead of the deadline and it is anticipated the submissions for the 2013 substances will be completed well in advance of that deadline. CASE STUDY 2: Product stewardship service for a SME Exponent has provided ongoing product stewardship support for a catalyst manufacturer, covering REACH and all other global chemical regulatory regimes, for over four years. Taking a holistic approach, we provide global regulatory strategy and advice to ensure that regulatory requirements from a number of countries can be effectively overlapped. Exponent also provides more technical support by preparing and submitting regulatory documentation for REACH and other chemical notifications, preparing and reviewing European safety data sheets and determining the classification and labelling of the substances for GHS inside and outside of the EU. We also act as a sole representative for their Swiss notifications. In 2011 as part of this companies business was sold off we have handled all 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 2012

STAFF SELECTION Dr Caroline Harris – Centre Director (UK) Dr Harris is the head of Exponent International and director of Exponent's Chemical Regulation and Food Safety Centre. She has a strong international reputation and has published papers on a range of subjects including dietary risk assessment, infant and child exposure to pesticide residues and risk perception. She acts as a technical consultant to a number of international bodies, including the FAO and the WHO, and has been a member of the UK’s Advisory Committee on Pesticides since 2009. Julian Reddy – Head of REACH and Chemical Notification Services Mr Reddy is an experienced regulatory project manager and has supervised complex regulatory programmes undertaken on industrial chemicals and biocides. In addition, he has particular experience of Asian chemical notification schemes. Mr Reddy manages Exponent’s Derby office which specialises in REACH and the global notification of industrial chemicals. He is responsible for the management of individual projects as well as overall programme management for clients and consortia. John Hislop – REACH Regulatory Specialist Mr Hislop specialises in REACH and particularly the registration requirements for phase-in substances. He also has more than 17 years of experience working on global notifications of new chemical substances. Mr Hislop has considerable experience in development of testing programmes for chemicals for regulatory purposes, specialising in the use of an 'intelligent approach' to safety testing and is a leading advocate of the principle of the read-across approach. Dr Alec Willis – REACH Regulatory Specialist Dr Willis leads Exponent’s capabilities for chemical safety reports and exposure scenarios. He has experience in SIEF management, production of registration dossiers and SIEF and consortia representation for clients. He has also helped clients across a range of industries prepare for REACH by providing regulatory strategy and advice and performing vulnerability analysis. Dr Willis is an experienced project manager, managing a large number of multi-disciplinary REACH projects.

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PROFILE: Exponent International Limited

CLIENTS


SERVICES PROVIDED Registration dossiers (joint, lead, NONS, intermediate) CLP – GHS including SDS generation and EU/International SDS generation Articles and SVHCs including software solutions

PROFILE: H2 Compliance

CONTACTS

Only representative services

Website

www.h2compliance.com

E-mail

ursula.hayes@h2compliance.com

Head office

Unit 4A, Nutgrove Office Park, Nutgrove Avenue, Rathfarnham, Dublin 14, Ireland

Tel

+353 1 2989146

Contact

Ursula Hayes

Directors

John Hayes

Directors

Kevin Hoban

Directors

Grant Kinsman

Ownership

Private company

Locations

Ireland (Dublin, Cork), USA (New Hampshire)

Founded

2006

REACH management software (element1) Sief services and facilitation Biocides, cosmetics and detergents support Integrated chemical regulatory management (product stewardship) CORPORATE DEVELOPMENTS & ACHIEVEMENTS

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

2010/11

Turnover, group

2006

Dublin Office established

2007

Cork Office established

2008

Strong client base and partner network development

2009

USA office opened

2011

Irish Small Firms Association category winner

2012

Deloitte Technology Fast 50 award recipient

ACCREDITATIONS Approved ReachReady Gold member Approved Only Representative Organisation member PARTNERS OO OO

The Redstone Group KMK Regulatory Services SafeBridge Consultants Inc

-

OO

Turnover, chemical service provision

-

CLIENTS

No of offices

3

No of countries represented

-

Confidential clients including those in the following sectors: pharmaceuticals, industrial chemicals, mining/ minerals, lubricants, fragrances, medical devices and information technology.

Staff, group

13

Staff, chemical service provision

-

SERVICE AREA BREAKDOWN Other 5% IT & software 15% Consultancy/ advisory 40%

Representation & management 40%

GLOBAL OFFICES Ireland (Dublin and Cork) USA (New Hampshire)

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TESTIMONIALS Stewardship services: "H2 Compliance was carefully selected to allow us to continue to meet the changing needs of our new and existing client base. We based decisions on their ability to provide all required regulatory support with one sourced compliance organisation. With their assistance, we have successfully met the REACh and SDS deadlines of 2010 without issue. I have found the team to be highly flexible with our deadlines, effective with providing accurate information, and most importantly focused on needs of clients." – Michael Goluszka, La-Co Industries. Dossier services: "H2 Compliance supported us for the construction of two lead registration dossiers for the December 2010 registration deadlines. Both dossiers were submitted on time and within the agreed budget." "H2 Compliance and its partners bring a wealth of experience to this technical area and have a high quality of communication and project management. We have always found communications to be efficient and with due regard for the confidential nature of the relationships within the consortia environment." "We have found the relationship with H2 Compliance to be strong and we are happy to recommend the firm for this type of activity." – a large US diversified chemical manufacturer.

Chemical Watch | Global Service Providers Guide 2012


H2 Compliance act as only representative for a plumbing supplies company in Chicago which formulates novel paint and marking systems and chemical supplies for the plumbing industry. H2 Compliance provides an integrated set of services for the client including REACH dossiers for monomer substances, safety data sheets and C&L notifications as an importer. With the growing complexities associated with international GHS adoption, H2 provides support for the development of a full suite of SDS for all their international markets including product labelling and appropriate transport labelling. The client commends H2 Compliance on their expertise, professionalism and timeliness and continues to expand on service requirements to support their growing business. CASE STUDY 2: Pharmaceutical and healthcare sector support H2 Compliance has deep expertise within the pharmaceutical industry whether through gap analysis, team development or strategic advice on intermediates and strictly controlled conditions. H2 build full registration dossiers and upgrades to NONS dossiers including CRO oversight, RSS and submission. H2 are commended on their collaborative platform, “element1” used for professional execution, data availability and total transparency. Our clients enjoy the fixed price model we typically operate, flexibility in working hours and deep strategic thinking. “I wish all of our partners and consultants were as easy to work with as H2 Compliance” – a top ten pharmaceutical client CASE STUDY 3: Product stewardship programme to assure ongoing market access H2 Compliance has developed and implemented a product stewardship programme for a global blue chip firm. The initial distinct strands of support have developed into an integrated programme with the establishment of a formal role within the company to manage the product life cycles and organisations. H2 Compliance provided the tools, structure and strategies for a robust and cost effective product stewardship programme. H2 Compliance managed the implementation of the system and has since extended the system to include their supply chain. The client has placed their trust in the knowledge and experience of H2 Compliance. There have been no market access issues since the programme was implemented.

Beth L Bidstrup, MHS, CIH – Principal Occupational Scientist Beth Bidstrup has been a member of the H2 Compliance technical team for almost three year providing leadership for dossier, CLP and product stewardship services. Beth’s background includes 20 plus years within the pharmaceutical industry specialising in chemical control management and occupational health roles at both the corporate and site level. Beth received her BSc in industrial hygiene and environmental toxicology from Clarkson University and her master’s of health science in industrial hygiene and safety from The Johns Hopkins University. She received her Certification in Industrial Hygiene (CIH) in 1993. Colin Smith, CBiol, MSB, ERT – Regulatory Toxicologist Colin Smith has recently joined the H2 Compliance team after having worked for several years as an inspector for the Irish competent authority for REACH and CLP; there he was involved in all aspects of REACH and CLP. Colin was involved in both the drafting of the technical annexes of CLP and the work of the UN GHS subcommittee; he also acted as a technical advisor on human health to the Irish representatives of the ECHA Member State, Risk Assessment and Caracal committees. Colin started his career working as a toxicologist for the UK Ministry of Defence and achieved chartered biologist status in1997 before taking up the role of laboratory manager for an in vitro alternatives testing laboratory for a multinational biocides and speciality chemical company; during this time he qualified as a European registered toxicologist in 2004 and became a study director with responsibility for GLP compliance within the laboratory. Bart O’Keeffe – Representative Services Manager Bart O Keeffe has four years’ experience working in the chemical regulations Industry. Bart holds a BEng in chemical and biopharmaceutical engineering and is a certified associate in project management (CAPM). Bart has extensive experience of the REACH regulation and currently manages the only representative service within H2 Compliance. He has also worked on dossier development under REACH and CLP implementation since December 2010.

STAFF SELECTION John Hayes – Chief Regulatory Officer John Hayes has more than 14 years’ experience in the pharmaceutical and IT sectors. He has a BSc in biotechnology and a PhD in physical chemistry. John has extensive environmental and chemical regulatory knowledge. This experience has been applied to many different scenarios including government affairs and lobbying, health and safety, production, environmental programme development and waste management. Kevin Hoban – Chief Operations Officer Kevin Hoban has 18 years’ experience in the IT, pharmaceutical and metals industries. He holds a BSc and MSc in industrial chemistry, a diploma in environmental engineering and is a professional project manager, PMP. Kevin ensures that services are delivered in a professional, systematic manner with transparency and value for money a cornerstone. Grant Kinsman – Chief Executive Officer Grant Kinsman has 25 years’ experience in IT industries.  He holds a BSc (Hons) in mechanical engineering. Grant has extensive global technology, product development, marketing and business start-up experience. He has a broad knowledge of the business value delivery system including operations, R&D, business planning, commercialisation, intellectual property and licensing.

Chemical Watch | Global Service Providers Guide 2012

Page 91

PROFILE: H2 Compliance

CASE STUDY 1: Solving the complexities of labelling and packaging


VITAL STATISTICS

2010/2011

Turnover, group

-

Turnover, chemical service provision

-

No of offices

-

No of countries represented Staff, group

PROFILE: Harlan Laboratories

CONTACTS Website

www.harlan.com/crs

E-mail

crs.uk@harlan.com

Head office

8520 Allison Pointe Blvd Suite 400, Indianapolis, IN 46250, USA

Tel/ Fax

+44 (0)1332 792896/ +44 (0)1332 799018

Contact

James Gillespie

Directors

Hans Thunem

 

Manuela Leone

Ownership

Private company

Locations

Worldwide offices and operations

Founded

1931

OVERVIEW Harlan Laboratories is a global leading provider of essential, non-clinical contract research, research models, animal diets, and services to the pharmaceutical, biotech, medical device, agrochemical, and chemical industries, as well as to academic and government research organisations. Harlan Laboratories is the market leading CRO offering regulatory advice, safety testing and safety assessment of chemicals. Our project leaders 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. UYnderstanding the value of close relationships and collaboration with our costumers we act locally. Stability, reliability, consistency, and quality are what Harlan Laboratories offers with decades of proven expertise in both research models and services, and contract research services. As important as good customer service and relationships are, though, it’s really all about scientific excellence. Today, research is increasingly being outsourced, and researchers need to have confidence in their supplier partners. Stability, reliability, consistency, and quality are all essential. That’s what Harlan Laboratories offers with our passion for science and decades of proven expertise in both research models and services, and contract research services. Products and services Harlan is made up of two major business units offering local expertise, presence, service, and state-of-the-art facilities in all of the countries it serves. Contract Research Services provides non-clinical and pre-clinical laboratory research services supported by state-of-the-art facilities worldwide. Our core capabilities are in: 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

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12 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. 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 multi-site studies, if necessary.

Chemical Watch | Global Service Providers Guide 2012


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 researchers and clients in pre-validation and formal validation studies.

John Handley, BSc MSc CBiol FSB – 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 silico 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 AALAC OO ISO/IEC 17025 OO EN 45011 OO GLP OO GMP OO GEP CLIENTS Chemicals Industry Agrochemicals Industry Pharmaceuticals Industry

Chemical Watch | Global Service Providers Guide 2012

John Handley is global vice president Operations at Harlan Laboratories Ltd and has some 26 years’ experience of working in the contract research industry. Following the completion of his Masters research in acid rain and the associated toxicity of aluminium to rainbow trout, John worked at the University of Cardiff on a research contract to the EU, developing methods for chemical registration. From there he moved to Huntingdon Research Centre where he worked in the Aquatic Toxicology department for four years. John moved to Safepharm Laboratories in 1989 to design and set up the ecotoxicology facility. In 2005 he became Operations Director for the company while still retaining management responsibility for the department of Ecotoxicology until 2007 when the company was acquired by Harlan Laboratories Ltd and he was made general manager for the UK. In January 2009 he was appointed vice-president Environmental Safety and Metabolism across all Harlan CRS sites. In August 2010 he took control of all operational units in the Harlan CRS structure. John is a member of the Society of Environmental Toxicology and Chemistry and participates on UK shadow OECD discussion panels for ecotoxicology and biodegradation. He is a EUROTOX registered toxicologist. Ciriaco Maraschiello Ciriaco Maraschiello is a biochemist and graduated in biological sciences in 1992 with a further DEA in immunology and genetics obtained in Belgium. He moved to Spain in 1993 to gain some work experience under the ERASMUS programme and stayed there for six months to do biochemistry investigations applied to nutrition. He obtained his PhD in 1998 and developed his doctoral work within the framework of the European AIR (Agro-Industry Research) program consisting of investigating a specific topic on antioxidants, free radicals and lipid oxidation with a special focus on ageing, atherosclerosis and consumer safety. Ciriaco started his working career as a study director in 1998 with Spanish CRO Cidasal which was acquired in 2005 by Harlan Laboratories Inc. Ciriaco assumed responsibility for the Pharmacokinetics and Analytical Chemistry department in the first years of his professional career and was then appointed as the director of Science and Operations of Harlan CRS Spain with a strong focus on toxicology. In August this year Ciriaco was appointed head of Global Toxicology for Harlan CRS. Robert L Guest Bsc (Hons), C Biol, MSB Robert Guest has worked within contract research services at Harlan Laboratories Ltd since January 1980. He gained his BSc (Honours) degree in biological sciences at Nottingham Trent University in 1990 and has occupied technical, study director and managerial positions in a GLP-accredited laboratory conducting regulatory short-term toxicology studies on behalf of the chemical, agrochemical and pharmaceutical industries. Robert is currently manager of Alternative and Acute Toxicology based at Shardlow, UK and has been responsible for implementation of the 3Rs in regulatory toxicology by the integration of in vitro and ex vivo tests into tiered testing strategies.

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PROFILE: Harlan Laboratories

Alternative and in vitro toxicity


SERVICES PROVIDED REACH Cost Assessment Tool (REACH-CAT) Reports ICF International and our partner Penman Consulting have developed REACH-CAT Reports, a tool designed to help your business understand the work and costs associated with 2013 and 2018 REACH registrations. REACH-CAT Reports builds on the knowledge and experience gained in successfully preparing the registration materials for hundreds of substances during the 2010 registration process for REACH. For each substance your business might register, our experts can summarise the actions your company would take for successful registration, assess how your business can fill data gaps to meet extensive REACH requirements, and provide indicative costs. REACH-CAT Reports will help you to make sound business decisions about which substances to register and your registration strategy.

PROFILE: ICF International

CONTACTS Website

www.icfi.com

E-mail

reach@icfi.com

Head office

9300 Lee Highway, Fairfax, VA 22031, USA

Tel

+1 703 934 3000

Fax

+1 703 934 3740

Contact

Stephanie Barrett +32 485 319 961

Directors

Sudhakar Kesavan, Chairman and CEO

 

John Wasson, President and COO

 

Isabel Reiff, Executive Vice President

Ownership

Public company (NASDAQ:ICFI)

Locations

UK, Belgium, Russian Federation, China, India, Brazil, Canada, USA

Founded

1969

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

OVERVIEW ICF International partners with commercial and government clients to deliver professional services and technology solutions in the energy and climate change; environment and infrastructure; health, human services, and social programmes; and homeland security and defence markets. The firm combines passion for its work with industry expertise and innovative analytics to produce compelling results throughout the entire programme lifecycle, from research and analysis and design through implementation and improvement. Since 1969, ICF has been serving government at all levels, major corporations, and multilateral institutions. More than 4,000 employees serve these clients worldwide. VITAL STATISTICS

2010/11 For Q1-Q3 2011 US$627m

Turnover, group Turnover, chemical service provision

-

No of offices

50

No of countries represented

8

Staff, group

4,000

Staff, chemical service provision

90

ICF International has more than 30 years of experience and more than 200 scientific staff focused on toxicology, chemistry/environmental fate, exposure assessment, risk characterisation, and risk management. Our experts have applied this knowledge and experience in preparing chemical dossiers and safety reports that meet the specific requirements of REACH. Examples of support we can provide include assisting with classification and labelling, preparing dossiers including chemical safety assessments/reports, helping with safety data sheets, and developing exposure scenarios. See our website for more services provided. Business process improvement Economic challenges combined with the new REACH requirements are leading organisations to streamline their operations. Organisations complying with REACH have opportunities to improve existing business processes and develop new ways to respond to new and emerging REACH data requirements. ICF International can help determine the most effective strategies for dealing with these changes and align business processes, resources, and people to support your organisational mission. ICF has worked with clients for years to evaluate, design, reengineer, and implement business processes and information management strategies. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2009

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

2010

Northern Virginia Technology Council green award

2010

Companies As Responsive Employers (CARE) award

2010

REACH outstanding project contributor by a major European consortium

2011

Rank #80 on Forbes America’s Best Small 100 Companies

2011

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

2011

Environmental Finance Market Survey – Best Advisory/ Consultancy North American Markets (All)

2011

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

2011

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

SERVICE AREA BREAKDOWN Consultancy/ advisory 100%

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

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Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 3: Classification and labelling

CMMI Level 3 designation Project Management Institute global executive council Project Management Institute registered education provider

ICF International has made classification and labelling recommendations for hundreds of industrial chemicals for several European-based chemical consortia and international chemical companies. ICF’s experience using read-across strategies and weight-of-evidence arguments has provided our clients with recommendations in accordance with CLP and GHS regulations. ICF’s classification and labelling recommendations have been used to populate safety data sheets in the United States and Europe and have also been incorporated into REACH chemical registration dossiers. ICF reviews previous classifications under other regulations combined with references from comprehensive literature searches and proprietary studies supplied by the client. Toxicokinetic, acute, subchronic, chronic, irritation, sensitisation, carcinogenicity, mutagenicity, reproductive toxicity, developmental toxicity, physicochemical, environmental fate, and ecotoxicity data are then objectively analysed to identify critical effects, data deficiencies, and NOAELs or LOAELs.

PARTNERS Penman Consulting BVBA: ICF’s partnership with Penman Consulting enables us to provide an even more complete range of REACH services to our clients. CLIENTS OO OO

OO OO

a major American chemical industry trade association several petrochemical and refining industry REACH consortia (subcontractor to Penman Consulting) two major trade associations in the metals industry a major international chemical company; and many more...

TESTIMONIALS

STAFF SELECTION

Recognised on REACH project as outstanding contributor by a REACH consortium for a major European trade association in December 2010. Recognised in December 2010 by a major REACH consortium for excellence in operational management on the 2010 REACH registrations from 2008-2010

Robert Hegner, PhD – Senior Vice President

CASE STUDY 1: REACH consortium operational and Sief support ICF International has provided comprehensive programme management and Sief management support for several major REACH consortia since 2008. These consortia represent hundreds of member companies and high production volume substances. ICF’s operational support includes supporting and managing communication among consortia members, providing meeting support, managing consortia websites and data portals, and managing the dossier production and consortium review and approval processes. ICF also provides Sief management services, addressing thousands of technical, policy, regulatory, and process enquiries from Sief participants. ICF International also supported consortia in setting data sharing and data access costs and policies. We communicated these costs as well as technical information to Sief members for each substance within the scope of the consortia and worked with the consortia legal teams and technology platforms to provide, disseminate and collect revenues from letters of access. CASE STUDY 2: IUCLID data entry and dossier preparation ICF International has provided comprehensive technical support for dossier preparation in advance of the 2010 substance registration deadlines for several European-based chemical consortia. ICF managers, toxicologists and exposure scientists worked collaboratively to produce hundreds of dossiers for REACH registration in 2010. Substances included organic chemicals and metal compounds. Each dossier included summary information on production, use, physical and chemical properties, environmental fate, ecological effects, human health effects, exposure, and risk management. ICF provided detailed technical support for more than 100 dossiers and other support for more than ten percent of the dossiers submitted for the 2010 REACH registration. ICF’s technical responsibilities included data collection, literature review, data preparation and entry into IUCLID, mapping of lifecycle stages for industrial chemicals, identification of exposure scenarios, exposure modelling using ECETOC TRA and other tools, risk characterisation, and preparation of various other documentation needed for registration. ICF also reviewed articles to determine if a substantial human sensitisation response could be anticipated following exposure to high-volume substances.

Chemical Watch | Global Service Providers Guide 2012

Dr Hegner has more than 35 years of experience in programme management, risk analysis, and original research. His risk analysis experience includes developing the Air Toxics Risk Assessment reference library for the US EPA and assisting in the agency's initial efforts to develop a framework for ecological risk assessments. He has published more than 20 peer-reviewed research papers on the endocrine and environmental regulation of complex vertebrate reproductive cycles. Stephanie Barrett – Senior Manager Ms Barrett, based in ICF's Brussels, Belgium office, has more than15 years of experience in environmental policy and regulatory analysis and project management. Ms Barrett's educational background includes environmental policy, environmental law, and geology coursework. Her professional experience includes REACH consortium project officer positions and Sief facilitation support. Ms Barrett manages projects, budgets, and staff to ensure that client needs are met on time and within allocated resources. Elizabeth Dederick, PhD – Manager Dr Dederick has five years of experience in exposure analysis and risk assessment. With expertise in REACH hazard and exposure assessment, she specialises in designing exposure algorithms for unique pathways of exposure. Dr Dederick trains clients in the use of various software applications, and has written technical and user manuals. While completing her PhD, she was employed by The LifeLine™ Group, where she assisted in the design of aggregate and cumulative exposure analysis software models. She has also conducted multiple literature reviews and is familiar with toxicological literature for multiple chemicals including nanomaterials and endocrine disruptors. Dhyanesh Doshi – Senior Associate Mr Doshi, based in Mumbai, India, has more than four years of experience in human health and environmental risk assessment. For the last two years, he has assisted consortia of multinational companies based in Europe and the United States in complying with REACH requirements. He has extensive hands-on experience in developing robust summary dossiers and endpoint summary records in IUCLID and is also proficient with data management tools such as REACHsuite. Mr Doshi is adept in determining DNELs and has experience working with international hazardbased classification systems such as GHS, CLP, and DSD. Candace Prusiewicz – Technical Specialist Dr Prusiewicz has more than 12 years’ professional industrial experience. She has conducted research developing novel synthetic routes to compounds of therapeutic interest. She has an extensive background in analytical chemistry developed during her time working in a quality assurance laboratory in the chemical manufacturing industry. Since earning her PhD, her professional focus has been in the area of scientific writing, specifically researching, reviewing, and summarising toxicological data to support human health risk assessments, hazard communication and worker safety programmes.

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PROFILE: ICF International

ACCREDITATIONS


PROFILE: International Cosmetics & Chemical Services Ltd

GLOBAL OFFICES USA: International Cosmetics and Regulatory Specialists LLC UK: International Cosmetics and Chemical Services Ltd SERVICES PROVIDED Responsible person, product information files, and safety assessment, cosmetic product safety report We provide full regulatory services in Europe, including labelling requirements. Responsible person (RP) services. RP is responsible for: OO product information file (PIF) for each product OO safety assessment OO address on all product labelling OO access for the competent authorities (27 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.

CONTACTS Website

www.intlcosmetics.com

E-mail

info@intlcosmetics.com

Head office

947 Manhattan Beach Boulevard, Suite A, Manhattan Beach, CA 90266, USA

Tel

+1 310 545 3223

Fax

+1 310 546 6204

Contact

Georgia@intlcosmetics.com

Directors

Janet Winter Blaschke

 

Georgia Boehm

Ownership

Private company

Locations

USA, UK

Founded

1997

Only representative (REACH), CLP notifications (sole representative)

OVERVIEW International Cosmetics and Regulatory Specialists LLC, a US organisation and International Cosmetics and Chemical Services Ltd, a UK entity are sister companies comprised of experienced professonals in regulatory affairs, international product registration, and international labelling compliance, with an emphasis on technical services for the EU, USA, Canada, Asia, South America, and the Middle East. Please enquire about your specific needs. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

2

No of countries represented

28

Only representative services for companies needing chemical registrations for the EU scheme under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Late pre-registration and full registrations have already been successfully provided for many clients. CLP notification services are also available, in addition to safety data sheets to meet the requirements of REACH and CLP. US agent, cGMP audits and training, electronic US FDA registrations Products such as Acne and any product containing SPF ingredients must be registered with the FDA. We can act as the US agent for foreign manufacturers (which is mandated by FDA) and provide the mandatory facility, distributor and product FDA electronic registrations. FDA registrations must now be done electronically, which is a service we provide. We provide cosmetic and over-the-counter drug label review, training and cGMP facility and standard operating procedure audits. Expert witness testimony services in many areas of product development, product liability, and technical services are also available.

Staff, group

6

Training for GMPs and ISO manufacturing standards

Staff, chemical service provision

3

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

SERVICE AREA BREAKDOWN Training 20%

Information 10% Representation & management 10%

Page 96

Consultancy/ advisory 60%

CORPORATE DEVELOPMENTS & ACHIEVEMENTS REACH 2007

Formed REACH Chemical Consulting, Ltd now known as International Cosmetic and Chemical Services, Ltd.-UK

2008

Filed pre-registrations for US and international companies to meet the EU regulation.

2009

Among the first only representatives to successfully complete a cosmetic ingredient full registration in 2009 prior to the first 2010 deadline. This resulted due to a company who missed the pre-registration phase while importing finished product using the ingredient at 1 ton or more the previous three years.

2010

Preparation of safety data sheets (SDS) to meet the REACH and CLP requirements.

Chemical Watch | Global Service Providers Guide 2012


Continuing with SDS creations, REACH late-preregistrations, Sief coordination for clients and their chemicals, continue with CLP notifications. ISO

STAFF SELECTION Janet Winter Blaschke, BA, Biology, University Redlands OO OO

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, USA.

2010

Designated expert Cosmetic GMP, Microbiology and Sunscreens workgroup in London

2011

Designated expert Natural and Organic Terminology workgroup in Kyoto, Japan

OO

cGMP audit

OO

ICRS continues to excel in meeting cGMP compliance training and audits in the USA as well as internationally. These activities are designed to meet the individual companies and their unique cultures. Staff use ISO GMPs, FDA cGMPs as well as country specific regulations depending on the market and or country needs.

OO

OO

OO

Georgia Boehm, AA Business Management, Glendale College OO

OO

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

OO

OO

OO OO

OO

Alterna, Arbonne International, California Tan, CB Fleet Co, Circle of Friends, Contem 1g (Brazil), Davi (Mondavi) Skin, Disney Consumer Products Inc, Dermanew, Econet, Inc., Frederic Fekkai, Freeman Beauty, Giorgio Nardi (Italy), Go Smile, Henkel Consumer Goods, ICN Pharmaceuticals (Valeant Pharmaceuticals), Johnson and Johnson Consumer Products Inc, Jordana Cosmetics Corp, Juvena/La Prairie (Switzerland, Germany), Laboratoire Labothene Cosmetique GMbH (Germany), Leaf & Rusher, M&K (JK Mueller & Myung Sun), Nu Skin, Ole Henriksen, Pental Soap Products (Australia), Pierre Fabre DermatoCosmetique (France), Pola Cosmetics (Japan), Procter and Gamble, Rock & Republic, Sexy Hair, Smashbox, TIGI (Toni and Guy), Twincraft Soap Company, Zenyaku USA, and many others.

regulatory manager - seven 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, Italian, and Spanish

Harmony Gates, MS Chemical Engineering OO

chemical engineer - 12 years’ experience in regulatory affairs in the US, Canada and the EU; specialising in environmental regulatory issues

Robert Blaschke, BA, French, Loyola Marymount University OO

OO OO

regulatory affairs specialist.- four years’ experience in FDA compliance in the USA expert with FDA electronic registrations and IT portal IT specialist

Monique Chheoun, BA Asian Studies, California State University at Long Beach OO OO

Chemical Watch | Global Service Providers Guide 2012

director Regulatory Affairs - International Cosmetics & Regulatory Specialists LLC, expert in yield and accountability documents for compliance with REACH regulations 30 years of experience in cGMP compliance, regulatory and quality systems, international registrations, FDA registrations, FDA drug compliance for claims and labelling and facility corporate experience: ten years at Neutrogena Corporation, six years at Herbalife International, and contract manufacturing management

Deborah Rediet, BA French and International Relations, California State University Long Beach

Manhattan Repro (graphic design for labelling) CLIENTS

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, United Kingdom post graduate certificate in REACH management, University of Hull, UK

specialist – product information file administrator fluent in Cambodian

Page 97

PROFILE: International Cosmetics & Chemical Services Ltd

2011


SERVICES PROVIDED Advisory Services to help you advance your business Auditing Services to help you control operations Certification

PROFILE: Intertek

CONTACTS Website

www.intertek.com/green

Services to help you reach new markets

E-mail

green@intertek.com

Outsourcing

Head office

25 Savile Row, London W1S 2ES, UK

Services to help you focus on core activities

Tel

+44 (0)20 7396 3400

Quality Assurance

Contact

Marc Thouin

Services to help you meet expectations

Directors

Sir David Reid, Chairman

Training

Wolfhart Hauser, Chief Executive Officer

Services to help you improve your performance

 

Lloyd Pitchford, Chief Financial Officer

Testing

Ownership

Public

Services to help you protect your reputation

Locations

Intertek is the industry leader with more than 30,000 people in 1,000 locations in over 100 countries.

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Founded

The Intertek story starts at the inception of the modern testing industry. The history of Intertek spans 126 years, and evolved from the combined growth of a number of innovative companies.

OVERVIEW Intertek helps organisations across a wide range of industries to sharpen their competitive edge by providing advanced measurement, expert consulting related technical support services, and sustainability solutions. Our experts and laboratories provide critical support to our clients in their global trade, not just with data, but with essential knowledge to accelerate development of their next generation products, to improve their manufacturing, products or production processes or to enhance their efficiencies. VITAL STATISTICS

ASG in Manchester, UK was acquired from Zeneca and Avecia

2007

MSG in Wilton, UK was acquired from ICI

2010

Intertek Acquires CIBA Expert Services and Cantox Health Sciences International

2011

Intertek Acquires Moody International

2011

Intertek Acquires Analytical Sciences Americas (ASA)

2011

Intertek continued to expand and develop services in the 25plus industries it operates in

2011

Intertek is a partner to some of the world’s most loved brands and their suppliers and this work continued in 2011

2011

Demand for Intertek’s work was fuelled by its clients’ desire for greater quality, safety and sustainability in their products, their drive for supply chain and cost efficiency and their expansion into new markets and product innovations

2011

Intertek’s underlying business grew at a rate of 8% during the year – a strong performance given the pressure of global economic uncertainty on many companies

2010/11

Turnover, group

£1,374.2m

Turnover, chemical service provision

£151.5m

No of offices

1000+

No of countries represented

110+

Staff, group

30,000+

Staff, chemical service provision

2,000+

SERVICE AREA BREAKDOWN

Other 29%

Training 3%

Consultancy/ advisory 10% Information 3%

Laboratory 55%

GLOBAL OFFICES 2 Riverway, Houston, TX 77056, USA, +1-877- 274-0181 Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49 711 27311 152 4/F, Block B, No.6, Shibei Industry Zone Lane 1218 Wan Rong Road, Shanghai, 200436, China +86 21 6181 5282

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2004

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: Dr Naeem Mady – industry segment council board member and a national board council member at the the Plastics Industry Trade Association (SPI) Dr David Bechtel – diplomat of the American Board of Toxicology. Dr Paul Lambert – committee member of the European Structural Integrity Society (ESIS TC4) Dr Ian Fletcher – member of the EPSRC ‘college’ for peer review Dr Jeff Franks – Royal Society of Chemistry, Membership Affairs Board Dr Neil Everall – European editor of Applied Spectroscopy journal CLIENTS Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo, ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens

Chemical Watch | Global Service Providers Guide 2012


TESTIMONIALS

STAFF SELECTION

"Working with Intertek Group as our EU REACH only representative has been a rewarding experience. Intertek has provided guidance to CITGO, with respect to legal issues, suppliers, customers and changes of the new EU legislation. CITGO has relied on Intertek's global knowledge and assistance to meet each and every goal within the strict timeline demanded by legislation, suppliers and customers. Intertek continues to help CITGO develop and grow our markets." Citgo

Dr Andrew Swift – Executive Vice President Chemicals and Pharmaceuticals

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 on-site to better define the case. After a few hours of explanations on-site 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 € 50k in consulting charges and multiples thereof in testing costs. CASE STUDY 2: Intertek: helping to reduce letter of access costs Letter of access costs for a client were unacceptably high. Intertek’s Regulatory Services Group in the EU reduced the client’s letter of access cost from €300,000 to €80,000. This result was made possible by leveraging a thorough understanding of the science behind REACH in addition to the business practices surrounding the implementation. As a neutral service provider, Intertek was able to challenge the valuation of studies based on science, fairness and transparency. CASE STUDY 3: 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.

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. Neil Chapman – Vice President, Chemicals and Pharmaceuticals Americas Neil has been in his current, joint role of business development for Commodities and Chemicals and Pharmaceuticals divisions since 2006. In this joint role, Neil is responsible for ensuring superior customer support across the business groups in addition to growing the materials testing business in the Americas. Neil attended Chelmsford College in the UK where he graduated in chemistry. Dr Marc Thouin – Vice President, Regulatory Services Dr Thouin is vice president for regulatory services and bears the operational responsibility globally. He studied natural sciences at the Swiss Federal School of Technology in Zuerich and obtained his PhD in toxicology in 1983, followed by a postdoctoral study at GDSearle in Chicago, USA. Torben Nörlem, Esq – Chief Counsel Torben Nörlem, Intertek’s senior legal counselor, has a LLM in Law from the legal faculty at Copenhagen University and 15 years’ experience working with product related legislation and regulatory framework. Torben has been working as chief counsel for health and environment with Interek since 2008. Torben was responsible for legal affairs related to the REACH legislative process and was a participant of the Danish government negotiation team during the negotiations in the European Union. He was also responsible for implementation and administration of EU rules regarding chemicals in electronics in Denmark. Dr Michael Leise – Senior Expert Consultant Michael Leise is one of Intertek’s regulatory affairs senior expert 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 aquired environmental expertise at TÜV Rheinland before he joined Ciba Specialty Chemicals in Lampertheim as head of product safety in 1995. Dr Manuela Corazza– Global Regulatory Operations Manager Manuela Corazza is Intertek’s country manager for Italy’s Regulatory Services, Global Operations support manager, and a senior regulatory projects manager. Karen Levins – SVP, Global BD & Marketing, Intertek Cantox Health Sciences Karen Levins serves as Interteks’s senior vice president, Global Business Development Cantox and vice president Chemicals Group Cantox. As a regulatory toxicologist with more than 19 years’ experience, Ms Levins helps the chemical industry understand and comply with global regulations controlling the manufacture, importation, distribution, and use of new and existing products.

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PROFILE: Intertek

Intertek was selected by Eastman Kodak Company for inclusion in the Kodak Certified Supplier Programme. Kodak utilises world-class processes and demands the same of its suppliers in terms of performance, reliability, cost, and delivery of services. Intertek’s certification by Kodak applies to global chemical notifications and associated regulatory consulting services including support in relation to regulations and compliance laws in other countries. Examples of chemical notifications include China notification and United States TSCA notification.

Andrew Swift is executive vice president of Intertek's Chemicals and Pharmaceuticals division, which role he assumed in January 2008. Prior to this, he was vice president of global outsourcing within Intertek's Commodities Division. Dr Swift joined Intertek in 2001 as business development manager of the group's laboratory facilities at Sunbury (UK). Both of Andrew's degrees are from UMIST and he is a chartered chemist of the Royal Society of Chemistry.


GLOBAL OFFICES JSC International Limited, Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE, United Kingdom SERVICES PROVIDED REACH services Website

www.jsci.co.uk

E-mail

enquiries@jsci.co.uk

Head office

Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE, UK

Tel

+44 (0)1423 520245

Fax

+44 (0)1423 520297

JSC consultants have significant experience in all aspects of REACH. We have prepared a large number of registration dossiers and chemical safety reports (CSRs) and have provided expert advice on specific areas of REACH such as data evaluation and study monitoring. JSC have Sief/ consortium management experience and ensure that the deadlines of your project are met. We are able to help with the preparation of consortium agreements, communication within the consortium and ensure an effectively running consortium. JSC are able to help downstream users identify their obligations and provide training to ensure continued compliance.

Contact

Dr Samantha Wright or Dr Richard Elsmore

CLP/GHS

Directors

Lucy Croucher, Managing Director

 

Denis Kaye, Finance Director

Ownership

Private company

JSC experts are able to assist with classification, labelling and safety data sheet creation including the extended safety data sheet containing exposure scenarios.

Locations

UK

Founded

1992

PROFILE: JSC International

CONTACTS

DGSA JSC can offer dangerous goods safety adviser services for the transport of hazardous goods. Our experts can act as your company DGSA, provide support, auditing and training.

OVERVIEW JSC International Limited is a privately owned independent European consultancy company predominantly providing regulatory support to the chemical, agrochemical and biocides industries. At JSC we have a dedicated team of highly motivated people with backgrounds from government, industry and contract research. Our integrated, cross discipline working practices enable us to provide novel and innovative approaches to problem solving, supported by our excellent contacts with regulatory officials and scientific experts throughout the world. VITAL STATISTICS

2010/11

Turnover, group

undisclosed

Turnover, chemical service provision

undisclosed

No of offices

1

No of countries represented

30+

Staff, group

22

Staff, chemical service provision

19

JSC offers regulatory support for both active substances and biocidal products. We have experience of submitting active substance dossiers for a wide range of product types under the BPD. For biocidal products we routinely submit national registrations and have good contacts with regulatory authorities in all member states within the EU. We are also active in submitting BPD product dossiers following Annex I inclusion. We are able to offer support to a diverse range of biocidal products. JSC can also offer more general regulatory support to biocide manufacturers and formulators in areas such as scope issues, efficacy testing, claim support and risk assessment. Agrochemical products JSC has extensive experience in the preparation, submission and regulatory support of EU dossiers and national draft registration reports. We have an excellent track record of successful EU approvals and national authorisations and are well-placed to assist you in the development of strategies to support your compounds in Europe. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

SERVICE AREA BREAKDOWN Training 5%

Biocidal products

Other 5%

Representation & management 20% Consultancy/ advisory 70%

1992

EU offices of JSC formed â&#x20AC;&#x201C; US owners

1996

Offices relocated to Harrogate

2004

Management buy-out

2005

Biocides expertise consolidated

2006

Development of expertise in REACH

2008

Consolidation of REACH capability

2010

Preparation and submission of a large number of REACH dossiers/CSRs

ACCREDITATIONS All technical staff are qualified to degree level or higher (MSc and or PhD). Our senior toxicologists are Society of Biology/ British Toxicology Society and EUROTOX registered and our DGSA has current certification. We employ a number of Chartered Biologists (CBiol) including two fellows of the Society of Biology (FSB). PARTNERS Network of locally recognised contacts across the globe.

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Dr Richard Elsmore – Regulatory Affairs: Biocides and REACH

Our clients range from large international companies to SMEs located worldwide.

Richard Elsmore has held a number of senior roles with speciality chemical manufacturers and formulators and has experience of working with a wide range of product chemistries; he has a practical background of operating within the global chemical market and with FMCG’s. Richard has worked in technical, regulatory and business management positions and has been involved with a number of industry bodies at EU level. He is also a director of the British Association for Chemical Specialities (BACS). Richard has experience of submitting a number of dossiers under REACH (1907/2006), BPD (98/8/EC) and PPPD (91/414/EEC) as well as submissions to national regulatory authorities. He has been actively involved with a number of industry bodies on the implementation of the EU legislation and in the area of efficacy testing and claim support. He also sits on the BSi Technical Committee on disinfectant standards (CH/216) and has represented BSi within CEN. He has also worked on both method development and the assessment of individual chemicals in the human and environmental risk assessments programme (HERA).

TESTIMONIALS We are unable to identify our clients due to client confidentiality constraints. CASE STUDY 1: REACH dossier preparation JSC has provided REACH dossier preparation for a number of complex and hazardous chemical substances. These substances have required the identification of data gaps and where necessary, placing and monitoring of studies. JSC has also been responsible for the production of the registration dossiers for the lead registrants and members of the consortia in IUCLID 5 and for developing the chemical safety report and working with the consortia members to identify downstream user descriptor codes. These projects were successful culminating in the submission of substance dossiers for the 2010 deadline. During the development of these dossier and safety assessments JSC has had to work with consortia members and downstream users to identify relevant use patterns and in the development of appropriate RMM and in the production of meaningful extended SDS. CASE STUDY 2: REACH downstream user support JSC has successfully provided support to downstream users. Through training and consultations, JSC has provided the expertise and knowledge for downstream users to determine their obligations under the REACH Regulation, understand the implications of supply chains and effectively plan their regulatory strategy and compliance. CASE STUDY 3: New substance registration JSC successfully submitted one of the very first REACH dossiers for a new non-phase in substance. This substance dossier has now been upgraded through the tonnage bands.

Dr Justine Weyman – Regulatory Affairs: Agrochemicals and REACH Justine has experience of working on REACH projects for a number of years and is responsible for project management, assistance with product dossiers and contacts with ECHA and national regulatory authorities. Her background is both within national regulatory authority, industry and consultancy. Peter Chapman – Director of Regulatory Affairs Peter has many years’ experience in pesticides registration matters having previously held senior roles in the UK regulatory authority both in a national and international capacity. He has worked extensively with the European Commission, the European Food Safety Authority and most EU Member States. His main focus is on providing up to date advice on regulatory matters relating to pesticide active substances and plant protection products.

STAFF SELECTION Lucy Croucher – Managing Director Lucy Croucher has been working in the area of European agrochemical regulatory affairs since 1994. She has managed large scale projects for the preparation, submission and support of EU dossiers for existing active substances, resubmissions and new active substances under Directive 91/414/EEC. To date, JSC has been involved in the successful approval of 17 active substances. Lucy is currently advising Clients on Annex I renewals and the implications of Regulation (EC) No 1107/2009. Dr Samantha Wright – Regulatory Affairs: REACH Samantha Wright is an experienced REACH manager with previous responsibilities for tracking and implementing worldwide legislation to ensure global regulatory compliance. Samantha has experience in the preparation and submission of REACH dossiers and consortium management, as well as a number of years authoring safety data sheets and determining classification and labelling. Samantha has been involved with strategy planning for business compliance and delivering training for REACH and CLP. Samantha’s background in regulatory affairs was gained through working with clients in the cosmetic, pharmaceutical and industrial sectors.

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PROFILE: JSC International

CLIENTS


SERVICES PROVIDED Hazardous substance consulting Safety data sheets Generation of EU safety data sheets (SDS) in accordance with current legislation (including GHS) for substances or compounds in all European and other languages ie Turkish, Russian, Malay, Chinese Mandarin and Thai, with particular consideration of national requirements MSDS for US/ Canada according to current local legislation. Permanent updating of safety data sheets (SDS) pursuant to statutory requirements. You can choose your own personal layout, or to individualise to your corporate identity.

PROFILE: KFT Chemieservice

CONTACTS Website

www.kft.de

E-mail

mail@kft.de

Head office

Im Leuschnerpark 3, 64347 Griesheim, Germany

Tel

+49 6155 86829 0

Fax

+49 6155 86829 25

Contact

Dr Karl-Franz Torges, Ludwig Winkler

Directors

Dr Karl-Franz Torges, Managing Partner

Generating of working instructions pursuant to §14 of the Ordinance on Hazardous Substances (Gefahrstoffverordnung – GefStoffV) and the technical standards for hazardous substances (TRGS) 555.

Ownership

Private company

Labels

Locations

Griesheim (near Darmstadt), Germany

Founded

1995

Creation of the right labels including individual layouts to adhere to current regulations/ languages with particular considerations of the biocide directive. Labelling for exports to US and Canada to meet their prevailing standards

Working instructions

OVERVIEW KFT Chemieservices’ business is the 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.

Research Customised substance data research, marketability check, limitations for chemicals prohibition ordinance and substances of very high concern (SVHC), special packaging and labelling requirements. Product registration

Turnover, group

-

Registration pursuant to §16e of the German Chemicals Act (ChemG), the German Federal Institute for Risk Assessment (BfR), the German Detergents and Cleaning Agents Act (WMRG) and product registrations in Switzerland, Greece, the Netherlands, the US and other nations.

Turnover, chemical service provision

-

REACH

No of offices

1

No of countries represented

1

Staff, group

9

Staff, chemical service provision

5

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 third-party representative services pursuant to article 4 (REACH) OO representative services as lead registrant OO registrations according article 11 and 19 of REACH 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.

VITAL STATISTICS

2010/11

SERVICE AREA BREAKDOWN IT & software 2% Laboratory 3% Information 14% Representation & management 16%

Legal Training 8% 2% Consultancy/ advisory 55%

Biocides With an experienced team we handle registrations of biocide substances, coordinate study generation, prepare the dossiers and do the authority management. Training and coaching Online training (webinars) are available on a regular basis and on demand for REACH, biocides, MSDS, GHS and CLP

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1995

Foundation of KFT Chemieservice in Rellingen , near Hamburg, Germany

1996

First training for the generation of MSDS for Europe and US

1998

First registration according to the existing substances regulation 793/93/EC

2000

Relocation of the company to Griesheim, Germany

2008

First only representative contract with Brazilian company

2010

> 3000 pre-registrations, > 60 substances registered, first biocide substance registered

2010

Launch of KFT-ChemDoc24.de

2011

First substances in articles notified

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 OO and ultimately issues approval for marketing

CASE STUDY 3: REACH lead registrant support Our strength is the support of the medium-sized industry, whose core competence does not lie within the production or handling of chemical products. The REACH requirements are particularly problematic here. KFT Chemieservice verifies the requirements. If there is no lead registrant or Sief facilitator appointed for strategic products, we evaluate the registration capacity of the material by our customers, check the competition situation and identify possible co-registrants. After a positive economic evaluation by our customer, we facilitate the registration of the material. Thus, we cover all steps of the process. We perform the Sief survey with the available data in consideration of the interests of other Sief participants, find the existing data and data gaps, undertake negotiations with data keepers and contract testing labs to close the data gaps. We create the IUCLID file and the CSR and take care of registration with the ECHA. As a result of this, the client receives the registration number. KFT markets the letter of access to other registrants. As an additional service, we create the safety data sheets with appendix (exposure scenarios) in all EU languages. We provide one-stop service for the client. STAFF SELECTION Dr Karl-Franz Torges – 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, ecotoxocology, 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.

CASE STUDY 2: Marketability study 2 Medium sized chemical companies strategically expand their marketing range. In-house experts are normally familiar with the details of European regulations. But what are the regulations for transport, warehousing and labelling in exotic countries? We check the requirements in this area using the target country list, create checklists and make recommendations for labels. The customer receives detailed and reliable documentation about the requirements.

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PROFILE: KFT Chemieservice

CORPORATE DEVELOPMENTS & ACHIEVEMENTS


GLOBAL OFFICES LAUS GmbH, Kirrweiler, Germany SERVICES PROVIDED Chemicals Two new important European regulations are relevant for manufacturers or importers of chemical substances: OO the European Regulation REACH (Registration, Evaluation, Authorisation of Chemicals, EC No 1907/2006) became effective on 01 June 2007. REACH affects all new chemicals as well as existing substances (EINECS Inventory) OO the EU Regulation (EC No 1272/2008) on classification, labelling and packaging of substances and mixtures (CLP), entered into force on 20 January 2009. The CLP-Regulation introduces the globally harmonised system of the United Nations for the classification and labelling of chemicals (GHS) into the EU

PROFILE: LAUS

CONTACTS Website

www.laus.de

E-mail

info@laus.de

Head office

Auf der Schafweide 20, 67489 Kirrweiler, Germany

Tel

+49 6321 96299 0

Fax

+49 6321 96299 29

Contact

Dr Dietmar Kuhn / Anette Rudolf

Directors

Dr Dietmar Kuhn, Managing Director

 

Jutta Paulus, Managing Director

 

Joerg Paulus, Managing Director

Ownership

Private Company

Locations

Germany

Founded

1991

REACH/ CLP compliance with LAUS OO OO OO OO OO OO

OVERVIEW LAUS is a competent partner for all necessary studies according REACH. We supply the right test strategy for your substances in order to avoid unnecessary studies. REACH having become effective, experience in testing and registration of chemicals is more important than ever. Besides specialisation, original ideas and innovation, high demands are necessary in order to correctly interpret the REACH guideline concerning the scope of studies. In our internationally active GLP test facility we provide you with all necessary data and help you in fulfilling the regulation demands. Due to our experience with registration authorities, we can work out an individual testing scenario for REACH together with our customer. Taking into account the physico-chemical properties, the necessary and useful studies are chosen in cooperation with the toxicologists. With this strategy, cost for testing is minimised, and time-lines are shortened considerably, not to speak of animal welfare. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

1

Staff, group

30

Staff, chemical service provision

30

SERVICE AREA BREAKDOWN Consultancy/ advisory Representation 5% & management 5%

OO

sameness/ identity physico-chemical properties (EU and UN methods) toxicology – in vivo studies/ in vitro studies mutagenicity and genotoxicity aquatic and terrestrial ecotoxicology environmental fate and behaviour analytical chemistry

Biocides/ biocidal products The current regulatory framework for biocidal products and their active substances is established by Directive 98/8/EC of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market and a number of implementing Commission Regulations, in particular Commission Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme. OO stability studies – accelerated storage stability, low temperature stability, long term stability OO physico-chemical properties (CIPAC, EU and OECD) OO toxicology OO in vivo studies/ in vitro studies OO mutagenicity and genotoxicity OO aquatic and terrestrial ecotoxicology OO environmental fate and behaviour OO analytical chemistry Veterinary medicinal products The EU legal framework for veterinary medicinal products (VMP) is primarily laid down in Directive 2001/82/EC, as amended by Directive 2004/28/EC as well as Regulation (EC) 726/2004. For the environmental impact assessment LAUS provides you with all necessary data and helps you in fulfilling the demands according the current guidelines (CVMP/VICH/790/03-FINAL, CVMP/VICH/790/03FINAL and EMEA/CVMP/ERA/418282/2005-Rev1). Phase II: Tier A and Tier B: OO physico-chemical properties OO aquatic and terrestrial ecotoxicology OO environmental fate and behaviour OO analytical chemistry

Laboratory 90%

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Agrochemicals Together with experienced partners we provide the following services: OO regulations and procedures for dossier preparation for active ingredients and plant protection products (Annex II / Annex III ) in accordance with Directive 91/414/EEC OO dossier completeness check OO determination of study profiles OO contracting and monitoring of studies OO dossier compilation LAUS provides the necessary studies: OO physico-chemical properties OO toxicology – in vivo studies/ in vitro studies OO mutagenicity and genotoxicity OO environmental fate – ecotoxicology/ biodegradability OO field studies and residual analysis OO development of analytical methods

PROFILE: LAUS

Human pharmaceuticals / medical devices We test the effects of drugs, medical devices and medicinal products for human use. All studies are carried out according to EC/FDA/ICHguidelines, the legal requirements such as Directive 2001/83/EC and EMEA/CHMP/SWP/4447/00 and according to GLP. OO toxicology – acute, subacute and chronic studies, carcinogenicity studies, reproduction studies OO environmental fate – ecotoxicology/ biodegradability OO mutagenicity studies – bacterial reverse mutation test (Ames test), mammalian chromosome aberration test, mammalian cell micronucleus test, mammalian cell gene mutation test - mouse lymphoma-/ HPRT-test OO analytical chemistry OO extractables/ leachables Cosmetic products LAUS offers alternative methods to animal tests in the field of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetics products (Cosmetics Directive). OO in vitro skin corrosion and irritation OO in vitro eye irritation OO in vitro mutagenicity and genotoxicity OO skin sensitisation OO in vitro skin penetration OO safety evaluation OO technical product file CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1991

Foundation in Neustadt/Weinstraße, Germany

1999

First GLP certification

2006

New laboratory in Kirrweiler, Germany

2011

Opening of second laboratory building in Kirrweiler

ACCREDITATIONS Good Laboratory Practice (GLP) STAFF SELECTION Ms Jutta Paulus – Head of Quality Assurance Mr Jörg Paulus – Head of Laboratory Mr Dr Dietmar Kuhn – Managing Director Ms Anette Rudolf – Manager Business Development

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Page 105


SERVICES PROVIDED Regulatory consultancy and dossier preparation LSR Associates has the experience and knowledge to provide the full range of regulatory services to the chemical, crop protection and biocide industries and covering: OO strategic regulatory advice and expert regulatory consultancy for all areas of safety assessment OO full development project management and critical issue review OO preparation of dossiers and product submissions, including post submission support through the regulatory process For industrial chemicals, LSR Associates covers all aspects of worldwide notifications (for example the EU and China). For the EU whether you are a manufacturer, an importer or a user, we are uniquely positioned to help you in your REACH compliance efforts including: OO development of compliance requirements and strategies OO interpretation of regulations OO data adequacy/data gap analysis and testing plans OO registration dossier preparation (lead, joint, Article 26, PPORDS) OO expert waivers to save time and resources OO exposure scenarios and chemical safety assessments and reports OO representative services (OR, consortia, Siefs) OO consortium and task force representation services OO literature searches Ensuring that your chemical substance reaches its full potential in the worldwide marketplace means registering it in all of your target countries. However, as you know, each of those countries can have their own very unique notification system. Our team of chemical experts has extensive knowledge of notifications and recent legislative changes throughout the world. We have made submissions for our customers in all of the major markets including: EU, USA, Japan and China In fact, we have submitted more than 2,000 substance notifications worldwide.

PROFILE: LSR Associates

CONTACTS Website

www.lsr-associates.com

E-mail

info@lsr-associates.com

Head office

Woolley Road, Alconbury, Cambs, PE28 4HS, UK

Tel

+44 (0)1954 212132

Contact

info@lsr-associates.com

Ownership

Private company

Locations

UK, Japan and USA

Founded

2006

OVERVIEW LSR Associates is a regulatory consultancy group providing support to the chemical, crop protection and biocide industries in their worldwide registration efforts. LSR Associates has the people with the expertise, experience and support network to mirror the in-house safety assessment capabilities of major development companies and offers strategic regulatory advice covering all areas of safety assessment. With a proven track record of achieving major registrations for both new and existing substances, LSR Associates has the innovative ideas to provide cost effective solutions to difficult regulatory issues. Many of our senior consultants serve on a number of key committees and working groups, with representation within the UK industry and governmental groups. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

3

No of countries represented

>40

Staff, group

33

Staff, chemical service provision

18

SERVICE AREA BREAKDOWN Training Other 5% Laboratory 3%

Consultancy/ advisory 60%

GLOBAL OFFICES LSR Associates Ltd: Woolley Road, Alconbury, Cambs, PE28 4HS Tel:+44 (0)1954 212132 LSR Associates Inc: 8480 Honeycutt Road, Raleigh, NC 27615, USA Tel: +1 919 714 7275 LSR Associates Ltd, Japan: Bancho Kaikan, 12-1 Gobancho, ChiyodaKu, Tokyo 102-0076 Tel: +81 (0) 3 3238 6381-7

Page 106

LSR Associates offers representative services for both EU (third party representation) and non-EU companies (only representation). We currently represent over 70 companies, supporting more than 1,500 substances. Agrochemicals and biocides LSR Associates has extensive experience in the global registration of agrochemicals. Our consultants have been responsible for 10 new active substance submissions in EU alone, comparable to any agrochemical company. This expertise is directly transferrable to both biocides and chemicals projects. CORPORATE DEVELOPMENTS & ACHIEVEMENTS

3% Information 4% Representation & management 25%

EU representation

2006

LSR Associates Limited formed out of a regulatory group with more than 15 yearsâ&#x20AC;&#x2122; experience providing consultancy support from within a major CRO

2011

Offices opened in US and Japan

PARTNERS LSR Associates has a network of consultants to provide the local knowledge needed for management of country specific registrations. CLIENTS LSR Associates has a large portfolio of clients covering more than 40 countries and ranging from large multinationals through to smaller specialised companies. Our customers cover the whole spectrum of the chemical, crop protection and biocide industries.

Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 1: Modelling QSARs LSR Associates is experienced in the application of modelling/QSARs. A regulatory authority had requested a significant set of environmental data to be provided by our client unless it could be demonstrated that the substance was not bioaccumulative. We applied molecular modelling to determine that the molecular weight/dimension criteria were met such that the substance would not bioaccumulate. No studies were therefore required. CASE STUDY 2: Avoiding vertebrate testing where possible

PROFILE: LSR Associates

LSR Associates will work with our clients to avoid vertebrate testing wherever possible. A client with an EU NONS substance needed a tonnage upgrade under EU REACH which required the filling of a reproductive toxicity endpoint. By gaining a detailed knowledge and understanding of use information, combined with an expert review of the available toxicity data for the substance, we were able to justify the derogation of the study. CASE STUDY 3: Only representation LSR Associates acts as only representative (OR) for more than 70 companies. Although not a direct OR responsibility, we have been able to act as a facilitator for discussions between the numerous parties in the supply chain where communications had become difficult. We have also been very active in the determination of substance sameness for our clients. STAFF SELECTION Phil Saunders – Head of Regulatory Affairs Phil manages the LSR Associates team based in the UK (covering both agrochemical and chemical/REACH), and has more than 30 years’ experience in product safety. Phil has a proven track record of defining regulatory strategies to defend challenging compounds and maintaining markets for both proprietary and commodity companies. Previous to joining LSR Associates, Phil provided high level consultancy services to the both the agrochemical and chemical industries. Phil has also been a product safety manager for a major agrochemical company. Christopher Cordon – Chemical Regulatory Affairs Team Leader Chris is the team leader for the Chemical Regulatory Services group within LSR Associates. He has particular expertise in project management and in the design of programmes of work to support global product registration. He has set up and monitored numerous studies in China for new substance notification work since this service was first offered by LSR Associates in 2005. David Howes – Chemical Regulatory Affairs Specialist David specialises in the area of chemical risk assessment, chemical grouping for read-across and computational chemistry for chemical regulatory purposes, utilising his previous 20 years’ laboratory experience in environmental analysis and physico-chemical property determination. David was a key driver in interpreting the EU REACH regulation and its implementation within LSR Associates Ltd, and was previously involved in the preparation of new notification dossiers for global submission. David has experience of working with a wide variety of clients, advising them on notification and test strategies. Barbara Ganney – Representation Services Manager Barbara is the leader of the Representation team within LSR Associates. She was instrumental in setting up the service and co-ordinated the preregistration of over 1500 substances. Barbara has significant project/ process management experience supported by a background in Quality Assurance (GxP).

Chemical Watch | Global Service Providers Guide 2012

Page 107


SERVICES PROVIDED Global HSE regulatory and auditing information

PROFILE: Mercer

CONTACTS Website

www.mercer.com

E-mail

dee.woodhull@mercer.com

Head office

1255 23rd Street, NW; Suite 250, Washington, DC, USA

Tel

+1-202-331-2630

Fax

+1-202-463-8006

Contact

Dee Woodhull

Locations

Washington, DC, USA

Founded

2008

Contents of a Mercer HSE networks country profile – general information

OVERVIEW To ensure business success, modern high-performing global companies must know and understand their obligations under the laws and regulations in the countries in which they do business. Finding accurate, up-to-date and accessible (accurately translated) information, however, can be extremely difficult, time consuming and expensive. To help companies address the need to understand the environmental and occupational health and safety (EHS) laws and regulations of countries outside the US, Mercer ORC Networks has developed its Country Profiles™ services. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

45

Staff, group

-

Staff, chemical service provision

-

SERVICE AREA BREAKDOWN

Information 100%

GLOBAL OFFICES Washington, DC, USA

Page 108

Mercer HSE Networks Country ProfilesTM answer multinational companies’ needs for a means of identifying HSE legislation and resulting regulatory and enforcement policies in individual countries and in the provinces of larger countries such as China, Australia and Canada. Each of Mercer HSE Networks’ latest country profiles contains a detailed self-assessment checklist that can be used to assist in auditing implementation of regulatory requirements. Mercer HSE Networks Country Profiles currently cover more than 50 countries and provinces. New provinces and countries are being added regularly. The country profiles can be purchased by annual subscription either individually, as an entire library, or as specific groupings by region.

1. Introduction and limitations 2. General overview OO 2.1 Summary OO 2.2 Approach to environmental and occupational health and safety issues 3. Legislative and legal process OO 3.1 Promulgation of laws/regulations OO 3.2 International agreements OO 3.3 Liabilities and penalties 4. Regulatory agencies OO 4.1 Environmental OO 4.2 Occupational health and safety 5. Key laws and regulations OO 5.1 Environmental OO 5.1.1 Key legislation OO 5.2 Occupational health and safety OO 5.2.1 Key legislation 6. Other local resources Contents of a Mercer HSE networks country profile – environmental 7. General environmental requirements 8. Air quality/emissions 9. Wastewater discharges 10. Water resources 11. Hazardous waste management 12. Solid (non-hazardous) waste management 13. Radioactive materials handling and disposal 14. Hazardous/dangerous substances compliance programmes OO 14.1 Asbestos OO 14.2 Ozone-depleting substances OO 14.3 PCBs OO 14.4 Batteries OO 14.5 Recycled plastics OO 14.6 RoHS/WEEE OO 14.7 REACH 15. Environmental noise 16. Tank storage management OO 16.1 Above-ground tank management OO 16.2 Underground tank management 17. Remediation 18. Property transactions/due diligence 19. External emergency planning

Chemical Watch | Global Service Providers Guide 2012


20. General occupational health and safety requirements 21. Health and safety representatives and committees 22. Worker right-to-know/hazard communication 23. Employee medical and well-being requirements OO 23.1 Facility and personnel medical requirements OO 23.2 Employee well-being OO 23.3 Wellness programmes OO 23.4 Work-life requirements OO 23.5 Female/young workers 24. Work environment and controls 25. Machinery, equipment and controls 26. Electrical safety OO 27. Chemical and substance management OO 27.1 Compressed gas OO 27.2 Flammable liquid storage OO 27.3 Other chemical management 28. Industrial hygiene and exposure limits OO 28.1 Chemical hazards OO 28.2 Biological hazards OO 28.3 Physical hazards 29. Personal protection equipment OO 29.1 Areas and types of protection OO 29.1.1 Eyes and ears OO 29.1.2 Hands OO 29.1.3 Respiratory OO 29.1.4 Body and feet OO 29.2 Equipment selection, standards, training and maintenance 30. Internal emergency response requirements OO 30.1 Fire safety and protection OO 30.2 Life safety OO 30.3 Emergency and evacuation plans 31. Ergonomics and work organisation Environmental audit checklist questions OO OO OO OO OO OO OO OO OO OO OO OO OO

general environmental requirements air quality/emissions wastewater discharges water resources hazardous waste management solid (non-hazardous) waste management radioactive materials handling and disposal hazardous/dangerous substance compliance programs environmental noise tank storage management remediation property transactions/due diligence external emergency planning

Health and safety audit checklist questions OO OO OO OO OO OO OO OO OO OO OO OO

general occupational health and safety requirements health and safety representatives and committees worker right-to-know/hazard communication employee medical and well-being requirements work environments and controls machinery, equipment and controls electrical safety chemical and substance management industrial hygiene and exposure limits personal protection equipment internal emergency response requirements ergonomics and work organisation

Chemical Watch | Global Service Providers Guide 2012

Partial listing of country profiles now available Argentina Australia – Queensland Australia – Western Austria Brazil Canada China (PRC) OO Beijing OO Chengdu – Sichuan Province OO Qingdao – Shandong Province OO Shanghai OO Taiwan (ROC) OO Tianjin OO Wuxi – Jiangsu Province OO Zhuhai – Guangdong Province Colombia Czech Republic Denmark European Union Finland Germany Hungary India Indonesia Israel Italy Japan Malaysia Mexico New Zealand Norway Peru Poland Romania Russian Federation Saudi Arabia Singapore Slovakia South Korea Sweden Taiwan Thailand Ukraine Venezuela Vietnam

PROFILE: Mercer

Contents of a Mercer HSE networks country profile – occupational health and safety

For more information about Mercer ORC Networks Country Profiles, meetings or other consulting services, please contact: Dee Woodhull, 1255 23rd St. NW, Suite 250, Washington DC 20037 +1 202 331 2630 PARTNERS The Isosceles Group, a Sleeman, Hanley and DiNitto Company CLIENTS Multinational organisations with HSE compliance needs in a variety of countries.

Page 109


SERVICE AREA BREAKDOWN Consultancy/ advisory 17% Representation & management 3%

PROFILE: NOTOX

CONTACTS Website

www.notox.nl

E-mail

marketing@notox.nl

Head office

Hambakenwetering 7, 5231 DD ‘s-Hertogenbosch, The Netherlands

Tel

+31 73 6406700

Fax

+31 73 6406799

Contact

marketing@notox.nl

Ownership

Privately owned

In Europe, main facility in ‘s-Hertogenbosch, with support offices in Switzerland and UK. Additional support offices in Tokyo, Japan and in the USA main facility in Ashland (Ohio)

Locations

Japan, UK, Switzerland, The Netherland, USA

Founded

1983

SERVICES PROVIDED

Laboratory 80%

GLOBAL OFFICES

OVERVIEW NOTOX 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 toxicology studies. Our operations have been endorsed by the GLP monitoring authorities (OECD/EPA/FDA/ JMAFF certification). NOTOX is part of WIL Research Company, Inc which consists of more than 1,000 dedicated scientific, technical and support personnel with locations in the United States, Europe and Japan. The United States locations include Ashland OH; Hillsborough NC; and Boothwyn PA. NOTOX 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. For successful registration of your compound with ECHA, it is necessary to provide a set of elementary physical and chemical characteristics and spectral data analysed by MS, IR, UV-Vis and NMR to confirm the compound identity. A full listing of our phys-chem capabilities is available upon request. We help you to select the appropriate test and perform these tests according to OECD, EC or OPPTS guidelines. Whenever possible, NOTOX prepares expert statements instead of more costly full studies. NOTOX statements are recognised by the competent authorities worldwide. We supply a certificate of analysis after completion of the required determinations (content and impurity profiling). In Europe, NOTOX is located in 's-Hertogenbosch, The Netherlands, with a supporting office in Switzerland. Our office serving Japan is located in Tokyo. Services provided by NOTOX BV: dedicated and crystal clear. VITAL STATISTICS Turnover, group

2010/11 -

Turnover, chemical service provision

-

No of offices

8

No of countries represented

40-50

Staff, group

1,000

Staff, chemical service provision

Page 110

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 NOTOX team remains dedicated and its objectives clear. Crystal clear! REACH compliance REACH consultancy and Sief management and full testing portfolio REACH safety testing To help you comply with the regulations NOTOX has set up a 10-step action plan which will cover all aspects of the registration needs for both phase-in (EINECS materials) and the non-phase-in substances (new chemicals). The different steps are given below. For each of these steps we can provide more details on the activities within that step and the cost estimation for completing that part of the work. Full service portfolio for Annex 7-8-9-10 Registration Australasia, including Japan and China Registration chemicals worldwide NOTOX 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 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

-

Chemical Watch | Global Service Providers Guide 2012


delivering a high level of quality has always been our strength. NOTOX has achieved Good Laboratory Practice (GLP) compliance status for more than 20 years, with the most recent GLP endorsement statement signed in May 2011. NOTOX publication was referenced in the guidance document 117 for OECD 443 guideline. NOTOX published article is referenced in the guidance document 126 for the OECD 203 guideline. NOTOX had award winning poster at EUROTOX 2011. meeting regulatory requirements is a standard procedure at NOTOX, but our quality policy reaches far beyond that. One example is the extra care we take in animal welfare. Our in-house animal welfare officer and the animal ethics committee ensure a high level of quality care for all our laboratory animals. Animal welfare is an important part of our daily agenda. 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.

CASE STUDY 3: Complete hazard and exposure assessments

Non-disclosure agreements prohibit this level of information

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. NOTOX’s experienced team consists of regulatory experts in chemistry, environmental fate and behavior, residues, ecotoxicology and human toxicology. In addition to outstanding technical knowledge, NOTOX 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.

TESTIMONIALS

STAFF SELECTION

Consult the NOTOX telegraph, via www.notox.nl

Wilbert Frieling, DVM – Managing Director

OO

OO

OO

OO OO

OO

CLIENTS

CASE STUDY 1: NOTOX 10 steps to REACH compliance We understand clearly that each situation is different and we therefore advocate discussing this in a personal meeting using a REACH-inventory questionnaire going through the following distinct steps: OO Step 1 - Inventory OO Step 2 - Pre-registration: closed 1 December 2008 OO 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 - Exposure information (1-10 t/y) and/or chemical safety assessment/report (CSA/CSR)* OO Step 8 - Prepare a test proposal (> 100 t/y)* OO Step 9 - Dossier preparation* OO Step 10 - Dossier submission and after care* * steps also apply to non-phase-in substances CASE STUDY 2: Representation NOTOX’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. NOTOX’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 wellestablished 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, 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. Chemical Watch | Global Service Providers Guide 2012

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 NOTOX 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 NOTOX joined WIL Holding in 2005, he was appointed as managing director of NOTOX 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). Dr Ilona Enninga – Technical Director Ilona C Enninga graduated in biochemistry and molecular virology (cum laude) in 1981. She worked for five years as research associate at the Laboratory of Radiation Genetics and Chemical Mutagenesis at the University of Leiden, The Netherlands, which was concluded with a doctor’s degree in 1986. In 1998 she became a Eurotox registered toxicologist. From 1995 to 2004 she was respectively secretary and chairman of the registration committee on Board Certification of Toxicologists. Presently, Dr Enninga is an active member of several societies of toxicology. She has published in various internationally recognised journals.

Page 111

PROFILE: NOTOX

ACCREDITATIONS


SERVICES PROVIDED Comprehensive assistance in the registration of agrochemicals including dossier preparation, study management, organisation of trials and communication with authorities Our services include preparation of the application, compilation of the dossier, expert evaluation of the documents, communication with authorities and institutions including facilitation of the document flow between them, and any other activity needed for the successful registration process. Having solid experience in the registration of agrochemicals we minimise the complexity of this procedure for our partners. We share information with our clients at every stage of our activity. Our policy is to make the registration process transparent and traceable. Apart from complete registration support we can also provide a range of case bound services like helping to sort out complications at any stage of an already launched registration.

PROFILE: Polgar ACRO

CONTACTS Website

www.polgar-acro.eu

E-mail

info@polgar-acro.eu

Head office

Polgar ACRO Kft, H-1031 Budapest, Szentendrei ut 190/B, I floor, 8, Hungary

Tel

+36 70 3157766

Fax

+36 1 437 03 52

Directors

Tatsiana Palchekh

 

Andrey Kuznetsov

Locations

Russia, Ukraine, Moldova, Belarus, Kazakhstan

Founded

2010

Organisation of demo-trials and public hearings

OVERVIEW Polgar ACRO Agrochemical Consulting and Registration Office was created to guide foreign producers and suppliers of agricultural chemicals through the labyrinth of the registration procedure in CIS (Russia, Ukraine, Kazakhstan, Moldova and Belarus). Polgar ACRO provides wide range of regulatory services including comprehensive support for registration of pesticides, biocides, bio pesticides, microbials, fertilisers, pest control agents, surfactants and other products. VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

3

No of countries represented

6

Staff, group

12

Staff, chemical service provision

9

SERVICE AREA BREAKDOWN Information 20%

Consultancy/ advisory 80%

GLOBAL OFFICES Budapest, Hungary – Headquarters Moscow, Russia Kiev, Ukraine

Page 112

Polgar ACRO offers a wide range of services in testing of agrochemicals including: OO hygienic assessment of pesticide as a part of the general toxicological-hygienic evaluation of a formulation aimed at receiving an affirmative expert report – organisation and administration of testing procedures, field trials with the specialists from the toxicological center, organisation of on-site tests (field, equipment, transport, working clothes, etc) OO biological efficiency trials – organisation of preliminary testing of agrochemical product to assess its effectiveness in the climatic conditions of CIS, setting-up testing procedures and processes, definition of the effective norm and the minimum number of trials to reduce expenses Assistance in patent issues Producers and distributors of generic products may often face the necessity to avoid the violation of patents. Pоlgar ACRO can always help to find the answers to patent questions and receive official conclusions from the State Patent Committee Registration of brand names Registration of a brand name is recommended to make sure that the unique name of a product is never used by any other company. This is especially important if a manufacturer is using the same name for its product in several countries, so this brand is associated with a particular product of a particular company all over the world. Polgar ACRO offers assistance in the registration of brand names and trade marks for agrochemical products. Guidance through legislative issues around registration of pesticides and other agricultural chemicals We provide professional consultations to help clients to make an informed decision – to weigh all pro and contra, to find out more about the registration procedure, timeline and costs in Russia, Ukraine, Belarus, Moldova and Kazakhstan. We provide consultations independently from our clients’ intention to request a full registration support in future.

Chemical Watch | Global Service Providers Guide 2012


2010

Polgar ACRO was established. Russian and Hungarian offices were opened. Company also starts to offer registration support in Moldova and Kazakhstan.

2011

Ukrainian office of Polgar ACRO is established in Kiev. Eight successful submissions for registration of agrochemicals in Russia were delivered. Polgar starts to provide regulatory support in Belarus.

2012

Fourteen new submissions for pesticides, two for bio pesticides, two for microbials are finalised in January. Three adjuvants, two disinfectors and four agricultural pesticides are in the submission process.

PARTNERS OO

GAB Consulting GmbH

CLIENTS Some of our recent clients: OO Andermatt Biocontrol AG (Switzerland) OO Agriphar SA (Belgium) OO Indofil Industries Ltd (India) TESTIMONIALS “We chose Polgar ACRO to help us registering our baculovirus products for the Russian and Ukrainian market. Our collaboration started in January 2011. We highly appreciate the transparency of collaboration. We exactly know all steps and get regularly updated about the actual situation. Employees of Polgar ACRO are offering a brilliant service looking for fast and pragmatic solutions whenever problems occur. We can recommend Polgar ACRO as a consultant without any doubts” – Andermatt Biocontrol AG “We are using Pogar ACRO Regulatory Services for registration of our products in CIS countries where registration procedure is complicated and frequently changing. They have provided us excellent support in the areas of professional consultations including the guidelines, study management, field trials, interpretation of results, dossier preparation, and communication with the authorities.  “Polgar’s staff are thoroughly professional in their approach to the business. Timely follow-up with the authorities and technical support are critical to the registration process, and for this we can vouch for Polgar ACRO. They were always friendly in their approach to us and never felt that we are just one of the many clients. They were always there to solve our problems with enthusiasm. They are reliable professional consultants  having expertise in their chosen field” – Indofil Industries Limited

CASE STUDY 1: Introduction of new registration requirements in Russia: Ecological expertise The situation: 2011 was complicated for all applicants for certification of agrochemicals in Russia due to some serious changes in the registration requirements. The situation was aggravated by the fact that the changes were introduced after all the applications of 2011 had been submitted and contracts with expert institutions signed. State Ecological Expertise (SEE) became mandatory for all agrochemicals contrary to previous rules when the expertise was only applied to active ingredients and products new on the Russian market.  Although, the new rules came into force and were applied right away, the State registration system itself was not ready to process such a number of SEEs. The system simply had no resources and capacity – no time, no experts and no equipment. This resulted in long waiting lists and all the applicants where shifted back in time for about six months. Our approach: Ecological expertise is a complicated procedure consisting of several steps and thus it was very hard to find a professional who could take the responsibility to support the expertise on each step and be responsible for the final result. We noted the unsuccessful experience of other companies trying to outsource the whole procedure to one agent, so Polgar ACRO decided to find several contacts, each professional and experienced in a particular stage of the expertise. After a comprehensive background study we divided the procedure into three blocks: 1) organisation of the expertise and public hearings, 2) preparation of technical documentation and expertise report and 3) support of the application for state expert conclusion on SEE.  The most challenging and risky issue was the coordination of three agents not connected with each other and none of them responsible for the final result. However, due to a very strict and comprehensive contract between Polgar and sub-agents, tight deadlines defined and everyday coordination we managed to finalise the procedure within 2.5 months against the usual six month and get a positive conclusion from the Expert Committee.  STAFF SELECTION Mikhail Tkachuk – Registration Team Leader Mikhail is a registration team leader of Polgar ACRO Ukraine. Mikhail is responsible for registration of conventional herbicides and insecticides, bio pesticides and microbials. Apart from this, he represents Polgar ACRO in the dialogue with the Ukrainian registration authorities. Mikhail has got PhD in plant engeneering. From 1986 to 1994 he was working as an engineer at the plant physiology department of the Ukrainian Academy of Science. From 1994 to 2010 Mikhail was working first as a lead specialist and then as a head of registration department in the Chemical Products Safety division of the Ministry of Environment and Natural Resources of Ukraine. Andrey Borodavchenko – Senior Regulatory Affairs Manager Andrey is a senior regulatory affairs manager in Polgar ACRO Russia. His responsibility is supervision of all ongoing registrations, scientific guiding of other registration managers and communication with local authorities. Andrey joined our team in 2010 having had impressive professional experience and a PhD in agronomy behind him. Previously, Andrey worked for the LLC MARUS, a Russian subsidiary of Makhteshim-Agan Industries Ltd as a registration and development manager and, before that, for the Moscow team of Sumitomo Corporation in the same position. His earlier experience includes also employment by the Russian pesticide manufacturer August and the Moscow division of the All-Russian Institute of Plant Protection.

Chemical Watch | Global Service Providers Guide 2012

Page 113

PROFILE: Polgar ACRO

CORPORATE DEVELOPMENTS & ACHIEVEMENTS


SERVICES PROVIDED Our sustainability and climate change services

PROFILE: PwC

CONTACTS Website

www.pwc.nl/nl/reach

E-mail

Bas.coolsma@nl.pwc.com

Head office

Thomas R Malthusstraat 5, 1066 JR, Amsterdam, PO Box 90357, 1006 BJ, Amsterdam, The Netherlands

Tel

+31 (0)88 792 64 56

Contact

Bas Coolsma – Senior manager Sustainability and Climate Change

Directors

Hans Schoolderman – Partner Sustainability and Climate Change

Ownership

Partnership

Locations

Global presence

Resource scarcity. Climate change. Environment. Supply chain integration. Inclusive business. Our world is fast filling up with a new breed of issues influencing both companies’ supply chain operations as well as their impact on the environment and society. Today’s smart organisations are tackling these issues head on, managing the risks and exploiting the opportunities across the value chain, as these issues are critical to business continuity, cost and reputation management. With a global network of more than 700 sustainability and climate change professionals, PwC offers a broad range of advisory, assurance and tax services that guide clients through the complexities of adapting to a lowcarbon economy and a resource constrained world. With approximately 30 professionals, the Dutch Sustainability and Climate Change team is based in Amsterdam, The Netherlands. The global REACH centre of excellence is embedded in this team as part of our “sustainable resource management services”. Specific REACH services for the chemicals sector

OVERVIEW At PwC in the Netherlands more than 4,600 people work together in 12 offices and from three different perspectives: Assurance, Tax and HRS and Advisory. We provide industry-focused services and search for surprising solutions, not only for national and international companies, but also for public sector and civil-society organisations. PwC firms provide industry-focused assurance, tax and advisory services to enhance value for their clients. More than 169,000 people in 158 countries in firms across the PwC network share their thinking, experience and solutions to develop fresh perspectives and practical advice. The chemicals sector is facing an increasingly complex (regulatory) environment concerning (non) financial reporting, risk management, safety and environment. PwC offers a strong and reliable network of dedicated industry experts. We strive to co-create innovative value for our clients from their local or multinational operations, to develop a competitive advantage across the value chain, and to ensure that all corporate stakeholder expectations are recognised and met. Building brand trust, brand growth, and brand effectiveness is the purpose of our practice. Based on our expertise, we provide sector specific services and seek to find surprising solutions. We help our clients on their pathway towards a sustainable future by supporting further integration of responsibility into their business practices by contributing our expertise with passion and an open mind. VITAL STATISTICS

2010/11

Turnover, group

€664.4m

Turnover, chemical service provision

€63m

No of offices

12

No of countries represented

158

Staff, group

4,600+

Staff, chemical service provision

PwC supports its clients with a focus on the financial and risk management aspects of REACH. We have a proven track record showing that we bring added value to the business issue REACH. Besides securing a company’s license to the market, we help our clients to recognise opportunities more easily and capitalise on them. Our services can be categorised into: OO REACH compliance services aimed at securing compliance through business processes. We will make an analysis of potential business or compliance risks and completeness of costs and revenues. OO Sief financial management and administrative services to support companies with the various challenges and risks associated with the set-up and execution of a fair, transparent and nondiscriminatory cost sharing process. OO Authorisation services aim to support our clients with the authorisation regime of the REACH Regulation managing their SVHCs (substances of very high concern). PwC helps its clients by determining the impact of the classification as SVHC on their organisation and business continuity. PwC supports companies and sector organisations to prepare for the authorisation process, eg by building business cases using company data on the socio-economic value of (sub)industries and products. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1849

Samuel Lowell Price sets up in business in London.

1854

William Cooper establishes his own practice in London, which seven years later becomes Cooper Brothers.

1998

Worldwide merger of Price Waterhouse and Coopers & Lybrand to create PwC

2008

PwC publishes global survey ‘Waking up to REACH’

2009

PwC publishes articles in Chemical Watch on ‘REACH consortia need financial safety nets’ and ‘Managing transaction risks in REACH Joint Submissions’

2010

PwC publishes article on ‘VAT Challenges for REACH cost sharing’ in Chemical Watch

2011

PwC publishes article on ‘2013 Siefs need to use more transparent administration’ in Chemical Watch

-

SERVICE AREA BREAKDOWN Other 20% Consultancy/ advisory 40% Representation & management 40%

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Chemical Watch | Global Service Providers Guide 2012


CLIENTS

STAFF SELECTION

PwC continues to serve the leading market share in the industry. Our chemicals industry practice is comprised of a global network of nearly 3,000 partners and client service professionals. Our chemicals team encourages dialogue on emerging trends and issues by holding conferences for industry executives. PwC is also a sponsor of leading industry conferences and frequently authors articles for, or is quoted in, leading industry publications. Our involvement with these organisations represents PwC’s commitment to furthering industry dialogue with chemicals industry leaders.

Hans Schoolderman – Partner Sustainability and Climate Change

The client, a multinational industrial products manufacturer, prepares for REACH compliance, as a lead registrant of 25 substances. Data, costs and access to parts of dossiers need to be shared with direct competitors in substance information exchange forums (Siefs). The client is challenged to implement and run a Sief financial administration which 1) is based on clear valuation and allocation principles; 2) is compliant with EU competition law; 3) mitigates business continuity risks following possible failure to deliver a letter of access to competitors. PwC supported the client to realise a 57% increase of the value of the data to be shared, representing a value of €1.2m. The client managed to invoice its competitors prior to giving access to the dossier by means of a token. PwC supported preparation of Sief agreements, dossier valuation, cost allocation, licensing. As well, a VAT burden is avoided and the Sief administration is audited. CASE STUDY 2: Strategic approach to REACH compliance – global aerospace and transportation manufacturing company PwC assessed whether the client’s processes and operations are impacted by REACH, through the identification of the regulatory requirements in the context of the client’s operations. The terns were compared to the current position of the client and to leading organisations’ approaches. Thereafter, the company’s two divisions were assessed in more detail and process were mapped. The findings and recommendations were tailored to the specific divisions, products and manufacturing processes, and consisted of strategic and operational improvements on both site and corporate level. As a result, the client changed the REACH governance structure and implemented significant changes to its operational and internal audit processes in order to become and remain REACH compliant.

Bas Coolsma – Senior Manager Sustainability and Climate Change Bas holds a master’s degree in environmental health science and brings broad experience in organising sustainability driven transformations in the chemicals sector. He is focused at EU REACH and the emerging topic of sustainable materials. Bas is responsible for the REACH proposition of PwC NL. Bas executed many REACH assessments and reviews and manages several REACH consortia and REACH compliance programmes for clients in the global chemicals sector. Geoffrey Schouten – Manager Sustainability and Climate Change Geoffrey Schouten is a chemist by training and has ten years of experience as a chemicals management consultant. He has supported various multinational chemical companies with regulatory compliance issues. Geoffrey has been leading multiple REACH registration projects and REACH consortia, in which he was responsible for successful and timely registration of over 20 substances. Geoffrey has also worked on projects for the European Commission, such as the review of ECHA. Stephan Roest – Assistant Manager Sustainability and Climate Change Stephan has a background in chemical engineering and systems engineering, policy analysis and management at Delft University of Technology. He gained extensive experience in EU environmental regulations as REACH and EU ETS. He is helping clients with assessing business impact, respond to obligations and implement necessary business changes coming from EU regulations and local legislation. Stephan supports several lead registrants and consortia with registrations and Sief administration for the REACH regulation.

CASE STUDY 3: Preparing for socio-economic assessment – sector organisation With the objective to prepare for REACH authorisation, PwC supported an EU industrial sector organisation. We collected and analysed socioeconomic and usage data throughout the downstream supply chain. The data was provided by 15 different companies and combined into a comprehensive description of direct and indirect value of the products involved. The report serves as a starting point for advocacy during the REACH authorisation process.

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PROFILE: PwC

CASE STUDY 1: Sief administration support – industrial products manufacturer

Hans has a dual focus on climate change and sustainability. Hans is experienced at working for Dutch, EU- and US based multinationals. His key focus industries are manufacturing and chemical industry, energy and utilities and transport and logistics. Hans is the author of a series of expert opinions targeted to issues in his key focus industries.


GLOBAL OFFICES REACh ChemAdvice GmbH, Germany Regional office, USA Regional office, India

PROFILE: REACh ChemAdvice GmbH

CONTACTS Website

www.reach-chemadvice.com

E-mail

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

Daniela Wallinda

Directors

Dr Rudolf Staab, Managing Director

 

Daniela Wallinda

Ownership

Privately owned company

Locations

Germany, USA, India

Founded

2007

SERVICES PROVIDED

OVERVIEW REACh ChemAdvice GmbH is a sister company of ChemAdvice AG. It was formed by a group of senior executives with decades of experience in the chemical industry, in collaboration with a team of REACH specialists. As an independent representative with no direct involvement in the production or trading of chemicals, REACH ChemAdvice can act on your behalf without bias. This is very important, especially if you have multiple agents, indirect exports, or want to alter your supply chain into Europe. Founded to help non-EU manufacturers to comply with REACH as only representative, the company now supports EU producers and importers as consultant and/or third party representative, and downstream users as consultant in all REACH matters. Unlike most advisors, we offer the complete scope of REACH-related services: in-house and through our network. REACH ChemAdvice would like to transfer the lessons learned from REACH to the new European Cosmetics Regulation, where the challenge for the cosmetic industry is implementing both regulations at the same time. Our REACH specialists with their background in cosmetics provide a best fit for our clients to comply with both pieces of legislation. As a member of ERPA (European Cosmetics Responsible Persons Association) and ICADA (International Cosmetic and Detergents Association eV), REACH ChemAdvice is actively involved in working groups developing guidance as a support for the cosmetic industry, representing industries´ interests at the respective authorities and giving customers the latest news. Through our support, your company will get advice and efficient implementation of regulations in the chemical and cosmetic industry. VITAL STATISTICS

2010/11

Turnover, group

ca €2.5m

Turnover, chemical service provision

ca €2.5m

REACH services Once you select REACH ChemAdvice as your REACH-consultant, we will be pleased to provide a comprehensive range of services customised exactly for your needs: OO only representative (Art 8 of the REACH-Regulation) OO third party representative (Art 4 of the REACH-Regulation) OO late pre-registration OO SIEF communication OO creation and submission of IUCLID 5 dossiers (inquiry, PPROD, registration) OO consortia management/consortia representation OO toxicological evaluation/studies/tests /reports OO creation of chemical safety reports (CSR) OO strategy development for the registration OO REACH workshops OO REACH due diligence OO data gap analysis OO training and project management OO authority relation management OO data vendor management (LoA purchase) OO creation of REACH-compliant MSDS in all EU-member states languages CLP notifications/CLP-group notifications. 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: OO regulatory workshops for the cosmetic industry OO supply chain analysis OO notification according to Art 13 of the Cosmetics Regulation 1223/2009 OO data gap analysis OO creation of PIF (product information files) according to Art 11 of the Cosmetics Regulation 1223/2009 OO training of RP (responsible persons) according to Art 4 of the Cosmetics Regulation 1223/2009 CORPORATE DEVELOPMENTS & ACHIEVEMENTS 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 Start cosmetics consultancy

No of offices

3

2011

No of countries represented

3

ACCREDITATIONS

Staff, group

10

Staff, chemical service provision

10

SERVICE AREA BREAKDOWN Training 10%

Other 5%

Information 20% Representation & management 5%

Page 116

Consultancy/ advisory 60%

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 As the project manager for the working group responsible person under the new Cosmetics Regulation at ICADA (International Cosmetic and Detergents Association), REACH ChemAdvice GmbH actively develops guidelines for the cosmetic industry, especially for SME (small and medium-sized enterprises). PARTNERS Our partners can be viewed on our website

Chemical Watch | Global Service Providers Guide 2012


Silvia Teige – Finance and Administration

Our clients are located in Europe, United States of America, Latin America, Africa, Middle East and Asia

Experience OO management assistant ChemAdvice GmbH OO management assistant to head of regional business unit Europe, NME, Africa, Clariant Masterbatches OO executive assistant to head of division pigments and additives, Clariant OO executive assistant to head of business unit additives, Hoechst AG and Clariant OO executive assistant to head of division chemicals, Hoechst AG

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 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 Experience OO senior vice president Masterbatches Clariant International OO reorganisation and re-engineering of business processes OO introduction of new marketing approaches for key accounts OO vice president additives within Hoechst AG and Clariant International OO strategic repositioning of the business OO integration and reorganisation of the business post-merger OO vice president specialty chemicals within Hoechst AG OO strategy development and implementation OO business re-engineering, efficiency improvement activities and relocation efforts OO development of new markets and applications M&A transactions OO member and chairman of the board of several companies within the chemical, food ingredients and plastic processing industry Education OO MS in inorganic chemistry (Diplom-Chemiker – Saarbrücken, Germany) OO PhD in inorganic chemistry (Dr rer nat – Saarbrücken, Germany) Daniela Wallinda – Director Experience Sales manager OO purchasing and sales of chemical raw materials for coatings OO foundation and development of the new business unit cosmetics Supply Chain Activities OO customer relationship management (SME and key accounts advisor) OO supplier relationship management (European and non-European suppliers advisory) REACH Consultant OO internal and external consulting services OO focus on non-European manufacturers including only representative services Education OO practical education as a businesswoman engaged in wholesale and export trades (Groß- und Außenhandelskauffrau, Syntana GmbH) OO business administration, University of Applied Sciences (Diplom-Kauffrau (FH), Fachhochschule für Oekonomie und Management, Essen) OO diploma in REACH: Business networks – in response to challenges deriving from the new European Chemical Regulation

Chemical Watch | Global Service Providers Guide 2012

Prof Dr Dieter Mayer – Toxicologist Experience OO Institute of Human Genetics, University of Heidelberg Germany OO Institute of Environmental Health, University of California, Davis, US OO scientific director Centre International de Toxicologie, Evreux, France OO professor, Johann Wolfgang Goethe University, Frankfurt, Germany Institute of Pharmaceutical Technology OO guest professor Johannes Gutenberg University, Mainz, Germany, Institute of Toxicology, Risk Assessment, Methods in Modern Toxicology OO guest professor, German Society of Pharmacology and Toxicology Industrial Career OO toxicologist, global head of toxicology Hoechst AG, Hoechst Marion Roussel, Aventis SA Dr Sebastian Hoffmann – Scientific Consultant Experience REACH consultant (TÜV Rheinland BioTech GmbH) OO project management and scientific consulting OO hazard and risk assessment OO expert for human health hazards and in vitro toxicological methods Scientific officer (European Commission, Joint Research Centre, Italy) OO assessment (validation) of in vitro test methods OO management of scientific projects OO assessment of data reliability and relevance OO 25 peer reviewed publications OO scientific employee (University of Konstanz) OO assessment of pharmaceutical safety test methods OO test method development and standardisation Education OO diploma in statistics (University of Dortmund, Germany) OO PhD in biology (university of Konstanz, Germany) Jim DeLisi – Regional Head, North America Experience President Fanwood Chemical, Inc. OO sale of organic intermediates in North America, South America and Europe OO tariff and trade affairs OO monitoring of imports and exports OO REACH Chairman SOCMA, International Trade Committee Chairman Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health/Science Products and Services Education OO BA in business administration (Rutgers College, USA) OO MBA in chemical marketing (Fairleigh Dickinson, USA)

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PROFILE: REACh ChemAdvice GmbH

CLIENTS


SERVICES PROVIDED General consulting services

PROFILE: REACH master y

CONTACTS Website

www.reachmastery.com

E-mail

info@reachmastery.com

Head office

Via Giovio 16, 22100 Como, Italy

Tel

+39 031 269513

Fax

+39 031 2756370

Contact

monicalocatelli@reachmastery.com

Directors

Monica Locatelli

Ownership

Private company

Locations

Italy

Founded

2008

OVERVIEW REACH mastery is a provider of a wide range of services in the area of chemical regulatory affairs. The staff is composed of a highly motivated team, skilled in different scientific areas: chemistry, biology, human health and environmental toxicology. Our commitment is to assist customers 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 alternatives to animal testing like in-vitro and in-silico methods, through the high quality of our services and expert support VITAL STATISTICS

2010/11

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1

No of countries represented

1

Staff, group

5

Staff, chemical service provision

5

SERVICE AREA BREAKDOWN Training Legal 1% Other 5% 2% Information 2% Representation & management 15%

Consultancy/ advisory 75%

Supply chain communication: OO importers and manufacturers, downstream users and manufacturers/ importers of articles, 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. Strategic implementation of European regulations: OO participation in consortia, co-registrants agreements, data sharing, deadline and tonnages for registration are decisions that can be managed in order to find the most cost effective solution and the most protective choice on the market. Chemical management and product stewardship: OO The market will constantly change over time. Companies must face new challenges to strategically select secure suppliers and to identify growing sector markets. Our business development experts will support companies with the right advice, in compliance with the provisions of the regulation. Implementation of IT systems to manage chemicals: OO we help companies in developing internal management systems to integrate existing tools to monitor the presence of chemical substances, including deadlines, total amounts, risk management measures and so on. REACH services Consortia management: OO a lot of experience has been gained on consortia rules and management. We will also provide legal advice, agreement documents, meeting location, cost calculation, managing of LoAs. Data-gap analysis and data collection: OO 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 considering also the quality of the data. OO each single study is evaluated and rated to check relevance and adequacy to fill the requirements. Testing strategy development, in vitro strategies development, QSAR modelling OO 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 Managing of analytical identification and inquiry dossiers OO our great expertise in analytics, and vast experience of enquiries, allows us to face one of the most critical aspects of the REACH Regulation with ease and without problems Tests monitoring OO 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. Dossier preparation (IUCLID compilation) OO dedicated experts are managing our IUCLID compilations Human health and environmental risk assessment OO the focused experience and the support of highly experienced toxicologists let us make risk assessment the core part of the developing registration dossier. CSA-CSR OO REACH mastery is part of the CHESAR consultation group in ECHA. We have followed the development of the tool since the beginning and we are between the first expert in Europe CLP/GHS services OO OO OO

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data collection and assessment of classification and labelling CLP notification MSDS compilation Chemical Watch | Global Service Providers Guide 2012


FEED and FOOD registration OO OO OO OO

dossier preparation risk assessment test monitoring assistance to customer regarding EFSA calls for data

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 up to the actual size

PROFILE: REACH master y

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

PARTNERS Lisam systems as formal partner and RTC, Mario Negri, Vitroscreen, as preferred cooperations CLIENTS We are working for about 40 customers around Europe; they are producers, 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: Nickel Fluoride Consortium The consortium was formed and the registration achieved in less than one year. The substance was a CMR, already partially inserted in the European RAR for nickel compounds. A huge quantity of information had to be managed in order to develop a dedicated CSR. The cooperation with the nickel consortium was complex and delicate, but the registration proceeded successfully in October 2010. CASE STUDY 2: First Tier registration In 2010 we prepared about ten main dossiers on behalf of lead registrants, complete with exposure scenarios above 1,000 tons and we submitted more that 100 joint dossiers providing complete assistance in retrieving lead registrant identity, letter of access costs, analytic development, inquiry process for non phase-in substances and CSR adaptation. CASE STUDY 3: CLP notification In 2011 more than 1000 substance have been notified on behalf of our customers, after extensive bibliographic research, read across approach and computational predictions. STAFF SELECTION Dr Monica Locatelli – Founder and Director After obtaining a degree in chemistry, ten years in R&D and a specialisation in toxicology applied to risk assessment, Monica has been working in the regulatory field and on the implementation of the REACH Regulation since 2001, when it was still just a proposal. Her cooperation with many specialists based in international companies and universities has enabled her to specialise in consortia management and dossier preparation. Dr Costanza Rovida – REACH Regulatory Specialist Costanza graduated in chemistry, and after a 15 years’ experience in the field of analytical chemistry, she worked for three years at the European Commission (ECVAM), 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 the integrated development of alternative toxicological methods to animal testing. She is responsible for the management of individual projects and global customer assistance Chemical Watch | Global Service Providers Guide 2012

Page 119


SERVICES PROVIDED One stop-shop service ReachCentrum’s overall services to achieve registration and beyond (evaluation, authorisation) are settled around five core fields of expertise: OO project management support OO financial and data management support OO Sief support and supply chain communication OO legal support; and OO audit management support. As for project management support, ReachCentrum‘s experienced and dedicated staff organise and oversee meetings, check upon actions and the progress of technical dossiers, and take care that deadlines are respected. Our clients benefit from a secure document exchange platform, where all relevant files are either shared or can be stored as archives.

PROFILE: ReachCentrum

CONTACTS Website

www.reachcentrum.eu

E-mail

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

Admin, financial, data management, audit and legal support

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, lead registrant and Sief leadership team support services, consultancy and workshops. Our services and support tools are designed for European and nonEuropean companies working on their own or in close collaboration with other companies. Currently we manage about 100 consortia and 25 lead registrant and Sief leadership team support projects, comprising very large and complex groups of 80 substances and 45 members to very specific and specialised one-substance projects. VITAL STATISTICS

2011/12

Turnover, group

-

Turnover, chemical service provision

-

No of offices

1 EU + ASIAPACIFIC

No of countries represented

Financial issues for a project are handled in-house. Support is backed-up 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, including support in legal remedies and contract management. Sief support and supply chain communication − LiS ReachCentrum has extensive experience in Sief and supply chain communication. In order to support industry in their communication obligations, we have a user-friendly and secure communication platform in place – LiS – through which documents can be shared or surveys conducted. ReachCentrum can act as the focal point for all requests concerning a substance in a Sief or for transferring relevant information up and down the supply chain as well as for contacts with authorities. Training, workshops and e-learning solutions ReachCentrum organises a series of courses covering all aspects of the REACH legislation as well as the 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 using its REACH boot camps. From 2012 ReachCentrum is an accredited training centre as well as an authorised training assessment centre by the UK Learning and Performance Institute CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Founded by Cefic (the European Chemical Industry Council)

Staff, group

16

2008

Doubled number of staff employed

Staff, chemical service provision

16

2010

LoA e-shop successfully launched

2010

Over 400 lead dossiers successfully registered

2010

Through the LoA e-shop 342 Siefs allowed their Sief members to access the registration dossier

2010

About 900 people attended ReachCentrum events (about 90 events)

2010

LINKinSIEF, the ReachCentrum Sief communication platform was launched

2011

Partnership with national associations service providers for offering REACH workshops and training courses to support local chemical industry

2011

Partnership with TNO Triskelion and with Zieta Technologies (India and US) for offering REACH workshops and training courses and with Zieta Technologies for offering REACH workshops and training courses in India and US

SERVICE AREA BREAKDOWN Training 20%

Legal 20%

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Consultancy/ advisory 30%

Representation & management 30%

Chemical Watch | Global Service Providers Guide 2012


Partnership with SCAS Europe to deliver support services related to Asia-Pacific chemical notifications and registrations

CASE STUDY 2: REACH awareness boot camp and IUCLID5 training courses

2011

Launch of REACH audit service

2011

Launch of a series of e-learning packages to facilitate a better learning of REACH requirements in US and EU

2011

Launch of a unique REACH 2013 support programme for SMEs in collaboration with ChemicalWatch, REACH Delivery and ChemSIX.

ReachCentrum created a REACH awareness boot camp in 2011 giving newcomers a quick grasp on what they have to do to start the registration process for 2013. The five-day course covered REACH and visualised a project plan for working on once back in the office. It also covered the use of IUCLID5 for creating the substance datasets needed for registration dossiers. Companies attending the boot camps were better prepared to manage themselves internally and communicate effectively within the Sief. IUCLID5 training has grown simple classroom training focusing on functional use, to a blended learning solution offering web-based virtual learning, self-study e-learning, while keeping its classroom training. Each course focuses on creating a IUCLID dossier to send to ECHA. In 2010 it was possible for some companies to submit dossiers at the end of the training, and the same will be encouraged for 2013 registrations. For the participants, having trainers able to respond to IUCLID5 and understand REACH ensured practical questions could be answered immediately.

ACCREDITATIONS OO OO OO OO

Accredited as authorised training assessment centre Accredited as authorised REACH training centre Certified on-line learning facilitator Certified lead auditor for environmental management systems

PARTNERS Zieta Technologies for US and India; REACH Global Services (RGS) for Turkey; national association services providers; TNO Triskelion; SCAS Europe; LearningSpan CLIENTS ReachCentrum offers its services to a wide range of chemical companies, from all major multinationals to SMEs and only representatives (OR) from all over Europe and beyond, including downstream users and distributors. TESTIMONIALS "As a pilot of the REACH auditing system of ReachCentrum, I can only encourage other companies to conduct an auditing exercise for developing internal REACH management processes. It provides a good overview of the key issues in REACH implementation in various functions in a very concise, cost-effective and inspiring manner. The results are easy to implement and the review process fosters internal dialogue, which is essential for all REACH implementation activities" – Helena Huttunen, Kemira Oyj “After having attended the ReachCentrum boot camp, I wanted to testify of my high satisfaction. I think that my entry to the REACH world could not have been better: during one week, we could understand the whole process, and had accurate overviews of every topic with highly skilled facilitators. They were able to answer all questions in a positive and open-minded attitude. Even the case studies – homework for most of them – were built in such a way that the learning was enjoyable. Last but not least, I also enjoyed the brilliant food cooked by a chef, and dinners in a friendly atmosphere” – Patrick Karpe, quality, regulatory and HSE manager, Axcentive CASE STUDY 1: An authorisation case study A group of producers of a substance formed a consortium and registered this substance in 2010. During the preparation of the registration dossier it became clear that the substance would be added to the candidate list. A subgroup of companies from the original consortium decided to form a task group with the aim of preparing together the common parts of the authorisation application. Not all members of the consortium became part of the task group, because they decided not to apply for authorisation, but to try to find alternatives before the sunset date. Meanwhile, the substance has now been placed on the authorisation list and the remaining companies who did want to apply for authorisation decided to share costs as much as possible and make the process efficient. ReachCentrum helped these companies to set up this separate and open task force and arrange all legal and financial aspects. The group is now actively preparing the authorisation application and ReachCentrum supports with the project management, finances and legal issues and acts as trustee for the business confidential and competition law sensitive information.

Chemical Watch | Global Service Providers Guide 2012

CASE STUDY 3: Sief leadership team support A customer approached ReachCentrum for support registering a number of substances in 2013. As the situation for each substance was not clear, an initial survey was conducted in all concerned Siefs. With the result, the project was then further defined. For orphan substances a tailor–made service comprising administrative, communication, legal and financial services was set up; for substances where Sief members showed an interest to become also active in, Sief leadership teams were established, and in some cases even regrouping two or three substances because of similar properties into one SLT was possible. ReachCentrum finalised all contractual issues around the project(s) and dossier preparation is well underway for all substances. STAFF SELECTION Leo Appelman – Managing Director A toxicologist by profession, before joining ReachCentrum as managing director in 2007, he had worked for nearly 17 years in a global paint manufacturing company dealing with all health, safety and environmental issues. He was the REACH facilitator for the coating business, and head of the HSE department servicing its business units worldwide in their marketing approach. He was also involved in the registration of biocidal products and notifications for new chemical substances. Mark Meesters – Manager Support Services Mark worked as a regulatory affairs manager in the chemical industry for seven years before joining ReachCentrum in 2007. His main responsibilities include product safety, compliance with chemicals legislation and preparation for REACH. He is a chemist and lawyer by training. He joined ReachCentrum to head the consortia management services, and is responsible for managing consortia and coordinating the activities of the ReachCentrum consortia managers. Vincenzo Girardi – Head of REACH Training and Workshops Vincenzo has more than 20 years’ experience as a professional trainer, with experience in the information technology, consumer goods, banking and pharmaceutical industries. As a trainer, and certified online learning facilitator he has advised on, managed and delivered numerous training projects. At ReachCentrum his role is to develop and deliver training workshops and webinars on all REACH IT tools as they are released to industry. He is a member of the Learning and Performance Institute. Vincent Navez – Senior Legal Advisor After studying European and economic law in Belgium, Vincent had six years practical experience as legal advisor at the European Consumer Centre in Barcelona, working for the European Commission ECC-network. He joined ReachCentrum to deal with REACH legal interpretation and implementation and to give legal advice and guidance, as for example on data sharing, consortia formation, the authorisation process or the legal remedies.

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PROFILE: ReachCentrum

2011


SERVICE AREA BREAKDOWN Training 5% Legal 20%

Consultancy/ advisory 30%

PROFILE: REACHLaw

CONTACTS Website

www.reachlaw.fi

E-mail

sales@reachlaw.fi

Head office

Keilaranta 15, 02150 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

Helsinki, Brussels, New Delhi and Istanbul

 

Mr Frederik Johanson, Head of Environmental ServicesPartner

SERVICES PROVIDED

 

Mr Jouni Honkavaara, CFO-Partner

IT & software 5% Laboratory 10% Information 5%

GLOBAL OFFICES

Mr Riku Rinta-Jouppi, Head of Global Compliance Partner Mr Stephen van Heerden, Sales Director Dr Ying Zhu, COO - Partner Private company

Locations

Finland, Belgium, India, Turkey

Founded

2006

REACH authorisation services

OVERVIEW REACHLaw provides service solutions to companies and public organisations in the fields of compliance and sustainability globally. Combining the know-how of complex technical issues, legislation and business, we support our customers in managing the critical challenges that global regulations place on their business. Besides facilitating companies in meeting their business requirements, we also assist them in understanding the opportunities associated with environmental regulatory issues to gain a competitive advantage. In addition to our in-house expertise, we have local partners in Europe, Asia, USA and Latin America to ensure that our clients get access to specialised competencies and local market knowledge. Having a multicultural team, REACHLaw is able to serve its clients in the following languages: English, Finnish, French, German, Spanish, Swedish, Chinese, Hindi, Russian and Turkish. VITAL STATISTICS

2010/11

Turnover, group

€10.8m

Turnover, chemical service provision

€10.1m

No of offices

4

No of countries represented

40+

Staff, group

30+

Staff, chemical service provision

25+

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REACH and CLP services With our interdisciplinary team of experts we support businesses as their service provider or as their only representative in fulfilling the REACH requirements. We manage consortia, lead registrant projects and regular registrations. In addition, we assist companies with the most complex REACH processes such as authorisation, exemptions and various legal issues, always from customer´s business perspective. Furthermore, we aid our customers in accomplishing the requirements of the CLP regulation: notification, classification and labelling.

Dr Mathias Berner, Partner

Ownership

Representation & management 25%

Authorisation is one of the most complex challenges for companies under REACH. Regardless of successful registration, substances of very high concern included in Annex XIV of REACH may in principle no longer be used after the sunset date, unless the manufacturer, importer or downstream user has obtained an authorisation for specific uses from the European Commission. The first deadline to submit applications for authorisation is 21 February 2013. REACHLaw offers a full set of services to help companies comply with the authorisation provisions, notably: preparation of authorisation dossier, participation in consortia, representation following submission of application and authorisation exemption studies. Global compliance services For those companies operating globally or with the intention of going international, we assist them in monitoring and keeping up-to-date with the upcoming changes in the regulations and performing the required notifications and registrations outside the EU. Through our in-house expertise and local partners around the world, we are able to support companies ensuring compliance worldwide. Furthermore, we also provide compliant SDSs and legal consulting, according to the market requirements in question. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 2006

Established in Helsinki

2008

Partnerships with 20+ local partners in Asia, Europe, Latin America, USA and India were established. 3000+ REACH pre-registrations submitted

2009

REACHLaw received internationalisation award from the president of Finland. Customers in 40+ countries. Brussels and New Delhi offices opened. REACHLaw established REACHLaw Environmental Ltd. REACHLaw delivered more than 50 events globally, having 1500+ attendees in total

2010

300+ REACH registrations submitted. REACHLaw launched global compliance services outside the EU. The attendees to our events increased considerably reaching the amount of 2500+

Chemical Watch | Global Service Providers Guide 2012


2012

Istanbul office opened. REACHLaw supported large companies to ensure compliance with global chemical regulations. Supporting 20+ REACH lead registrant cases. Increasing the number of full service customers to ensure compliance in REACH and other chemical regulations globally

ACCREDITATIONS Internationalisation award from the president of Finland in 2009. AAA financial rating in 2010. Innovative - Growth sustainable company by Europe Innova in 2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011. Young Innovative Growth Company Programme by TEKES completed in 2012. PARTNERS Selected partners: Chemtopia, ChemRisk, Cleantech, Chemitox, Dynamic Orbits, Mourao Henrique Consultores Associados, Chamber of Chemical and Petrochemical Industry of Argentina – CIQyP. CLIENTS More than 200 customers from 40+ countries, from Fortune 100 companies to SMEs. Major industry sectors served: oil, chemicals, specialty chemicals and metals. Our customers are manufacturers, importers, traders, downstream users, retailers and governmental organisations. TESTIMONIALS “Over the years REACHLaw has advised OMG on several strategic REACH and CLP issues and in the planning of our 2010 registrations. For one substance REACHLaw managed the whole lead registrant registration process in 2010. We are very pleased with REACHLaw service” – Dr Thomas Slotte, OMG Kokkola Chemicals Ltd. “REACHLaw has performed a regulatory compliance programme for our organisation. We chose them because they have a very good understanding of our business processes as well as regulatory and organisational knowledge in our sector of chemicals and minerals distribution and trading. With REACHLaw´s assistance we have made the necessary changes to the AIN organisation to cope with the regulatory challenges of today. We are very satisfied with REACHLaw service.” – Dr Franck Thiebault, Quality and Regulatory Manager Chemicals and Minerals at CellMark (Alcan International Network). “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 – supply chain risks The European space industry is strongly impacted by the REACH Regulation, especially in its role as downstream user and supplier of complex articles. The main risks associated with REACH for the space industry are posed by unregistered chemicals and obsolescence of critical raw materials due to their identification as SVHC. REACHLaw has been assisting the European space industry with the following issues: OO performance of dedicated analysis of compliance risks and their management and of potential obligations of different actors involved in European space programmes OO substance and use-specific assessments of potential REACH obligations (registration, authorisation etc) OO continuous update on relevant REACH and CLP developments, notably SVHC and authorisation.

Chemical Watch | Global Service Providers Guide 2012

CASE STUDY 2: Lead registrant registration REACHLaw was contacted by a client to support them as a service provider in a lead registrant case. Our client, acting as importer under REACH, wanted to register the substance in 2010. In order to complete the registration it was decided to form a lead registrant group with some of the other major importers of the substance. REACHLaw facilitated in this process, including performing all the legal formalities and management of the leadership group. REACHLaw conducted all the technical work, negotiations with other consortia for read-across data and the planning of testing. The lead registrant dossier was successfully submitted to ECHA. REACHLaw also submitted the individual dossiers for many of the members of the leadership group STAFF SELECTION Mr Riku Rinta-Jouppi, MA (Law), MSc, Head of Global Compliance – Partner Graduate of Cambridge university. He is broadly recognised as one of the leading European legal experts in chemicals regulations. In addition to his legal qualifications he holds a masters degree in bio-information technology. Mr Rinta-Jouppi is responsible for REACHLaw global compliance services. Mr Tim Becker, MA (Law) – EU Compliance Officer Mr Becker is a German-qualified lawyer. He has been acting as legal adviser at REACHLaw since 2008. He has also worked previously with ECHA in its guidance team. His main responsibilities in the company include REACH and CLP legal and regulatory expert advice, risk communication and compliance issue management. Since 2011 he has been responsible for advising the European space industry on the impact of REACH on the continuation of launcher and satellite programmes. Mr Becker is strongly specialised in cross-border issues with nonEU countries and the determination of exemptions from the REACH registration and authorisation requirements. Dr Kati Vaajasaari, PhD (Technology) – Project Director Dr Vaajasaari is working as a leader in REACH lead registrant projects for REACHLaw. Her responsibilities include project management and technical expertise in chemical safety assessment. She specialises in environmental fate, pathways of substances, environmental exposure assessment and risk characterisation of chemicals and products. She has several years’ experience in these fields. Mrs Jaana Laitinen, MSc (Environmental Sciences) – Specialist in Chemical Risk Assessment Mrs Laitinen specialises in environmental exposure assessment and ecotoxicology. She has several years of experience in risk assessment of chemicals, veterinary medical products and contaminated sites. Her responsibilities include technical expertise in qualitative and quantitative exposure assessment and risk assessment. Mrs Mia Blåfield, MSc (Toxicology) – Toxicologist She is working as a toxicologist for REACHLaw. Her responsibilities include evaluation of human health hazard of chemicals and human exposure and risk assessment of chemicals. She has several years of experience of working in the field of regulatory toxicology. Ms Sini Suomela, MSc (Organic Chemistry) – Technical Project Manager Ms Suomela is responsible for the REACH member registrant projects. She has an extensive knowledge of different kinds of REACH registrations. She has experience in the physicochemical part of the lead registrant projects. She has also taken care of many REACH inquiries and CLP notifications.

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PROFILE: REACHLaw

2011


SERVICE AREA BREAKDOWN

PROFILE: Risk & Policy Analysts (RPA)

Training 5%

CONTACTS Website

www.rpaltd.co.uk

E-mail

post@rpaltd.co.uk

Head office

1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK

Tel

+44 1508 528465

GLOBAL OFFICES

Fax

+44 1508 520758

UK

Contact

Nigel Tuffnell

Directors

Pete Floyd

 

Meg Postle

Ownership

Private

Locations

UK

Founded

1990

Consultancy/ advisory 95%

SERVICES PROVIDED REACH – authorisations RPA assists industry clients with the development of applications for authorisation under REACH which will be submitted to ECHA from 2013. These studies can involve detailed analyses of supply chains, of alternatives and the preparation of socio-economic analyses. REACH – restrictions

OVERVIEW Risk & Policy Analysts Ltd (RPA) was established in 1990 as an independent specialist consultancy. Over the past 20 years, RPA has gained extensive experience in chemicals policy, risk assessment and risk management. This work has included the development and application of quantitative and qualitative methodologies for assessing health and environmental impacts. RPA is particularly proud of its development and application of frameworks and techniques in the field of socio-economic analysis (SEA) to chemical risk management and its reputation for excellence in this area. RPA has been working with industry clients since 2001 on the implications of the new EU regime for chemical risk management. We also work closely with the European Commission and ECHA on the development and implementation of REACH and of 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 chemicals etc and this has resulted in detailed studies on more than 50 high profile chemicals. Although much of this experience was gained when preparing risk reduction strategies under the Existing Substances Regulation, we are now advising a range of industry organisations on how to respond to the threat of REACH Authorisation and on the scope and detail of the SEAs needed to justify continued use of a substance. RPA’s multi-national staff routinely undertakes detailed analysis and consultation with industry and regulators in most European languages. VITAL STATISTICS

2010/11

Turnover, group

£1.4m

Turnover, chemical service provision

£0.8m

No of offices No of countries represented

2 Focus on EU-27

Staff, group

22

Staff, chemical service provision

10

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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 socio-economic analyses which may be used to inform the development of a restrictions dossier. REACH – registration/compliance RPA provides advice on all aspects of REACH compliance to companies of all sizes throughout the supply chain. Regulations and impact assessment RPA advises industry clients and regulators on the (potential) impacts of regulations and regulatory change. Recent examples include work on mercury legislation, occupational exposure limits, nanomaterials, CLP, carcinogens and mutagens at work, Cosmetics Regulation, Biocidal Products Directive and the Water Framework Directive. CORPORATE DEVELOPMENTS & ACHIEVEMENTS 1992

RPA develops a risk-benefit analysis methodology for chemical risk management for the UK authorities

1996

First (of more than 40) projects for the European Commission on chemical risk management.

1998

RPA wins its first major framework contract for the UK authorities on chemical risk management which led to the preparation of numerous risk reduction strategies

2000

OECD publishes guidance documents on socio-economic analysis (SEA) and chemical risk management prepared by RPA

2001

RPA commences work with industry clients and with the European Commission to assess the potential costs and benefits of the then EU Chemicals Strategy which became the REACH Regulation

2004

RPA wins its first major framework contract for the European Commission on chemicals

2005

RPA starts work on several REACH implementation projects including leading RIP 3.9 on socio-economic analysis (SEA)

2008

RPA is a member of one of the consortia for the European Chemicals Agency (ECHA) REACH framework contract

2009

RPA first contracted by industry clients to support applications for authorisation under REACH with a focus on SEA work. Further contracts follow.

2011

RPA leads one of the consortia for the second ECHA REACH framework contract Chemical Watch | Global Service Providers Guide 2012


STAFF SELECTION

RPA works with DHI, TNO, RIVM, FoBiG, ARCHE, Hydrotox, Royal Haskoning and Denehurst amongst others.

Meg Postle – Director

CLIENTS OO

OO

OO OO

OO

European Commission (including DG Enterprise, DG Environment, DG Employment and DG Sanco) national authorities (including those in the UK, Germany, Denmark, France and the Netherlands) ECHA numerous European/international industry/trade associations (including AISE, APEAL, CEFIC, COLIPA, ETINSA, Eurocommerce, Eurometaux, ICMM, International Zinc Association, Lead Development Association, Nickel Institute and UKWIR); and a range of companies (from multinationals to SMEs) and consortia.

CASE STUDY 1: Provision of analysis of alternative and socioeconomic analysis support services Risk & Policy Analysts Ltd 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 update the chemical safety assessment and to provide additional interpretation of toxicological data for both the substance and the alternatives. RPA will help the consortium submit an Application for Authorisation in advance of the sunset date for the substance. CASE STUDY 2: Assessing the health and environmental impacts in the context of socio-economic analysis (SEA) under REACH Risk & Policy Analysts Ltd led this DG Environment study, which was also overseen by ECHA. The objective of the study was to provide scientific, economic and technical advice concerning regulatory decisions within the framework of REACH authorisations and restrictions. The key output of the study was the Logic Framework, which was developed to primarily support the ECHA guidance on preparing SEAs for REACH. The aim was not to reinvent a new approach but rather to provide further, more detailed insight into how particular aspects of the overall SEA process for restrictions and authorisation might be addressed. The full report was published by DG Environment in July 2011. CASE STUDY 3: Annex XV Dossier for Hydrazine Risk & Policy Analysts (RPA) was contracted by ECHA to collect and provide background information on the markets, uses, releases of and alternatives for hydrazine with the aim to support the development of an Annex XV 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 2012

Meg is an environmental economist and policy analyst with more than 20 years’ experience of consultancy. She has led RPA’s work for the European Commission, the UK Government and a range of industry bodies: on business, health and environmental impact assessments of REACH; and, on the direct and indirect impacts of proposed restrictions and other controls on the use of hazardous chemicals within the EU. She led the project for DG Environment on the development of Logic Framework for socio-economic analysis (SEA) under REACH and has conducted training on SEA to both RAC and SEAC members of ECHA. More generally, she is overseeing preparation of SEAs to support authorisation applications for a range of industry clients. Dr Peter Floyd – Director Risk assessment expert with more than 25 years of 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. Phil Holmes – Technical Director, Chemical Science Phil Holmes is a technical director at RPA with more than 30 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 Institute of Biology/ British Toxicology Society/EUROTOX. Dr Jan Vernon – Technical Director, EU Policy Jan Vernon has worked on the impacts of environmental, health and safety policy for more than 25 years. She has managed studies for the European Commission, UK government and international industry associations on a wide range of national and EU environment and safety policies covering chemicals, biocides and consumer products as well as the marine environment and water quality. Panos Zarogiannis – Principal Consultant Chemist with extensive experience of developing risk reduction strategies for several chemical substances under the Existing Substances Regulation as well as numerous SEA-related studies and in the development of TGDs for REACH. He has managed several studies in support of the development of Annex XV dossiers by ECHA and is now working for several major industrial clients on the development of authorisation dossiers Nigel Tuffnell – Senior Consultant Nigel has been involved in the assessment of EU and UK chemicals legislation and associated guidance in studies for EU and UK governmental bodies and for industry. He has particular knowledge of the application of REACH, CLP, biocides and pesticides legislation to support industry clients. His experience includes projects to assess the impacts and guidance following the introduction of REACH and CLP, the usage patterns of amenity pesticides and REACH reporting requirements. He has also been actively involved in studies on the impacts of the Biocidal Products Directive (BPD) and its proposed amendments and the impacts of the Cosmetics Regulation.

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PROFILE: Risk & Policy Analysts (RPA)

PARTNERS


GLOBAL OFFICES

PROFILE: Royal Haskoning

CONTACTS

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

Website

www.royalhaskoning.com/processandchemicalindustry

E-mail

chemicalsmanagement@environment.royalhaskoning.com

Head office

Haskoning Nederland BV, PO Box 151 – 6500 AD Nijmegen, Netherlands

SERVICES PROVIDED

Tel

+31 (0)243 284135

Fax

+31 (0)243 228170

Contact

Mr Christiaan van Daalen/ Mr Tjeerd Bokhout

Directors

Mr Rob Schonk, Director Process and Chemical Industry

Ownership

Private company

Locations

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

Royal Haskoning provides a full range of REACH services, varying from consortium management to preparation of the technical dossier and the chemical safety report. Royal Haskoning experts prepare and submit both lead and individual registration dossiers and support clients with both their REACH strategy and day-to-day practical questions. Although Royal Haskoning does not provide laboratory services, it provides support in laboratory selection and study monitoring.

Founded

1881

REACH

REACH driven engineering

OVERVIEW The firm was founded in 1881 in the Netherlands. At present our 3,900 employees combine a wide range of knowledge and experience. Rooted in a technical background, our consulting services focus on the broad field of the interaction between people and their environment. We are committed to working enthusiastically with our clients to achieve sustainable solutions in an increasingly complex society. The expertise and experience of our professionals in a variety of disciplines allows us to consider all technical, logistical, legal, organisational, social, environmental and economic aspects of the projects of our clients, in order to subsequently develop sustainable and practical solutions. We have been working with the industry on chemicals management for several decades and contributed to the implementation of many legislative programmes. VITAL STATISTICS

2010/2011

Turnover, group

€335m

Turnover, chemical service provision

-

No of offices

57

No of countries represented

17

Staff, group

3,900

Staff, chemical service provision

60

SERVICE AREA BREAKDOWN Legal 5% IT & software 5% Laboratory 2% Information 15% Representation & management 15%

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As a result of REACH the risk management measures of both manufacturers and downstream users may be affected due to the changed insights in hazards and risks arising from the use of their products. Royal Haskoning provides a unique combination of knowledge on chemicals management and engineering to deliver lean and mean organisational and technical solutions. GHS/CLP Royal Haskoning can assist you with services varying from technical support to total solutions for implementation of GHS. The services include, but are not limited to: regulatory consultancy and compliance checks, GHS/CLP implementation, CLP notification, (re-)classification of substances and mixtures, training on GHS/CLP. Safety data sheets Royal Haskoning provides a full safety data sheet service including the preparation of the annex of the extended SDS (eSDS). Storage of chemicals and (external) safety Royal Haskoning can assist you with assessing, designing and permitting of storage facilities for hazardous chemicals, modelling of external safety (SEVESO) and assessing aspects such as explosion safety (ATEX). Other services Royal Haskoning provides a wide range of services that provide solutions for multidisciplinary challenges to industry, such as engineering/design of installations and buildings, responsible care and environmental impact assessments. To find out more, visit: www.royalhaskoning.com CORPORATE DEVELOPMENTS & ACHIEVEMENTS

Training 8%

Consultancy/ advisory 50%

1881

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

1981

Haskoning is granted the designation 'koninklijk' (Royal) at its 100th birthday.

1991

EaSI is developed by Royal Haskoning: a database with hazard information from legislation all over the world

1994

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

2005

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

2007

Royal Haskoning joins the organisation of ChemCon Conferences

2011

130th birthday

Chemical Watch | Global Service Providers Guide 2012


ISO 9001 ISO 14001 OHSAS 18001 PARTNERS ChemCon Conferences CLIENTS The clients of Royal Haskoning are located in many different industries. Because Royal Haskoning provides many more services than chemicals management alone, it has service relations with clients covering a wide variety of solutions. Clients are, for example, in pharma, flavours and fragrances, plastics, petrochemicals, paints and coatings, minerals and metals. CASE STUDY 1: Optimal use of alternative methods to reduce animal testing and costs. A group of manufacturers and importers of natural complex substances cooperated with Royal Haskoning to prepare a series of REACH Registration dossiers for related substances. For the preparation of dossiers for these specific substances all parties committed to the optimal use of alternative methods to testing. Royal Haskoning created a category of the substances and used information on both the substances and their many constituents to complete the technical dossiers. To cover the data gaps, QSARs were applied for several physico-chemical and ecotoxicological properties and RH provided guidance on in-house testing to efficiently generate adequate data for physico-chemical properties. The exposure assessment and risk characterisation were performed by using CHESAR and applying higher tier modelling like the advanced REACH tool (ART) for worker exposure and the higher tier possibilities EUSES offers to reduce the estimated releases to the environment and to achieve realistic maximum use levels on a site. This approach allows the industry to remain flexible within its current operational environment. CASE STUDY 2: Tailor-made interim risk management measures To a consortium on inorganic substances with registration deadlines in 2010 little information was available on repeated dose toxicity and developmental toxicity. To save costs and time the Annex VIII studies were waived and higher tier tests were proposed. Until these higher tier tests can be conducted interim risk management measures (RMMs) had to be implemented. An alternate derived no effect level (DNEL) for the substances was established using an expert insight in existing occupational exposure limits (OEL) for surrogate substances. Where the Chesar exposure assessment led to rigorous RMMs, or incompliance, we used experts tools, eg higher tier modelling using ART and Consexpo. We also devised an occupational exposure measurement program to be able to compare safe levels of use with the actual industry situation and reduce uncertainties. This approach enabled us to generate a realistic exposure assessment with a minimal set of RMMs.

Mrs Dr Ingrid Sterenborg – Senior Expert Toxicology Ingrid Sterenborg studied environmental hygiene and obtained her PhD degree on the physiological mechanism of metal tolerance in springtails, she started her career in environmental consulting, with particular expertise in regulatory toxicology. In 2011 Ingrid will complete her post-doctoral education to become a EUROTOX registered toxicologist. She prepared several dossiers for biocidal and plant protection products as well as REACH dossiers and prepared data gap analyses, proposed testing strategies and prepared expert statements for several toxicological endpoints. Ms Conny Hoekzema Msc – GHS/CLP and SDS Expert Conny Hoekzema has five years’ experience in the field of chemicals management. She has extensive knowledge and experience in safety data sheets and classification and labelling. Furthermore, she is closely involved in the preparation of REACH registration dossiers and chemical safety reports, both with a focus on the environment. She is an experienced trainer who provides training courses on IUCLID5, safety data sheets and classification and labelling for a variety of audiences. Mr Tjeerd Bokhout, MSc MBA – Consortium Manager Tjeerd Bokhout is an experienced consultant and project manager on environmental and chemicals management projects in Europe and abroad (mainly Asia). Tjeerd holds both an MSc and MBA and has a strong focus on the business case of his clients. Tjeerd has a vast network in the global community on chemicals legislations. He has experience in the support of chemical industry and governmental bodies with requirements of REACH. Tjeerd manages several REACH consortia and provides strategic advice on REACH implementation. Tjeerd is also active as director of ChemCon Conferences, the world’s leading conference on chemical control legislation and trade aspects. Mr Leo van der Biessen Msc – Senior Expert Occupational Exposure Leo van der Biessen has more than 20 years’ practical experience in controlling and managing chemical exposure risk in the chemical process industry and its downstream users. In 1990 he joined a leading health and safety service provider in the Netherlands where he devised chemical risk assessment and control strategies as well as worker protection regimes. He joined Royal Haskoning in September 2002. Leo is a board member for chemical safety of the Dutch Industrial Hygiene Association. Mr Christiaan van Daalen Msc – Project Manager Christiaan van Daalen is trained as an environmental scientist, specialising in both regulatory toxicology and business communication with a focus on REACH. He has been involved in the production of several large dossiers under REACH and advises on various REACH implementation processes. Beside the preparation of technical dossiers Christiaan acts as project manager in many REACH registration projects for individual companies and consortia and he is teamleader of the advisory group in Nijmegen.

STAFF SELECTION Mrs Froukje Balk Msc – Senior Expert Ecotoxicology Froukje Balk is a biologist by training and a EUROTOX registered toxicologist specialising in ecotoxicology and environmental fate and behaviour of chemicals with more than 25 years of experience, including seven years in the laboratory. She is involved in the risk assessment (both effects and exposure) of chemical substances, mainly related to the European chemicals legislation on existing chemicals and biocides.

Chemical Watch | Global Service Providers Guide 2012

Page 127

PROFILE: Royal Haskoning

ACCREDITATIONS


SERVICES PROVIDED Registration of chemicals – REACH

PROFILE: SCC

CONTACTS Website

www.scc-gmbh.de

E-mail

scc@scc-gmbh.de

Head office

Am Grenzgraben 11, 55545 Bad Kreuznach, Germany

Tel

+49 671 298 46-0

Fax

+49 671 298 46-100

Contact

Dr Werner Koehl (Chemicals, REACH, Consumer Products)

Directors

Dr Friedbert Pistel, Owner and President Dr Albrecht Heidemann (Agrochemicals and Biopesticides)

 

Dr Monika Hofer (Regulatory Science)

 

Dr Hans-Josef Leusch (Biocides)

 

Dr Werner Koehl (Chemicals, REACH, Consumer Products) Ruud Huibers MSc (Feed and Food Additives and Veterinary Medicine)

Ownership

Private company

Locations

Germany and Japan

Founded

1989

Registration of consumer products

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

2010

Turnover, group

-

Turnover, chemical service provision

-

No of offices

2

No of countries represented

2

Staff, group

90

Staff, chemical service provision

45

SERVICE AREA BREAKDOWN

Representation & management 18%

SCC has the experience to deal with all relevant scientific and regulatory aspects that may arise for general and overall evaluation of materials or chemicals for intended applications, and has prepared risk assessments for given exposure (direct or indirect) scenarios. We have successfully made numerous dossier preparations for various cosmetic ingredients, eg hair dyes or CMR Cat 3 substances for evaluation by European expert groups (SCP, SCNFP), and on cleansing ingredients or formulations for industry associations, such as HERA. Registration of agrochemicals and biopesticides The SCC agrochemicals and biopesticides department considers current and future regulatory and legislative needs and developments in the common agricultural policy of the EU, and stays up-to-date on the latest scientific research data. For this reason, the agrochemicals and biopesticides department is at the forefront in strategic planning and defence, negotiations with authorities, or task force support. Registration of biocides

IT & software 2% Information 10%

Consultancy/ advisory 70%

GLOBAL OFFICES Bad Kreuznach in Germany (HQ) and Tokyo in Japan

Page 128

SCC has prepared hundreds of chemical notifications for new chemical substances (including high volume products of more than 1000 t/a) and successfully filed over 100 lead dossiers for the 2010 deadline under REACH. SCC has established a network to the competent authorities within the entire EU and is recognised as a reliable and competent partner by the authorities (eg ECHA) and EU industry organisations (eg Cefic or HERA). SCC can provide you with: OO only representative support OO support in the (pre-) registration process OO support in prioritisation/advice on required action in your company for the upcoming deadlines OO data review and identification of data gaps OO establishment of study requirements as well as organising and monitoring of those studies OO analysis of potential analogous/family approaches and development of test strategies OO comparison of intended uses and identified uses 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/defense of the dossier at authority level OO Sief and consortia management including trust account OO C&L support (CLH dossier according to Annex XV, eSDS including Annex) OO QSAR tools, eg to support group approaches

The SCC biocides department has successfully submitted dossiers for more than 20 existing biocidal active substances according to the Biocidal Products Directive 98/8/EC, covering nearly all product types. We have established good working relationships with many competent authorities in the EU and have become an acknowledged partner of authorities and industry. Currently, we are involved twofold: defending active substance dossiers already submitted and preparing dossiers for biocidal products. Registration of feed and food additives and veterinary medicine The SCC feed and food additives and veterinary medicine department successfully delivered 36 application dossiers for re-authorisation as a feed additive for the 2010 deadline, which is about 10% of all dossiers filed. Our expertise and connections with governments 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.

Chemical Watch | Global Service Providers Guide 2012


Regulatory science

Isabel Kirbach

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.

Mrs Kirbach has a master’s degree in chemical engineering. She has worked at SCC for eight years and her focus is on Sief and IUCLID 5.

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

Dr Krone has a PhD in geosciences. She has worked at SCC for five years, where she focuses on general regulatory affairs and consortia management. Also, she is coordinator of all chemical issues involving our Liaison Office in Tokyo, Japan. Dr Ingo Walter Dr Walter has a PhD in food chemistry. He has worked at SCC for four years, focusing on risk assessments, C&L and MSDSs. Dr Albrecht Heidemann Dr Heidemann has a PhD in biology. He has been with SCC for 18 years and is head of the Agrochemicals and Biopecticides department.

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

Dr Hofer has a PhD in chemistry. She has been with SCC for 13 years and is head of the Regulatory Science department.

2000

Establishment of Biocides department

Dr Hans-Josef Leusch – Head of Biocides Department

2004

GLP archive certification

2007

Establishment of Liaison Office in Tokyo, Japan

Dr Leusch has a PhD in agronomy. He has been with SCC for 12 years and is head of the Biocides department.

2007

Establishment of Feed and Food Additives and Veterinary Medicine department

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.

Dr Monika Hofer

Ruud Huibers MSc – Head of Feed and Food Additives, Veterinary Medicine Department Mr Huibers has a master’s degree in agriculture and natural environment. He has worked at SCC for five years and is head of the Feed and Food Additives and Veterinary Medicine department. Dr Bernd Brielbeck – GLP Archive Dr Brielbeck has a PhD in chemistry. He has worked at SCC for 11 years 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. CASE STUDY 1: General remark All names of our clients and projects are restricted under the highest level of confidentiality. Therefore we are unable to focus on individual case studies. Our consultancy has an excellent proven track record in all regulatory areas where we are active. Only one proof of our success is the fact that in the two decades of our existence, we have grown from a small national business to become a global player. STAFF SELECTION Dr Werner Koehl – Head of the Chemicals, REACH, Consumer Products Department Dr Koehl has a PhD in food chemistry and is a certified expert for toxicology. He has worked at SCC for 11 years and is head of the Chemicals, REACH, Consumer Products 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.

Chemical Watch | Global Service Providers Guide 2012

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PROFILE: SCC

GLP archive

Dr Charlotte Krone


SERVICES PROVIDED Regulatory compliance OO

OO

PROFILE: Science & Environnement

CONTACTS

OO

Website

www.sci-env.ch

E-mail

saouter.e@sci-env.ch

Head office

22 route Pré-Bois, CP 1863, CH - 1215 Genève 15, Switzerland

Tel

+41 (0)22 788 2314

Fax

+41 (0)22 788 2316

Contact

Dr Erwan Saouter

OO OO

REACH: data collection, analysis and submission to ECHA via REACH-IT. REACH registration dossiers (IUCLID), chemical safety reports (CSR), safety sata sheets, Chesar, exposure scenario etc. biocide classification and labelling: notification C&L, classification of substance and mixtures according to CLP, GHS UN, DSD, DPD ecolabels registration dossiers (China, US ...)

Regulatory information OO OO OO OO

Dr Chiara Perazzolo OO

literature review, study assessment and validation model prediction and QSAR organise and follow-up of laboratory testing extended-safety data sheet (e-SDS) drafting, update and regulatory audit global product strategy (GPS) summary and (eco)toxicological profile

Directors

Dr Erwan Saouter, Director S&E

 

Dr Christine Reteuna, Director EquiTox

 

S&E and EquiTox have been associates since 01.2012

Ownership

Private company and SCOP

OO

Locations

Geneva, Switzerland; Lyon, France

Impact assessment and eco-design

Founded

2007, 2011

OO

Product advocacy and project management OO OO

OVERVIEW

OO

Science & Environnement and EquiTox offer many areas of expertise, which linked together, provide a global and comprehensive approach to worldwide chemical safety regulation and sustainability. From chemical safety and regulatory affairs, life cycle assessment, carbon footprint, eco-design or ecolabel: we offer to companies and organisations a wealth of expertise. Science & Environnement and EquiTox have joined forces in a strong association in order to reinforce their chemical safety offers. It is now 6 highly qualified experts, with each from 10 to 20 years of experience working in human, environmental and regulatory affairs department of big international chemical companies. We can now take care of your regulatory needs worldwide, from Europe to US and Canada, but also for China.

OO OO

product defence strategy animation and technical representation in consortia communication strategy environmental risk assessment (cosmetics, industrial chemical, biocides etc) human health safety assessment (cosmetics, industrial chemical, biocides etc) life cycle analysis (LCA) support in the development and eco-design of new products

Training OO

OO

OO OO OO

risk assessment, classification, eco(toxicology) and physico-chemical testing methods REACH regulation (hazard and risk assessment, CSR, eSDS, exposure scenario) CLP regulation and GHS (hazard, classification, labelling) eco-design, eco-toxicity, eco-label theory and practice life cycle assessment

CORPORATE DEVELOPMENTS & ACHIEVEMENTS

2010/11

2008

Science & Environnement founded

Turnover, group

€650k

2011

Approved as REACH Ready Supplier

Turnover, chemical service provision

€360k

2012

Association with EquiTox

VITAL STATISTICS

No of offices

2

No of countries represented

2

Staff, group

9

Staff, chemical service provision

6

SERVICE AREA BREAKDOWN

Bibra, ToxMinds, Sci Basics, Maneco CLIENTS

Information 10%

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REACH Ready approved supplier European registered toxicologists (EUROTOX) Member of the French Society of Toxicology (SFT) Member of the Society of Environmental Toxicology and Chemistry (SETAC) PARTNERS

Training 10% IT & software 5%

Representation & management 10%

ACCREDITATIONS

L’Oréal, Les Laboratoires Expansciences, Procter & Gamble, Nestlé, Ville de Genève, Jungbunzlauer, Septodont Consultancy/ advisory 65%

CASE STUDY 1: REACH registration dossier compliance check Science & Environnement responded to a demand to evaluate the quality of data and to check the compliance of dozens of REACH registration dossiers for chemicals used in the chemical and cosmetic industry.

Chemical Watch | Global Service Providers Guide 2012


CASE STUDY 2: Trustee in a Sief

Stéphanie Moulin – Regulatory Toxicologist – EquiTox

Science & Environnement has been asked to play the role of a trustee in a Sief to help several parties to agree on data share. We reviewed information from the different parties and decided whether the substances and/or exposure scenarios were close enough to allow data share, while maintaining the confidentially of all the different parties.

Stéphanie has ten years of professional experience as a toxicologist in regulatory affairs in chemical industry at Rhodia. She also worked at CNRS and as a teacher. Her expertise covers areas like: selection and qualification of CROs, hazard and risk assessment for human health, products’ registration strategies in Europe and in other zones, and advocating for products.

CASE STUDY 3: Integrated environmental risk assessment

PROFILE: Science & Environnement

Science & Environnement was approached to evaluate the environmental risk of several dozens of substances used in production sites spread all across Europe. A tailor-made risk assessment scaling tool was developed for EHS (environmental health and safety) managers to perform their environmental compliance check with the ES (exposure scenario) of the eSDS. A full-day training workshop intended to EHS managers on eSDS interpretation was also given by Science & Environnement. STAFF SELECTION Dr Erwan Saouter – Regulatory Ecotoxicologist and Director of S&E Founder of the S&E company, Erwan Saouter has more than 20 years of professional experience with private companies (Procter & Gamble), public research organisations (US Agency for Environmental Protection, Institut National de la Recherche Scientifique Quebec). His expertise covers many areas: risk assessment, communication science, sustainable development and stakeholders dialogue, scientific public relations, and relations with the media and governments. Dr Chiara Perazzolo – Regulatory ecotoxicologist – S&E Chiara Perazzolo accumulated 11 years of experience in both industrial (GlaxoSmithKline) and academic (University of California, U.S.A., University of Geneva and Lausanne, Switzerland) research. In charge of REACH dossiers, she evaluates IUCLID data and prepares IUCLID robust summaries, CSA/CSR. Dr Benoit Fraysse – Regulatory Ecotoxicologist – EquiTox Regulatory eco-Toxicologist with more than ten years of experience including, six years within Rhodia. After his PhD at the French Nuclear Safety Institute, Benoit developed his expertise with three years in postgraduate positions, mixing teaching in higher education and research (French institutes and universities). Benoit’s fields of expertise are related to the combined analysis of hazardous properties of chemicals, ie phys-chem, environment and health, based on both experimental and in silico (QSARs) tools, keeping in mind the regulatory goals (SDS, classification risk assessment…). Dr Christine Reteuna – Regulatory Ecotoxicologist – Director of EquiTox Following her PhD in environmental toxicology, Christine began her career in the Ministry of Environment, in the registration of chemicals. She then moved to industry where she assisted different business like consumers market (cosmetics, detergency) and industrial markets (metal treatment, oil market) to solve environmental problems on a variety of products. She realised many regulatory dossiers in Europe and in other geographic zones and she participated to the knowledge improvement of chemical substances properties through data search, tests monitoring, development of