Global Service Providers Guide 2013

Transcription

Global Service Providers
Guide 2013
A guide to chemicals
management and
control services
sponsored by
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Chemical Watch | Global Service Providers Guide 2013
Foreword
I’m very pleased to welcome you to Chemical Watch’s
third annual service providers guide and directory. When
we launched this publication series, we were responding
to our readers who wanted information about the service
providers out there, who they are, what they do and also
some context in terms of the overall market and what
everyone else is saying and doing. This combination
of intelligence has proved to be a winning formula with
copies of our guide going like hot cakes at conference and
exhibitions.
Continuing to respond to reader feedback, in this third
edition we have split our survey of opinions into three
separate surveys in order to improve response rate still
further – to over 1,300 respondents – and get a grainier
picture.
A star feature is our first review of the jobs market,
including a survey to find out how much various personnel
in chemicals regulatory compliance and related service
industries actually earn, and to see how satisfied they are
with their jobs! Can you afford not to take a look?
In addition, we provide a first in-depth article written
by our author Cynthia Challener examining the policies
and politics concerning chemicals regulation and risk
management in the US. And, of course, we bring you the
findings of our annual survey, looking at the drivers, issues
and progress with regulatory compliance, looking at what
service providers and their clients dealt with in 2012 and
their predictions for 2013.
We are also continuously improving the directory
section of the guide to ensure it provides companies with a
quick and unbiased review of the different services offered
by each provider to save them time and money, and give
them a robust selection of firms to choose from to meet
their compliance needs.
We hope you enjoy reading our longer-than-ever guide
and look forward to your feedback for next year.
Mamta Patel
Editor
Page 1
We offer our congratulations to the
2012 Environmental Law Institute Honoree:
A scientific and regulatory consulting firm
Mayor Michael Bloomberg and
providing experts that assist companies
the
Citychemicals
of New York
making or
using
to market and
sustain their products globally.
· Chemical Product Stewardship
· Chemical Regulation under
TSCA & REACH
· Pesticides and Biocides
· Global Chemical Notification
· Nanotechnology
· Biobased Chemicals and Biofuels
· Food Contact Chemicals
· Metals
· Cosmetics
· Risk and Exposure Assessment
www.actagroup.com
Global Chemical Product Innovation and DevelopmentTM
Beijing, China
86-10-84534538
Manchester, U.K.
+44 (0) 161 212 7405
Washington, D.C.
(202) 266-5020
Contents
Chemical service providers editoral...... 5
Increasing complexity extends
throughout the supply chain................... 5
US chemical manufacturers and
users dealing with GHS implementation
and an EPA looking to extend its
authority................................................. 16
Key country regulatory highlights
in 2013 .................................................. 21
A look at the chemical management
and control jobs market........................ 22
Using service providers and future
market trends........................................ 27
Profiles........................................36
24-7 Response...................................... 36
3E Company......................................... 38
ACTA..................................................... 40
ARCADIS............................................... 42
ARCHE.................................................. 44
bibra toxicology advice & consulting... 46
Bioagri................................................... 48
Blue Frog Scientific............................... 50
Brixham Environmental Laboratory...... 52
BSL BIOSERVICE Scientific
Laboratories GmbH.............................. 54
Bureau Veritas....................................... 56
CEHTRA................................................ 58
Centro Reach........................................ 60
Chemsafe.............................................. 62
Chemservice......................................... 64
ChemService Srl Controlli e Ricerche.. 66
Chilworth – a DEKRA Company........... 68
CS Regulatory Ltd................................. 70
CURRENTA GmbH & Co.OHG............. 72
DHI........................................................ 74
Dr. Knoell Consult GmbH...................... 76
EBRC Consulting.................................. 78
ECOonline............................................. 80
ENVIRON.............................................. 82
Equitox.................................................. 84
ERM....................................................... 86
CW Research Ltd, trading as Chemical Watch,
publishes news and intelligence to help companies
achieve sound chemicals management that responds
to the many non-regulatory drivers as well as
meeting responsibilities under chemicals legislation
worldwide, including regimes such as REACH, CLP,
GHS and TSCA. We keep you abreast of policy and
business trends across the EU, North America, Asia
and the rest of the world. Because we are not tied
to any trade associations, government or campaign
group, we are able to offer objective news and
analysis for all sectors.
CW Research Ltd,
140B Longden Coleham, Shrewsbury SY3 7DN, UK
Tel: +44 (0)1743 818 101
Fax: +44 (0)1743 818 121
email: [email protected]
www.chemicalwatch.com
Exponent International Limited............. 88
Harlan Laboratories.............................. 90
ICF International ................................... 92
IHS......................................................... 94
International Cosmetics &
Chemical Services................................ 96
Intertek.................................................. 98
iPoint-systems gmbh........................... 100
JSC International................................. 102
KFT Chemieservice............................ 104
National Chemical Emergency
Centre (NCEC).................................... 106
Pace Analytical - Regulatory
Services.............................................. 108
REACh ChemAdvice........................... 110
REACH Mastery.................................. 112
ReachCentrum.................................... 114
REACHLaw.......................................... 116
Risk & Policy Analysts......................... 118
Royal HaskoningDHV.......................... 120
SCC..................................................... 122
Selcia................................................... 124
SGS..................................................... 126
Reach Only Representative Ltd.......... 128
SSS (Europe) AB................................. 128
Swissi Instituto Suizo de Seguridad... 130
TNO Triskelion..................................... 132
ToxMinds............................................. 134
TÜV SÜD Industrie Service GmbH..... 136
WIL Research...................................... 138
Wildlife International, a division of
EAG..................................................... 140
WTConsulting...................................... 142
YASH Technologies............................. 144
Niche firm Profiles........................ 147
AG-HERA............................................ 147
ALTox................................................... 147
BIG vzw............................................... 147
Caleb Management Services............. 147
CFCS-Consult..................................... 148
Editor
Mamta Patel, [email protected]
Contributing Editor
Cynthia Challener, [email protected]
Profile production
Nick Hazlewood, [email protected]
Client Relationship Director
June Meagher, [email protected]
Account Managers
Kerry Williamson, kerry @ chemicalwatch.com
Lotte Spencer, lotte @ chemicalwatch.com
Glen Marechal, glen @ chemicalwatch.com
Head of Marketing
Richard Butterworth, richard @ chemicalwatch.com
Operations Director
Stuart Foxon, [email protected]
Managing Director
Julian Rose, [email protected]
ChemSW............................................. 148
CONUSBAT......................................... 148
Crowell & Moring................................. 148
Danger and Safety srl......................... 149
DR. MACH Chemical Compliance
& Competence.................................... 149
Ecotox Services International............. 149
ES4chem............................................. 149
eSpheres............................................. 150
Eupoc.................................................. 150
Eurideas Linguistic Services.............. 150
FinnREACH......................................... 150
FoBiG.................................................. 151
GHS Expert Ltd................................... 151
Greenwich Chemical Consulting........ 151
IGCON................................................ 151
Jongerius Consult BV......................... 152
JRF Global.......................................... 152
Linmark Consulting............................. 152
LKC Switzerland Ltd............................ 152
McKenna Long & Aldridge LLP.......... 153
Peter Fisk Associates.......................... 153
REACH Delivery.................................. 153
REACH Global Services..................... 153
Reach Only Representative Ltd.......... 154
REACHReady ..................................... 154
REACHWise........................................ 154
ReFaC................................................. 154
Regulatory Services International...... 155
Steptoe & Johnson LLP...................... 155
The Wercs........................................... 155
Tox Focus, LLC.................................... 155
toExcel International Ltd..................... 156
Toxservices LLC.................................. 156
Verdant Law, PLLC.............................. 156
wca environment................................. 156
Wercs Professional Services, LLC...... 157
WRc plc............................................... 157
WSP Group......................................... 157
A-Z Listings................................. 158
Distribution policy
Copying of this document including electronic
circulation is not permitted without consent of the
publisher.
Disclaimer
While Chemical Watch takes every effort to
ensure the accuracy of this guide, we cannot take
responsibility for any adverse consequences arising
from actions taken in response to our content
and we recommend that readers take appropriate
professional advice.
Designed and typeset by Ministry of Design, Bath,
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Front cover image ©iStockphoto.com/dra_schwartz
First published 2013
Copyright and Database Rights
© 2013 CW Research Ltd. All rights reserved
Page 3
Introduction
Effective chemicals management and control programmes
cover the full lifecycle of chemicals manufactured,
processed, used as raw materials or sold. As such, they
touch all aspects of a company’s operations from new
product development to purchasing to customer selection
and support. They also require an extensive skill set,
including, but not limited to, regulatory, administrative,
project and information management, legal, chemistry,
toxicology, laboratory and software expertise. Much of this
work can be completed in-house at larger firms, and has
been done, even as budgets have shrunk due to declining
sales, but is generally outsourced by SMEs. Even for large
companies, however, there are many times that specialist
skills or a particular type of experience are required to
ensure successful project implementation. Firms offering
consultancy/advisory, management/administrative, legal,
training, laboratory and technical, information/data
management and software/IT services fill these needs.
In the following pages, we take a closer look at some of
the key drivers, discussions, issues and solutions ongoing
in this dynamic market.
CHEMICALS MANAGEMENT AND CONTROL
Increasing complexity extends throughout the supply chain
EU REACH, country-specific chemical management
regulations, country-specific GHS requirements and
product-specific legislation on biocides, agricultural
chemicals and cosmetic products place growing burdens
on not only chemical manufacturers and processors and
their distributors and direct customers, but all firms that
produce or handle products containing chemicals identified
as presenting some risk or hazard. Simply staying abreast
of these various regulatory requirements is a real challenge
for companies selling in multiple countries and regional
markets, and often a new process for many downstream
users. Compliance requires both significant resources
and extensive knowledge, which, in the current difficult
economic climate, can be overwhelming even for larger
organisations to access, and may not be possible for
smaller- and medium-sized enterprises (SMEs) to obtain.
Many companies, therefore, are delaying activities or taking
minimalist approaches to compliance, while others remain
unaware of their responsibilities. Some of the impacts of
this situation on the chemicals management and control
service providers market were observed in 2012, and more
are expected to come to the fore in 2013.
Leading drivers
Not surprisingly, REACH and GHS compliance
requirements helped continue to drive the workload of
chemicals management and control professionals in 2012.
The results of the Chemical Watch survey confirm that
REACH is a major regulatory driver (Figure 1). In fact, an
overwhelming 89% of survey participants cited REACH as
the main global driver, followed by the EU CLP Regulation
(65%), and other national schemes for the Globally
Harmonized System (GHS) for chemicals classification
and labelling (46% of respondents). Other drivers include
US TSCA inventory reporting requirements and biocides
regulations. Notably, 27% of respondents specifically
mentioned China’s new chemical notification (MEP order 7).
The next REACH deadline is 31 May 2013, and forwardthinking companies were preparing. Others were dealing
with ECHA decisions on phase one registrations and
beginning the authorisation process. Work also continued
on extended safety data sheets (eSDSs) and exposure
scenario development as required by REACH and CLP.
In addition, reflecting work in industry, many service
providers experienced higher workloads related to productspecific regulations, and all of these regulations drove
demand for laboratory testing services and increased the
need for more extensive software and data management
capabilities.
A leading fragrance and flavour company, for example,
has a large EU portfolio of manufactured and imported
chemicals and continues to invest in new and developing
markets that are introducing increasingly challenging
regulations, for example, in Asia. The changing global
registration environment and chemical management and
control issues have focused greater regulatory attention on
such markets for the company, according to a company
spokesperson. For another multinational, Eastman
Chemical Company, meeting the requirements of the new
US Chemical Data Reporting (CDR) Rule was a major
concern in 2012, along with REACH and Asian regulations.
While Jan Schüller, director REACH & regulatory affairs for
Eastman Chemical EMEA B.V., expects GHS requirements
will be big in 2013.
Page 5
Chemical service providers
Chemical service
providers
Figure 1
Leading regulatory drivers for survey participants
REACH
89%
CLP
65%
National GHS classification, labelling and inventory
notification regulations
46%
Biocides regulations
29%
US TSCA inventory reporting
28%
China new chemical notification (MEP order 7)
27%
Nanomaterials regulations
25%
China: registration of general hazardous chemicals
(SAWS Order 53)
23%
Food contact material regulations
22%
China: registration of hazardous chemicals for environmental
management (MEP Order 22)
21%
Other country new chemical notifications
20%
Cosmetics regulations
20%
Packaging regulations
19%
International Carriage of Dangerous Goods by Road (ADR)
16%
Korea: Notification under TCCA
15%
International Maritime Dangerous Goods (IMDG) Code
15%
Other country chemical manufacture/import inventory
reporting
15%
Agrochemical regulations
13%
Japan: notification and annual reporting under CSCL
13%
Taiwan: nomination to existing chemicals inventory
11%
Taiwan: registration of designated substances under TCSCA
11%
Turkey: notification under CICR
10%
Pharmaceutical regulations
9%
Medical devices regulations
8%
Veterinary product regulations
4%
Other
4%
0%
20%
40%
60%
80%
100%
% of participants
Several survey respondents also provided more
specific comments regarding the regulatory drivers that
are impacting their chemical management and control
activities. Some were very specific, such as the Australian
OHS regulation, Canada’s chemical regulations, the US
state of California’s green chemistry initiative, and the EU’s
Directives on the restriction of hazardous substances in
electrical and electronic equipment (RoHS) and on toy
safety. Others were concerned with additional programmes
that have international scope, including the Chemicals
Page 6
Weapon Convention and updates to protocols, the
International Carriage of Dangerous Goods by Air (IATA),
and the Stockholm Convention.
Non-regulatory drivers can have a significant impact
on the growth of the chemicals management and control
sector as well. Not surprisingly, 49% of participants in the
Chemical Watch survey identified economic growth as
the major factor (Figure 2). Not far behind were customer
pressure (42% of respondents) and governmental polices/
spending (37% of participants). Other non-regulatory
Figure 2
Leading non-regulatory drivers for survey participants
Economic growth
49%
Customer pressure
42%
Governmental policies/spending
37%
NGO pressure
27%
Non-statutory ‘voluntary’ corporate initiatives/CSR
22%
Downsizing of inhouse chemical management and control teams
19%
Increased commercialisation/better management of service
provider business
14%
Outsourcing of business support functions
(by client organisations)
11%
Other
3%
0%
20%
40%
60%
% of participants
Key trends and issues in chemicals
management and control
Requests for REACH support varied significantly for
many service providers, but continued to account for a
good portion of business in 2012. The main activities
included preparation for the second registration deadline
for substances with sales volumes of 100-1000 tonne,
responding to ECHA decisions on substances submitted
during the first phase, and the beginning of activities
related to authorisation.
For example, the majority of work for independent
registration and development management services
firm LKC involved administration of data sharing
in advance of the May 2013 registration deadline,
including communication obligations within the supply
chain, according to COO, Matthew Kane. Others have
found, however, that the global recession has taken a
toll on REACH activity. Where possible, notes Stephen
Van Heerden, Sales Director at REACHLaw Ltd, many
companies have switched the 2013 REACH registrations
to the 2018 REACH deadline due to the impact of the
economic recession on resources.
José V. Cantavella Cabedo, project manager for
Sief/Consortia/Business Development at Chemsafe Srl,
adds that not many large companies are taking the
Lead Registrant role, which may mean that a number
of chemicals will not be registered. Dieter Reiml, with
TÜV SÜD Industrie Service GmbH, agrees that many
companies are delaying the process despite experiences
from 2010, and there is as yet little action in many
substance information exchange fora (Siefs). Even those
who are taking action and have first phase experience are
finding it difficult, because there is less data available on
the substances involved, testing labs are at least partly
overloaded, and the ‘rules and conditions’ continue to
change, including an update to the IUCLID software and
the publication of new guidance from ECHA, according
to Klaus Schneider, general manager, Forschungs-und
Beratungsinstitut Gefahrstoffe GmbH (FoBiG).
“We are concerned that many substances remain
unsupported, and that a last minute rush to submit dossiers
will swamp both testing houses and regulatory consultancy
firms,” concludes Samantha Wright, regulatory affairs:
REACH, with JSC International. Beyond that, she is also
concerned that substances that are not supported could
be taken off the market, which would have a knock-on effect
on a range of different products.
In addition to preparing for the second phase of
REACH, companies have also had to begin dealing with
the consequences of the first phase of the programme.
Companies have had to respond quickly to ECHA’s draft
decisions on evaluation of 2010 submitted dossiers in order
to prevent them from becoming final, according to Barbara
Vogt, a principal with Tox Focus LLC. “Some involved
clarification and refinement of scientific positions, while
others were simply corrections of administrative errors.
However, resubmission of a corrected dossier was made
more complex due to the need to gain consensus among
Sief participants and to upgrade the dossier from IUCLID
5, version 3 to version 4. As a result, the time and cost
was often higher than anticipated,” she comments. Some
updates had to be made, according to Karl-Franz Torges,
managing partner of KFT Chemieservice GmbH, because
other registrants wanted to join and were only prepared to
join if the quality of the dossier was improved.
Test proposals from the first phase of REACH and
spontaneous dossier updates were also a bigger
proportion of business for consultancy CEHTRA. “ECHA
has begun to challenge testing proposals, categories
and read-across strategies, with potentially expensive
consequences for registrants,” says Paul Thomas, senior
ecotoxicologist and director of its Lyon Agency. Meanwhile
law firm McKenna Long & Aldridge LLP was involved
in the legal assessment of several ECHA compliance
check decisions and brought two cases before the
Board of Appeal. The consequent workload from REACH
registrations is not likely to lessen any time soon, our
respondents feel. REACHLaw’s Mr Van Heerden adds that
a lot of companies that submitted intermediate registrations
as an easy way out have found that they must redo their
dossiers, which has doubled their costs. “As time goes on,
Page 7
drivers noted by one in five or more respondents included
NGO pressure and voluntary corporate initiatives. In
addition, several very specific and interesting issues
were pointed out by survey respondents, including green
chemistry initiatives, the advancement of electronic
monitoring and detection devices, the integration of
science within the regulatory framework, the knowledge
and expertise loss due to retirement, the need to
demonstrate efficiency and discontinuation of products in
the supply base.
Extended safety data sheets
Extended safety data sheets (eSDSs) and exposure
scenarios created much work for all types of service
providers. Not only did eSDSs require updating with new
data and a new format, but the annexes summarising
exposure scenarios had to be developed and
manufacturers had to incorporate use information for raw
materials based on the eSDSs received from suppliers,
according to Benoit Fraysse, an eco-toxicologist with
Equitox. NCEC’s Dr Whiting notes that it has been difficult
in some cases to ensure that the given scenarios match
a company’s actual uses. Publication of the classification
and labelling inventory on ECHA’s website also reportedly
caused headaches, because many downstream users
thought it was an ‘official’ classification that would require
changes to eSDSs.
One of the biggest challenges has been the hesitation
by companies to prepare or to order eSDSs. There is still a
lot of uncertainty whether this approach will be the solution
for the future, according to KFT Chemieservice’s Mr Torges.
He notes that most large international clients that initially
supplied the annexes as separate PDF documents in
English are planning to supply legally compliant eSDSs
during 2013. “Developing comprehensive, compliant, and
accurate exposure scenarios and eSDSs is incredibly timeintensive and can burden a company’s in-house product
stewardship and regulatory compliance resources,” asserts
Jeffrey Starr, vice president of marketing for 3E Company.
“As such, companies are increasingly partnering with
reliable outsourced solution providers. While there is no
single ‘REACH Solution’ that can be purchased that takes
care of all aspects of REACH, there are reliable providers,
who are well-versed in data and information as it relates to
global Environmental Health and Safety regulations, and
who thoroughly understand the EU regulatory environment
that are available to help.”
For Agnes Botos, REACH, GHS, ADR, and EHS
consultant with GHS Expert, mixture classification also
became a noticeable issue in 2012, as companies began
looking toward the June 2015 CLP deadline. In fact, about
25% of KFT Chemieservice’s clients ordered eSDSs for
mixtures according to CLP requirements. Mixtures present
a complex issue, however. “Our clients do have some
concerns about how substances and exposure scenarios
from the REACH process translate into data for mixtures at
the production and safety data sheet stage,” NCEC’s Dr
Whiting indicates. “We hope that industry will work together
to take a pragmatic approach on this element, although
it may prove the case that adopting CLP for mixtures
highlights a number of data gaps in the process, and filling
those gaps will be a key task in 2013.”
Testing labs were particularly affected by CLP
requirements and found clients needing help with testing
of compounds to determine the substance classification,
the development of ad-hoc testing strategies and eSDS
preparation once the testing data was obtained, according
to Carlotta Casalegno, regulatory & development specialist
with ChemService Srl Controlli e ricerche. The tests in
most demand in 2012 were aquatic long-term tests on
invertebrates (OECD 211 on Daphnia) and biodegradation
tests, which she expects will remain popular in 2013.
Building GHS alignment
Implementation of the GHS is another complex issue,
largely because while there is an international UN
framework, each country had adopted its own version, and
thus the requirements still differ from country to country.
“As much as GHS is meant to drive global harmonisation,
individual countries are allowed to select the physical
hazards, the health and environment classes and the
associated categories within each class that they wish
to adopt, and most countries that have implemented
Page 9
we are convinced that ECHA will dig deeper into dossier
quality and the current industry policy of minimising Annex
IX and X test proposals will probably be scrutinised,”
predicts CEHTRA’s Mr Thomas.
Authorisation activities picked up as well in 2012.
McKenna Long & Aldridge LLP and ReachCentrum each
established authorisation consortia for the preparation
of joint authorisation applications (chromium trioxide
and miscellaneous chromium compounds for McKenna
Long & Aldridge LLP and di(2-ethylhexyl)phthalate
(DEHP) hexabromocyclododecane (HBCDD) and sodium
dichromate for ReachCentrum). In addition, individual
companies are monitoring the presence of SVHCs in their
processes and supply chain and developing mitigation
strategies related to these substances: identifying in
which processes SVHCs are used, which uses need to be
covered in an application for authorisation and for which
chemicals, alternatives are available, explains Maaike Bilau
with the REACH & Product Stewardship Services business
of ARCADIS Belgium nv. “Consortia are now working with
the members to make sure that these applications for
authorisation are robust and can be submitted on time.
However, we are also more and more in contact with
singular downstream users that seek an authorisation for
their very specific downstream use,” adds Leo Appelman,
managing director of ReachCentrum. In light of the
growing REACH candidate list of substances of very high
concern (SVHCs), clients of SGS-CTS are taking a closer
look at risk assessment rather than doing a complete
screening of the list, according to Dr Anne Kleinkauf, a
Reach consultant with the firm.
This process has actually had a positive aspect,
according to NCEC REACH consultancy manager, Robert
Whiting. “Companies have been forced to work together and
look openly at the issues that specific substances present.
Many have also taken a proactive and considered approach
to managing risk and how the logistics within their own
production processes work,” he remarks. “We believe the
result of such an approach will have a positive impact on
how risk is managed, with an increasing emphasis placed
on the use of safer alternatives.” However, communication
is absolutely vital and there are still many in the downstream
user category that don’t fully understand the regulation
or how they are covered, such as those in the cosmetic
industry, according to Janet Blaschke, managing director of
International Cosmetics & Chemical Services, Ltd. UK.
For those companies that are not taking their REACH
responsibilities seriously, both service providers and
their clients would like to see ECHA and Member States
become more aggressive with their enforcement activities.
Companies that have invested significant resources want
to protect their investments and keep ‘free-riders’ away.
“We saw some enforcement activities under REACH, but
they were focused on eSDSs and others did not end in any
measurable citations. While ECHA has done a remarkable
job and is very responsive, it must take seriously its role
as an enforcement agency and issue real violations for
significant deficiencies if the legislation is to be viable,”
KFT Chemieservice’s Mr Torges asserts.
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searchable, easy-to-use database that provides quick
access to official GHS classifications, including substance
classifications published by the relevant authorities, as
well as translated GHS classifications, labels, full text,
and phrases. Such regulatory data tools or integrated
regulatory content should also include expert rules that
take into account national deviations as well as UN Purple
Book rules, templates for key hazard communication
documents, and multilingual phrase libraries. This system
can be integrated with an authoring platform for the inhouse generation of hazard communication documents,
and can even be integrated with the purchasing system
for management of in-bound vendor eSDSs. The other
major option is, of course, to outsource these activities to a
service provider.
Global compliance efforts
Demand for help in compliance with national chemicals
regulatory requirements, particularly in Asia, continues
to be keeping many busy. “An increasing number of our
clients have realised that compliance with REACH alone
is not sufficient because they have global activities and
thus have to deal with, often new, regulations in nonEU target markets,” notes Michael Cleuvers, head of
industrial chemicals – global regulatory affairs for Dr. Knoell
Consult GmbH. There has been enough of an increase in
demand that the company has established subsidiaries
in China and Thailand and enhanced its cooperation with
partners in Japan and South Korea. Linmark Consulting
also had requests for support with the Korean Reach pilot
programme, and its principle consultant, Martin Richards,
expects to see more activity from China and Korea in 2013,
particularly relating to data access. Because rights to data
developed by consortia may only be relevant for EU REACH
use, companies may need to go back to each original data
owner to get new licences. McKenna Long & Aldridge was
involved in extensive international product labelling and
product composition work in 2012, and partner, Ursula
Schliessner, expects more of the same in 2013.
Other companies did not have the same experience
with requests for non-EU projects. “While some work
was generated from China, Turkey and Russia, it was
not significant compared to other business areas, and
the amount of projects coming from Turkey was actually
disappointing compared to 2011,” observes Dieter
Drohmann, managing director of Chemservice GmbH and
director of Chemservice Turkey. However, even if projects
weren’t initiated in 2012, Steven Green, director of CS
Regulatory Ltd believes that many of his customers have a
large interest in staying abreast with updates on countryspecific regulations, and he expects that these national
regulations are likely to be of greater importance in 2013,
once the REACH deadline has passed.
US regulations have kept companies that manufacture
and sell products in that country on their toes (see section
below for details). Along with GHS requirements, which
Ashland expects will become an important issue in the
next 24 months, Bernie Lindquist, a senior toxicologist
with Ashland, is also paying close attention to Canada’s
inventory update and is watching whether or not Mexico will
bring its inventory online in 2013.
US firms also faced issues from the EPA related to risk
assessment reform, prioritisation of chemicals to be subject
to risk assessment, questions regarding confidential
business information, increasing product deselection
activity on the state level and whether or not any progress
Page 11
GHS have chosen to keep some of their existing hazard
classification and communication that is not yet part of
the GHS. As a result, there will be far less harmonisation
between countries and regulatory authorities within each
country than originally anticipated. We anticipate this lack
of harmonisation will continue to be a source of concern for
companies with global operations, necessitating – in many
cases – access to proven regulatory data and compliance
tools to help support conformance processes,” observes
3E’s Mr Starr.
Even simple translation from the former EU system to
the new GHS system hasn’t been as easy as , sometimes
assumed, notes Ineke Gubbels, director of IGCON. “Many
mistakes have been made in simple translations by the
automated programs that are commercially available, and
as more countries implement GHS, this issue will continue
to be a problem.”
Software and data management companies have thus
focused on leveraging their products for this application.
“GHS has been the single strongest driving force for
companies around the globe to reevaluate how they are
handling their hazard communication compliance. With
so many regions/countries around the world making slight
to major changes to the proposed UN GHS standard,
companies are finding that compliance with these
regulations is not possible without strong, configurable
automation tools,” states Steffan Kilmer, International
Business Manager for The Wercs. Companies who have a
desire to expand into new markets will find it increasingly
difficult to comply and thus ship their products. Having
powerful software to help handle this growing demand
is no longer a ‘nice-to-have’, he says, but a necessity for
enabling the continuation of global business.
GHS implementation has moved to the forefront in
the US, where the country’s new Hazard Communication
Standard (HCS) was adopted by the Occupational Safety
and Health Administration (Osha) in 2012. The new standard
requires significant changes to labelling and documentation
processes, practices and systems, according to Francis
Trudeau, senior product manager for product stewardship
solutions with IHS. “We expect this law will have the greatest
impact on companies operating solely in North America,
as most global companies have already adopted GHSbased processes in support of operations where GHS
has previously been adopted.” However, he adds that the
impact of GHS will continue to be felt beyond the US and
EU. “New implementations of GHS, as well as GHS revisions
by countries that have already adopted the UN Purple Book,
were driving the current regulatory compliance agenda last
year and will continue to do so in 2013.”
Honeywell Performance Materials and Technologies
is a good example of a company faced with extensive
GHS requirements in the US. “The US Osha GHS ruling
is a significant issue that will add real complexity to the
chemical management and control requirements that we
already face, including compilation of eSDSs, preparation
for 2013 REACH registrations, substance notifications in
China and following up on GHS implementations globally,”
says Guy Verbiest, PMT EMEA product stewardship leader
for the company. “These items are of particular interest to
our company, as our product portfolio is very extensive and
targeted to a global market. Any REACH-like regulation or
GHS implementation is of significant interest to Honeywell.”
There are many possible strategies for dealing with GHS
compliance, according to Mr Starr from 3E Company. Many
companies choose to use reference tools that centralise
all global chemical regulatory information into a robust,
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Product legislation
Product-specific regulations, on the other hand, required
significant attention in 2012 and are expected to have
an even bigger impact in 2013. “In general, the various
changes to product-specific regulations that came into
force in 2012 have contributed to making it ever harder
for industry to continuously stay in compliance with all
applicable product regulations,” remarks Dr Kleinkauf of
SGS-CTS. She anticipates that product testing as a measure
of quality control will continue to gain further importance
as companies work to minimise product liability claims and
maximise product safety. In addition to cosmetics, biocide,
and food contact legislation, ADR/RID (hazardous goods
regulations) will bring further changes in 2013.
In 2012, according to Christine McAlinden, Director of
toXcel International Ltd, there was a growing awareness
among cosmetic producers regarding their obligations to
compile a comprehensive safety assessment and product
file in compliance with the new EU Cosmetic Regulation.
“For smaller companies with no regulatory experience
or resources, however, meeting these requirements is
particularly challenging. There is minimal understanding of
the safety assessment requirements and the production of
official guidance by the European Commission’s Scientific
Committee on Consumer Safety has been slow, with the
latest released just in December 2012,” she says.
The new Cosmetics Regulation, which will be fully
implemented in July 2013, is expected to have a significant
impact on the industry. “The electronic notification system
will help the Competent Authorities rapidly determine the
state of compliance for a company and its products, and
we are therefore expecting a big jump in enforcement,”
states Ms Blaschke of International Cosmetics & Regulatory
Specialists. She adds that the Product Information File (PIF)
requirement is more detailed than was previously required
under the old Cosmetics Directive, and the requirement
for a ‘responsible person’, similar to a requirement under
EU legislation on medical devices, is new and also needs
to be addressed by most SMEs. “All of which will no doubt
lead to an increase in the cost of doing business in the
EU,” she concludes. As an example, a significantly higher
amount of in vivo toxicity studies has been required for
cosmetic ingredients dossiers, according to Jean-Luc
Garrigue, director scientific affairs – Europe for BIOAGRI,
a Mérieux NutriSciences Company. “Many companies have
anticipated the animal testing and marketing bans that take
effect in March 2013, and have accelerated their safety
evaluation programmes for strategic ingredients,” he says.
The new biocidal products Regulation (BPR), which
replaces the current Directive (BPD) in the EU, is also
proving to be a challenge for industry and regulator
alike, according to JSC International’s Richard Elsmore,
regulatory affairs: biocides & REACH. The legislation was
published in June 2012 and takes effect at the beginning
of September 2013. Companies are currently still
working under the BPD, and the inclusion of more active
substances on Annex I is triggering the requirement for
any biocidal products containing these active substances,
which is many more than have been required in the past,
to apply for product authorisation in order to stay on the
market. The changes in legislation will further impact active
substance manufacturers, formulators and producers of
articles that have been treated with biocides (even those
treated outside the EU).
Several other requirements of the BPR are challenges
for industry as well. “The regulation impacts data protection
and data sharing with third parties, which is of real
concern for our clients,” notes LCK’s Mr Kane. CEHTRA’s
Sara Kirkham, senior regulatory affairs consultant, adds
the involvement of ECHA within the process, new dossier
formats and data requirements, and labelling of articles
to the list. He also notes that several anomalies have been
found in the Regulation that must be addressed in order for
the market to continue to function after the application date.
“Even so, we have observed that most affected companies
are slowly starting to move forward to ensure that they are
compliant when the BPR goes into effect. Service providers
like CEHTRA are helping these firms develop strategies
to keep their products on the market in the face of high
product authorisation costs,” she says.
The food processing and packaging industry will be
challenged in 2013-14, according to Ms Laurence Gasnot,
food additive and contact expert at CEHTRA. The French
Agency of Food, Environmental and Occupational Health
and Safety (Anses) will be reassessing the ‘technological
aids’ necessary to process foods (antifoaming agents,
enzymes, mineral oils, etc) listed in Annexe IB of the
French Arrêté, which are authorised until the end of 2014.
Furthermore, demand for food contact services has
increased since publication in 2011 of the EU’s Regulation
on materials and articles intended to come into contact with
food.
Another new issue is that Regulation EC N° 1223/2009
on cosmetics requires the assessment of the safety of
possible migrants coming from the packaging that is in
contact with the cosmetic product, without giving any guide
for such assessment. The mechanisms that determine
the extent of this interaction (migration, permeation)
has been fully studied for food packaging; therefore, a
similar approach may be developed for cosmetic products,
according to Ms. Gasnot.
All of these changes to product-specific regulations
in the EU are taking place at the same time that REACH
authorisation requirements must be met. “It is very
important that companies seeking alternative substances
as a result of REACH requirements make sure that they
stay abreast of these other product regulations,” stresses
Linmark Consulting’s Mr Richards. It is certainly possible
that some alternative substances may require registration
under the various product-specific regulations.”
Training needs
Not surprisingly, the growing requirements under EU and
non-EU regulations have spurred interest in various types
of training programmes as well. “We have seen a growing
demand for training on technical topics, such as exposure
scenarios and their implications for the preparation of
eSDSs, administrative issues, including Sief or supply chain
management, and compliance with non-EU regulations,”
notes Dr. Knoell Consult’s Mr Cleuvers.
REACHLaw has observed an increase in the need
for awareness building on several aspects of REACH
authorisation and biocides regulations, due to the fact that
deadlines are approaching and companies are concerned
about losing the ability to market their products and,
consequently, also losing revenue streams, according to
Mr Van Heerden. ReachCentrum, meanwhile, has also
experienced strong interest in two of its most extensive
Page 13
will be made on modernisation of the country’s ageing
Toxic Substances Control Act (TSCA) legislation.
training programmes - REACH Awareness bootcamp
and Risk Assessment week. These programmes are
very successful, according to Vincenzo Girardi, head
of training with the firm, because participants receive
in just five days a complete overview of the topic with a
combination of practical hands-on exercises and theory.
“For 2013, we are also expecting more demand for tailored
training programmes related to REACH registration and
authorisation, including onsite sessions as well as webinars
and online solutions that allow participants to follow
the training from many different locations, continues Mr
Girardi. Aside from regulatory training, there is always the
ongoing need for training in basic emergency response
activities, such as practical spill response, the UK’s control
of substances hazardous to health (COSHH), and Hazmat
1st Response, according to NCEC’s technical consultant,
Mr Paul Rast-Lindsell. “We expect interest in these courses
to continue to rise. However, we do find that requests for
training often come after an incident, problem or audit that
has highlighted the need.”
Of course, there are some specialist skills and areas of
expertise that cannot easily be obtained through training
courses, and providers that have these capabilities,
including legal, testing and software and information
management services, have and will continue to benefit.
Legal services
Key services provided in 2012 by ReachCentrum and
ReachLaw included preparation for Only Representative
(OR) inspections; addressing issues associated with the
registration of substances outside of joint registrations;
drafting of authorisation consortium agreements; legal
assessment of opportunities for appealing ECHA
adverse decisions; support for understanding the ECHA
dissemination policy and drafting confidentiality claims:
studies on exemptions from authorisations and the article
status of objects plus substance exemptions; support for
implementing or interpreting rules of consortia and Sief
agreements; and ongoing merger & acquisition and OR
change of identity activity.
Ms Isaline van der Straten, a legal advisor for
ReachCentrum, expects that in 2013 the firm will see
the greatest demand for legal support related to the
authorisation process (relationships with DUs, competition
law compliance); updates of registration dossiers,
read-across and fair cost sharing; and REACH-like
legislation adopted or under development in non-EU
countries. For REACHLaw, many of the same issues will
be relevant, according to Mr Van Heerden, as well as
SME determination for ECHA fee calculation, compliance
clauses in supply contracts and industry obligations under
the new EU biocidal products Regulation
With respect to legal decisions, Mr Van Heerden points
to two cases of particular note in 2012, including the
determination that ORs can apply for authorisation, which
levelled the playing field for non-EU and EU manufacturers,
and the withdrawal of ECHA registrations due to incorrect
SME determination, which may lead to supply chain
disruptions and provides an indication of potential
enforcement issues.
The evolving case law of the Board of Appeal (BoA),
including on substance identity, is also of significance,
according to McKenna Long & Aldridge’s Ms Schliessner,
because it will determine how active companies will be
in challenging ECHA decisions. She notes that the NV
Elektriziteits case (http://echa.europa.eu/documents/101
Page 14
62/13575/a_001_2010_decision_en.pdf) was reassuring,
because it confirmed the BoA’s broad power of review.
Important cases to look out for in 2013, according to
ReachCentrum’s Ms van der Straten, include the expected
final decisions of the BoA on two appeals related to
evaluation (case A-005-2011 lodged by Honeywell on
testing involving animals, and case A-001-2012 lodged by
Dow on read-across), as well as the court case ChemSec/
ClientEarth vs. ECHA before the EU Courts, which may
have an impact on the interpretation of REACH and other
regulations. Meanwhile, REACHLaw’s Mr Van Heerden
believes that ECHA and Member States’ REACH-ENFORCE-3 project, enforcement on unjustified intermediate
registrations, and possible challenges of candidate list
inclusions should be watched in 2013.
Ms Schliessner also believes that it will be interesting
to see whether any BoA decision is appealed in the
EU General Court – considered to be an unlikely event
because of the lack of suspensive effect in the General
Court, and because the General Court does not generally
get entangled with technical questions. She is uncertain if
the 2013 REACH Review will have any substantial effect,
and wonders if publication of registrant names by ECHA
will lead to more national court cases. “We anticipate
that companies may claim unfair trade practices against
registrants who submitted low quality registration dossiers
that are not actively pursued by ECHA or are using data not
compensated for, and hence are effectively ‘free-riding’,”
she adds.
Testing times
The second registration deadline for REACH approaching
as it does, at the same time that data requirements for
other country regulations, GHS, and many product-specific
regulations must soon be met, has ensured continued
high demand for testing services. “Many of these test
requirements have been the result of ‘data gap analyses’
and are needed to determine the properties of substances
that were not known or impossible to gather from the supply
chain,” SGS-CTS’s Dr Kleinkauf observes.
ChemService Controlli e ricerche experienced a
20% increase in the number of ecotoxicological studies
completed in 2012 compared to 2011, with tests on
aquatic organisms (algae, Daphnia, fish and aquatic
plants), terrestrial organisms (soil microflora, earthworms)
and biodegradation testing, being the most common. Ms
Casalegno points to REACH, the BPR, the EU veterinary
products Directive, and CLP as the major drivers. In
2013, once ‘last-minute’ REACH testing is completed,
new requirements for cut-off criteria (persistent,
bioaccumulative, and toxic (PBT) and endocrine disruption
properties) for the BPR will keep ecotoxicological testing as
the key growth area in 2013 as well. Meanwhile BIOAGRI’s
Mr Garrigue reports that the EU cosmetics Regulation, with
its ban on animal testing beginning March 2013, led to
more than a 110% increase in the number of in vivo toxicity
studies completed in 2012 over 2011, including genetic
toxicity studies, local lymph node assays, developmental
toxicity studies, 28-day and 90-day oral toxicity studies, and
screening for developmental toxicity studies (OECD 421).
There have been some additional challenges with
respect to the more recent data requirements that are
driving such tests. For one thing, it has been more
challenging to fill data gaps with non-test data and
by using read-across for the second phase REACH
substances, according to Tox Focus’s Ms Vogt. She
notes that lab availability has been an issue, but not
an insurmountable one. Smaller companies have also
often found it difficult to obtain data about the uses and
conditions of sold substances and mixtures, according
to KFT Chemieservice’s Mr Torges. “Most medium-sized
companies are not capable of retrieving this data, and we
expect to see a growing demand for this type of support in
the future.”
Such extensive data requirements have also led to the
need for more effective data management within companies.
Perhaps the most challenging issue today though is the need
to address management of chemical risk throughout the
supply chain. “Organisations face accelerating regulations
with more stringent reporting requirements. These protocols
now require companies to collect data across the value
chain, from product design to manufacturing,” IHS’s Mr
Trudeau states. “Achieving this goal is a significant challenge
for companies that rely on single-function systems and
manual processes that were not meant to handle today’s
complex protocols,” he continues.
As a result, companies are struggling to analyse,
share and distribute key information related to supplier
compliance and corporate risk across various functional
groups, according to 3E Company’s Mr Starr. “In 2012,
many companies reached the realisation that their data
management initiatives were inadequate; once data is
acquired, the majority of companies do not have sufficient
methods in place for validation or maintenance to ensure
data is accurate or kept up to date. Suppliers need help in
gaining access to and understanding the global product
regulations with which they must comply. The ability to
effectively ensure supplier product compliance is critical to
business continuity and to avoid supply chain disruptions.”
As a result, in 2013, 3E Company expects that the focus
on data management as a critical component of effective
supply chain risk management initiatives will continue, with
many companies striving to create a central repository of
regulatory and product information to reduce supply chain
risk while minimising data management costs. Mr Kilmer
of The Wercs also expects that content delivery via ‘cloud’
systems, which was heavily emphasised in 2012, will
continue to be an important component of such solutions
in 2013, as will more effective systems that enable business
process outsourcing for regulatory departments.
Communication challenges
There is also a need for information management systems
outside of the chemicals regulatory compliance arena
that can incorporate information derived as a result of
chemicals laws. “New trends in nonfinancial reporting,
driven by investors, NGOs and communities, are leading
to significant changes across the global business
landscape,” observes IHS’s Mr Trudeau. Stock exchanges
are now requesting that sustainability information be
included in reports to investors, and the International
Integrated Reporting Council, a newly formed organisation
with significant corporate participation, is calling for
organisations to combine nonfinancial information,
including product stewardship and sustainability metrics,
along with their financial reporting. With respect to the
growing need for communication throughout the supply
chain, there are mixed feelings as to the level of progress
that has been made. Mr Drohmann of Chemservice feels
that, at this point, most companies realise that regulatory
affairs activities are a business strategy that can help
differentiate suppliers from the competition. CEHTRA’s
Page 15
Mr Thomas, however, doesn’t believe that the expected
improvements throughout the supply chain have really been
achieved yet, even though he points out that many clients
have indicated that REACH has ultimately strengthened
their relationships with their suppliers and customers.
CS Regulatory has also experienced mixed results,
according to Mr Green. “Most downstream users still need
significant support, and while communication within the
supply chain seems to be working fairly well, accurately
tracking that communication beyond two or three steps
either way of your own perspective on the chain continues
to be a challenge,” says Mr Green. He is heartened,
though, at the growing knowledge and awareness of
regulatory aspects that downstream users seem to be
gaining. Ms Blaschke, on the other hand, has seen only
minimal improvements in supply chain communication and
believes that only an increased threat of enforcement will
have a real impact.
The problem for Dean Leverett, principal consultant
with wca environment Ltd, is that downstream users are
becoming increasingly involved in aspects of chemicals
management that they have limited experience with or
understanding of. This is particularly so for those involved
in the use of substances that are candidates for, or
subject to, restriction or authorisation under REACH. “The
requirements for socio-economic analysis (SEA) that
now frequently accompany such regulatory intervention
are not well understood by downstream users, despite
their key role in providing compelling supply chain data.
Unfortunately, we find that many manufacturers often
have limited or no appreciation of the final products their
materials are used to produce.”
One downstream user and manufacturer of chemicals
says it saw some improvement in communication in
2012, but not nearly enough to satisfy the company. The
spokesperson does expect greater communication in 2013
because of the urgency of the 2013 deadlines. “However,
this situation is unsatisfactory, with companies leaving such
issues to so very late and entering into panic mode.”
Ashland, meanwhile, has not seen any significant
change in communication throughout the supply chain.
“We are still prising information from suppliers, and the
need to do so is a source of frustration. Internet ‘rooms’
are helpful, but there isn’t enough of this type of tool, and
there are still a lot of battles over confidentiality,” says Dr
Lindquist. Honeywell, on the other hand, did not experience
any supply chain disruptions, but has, in response to the
growing amount of chemical management and control
requirements, reorganised its Product Stewardship
department so that services and resources can be
deployed globally when needed, according to Mr Verbiest.
Eastman also did not suffer supply interruptions in 2012,
so has not focused much attention there. “Our suppliers
are usually big chemical companies who have their REACH
ducks in a row,” Mr Schüller feels.
The important role that downstream users play is
becoming more apparent as implementation of REACH
progresses, and the possibility of supply chain disruption
is growing. While most service providers have not
encountered significant problems, some, such as CS
Regulatory, have observed cases where suppliers have
withdrawn substances from the market or elected to
register substances only as isolated intermediates under
strictly controlled conditions, whereby the substances can
only be handled under any other conditions. “We believe
that there is also potential for greater disruption within
supply chains as the effects of the regulatory process
continue to take hold,” Mr Green says.
In general, according to Chemservice’s Mr Drohmann,
it seems that larger companies have increased their
chemicals management and control activities, but SMEs
often are not able or are unwilling to address this issue,
particularly given the lack of enforcement. With movement
on the REACH authorisation process and anticipated
increased enforcement, further participation by all types
of downstream users is expected in 2013. Ashland’s Dr
Lindquist agrees: “SMEs do not have the resources to
comply with REACH and we expect to see some of them
drop out.”
Special US section
US chemical manufacturers and users dealing with GHS
implementation and an EPA looking to extend its authority
In the US, political gridlock has meant little legislative
progress in recent years, and not much is expected to
change in 2013. With major financial issues – and battles
– to occupy Congress for at least the first half of the
year, little legislative action on chemicals management is
anticipated. However, companies – both manufacturers
and users of chemicals – will be kept quite busy meeting
Osha GHS requirements, keeping up to date with actions
of a more aggressive EPA, and responding to numerous
programmes taking shape at the state level.
GHS compliance
One area of activity that has not been impacted by the
political paralysis in Washington has been the adoption
of the Globally Harmonized System (GHS) by the US
Page 16
Occupational Safety and Health Administration (Osha).
“Promulgation of Osha’s Hazard Communication Standard
(HCS) 2012 indicates that US regulatory authorities
are clearly capable of executing sweeping regulatory
changes,” notes Mr Starr from 3E Company. According
to Osha, changes to the HCS will affect over 43 million
workers in over 5m workplaces. The biggest changes in
the new HCS relate to Hazard Classification, Labels, Safety
Data Sheets and training.
In fact, The Wercs’ Mr Kilmer expects that GHS
compliance will be a “regulatory cliff” for chemical
companies. “We expect many will wait too long to prepare
and comply, and that the consumer retail industry, and
not the government, will end up being the chief driver for
achieving GHS compliance.”
TSCA reform and legislation
The need for TSCA reform continues to top the agendas
of all of the leading chemical industry trade groups, and
is also recognised by members of Congress and other
stakeholders. “The safety of chemicals has received a
lot of public attention recently, and our national chemical
management regulation needs to be updated to address
such concerns,” says William E. Allmond, vice president
of government and public relations for the Society of
Chemical Manufacturers and Affiliates (Socma). However,
adds Mike Walls, vice president of regulatory & technical
affairs for the American Chemistry Council (ACC), a
modernised TSCA must ensure protection of public health
and include strict government oversight, while preserving
the innovative nature of the chemical industry, which is a
major driver of economic growth in the US.
Progress to date has been slow, but as Mark Duvall, a
principal with law firm Beveridge & Diamond sees it, much
has been achieved; the basic issues have been identified,
different approaches have been discussed with various
stakeholders, and members of Congress have been
educated about the issues.
With two alternative pieces of legislation expected
to be proposed in 2013, ACC believes that an important
crossroads in the TSCA reform process has been reached.
Senator Frank R. Lautenberg (D-NJ) is expected to
reintroduce his “Safe Chemicals Act,” which was approved
in July 2012 by the Senate Environment and Public Works
(EPW) Committee without any support from Republicans.
Meanwhile, Senator David B. Vitter (R-LA) has publicly
committed to introducing a bill that many in industry
believe will take a more reasonable approach and have
the potential for gaining bipartisan support. Having two
proposals with contrasting legislative language creates the
real opportunity for progress, according to Mr Duvall.
It is unlikely, particularly given the major budget and
financial issues that must be addressed in the first half
of the year, that any legislation will pass the Senate in
2013, but it is not inconceivable. Key points that will need
to be addressed include the use of sound science and
a risk-based approach to the prioritisation and review of
chemicals, collection of data from users of chemicals
as well as producers and processors, strengthening of
federal pre-emption of state regulations, and appropriate
treatment of confidential business information (CBI), which
is critical for maintaining the global competitiveness of the
chemical industry, according to both ACC and Socma.
“We believe that if Democrats and Republicans focus on
these areas where there is common ground, targeted,
workable solutions can be developed that will improve
the effectiveness and efficiency of the current TSCA law,”
Socma’s Mr Allmond says.
In the vacuum created by the lack of actual TSCA
modernisation, the EPA and individual states have stepped
up their efforts to manage chemicals risk in other ways.
“There has been, and will continue to be, pressure on
individual state legislatures to create their own chemical
management laws. The EPA is also taking steps to
implement programmes designed to keep pace with other
regulations, such as REACH, where new chemicals are
not necessarily the focus,” observes Jennifer Reed, new
business development manager for Caleb Management
Services Ltd. “We do not see this state or federal
regulation activity slowing down until progress with TSCA
modernisation is made.”
Individual states within the US are taking actions, such
as issuing bans on specific chemicals like bisphenol A
(BPA) and restricting the use of cadmium. Washington’s
Children’s Safe Products Act, which requires manufacturers
and retailers to notify the state if they sell certain children’s
products containing any one of 66 chemicals of high
concern to children, required notifications beginning in
2012. Maine has a similar law with a list of 49 chemicals
of high concern, and New York, Minnesota, Arkansas and
other states have bills pending that have similar provisions,
observes SGS-CTS’s Emilie Viengchaleune, global
marketing coordinator for Global Sustainability Services.
“This trend in emerging regulatory frameworks for the safety
of chemicals in children’s products is forcing the industry to
re-evaluate its compliance strategy and look at risk-based
approaches regarding the materials that go into children’s
products,” she remarks.
Adds Ms Vogt of Tox Focus: “With so many varying state
laws, interstate commerce is becoming very difficult for
industry.” The state that has been most active is California,
which, according to a spokesperson from the California
Department of Toxic Substances Control, plans to finalise
its Safer Consumer Products Regulations by April 2013. The
most troubling aspect of this green chemistry initiative for
industry is the restriction of products containing chemicals
found on a ‘Candidate Chemicals’ list of an expected 1,200
substances. Initially, a short list of ‘prioritised products’
will be generated that will require reformulation with ‘safer
chemicals’ to be determined via an ‘alternative analysis’.
Meanwhile, at the federal level, the EPA has sought to
expand its authority under the existing TSCA Regulation
to the fullest extent possible. Its focus has shifted to
existing chemicals including their risk assessment, wider
dissemination of risk information and encouragement of the
development of safer alternatives.
One agency proposal that is causing concern to
industry is the potential requirement for disclosure of
specific chemical identities in health and safety studies
submitted to the EPA for chemicals that have not yet been
manufactured. According to Socma’s senior manager
of government relations, Dan Newton, if such a rule is
adopted, some of the trade group’s members would
seriously consider not manufacturing new chemicals in
the US. “The protection of chemical identities is critically
important for preventing competitors from learning key
information about new products; without that protection so
early in the product lifecycle, it may not be economically
sound to invest in new product development,” he explains.
Claiming CBI is further complicated by the fact that
requirements are different in the US and Europe. “Industry
is entering a new era. Corporate EHS, product stewardship
and legal staff need to decide whether they will proactively
Page 17
Both The Wercs and IHS note that, because important
training requirements must be met by the end of December
2013, implementation of the Osha HCS is a critical product
management issue for chemical companies this year.
The new classification procedures follow a very different
approach than was previously used and training and
implementation will be a big issue for US companies and
those selling into the US market. Tom McKellar-Smythe,
senior regulatory consultant with Caleb Management
Services Ltd, also warns that chemical manufacturers
and distributors should not wait to start working to meet
the 1 June 2015 deadline for hazard reclassification and
the production of GHS labels and SDSs, because these
activities require a great deal of time and resources.
declassify substances or try to substantiate confidentiality
claims. However, rights to CBI may be questioned as
the EPA attempts to expand the guidelines of its current
statutory authority,” says Bonita Reynolds, senior regulatory
specialist with 3E Company.
Both ACC and Socma believe that carefully structured
generic names could provide the necessary protection of
proprietary information while still enabling public access
to safety and hazard information. They have also asked the
EPA to require upfront substantiation of the need for CBI
in order to prevent overuse of this important aspect of the
TSCA regulations. “We would, however, like to see much
more guidance from the EPA on how to develop effective
generic names, and in the meantime, ACC is working on
possible approaches that we will share with the agency,”
notes Christina Franz, director of regulatory & technical
affairs with ACC.
Prioritisation of particular chemicals for review is also
high on the agency’s agenda. In 2012, the EPA launched
an ‘Existing Chemicals Strategy’ that, among other
things, identified a work plan of 83 chemicals for further
assessment. The EPA released five draft risk assessments
in January 2013, and is now seeking public comment and
they will be subjected to peer review. An additional two
draft risk assessments addressing medium- and longchained chlorinated paraffins should be released soon, and
the agency will be conducting another 18 risk assessments
in 2013 and 2014. Both Socma and ACC approve of the
EPA’s stepwise process for the review of the work plan
chemicals and applaud the agency’s focus on actual uses
of the chemicals. One unanswered question, however, is
what will happen at the end of this process. “No action has
been taken by the EPA under TSCA section 6 since 1991.
Therefore, extensive discussion is needed to determine
what approaches might not only be effective, but also
possible, under the existing TSCA legislation,” remarks
Beveridge & Diamond’s Mr Duvall.
ACC would also like to see the EPA hold another
stakeholder meeting on prioritisation in 2013. The
organisation has developed a comprehensive, scientificallybased prioritisation system that takes into account both
hazard and exposure and has shared this tool with the
agency and other stakeholders, according to Ms Franz.
She wants to see the EPA make additional progress on its
methods for selecting chemicals for review.
Another approach for the agency with respect to
existing chemicals is the issuance of Significant New
Use Rules (SNURs), over 300 of which were initiated in
2012. Many of these rules were related to aquatic toxicity
issues or for chemicals that aren’t very soluble. SNURs
are a serious concern for industry because they can
impact the entire supply chain; many users of chemicals
avoid purchasing such regulated substances, and both
Socma and ACC are anxious that the EPA uses its authority
appropriately to issue SNURs.
One particular proposed SNUR – polybrominated
diphenyl ether (PBDE) flame retardants – has caught a
significant amount of attention. In the past, the EPA has
avoided using SNURs for articles, and only regulated single
articles if it did issue such a SNUR. For PBDEs, however,
which are being phased out in the US, the proposed SNUR
would cover all articles, and it appears that the agency is
attempting to achieve widespread changes, according to
Sarah Brozena, senior director of regulatory & technical
affairs with ACC. Mr Duvall notes that this approach is
challenging for the EPA and a real concern for industry.
The agency has agreed to hold workshops with industry
Page 18
in 2013 on its decision-making processes for SNURs, and
particularly for substances that are difficult to test and
multicomponent products.
It is worth noting that some of the EPA proposals
outlined above have yet to receive approval from the
Office of Information and Regulatory Affairs (Oira) in
the Office of Management and Budget (OMB), and it is
not clear when or if they will be released. For example,
the proposal on CBI claims for chemical identities in
Premanufacture Notifications (PMNs) has been pending
since December 2011, and the final SNUR on PBDEs has
not yet been submitted for Oira approval. Others of note
include a proposal regarding reporting requirements for
nanomaterials under the Federal Insecticide, Fungicide,
and Rodenticide Act (Fifra), and a SNUR for nanomaterials
and a ‘chemicals of concern’ list under TSCA (from
December 2009). President Obama’s appointment as head
of the Oira could have an impact on the future of these
proposals.
In addition to the larger number of SNURs in 2012,
industry also had to comply for the first time with the
updated Chemical Data Reporting (CDR) rule, which
replaced the Inventory Update Reporting (IUR) rule.
Companies had to report an expanded set of chemical
production and import volumes using a new online portal
and coding system. “The CDR also requires tracking of
data for each year, rather than just every five years, so
companies, including distributors, need to be sure that they
are collecting all of the necessary data that is required,”
notes Jennifer C. Gibson, vice president of regulatory
affairs for the National Association of Chemical Distributors
(NACD).
The CDR is very important to both industry and the EPA.
The agency will be using the information gathered in this
programme for its prioritisation of work plan chemicals,
among other activities. “Therefore,” asserts Robert Kiefer,
director of regulatory & technical affairs with ACC, “It
is imperative that the CDR is implemented correctly. It
provides a valuable mechanism for the EPA to screen
manufacturing, use and exposure information on chemicals
in commerce.” The EPA recently released chemical use,
production, and other data collected in 2012 under the
CDR rule.
The EPA has also introduced several new interpretations
of existing TSCA provisions, particularly for chemicals
that have been on the TSCA Inventory for many
years. Companies need to stay abreast of these new
interpretations, because it is possible that compounds
previously considered by industry to be covered by TSCA
inventory listings are no longer included from the EPA’s
perspective. Simply following established industry practice
does not guarantee compliance anymore.
Altogether, these activities are designed to help the EPA
address existing chemicals, which is an area of weakness
in the current TSCA legislation. “Even in the absence of
TSCA reform, existing chemicals will continue to be in the
spotlight,” observes Caleb’s Ms Reed. “More now than ever,
companies need to ensure that they stay current with and
understand new requirements. The days of ‘My chemical is
on the inventory, so I don’t need to do anything’ are over.”
Enforcement activities
As well as expanding its authority under TSCA in light of
the lack of legislative progress in Washington, the EPA
has also stepped up its enforcement activity, largely under
the General Duty Clause in the Clean Air Act. NACD’s
Clean Water Act issues
Under the Clean Water Act, there is anticipation that
legislation to remove the requirement for a water permit for
Fifra-compliant applications will be reintroduced in 2013,
after being defeated by Senate democrats in 2012. The
legislation is designed to prevent potential negative impacts
of the permitting requirements, which have been reported
to lead to increased disease incidence such as West
Nile virus, due to higher costs and the fact that pesticide
applicators are no longer offering certain services in order
to avoid permitting issues. With respect to endocrine
disruptors, the EPA is planning to complete the review of its
initial round of testing in 2014 and issue test orders for Tier
2 testing in Fiscal Year 2014.
Trouble with the Endangered
Species Act
The Endangered Species Act (ESA) and its potential impact
on the use of agrochemicals will also be an important issue
for Congress. There has been much litigation regarding
the EPA’s compliance with the ESA with respect to its
pesticide approvals. Of note is the lawsuit filed by the
Centre for Biological Diversity in January 2011 on over 300
pesticides that could impact growers of all types of crops
across the nation. Despite numerous settlement talks in
2012, no conclusions were reached. The EPA files a motion
to dismiss and the decision on this motion is expected in
2013. BPA in polycarbonate used for baby bottles and beverage
containers.
Can the EPA manage it all
Based on the above discussion, it is clear that the EPA’s
agenda is laden. The fact that a large number of the EPA’s
proposals remain held up by OMB while it continues to add
new programmes and actions has many in the industry
questioning whether or not the EPA will be able to meet
its commitments. In many cases, the policy initiatives that
the agency is taking on are complex and difficult issues
that would not be easy to address, even if the EPA had
unlimited time and resources. On the contrary though, the
agency is facing the prospect of funding decline given the
current federal budget deficit. How deep any cuts might be
is unclear, and thus their impact is also unknown.
US exports
Looking beyond specific US regulations, there are
international regulations that have an impact on US
chemical manufacturers and downstream users. REACH,
of course, is a major consideration for companies that
export to the EU. Chemical distributors discovered in the
first round of REACH that they are largely responsible for
passing information throughout the supply chain, according
to Gibson, and most NACD members seem to have a good
understanding of their role now.
REACHLaw’s Mr Van Heerden reports that his company
has found that most larger US firms have a good awareness
of REACH, while SMEs don’t seem to be taking much
action. Some of Socma’s members, which are generally
smaller, batch manufacturers of fine and speciality
chemicals, decided after the first phase of REACH that
it was too costly to do business with the EU. Mr Allmond
expects that with the second phase of registrations
covering smaller volume chemicals, additional members
will decide that exporting to Europe is not cost-effective.
Trade agreements and regulations?
However, he does note that a possible Free Trade
Agreement between the US and EU could have an impact
on REACH and TSCA both. “The chemical industry could
benefit tremendously from such an agreement. In 2011
alone, the industry paid over $1bn in tariffs on chemicals
exported to the EU, and $600m of that was for fine and
speciality chemicals. Any agreement would have to
address TSCA and REACH requirements, and thus could
have an impact on these regulations for both US and
European manufacturers,” Mr Allmond says.
Specific product regulations
Beyond compliance
With respect to specific product legislation on the national
level, two different versions of legislation on cosmetics
safety that targeted the greater disclosure of substances
used in cosmetics were introduced in Congress in 2012,
but were not advanced. No other major new rules for
consumer products were enacted, either, according to
SGS-CTS’s Ms Viengchaleune. The latest development in
this area was the Consumer Product Safety Improvement
Act (CPSIA), which was implemented from 2008-11 and
resulted in a ban on the use of heavy metals (via ASTM
F 963) and stricter restrictions on lead in a much broader
range of children’s products. However, the US Food and
Drug Administration (FDA) did finalise a ban on the use of
Voluntary industry programmes can have a significant
impact on individual companies and the industry as a
whole. The programmes mentioned above – Responsible
Care, Responsible Distribution and ChemStewards – have
helped large and small manufacturers and distributors alike
in the US – and increasingly around the world – implement
employee environmental, health, safety and security
management programmes and continuously improve their
performance in all of these critical areas. The industry trade
associations also continue to develop these programmes.
For example, ACC is enhancing Responsible Care with
the recent adoption of a new Product Safety Code and
expansion of its Process Safety requirements.
Page 19
Ms Gibson notes that the slowing of the economy, the
perception of important regulatory failures in food and
product safety, airline maintenance and the financial
system, and the democratic administration have also
contributed to the increased level of enforcement.
The situation is quite challenging, particularly for
small manufacturers and distributors that have limited
resources. The fact that the EPA is relying on a very
vague regulation makes it even more difficult. The GDC
requires that companies with an undefined set of ‘other
extremely hazardous substances’ manage their chemicals
safely. “This general regulation gives the EPA tremendous
power to require facilities to change their procedures and
designs, and the facilities have limited recourse to question
the agency’s allegations,” Ms Gibson claims. Even for
companies committed to programmes like Responsible
Distribution, ChemStewards and Responsible Care and
who operate in a responsible manner, it seems not to be
difficult for the EPA to find a problem and issue a citation
she says.
investors are watching closely, too, as nonfinancial metrics
are considered a reliable indicator of risk management.”
Clearly, with the many compliance requirements
associated with existing US-based regulations, the
EPA looking to expand its authority under TSCA, the
Senate expected to propose new TSCA legislation, the
second phase of REACH registrations becoming due,
and international chemicals management and control
regulations growing at a rapid pace, 2013 promises to be
another challenging year for US manufacturers, processors,
distributors, and users of chemicals and those looking to
participate in the US marketplace.
Key country regulatory highlights in 2013
Europe
OO
OO
OO
OO
OO
OO
OO
Application dates for first chemicals to need
authorisation under REACH in February and August
Animal testing ban on cosmetics or cosmetic
ingredients into force on 11 March
Second REACH registration deadline (31 May) for
production/import volumes between 100 and 1,000
tonnes/year
EU Commission to review endocrine disrupting
chemicals (EDC) provisions of REACH on 1 June
China
OO
OO
OO
OO
EU cosmetics Regulation comes into force on 11 July
EU biocidal products Regulation into force on 1
September
EU Commission to propose criteria for identifying
EDCs by December
OO
OO
OO
OO
OO
EPA publishes first draft risk assessments from 83
existing chemicals prioritised in 2012 for public and
peer review, more expected in 2013
Republican and Democrat senators expected to
introduce bills to reform TSCA in spring;
California to adopt final Safer Consumer Products
rule in the spring
Requirements under Osha’s 2012 Hazard
Communications Standard to implement GHS take
effect, including new training duties by December
2013
Dodd-Frank Wall Street Reform and Consumer
Protection Act ‘conflict minerals rule’ requires first
disclosure on use of tantalum, tungsten, tin or gold
from Democratic Republic of Congo and surrounding
countries in 2013. Returns to be filed by May 2014
Canada
OO
OO
Information required to be submitted for 2,700
substances added to Domestic Substances List in
December 2012
Amendments expected to hazardous products Act
(HPA) and controlled products Regulations (CPR)
in spring to align them with GHS requirements for
chemicals in the workplace
List of hazardous chemicals for priority environmental
management is expected to be issued before the
summer
Revised Catalogue of Hazardous Chemicals due to
be published in 2013 triggering requirements under
several new or recently amended laws
Possible revision of GHS standards to align with
fourth revision of GHS
Finalisation of third (and possibly final) batch of food
contact additives approved by MOH
Taiwan
OO
US
OO
Measures for Environmental Administration
Registration of Hazardous Chemicals (MEP Order
22) come into force on 1 March
Legislation amending the Toxic Chemical
Substances Control Act (TCSCA) requiring chemical
manufacturers and importers to register designated
priority substances expected to be adopted by April
Japan
OO
Schedule set for new chemical notifications from April
to December under Chemical Substances Control
Law (separate schedule for low-volume substance
notifications)
South Korea
OO
Proposed Act on chemicals registration and
evaluation, dubbed “K-REACH”, due to be adopted
by the summer
Mexico
OO
Proposal for chemicals regulation (policy and legal
options) to provide a legal framework for recently
published first national chemicals inventory possible
Malaysia
OO
Regulations on classification, labelling and safety
data sheets for the use of hazardous chemicals in
the workplace and industry (‘CLASS’) due to be
issued for consultation
Vietnam
OO
Revision expected of main chemicals management
law, Decree 108/2008
Page 21
IHS believes that voluntary nonfinancial reporting is
another type of industry effort that is gaining increased
visibility. “Nonfinancial reporting issues have a broad
impact that reaches from resource acquisition to the bottom
line, and standards now approach the rigour required
for financial reporting,” observes Mr Trudeau. He adds
that more than 95% of the world’s 250 largest companies
now provide nonfinancial reporting. “With sustainability
information now widely available in the public domain,
companies are aware that environmentally conscious
stakeholders and customers can compare sustainability
performance among competing companies. Institutional
CAREERS AND SALARY SURVEY
A look at the chemical management and control jobs market
For the first time, Chemical Watch asked specific questions
about the salaries and career prospects of chemical
management and control professionals, those working
within industry and those working as service providers. Our
first question asked about the changes in the size of these
teams, both last year and for the next 12 months. About
half of respondents reported no change whatsoever last
year, while 37% said there had been an increase (Figure
3). Around 13% said there had been a decrease, which
may reflect greater outsourcing by industry, or smaller
teams due to the general economic downturn. The range in
responses reflects the fact that there are many varied and
conflicting factors that influence the job market.
Similar figures are reported for the next 12 months, with
around a third of participants expecting to see staffing
increase and more than half expecting no change during
that time. Nearly 9% actually expect a decline. As a whole,
it appears that the global market for chemical management
and control professionals increased last year, and will
continue to do so over the next 12 months.
Figure 3
Staffing trends within your employer
100%
90%
Figure 4
8.7%
12.9%
55.9%
50.1%
80%
37.0%
70%
50%
47.2%
60%
40%
50%
30%
40%
37.0%
35.4%
10%
30%
59.0%
42.6%
20%
0%
Last 12 months
Decreasing
Next 12 months
Static
Increasing
10%
0%
In your country
Poor
REACH continues to be a key driver of demand for
chemicals management and control skills. For some
companies, there are concerns about workloads following
the upcoming deadline in 2013, particularly because the
next deadline is several years away. “REACH by nature
is not a process that is evenly spread out. The three
registration deadlines have resulted and will result in some
quite extreme peaks and troughs in REACH compliance
activity, which creates a volatile job security situation,” says
Caleb’s Mr McKellar-Smythe.
Many others, however, feel that the job market remains
strong. For example, Linmark Consulting’s Mr Richards
expects the job prospects for regulatory professionals
to remain good in 2013, within both chemical producers
and consultancies. “Due to the importance of REACH in
allowing products on the European market and the diversity
Page 22
4.0%
10.2%
90%
70%
20%
Job prospects
100%
80%
60%
of global regulations, the roles of regulatory professionals
are becoming increasingly important within the chemical
industry,” he says.
The current REACH deadline is just one part of the
story, according to Ms Schliessner of McKenna Long &
Aldridge. “Companies also have to simultaneously deal
with authorisation and compliance check decisions, as
well as CLP compliance and enforcement. Hence the
workload is ever increasing, not diminishing. Additional
employment opportunities should thus be expected, unless
current staffers continue to work overtime due to the bleak
economic outlook. There should certainly be no lay-offs.”
The results of the Chemical Watch survey support these
sentiments. Nearly 96% believe that job prospects are good
or stable in the global market and nearly 90% feel the same
is true in their local market (Figure 4).
That confidence is also reflected by the fact that
nearly 90% of respondents to the Chemical Watch survey
indicated that they feel their job security has either
increased or remains the same in their specific role and
across all roles, compared to the last 12 months (Figure 5).
Stable
Globally
Good
“To my mind,” adds Chemservice’s Mr Drohmann, “jobs
are safe. Good regulatory affairs people are not generally
available on the jobs market, and if they are, extraordinary
salaries must be offered to attract them, at least in Europe.
We have started training people newly graduated from
universities, even though it is an investment to get them
to reach the necessary skill level.” JSC International’s Dr
Elsmore sees continued demand for high quality regulatory
support for industry driving growth within specialist
consultancy firms and shortages in the availability of
expert staff. Dr Knoell Consult’s Mr Cleuvers concludes:
“Compliance with global chemical management systems
is still an emerging issue, and professionals with expert
knowledge in this area are needed. We hired a lot of
people in 2012. I consider these jobs to be safe.”
Page 23
Figure 5
Figure 7
Job security compared with 12 months ago
100%
90%
Career progression opportunities
100%
11.3%
14.4%
80%
80%
70%
70%
60%
66.1%
40%
30%
30%
20%
20%
0%
19.9%
19.6%
In own role
Across all roles
Less secure
Similarly secure
More secure
In addition to largely feeling secure in their positions,
the majority of participants (60%) in the Chemical Watch
survey also felt satisfied with their roles (Figure 6). Of the
remaining, 29% do not feel strongly one way or the other,
and around one in ten are dissatisfied. This could be due to
the fact that many in the sector find themselves faced with
high requirements and limited resources to carry out their
tasks, according to Mr Van Heerden of REACHLaw.
Figure 6
Job satisfaction
Dissatisfied
11.2%
Satisfied
59.8%
Neither
satisfied or
dissatisfied
29.0%
Also on a positive note, many of the Chemical Watch survey
respondents (63%) believe that their career progression
prospects are good in the wider jobs market. They are,
however, less hopeful about the change for advancement
within their current employer, with only 38% indicating that
they have good opportunities for advancing their careers
within the same company (Figure 7).
International Cosmetics & Regulatory Specialists’s
Ms Blaschke gives a potential explanation for this finding:
To her, it seems that regulatory support staff are hired
at two extremes of the spectrum: basic entry-level and
clerical staff to do compulsory paperwork, and higherlevel worldwide upper management specialists in overall
compliance. “I have seen very little evidence of mid-level
jobs, and it appears that opportunities for advancement for
junior staff members are minimal,” she notes.
Page 24
31.0%
36.7%
50%
40%
10%
25.3%
60%
68.8%
50%
6.0%
90%
63.0%
38.0%
10%
0%
In your company
Poor
Neither
Wider jobs market
Good
Salary trends
Participants in the Chemical Watch survey kindly shared
information on their current positions and salaries. A
summary of the results is presented below. For the first
time, we provide useful data on salaries, pay rises, and
bonus levels in the global chemical management and
control community.
The group of survey respondents includes regulatory
affairs experts with a range of titles and positions (Figure
8). The largest groups were project/team managers (29%)
and specialists/technicians (29%), followed closely by
senior managers (24%). Directors/partners represented
12%, juniors/graduates 3% and government officers 3.4%.
The average age of the survey respondents is 45, with
just over 44% of them female. The average global salary
for chemical management and control professionals is
€46,200 (US$61,700), and almost half of the professionals
have global responsibilities within their organisations.
Unfortunately, the gender gap remains among our sample,
with men earning an average €55,700 and women just
€44,300.
The average salary is broken down by job title in Figure
8. Surprisingly, regulators receive the highest salaries, and
otherwise there is not a tremendous variation in pay levels
for the job titles shown in the chart, except for business
management/development positions, which earn a little less
than the rest, but are likely to receive larger bonuses.
There is, however, some differentiation in salaries
depending on the type of organisation (Figure 9). Survey
respondents working for government agencies earn
the most, followed closely by those working for trade
associations or professional bodies, both receiving average
salaries above €50,000.
Figure 8
Figure 9
Average salary by job title
Average salary by organisation type
Business management/development
Chemicals, life sciences and similar
37.2
45.4
Consumer products, cosmetics and similar
Consultant
44.6
Engineering, automotive, aerospace and similar
EHS management
44.4
47.9
Government & agencies
Other
52.7
49.6
Other
Product safety/stewardship
45.3
47.9
Other manufacturing
Regulator
46.8
53.0
Service provider, including consultants, laboratories, lawyers etc
Regulatory affairs management
46.6
46.1
Trade association or professional body
Toxicologist/chemist/scientist
50.7
45.3
Average salary
0
46.2
0
10
20
30
40
Euros 000s
50
60
Those employed by consumer products firms, nonchemical manufacturers and service providers earn
average salaries approaching €47,000. In addition, average
salaries were fairly close regardless of company size,
although participants at larger (over 250 employees) and
medium-sized (50-250 employees) firms had a slightly
higher average salary (slightly over €46,000) than those at
small-sized (less than 50 employees, €44,600) firms.
Basic salaries also vary significantly depending on
location (Figure 10). Chemical Watch survey respondents
in Europe earn an average €53,800, which is well above
the nearest amount of €35,900 for professionals in North
America, and significantly higher than the average salary
for survey participants in the rest of the world (€30,700).
20
30
Euros 000s
40
50
60
Figure 10
Average salary by job region
Europe
53.8
North America
35.9
Rest of world
30.7
Average
46.2
0
10
10
20
30
Euros 000s
40
50
60
Page 25
47.1
Not surprisingly, salaries also vary according to the
age of the survey respondents, with those aged 46-50
earning the most at €54,800, followed by those aged 3645 (~€50,000) and 51-55 ((~€48,000). The oldest survey
participants (over 65) earn the least at €28,800, which
probably represents reduced hours, while the youngest
respondents receive salaries just over €30,000 (Figure 11).
Over two-thirds of the Chemical Watch survey respondents
(70%) were entitled to a bonus. Of those that did receive
a bonus, the average bonus was 11.0%, with European
bonuses lower at around 9.5%, North American bonuses at
12.4% and those in the rest of the world at 16.7%.
Meanwhile, the average pay rise for those who stayed
in the same role was 2.4% and for those that gained a
promotion this increased to 7% (Figure 12). Participants
in Europe received the smallest pay rises, although those
awarded in North America weren’t significantly higher.
However, straight pay rises awarded in other parts of the
world were as much as three times those given in Europe
and North America.
Figure 11
Figure 12
Average pay rise
Europe
2.0
2.4
5.9
North America
2.4
3.0
7.6
Rest of world
6.0
7.1
10.5
Average
Average salary by age
2.4
3.0
21-25
7.0
33.9
26-30
0
33.9
31-35
Only
promotions
44.3
36-40
41-45
49.5
46-50
54.8
51-55
47.7
56-60
40.9
61-65
41.7
>65
28.8
10
20
30
Euros 000s
Page 26
40
50
4
6
%
Including
promotions
8
10
12
Excluding
promotions
Jobs and salaries in the UK and
Europe
49.3
0
2
60
While there is a lot of work to be done in the regulatory
and product safety areas, many firms are relying more on
in-house staff, as was noted in the Chemical Watch survey.
That trend has also been observed by John Sherratt,
business manager with placement firm VRS Regulatory, and
he attributes it to the challenging economic environment
that companies are facing today. He notes that companies
are keeping head counts down and external expenditures
limited, and using employees unless the project requires
specialised expertise that cannot be found internally.
The good news, according to Mr Sheratt, however, is
that for professionals with those specialised capabilities,
demand is very strong, and salaries are increasing. In
particular, people with REACH and biocide/agchem
registration experience, knowledge of testing, and
expertise in fate/exotoxicity analyses are in short supply
and high demand. In fact, for Nonstop Recruitment,
the demand for environmental fate specialists and
ecotoxicologists was even higher than expected in 2012,
according to Abid Kanji, country manager, toxicology,
ecotoxicology, regulatory affairs & REACH.
For other chemical management and control positions,
while the job markets in Germany, Netherlands, and
Belgium picked up markedly in 2011, it was the UK that
experienced a real increase in demand in 2012, according
to Mr Kanji. However, he notes that demand for regulatory
staff to support REACH, biocides and agchem regulations
has been greatest for junior to mid-range level positions,
and opportunities remain few and far between for directorlevel positions.
The US employment scene
Within the chemical manufacturing and downstream
manufacturing sectors, there is real demand for positions
at every level now, and in all types of positions, including
engineering and chemical risk management, according to
Greg Harper, vice president of the industrial practice for
Charles Aris Inc, a placement firm in Greensboro, NC USA.
“The economy is recovering, and not only is increased
demand for goods driving the need for more highly skilled
people, many employees who postponed retirement
because of the poor economic situation are now taking that
step and leaving additional positions vacant,” Mr Harper
notes. Further adding to the demand is the movement to
bring manufacturing back to the US.
Specifically for positions in the chemical risk
management area, the increasing regulatory requirements
around the world are an additional factor that is coming
into play. “These positions require specialised skills, and
there is a shortage in the US of people with these abilities,
because we don’t have that many graduating students
that have majored in these areas. So while there are fewer
of these types of positions available compared to, for
example, process engineers, people with these skills and
relevant experience are in higher demand and hard to find.”
As a result, his company, which is usually retained only for
filling the highest level positions, is currently being hired to
fill positions at the $80,000 level.
Another indication of the shortage of talent in the
chemical risk management field is the fact that consulting
firms in the US are turning to placement companies for
help with their hiring. “Usually, consulting firms have no
problem attracting people to fill positions. We have been
told by several firms that they are at capacity due to human
resource limitations. That they are looking for recruitment
firms to help find people means that the market is really
tight,” Mr Harper says.
The tightness has led to an increase in salaries. In
the recent past, he says, companies could differentiate
themselves from the competition with non-salary offerings,
but that is no longer enough.
The agriculture industry will be another source of new
jobs, and not just in the US. “All over the world, the average
age of employees in this industry is very high. There are
going to be a lot of people retiring over the next several
years, and we are expecting to see substantial growth in
hiring in this industry just to replace them, let alone the jobs
created by growth,” he predicts.
Most importantly, he expects that tight conditions in
the chemicals management and control – and general
manufacturing – job market in the US will continue for the
foreseeable future.
SERVICE PROVIDERS
Using service providers and future market trends
Given that the upcoming REACH deadline covers a far
greater number of chemicals with less available data, and
that other product-specific regulations will soon come
into force that also require extensive product data, it is
not surprising that laboratory testing was identified by
participants in the Chemical Watch survey as the most-used
type of service at the time of the survey, late in 2012 (nearly
29%, Figure 13). Consultancy services were second in
demand (almost 26%), which is also to be expected given
the complexity of many of the current regulatory systems
and requirements. There was also a real need for IT &
software services (12.4%) and training assistance (9.7%).
Figure 13
Services retained by participants
Training
9.7%
Other
services
3.2%
Consultancy
25.6%
Information
7.3%
IT & software
12.4%
Representation
& management
6.9%
Legal
6.4%
Laboratory
28.5%
Page 27
On the disappointing side, NonStop saw a 70% decline
in demand for toxicologists in 2012 as compared to 2011.
Interest did increase towards the end of the year, but not in
a manner that indicates any urgency. “It is possible that this
lack of growth/demand for toxicologists is due to the fact
that demand was extremely high in 2011, and the majority
of positions were filled. I am optimistic, though, that growth
will return in 2013,” Mr Kanji comments.
NonStop also expects demand for regulatory staff within
the flavour and fragrance industry to increase three-fold due
to the EU cosmetics legislation. There is a concern about
availability of candidates though, according to Mr Kanji. He,
therefore, expects that some cosmetic companies will be
willing to train people with experience in chemical and/or
consumer products regulatory affairs activities.
Also on the positive side, salaries are, at a minimum,
steady and definitely not declining for all positions in this
sector, according to VRS Regulatory’s Mr Sherratt. “In
fact,” he says, “the overall job market and demand in the
chemical management and control sector have been pretty
steady in the UK and Europe despite the recent global
recession and current economic situation, and the situation
is not expected to change in the foreseeable future.”
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PPP
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e-SDS Services
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Industrial Hygiene
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Study Design & Monitoring
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Figure 14
Interestingly, compared to the fairly significant differences
in the distribution of services used in 2010 and 2011, only
minor differences can be seen between 2011 and 2012
(Figure 16). Laboratory testing, as noted above, was in
greatest demand in 2012, as was the case in 2011. The
level of demand for the other main categories of services
was also similar in the last two years. The only differences
were a slight decline in the use of representation and
management, information and legal services, which was
counterbalanced by an increase in the demand for training
and other services.
Figure 16
Changes in the proportion of spending on provider service types
100%
Percent of chemical management work performed by in-house
teams at survey participant firms
90%
80%
100%
70%
90%
60%
80%
50%
70%
40%
60%
30%
50%
20%
40%
10%
30%
0%
20%
10%
0%
2010
2011
80-100%
40-60%
60-80%
20-40%
2012
0-20%
2010
2012
Other services
Laboratory
Training
Legal
Information
Representation &
management
Consultancy
IT & software
This increase in in-house spending most likely reflects the
current and challenging economic climate and is therefore
not unreasonable. In response to the increasing complexity
of global regulatory requirements related to chemical
management and control, more companies in 2012 pushed
towards establishing separate compliance divisions than
towards the integration of their compliance activities with
the overall management activities of the company (Figure
15).
2011
With respect to the frequency with which Chemical Watch
survey respondents use external chemical management
and control services, regardless of the type of service,
they utilise them on an occasional basis (30-53%) far more
than on a frequent (10-27%) or permanent (10% or less)
basis (Figure 17). Both consultancy and laboratory services
are the most likely to be used on a frequent or permanent
basis by survey participants.
Figure 15
Integration changes at survey respondents over the last 5 years
Move towards general
management
24%
Remained
the same
45%
Move towards separate
compliance divisions
31%
Page 29
Expenditures on outsourced chemicals management and
control services in 2012 was measured in the Chemical
Watch survey. The 289 respondents who are purchasers
of services invested on average approximately €1.3m
on outsourced services, which equates to a total yearly
expenditure of €370m. Alongside this, an increasing
proportion of work is going to in-house teams (Figure
14). In fact, in 2012, 78% of respondents indicated that
60% or more of spending on chemicals management and
control activity was for in-house efforts, which is up from
approximately 61% in both 2010 and 2011. In fact, on
average, 72% of chemical management and control work
was performed in-house in 2012, compared to 63% in 2011
and 62% in 2010.
Figure 17
Frequency of service retention by survey participants
Consultancy/advisory
10%
26%
49%
Representation & management
3% 10%
30%
Legal services
3% 12%
53%
Laboratory
10%
27%
37%
IT & software solutions
9%
17%
38%
Information services
9%
16%
35%
Training
2%
21%
52%
Other services
2%
21%
0%
Permanent
52%
% of participants
Frequent
100%
Occasional
Customer perceptions of the service
provider market
Even though the preference appears to be to use in-house
chemical management and control resources as much
as possible, it appears that the continued growth in the
number of regulations being developed and implemented
around the world will require chemical, consumer product,
and other manufacturers and suppliers that participate
in global markets, to increase their reliance on external
service providers for assistance. There is, however, concern
in some cases about the ability of service providers to
meet the full extent of their needs.
The specific concerns of end users of chemical
management and control services depend largely, of
course, on the location of their largest customer bases. For
one large downstream manufacturer of speciality products,
REACH, CLP, GHS and the changing global registration
environment, are at the top of the list because the company
has a large EU portfolio of manufactured and imported
chemicals, and is also moving into new and evolving
markets with developing regulations (e.g. Asia Pacific).
Honeywell Performance Materials and Technologies
has a similar focus, with major elements of its chemical
management and control programme in 2012 covering
compilation of eSDSs, preparation for the 2013 REACH
registrations, substance notifications in China and following
up on GHS implementations globally, including adapting
label systems to the new requirements, according to Mr
Verbiest.
Page 30
For speciality chemical firms Eastman and Ashland,
it is not surprising that US-based regulations are high on
the list of issues to deal with, followed by REACH and
increased country-specific regulations, again particularly
those in Asia. Meeting the first reporting requirements of
the new US EPA’s Chemical Data Reporting (CDR) rule was
a big task in 2012, according to Eastman’s Mr Schüller.
Compliance with the new GHS requirements will have a
huge impact in 2013 for both companies. Managing conflict
minerals and international food contact compliance and
staying on top of the Canada inventory update will also be
important for Ashland in 2013, says Dr Lindquist.
While these increased regulations have not, for the
most part, had any major effect on the availability of
chemicals, Ashland has experienced some loss of ability
to manufacture certain products because certain countries
are in the middle of implementing requirements under
global chemical conventions. Sourcing raw materials used
in products manufactured in the EU has also become an
issue for Ashland.
A lack of significant improvement in supply chain
communication is not helping the situation. One large
downstream producer says it has observed some
improvements, but not nearly enough, particularly given the
urgency of the 2013 REACH deadline.
Honeywell is also unhappy with the current status
of supply chain communication. “Many companies,
particularly distributors and SMEs, are requiring
statements and/or confirmation that are not required by
any regulations, and are thus adding significantly to the
workload of our regulatory compliance efforts.” Mr Verbiest
says. “The basis for the requests is largely due to a lack of
understanding of the regulations, and the need for eSDSs
and a lack of IT technology to cope with them have made
clear communication even more difficult. Unfortunately, we
do not expect much improvement in 2013, either; the new
registration deadline will mean that a significantly greater
number of eSDSs will be requested, and managing the
language requirements for the very technical extensions
will be challenging.” Eastman, too, would like to see more
standardisation of eSDSs across and down the supply
chain to make the process more efficient and effective,
according to Mr Schüller.
For service providers, however, the increasing work
load does mean that these companies anticipate a need for
external support. In 2012, a leading flavour and fragrance
manufacturer outsourced support for toxicological studies,
risk assessment and registration services because the
company does not have in-house toxicological facilities and
the registration workload was very high. Those workloads
are expected to increase further in 2013 due to the need
to begin preparations for the REACH 2018 deadline and
other global registration demands, and thus the company
will be increasing its use of service providers, according
to a spokesperson. Honeywell also mainly uses outside
consultants for compiling and follow- up of substance
notifications and registrations. The intensity of such
requirements has increased recently, and Mr Verbiest
anticipates that it will continue to do so over the next few
years, because more countries have started or planned
for substance or product inventories. There will thus be
greater need for external support to meet these growing
requirements. And while Ashland does not cite any specific
services over others, the company’s need for global
consultants has become more frequent, and will continue to
do so, according to Dr Lindquist.
between clients and service providers has also declined by
10%.
Figure 19
Satisfaction levels in 2012 and 2011
Availability
53%
70%
Personal relationship
60%
70%
Experience/knowledge in all countries in which you operate
43%
50%
Offering flexibility
48%
53%
Adding value on top of agreed deliverables
34%
49%
Technical knowledge
68%
75%
Providing value for money
44%
47%
Price of service
33%
41%
Figure 18
Change in overall satisfaction levels for survey respondents
Delivering on schedule
57%
63%
% of participants
100%
90%
3%
9%
80%
3%
2%
19%
25%
Meeting your brief
62%
72%
70%
60%
0%
50%
40%
88%
78%
30%
73%
20%
10%
0%
2010
Dissatisfied
2011
Neither
2012
Satisfied
% of participants satisfied
2012
100%
2011
Prices, always a point of contention, are becoming a bigger
issue; only 33% of clients are currently satisfied with the
prices charged by their service providers, which is down
from 41% in 2011 (Figure 20).
Given the decline in overall satisfaction, it is interesting
that fewer Chemical Watch survey respondents are
currently considering changing suppliers (with those saying
‘yes’ or ‘possibly’ down from 61% last year to 53% this year;
Figure 21).
There has also been a marked drop in satisfaction levels
in qualifying characteristics of service providers (Figure
19). For example, just 53% of this year’s participants
are satisfied with the availability of the service provider
compared to 70% in 2011, while just 62% are happy that
their briefs are being met, a drop of 10 percentage points
from last year. Satisfaction with personal relationships
Page 31
All of these users of chemical management and control
service providers, however, are very careful about which
firms they do business with. Honeywell uses a substantial
pool of consultants and has been rather conservative in
its choices, according to Mr Verbiest. “We do have the
impression that a number of ‘new’ consulting shops are
not really experienced or knowledgeable about what they
are trying to sell,” he notes “We do not want to spend our
time educating new consultants, and have therefore mostly
retained the services of long-term and well -established
firms; the cost for these providers may be higher, but we
still feel that we get value for money with them.”
Ashland, too, tries to work with firms with which they
have had past experience and have been satisfied, and
particularly those with whom they have established a
relationship over time. That is not always possible, of
course, and says Dr Lindquist, the company has several
projects underway now for which they are evaluating the
quality of the service. Meanwhile, a leading flavour and
fragrance producer has had some disappointments in
2012, with some service providers overestimating their
capabilities. “Some providers appear to lack project
management skills and business acumen and have a poor
appreciation of strategic goals,” says a spokesperson for
the firm. As a result, the overall level of satisfaction with
providers has declined in the last year, and the company
is looking for providers with a commitment to accuracy,
efficient communications, effective working processes and
quality.
Our survey suggests that this company is not alone
in feeling less satisfied with chemical management and
control services recently. In fact, overall satisfaction levels
with the work of service providers have decreased from
88% at the time of the first survey at the end of 2010, to
78% last year and 73% currently (Figure 18).
Figure 20
Satisfaction levels of survey participants with prices charged
for services
Dissatisfied
12%
Satisfied
33%
Chemical Watch survey respondents also indicated
that, as VRS Regulatory’s Mr Sherratt noted for job seekers,
having well-established expertise is of critical importance
if service providers are to be successful. Staff with relevant
expertise and proven experience on similar projects were
cited most often (86% and 79%, respectively) as the top
factors when users are selecting a new service provider
(Figure 22). In-depth knowledge of country-specific
regulations was also important for a significant number
of respondents (66%). Other factors of note include
availability (51%), proposal quality (51%) and global
capabilities (46%).
Figure 22
Most important choice factors for survey participants
Neither
54%
Expertise of key staff
86%
Proven experience on similar projects
79%
Figure 21
Interest level of survey respondents in changing suppliers
100%
In-depth knowledge of country-specific regulations
66%
Availability
90%
80%
70%
46%
39%
51%
47%
Comprehensiveness/accuracy of proposal
51%
60%
Ability to operate on a global scale
50%
40%
30%
48%
51%
46%
44%
Contract price
20%
37%
10%
0%
6%
10%
9%
2010
2011
2012
No
Possibly
Yes
Nevertheless, more than half of users say they are thinking
about changing their suppliers for various reasons and
chief among them is value for money. Lack of availability,
flexibility and on-time delivery were also cited by several
different respondents as major reasons for switching to a
different supplier. Some, on the other hand, have developed
new needs that their existing suppliers can’t meet, and
while satisfied with the support they have received to
date, need to find an alternative provider with the relevant
expertise.
Honeywell’s Mr Verbiest, for example, while satisfied
with his established pool of providers, says he is also
looking for new capabilities. “We would like to see service
providers, if possible experienced, that can help us look
at relatively new regions for our chemicals control portfolio,
regions such as Russia, India, South America and the
Middle East. With countries in these regions looking at
‘easy-to-implement’ regulations that are copies of REACH
or drop-ins for the UN GHS, we anticipate significantly more
regulatory needs in the global marketplace.” For similar
reasons, translated resources are described as a critical
need for Ashland.
Page 32
Appropriate accreditation/certification
35%
Recommendation from peers
28%
Independence of supplier organisation
21%
ISO9001 or equivalent (quality management)
19%
ISO14001 or equivalent (environmental management)
17%
Inhouse equipment/software
13%
Large size of supplier organisation
5%
Proximity to your office
4%
0%
20%
40%
60%
80%
100%
% of participants
Fig. 23
Figure 24
Anticipated future need for in-house staff
1%
Next 12 months
8%
37%
Next 5 years
2%
11%
Strict adherence to project protocols
28%
48%
0%
Most important relationship factors for survey participants
7%
47%
100%
% of participants
Increase significantly
Decrease
11%
Increase
Static
Decrease significantly
47%
Building long-term relationships with individual staff
47%
Service level agreements in place
37%
Suppliers keeping costs as low as possible
33%
Regularly reviewing (and at times changing) suppliers
27%
Figure 25
Regular face-to-face meetings
Anticipated future need for external services
23%
Paying more to get better value
2%
Next 12 months
13%
5%
Use of penalty clauses
3%
0%
The outlook is even stronger for external service demand,
according to the survey results. In the next 12 months, while
44% expect demand to remain static, another 49% expect
an increase, and that number rises to 59% for the next
five years with 8% of respondents predicting a significant
rise in demand (Figure 25). One leading manufacturer’s
experience matches the results of the survey: the company
says it increased its use of external services in 2012
compared to 2011, and expects it will do so again in 2013
due to increasing workloads for REACH 2018 and global
registration demands.
44%
44%
2%
Next 5 years
10%
20%
30%
40%
50%
8%
5%
51%
31%
8%
% of participants
Implications for the future demand
for services
Overall, participants in the Chemical Watch survey were
positive about the health of the services market. With
respect to the need for in-house staff, 47% of survey
respondents expect the situation to remain static over the
next 12 months, while 45% anticipate need to increase
(Figure 24). That increases further in the longer term, with
expectations for an increase in the need for in-house staff
rising over the next five years to 59%.
0%
% of participants
Increase significantly
Decrease
Increase
100%
Static
Decrease significantly
Of the services that will be used in the next 12 months,
the greatest percentage of participants in the Chemical
Watch survey expects demand for training and information
services to increase (64% each; Figure 26). Demand for IT
& software, consultancy/advisory and laboratory services
are, meanwhile, expected to increase by 56%, 51% and
47%, respectively.
Page 33
As mentioned by Dr Lindquist of Ashland, companies
looking for external support for chemical management
and control activities often prefer to work with providers
with whom they have developed a relationship. Survey
respondents indicated that certain aspects of those
relationships are more important than others (Figure 23).
Strict adherence to project protocols and having long-term
relationships with individual staff were identified as the top
factors by 47% of the survey participants. Having service
level agreements in place (37%), keeping costs under
control (33%) and conducting regular reviews (27%) were
other factors that can have a strong positive influence on
the relationship between service providers and their clients.
Figure 26
Figure 27
Anticipated need for external sector services by survey
participants in the next 12 months
Anticipated need for external sector services by survey
participants in the next 5 years
36%
7%
63%
8%
56%
Legal services
Legal services
47%
5%
59%
36%
49%
5%
Laboratory
Laboratory
40%
56%
63%
5%
8%
32%
5%
Information
Information
34%
64%
29% 2%
69%
2%
Training
Training
32%
64%
29% 4%
66%
4%
Other(s)
Other(s)
81%
17%
% of participants
Increase
36%
IT & software
IT & software
0%
56%
7%
45%
47%
Static
26%
2%
100%
Decrease
These numbers change only slightly when looking five
years into the future (Figure 27). The largest percentage of
survey participants (over 66%) expect that the demand for
information and training services, along with IT & software
support, will continue to increase, followed by laboratory
and consultancy services (~55%). Most importantly, in all
of the service categories, respondents were more likely to
predict that demand is likely to rise over the next five years
than in the next 12 months.
It is interesting to see how the survey results were borne
out in our qualitative discussions. Chemical manufacturers
Givaudan, Eastman Chemical, Honeywell Performance
Materials & Technologies and Ashland have external
service needs that fall into the leading categories identified
by the survey. Givaudan outsources toxicological and
environmental studies, risk assessment and registration
services, while Honeywell mainly uses outside consultants
for compiling and follow -up of substance notifications and
registrations. Eastman, meanwhile, uses a consultant to
send Sief surveys for REACH in order to gauge the interest
in co-registration when the company is the Lead Registrant,
and outsources laboratory testing. Ashland, on the other
hand, turns to external consultants as issues arise, and
particularly those that can address global chemical
management and control requirements.
Page 34
9%
35%
30%
56%
7%
43%
51%
0%
72%
% of participants
2%
100%
Increase
Decrease
A breakdown of theStatic
anticipated growth
in demand for
specific external sector services over the next five years,
as indicated by respondents to the Chemical Watch survey,
is shown in Figure 28. Demand for guidance on how to
interpret regulations is expected to increase the most (64%),
followed by support for material safety data sheet (MSDS) and
chemical hazard database information management activities
(60% and 56%, respectively) and product compliance
assistance (57%). Over half of survey participants also expect
to see increases in the need for training courses, regulatory
policy tracking support and IT solutions for regulatory
information management and MSDSs.
Concluding remarks
It’s a good time to be in the chemical management and
control service market. With increasing country-specific
and product specific regulations being introduced around
the globe, implementation of individual GHS requirements
and all aspects of REACH now moving up to full gear, the
compliance workload is increasing. Many companies are
striving to rely on in-house staff as much as possible, but
must turn to external service providers with specialised
areas of expertise. Therefore, demand for services is
expected to increase in both the short and long terms.
Chemical management and control service providers
would do well to note, however, that when companies do
commission their services, they look for providers with
proven expertise and experience, that meet deadlines,
manage projects well and generally go beyond the
minimum. Providers with a recognised history of excellent
performance, an awareness of changing market dynamics
and the ability to understand and address client needs, will
therefore benefit most from the anticipated growth.
Figure 28
Anticipated need for specific external sector services by survey participants over the next five years
Product compliance
Supply chain communications
Consultancy/
advisory
48%
47%
46%
6%
48%
5%
Registration strategies
42%
52%
6%
Assessment of data quality
40%
55%
6%
Testing strategies
33%
61%
6%
SVHC advisory services
32%
61%
7%
Corporate strategy/strategic planning
32%
62%
6%
Chemical transport and warehousing advice
68%
21%
Dossier preparation & safety assessment, including CSA/ CSR
40%
GHS notification
Representation
& management
11%
49%
7%
54%
6%
44%
Registration services
56%
35%
CLP notification
9%
58%
32%
10%
Management (SIEF, Consortium etc)
25%
65%
10%
Representation (Lead, Only representative, 3rd party etc)
24%
65%
11%
Business process outsourcing (BPO)
73%
15%
(Material) safety data sheets
Information
Laboratory
12%
60%
38%
2%
Chemical hazard database
56%
42%
1%
Regulatory/policy tracking
55%
44%
1%
Managed regulatory content
45%
Ecotoxicology
43%
52%
4%
Environmental fate & degradation
41%
53%
5%
Human health toxicology
39%
57%
4%
53%
2%
Physical & analytical chemistry
37%
58%
5%
Exposure testing
36%
60%
5%
Environmental monitoring
34%
61%
5%
SVHC testing
IT solutions
2%
41%
57%
Environmental risk assessment
3%
34%
64%
64%
31%
5%
Regulatory information management
56%
42%
2%
(Material) safety data sheet systems
54%
43%
3%
Substance inventory management systems
49%
46%
4%
Supply chain management/ communications systems
46%
49%
4%
EH&S solutions
Consortia/registration management solutions
CPD/CES certified training
Lobbying/advocacy
Other
23%
Insurance
18%
0%
7%
60%
7%
71%
6%
78%
% of participants
Increase
7%
77%
33%
Legal representatve
4%
60%
34%
16%
10%
42%
54%
Bespoke/inhouse training
10%
70%
20%
Training courses/webinars
4%
67%
23%
Laboratory information management solutions
Training
57%
39%
Static
5%
100%
Decrease
Page 35
Guidance on regulation interpretation
SERVICE AREA BREAKDOWN
Other
20%
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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.
2011/12
Turnover, group
<£100,000
Turnover, chemical service provision
<£100,000
No of offices
No of countries represented
Representation
& management
20%
Training
20%
Website
VITAL STATISTICS
Consultancy/
advisory
20%
1
All
Staff, group
10-100
Staff, chemical service provision
10-100
With the introduction of REACH, CLP, GHS etc, there is a greater
expectation that publicised emergency telephone numbers not only operate,
but are directly answered by someone who can provide pro-active advice.
More and more, manufacturers and distributors of hazardous goods are
subscribing to the standards set by the chemical industry’s Responsible
Care initiative. Companies that commit to the programme are required to
implement a wide range of health, safety and environmental measures
including the provision of a reliable Level 1 response.
Chemical emergency line – 24 hours a day, 7 days a week
All calls to the Chemical and Hazmat Emergency Line are recorded
and detailed reports are sent to the client. Contact information for key
personnel is held on our system should urgent notification be required –
usually in the case of a major incident.
Using modern communications technology, with extensive back-up functionality,
24-7 Response offers a robust and cost-effective solution to the demands of
operating a specialist emergency telephone number round the clock.
There has been an increase in the requirements for companies supplying
chemicals and hazardous goods to display emergency telephone
numbers. There is also a greater focus on how these numbers operate
and what type of specialist advice can be accessed by the caller. Some
of these demands are regulatory obligations, whilst others reflect the
expectations of industry and those transporting or using the products.
For example, all REACH compliant safety data sheets must display
an emergency number and, as GHS is rolled out to other regions, this
requirement will no doubt increase – as will the need for advice to be
provided in local languages.
24-7 Response has developed a robust process that enables advice to
those dealing with incidents involving hazardous goods to be given in the
language of the caller.
The Multilingual Emergency Line number(s) can be displayed on safety
data sheets, product labels and transport documentation. Using a unique
system devised by 24-7 Response, expert advice is easily accessible and
delivered, if necessary via translators, by one of their team of incident
advisors. They are all chemists and have, between them, nearly 20 years’
experience of providing expert advice to those dealing with emergencies:
OO
24 European languages;
OO
primary Asian languages and Arabic;
OO
regulatory obligations met in China and elsewhere;
OO
built in back-up and failsafe functionality;
OO
all calls are recorded;
OO
reasonably priced;
OO
incident responders are all chemists;
OO
mobile phones not relied on for providing advice.
REACH consultancy compliance help and advice
With an in-depth understanding of the regulations that apply to the
transport and supply of chemicals, our consultants can help companies to
comply with REACH, CLP/GHS, IATA, ADR, lithium battery transport and
other international regulations.
24-7 Response offer a number of services based around REACH, the key
Page 36
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.
CLP and CLP notifications
We can help you to manage the classification, labelling and notification
processes associated with CLP.
Dangerous goods transport advice (DGSA)
There is a legal requirement under ADR for anyone involved in the
loading, unloading or transportation of dangerous goods to appoint a
dangerous safety goods advisor (DGSA). 24-7 Response has a team of
qualified DGSAs that are able to offer advice or act as your DGSA.
Through our sister company, PTF Training, we also run regular SQA
accredited DGSA training courses.
Chemical incident management and clean up
Incident management response: situations often occur when the presence
of an expert on the scene is required, 24-7 Response can contact an oncall OHES incident manager and arrange for them to attend the scene.
Training
Drawing on our incident advisors’ expertise, we have designed training
courses that will give your staff an understanding of the risks when
handling chemicals – and mitigate the consequences should things go
wrong.
Chemical transport training
Chemical safety training
CLP (classification, labelling and packaging) training
Lithium battery safety and legislation training
DGSA training
PARTNERS
Westfarmers, OAMPS, OHES, PTF Training, PTF Consultancy
TESTIMONIALS
“We have found 24-7 has provided us with a completely professional and
efficient service, it is very important to know that all calls are dealt with by
professionals and that any advice complies with regulations at all times.
As the implications of any incidents relating to fuel spillages etc have the
potential to be very serious the experience with the emergency response
service has been excellent and we would strongly recommend 24-7 to
anyone within the industry.” – Ray Fowler at Goff Petroleum
“Our dealings with 24-7 Response have been of a high standard. It is
reassuring to both ourselves and our customers to have the back-up of
a credible and professional supplier in the HS&E field.” – Neil Ryding at
FAST Exocet
CASE STUDY 1: First aid
A catering assistant got a splash of caustic automatic dishwashing
detergent in the eye. His colleague called the emergency number and
said that he had rinsed the victim’s eye out for 15 minutes (as per the
advice given on the product label and SDS), however he was still in
significant discomfort and the caller was about to drive him to the nearest
accident and emergency department.
The advice given by our incident advisor was not to take him to hospital,
but to continue to rinse the eye and call an ambulance so that it could be
irrigated all the way to A&E. This may have prevented irreparable damage
to the eye and stopped the incident escalating to a point where the HSE
could have been involved.
Being able to offer quick and correct first aid advice reduced the risk of
serious personal injury and the employer’s liability claim, which could
have potentially run to a six figure sum.
STAFF SELECTION
Caroline Raine – Principal Consultant of 24-7 Response
Caroline assists those managing major emergencies, to help minimise the
impact of a chemical incident. Caroline is a chemical legislation expert,
with experience of interpreting and implementing EU legislation relating
to hazardous chemical substances. This experience has been developed
while working directly in the chemical industry and on consultancy
projects. Caroline is a qualified dangerous goods safety advisor, for the
transport of hazardous goods by road and rail. In addition Caroline is a
committee member of the Chemical Hazards Communication Society
(CHCS) and is a founder member of the British Association of Dangerous
Goods Professionals (BADGP).
Richard Shreeve
Richard has more than 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.
Stephen Walker
Stephen has recently joined the 24-7 Response team as an incident
advisor and regulatory consultant. He has a strong chemical regulatory
background, in particular the production of safety data sheets and
labels for a variety of different countries. He also has several years of
experience in providing Level 1 emergency advice to those dealing with
chemical incidents.
Darryl McLeod
Darryl joined 24-7 Response as an incident advisor in August 2012, with
several years’ previous experience of chemical emergency response,
chemical hazard legislation and hazardous waste management. Darryl
works within the areas of incident response, DGSA consultancy, tanker
training and chemical hazard awareness, among others. Darryl is also an
Associate Member of the Emergency Planning Society, with a particular
interest in HazMat/CBRNe and transport security.
Page 37
PROFILE: 24-7 Response
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.
GLOBAL OFFICES
Carlsbad, CA, USA: 3E Company's world headquarters and the worldrenowned EH&S Mission Control call centre
Copenhagen, Denmark: European headquarters and SDS authoring and
related regulatory services centre-of-excellence
Montreal, QC, Canada: SDS management products and services operations
Bethesda, MD, USA: Ariel global regulatory data development and operations
Kingsport, TN, USA: SDS authoring centre-of-excellence
Canton, OH, USA: MSDgen SDS authoring platform product, operations
and support centre
PROFILE: 3E Company
CONTACTS
Website
www.3ecompany.com
E-mail
[email protected]
Head office
3207 Grey Hawk Court, Carlsbad, CA 92010, USA
Tel/ Fax
+1 760 602 8700/ +1 760 930 6662
SERVICES PROVIDED
Directors
Robert S Christie, President and CEO
Leo Oves, Vice President, Research and Development
Jeffrey Starr, Vice President, Marketing
Greg Merwin, Vice President, Global Sales
Andrea Verspay, Vice President, European Sales
Alan Goodman, Director, Asia and Latin America Sales
Alex Ortiz, Vice President, Ariel US Operations
Clark VanScoder, Vice President, MSDgen Operations
Regulatory data access and delivery – decision support
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® – integrated chemical, regulatory, toxicity and
eco-toxicity data, vendor MSDS data, expert rules, multilingual phrases,
document and label templates, and data loading tools for managing EH&S
compliance activities in SAP EHS management and SAP Material Master.
OVERVIEW
SDS authoring
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 SDS 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;
SDS authoring systems and services; SDS distribution and management;
transportation; emergency response; regulatory reporting and hazardous
waste management.
Professional services
MSDgen ® SDS Authoring Software – an enterprise software solution
suite designed for companies’ in-house EH&S staff
SDS authoring services – provides outsourced or co-sourced
assistance with authoring SDSs via 3E’s own fully-dedicated, in-house
staff of highly qualified, multi-lingual authors
SDS distribution – facilitates the dissemination of SDSs to all stakeholders
Turnover, group
-
-
No of offices
6
-
Staff, group
-
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 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 SDSs and labels
DGSA (dangerous goods safety adviser) – 3E can serve as a
company’s DGSA
-
Supply chain data and sustainability tools
VITAL STATISTICS
2011/12
IT & software
10%
Other
5%
Consultancy/
advisory
5%
SDS management and workplace safety
Information
80%
Page 38
Supply Chain Product Compliance Management – products and service
to facilitate compliance with regulatory and market driven requirements
related to detailed information about the source and origin of products
3E Green Product Analyser – provides powerful regulatory and
toxicology analysis of products
SDS management: a variety of products and services for the
management of vendor supplier SDSs.
Transportation: 24-7-365 global hotline access for guidance and
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.
CORPORATE DEVELOPMENTS & ACHIEVEMENTS
1998
Company founded
2004
Acquisition: Ariel Research Corporation; international expansion
2007
Acquisitions: HSE Systems and MSDS Solutions
2008
REACH and GHS initiatives
2009
AMR Research (now Gartner) publishes report, “3E moves its
way to outsourced MSDS management leadership”
2010
Acquired by Verisk Analytics
2002
-13
Seven-time winner Environmental Business Journal Business
Achievement awards. Winner of five 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, Kyocera, CIRS, ChemSW, SciQuest,
Kelaroo, Waste Management, RegScan, Redstone, SOCMA
ChemStewards
CLIENTS
Illinois Tool Works, the Linde Group, Kraton Performance Polymers,
Inc, Vestas, Banner Health, City of Manassas School District, PJ Food
Service, a subsidiary of Papa John's, Spartech Corporation, Perstorp,
Cabela's,Shell Oil, Brenntag, Sumitomo Chemical, KMG Chemicals Inc,
Supreme Chemicals of Georgia, JM Huber Corporation, City of Amarillo,
GrafTech International, Cabot Microelectronics Corporation, Novelis,
Southwest Airlines, Eastman Chemical, DTE Energy, Costco Wholesale
Corporation, Temple-Inland, Exelon Corporation, America West Airlines,
Western Medical Center – A Tenet Hospital, Cleco, Menasha Corporation
TESTIMONIALS
“Working as a team, these companies built a new SAP EH&S platform for
Europe, which will also be used as a global SAP template in the years to
come. The cooperation between IDS Scheer Consulting and 3E Company
created a powerful combination of process know-how, implementation
experience and state-of the- art content.” – Linde AG.
“We are confident that WebInsight provides us with the comprehensive
coverage that we require to support our regulatory compliance initiatives. The Ariel content found in WebInsight is current, and our team knows and
respects that it is a reliable source of information.” – Kraton Polymers.
CASE STUDY 1: Vestas Wind Systems blows away global
deployment challenges with 3E Online-SDS
Industry: manufacturing – wind turbines
Challenge: Vestas had no way to consistently and efficiently manage
3500 SDSs in multiple languages across its 14 business units.
Solution: 3E Online-SDS
Results: “Perhaps one of the most significant benefits is having
increased confidence that SDS updates are being executed in an efficient
and reliable manner. Prior to deploying 3E Online, the updating process
was one of our biggest challenges. SDSs were always updated, but
weren’t always proliferated to all of our different sites.
CASE STUDY 2: Illinois Tool Works relies on MSDgen to forge
accurate, compliant, multilingual SDSs
Industry: diversified industrial manufacturer of value-added consumables
and specialty equipment operating 800 decentralised business locations
globally, including 200 outside the US.
Challenge: each business responsible for developing SDSs using their
own method and technology, resulting in inconsistent and sometimes
inaccurate SDSs, which propagated throughout the enterprise.
Solutions: MSDgen authoring software.
Results: “We are confident that MSDgen is providing us with the
regulatory information we require to conform to the regulations and
initiatives impacting our business. Authoring SDSs can be quite complex
and cumbersome, especially when authoring on a global basis. MSDgen
eliminates much of the complexity by always ensuring that we have
access to the regulatory information we require – at the click of a button.
As a result, the data on our SDSs has become more reliable, and the
quality of our SDSs is more consistent.”
STAFF SELECTION
Pernille Brinklov, Managing Director, 3E Company Europe
Pernille Brinklov is responsible for managing 3E’s European operations,
interfacing with product management, sales, senior management and
customers to ensure operational plans and activities are aligned with
business priorities and customer needs. Ms Brinklov has an extensive
background in international business, working for several international
companies in an environmental, health, safety and sustainability
management capacity, including Biogen Idec, CP Kelco & Huber
Engineered Materials and Novo Nordisk A/S. She has been responsible
for establishing and maintaining EH&S Management Systems and
has a Six Sigma green belt. She has her Bachelor of Science degree
in chemical engineering and actively participates in several local and
international environmental health and safety events.
Kami Blake, Solutions Engineer, 3E Company
Kami Blake is a Solutions Engineer with 3E Company. In this role, she
provides technical expertise to assess regulatory requirements, information
management technology and analysis of existing HazMat programs to
develop compliance solutions. Ms Blake launched her career in 1982 in
the United States Marine Corps and is a two time Navy Achievement Medal
recipient for small systems implementation and training.
Prior to joining 3E in 2002, Ms Blake served in quality assurance, supply
chain management and process engineering roles in the biotech and
medical device manufacturing industries.
As a technical writer, Ms Blake has authored articles on regulatory challenges
and compliance solutions that appear in prestigious EH&S journals and
publications. She also shares her HazMat related expertise during discussion
groups, serves as an expert panelist and presents topics of concerns at
national and regional environmental, health and safety conferences.
Scott Stephens, Regulatory Research Analyst
Scott Stephens oversees regulatory research for Western Europe and
also for Russia and the former Soviet Union, in support of Ariel products,
including WebInsight. Prior to joining 3E Company, Mr Stephens
worked in a number of different capacities, including as a corporate
governance analyst, a foreign media analyst and an editor for several
English language publications in Central Europe. Mr. Stephens earned
his master of public administration in 2004 from Maxwell School at
Syracuse University; his undergraduate degree is in German and Russian
languages and literatures from the University of Kansas.
Page 39
PROFILE: 3E Company
Hazardous waste management and classification services: that
support customers’ hazardous waste management obligations, including
proper storage and disposal.
GLOBAL OFFICES
The Acta Group LLC
2200 Pennsylvania Avenue, NW
Suite 100W, Washington, DC 20037-1701
Tel: +1 (202) 266-5020
The Acta Group China LLC
1009 Tongguang Tower
No 12 Nongzhanguan Nanli
Beijing, China 100125
TEL: 86-10-84534538
PROFILE: ACTA
CONTACTS
Website
www.actagroup.com
E-mail
[email protected]
Head office
23, New Mount Street, Manchester, M4 4DE, UK
Tel
+44 (0)1612127405
Contact
[email protected]
Directors
Lynn L Bergeson and Lisa M Campbell
Ownership
Private company, affiliated with:
Bergeson & Campbell PC
B&C Consortia Management LLC
Locations
US, UK and China
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 clients’ existing problems and to minimise future difficulties.
We take a multi-disciplinary approach in assisting our clients. Attention
must be paid to the interplay of all branches of government and interest
groups. Our capabilities, borne of site- and issue-specific experience,
combined with our national and international view on policy and regulatory
developments, position us to handle all these tasks with judgment,
creativity, and efficiency.
OVERVIEW
The Acta Group LLC is a leading international specialist in chemical
product approval, support, and regulatory defence.
Acta was 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 manages 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 regulatory team
provides project management for fast-track product approval by building
support and defence packages for product portfolios.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
3
>25
Staff, group
>25
>25
Training
5%
Other
5%
Consultancy/
advisory
30%
Legal
25%
Representation
& management
20%
IT & software
5%
Information
10%
Page 40
Global product registration and agent services (only
representative services)
Regulatory chemical product notification, registration, and technical
defence under the framework of global chemical programmes. Acta
concentrates on obtaining, maintaining, and supporting product approvals
and efficiently overcoming commercial or regulatory impediments to
the successful and profitable marketing of approved products. The
multi-disciplinary skills offered by Acta professionals are essential to
obtaining cost-effective and timely product approval. Jurisdictions we are
active in are: North and South America, European Union, Switzerland,
Turkey, Australia and NZ, Malaysia, China, Japan, South Korea, Taiwan,
Philippines, Singapore, and Indonesia.
Data compensation support services and trade infringement/
competition issues
Acta is engaged in numerous data compensation and competition-related
issues at the global level. Activities range from supporting, evaluating,
preparing, and managing data cost on behalf of the data owner as well
as for those entities seeking data access. As a result of recent activities
in association with the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) legislation, many clients continue to
evaluate and pursue competition-related issues. We are actively engaged
in data compensation and competition-related disputes.
Technical document preparation activities
Undertaking the appropriate document preparation and coordination to
support a registration and post registration activities, ie chemical substance
dossier preparation, exposure assessments, hazard assessments,
specific effect analysis and assessments, petitions, response to comment
documents, inquiries, and safety data sheet (SDS) preparation.
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
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
Bergeson & Campbell, PC
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.
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.
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 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 is distinguished by his experience in both testing and
consultation environments, as well as his practical expertise in both
environmental modeling and monitoring. He focuses on regulatory
compliance for industrial chemicals, biocidal products/substances, and
fertilisers. Mr Bourne's services also include guidance in environmental
and human health risk assessment, and product classification, labeling,
and safety.
Dr Hayley Clayton, PhD – Regulatory Specialist
Dr. Clayton has a deep understanding of risk assessment, regulatory
compliance, and dangerous goods safety. She is an IATA-certified
Dangerous Goods Safety Advisor and transport specialist, and has over
a decade of experience regarding the sale, possession, and transport
of restricted chemicals in compliance with UK and European legislation
including REACH, RoHS, and WEEE. Dr Clayton received a PhD in
supramolecular chemistry from the University of Huddersfield.
Page 41
PROFILE: ACTA
PARTNERS
Ms Bergeson has for over two decades assisted individual companies
and a wide range of trade groups and ad hoc consortia on 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
Centres of excellence for our product stewardship services are located
in both Europe (Belgium and Switzerland) and the US, with partners in
growing markets in the Asia-Pacific and South America regions.
For Europe, contact ARCADIS Belgium: Citylink, Posthofbrug 12,
2600 Antwerpen-Berchem, Belgium. Alain Vassart, +32 3 328 62 48,
[email protected]
For the US, contact ARCADIS US: 4665 Cornell Road, Suite 350,
Cincinnati, Ohio 45241, USA. Michelle Langefeld, +1 513 860 8700,
[email protected]
PROFILE: ARCADIS
CONTACTS
Website
www.arcadis.com/Global_Product_Stewardship.aspx
E-mail
[email protected]
[email protected]
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+
Our global product stewardship (GPS) practice focuses on:
OO
product stewardship systems and programmes
OO
global regulatory surveillance
OO
due diligence reviews
OO
sustainability support
OO
supply chain management
OO
registration support, permitting, and licensing
OO
strategic scientific solutions
Examples of our work are provided below.
Founded
1888
REACH from A to Z
OVERVIEW
ARCADIS is an international company providing consultancy, design,
engineering and management services in infrastructure, water,
environment and buildings. We enhance mobility, sustainability and
quality of life by creating balance in the built and natural environments.
The company has an extensive international network supported by strong
local market positions. From that position, we help clients around the
world to solve their most difficult product stewardship challenges and
bring their products to market in a compliant and safe manner.
VITAL STATISTICS
2012/13
Turnover, group
€2.4bn
€5m
300+ covering all
regions of the world
No of offices
40
Staff, group
21,000+
49
IT & software
5%
Laboratory
5%
Information
5%
Representation
& management
20%
Page 42
Training
5%
Consultancy/
advisory
60%
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. Currently, a major
focus is REACH and CLP/GHS in all its aspects: we provide scientific and
managerial support, combined with pragmatic and strategic advice, resulting
in regulatory compliance in an efficient and cost-effective way. ARCADIS
supports multinational companies in the chemical and pharmaceutical sector
with the development and implementation of their REACH compliance
programmes, organises compliance audits and provides on-site employee
training. The team develops read-across approaches and intelligent testing
strategies, acts as study monitor, performs risk assessments (CSA/CSR),
supports communication in the supply chain and evaluates extended safety
data sheets. Finally, as consortium manager, ARCADIS is responsible for
the general and financial management of several consortia. In this role, we
act as trustee and guarantee fair, transparent and non-discriminatory cost
sharing between members and the Sief.
EU biocidal product authorisation and US FIFRA registration
The Biocidal Product Regulation (EU) 528/2012 enters into force on 1
September 2013. Being compliant with the new requirements of this
Regulation is the legal prerequisite to market your biocidal products in
Europe and will have an important impact on resources needed and time to
market for all companies in this sector. EU BPR and US Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) registrations involve timeconsuming and costly processes requesting various expertise. ARCADIS
can provide regulatory and/or technical support in the complex process of
getting your biocidal products authorised in both the EU and the US.
Supply chain management and product stewardship support
ARCADIS has helped our clients to manage supply chains for products as
diverse as household consumer products, automotive components, pulp
and paper, polymer, metals and their alloys, pesticides, and food storage
containers. We work with our clients to create a structured means of
informing, managing, and exchanging information throughout a product’s
global supply chain. This process can also be used effectively to perform
third-party compliance audits and enhance supplier communication. We
help our clients to work through language and cultural barriers to receive
the assurance they need from their suppliers.
1888
Parent company Heidemij formed in the Netherlands
1993
Geraghty & Miller merges with Heidemij
1998
Global company becomes ARCADIS.
2002
BBL (US consulting firm est 1984) establishes a global
product stewardship (GPS) practice in the US
2005
ARCADIS merges with BBL
2006
ARCADIS Belgium is established as a second GPS centre of
excellence
2008-10
For the 2010 registration deadline, ARCADIS manages
several REACH consortia and supports clients on
approximately 100 REACH registration dossiers
2011
ARCADIS continues to be engaged by multinational
companies, REACH consortia and Competent Authorities as
their key service provider for developing and implementing
their REACH compliance strategy related to registration, DU
obligations and/or authorisation
2011-12
ARCADIS acquires BMG Engineering Ltd in Switzerland, a
leading company in the fields of product stewardship and
REACH. ARCADIS acquires Langdon/Seah in China and EC
Harris in the UK, which provides additional strength in key
environmental consulting service areas in these regions
ACCREDITATIONS
European Registered Toxicologists; European Registered Chemists; Diplomats
of the American Board of Toxicology (DABT). The ecotoxicology laboratory of
BMG is GLP-certified and also accredited according to ISO/IEC 1025.
CLIENTS
ARCADIS works for many multinational clients around the world. We have
built sound relationships with clients in following market sectors: chemical
production, pharmaceuticals, automotive, rare earth compounds, consumer
goods, oil and gas, governments and policy-makers, and others.
CASE STUDY 1: Product stewardship services for a multinational
producer of homecare and personal care products
In addition to REACH support, ARCADIS has been providing general
regulatory and product safety services to multiple businesses within this
Fortune 100 company for years. Key activities include:
OO
human and environmental safety assessments;
OO
updating product material safety data sheets;
OO
US TSCA import/export review;
OO
scientific manuscript preparation;
OO
developing website content;
OO
support for green certification, and
OO
global product registrations.
CASE STUDY 2: Regulatory surveillance and auditing for
pharmaceutical and biological companies
Multinational companies engage ARCADIS to support their environmental
health and safety teams with regulatory compliance around the world.
We monitor changes in specific legislation on chemicals, articles, medical
devices, and biological substances and partner with our clients to develop
strategies (including processes and tools) to confirm and document
compliance. We work with our clients to integrate those strategic solutions
into their business processes. Through our thorough understanding of
our partners’ existing processes and evaluation of potential compliance
gaps, ARCADIS has tailored new product introduction processes so our
partners can produce globally compliant products, resulting in a dramatic
decrease in new product holds at customs.
CASE STUDY 3: Authorisation under REACH
The first authorisation dossiers have been submitted to ECHA and many
more are under development. ARCADIS has significant experience with
the preparation of this type of dossiers for consortia. Successful dossiers
combine several ingredients: an extensive network of contacts with
downstream users, industrial knowledge of processes (beyond what is
required for a registration dossier), expertise in the field of human health
and environmental risk and impact assessment, as well as the knowledge
to perform a socio-economic analysis. Data collection is crucial: mapping
of the supply chain, information on availability and functionality of possible
alternatives, additional exposure data for better characterising remaining
risks, expected effects on social and economic level, etc, defining the
consequences of a refusal (non-use scenarios), and most often, additional
exposure data to better characterise the remaining risks. ARCADIS
supports our clients’ business success by offering all of the fields of
expertise that are required to define the consequences of a refusal of
authorisation (non-use scenarios) vs the continued use of the substance.
STAFF SELECTION
Andreas Häner PhD – Microbiologist / Ecotoxicologist
Dr Häner holds the academic degrees of MSc in biology and a PhD in
environmental microbiology. Over the last 17 years at BMG Engineering
Ltd, he has been a specialist in the fields of chemical safety (such as
product stewardship, legal compliance, REACH, GHS) and environmental
risk assessment .and has supervised non-clinical GLP studies (aquatic
toxicology and biodegradability) in BMG’s own ecotoxicology laboratory.
Nele Deleebeeck PhD – Ecotoxicologist
Dr Deleebeeck holds the academic degrees of MSc in biology, MSc in
environmental sciences and technologies, and a PhD in applied 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
Ms Sellers edited and co-wrote Nanotechnology and the Environment
(2008) which explores the implications of this new technology. She has
presented seminars and short courses to professional societies and
multinational clients. In December 2012, she presented the results of
the RIVM report on the definition of nanoparticles during a ChemWatch
seminar. She has advised clients on issues ranging from the consequences
of nanoparticle exposure to the nuances of regulatory registration. She
holds a BS in chemistry and a MS in environmental engineering.
Maaike Bilau PhD – Biologist
Dr Bilau is a European registered toxicologist with a proven track record
in the development of REACH compliance strategies for chemical and
pharmaceutical companies. In this type of projects, stakeholder management
and management of change is key. Together with the companies, she works
on performing supply chain risk assessment, developing SVHC mitigation
plans, eSDS compliance process flows etc. In addition, she is involved in
human health hazard assessment and development of exposure scenarios
(focus on occupational and consumer exposure), as the basis for the
development of chemical safety assessments and reports.
Nathalie Schraepen MSc Eng – Environmental risk assessor
Ms Schraepen holds the academic degrees of MSc Eng in biochemistry
and MSc in environmental sciences. She has more than 15 years’ industry
experience (Procter & Gamble). She managed issues related to product
safety and environmental toxicology, designed environmental testing
programmes for a variety of business categories and industrial chemicals
(mainly organics and surfactants). She has been active in industry
association work (AISE) and key contributor of the HERA environmental
risk assessments of several surfactants used in household care products.
Page 43
PROFILE: ARCADIS
SERVICES PROVIDED
REACH
The REACH Regulation is the biggest piece of chemical legislation ever.
ARCHE is well placed to help you set up a REACH implementation plan
and assist you with the fulfilment of your obligations as producer, importer,
distributor and/or downstream user of phase 2 and 3 substances under
REACH. We can assist in (a) literature search and data evaluation; (b)
IUCLID; (c) exposure scenarios; (d) CSA/CSR; (e) read-across and data
waiving; (f) QSAR; and (g) REACH dossier submission, updating and
follow-up.
PROFILE: ARCHE
CONTACTS
Website
www.arche-consulting.be
E-mail
[email protected]
Head office
Stapelplein 70, box 104, 9000 Gent, Belgium
Tel
+32 9 265 87 58
Contact
Marnix Vangheluwe
Directors
Marnix Vangheluwe
Patrick Van Sprang
Ownership
Private company
Locations
Gent and Leuven, Belgium
Founded
2009
Classification of substances and complex mixtures under CLP/GHS
OVERVIEW
ARCHE was founded in 2009 by key experts from EURAS who hold a
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
2011/12
Turnover, group
-
-
No of offices
2
1
Staff, group
14
14
In order to remain compliant with all the current legislation related to the
hazard classification of substances and (complex) mixtures, ARCHE
provides services on: (a) identification of obligations under CLP and
REACH; (b) re-classification of substances/mixtures to meet the new CLP
requirements; (c) updating and assignment of classification according to
CLP and REACH requirements, including preparation of CLP notification
dossier; (d) compliance check of (e)SDS for classified substances with
regard to format, content, and agreement with the information included
in REACH registration dossiers; (e) evaluate whether the uses and
operational conditions that are described in he exposure scenarios cover
the activities for a specific downstream user.
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 physico-chemical
characterisation); (e) modelling and risk/exposure assessment of the
effluent mixing zone.
Biocides, pesticides and plant protection products (PPPs)
ARCHE has extensive expertise and a proven track record in delivering
solutions to environmental problems at all stages in the registration/
review of biocides, pesticides and PPPs. Offered services include: (a)
effect and exposure assessment for active substances and products; (b)
data gap identification and designing higher-tier studies; (c) exposure
modelling (FOCUS suite of models, EUSES, 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; and (h) product stewardship.
Training
IT & software 7%
5%
Representation
& management
5%
Consultancy/
advisory
83%
2009
Foundation of ARCHE (staff: five people)
2010
Expansion of the team to 12 people, with offices in Ghent
and Leuven
2013
Further expansion to 14 people, and further development of
the services on biocides and pesticides
PARTNERS
EBRC Consulting GmbH, Hannover
PietConsulting
GLOBAL OFFICES
PJ Van Benedenstraat 4, box 203
3000 Leuven, Belgium
Tel: +32 16 28 49 00
Page 44
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 physico-chemical
and (eco)toxicological properties were conducted, and where needed
testing programmes were designed and managed. The outcome of
such research programs was combined with the results of the exposure
assessment and relevant exposure scenarios that were also generated
by the experts working at ARCHE. These risk characterisation exercises
provided the operational conditions under which safe use of metals and
metal compounds could be ensured for men and environment. In addition,
all information that was used in the CSR was entered into the ECHA data
information format (IUCLID).
CASE STUDY 2: MeClas – metals classification tool
Most complex materials in the metals sector contain a spectrum of
different metals (compounds) and minerals, which therefore requires
extensive physico-chemical, toxicity and ecotoxicity reference data sets.
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. 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. The classification tool can be simply accessed by
registering via www.meclas.eu
CASE STUDY 3: Environmental risk assessment of a biocidal
product for milk extraction systems
Our experts compared two environmental risk assessment methods
for a disinfectant for milk extraction systems: 1) the emission scenario
document for biocides (ESD) based on local consumption estimates on a
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 45
PROFILE: ARCHE
CLIENTS
PROFILE: bibra toxicology advice & consulting
IT &
software Training
1%
Information 3%
6%
Representation
& management
12%
CONTACTS
Website
www.bibra-information.co.uk
E-mail
[email protected]
Head office
Cantium House, Railway Approach, Wallington, Surrey,
SM6 0DZ, UK
Tel/ Fax
+44 (0)20 8544 4150/ +44 (0)20 8544 4151
Contact
Peter Watts
Directors
James Hopkins, Managing Director
London
Peter Watts, Director of Toxicology
SERVICES PROVIDED
Graham Hunt, Commercial Director
Dossier preparation, including CSA/CSRs (DNEL/DMEL derivation)
Ownership
Private company
Locations
United Kingdom
Founded
1961, acquired by current management 2005
Highly skilled in working directly into IUCLID preparing technical dossiers
required under REACH and the Biocidal Products Directive, and in describing
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.
Consultancy/
advisory
79%
GLOBAL OFFICES
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.
Indeed, we have 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
2011/12
Turnover, group
£1.4m
£1.4m
No of offices
1
1
Staff, group
15
13
Human health hazard and risk assessment
The bibra team of toxicologists has worked together over many years,
providing robust human health hazard and risk assessments for a diverse
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.
Page 46
1960
Formation of BIBRA
1960
Establishment of Toxicology Information and Advisory
Department
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
ACCREDITATIONS
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.
Our senior toxicologists are all Society of Biology/British Toxicology Society and
EUROTOX registered toxicologists. We are a REACHReady approved supplier
CASE STUDY 3: Provision of alerting service to keep industry upto-date on emerging issues
PARTNERS
Bibra toxicology advice & consulting was asked by an industry sector
group to provide an ongoing service to track the emerging toxicological
literature on a range of chemicals of particular interest to their members.
Using a range of carefully tailored search and alerting strategies (SDI
– 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.
TSGE
Enviresearch Ltd
Linmark Consulting Gmbh
wca environment Ltd
ReFaC
Campden BRI group
Leatherhead Food International Ltd
CLIENTS
Many of our clients have a need for confidentiality so those listed below
are just a small sample of the types of organisations that we work with:
OO
Actavis Group
OO
CSL Behring Biotherapies for Life
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.
STAFF SELECTION
James Hopkins – Managing Director
James was a senior toxicologist of high repute at BIBRA before leading the
management buyout in 2003. The new company, bibra toxicology advice &
consulting, has performed impressively under James's guidance, reporting
record results in 2011/12. James has wide experience in reviewing/
evaluating toxicological data for a range of chemicals in a cross-section of
industries and has also compiled numerous critical reviews of chemicals
and several strategy documents for national governments.
Peter Watts – Director of Toxicology
Peter is our director of toxicology and is a BIBRA veteran of over 30
years. His vast experience includes reviewing and critically evaluating
toxicological data and providing risk assessments on numerous
chemicals for government departments and industrial organisations. He
helped in the preparation of the 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 trainees, range in
practical experience from ten to 35 years. All are extremely skilled in
chemical hazard and risk assessment and have been heavily involved in
REACH-related work during the past four to five years.
Page 47
PROFILE: bibra toxicology advice & consulting
1961
Other Consultancy/
advisory
5%
15%
Representation
& management
5%
PROFILE: Bioagri
CONTACTS
Website
www.merieuxnutrisciences.com
E-mail
[email protected]
Head office
Rodovia SP 127 km 24, 13412-000 Piracicaba SP, Brazil
Tel/ Fax
+ 55 19 3429 7700/ + 55 19 3429 7713
Contact
Dr Jean-Luc Garrigue
Directors
M. Luis Fernando Torres Maida
Dr Paulo Silva
Dr Milton Vargas
M Edivan Tonhi
GLOBAL OFFICES
Headquarters Mérieux NutriSciences: Chicago, USA
Headquarters Bioagri Laboratorios: Piracicaba, Brazil
Sales Offices: Piracicaba (Brazil), Lyon (France), Resana (Italy) Shengai
(China)
SERVICES PROVIDED
M Celso Zaccaria
Ownership
Mérieux Nutrisciences
Locations
Brazil, France, China
Founded
1991
Toxicology
OVERVIEW
Bioagri is the Brazilian business unit of Mérieux Nutrisciences, the US group
headquartered in Chicago (US), dedicated to human public health and
owned by INSTITUT MERIEUX. Bioagri is the largest CRO in Latin America
(>1000 employees) serving the chemical, cosmetic, food, pharmaceutical
and crop protection industries worldwide. Services encompass toxicity,
physico-chemistry, ecotoxicity, analytical and microbiological studies, and
residues analysis under applicable regulatory guidelines.
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,
towards the following unique strengths:
OO
reactivity, very short decision-making centres (in Brazil, Europe 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
high flexibility of our project management dedicated to studies;
OO
global network and access to key opinion leaders in China, Brazil,
USA and Europe.
The acquisition in 2012 by Mérieux Nutrisciences of CHELAB laboratories
located in Italy contributed to a global expansion of the services offered
(including in vitro toxicology, and efficacy of cosmetics and biocides).
Overall, Bioagri (in association with Chelab) offers to the chemical, cosmetic,
food, pharmaceutical and crop protection industries one of the best performing
turn-key solutions, with high quality standards for a large range of CRO
services within undisputed financial robustness and international footprint.
VITAL STATISTICS
2012/2013
Turnover, group
US $60m
US $38m
No of offices
16
3
Staff, group
950
450
Page 48
Laboratory
75%
In Italy the following in vitro studies are conducted:
OO
acute skin corrosion – human reconstructed epidermis (EST1000)
OO
acute skin Irritation – human reconstructed epidermis (EPISKIN)
OO
acute eye irritation/corrosion – human corneal epithelium (HCE)
OO
skin sensitisation – direct peptide binding assay (DPBA); MUSST
(CD86 expression on U937 dendritic cell line); hCLAT (CD86/CD54
expression on THP1 dendritic cell line)
OO
genetic toxicity – Ames test; mouse lymphoma assay (tk locus); in
vitro micronucleus test
OO
phototoxicity – 3T3-NRU test.
In Brazil all classical acute to long-term toxicity studies are conducted
in rodents, rabbits, guinea pigs and dogs, by oral, dermal, inhalation or
intraperitoneal route, under supervision of an animal welfare ethical committee:
OO
acute oral, dermal or inhalation toxicity;
OO
acute dermal or eye irritation study
OO
skin sensitisation (LLNA, M&K, 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 (alone or combined with chronic toxicity).
Physico-chemistry
Conducts all required studies on physico-chemical properties of
products according to OECD, EU and US-EPA guidelines (eg molecular
identification, vapour pressure, n-Octanol partition coefficient, etc)
Ecotoxicology
Evaluates all classical effects of products on aquatic and soil organisms:
OO
ready 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
OO
OO
OO
OO
OO
fish bioconcentration (Danio rerio)
honeybees acute oral or contact toxicity (Apis mellifera)
avian acute oral/ dietary toxicity (Japanese quails)
sediment/water microcosm biodegradation
aerobic or anaerobic soil metabolism
leaching in soil columns
adsorption/ desorption
2011
Brazil becomes a full adherent to the OECD Council Acts
related to the Mutual Acceptance of Data in the Assessment
of Chemicals. Consequently, GLP preclinical safety test
data on pesticides and chemicals generated at Bioagri are
accepted in OECD countries and adhering non-members.
2012
Mérieux NutriSciences announces the acquisition of Italybased CHELAB, a market leader in chemical, microbiological
and in vitro toxicology laboratory services.
Analytical chemistry
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)
Mass spectrometry
Performs qualitative/quantitative assays of the active ingredients and
impurities and metabolite identification (degradation in water, soil and
biological matrices).
Radiochemistry
Evaluates the behaviour and fate of pesticides in plants, animals and
soils, according to OECD and US-EPA guidelines.
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.
Safety evaluation of cosmetics and detergents in humans
In Italy: patch test (irritation) on volunteers, ophtalmological irritation test
on volunteers
Efficacy evaluation of cosmetics and detergents in humans
In Italy: in vivo determination of SPF, water resistance, hydratation test,
TEWL, assessment of anti-wrinkle and anti-cellulite products, etc...
1991
Bioagri foundation in Brazil by two PhD researchers from the
Centre for Nuclear Energy in Agriculture (University of São
Paulo).
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.
ACCREDITATIONS
GLP, OECD, AAALAC, INMETRO, ISO-17025
PARTNERS
Sister companies of Bioagri within Mérieux Nutrisciences: Silliker (food
safety) including Chelab-Silliker (in vitro toxicology), Biofortis (R&D in
nutrition, clinical trials and sensory analysis for nutrition and cosmetics)
European consulants (regulatory, toxicology), working with Bioagri under
confidential agreement.
CLIENTS
Leaders from the chemical industry, agrochemical and crop
protection industries, cosmetic industry, household products industry,
pharmaceutical and veterinary drugs companies
CASE STUDY 1:
Hundreds of GLP pre-clinical safety studies have been conducted in skin
sensitisation, genetic toxicity, developmental toxicity or systemic toxicity
studies for cosmetic ingredients for leading international companies,
matching sponsor’s expectations in >95% as far as time schedule and
scientific quality were concerned.
CASE STUDY 2:
A-to-Z tailor-made REACH projects have been managed for leaders of
the chemical industry, including: global/ local project management, data
gap analysis, testing strategy, physico-chemical, toxicological and/or
ecotoxicological testing, study monitoring support, IUCLID 5 completion
with dedicated hazard assessment assistance, and risk assessment
support when necessary (CSA/CSR).
CASE STUDY 3:
At Bioagri, thousands of studies were performed on hundreds of active
ingredients and formulated compounds used in agriculture, or chemical
compounds throughout the world, and >99% were accepted by the relevant
authorities. Today, 70% of GLP studies with agrochemicals done in Brazil
are conducted at Bioagri, based on the undisputed reputation of this lab for
performing tailor-made, reliable, timely accurate and cost effective studies.
STAFF SELECTION
Our technical staff includes about 300 hundred dedicated and
professionally trained scientists qualified in mammalian toxicology
(including VetD, MD, PhD, EUROTOX toxicologist, expert 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.
Page 49
PROFILE: Bioagri
OO
GLOBAL OFFICES
Edinburgh, Scotland, UK
Cardiff, Wales, UK
SERVICES PROVIDED
Scientific consultancy
PROFILE: Blue Frog Scientific Limited
CONTACTS
OO
regulatory testing design and study monitoring
intelligent testing strategies
ecotoxicology and environmental fate
environmental hazard and risk assessment
toxicology
human health hazard and risk assessment
compilation of dossiers and expert reports
Website
www.bluefrogscientific.com
E-mail
[email protected]
Head office
10 York Place, Edinburgh, Midlothian, EH1 3EP, UK
Tel
+44 (0) 131 523 1412
Contact
Damien Carson
OO
Directors
Damien Carson
Regulatory affairs
Tom Hargreaves
OO
Ownership
Private Limited Company
Locations
UK (Edinburgh and Cardiff)
Founded
2006
OO
OO
OO
OO
OO
OO
OO
OO
OO
OVERVIEW
Blue Frog Scientific is an independent regulatory consultancy, providing
scientific and regulatory affairs solutions to companies in all sectors of
the chemical industry. Blue Frog’s philosophy is achieving regulatory
compliance through the application of good science, innovation and
clarity; ensuring that all submissions are prepared efficiently and to a high
standard.
We offer scientific and regulatory affairs services with particular
experience in chemicals, human pharmaceuticals, veterinary medicines,
agrochemicals and feed additives.
Based in the UK, our core team of consultants coordinate operations and
our comprehensive network of associates (including contract laboratories,
legal support and financial accounting) ensures that we can assist our
clients in all areas of regulatory compliance. We have particular in-house
strengths in chemistry, toxicology, ecotoxicology, environmental fate,
and regulatory affairs. We utilise our network of associates when we
need leaders in specialised fields (eg reproductive toxicology) to address
issues requiring an expert opinion, statement or report.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
2
1
Staff, group
6
6
IT & software
10%
regulatory affairs for chemicals, human medicinal products, veterinary
medicinal products, agrochemicals and feed additives
project management
product defence
consortium and task force management
only representation of non-EU chemical companies under REACH
Chemicals (REACH)
Blue Frog Scientific provides a full technical and administrative
registration service for chemical substances under Regulation (EC)
No 1907/2006 (REACH). Our team is highly qualified and experienced
in preparing registration dossiers, chemical safety assessments,
coordinating with Siefs and consortia, and liaising with regulatory
authorities during and post dossier submission.
Key sectors of experience include:
OO
monomers, process chemicals, coatings and catalysts;
OO
oilfield chemicals and petroleum products;
OO
pharmaceutical intermediates;
OO
substances of unknown or variable composition, complex reaction
products or biological origin (UVCB);
OO
transported isolated intermediates (Article 18).
We also provide supply only representative services in accordance with
Article 8 of REACH for non-EU companies that manufacture or formulate
chemical substances and mixtures.
Consortium/Sief management
Blue Frog Scientific has developed a model for managing the financial
and administrative challenges of consortia and task forces. We are
currently managing consortia and Siefs under REACH as well as other
groups of companies collectively working on research and development
projects.
Our services include:
OO
provision of a consortium bank account;
OO
accounts payable and accounts receivable;
OO
VAT and tax accounting;
OO
purchase contract management;
OO
teleconferencing facilities;
OO
data storage and management via the secure Blue Frog Scientific
extranet.
Environmental risk assessment of human medicinal products
(HMPs) and veterinary medicinal products (VMPs)
Representation
& management
30%
Page 50
Consultancy/
advisory
60%
Blue Frog Scientific has extensive experience in assessing the potential
environmental risk posed by human pharmaceuticals and veterinary
medicines.
Environmental risk Assessment:
OO
authoring expert reports for inclusion in European marketing
authorisation applications and FDA filings;
OO
planning and coordinating the necessary activities required in the
preparation of risk assessments for regulatory submission;
OO
expert evaluation of laboratory studies;
Agrochemicals
Blue Frog Scientific and associates offer a full dossier service for
registering plant protection products throughout Europe.
Our range of services provides cost effective solutions to support placing
your products on the European market.
Data gap analysis:
OO
overview of quality of existing studies and identification of any data
gaps for re-submission of dossiers according to EC 1107/2009;
OO
preparation of updating statements.
Study management:
OO
regulatory testing design;
OO
testing strategies and study design (GLP/GEP);
OO
study monitoring;
OO
preparation of study summaries;
Dossier preparation and regulatory affairs:
OO
OECD and dRR sections 1 to 7 prepared to a high standard;
OO
communication with regulatory authorities within EU 27 to support
submissions.
Key sectors of experience include:
Insecticides: pyrethroid, neonicotinoid, organophosphate and carbamate;
Herbicides: organophosphorus, phenylpyrazole;
benzoylcyclohexanedione, chloroacetanilide;
Fungicides: triazole, anilinopyrimidine, amide, pyrazole;
Other: semiochemicals and biopesticides.
CLIENTS
Blue Frog Scientific supports a global client base of chemical,
pharmaceutical, veterinary, agrochemical and feed additive companies,
ranging from SMEs to large multinational corporations. We take our
clients’ confidentiality very seriously and will not disclose their identity.
CASE STUDY 1: REACH advisor to a European Defence Agency
Provided long-term support to a European Defence Agency in defining the
parameters of the defence exemption, training staff on the fundamental
aspects of REACH, and developing internal procedures for assessing
exempt/non-exempt chemical substances and complying with REACH.
CASE STUDY 2: Assessment of the environmental fate and
effects of the PPARgamma receptor agonist, pioglitazone
The environmental fate and effects of pioglitazone prescribed for the
treatment of type 2 diabetes were evaluated in an environmental risk
assessment. A predicted environmental concentration (PEC) for surface
water was estimated at 0.023 μg L-1, triggering a comprehensive
battery of laboratory evaluations. Pioglitazone and its major metabolites
were determined not to significantly adsorb to sewage solids, were
not persistent in the aquatic environment, did not bioaccumulate and
were non-toxic to aquatic organisms. Pioglitazone does not pose an
unacceptable risk to groundwater supplies, with concentrations not
anticipated to be a risk to aquatic organisms or human drinking water
supplies. Pioglitazone does not pose a risk of secondary poisoning.
STAFF SELECTION
Damien Carson BSc PhD – Director
An expert in chemical hazard and risk assessment with more than ten
years’ experience across a wide range of sectors in the industrial and
fine chemical industry. Expert in Good Laboratory Practice and testing
strategies.
Tom Hargreaves BSc (Hons) – Director
An expert in environmental hazard and risk assessment, with more
than 15 years experience in veterinary medicinal products, human
pharmaceuticals, agrochemicals and chemicals. Expert in Good
Laboratory Practice and testing strategies.
Nigel Halsall BSc PhD – Associate Director
An expert in environmental hazard and risk assessment with more
than 25 years experience in the agrochemical industry. Expert in Good
Laboratory Practice and testing strategies.
2006
Formation of Chemical Regulatory Services team within BMT
Cordah Limited, part of the BMT group of companies
2007
Development of REACH technical consulting services
supporting a global client base
2008
Development of human pharmaceutical and veterinary
medicine consulting services supporting a global client base
2010
Management buy-out of Chemical Regulatory Services
business by D Carson and T Hargreaves, forming Blue Frog
Scientific Limited
2010
Development of agrochemical consulting services
2012
Sustained growth leads to major expansion of company with
new staff and offices to support growing client base
ACCREDITATIONS
European Partner: Society of Environmental Toxicology and Chemistry
(SETAC).
Page 51
PROFILE: Blue Frog Scientific Limited
protocol development and environmental testing requirements to
GLP, and following international guidelines;
OO
preparing literature based “weight-of-evidence” risk assessments for
specialist products;
OO
multimedia mathematical modelling of the fate of pharmaceuticals in
soil, freshwater, sediment and marine compartments;
OO
deterministic and higher tier probabilistic assessment of effects on
biota and exposure concentrations;
OO
preparation of conclusions of risk, with relevance to the “real world”
and mitigation solutions;
OO
use of mammalian ADME data to refine models and aid conclusions
regarding bioaccumulation and secondary poisoning.
Key sectors of experience:
HMPs: AIDS, chronic kidney disease, ataxia, an.-inflammatory,
hypertension, diabetes;
VMPs: antibiotics, parasiticides, coccidiostats, antipyretics;
All classes of cattle, swine, sheep, poultry;
Oral drenches, injectables, pour-ons, in feed, in drinking water;
Product defence, particularly for two “priority list” substances.
OO
SERVICES PROVIDED
PROFILE: Brixham Environmental Laborator y
We offer laboratory based assessment of the environmental effects,
ecotoxicity and environmental fate of new and existing substances. Our
services can be easily classified according to the following industrial sectors:
Industrial chemicals (REACH)
Brixham Environmental Laboratory is part of a global testing alliance and
as such can offer a complete REACH service. We can provide both the
routine studies required for REACH and the studies required for substances
of very high concern (SVHC). The laboratory is able to conduct all of the
studies required to assess a substance against the PBT or vPvB criteria
and complete all of the aquatic studies listed within the OECD conceptual
framework for the testing and assessment of endocrine disrupting chemicals.
CONTACTS
Website
www.brixham-lab.com
E-mail
[email protected]
Head office
Freshwater Quarry, Brixham, Devon, UK, TQ5 8BA
Tel
+44 (0)1803 884400
Fax
+44 (0)1803 882974
Contact
Enquiry co-ordinator
Ownership
AstraZeneca UK Ltd (parent company)
Locations
Brixham, Devon, England
Founded
1948
Plant protection products
Brixham Environmental Laboratory has worked extensively for the plant
protection products industry for more than 30 years, generating both
ecotoxicological and environmental fate data. As well as working directly
with agrochemical companies, the laboratory also works on behalf of
consultancies who are preparing registration or re-registration submissions.
OVERVIEW
Biocidal products
Brixham Environmental Laboratory delivers 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, and is
licensed to work with radio-labelled materials.
Brixham Environmental Laboratory is experienced in designing the
appropriate testing strategy for a particular biocidal product and in
agreeing that strategy with the regulatory authorities. We are able to
deliver all studies required for the environmental component of the
submission, including various studies listed on the Biocidal Products
Regulation.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
83
83
Representation
& management
5%
Information
5%
Page 52
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
Consultancy/
advisory
20%
Laboratory
70%
Veterinary medicines
Solution driven, we work at the forefront of environmental research often
acting as a central hub on cross disciplinary collaborations with a range
of research institutes, funding bodies, industrial and academic partners,
ensuring realism and a pragmatic application of science.
1948
Established as a marine research station for ICI Paints
1960s
-70s
Environmental science began to dominate the laboratory's
function
1979
First environmental laboratory to be OECD GLP compliant in
Europe
1980s
Major expansion with growing reputation for high quality and
value environmental science
1993
The laboratory transferred to Zeneca Limited following the
demerger of ICI
1999
The laboratory became part of AstraZeneca Pharmaceuticals
2007
£12m laboratory refurbishment and expansion to include state
of the art facilities
1948
-2012
BEL was aligned with two research groups nominated, one of
which won, within the Outstanding Impact in Public Policy and
Services category at the Exeter University inaugural Impact
Awards
BEL continues to work at the forefront of environmental
science, with a large publication output every year.
Our expertise and testing helps to produce guidelines such as
OECD, ISO, ECHA and many more.
We continue to provide ecotoxicology and environmental fate
testing for a very wide variety of compounds.
More than 30 successful ERA submissions conducted since
EMA guidelines published in 2006
Please refer to our website for our latest news, achievements
and publications
ACCREDITATIONS
Good Laboratory Practice (GLP)
CLIENTS
Due to client confidentiality individuals cannot be named, but we work
with a wide range of clients including top pharmaceutical and chemical
companies, government agencies, consultants, third parties, local
authorities, petrochemical industries, specialty chemicals and many more.
CASE STUDY 1: Persistence testing
Through research funded by the UK government (Defra and EPSRC)
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 lifecycle 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.
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.
Dr Jason Snape − Environmental Foresight Business Manager
Jason is an environmental microbiologist and biochemist with 18 years'
laboratory and field experience in the biodegradation and persistence of
chemical products in the environment. He uses this extensive empirical
experience at the interface between science and science-based policy
and the development of pragmatic environmental regulations for exposure
and persistence assessment. Jason is actively involved in chairing/cochairing committees, task forces and working groups. His expertise has
also produced many published papers.
Dr Paul McCormack – LC/MS and MSn Specialist, Chemistry
Paul has over 12 years’ experience in liquid chromatography and
multi-stage mass spectrometry (LC/MSn). His experience includes the
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 disrupting chemical
Bisphenol-A that has been linked to human health effects.
Dr Gary Roberts − Senior SHE Specialist, Environmental Fate
Gary is a specialist in studying the environmental fate of biologically
active chemicals. Gary’s research interests include the biodegradability
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. Page 53
PROFILE: Brixham Environmental Laborator y
2011
PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
GLOBAL OFFICES
Our facilities are located in Planegg/Munich, Germany.
In addition, we have representatives in Switzerland, Japan, India, Poland,
Scandinavia, Italy and other countries.
SERVICES PROVIDED
For the chemical, agrochemical and biocides industry BSL BIOSERVICE
offers a broad scope of biological safety studies, which meets the
international regulatory requirements and includes the following services.
CONTACTS
Website
www.bioservice.com
E-mail
[email protected]
Head office
Behringstr 6/8, 82152 Planegg / Munich, Germany
Tel
+49-89-899 650-0
Fax
+49-89-899 650-11
Contact
Dr Iris Pfisterer, Dr Achim Abrecht
Directors
Dr Wolfram Riedel, CEO
Locations
Germany
Founded
1984
Toxicology for chemicals, PPP’s and biocides
OVERVIEW
BSL BIOSERVICE Scientific Laboratories GmbH is an internationally
active CRO with the focus on safety and efficacy trials for industrial
chemicals, agrochemicals, biocides, cosmetics, medical device, food
and pharmaceuticals. The interdisciplinary and internationally accepted
approach of the institute with its various accreditations, certifications
and numerous successful audits (GLP, DIN EN ISO 17025, GMP, FDA)
guarantees high-quality biological trials. The laboratories have in the
meantime been certified for the eighth time in accordance with GLP,
most recently in 2012, and all tests are performed in accordance with the
internationally valid guidelines (OECD, ISO, ICH, EU, EPA, MHW, FDA).
With more than 25 years of experience our team of scientists offers a
broad spectrum of biological test systems and is dedicated to meet the
customer´s individual needs by a high level of flexibility.
BSL BIOSERVICE is renowned for its communication, scientific input and
high quality standards.
BSL BIOSERVICE is a partner of the Eurofins Group, which is a global
leader in the pharmaceutical, food and environmental testing market and
offers also a comprehensive portfolio for the chemical and agrochemical
product sectors. The Eurofins Group, with an annual revenue of US$1bn,
has over 13,000 employees in more than 170 laboratories across 33
countries.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
6-10
Staff, group
170+
-
Consultancy/
advisory
10%
We cover all common toxiclogy services relevant for chemicals, plant
protection products (PPP’s) and biocides. This includes the classical in
vivo studies from acute to repeated dose and DART studies. In addition,
BSL puts a high emphasis on alternative in vitro testing strategies with
regard to the 3R strategy for refinement, replacement and reduction of
animal studies. We have established a big range of in vitro assays for all
endpoints where this is possible yet.
OO
irritation/corrosion (in vitro/in vivo)
OO
sensitisation
OO
dermal absorption (in vitro/in vivo)
OO
genetic toxicity (in vitro/in vivo)
OO
acute toxicity
OO
repeated dose toxicity
OO
reproductive and developmental toxicity (DART)
OO
toxikokinetics
OO
carcinogenicity
OO
neurotoxicity
OO
endocrine disruptor testing
Ecotoxicology and physico-chemical properties
Physico-chemical and ecotoxicology services including aquatic and
terrestric studies as well as studies on biodegradation and environmental
fate and behaviour are also part of our portfolio. These services are
offered in cooperation with the Eurofins Group and other experienced
partners and are project managed by BSL BIOSERVICE.
REACH services
With regard to REACH we can offer the full portfolio of studies, required
for the different tonnage levels according to Annex VII-X of the REACH
directive. Due to the large variety of chemicals tested for the REACH
deadlines in 2010 and 2013 we are well prepared to effectively support
you also for the upcoming deadlines.
Furthermore, as ECHA will continue with the evaluation of the registered
substances and testing proposals, we are happy to perform those higher
tier studies for you and support you in updating your dossier. Studies like
90-day toxicity (OECD 408) and reproductive and developmental toxicity
(OECD 414) are performed at BSL on a routine basis. With regard to the
latest discussions we have also established the EOGRTS (OECD 443) as
an alternative to the two-generation study (OECD 416).
Endocrine disruptor testing
In response to the EPA announcement of the Endocrine Disruptor
Screening Program for Biocides, we have established endocrine disruptor
testing services and can offer the full Tier 1 testing battery.
In vitro safety testing
OO
OO
OO
OO
OO
OO
mutagenicity, clastogenicity, carcinogenicity
skin and eye irritation/ corrosion – several models
dermal absorption
photo-induced toxicity
reproductive toxicity (embryonic stem cell test)
sensitisation – several models under development
Laboratory
90%
Page 54
STAFF SELECTION
With more than 25 years of experience, BSL BIOSERVICE and our team
of scientists will provide you with expert advice not only for standard
studies, but also for individual study designs and testing strategies, taking
into account substance properties as well as interdependency of many
studies required for example for REACH.
In addition to our internal consulting services we are backed up by an
experienced regulatory division within the Eurofins Group and other
partners that support us in covering the regulatory issues of chemicals,
agrochemicals and biocides.
Dr Wolfram Riedel, CEO
1984
Foundation under the name Dr Müller Lierheim AG
1992
GLP certification
1995
Within a management-buyout the company was renamed to
BSL BIOSERVICE Scienitific Laboratories GmbH
1995
Accreditation according to DIN EN ISO 45001/DIN EN ISO
17025 as first laboratory in Europe
2006
BSL BIOSERVICE becomes a partner laboratory of the
Eurofins group
2007
Expansion into an additional building and establishment of a
brand new state-of-the-art in vivo facility with a laboratory
area of 3000 m2
2009
BSL BIOSERVICE takes a leading role within the Eurofins
REACH Task Force as toxicology partner
ACCREDITATIONS
Good Laboratory Practice (GLP)
DIN EN ISO IEC 17025
Good Manufacturing Practice (GMP)
FDA approved
Radioactive handling permission
CLIENTS
Chemical industry
Agrochemical/ biocides industry
Pharmaceutical/ biotech industry
Food industry
Cosmetic industry
Dr Wolfram Riedel has worked as CEO of BSL BIOSERVICE since 1994.
He holds a master’s degree in biology and performed his PhD thesis at
the German Cancer Research Centre, Heidelberg, Germany.
He has extensive experience in toxicology and regulatory services and is
a member in various expert groups.
Dr Achim Albrecht, Scientific Director
With more than 20 years of experience in contract research, Dr Albrecht
is working today as Scientific Director in vivo Pharmacology/ Toxicology
at BSL BIOSERVICE. His experience includes biological safety testing,
safety pharmacology, safety toxicology and elaboration of expert reports
and statements for drugs and chemicals From 1995-2010 he has been
working at BSL as Head of in vivo Pharmacology and Toxicology, Study
Director in vivo and was writing biological evaluation reports. Dr Albrecht
has a PhD in veterinary medicine and is a member in various expert
groups.
Dr Marc Kunze, Senior Toxicologist
Dr Kunze studied pharmacy and toxicology and holds a PhD in
medicinal chemistry and a master in toxicology. After several years at the
university giving lectures on pharmacology and toxicology, he moved to
the pharmaceutical industry. He specialises in non-clinical and clinical
toxicology within drug development and risk assessment of chemicals.
As senior toxicologist at BSL BIOSERVICE, Dr Kunze is responsible
for preparation of study designs and project management of regulatory
toxicological studies. Additionally, he acts as an internal and external
consultant for all areas of toxicology.
Dr Iris Pfisterer, REACH Manager
As REACH Manager at BSL BIOSERVICE, Dr Iris Pfisterer is dedicated
to support our clients with all enquiries and questions about REACH and
project manages large projects. This may include projects from data gap
analysis via laboratory testing to the final dossier preparation. Dr Pfisterer
holds a master’s degree and PhD in biology and has supported our
clients at BSL since 2009.
Other staff
In total more than 170 people work for BSL BIOSERVICE. Our highly
educated and experienced staff comprise a large proportion of scientists
with a wide variety of expertise. They will provide you with excellent
services and are dedicated to meeting your individual needs with a high
level of flexibility.
Page 55
PROFILE: BSL BIOSERVICE Scientific Laboratories GmbH
Consulting, testing strategies and individual study designs
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.
PROFILE: Bureau Veritas
CONTACTS
Website
www.bureauveritas.com
SERVICES PROVIDED
E-mail
[email protected]
Head office
67/71 Boulevard du Château, 92578 Neuilly/ Seine,
France
The below are only a selection of Bureau Veritas services,
focusing on chemical risks
Tel/ Fax
+33 1 5524 7000/ +33 1 5524 7001
Contact
Marie-Laure Héraud, Chemical SGP Mgr
Directors
Didier Michaud-Daniel, CEO
Sami Badarani, CFO
Ownership
Listed private company (Paris Stock Market)
Locations
Global geographical coverage (140 countries)
Founded
1828
REACH assistance
Bureau Veritas offers a full range of services to assist manufacturers,
importers and downstream users in meeting their requirements for
the REACH regulation. Global project assistance is available, with
support ranging from training to technical support, such as chemical risk
assessment, Sief/consortium management and dossier submission,
SVHC and Annex XVII substances management and testing, and REACH
authorisation dossiers.
MSDS management – REACH/CLP context
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.
VITAL STATISTICS
2011/12
Turnover, group
€3.15bn
€15m
No of offices
900 offices + 330 labs
140
Staff, group
48,000 employees
200+ employees
Training
15%
Consultancy/
advisory
10%
IT & software
10%
Starting with a chemical risk approach, Bureau Veritas provides MSDS
management services, technical assistance for MSDS elaboration and
update within REACH and CLP context, especially for extended MSDS.
Bureau Veritas also provides training on e-MSDS, in order to assist with
programme implementation. Services are supported by a complete set of
dedicated tools.
Occupational hygiene and chemical workers exposure
Bureau Veritas delivers chemical risk prevention services, such as
employee monitoring, and exposure mitigation recommendations,
according to specific regulations (EU/US), to assist in setting a global
approach to chemical risk management.
Dangerous goods safety advisory (DGSA)
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 onpurpose by Bureau Veritas.
1828
Operations in marine
1910
Operations in industry
1929
Operations in construction
1984
Operations in government services, international trade
1988
Operations in certification
Since
1993
Deployment on all continents
2007
Bureau Veritas listed on stock market (Paris)
2008
Mining platform
2010
Commodities platform
Representation
& management
30%
Laboratory
20%
Information
15%
Page 56
CASE STUDY 3
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);
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.
OO
OO
OO
notification for European directives including pressure equipment,
machinery, electrical and electronic appliances, lifts, construction
products and personal protective equipment;
laboratory accreditations in 20 countries, delivered by bodies such as
HOKLAS, A2LA, UKAS, COFRAC and DAkkS;
notified body for European directives covering electrical products and toys.
PARTNERS
To offer further REACH services, Bureau Veritas has developed
partnership with other service providers.
CLIENTS
400,000 clients in various markets (aeronautics – agriculture – automotive
– construction and real estate – consumer products – food – governments
and public organisations – industrial equipment – international trade – IT,
telecoms and electronics – maritime industry – mines and minerals – oil
and gas – power and utilities – process Industries – chemical industries
and chemistries – retail – services – transport and infrastructures)
CASE STUDY 1
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.
STAFF SELECTION
Dr Gautier Vincent – Senior Toxicologist, Practice Leader
Gautier is a pharmacist and a civil engineer. He has 12 years’ experience
in regulatory toxicology and risk assessment. He has worked on different
regulations (REACH, CLP, Biocide, IPPC, etc). Prior to this, he had
been working for INERIS in France (technical agency for environmental
ministry) where he determined different toxicological thresholds (accidental
and chronic). As a registered toxicologist, he is a member of the French
Toxicology Expert Committee for acute exposure threshold levels.
Simon Hodge – Chemical Practice Leader
Simon holds a masters degree in environmental science, backed up
by 30 years’ experience delivering health, safety and environmental
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.
Page 57
PROFILE: Bureau Veritas
ACCREDITATIONS
GLOBAL OFFICES
CEHTRA Lyon – 80, rue Condorcet, 38090 Vaulx Milieu, France
CEHTRA Paris – 25, rue des Bas, 92600 Asnières sur Seine, France
CEHTRA Europe – 134, rue Saint Germain, 1410 Waterloo, Belgium
CEHTRA UK – 6th Floor City Gate East, Toll House Hill, Nottingham, NG1
5FS, UK
CEHTRA India – TC15/1764, Forest Office Lane (B51), Vazhuthacaud,
Trivandrum, 695014, Kerala, India
CEHTRA India – Cabin No: 245, Level 2, Elegance Building, Mathura
Road, Jasola, New Delhi, 25, India
CEHTRA North America – 24 Ivy Lea Crescent, Toronto, ON M8Y 2B6,
Canada
PROFILE: CEHTRA
CONTACTS
Website
www.cehtra.com
E-mail
[email protected]
Head office
43-45, rue Laroque, 33560 Sainte-Eulalie, France
Tel
+33 557775610
Fax
+33 557775620
Contact
Paul Thomas
Directors
Pierre-Gérard Pontal, President
Peter Jenkinson, CEO
SERVICES PROVIDED
Regulatory dossier services
Jason Nugent, Director CEHTRA North America
CEHTRA provides clients with bespoke services for the production of
regulatory dossiers worldwide or together with our partners, be that
in the field of general chemicals, cosmetics, biocides, pesticides or
pharmaceuticals. We have all the competencies in-house to do all or any
part of a project. We have contributed to, or realised over 1,000 projects
since CEHTRA was founded and we have produced well over 100
REACH dossiers, all of which were successfully submitted on time. We
use, verify and validate the algorithms of software such as ECETOC TRA,
FOCUS (for pesticides and ART) and improve on existing tools (eg by
adding a module to allow speedy formatting of final dossiers).
Ownership
Private company
Industrial hygiene and worker exposure studies
Locations
Bordeaux FR, Lyon FR, Paris FR, Brussels BE,
Nottingham UK, Delhi IN, Trivandrum IN, Toronto CA
Founded
2001
Nathalie Ledirac, R&D Director
Michel Guilhem, Director, Business Development
Philippe Adrian, Director CEHTRA Europe
Paul Thomas, Director CEHTRA Lyon
Peter Jenkinson, Director CEHTRA UK
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.
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
2011/12
Turnover, group
-
-
No of offices
8
5
Staff, group
50
45
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.
REACH OR Services
IT & Legal Training
software 2%
6%
2%
CEHTRA provides a REACH only representative (OR) service via its
subsidiary company LTS REACH-OR SAS.
Information
5%
Authorisation services
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.
Representation
& management
10%
Consultancy/
advisory
75%
Page 58
Consortium and Sief management
2001
Company established
2004
Opening of UK office
2008
Opening of Brussels office
2008
Opening of Lyon office
2009
Start of the Indian Joint venture
2011
Opening of North America offices
Philippe Adrian PhD − General Manager of Brussels Office
2012
Opening of ChemAdvocacy
Philippe Adrian has a PhD in soil science and over 20 years' experience
with agrochemicals and biocides. Prior to his current position he worked
as research scientist in Germany. Later he worked at CNRS in France
and then Rhone-Poulenc Agrochimie and FMC. In 2001 he created
CEHTRA with Pierre-Gerard Pontal and manages the environmental fate
team. He has developed modelling expertise for pesticides according to
current models, as well as biocides using relevant TGDs.
Number of European registered toxicologists (ERT) and other certificates:
OO
11 ERTs
OO
one IOB/UKEMS GT
OO
two Chartered chemists (MRSC)
OO
one CIH (Certified Industrial Hygienist)
PARTNERS
LTS REACH OR, ChemService GmbH, ECOonline, NCEC, ERM
CLIENTS
Chemical companies, flavours and fragrances, petrochemicals, cosmetic
companies, plant protection industry, biocides, veterinary products,
pharmaceuticals.
TESTIMONIALS
“CEHTRA helped us to submit ten 2010 REACH dossiers as lead
registrant. We greatly appreciated their expertise in toxicology and
ecotoxicology in particular in cases where the protocols of standard
studies needed to be adapted to the test substances. In fact many of our
substances turned out to be ‘difficult to test’ due to their physico-chemical
properties. We have decided to use them again and are once more
confident of success for our 2013 dossiers.” – signed DRT
CASE STUDY 1: SEA dossier for biocide
Nathalie Ledirac PhD, ERT – R&D Director
Nathalie has a PhD in cellular and molecular aspect of biology and 13
years’ experience with agrochemicals. She worked as a research scientist
at INRA in France on pesticide toxicity and has also participated in private
research on drugs for pharmaceutical industries (HMR, Galderma).
She joined CEHTRA in 2006 as a regulatory toxicologist and provides
expert toxicology advice in study monitoring and data interpretation.
She develops close partnerships with private and academic research
by increasing the scientific participation of CEHTRA experts in research
projects (research programmes, publications, model development for
pesticides, accreditation, etc).
Pierre-Gérard Pontal MD, ERT− President of CEHTRA
Pierre-Gérard Pontal is a medical doctor and has 27 years of experience
with industrial chemicals, agrochemicals and biocides. He has worked
for Rhone-Poulenc Chimie and Aventis cropscience in the product safety
and risk assessment group. He has been a member of numerous task
forces such as ECPA, ECETOC and UIPP and since 1994 a member of
the EUROPOEM group. He is a recognised expert for operator exposure,
having conducted more than 20 worker exposure studies.
The Biocides Products Regulation requires a socio-economic analysis of
substances which may be subject to substitution (CMR, PBT endocrine
disruptors, etc). ChemAdvocacy has been awarded a study on a national
authorisation dossier for a wood protection product (PT8), classified CMR,
PBT. We are developing a methodology, the first of its kind for biocide
products, inspired by the available guidance (REACH, etc), and we
have presented our proposal to the French Competent Authorities, with
expected finalisation of preparation for submission in early Summer 2013.
Michel Guilhem MSc – Director, Business development
CASE STUDY 2: In silico predictions a priority
In silico methodologies to replace experimental studies are becoming
a hot topic, especially with the 2018 REACH deadline approaching.
CEHTRA has heavily invested in an in silico toolbox we call i-SAFERAT
on the basis of high quality predictions based on best quality experimental
data where necessary coupled with a read-across and weight-of-evidence
approach. Our aim is to cut the cost of REACH substance submissions
for lower tonnage substances without compromising data quality.
Charles has a PhD in Geochemistry and over 12 years' experience as
an industrial hygienist, and was one of the first in France to obtain the
prestigious CIH certification (still only one of ten in France). He joined
CEHTRA in 2009 developing exposure scenario in REACH dossiers and
e-SDS. Through audits and other site studies, and using currents models
in risk assessment, he has gained a large experience in many industrial
sector activities and acquired a unique understanding of health and safety
industrial culture.
STAFF SELECTION
Jason Nugent MSc – Director of CEHTRA NA
Peter Jenkinson − PhD, GT – CEO and Director of UK Office
Peter Jenkinson has a PhD in reproductive toxicology and over 30 years'
experience in the CRO industry specialising in genetic toxicology. Latterly
he was the director of the Chemical Business Unit at Harlan Laboratories
with a primary role of developing the REACH services of the company. In
March 2010 he joined CEHTRA to open the UK office and has provided
expert toxicology advice, particularly for study monitoring and data
interpretation.
Michel has three master’s degrees in chemical, environmental and safety
engineering and over 30 years of experience, from R&D and regulatory
affairs project management at Dow Chemical to management positions
in world-class consultancies (ERM, ENVIRON) and in the pharmaceutical
industry EHS services (Janssen-Cilag). He joined CEHTRA in 2009 and is
in charge of OH&S and product stewardship services.
Charles Alarcon PhD, CIH – Industrial Hygienist
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.
Paul Thomas PhD, ERT − Director and Manager of Lyon Office
Paul Thomas has a PhD in aquatic ecotoxicology and 17 years'
experience with industrial chemicals, agrochemicals and biocides gained
at CIT, ATOFINA and AkzoNobel. He joined CEHTRA in 2008 as director
of CEHTRA Lyon specialising in REACH-related services and is manager
of the CEHTRA ecotoxicology team. Paul has contributed strongly to
numerous successful registrations including several fragrance molecules.
Page 59
PROFILE: CEHTRA
ACCREDITATIONS
SERVICES PROVIDED
REACH consultancy
Centro Reach provides in-company support on the REACH Regulation,
including impact assessment and liabilities, product portfolio analysis and
subsequent REACH compliance actions, supply chain communication
assessment up and down, helpdesk consultancy.
PROFILE: Centro Reach
CONTACTS
REACH services
Website
www.centroreach.it
E-mail
[email protected]
Head office
Centro Reach Srl, Via Giovanni da Procida, 11, 20149
Milan, Italy
Tel/ Fax
+39 02 8724 5901/ +39 02 3456 5631
Contact
Ralf Knauf
Directors
Bruno Brianzoli
Sergio Treichler
Ownership
Private Company
Locations
Milan
Founded
2007
Centro Reach offers skills in management of registration dossier
preparation for individual lead registrants, and/or among consortia, and
for joint submission applicants. We provide assistance and information for
registration requirements, IUCLID 5 compilation and registration submission,
letter of access management, Sief management and late pre-registrations.
Consortium management in technical, administration, legal and coordination
field is one of the key activities of Centro Reach. The company's wide expert
network is able to fulfil all our customers’ support needs.
CLP and SDS management
Consultancy and submission of CLP notifications under the CLP
Regulation, safety data sheet assistance and management for EU territory
as well as extra-EU areas are also basic activities of Centro Reach.
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 participating
in almost 20 consortia working on registrations for 2010 and 2013.
We have expertise in: CLP notifications, support for safety data sheets,
training courses, in-company consultancy, legal assistance for chemical
regulations, regulatory services for non-EU countries thanks to our
international network, and R&D in the field of NTM methods (QSAR projects).
VITAL STATISTICS
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 2007-2012 more than
3,000 participants have attended our training sessions which are also
offered through Confindustria system and dedicated service activities.
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
2012
Turnover, group
ca €1m
ca €0.7m
No of offices
1
All of the EU
Staff, group
6
3 (plus wide expert network)
Training
15%
Legal
5%
Information
5%
Representation
& management
15%
Page 60
Consultancy/
advisory
60%
Centro Reach supported again around 300 customers, many
of them not Federchimica members. More than 40 training
course sessions and one national workshop with over 120
participants were organised.
Centro Reach supports Italian University Master Reach
activities and published an updated version of its Inventory
on certified Italian laboratories for REACH registration
studies.
ACCREDITATIONS
Certified ISO 9001
PARTNERS
Reach Centrum, Certiquality, Mario Negri Institute, Assoservizi, Intertek,
DGM Italia, Field Fisher Waterhouse, PriceWaterhouseCoopers,
Lenviros, ARPA Em Romagna, others
CLIENTS
Mainly SMEs but also companies like MAPEI, BASF Italia, Bracco,
Polynt,
Clariant Italia, DSM Italia, 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 has been concluded at the end of 2012.
Further information can be found on the ORCHESTRA dedicated website
STAFF SELECTION
Bruno Brianzoli – Coordinator
In 1964, after graduating in chemical engineering at Politecnico di Milano,
Bruno joined the multinational group Solvay, where he worked until
January 2007. As managing director of the Solvay Group from 1997 to
1999 he was in charge of managing the business of the Solvay Sodi
Company (the production of sodium carbonate) in Bulgaria. From 2000
2007 he was general manager of the Solvay.
Sergio Treichler – General Director
At present Sergio is the central technical – scientific director of
Federchimica. He previously worked in the industrial and financial fields
for the World Bank in Uganda, Ethiopia and Paraguay. Sergio has been
a member of important groups in Cefic such as the Product Stewardship
Programme Council and HSE, Logistics and Energy Programme Council.
He is a member of the board of directors of Certiquality Srl and an advisor
of ICS-UNIDO.
Ralf Knauf – Business Development Manager
In 1980 after finishing his professional education in economy and industry
at the head office of Bayer AG, Germany, Ralf moved to Bayer Italia's
AgChem division, where for more than 25 years he was responsible for
international business and regulatory coordination in several different
Italian AgChem companies. In 2007 he joined Federchimica's product
safety within technical and scientific department, focusing on REACH and
related regulations. Since 2009 he has been heavily involved in Centro
Reach, coordinating training 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 300 in-company
activities and visits.
CASE STUDY 2: Titaniumdioxide ( TiO2 ) study in nanosize under
REACH
Centro Reach in cooperation with ARPA E Romagna has simulated
a IUCLID 5 dossier for a volume up to ten tons/year covering the
necessary endpoints with specific data of the substance in nanosize,
showing that REACH regulation can handle nanomaterials, and that
there is no scientific evidence for assuming that substances in nanosize
are automatically more toxic than those in bulk. Further work under this
project is in progress. The study was presented during NANOTECHITALY
2011 in November 2011.
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PROFILE: Centro Reach
2012
SERVICES PROVIDED
World regulatory affairs consulting
Chemsafe can assist its clients with a great range of regulatory affairs
services around the world ranging from the legal side to all the technical
matters in order to comply with international and national chemical control
legislation.
Chemsafe technical staff have long experience in all aspects of REACH.
Our team has prepared a large number of registration dossiers and
chemical safety reports (CSR) and have provided expert advice on
specific areas of REACH such as data evaluation and study monitoring.
Chemsafe has significant experience in programme and project
management and Sief and consortia management.
PROFILE: Chemsafe
CONTACTS
Website
www.chemsafe-consulting.com
E-mail
[email protected]
Head office
Chemsafe Srl, Via Ribes, 5, 10010 Colleretto Giacosa
(TO), Italy
Tel
+39 0125 538888
Fax
+39 0125 538475
Contact
José V Cantavella Cabedo
Directors
Dr Antonio Conto, European Registered Toxicologist
(ERT), Managing Director
Ownership
Private company
Locations
Italy, Qatar
Founded
2001
REACH and CLP/GHS
Chemsafe provides its clients with strategic, legal and technical support
in order to comply with REACH and CLP/ GHS. Our technical support
includes, for example, preparation of full registration dossiers (as lead
or joint submissions), data gap analysis, review and analysis of physicochemical, environmental fate. Ecotoxicology and toxicological data. CSA/
CSR preparation, human and environmental exposure scenarios (ES)
and risk assessment. Application of alternative strategies to testing such
as read across and QSARs.
IUCLID 5 preparation and submission to ECHA and pre/post dossier
submission contact with the authorities.
OVERVIEW
Chemsafe’s vision is to offer regulatory and technical /scientific solutions
and services in the field of chemical safety with a “key point” approach
and customer care attitude.
VITAL STATISTICS
2011/12
Turnover, group
€1.7m
€1.7m
No of offices
2
2
Staff, group
12
10
Legal
10%
Training
5%
IT & software
5%
Laboratory
5%
Information
10%
Representation
& management
20%
GLOBAL OFFICES
Chemsafe Srl, Colleretto Giacosa (To), Italy
Chemsafe International, Doha, Qatar
Page 62
Consultancy/
advisory
45%
Sief and consortia management
We can help our clients with a full/partial Sief and/or consortia
management system such as preparation of Sief and consortium
agreements, letters of access, data sharing, maintaining contact list,
archiving, billing and all the daily aspects of running a successful Sief or
consortia.
Only representative (OR) and third party representative (TPR)
Since 2008 Chemsafe has been acting as only representative for non
European manufacturers and fulfilling the pre-registration and registration
obligations as prescribed in Article 8 of REACH Regulation. Non-EU
companies must either rely on their importers, or retain a person in the
EU to represent their interests, these are the “only representatives”
(ORs). Appointing your own OR gives your company business freedom
and security as you will have regulatory independence from other
members of your supply chain; you will have a high level of confidentiality
by separating the company name from proprietary product constituents;
you will maintain supply chain privacy between buyers and sellers;
provides expertise and third-party review for submissions to the European
Chemical Agency (ECHA) and provides representation to both substance
information and exchange forums (Siefs) and consortia.
Chemsafe is acting as OR for different fields of expertise and for different
types of companies coming from USA, Switzerland, South America,
Middle East and Far East countries.
Furthermore we can act as a third party representative (TPR) for
companies not wanting to disclose their identity.
Legal advice
We advise our clients on legal aspects of chemical trade around the world
and related chemical control regulations.
Biocides and agrochemicals
Our team can prepare and submit dossiers for authorisation of active
substances and for registration of formulated products. Also, we can
do the technical equivalence for active substances. We coordinate the
regulatory strategy with the national and/or international authorities
in order to deliver a successful dossier for biocidal products and for
agrochemicals.
Cosmetics
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STAFF SELECTION
general regulatory support for cosmetic products.
competent person designation.
data evaluation, data gap analysis, read-across methodology, in silico
method application, testing programme design, and study monitoring/
coordination.
PIF (product information file) or PSR (product safety report).
administrative activity, including robust study summaries and
substance information sheet (SIS) with ingredient evaluation.
Dr Antonio Conto – Managing Director
Biology degree, European Registered Toxicologist (ERT).
Founder of Chemsafe
>25 years of experience in the chemical and toxicological field.
Lara De Luca – Head of Technical Department
Industrial chemist, with more than 11 years of experience.
Risk assessment, exposure scenarios, CSR/CSA.
Petrochemicals
Dr José V Cantavella Cabedo – Head of Legal Department
We advise our clients on legal aspects of chemical trade around the world
and related chemical control regulations.
Attorney, JD in environmental law, with more than 17 years of experience
Environmental and chemical law
2001
Start-up in Italy as “a one man” company
2004
Staff increase up to four people
2007
REACH services offered
2009
Biocides and agrochemicals group creation
2010
Technical consortia advisers for three international consortia.
Staff increase up to ten people
2011
Petrochemicals derivatives, wastes, cosmetics and
pharmaceuticals consortia management. Staff increase to 12
people.
2012
Office opening in Qatar in quarter three
Francesca Fasano – Head of Biocides Department
Industrial chemist, with more than 10 years of experience.
Biocides, agrochemicals and ecotoxicology.
PROFILE: Chemsafe
Elena Meriano – Head of REACH Registration group
Biologist, with more than 11 years of experience.
Technical dossier preparation, study monitoring, IUCLID.
Loredana Savin – Head of CLP/GHS group
Biologist, with more than 11 years of experience
Classification, labelling, GHS.
ACCREDITATIONS
Chemsafe is a full member of ORO, the Only Representatives
Organisation based in Belgium.
Chemsafe is also a full member of the Industrial Union of Turin, Italy.
PARTNERS
OO
Chemsafe is 100% privately owned.
CLIENTS
Our clients are manufacturers and importers involved in the market
sectors of: chemicals, pharmaceuticals, agrochemicals, biocides,
cosmetics, food, medical devices, nanomaterials and petrochemicals from
around the world. They vary from multinational companies to SMEs and
authorities.
TESTIMONIALS
Any persons or companies requesting testimonials or references will be
provided with them upon individual written request.
CASE STUDY 1: REACH testing progamme
Working together with a global supplier of chemicals Chemsafe devised
a detailed and comprehensive testing/study programme for REACH
registration of a wide range of products.
CASE STUDY 2: REACH dossier work
Our experience in dossier work is over 120 registration dossiers for Phase
of REACH, including lead and member dossiers. Some of these dossier
were UVCB substances. An important number of CSR and hundreds of
safety and extended safety data sheets had been prepared by our team.
CASE STUDY 3: Legal case
Last year Chemsafe successfully settled a legal case with the European
authorities, on behalf of one of our clients.
Page 63
GLOBAL OFFICES
Chemservice SA, Grevenmacher, Luxembourg
Chemservice GmbH, Worms, Germany
Chemservice Asia Co Ltd, Seoul, Korea
Chemservice Ltd Sti, Bodrum/Mugla, Turkey
Chemservice EHNS GmbH, Worms, Germany
Consortia Management GmbH, Worms, Germany
ChemCehtra SAS, Bordeaux, France
ChemAdvocacy SA, Grevenmacher, Luxembourg
PROFILE: Chemservice
CONTACTS
Website
www.chemservice-group.com
E-mail
[email protected]
Head offices
Chemservice GmbH /
Chemservice S.A.
Von-Steuben-Str 13 /
5, an de Laengten
D-67549 Worms, Germany /
L-6776 Grevenmacher, Luxembourg
Tel
+49 (0)6241 95480-0 /
+352-270776-1
Fax
+49 (0)6241 95480-25 /
+352-270776-75
Contacts
Karl-Heinz Reis /
Dr Günter Spang
Directors
Dr Dieter Drohmann, Managing Director
Karl-Heinz Reis, Director Global Regulatory Affairs
Dr Günter Spang, Director Toxicology and Risk
Assessment
Thomas Schäfer, Director Data and System Services
Ownership
Privately owned group of companies
Locations
Germany, Luxembourg, Korea, Turkey, France
Founded
2007
SERVICES PROVIDED
Global regulatory affairs consulting
Chemservice provides a broad range of services designed to assist clients
in preparing for and in complying with international and national chemical
control legislation. The application range for chemistry is extensive. Therefore,
chemical control legislation is comprehensive in order to assure product safety,
producer liability and consumer and environmental protection to regulate the
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
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 IUCLID 5 assistance, CLP notification, safety data sheet and label creation.
Through our new legal entity, ChemAdvocacy, we provide REACH
authorisation services (including SEA), advocacy and product
stewardship consulting.
Consortia, Sief and letter of access management
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
2011/12
Turnover, group
c €3m
c €3m
No of offices
7
5
Staff, group
30
28
Other
Training 5%
5%
IT & software
10%
Information
15%
Consultancy/
advisory
45%
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 Siefs 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.
Only representative and third party representative
We act for manufacturers outside the EU as only representative and
cover fully the registration and pre-registration obligations. The importers
of that non-EU manufacturer would no longer have duties as importers,
but will be regarded as downstream users. Only one registration
is needed by the only representative. Moreover, we act as only
representative for non-EU manufacturers of articles, which intentionally
release substances and we act as third party representative (of a
community entity) according to REACH Article 4.
2007
Start-up in Luxembourg
2008
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 SA with office in Luxembourg
Representation
& management
20%
Page 64
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
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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
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
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PhD in chemistry
>10 < 15 years of experience in GLP and GMP quality assurance
in the field of pharmacology and plant protection products, and
nanoparticles
Dr Günter Spang – Director Toxicology and Risk Assessment
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PhD in agronomy
>15 < 20 years of experience in regulatory affairs consulting,
including risk assessments and dossier preparation
Natalia Jansen-Bouriatchenko – Regulatory Affairs Advisor
(Ukrainian)
master in biochemistry
>15 < 20 years of experience in analytical and ecological chemistry,
ecotoxicology and toxicology
We have significant experience in global inventory registrations and
conducted around 120 notifications to the Turkish inventory and 300
nominations to the inventory in Taiwan. For 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).
Karl-Heinz Reis – Director Global Regulatory Affairs
CASE STUDY 2: REACH-Code-Model
Thomas Schaefer – Director Data and System Services
REACH does not distinguish between direct and indirect imports
into the EU. Therefore, non-EU business followed by export to EU is
more complicated – 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.
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master in biology
>20 years of experience in the field of risk assessments, PBT
assessments and CRO study director
IT specialist and SDS expert
>20 years of experience in IT and data systems
Yong Jiang – Regulatory Affairs Advisor (Chinese)
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master in chemistry
eight years of experience as chemical specialist, consultant and
compliance manager
Ah-Reum Seo – Regulatory Affairs Advisor (Korean)
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chemist
eight years of experience in R&D and regulatory affairs
CASE STUDY 3: REACH dossier work
Chemservice has experience with around 200 Tier 1 and 2 REACH
dossiers, including member and lead dossiers. Moreover, a significant
number of new substance registrations (non-phase-ins), inquiry dossiers,
PPORDS, chemical safety reports and extended safety data sheets were
successfully completed. Furthermore, we have acted on behalf of our
clients in more than 500 CLP-notifications.
Page 65
PROFILE: Chemservice
Our partner companies can be viewed on our website.
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PROFILE: ChemService Srl Controlli e Ricerche
GLOBAL OFFICES
ChemService Srl Controlli e Ricerche – Via Fratelli Beltrami 15
20026 Novate Milanese (MI), Italy
ChemService agent in China: Ms Ina Cui IGW First Chemical Co Ltd –
Suite 352, 3rd Floor, OG Plaza, Building C, No 327 Tian Yao Qiao Road,
Xuhui District, Shanghai, 200030, PR China.
CONTACTS
SERVICES PROVIDED
Website
www.chemservice.it
E-mail
[email protected]
Head office
Via Fratelli Beltrami 15, 20026 Novate Milanese (MI),
Italy
Tel
+39 2 3569961
Fax
+39 2 38201446
Contact
Cristina Marchiori, Sales Manager
Directors
Giacomo Ravetta, Managing Director
Ownership
Private company
Short and long term ecotoxicological tests on aquatic (alga, daphnia,
fish, activated sludge) and terrestrial organisms (earthworms). Tests on
soil microorganisms (OECD 216, 217), aquatic plants (OECD 221 on
lemna sp). Biodegradability testing (OECD 301). Tests on terrestrial plants
(OECD 208, 227), non-target arthropods and higher-tier tests on fish
(FELS, FET). Development and validation of analytical methods for active
substances and impurities, 5-batch analysis, physico-chemical testing,
spectral analysis (UV, VIS, IR, MS, NMR).
Affiliated with FINAGRO SPA
REACH and CLP
Locations
Novate Milanese (MI), Italy
Founded
1992
Ecotoxicology and biodegradability testing. Analytical methods
development and validation, physico-chemistry testing
OVERVIEW
ChemService Srl Controlli e Ricerche is a contract research organisation
(CRO) providing GLP testing and regulatory services for the plant
protection, biocidal, veterinary, industrial chemical and consumer product
industries. Our mission is to increase our customer’s competitiveness
and long-term profitability with high quality and reliable testing and
regulatory services. A long lasting experience in the fields of analytical
chemistry, physico-chemistry and ecotoxicology, coupled with a deep
knowledge of current regulatory framework and a strong attention to
long-term trends makes ChemService Srl Controlli e Ricerche the right
partner in regulatory environment. ChemService Srl Controlli e Ricerche
collaborates with EU authorities, being selected by Efsa for the assistance
to the Efsa scientific units on toxicology and ecotoxicology and by EU
in 2008 (EuropeAid/123060/D/SUP/RO) for building an ecotoxicological
laboratory in Romania.
VITAL STATISTICS
2011/12
Turnover, group
€5m
€5m
Analytical, physico-chemical, ecotoxicological testing and consultancy
services for CLP and REACH with data gap analysis, review of existing
data and ad hoc testing strategies. Preparation of registration dossiers
(lead/joint submissions), CSA/CSR (Chesar), human and environmental
exposure scenarios and risk assessment, eSDS. Use of alternative
strategies in vitro, in silico (OECD Toolbox, CAESAR, ToxTree, Lazar,
EPI Suite, etc) and read across/category approach. IUCLID 5 file
preparation and submission to ECHA. Contacts with ECHA during pre/
post (follow-up) dossiers submission.
Plant protection products (PPPs) and biocides
Testing and preparation of dossiers for authorisation of active substances
and for registration of formulated products (dRR format). Five-batch
analysis in accordance with EU, US, Latin America (Brazil, Argentina)
requirements and technical equivalence dossiers of active substances.
Data gap analysis and testing strategies. Human (operator, worker,
bystander, consumer) and environmental risk assessment, e-fate
modelling (eg FOCUS model for PPP). Scientific monitoring of efficacy
trials and preparation of biological assessment dossiers-BAD-for PPP.
Scientific monitoring of sub-contracted studies (toxicological studies),
consultancy for non-standard studies (operator exposure, dislodgeable
residues, radio-labelled material). Use of IUCLID (for PPP), CADDY (for
biocides). Dossier submission and follow-up with authorities.
No of offices
2
2
1992
ChemService Srl incorporated as international contract
research organisation in Milan, Italy.
1992
Achievement of ISO/IEC 17025 accreditation
1995
Achievement of OECD GLP compliance
2003
Beginning of regulatory services (dossier department)
2004
Erecting of new laboratories (1400 m2) and start-up of GLP
ecotoxicological testing facility
2008
Start of collaboration with Efsa and EU authorities
2011
Implementation of tests on aquatic plants (lemna) and soil
microorganisms.
2012
Implementation of higher tier tests on fish (fish life cycle
test), tests on non-target terrestrial plants and non-target
arthropods.
Staff, group
50
45
Training
5%
Consultancy/
advisory
35%
Laboratory
60%
Page 66
Good Laboratory Practice (GLP) and ISO/IEC 17025:2005
PARTNERS
IGW First Chemical Co Ltd , Shanghai – PRC acts as agent of
ChemService Srl Controlli e Ricerche in China’s territories. The specific
target of the venture is to handle the increasing demand of GLP testing
services from Chinese customers willing to enter EU, Brazil, Argentina
and US markets and to advise Chinese companies on global registration
requirements.
CLIENTS
Our clients are involved in the market sectors of: agrochemicals, biocides,
chemicals, veterinary products, food, medical device and antimicrobial
chemicals
TESTIMONIALS
“ChemService Srl Controlli e Ricerche has provided high quality
regulatory and testing services to our company for over ten years, having
prepared more than ten registration dossiers and having conducted
more than 200 physico-chemical and ecotoxicological GLP tests on our
agrochemical products” – Makhtheshim Agan Italia Srl
CASE STUDY 1: Inclusion of sulphur in Annex I (91/414/EEC)
ChemService successfully stewarded a fourth list substance, sulphur,
onto Annex I inclusion in 2010 after several years of work. Sulphur is
a widespread substance that has been used in agriculture for a long
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 taskforce
of 12 companies from all over the world, which was headed by an
Italian company and managed from ChemService across the revision
process. The technical and management experience of ChemService in
coordinating different facilities and the need of the task force members for
a common goal was crucial to the success of the project.
CASE STUDY 2: Successful chemical equivalence dossier for an
Annex I listed agrochemical
Finchimica, a SME manufacturer of agrochemicals, decided in mid 2010
to submit to the UK chemicals regulation directorate (CRD) a chemical
equivalence dossier for Pendimethalin technical, a selective herbicide
included in Annex I of Directive 91/414/EEC whose data protection
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
Since May 2009 ChemService Srl Controlli e Ricerche has been part
of a panel of experts selected by Efsa for assisting its scientific units on
toxicology and ecotoxicology (Multiple Framework Service Contract CT/
EFSA/AMU/2009/07, budget available €1m) and has been awarded two
specific contracts for the data entry of pesticide ecotoxicology endpoints
in a IUCLID 5 database. In October 2012 ChemService Srl Controlli e
Ricerche was awarded a specific contract for the collection of scientific
information within the public domain on the toxicity of chromium and
nickel in experimental animals and humans (NP.EFSA.CONTAM.2012.01,
budget €60,000).
STAFF SELECTION
Giacomo Ravetta – Managing Director
Masters degree in industrial chemistry, 20+ years’ experience in project
management in the EU and abroad (China, India, USA), as head of R&D
teams for the development of agrochemicals products. He developed
a broad network in the global community of chemicals production and
legislation and he has a strong focus on customers’ business. Since 2009
he has been managing director of Chemservice Srl Controlli e Ricerche
where he has brought his sound management and business oriented
background.
Dr Valeria Croce – Head of Regulatory Services
Masters degree in biology and PhD in environmental sciences, ten years’
experience in regulatory field, ecotoxicology and environmental risk
assessment. Head of the Dossier department she coordinates a team of
six regulatory experts plus a senior scientific consultant, with expertise
ranging from chemistry, agronomy, biology (toxicology/ecotoxicology),
e-fate modelling, environmental sciences. Since 2008 she has been
involved, as an ecotoxicology and regulatory expert, in EU and EFSA
projects.
Chiara Neri – Head of Ecotoxicological Testing Unit
Masters degree in biology, specialised in ecotoxicology and holder of
a European scholarship from 2004 to 2006 for a project on endocrine
disruption. In 2006 she joined ChemService Srl as study director for
aquatic and terrestrial ecotoxicological studies. Currently head of
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 3,000 GLP analytical studies from 2005-2011 (600+ in 2012).
Dr Carlotta Casalegno – Head of Regulatory and Development
Masters degree in biology and PhD in naturalistic and environmental
sciences, from 2000 to 2005 she was involved in basic environmental
research and EU projects management. In 2006 she joined ChemService
Srl as regulatory toxicologist and human risk assessor for PPPs, biocides
and REACH. In 2010 she worked for an international ONG (ECEAEBUAV) commenting on testing proposals for REACH Annex IX and X
substances and was appointed as ONG representative to support the use
of alternatives during ECHA committee (RAC, MSC) meetings in Helsinki.
She came back to ChemService in 2011 as head of Regulatory and
Development. Since 2009 she has been involved, as a toxicology and
regulatory expert, in Efsa projects.
Page 67
PROFILE: ChemService Srl Controlli e Ricerche
ACCREDITATIONS
GLOBAL OFFICES
PROFILE: Chilworth – a DEKRA Company
DEKRA Industrial GmbH
Handwerkstr. 15
D-70565 Stuttgart
Germany
CONTACTS
SERVICES PROVIDED
process safety consultancy
dust, fire and explosion protection
chemical reaction hazards
material testing
laboratory testing
regulatory testing
process safety training
Website
www.chilworth.co.uk
E-mail
[email protected]
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
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
OO
OO
VITAL STATISTICS
2011/12
Turnover, group
€1.8bn
€495m
No of offices
30+
80+
Staff, group
25,000
500+
Other
10%
Training
5%
Laboratory
50%
Page 68
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, while acting as study managers for a range
of toxicology and exotoxicology test programmes.
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.
Page 69
SERVICES PROVIDED
Registration of chemicals in the EU
Website
www.csregulatory.com
E-mail
[email protected]
Head office
The Old Courthouse, St. Peters Churchyard, Derby, UK
Tel
+44 (0)1332 380692
Fax
+44 (0)1332 380692
The CSR regulatory team provides project management to ensure
product approval and registration, and to build support and defence
packages for product portfolios. We compile supporting data packages,
conducting a number of QSAR assessments in-house as well as literature
searches and reviews to avoid new testing, and prepare the regulatory
compliance documents.
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.
Contact
Mr Steven Green
Worldwide notification of chemicals
Directors
Mr Steven Green
Mr Craig Deegan
Ownership
Private company
Locations
Head office only
Founded
2007
PROFILE: CS Regulator y Ltd
CONTACTS
OVERVIEW
CS Regulatory Ltd is an independent, privately owned organisation
accredited to ISO 9001:2008 successfully providing regulatory assistance
to suppliers of industrial chemicals throughout the world. Staff at CS
Regulatory offer a combined experience of more than 45 years of
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
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
7
7
Information
10%
Training
5%
Representation
& management
20%
Consultancy/
advisory
65%
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.
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 and IUPAC name derivation.
2007
CS Regulatory established as an LLP
2007
Established a global network of expert regulatory
consultants
2008
Incorporated as a private limited company
2009
Established the preferred partner agreement with LAB
Research Inc
2009
First achieved the ISO 9001:2008 accreditation for all
services, including registration
ACCREDITATIONS
ISO 9001:2008
GLOBAL OFFICES
Not applicable. CS Regulatory has a global network of independent
expert consultants for global regulatory compliance.
Page 70
PARTNERS
CiTox LAB preferred partner
CLIENTS
Craig Deegan − Director
Due to strict terms of confidentiality and the nature our business, CS
Regulatory does not release the identity of its clients. CS Regulatory
works with and assists a broad range of suppliers from international blue
chip companies and household names to small and medium enterprises
with their regulatory requirements.
Mr Deegan has been working in the field of international regulatory
affairs and health, safety and environmental consultancy for 18 years,
incorporating development of testing strategies based on risk hierarchy,
evaluation and interpretation of client specific requirements to ensure
best value for clients with an interest in REACH, CLP and worldwide
registration requirements. With detailed experience of the practical
application of risk management in the industrial environment, Mr Deegan
offers experience and knowledge that many regulatory consultancies lack.
Specific references can be provided to potential clients upon request
CASE STUDY 1: REACH registration by read across
CS Regulatory has been working with suppliers of related metal
compounds. With detailed data for the base metals available CS
Regulatory designed a strategy for REACH compliance based on sound
scientific principles and the pragmatic use of public domain, read-across
and QSAR assessment to reduce the need for animal testing and
achieving significant cost reduction of regulatory compliance.
CASE STUDY 2: REACH compliance as OR
CS Regulatory accepted the transfer of OR duties for a substance
registered in the EU as an isolated intermediate. On conducting due
diligence, however, it became apparent that there was a need to support
non-intermediate uses, albeit at lower tonnage bands. Based on OSOR
principles advocated by ECHA and expressed within the guidance,
CS Regulatory accepted the role of lead registrant to undertake the
necessary updates to the dossier and produce suitable chemical safety
assessment to ensure the ongoing compliance for the non EU supplier
and downstream users.
Tracey Thomas – Regulatory Specialist
Ms Thomas has been working in the field of health and medical
consultancy for 15 years. Her work within CS Regulatory incorporates
collecting and collating a wide range of information for notification/
registration dossier preparation, analysing study data information
(including trials data) and preparing relevant submissions to regulatory
authorities. Ms Thomas also acts as an advisor on CLP issues, preparing
evaluations of CLP impact and advising organisations of the viability of
their products from a CLP perspective.
Claire Lowe – Regulatory Affairs Officer
Mrs Lowe has been preparing regulatory documentation for ten
years, preparing registration dossiers in appropriate formats for global
compliance purposes, including IUCLID 5 format for REACH. Prior
to joining CS Regulatory, Mrs Lowe worked in forensic compliance
procedures, including the spectral analysis of drug formulations. Mrs
Lowe now assists CS Regulatory’s clients with regulatory compliance
documentation specifically for REACH.
CASE STUDY 3: DU compliance
CS Regulatory assisted an international supplier of armoury and projectile
products with their compliance requirements. The client had dual roles
as both a direct importer but also as a downstream user, and was unsure
of their compliance position. In seeking to ensure compliance with all
EU regulations, CS Regulatory was employed to assess the chemical
substances and products and articles from all suppliers to review the
REACH status, SVHC content and CLP compliance with a view to
determining our clients’ registration and notification obligations. By means
of site audits and review of the various supply chains and associated
documentation, CS Regulatory was able to determine the status of
products and provide recommendations for ensuring compliance plus
suitable documentation for use with downstream users. Assistance with
relevant notification requirements was also conducted.
CASE STUDY 4: Biocidal product review
CS Regulatory was employed by a non-EU organisation to assess the
propensity of some niche chemical products for use as potential biocides.
Utilising an approach with the member state authorities, it was possible to
determine whether the required substances could possibly be evaluated
as such (or had been) along with provision of budgets to allow for
determination of viability of supporting such products through the biocide
registration process. This allowed the client to quickly determine the
implications of supporting such products within the EU.
STAFF SELECTION
Steven Green − Director
Over a period of 20 years, Mr Green has successfully completed
chemical registration submissions throughout the world, having
negotiated with many regulatory authorities including EU member state
authorities, NICNAS, JMETI, MHLW, JMAFF, KMoL and SEPA/MEP. Mr
Green is an expert in regulatory strategy with an almost unique blend of
regulatory assessment and clearly defined business principles which is
essential to compliance with REACH.
Page 71
PROFILE: CS Regulator y Ltd
TESTIMONIALS
GLOBAL OFFICES
CHEMPARK Leverkusen, Germany
CHEMPARK Dormagen, Germany
CHEMPARK Uerdingen, Germany
SERVICES PROVIDED
PROFILE: CURRENTA
CONTACTS
Website
www.analytik.currenta.de
E-mail
[email protected]
Head office
CHEMPARK, Building K 46, 51368 Leverkusen,
Germany
Tel
+49 214 30 33777
Fax
+49 214 30 61209
Contact
Tobias Hedwig
Directors
Dr Günter Hilken, Managing Director
Dr Joachim Waldi, Managing Director
Dr Hans Richter, Head of Analytics
Ownership
Joint Venture (Bayer AG, Lanxess AG)
Locations
Germany
Founded
2008 (for former organisational structure please see
Corporate Developments & Achievements)
OVERVIEW
CURRENTA offers an extensive range of analytical services for research,
development and production in industry. Companies worldwide rely on
the skills of our experts and entrust their samples to our laboratories.
Methods range from standardised quality inspections to demanding
structural analyses. We help solve all your analytical tasks through a wide
range of methods, cutting-edge laboratory technology, the highest quality
standards and professional consulting services (REACH).
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
3
1
Staff, group
3.300
All services of the REACH regulation in the broadest sense, including:
OO
strategic REACH consulting
OO
impact analysis
OO
identification of data requirements
OO
literature searches
OO
identification of data gaps
OO
recommendation of an intelligent test strategy (category approach,
waiving, read-across, QSAR calculations)
OO
planning and performance of studies (physico-chemical and
ecotoxicological parameters; environmental fate and behaviour;
toxicological endpoints*)
OO
preparation of technical dossiers and chemical safety reports
OO
performance of exposure estimates and risk assessments
OO
PBT and vPvB assessments
OO
consulting on SVHC issues
OO
submission of registration dossiers and communication with ECHA/
national authorities
OO
active product defence, including the evaluation and authorisation
process
OO
representation in Siefs/ consortia
OO
consortium management
* toxicological endpoints in cooperation with qualified partners
1971
Bayer AG; Central Research / Zentrale Forschung
2002
Bayer AG; Standortdienste; Central Analytics
2003
Bayer Industry Services; Analytics
2008
CURRENTA, Analytics
CURRENTA, and its precursor organisations have been
dealing with all kinds of product safety issues for more than
40 years. Encompassing for instance the fields of German
BUA reports, OECD SIDS, EU-Risk assessments and many
more. In recent years the main focus is targeted at supporting
the customers in a successful REACH registration of their
products.
450
Training Other
2%
3%
Consultancy/
advisory
35%
Laboratory
45%
Information
5%
Page 72
Representation
& management
10%
ACCREDITATIONS
GLP, GMP, DIN EN ISO 17025, active member in international working
groups e.g. CEFIC, VCI, DIN
PARTNERS
Dr KNOELL Consult GmbH; cooperation with laboratories and expert
teams within the Bayer AG enterprise in single cases
CLIENTS
Valid confidentiality agreements with customers; diversity of
customers reaches from industrial sectors (chemistry, agrochemicals,
pharmaceuticals, cosmetics, plastics) to various company sizes (big
international companies and SMEs) and consortia management
PROFILE: CURRENTA
CASE STUDY 1:
CURRENTA successfully accomplished the REACH registration process
of more than 170 HPV substances to the satisfaction of its customers
since the REACH legislation is in force.
CASE STUDY 2:
CURRENTA offers broad experience in communication with international
authorities targeting on a satisfactory and expedient solution for all
involved parties. Currently, this includes in-depth consultancy for product
defence strategies of dangerous substances on the CORAP list which are
suspected to be PBT/vBvP or endocrine disrupting chemicals.
CASE STUDY 3:
REACH-registrations of nanomaterials.
STAFF SELECTION
Dr Hans Allmendinger – Head of REACH Team
REACH Team:
Dr Regina Schade-Lehn – Consortia Management
Dr Susanne Backens-Hammerschmidt – SMEs, NONs
Dr Lei Shi – Hazard and Exposure Assessment
Dr Jan Wölz – Hazard and Exposure Assessment, Endocrine
Disrupters
Dr Julia Schmitt – Hazard and Exposure Assessment, Modelling
Sabine Ranz – Hazard and Exposure Assessment
Further technicians REACH consulting: nine
Page 73
SERVICES PROVIDED
REACH registration services
DHI offers manufacturers and importers of substances following technical
expert services:
OO
guidance and strategic counselling on chemicals legislation and
REACH tasks;
OO
preparation of registration dossiers based on development of
individual testing strategies and integrated use of non-test methods
(QSAR, read-across, waiving);
OO
analysis of alternatives and SEA pertaining to REACH authorisation.
DHI further facilitates and manages Sief and consortia and provides third
party representation and only representative (OR) services.
PROFILE: DHI
CONTACTS
Website
www.dhigroup.com
www.tox.dhigroup.com
E-mail
[email protected]
Head office
Agern Allé 5, DK-2970 Hørsholm, Denmark
Tel
+ 45 4516 9200
Fax
+ 45 4516 9292
Contact
Jens Tørsløv, Head of Projects.
Directors
Asger Kej, Chief Executive Officer
Peter Rasmussen, Chief Financial Officer
Ownership
Not-for-profit organisation
Locations
27 worldwide offices and operations
Founded
1964
Regulatory services and IT based support tools
DHI facilitates company specific GHS strategies for global companies as
well as classification and labelling of chemical substances and mixtures.
Preparation of safety data sheets and REACH exposure scenarios and IT
tools for exposure scenarios. Training courses and webinars in CLP, SDS
and consolidation of exposure scenarios. Provider of regulatory data for
SDS software and chemical management systems including individual
lists on classification, substance names, exposure limits, CAS numbers,
phrase modules with 4,500+ phrases in more than 40 languages and
translation of company specific phrases.
OVERVIEW
Environmental laboratory
DHI is a global and independent consulting and research organisation
advancing technological development within the fields of water,
environment, health and toxicology. DHI supports the chemical industry,
working in close relationship with authorities, manufacturers and users,
providing excellent expertise within human and environmental risk
and safety assessments and documentation. Our integrated approach
combines chemical consulting and profound insight in regulatory
requirements with leading edge IT solutions and a top professional
laboratory.
The DHI laboratory conducts acute and chronic ecotoxicological studies
with organisms in water, sediment and soil and is specialised in carrying
out standardised and specialised tests concerning biodegradability,
toxicity, endocrine disrupting effects and bioaccumulation of chemical
substances, products and complex mixtures. DHI has experience as test
facility for offshore activities using sensitive marine organisms. DHI has
further practical expertise in testing for requirements under the scheme
for pharmaceuticals according to the European Medicine Agency (EMA).
VITAL STATISTICS
DHI offers regulatory assistance for both industry and authorities:
OO
data search and information retrieval;
OO
data gap analyses;
OO
toxicological services and testing;
OO
ecotoxicological tests;
OO
preparation of dossiers on biocidal active substances and biocidal
products;
OO
preparation of dossiers on active substances and plant protection
products;
OO
formulation of claims, notifications and expert reports and waivers.
2011/12
Turnover, group
€116m
€8.9m
No of offices
27
40
Staff, group
981
62
Pharmaceuticals and medical devices
Training Other
Legal 3%
2%
2%
IT & software
12%
Laboratory
7%
Information
1%
Representation
& management
1%
Consultancy/
advisory
72%
GLOBAL OFFICES
Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark,
France, Germany, Hungary, India, Italy, Malaysia, New Zealand, Norway,
Poland, Portugal, Romania, Singapore, Slovak Republic, South Africa,
Spain, Sweden, United Arab Emirates, United Kingdom, USA, Vietnam.
Page 74
Biocides and pesticides
Within pharmaceuticals, medical devices, medicinal products, veterinary
medicine and herbal medicine, DHI supports industrial companies and
authorities with human and environmental risk and safety assessments
and documentation; data screening, literature searches, comparative
evaluation of materials/toxicity, QSAR for prediction of toxicological
effects of chemical substances, evaluation of biocompatibility, safety
assessments and selection of tests in accordance with ISO 10993 and
regulatory services (EMEA, FDA, ISO 10993, ICH).
Food and feed safety
Use DHI for regulatory advice and safety or risk assessments of novel
foods, food contact materials, dietary supplements, food and feed
additives, contaminants, naturally occurring toxins, technical processing
aids, ingredients, whole foods and drinking water.
1964
Danish Hydraulic Institute (DHI) founded
1973
Approved as Authorised Technological Service Institute by the
Danish Minister for Science, Innovation and Higher Education
1982
VKI laboratory accredited by DANAK, the Danish
Accreditation and Metrology Fund
STAFF SELECTION
1989
VKI laboratory authorised to carry out test in compliance with
the OECD principles of GLP
2000
Designated as a resource centre for the Global Water Partnership
2001
Merge with VKI Institute for the Water Environment
2004
Designated the United Nations Environmental Programme
(Unep) Collaborating Centre for Water and Health
2005
Merge with Danish Toxicology Centre (DTC)
2004-2007 employed by the European Commission at European
Chemicals Bureau, Italy, where he participated in the development of the
technical guidance and tools assisting industry in complying with REACH.
Extensive experience as project manager with references within REACH
registration, environmental and human risk assessment of chemicals,
regulation of chemicals, industrial pollution control, capacity building,
preparation and chairing of workshops and training programmes.
2007
Establishment of the Environment and Toxicology unit
Ecotoxicology tests:
OO
in accordance with ISO 17025;
OO
accredited by DANAK, the Danish Accreditation and Metrology Fund;
OO
in compliance with the OECD and principles of good laboratory
practice (GLP).
PARTNERS
Software:
OO
ECOonline, Safeware Quasar Ltd, The Wercs, InterSolia AB
OO
Member of the GCC Network
CLIENTS
Brenntag AG, Cargill Inc, Chevron Products Company, Coloplast A/S,
Danisco A/S, Danish Environmental Agency, Delta, FeF Chemicals,
Ferring Pharmaceuticals A/S, ECHA, GE Healthcare, Halliburton,
Johns Manville, Knauf Insulation, KIST Europe, Leo Pharma, Magna
Industrial Company Ltd (Hong Kong), Nickel Institute, Novo Nordisk A/S,
Novozymes A/S, Owens Corning, Paroc Group, Rockwool A/S, Saint
Gobain, Statoil AB, Sun Chemicals, URSA insulation.
TESTIMONIALS
Specific references can be provided to potential clients upon request.
CASE STUDY 1: The chemical management system
ChemManager®
DHI evaluates the raw materials used by Radiometer and identifies
any deficiencies. DHI also prepares and maintains documentation for
Radiometer's own products in the form of safety data sheets. In this way,
Radiometer ensures compliance with current chemicals legislation and
uniform customers communication – regardless of the 20 languages in
use. The DHI databases and phrase libraries and web-based chemical
management system, ChemManager®, help ensure the quality. The
use of ChemManager® enables Radiometer to screen their products
for problematic substances (for example SVHCs) and to take proactive
action concerning the use of chemicals.
Lars S Rasmussen, MSc, Chemical Engineering – Business Area
Manager IT and Hazard Communication
Expert knowledge of European chemical legislation, in particular
classification, labelling and packaging of chemicals as well as MSDS
authoring. Broad knowledge on other parts of European chemicals
legislation as well as US and Canadian chemical regulation with regards
to MSDS authoring and hazard communication. Expert knowledge of
international regulations on transport of dangerous goods.
Karl-Heinz Cohr, MSc, Biochemistry – Chief Toxicologist
General experience in human toxicology, toxicological evaluations,
exposure scenarios and risk assessments, and development of proposals
for limit values (C-values, OEL, PDE, TDI). Specialist knowledge within
expert reports for the pharmaceutical and medico industry, REACH
including IUCLID, notification of new chemical substances, assessment
and control of risks from existing substances, mathematical modelling, ie
QSAR and read-across in risk assessment.
Poul Bo Larsen, MSc – Toxicologist
Has more than 25 years of experience in regulatory toxicology and
human health risk assessment of chemicals/chemical pollutants. Has
been employed at the Danish Technological Institute, the Institute of
Toxicology at the National Food Agency and for more than 14 years at
the Danish Environmental Protection Agency. Participated as a national
expert on human health risk assessment of chemicals in various
working groups at national level in OECD and the EU including the
Risk Assessment Committee at ECHA. Has worked with regulation and
assessment of hydrocarbons and with the EU risk assessment document,
and regulation and assessment of manufactured nanomaterials within EU
and OECD.
Anja Kamper, MSc, Biology – Laboratory Manager
Has extensive experience within ecotoxicological and biodegradability
testing of chemicals in aquatic and terrestrial systems, managing and
performance of laboratory studies according to OECD principles of
good laboratory practice (GLP), quality management, quality assurance
and quality control of laboratory activities, REACH, environmental risk
assessment and classification of chemicals and products, development of
environmental quality standards.
CASE STUDY 2: A science and technology based AoA to nickel
Since 2011 DHI has provided services on analysis of alternatives (AoA)
to the Nickel Institute. Nickel and nickel compounds are not identified as
SVHC under REACH but a number of salts are classified as Carc. 1A.
The project was initiated by the Nickel Institute in response to questions
by the French authorities regarding possible alternatives. Nickel based
catalysts are used in many chemical production processes, for example
production of fuel, fertilisers and bulk chemicals. Possible alternatives
include molybdenum, ruthenium and platin group metals. A careful
evaluation of the technical, economic and risk based suitabilities of the
alternatives concluded that substitution generally leads to increased
capital and process costs and/or inferior products.
Page 75
PROFILE: DHI
ACCREDITATIONS
Jens Tørsløv, PhD, Ecotoxicology – Head of Projects
GLOBAL OFFICES
Dr. Knoell Consult GmbH, Mannheim, Germany
Dr. Knoell Consult GmbH, Leverkusen, Germany
Dr. Knoell Consult GmbH, Wageningen, The Netherlands
Dr. Knoell Consult Ltd, Cardiff, United Kingdom
Dr. Knoell Consult Shanghai Ltd, Pudong, Shanghai, China
Dr. Knoell Consult Schweiz GmbH, Basel, Switzerland
Dr. Knoell Consult Thai Co Ltd, Chiang Mai, Thailand
FORIM GmbH, Mannheim, Germany
Cyton Biosciences Ltd, Bristol, United Kingdom
Knoell Academy GmbH, Mannheim, Germany
PROFILE: Dr. Knoell Consult GmbH
CONTACTS
Website
www.knoell.com
E-mail
[email protected]
Head office
Dynamostraße 19, 68165 Mannheim, Germany
Tel
+49 (0)621718858-0
SERVICES PROVIDED
Fax
+49 (0)621718858-100
Registration of industrial and specialty chemicals
Contact
Dr Michael Cleuvers
Directors
Dr Hans-Emil Knoell, Managing Director
Strategic advice and consulting, literature search, data evaluation, data
gap analysis, study monitoring. Testing and registration strategies, in silico
methods (QSAR), read-across and waiving strategies.
Dossier preparation, eg IUCLID5-files for REACH, toxicological and
ecotoxicological hazard and risk assessment, exposure modelling,
extended safety data sheets.
Post submission support, communication with authorities, OR- and TPRservices, full consortia management.
Dr Runar Eberhardt, Managing Director
Ownership
Private company, majority-owned by Dr Knoell
Locations
Germany, UK, Switzerland, China, Netherlands, Thailand
Founded
1996
Registration of agrochemicals and biocides
OVERVIEW
Provider of full-services in the areas of global regulatory affairs, product
safety and consulting for agrochemicals, biocides, industrial/specialty
chemicals, human and veterinary pharmaceuticals, medical devices
and cosmetics. Chemical business is a global business, and all around
the world new chemical legislation is appearing! Working with Dr. Knoell
Consult means that you can be sure to be in compliance with the latest
developments, not only in Europe (EU and non-EU), but also in the, USA,
Canada, South America and the entire Asia-Pacific region (China, Japan,
Korea, Australia and others).
With a global network of cooperation partners we match our services to
support your business needs.
VITAL STATISTICS
2012/13
Turnover, group
approx.> €30m
approx.> €26m
No of offices
10
5
Staff, group
305
260
Training
5%
Information
8%
Human pharmaceuticals, medical devices, cosmetics
Non-clinical/ pre-clinical services (study management, toxicology,
pharmacology, metabolism, pharmacikinetics, bioanalysis, biosafety
testing). Clinical services (design, initiation and management of phase I, II
and IV clinical trials and PASS), medical writing (eg expert opinions, study
reports). Pre- and post-marketing pharmakovigilance, PSUR, summary
of product characteristics (Core SmPC), summary bridging reports (SBR)
and post authorisation safety studies (PASS), classification of medical
devices, CE-marking, authorisation of cosmetics (INCI-listing, labelling
etc), food and food additives.
Animal health (veterinary drugs, feed additives)
Strategic advice, project management, auditing, managing and writing
of registration submissions, expert reports, successful marketing
authorisations. All routes, all therapies, all species.
Management of pharmacological, toxicological, residues and
ecotoxicological studies for feed additives.
Management of pre-clinical and clinical studies for feed additives, several
services for vaccines and neutraceuticals.
Representation
& management
25%
Consultancy/
advisory
63%
Page 76
Strategic advice and consulting, literature research, data evaluation, data
gap analysis, completeness check, study management and monitoring.
Dossier preparation, biological efficacy, residues and metabolism,
dietary safety, toxicology, human exposure, exposure modelling, PECreports, environmental risk assessment, ecotoxicology, CADDY-dossiers.
Regulatory affairs, communication with authorities, post-submission
report, full service provider.
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)
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 has been appointed as institution for the training of
experts in toxicology
2012
Set up of Dr. Knoell Consult Thai Co Ltd, in Thailand
2013
Knoell Iberia in Madrid in the course of incorporation
Qualified Cefic – partner
Ecotoxicology
> 30 ecotoxicologists
Dietary safety
>15 specialists
Product safety specialists (C&L, MSDS preparation)
> 30 specialists
Global regulatory affairs chemicals
> 10 specialists
PARTNERS
Consortium management, OR, TPR
SCAS Japan, SCAS Europe, BSL Bioservice, Ibacon, Currenta, Ceres
International, ,Tier3 solutions
> 10 t consortium managers
CLIENTS
> 12 specialists
Our clients are mainly the big international companies, but also SMEs.
Environmental fate and risk assessment
TESTIMONIALS
> 40 specialists
Residues and metabolism
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.
Efficacy, biological dossiers
CASE STUDY 1: REACH: consortium management and dossier
preparation
Vet pharmaceutical experts
As one example of our performance, Dr. Knoell Consult has managed
a huge consortium covering 370 substances in ten sub-categories and
submitted 55 successful registrations for this consortium in 2010 and
more than 120 are expected for 2013. To achieve this, we established
a team of about 30 scientists dedicated to this project (chemists,
toxicologists, ecotoxicologists, QSAR-specialists) who prepared the
entire testing and registration strategy, including category and analogue
approach, QSARs and exposure based waiving. Due to thorough
scientific justifications, new testing was reduced to a minimum.
CASE STUDY 2: Agrochemicals
Dr. Knoell Consult successfully submitted a number of AIR-I (Annex-I
renewal procedure) dossier for global R&D companies. The projects
were well recognised by the authorities, in particular bearing in mind that
neither industry nor authorities had experience with such projects. More
than 50 people based all over the world were involved in this project.
CASE STUDY 3: Biocides
Biocidal product registration in Spain: the Spanish Ministry of
Environment informed us that “our dossier for a wood-preservative was
the best organised and well-done dossier in comparison with the rest of
dossiers received from other companies.”
PROFILE: Dr. Knoell Consult GmbH
ACCREDITATIONS
Regulatory affairs agrochemicals/biocides
> 12 specialists
Human pharmaceutical experts
Ten
20
Selected staff
Dr Michael Cleuvers – Head of Industrial Chemicals and
Biocides, Global Regulatory Affairs
Torsten Hauck – Head of Agrochemicals, Global Regulatory
Affairs, Human and Environmental Safety, Environmental Risk
Assessment
Dr Volker Mostert – Managing Director Knoell Academy GmbH
Dr Marika Suhm-Tintelnot – Head of Industrial Chemicals and
Biocides, Human and Environmental Safety
Dr Elisabeth Wekel – Head of Industrial Chemicals and Biocides
– Product Safety
Dr Iain A MacKinnon – Managing Director, Dr. Knoell Consult Ltd
Dr Jan Tuinstra – Senior Expert REACH, Wageningen office
Stefanie Schick– Managing Director,Dr. Knoell Consult Schweiz
GmbH
Dr Sylvana P Müller Managing Director FORIM GmbH
Page 77
SERVICES PROVIDED
Industrial Chemicals – REACH
EBRC offers comprehensive scientific, regulatory and administrative
support on industrial chemicals, including:
OO
data gathering, literature searches and evaluation
OO
data-gap analysis, closing of data-gaps and study monitoring
OO
chemical safety assessment (CSA) and report (CSR)
OO
PBT and vPvB assessment
OO
technical dossier (IUCLID 5)
OO
identification of known uses
OO
development of exposure scenarios for HH and ENV
OO
risk characterisation
OO
classification and labelling
OO
safety data sheets
OO
consortium and Sief management
PROFILE: EBRC Consulting
CONTACTS
Website
www.ebrc.de
E-mail
[email protected]
Head office
Raffaelstr 4, 30177 Hannover, Germany
Tel
+49 511 898389 0
Fax
+49 511 898389 10
Contact
Torsten Grewe
Directors
Dr Rüdiger Battersby
Ownership
Privately owned
Locations
Germany
Founded
1993
Agrochemicals
Staff, group
50
Active substance approval and national product registration.
EU notification of active substances regulated under regulation (EC) No
1107/2009:
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
active substance approval) in EU member states including zonal dossiers:
OO
aII dossiers (dRRs) for registration and re-registration of plant
protection products, label extensions and formulation changes
OO
our services include the compilation of all required documents, the
conduct of exposure and risk assessments, biological dossiers,
advice in closing data gaps, the supervision of experimental studies,
as well as the submission of the application to competent authorities
and attendant contacts / services during the registration process.
OO
previous experience (among others) includes herbicides, fungicides,
insecticides, rodenticides and nematicides.
30
Biocides
OVERVIEW
EBRC is a privately-owned consulting organisation based in Hannover,
Germany, providing consulting services with a focus on chemical, biocidal
and agrochemical industries. Specialised scientific experience is available
in all key disciplines relevant for product safety with respect to human
health and environment. Task force management and coordination of
industry consortia is another important aspect of our work.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
1
EBRC provides experienced support for all key phases of the evaluation
and registration process of biocides.
Dossier preparation and defence in the regulatory process both for active
substances and biocidal products are our primary services.
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
Training
IT &
5%
software
5%
Representation
& management
15%
Special services
Consultancy/
advisory
75%
GLOBAL OFFICES
EBRC Consulting GmbH
Raffaelstr 4
30177 Hannover
Germany
Page 78
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
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
STAFF SELECTION
1993
Foundation of EBRC (initial staffing: six people)
Rüdiger Battersby – Director
2013
Continual growth, leading to a current staff count of 50
Dr Rüdiger Battersby is the founder and director of EBRC. After his PhD
in biochemistry, he took up a position as manager of a contract research
organisation in Hannover (IBR), from where he switched to EBRC. Apart
from his responsibilities as managing director and principal coordinating
toxicologist, he acts as supervisor for all of EBRC’s agrochemical,
biocidal and industrial chemical risk assessments. His professional
expertise encompasses involvement in the German government’s review
programme (BUA) on existing chemicals, representation of industry
consortia in RA conducted under the ESR programme (793/93) and at
EU-TCNES level, as well as the conduct of several dozen occupational
exposure surveys in various sectors of the chemical industry. Among
other professional activities, he is an appointed member of the German
Expert Gremium for Chemicals Safety of the German Chemical Society.
PARTNERS
ARCHE, Belgium
CLIENTS
A wide range of companies producing agrochemicals, biocides and
industrial chemicals and/or formulated products.
CASE STUDY 1: MEASE
On behalf of EUROMETAUX, EBRC developed a tool for the estimation
and assessment of occupational exposure (MEASE) which combines
approaches from the EASE expert system, from the TRA tool and from
the health risk assessment guidance for metals (HERAG). It represents a
widely-used first tier screening tool for occupational inhalation and dermal
exposure to metals and inorganic substances.
Arne Burzlaff – Senior Registration Manager Industrial
Chemicals
With its extensive background in metals risk assessments, EBRC was
contracted from 2005-2007 by the European Metals Industry to compile a
guidance document for the human health risk assessment of metals and
inorganic metal compounds. The HERAG documents provide guidance
to the worldwide regulatory and scientific community on several aspects
of risk assessment methodology for metals where classic tools developed
for organics are not applicable.
Dr Arne Burzlaff graduated as a chemist (2000) and obtained a PhD in
technical chemistry/biotechnology (2005). He worked for the German
Federal Institute for occupational safety and health, Division for
Chemicals and Biocides Regulation (2005-2007) on dossier evaluation
for biocides, collaboration in EU working groups and scoping issues
on borderline cases among legal frameworks. Since 2007 he has been
working at EBRC as senior scientist/toxicologist. In this position he has
been compiling REACH registration dossiers, with a focus on human
health hazard assessment and risk characterisation, and initiation and
monitoring of experimental studies on industrial chemicals.
CASE STUDY 3: RiCoG
Andreas Büsing – Senior Registration Manager Agrochemicals
The rigorous containment guide (RiCoG provides guidance to registrants
of isolated intermediates on how rigorous containment (RiCo) of their
intermediates can be assessed and documented according to the
stipulations of regulation (EC) 1907/2006 (REACH). In an integrated
assessment of SCC for an entire process (adopted from an approach
published by Hirst et al. (2002)), RiCoG can be used to prioritise individual
process steps requiring higher tier assessments, and provides an easy
and structured way to assess and to document RiCo for the remaining
process steps. Experts from various metals' industries have contributed
with their practical experience to the development of RiCoG.
Andreas Büsing graduated as a biochemist at the University of Hannover
(1984). After years of 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.
Silke Burger – Senior Registration Manager Biocides
CASE STUDY 4: Development of standard handling frequencies of
rodenticide baits
Dr Silke Burger graduated as a biologist (2000) and obtained a PhD in
molecular biology/toxicology (2004). Since 2006 she has been working at
EBRC as registration manager for biocides.
In this position she has been compiling dossiers in support of inclusion
of active substances in Annex I of Directive 98/8/EC and registration of
biocidal products with a focus on human and environmental exposure
assessments and risk characterisations, and further initiation and
monitoring of experimental studies on active substances and biocidal
products.
CASE STUDY 2: HERAG (Health Risk Assessment Guidance)
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.
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.
Page 79
PROFILE: EBRC Consulting
Training
10%
Consultancy/
advisory
10%
Information
10%
PROFILE: ECOonline
CONTACTS
Website
www.ecoonline.com
E-mail
[email protected]
Head office
Trudvangveien 77, N-3117 Toensberg, Norway
Tel/ Fax
+47 33 01 68 00/ +47 33 01 68 01
Contact
Mr Luis G Paulsen
Directors
Mr Øyvind Thorsen, CEO
Mr Kjell Hamnes, CTO
Ms Martina Jonsson, VP Product Management
Mr Luis G Paulsen, VP International Sales
Ownership
Privately held, employees
Locations
Norway, Sweden, Finland, Denmark, Switzerland
Founded
2000
IT & software
70%
GLOBAL OFFICES
Norway
Sweden
Finland
Denmark
Switzerland
SERVICES PROVIDED
Supply chain communication
SDS/eSDS authoring
OVERVIEW
ECOonline is one of the most widely used platforms for SDS authoring,
distribution, communication and management in Northern Europe.
Originating in the Internet hotspot of Scandinavia, ECOonline has
pioneered the SDS industry, and continuously improved the service.
Today more than 3,500 enterprises connect to the service online.
The platform is ideal for companies in most industries, and it is the perfect
solution for supply chains and industry bodies seeking efficient means of
exchanging, communicating and managing data.
All parts of the platform are offered online (Cloud, SaaS, ASP).
Connecting suppliers and downstream users online reduces time and
costs involved in nearly all aspects of handling SDSs and managing
substance inventories. A common web browser and internet connection
are the only requirements.
Available in 23 languages, it is designed to meet your requirements for
the REACH area. Our aim is to become the most preferred platform for
SDS communication and management in Europe, working with leading
consultants and members of industry.
A team of 65 employees, and a network of highly qualified consulting
partners, are ready to give a demonstration of the applications and
benefits.
Please contact Mr Luis Paulsen for more information.
VITAL STATISTICS
Turnover, group
2011/12
€7m
-
No of offices
6
8
Staff, group
Page 80
65
-
SDS/eSDS distribution
SDS/eSDS database
SDS substance/chemical inventory management
Workplace risk assessment
Employee exposure tracking and storing
Up and downstream reporting
2000
Founded by Mr Kjell Hamnes, long time industry professional
with a vision to create the first and most widely used online
platform for SDS communication. HQ in Tønsberg, Norway
2001
Launched the first integrated online service for SDS
communication
2007
Opened office in Gothenburg, Sweden
2011
Opened office in Helsinki, Finland
2011
Launched leading edge solutions for authoring and
managing exposure scenarios.
Technical documentation and articles covered.
Established representation in Germany.
2012
Ready with mobile applications and XML comm modules.
Established representation in Denmark, Iceland and Poland.
2013
Enhanced service for building and construction sector.
The most widely used service in the Nordic region. We
welcome all to explore how the service can benefit you and
meet your requirements.
PARTNERS
ECOonline works closely with local, regional and international consulting
partners in many different areas, including SDS authoring, substance
inventory management, risk assessment, dossier preparations, authority
notification, and occupational health.
Please contact Mr Luis G Paulsen if you would like to learn more about
opportunities for working together with ECOonline.
CLIENTS
STAFF SELECTION
Small and large, public and private, multinationals and locals, our clients
represent most segments and industries.
A total of more than 3,500 enterprises connect to the services.
Mr Kjell Hamnes – Norway, International
Please contact us for testimonials. We’ll be happy to provide you with
referrals that are relevant to your needs and your industry!
CASE STUDY 1: Automotive industry
OO
OO
OO
OO
a majority of auto dealers are connected to the service
a majority of suppliers are connected
auto dealers and repair workshops get their SDS directly in their
inventories, and reduce time spent on managing inventory and
performing relevant tasks
suppliers reduce time and costs in distributing SDS
CASE STUDY 2: Diagnostics manufacturer, and their suppliers of
laboratory products
OO
OO
OO
OO
OO
OO
the diagnostics manufacturer is part of a large international
corporation, with production sites and laboratories in many locations
its suppliers upload the relevant SDSs directly to the diagnostics
company’s inventory
the diagnostics company can then use all the data from the SDS
without having to re-enter them.
all designated staff can work and share information in the same
system, from any location
this improves communication, simplifies work processes, increases
speed, and reduces time spent on relevant tasks
no installations are required, no local IT maintenance costs involved
Ms Martina Jonsson – Sweden, International
Martina is international product manager at ECOonline, and a key figure
in Sweden on the issue of REACH and SDS management.
Mrs Christy Whiddon – Sweden, International
Christy is product manager. She has extensive background from the
chemicals industry, and has a PhD in surface and colloid chemistry.
Ms Pirjo Kuoppala – Finland, International
Pirjo is product manager. She has extensive background in the
electronics industry, and has degrees in mechanical engineering and
biochemistry.
Mr Luis G Paulsen – International and Partner relations
Luis is responsible for international operations and partner relations.
Mr Øyvind Thorsen – CEO
Øyvind has extensive background from the software and computer
industry.
CASE STUDY 3: Universities, hospitals, municipalities, public
institutions
OO
OO
OO
OO
OO
OO
OO
a majority of universities, municipalities, schools and hospitals are
connected to the service
SDSs are uploaded directly to their inventories
all data in the SDS are immediately available for use, and
automatically updated
the suppliers benefit from easy authoring and distribution of SDSs,
and the service to customers is greatly improved
communication upstream to the supplier is simplified in the platform
no local installations are involved, the entire service is available to all
users over the Internet
this saves time and money in the process of authoring, distributing
and managing the SDSs and documentation
CASE STUDY 4: Building and construction sector
OO
OO
OO
OO
an automated service enabling direct communication between
materials supplier, construction company and building project
SDSs are automatically transferred to the inventory for the project
saves time and workload for all parties
ensures all correct documentation is in place, including technical
information and workplace safety
Page 81
PROFILE: ECOonline
TESTIMONIALS
Kjell is the founder and head of product development at ECOonline. He
has pioneered the development of electronic tools for SDS authoring
and management in Northern Europe, and is a widely used resource by
industry and authorities on the issues of legislation and compliance.
GLOBAL OFFICES
Australia, Belgium, Brazil, Canada, China, Finland, France, Germany,
Hong Kong, Italy, Malaysia, Poland, Russia, Singapore, South Africa
Spain, The Netherlands, United Kingdom, United States
SERVICES PROVIDED
PROFILE: ENVIRON
CONTACTS
Risk management, strategic support and regulatory compliance
(REACH, CLP, biocides, PPP, cosmetics, food contact materials)
Website
www.environcorp.com
E-mail
[email protected]
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)
For 30 years ENVIRON has worked in partnership with clients to develop
and support product regulatory compliance strategies and prepare robust
technical dossiers and risk assessments for substances in industrial,
agricultural, biocidal and consumer applications. We balance clients’
technical, regulatory and commercial interests through sound science
and strategy; clients regularly entrust our multi-disciplinary team with their
most recalcitrant and critical problems. We provide strategic, scientific and
regulatory support for SVHC, from an initial proposal for inclusion on the
Candidate List to Authorisation, including business impact assessment,
socio-economic analysis and alternative analysis. We support
communication with the EC, ECHA and MSCA, and development of
policy, regulation and guidance. We audit product regulatory compliance
systems and support supply chain management. ENVIRON also acts as
consortium manager and only representative, and is independent from
testing facilities.
Joseph Rodricks (US)
Ownership
Private limited company
Locations
Over 85 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 engage with policy makers and regulators, and to
provide effective product stewardship programmes to manage risk, reduce
liability and enhance support from stakeholders. Striving always to be at
the leading edge of science, we deliver thoughtful and innovative solutions
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
2011/12
Turnover, group (2011)
€223m
-
No of offices
89
19
Staff, group
1,400
50
Representation
& management
10%
Laboratory
5%
ENVIRON evaluates obligations and provides support for regulatory
approvals required to market products across Asia-Pacific, America,
Europe and Africa. We assess new market opportunities, substance
notification and regulatory obligations, classification and labelling (GHS)
and packaging. Our established global network covers Argentina,
Australia, Brazil, California, Canada, China, Europe, India, Japan, Korea,
Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South
Africa, Switzerland, Taiwan, Turkey, and the US.
Product stewardship and troubleshooting
We have great breadth and depth of expertise in:
OO
toxicology (and toxicokinetic modelling)
OO
epidemiology
OO
exposure modelling, measurement and reconstruction
OO
risk assessment and mitigation
OO
ecotoxicology
OO
environmental fate
OO
regulatory affairs
OO
chemistry
OO
occupational health
OO
supply chain issues
OO
product vigilance
OO
advocacy
This means we are ideally placed to advise clients on problems – from
in-depth assessment of animal and human evidence for health effects to
concerns regarding measured exposure levels of substances in humans
and the environment and managing supply chain issues. We couple
internationally recognised expertise and reputation as leader in risk
management with client-focused solutions.
BOMCheck
Substances declarations web database for REACH, RoHS, batteries and
packaging compliance to facilitate supply chain management.
Consultancy/
advisory
85%
Page 82
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
2008
Acquired Gustitus Group.
2009
Acquired Arquipélago in Brazil
2010
Chemical Industry Association (CIA) REACH service
provider of the year
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 robust and comprehensive REACH dossiers
and CSRs for a group of high profile hazardous organic substances
with potential endocrine disrupting properties and a wide use pattern.
This involved use of novel arguments and original methods to better
characterise chemical fate, exposure and effects on humans and the
aquatic environment. CSAs were prepared using both measured and
modelled data for carefully defined exposure scenarios in order to be
accessible and useful to registrants and their customers alike.
CASE STUDY 2: Support for SVHC and Annex XIV REACH
We provided strategic and scientific support to help industry develop
and justify to policy makers a more credible, yet equally effective, risk
management option for a chemical than phasing out its use under REACH.
We prepared preliminary studies including CSR, alternatives analysis and
socio-economic studies to demonstrate impact of inclusion on Annex XIV.
CASE STUDY 3: Global regulatory approval – new consumer product
ENVIRON evaluated regulatory obligations in more than 50 countries,
considering chemical notification, packaging and labelling requirements,
for a company wishing to market a product globally. The review allowed
identification of key market opportunities. We then prepared notifications
for priority countries, including identification and management of local
representative to file documents, as needed.
CASE STUDY 4: Exposure data drives regulatory scrutiny
Detectable levels of perfluorooctanoate (PFO) have been measured in
the blood of the general population, raising concerns. For a multinational
company, we demonstrated exposure to PFO from certain consumer
articles (eg treated carpets, clothing, upholstery and cookware) in the
consumer environment is not expected to contribute appreciably to PFO
levels in the blood of the general population, or to cause adverse human
health effects, defensibly informing its product stewardship program.
CASE STUDY 5: Regulatory action related to product
contamination
A food packaging producer faced possible regulatory action associated
with residual levels of a potential carcinogen in a key product. Using
an integrated approach we showed that consumer exposure to the
contaminant from handling the packaging and ingesting the packaged
foods were within safe levels. The work also informed important strategic
decisions for the business (eg product viability, consumer perception and
communications) as well as supporting product regulatory notifications.
CASE STUDY 6: Review proposed carcinogenicity
classification
An industry association asked ENVIRON to review all available evidence
for the carcinogenicity of a product in order to comment on the basis
and technical merits of EC proposals to classify the substance as a
carcinogen.
STAFF SELECTION
Sue Bullock – Principal, product safety and regulatory compliance
Leading ENVIRON's product safety and regulatory compliance services
for over 20 years, Sue has provided strategic, regulatory and technical
assistance to industry relating to chemical policy and presence of
chemicals in the environment, the workplace and consumer products.
She has an extensive knowledge of REACH and helps companies
around the world engage with policy-makers, comply with global chemical
regulations, assess and manage health and commercial risks, manage
liability and deliver effective product stewardship across the supply chain.
Dr Henk Verhaar – Principal, chemist and ecotoxicologist
Over 20 years' experience in modelling the fate of chemicals in the
environment and assessing and predicting their ecotoxicity, Henk’s work
on predictive aquatic toxicology is widely used in Europe and the US
during the development of hazard assessment models for chemicals in
the aquatic environment. His expertise also includes derivation of safe
exposure levels and environmental statistics. Dr Verhaar has extensive
experience as a troubleshooter on chemical and ecotoxicological matters.
Dr Martina Vosteen – Principal, chemist and product safety
Dr Vosteen has 15 years of experience as a consulting chemist, including
coordination and management of hundreds of risk assessments regarding
product and environmental liability (financial losses) particularly for the
chemical, pharmaceutical, medical devices and food industries. She has
acted as technical/scientific expert in several product liability cases and
advises the industry in relation to REACH and other product regulatory
relations (cosmetics, pesticides, etc).
Dr Joe Rodricks – Principal, toxicologist
An internationally recognised expert in the field of toxicology and
risk analysis and their uses in chemical regulation, management and
stewardship. Since 1980 he has consulted for hundreds of manufacturers,
for government agencies and for the World Health Organization. He
has served on 15 boards and committees of the National Academy of
Sciences and the Institute of Medicine.
Page 83
PROFILE: ENVIRON
SERVICES PROVIDED
Regulatory compliance
OO
OO
PROFILE: EQUITOX
CONTACTS
OO
Website
www.equitox.eu and www.sci-env.ch
E-mail
[email protected]
Head office
63 rue André Bollier, 69307 Lyon Cedex 07, France
Tel
+33 (0)48 253 9018
Fax
+33 (0)97 231 0242
Contact
Dr Benoit Fraysse
Directors
Dr Christine Reteuna, Director EquiTox
Dr Erwan Saouter, Director S&E
EquiTox and S&E are associated since 01.2012
Ownership
Private company
Locations
Lyon, France
Geneva, Switzerland
Founded
2011 (EquiTox), 2007 (S&E)
OO
OO
REACH: data collection, data gap analysis and testing. REACH
registration dossiers (IUCLID) and submission to ECHA via REACHIT, chemical safety reports (CSR), exposure scenario and scaling, etc
biocides and cosmetics
classification and labelling: notification C&L, classification of
substance and mixtures according to CLP, GHS UN, DSD, DPD
registration dossiers (China, US...)
ecolabels.
Regulatory information
OO
OO
OO
OO
OO
literature review, study assessment and validation
model prediction and QSAR
organise and follow-up of laboratory testing
safety data sheet (SDS) drafting, update and regulatory audit
global product strategy (GPS) summary and (eco)toxicological profile
Product advocacy and project management
OO
OO
OO
product defence strategy
animation and technical representation in consortia
communication strategy
Impact assessment and eco-design
OO
OVERVIEW
EquiTox and Science & Environnement offer many areas of expertise,
which linked together, provide a global and comprehensive approach to
worldwide chemical safety regulation and sustainability.
From chemical safety and regulatory affairs, life cycle assessment,
carbon footprint, eco-design or ecolabel: we offer to companies and
organisations a wealth of expertise.
EquiTox and Science & Environnement have joined forces in a strong
association in order to reinforce their chemical safety offers. It consists
of five highly qualified experts, each with ten 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.
VITAL STATISTICS
2011/12
Turnover, group
€950,000
€750,000
No of offices
2
2
Staff, group
6
5
OO
OO
OO
environmental risk assessment (cosmetics, industrial chemical,
biocides, etc)
human health safety assessment (cosmetics, industrial chemical,
biocides, etc)
life cycle analysis (LCA)
support in the development and eco-design of new products
2007
Science & Environnement founded
2011
EquiTox founded
S&E approved as REACH Ready supplier
2012
Association between EquiTox and S&E
ACCREDITATIONS
OO
OO
OO
REACH Ready approved supplier
European registered toxicologists (EUROTOX)
Member of the French Society of Toxicology (SFT)
CLIENTS
Our clients range from multinational companies to SMEs, producing
industrial and specialty chemicals, petrochemicals, biocides and
cosmetics.
Our clients include: Bluestar Silicones, L’Oréal, Procter & Gamble,
Roquette, Laboratoires Expanscience, UIC Rhone-Alpes…
Training
10%
Information
3%
Representation
& management
30%
Page 84
Consultancy/
advisory
57%
STAFF SELECTION
EquiTox was asked to determine the octanol/water coefficient for multiconstituent substances. The most efficient way to obtain the logKow was
to use QSAR models. In order to provide reliable and robust predictions
the project was divided in four steps:
OO
QSAR models selection;
OO
QSAR validation;
OO
drafting of QSPR and IUCLID entries;
OO
training of the customer’s technical team.
The first key point was to find relevant QSAR models allowing obtaining
relevant predictions considering the structural specificities of the
substances of interest. In addition, the selection was driven by the need
to comply with REACH data submission requirements and the latest
recommendation from ECHA for the submission of QSAR prediction in the
frame of a registration dossier. The training session was built for helping
the technical team to gain in autonomy in case of comments from ECHA
or any competent authority, and to better know the boundaries of the use
of QSAR tools for improving their use in regulatory frameworks.
Dr Christine Reteuna – Regulatory Ecotoxicologist – EquiTox
CASE STUDY 2: Extended SDS – analysis and implementation at
industrial site levels
More and more raw materials are supplied with an extended Safety Data
Sheet describing way to handle the supplied chemicals. EquiTox and S&E
were in charge of developing a process for managing this new workload
and this new regulatory constraint for European Chemical companies.
One of the main requirements was to deliver proposals that can be easily
transposed to any European plant. It was needed to work in parallel on:
OO
the training of key people (HSE, product-stewardship, plant
management…) on the different drawbacks related to this new set of
information (regulatory, administrative, relationship with customers,
technical skills…);
OO
the internal IT solutions for tracking a raw material on a manufacturing
site, from the purchase service to the plant facilities;
OO
the description of the occupational tasks, starting from HSE language
to REACH understandable vocabulary, and the comparison with the
exposure scenarios requirements;
OO
the IT solutions for checking the OC and RMM compliance for
environment through scaling.
In addition, EquiTox and S&E were asked to deliver a solution limiting
the related workload for non-dedicated people and to cover the updating
processes.
CASE STUDY 3: Follow-up of testing proposals consequently to
REACH 2010 registrations
Many 2010 REACH registration dossiers has been submitted to ECHA
with poor understanding of the consequences of the indication of “Annex
IX and X testing proposals”. The registrants now face ECHA’s draft
decision requesting them to perform animal testing that will cost several
€100k, and they are disconcerted. A lack of continuity in service provider
capacities can put a registrant in difficulties for its business sustainability.
Following the reception of a draft decision, a customer contacted EquiTox
for following up the work done by a third party back in 2010. In a very
short period of time, it was necessary to review the entire registration
dossier, to define all the available options and the related legal and
business risks, and to submit comments to ECHA. Once the consensus
was reached between the customer, ECHA and the member state
competent authorities, the decision was finalised and a panel of CROs
has been contacted for budgeting the studies.
After obtaining her PhD in environmental toxicology, Christine began her
career in the French Ministry of Environment for the implementation of
chemical regulations. She then went into industry for 19 years (Rhodia),
as an expert in regulatory ecotoxicology. It enabled her to work for both
consumer market (cosmetics, detergents, etc) and industrial market (metal
processing, oil market, etc), and address environmental issues in a wide
variety of products. She was also an Industry representative in several
scientific (ECETOC) and professional organisations (UIC, ASPA, Cefic…).
Christine developed specific skills in the assessment of environmental
impact of chemical products (eg polymers, surfactants, cosmetics);
covering data collection, study monitoring, the establishment of
ecotoxicological profiles, product classification and risk assessment. She
took part in the production of several regulatory dossiers and their support
against competent authorities.
Dr Erwan Saouter – Regulatory Ecotoxicologist and Director of S&E
Founder of the S&E company, Erwan Saouter has more than 20 years
of professional experience with private companies (Procter & Gamble),
public research organisations (US Agency for Environmental Protection,
Institut National de la Recherche Scientifique Quebec).
Erwan has developed expertise in the fields of environmental science
and risk assessment, scientific communication, sustainable development
and stakeholder dialogue, scientific public relations, communication with
media and governments.
Stéphanie Moulin – Regulatory Toxicologist – EquiTox
Stéphanie spent ten years working in the chemical industry for Rhodia, as
regulatory toxicologist. She also worked for the CNRS (French national
scientific research center) in the chemical risk prevention unit, and has
teaching experience.
Stéphanie’s main fields of activities are the development of testing
strategies and the use of in vitro methods, the cost optimisation
based on analogy and weight of evidence approaches, the selection
and qualification of CROs, the registration strategies in Europe and in
other zones, and chemical product defence. In addition, Stéphanie is
specialised in human health risk assessment, with a focus on the safety
assessment of cosmetic products.
Dr Marie-Laure Teisseire – Regulatory ecotoxicologist – EquiTox
Marie-Laure started her career in research research, in the field of ground
and surface water pollution, and teaching (six years at the University
of Reims) and continued as a regulatory ecotoxicologist for a Chemical
Company (Rhodia).
The main projects managed by Marie-Laure, such as notification of new
substances in EU or China or compilation of REACH dossiers, allowed
her to improved her expertise in environmental exposure assessment
to environmental risk characterisation and the definition of risk reduction
strategies. Several other fields of expertise are environmental and
physico-chemical hazard assessment of chemical products, study
monitoring and hazard communication (SDS, C&L).
Dr Benoit Fraysse – Regulatory (Eco)toxicologist – EquiTox
Once he had his PhD, obtained in collaboration with the French
Nuclear Safety Institute, Benoit gained in expertise with three years in
postgraduate positions, mixing teaching and research positions (French
institutes and universities). He joined the French chemical company
Rhodia, where he spent six years.
Benoit specialises in analysis of the hazardous properties of substances
(physical chemistry, environment, health) combining experimental tools
or in silico (QSARs) methods. As regards international issues, Benoit
has particularly developed his expertise in the fields of developmental
toxicity and the assessment of health risk to workers (REACH and
biocide exposure scenarios), and active discussion with the competent
authorities.
Page 85
PROFILE: EQUITOX
CASE STUDY 1: Use of QSAR for multi-constituent substances
OO
OO
OO
OO
OO
Toxicology, ecotoxicology and risk assessment
CONTACTS
PROFILE: ERM
chemical safety assessments
CLP notifications
Sief management
REACH compliance assessments
support advocacy
Study placement/ protocol review and development, development of
(robust) study summaries, review of data for classification purposes
EHS risk assessments
Website
www.erm.com
E-mail
[email protected]
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),
Dominique Gangneux (UK), Kathleen Goossens
(Belgium), Dirk Nuyens (France), Rudolf Wilden
(Germany)
Ownership
Locations
140
Founded
1971
Classification, labelling and packaging (CLP/GHS)
Classification support, safety data sheet (SDS) and label authoring
SDS and label review and improvement
Emerging chemical control laws around the world
New chemical notification, tracking of emerging legislation bans/restrictions
Downstream product legislation, eg food/food contact, biocides
OO
OO
OO
OO
OO
OO
food contact notifications
compliance with country-specific legislation
FIFRA / BPD/BPR support
national registrations
local/ regional registration
labelling and claims support
Lifecycle assessment and sustainability
OVERVIEW
Environmental Resources Management (ERM) is one of the 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.
OO
VITAL STATISTICS
OO
2012
Turnover, group
$572m
$10m
No of offices
140
39
Staff, group
> 4,500
>50
OO
OO
OO
OO
OO
OO
carbon footprinting 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
2010
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
2012
Technical partnership with ReachCentrum for preparation of
the application for REACH authorisation
Training
10%
ACCREDITATIONS
Representation
& management
20%
ISO 9001 & ISO 14001
PARTNERS
Consultancy/
advisory
70%
GLOBAL OFFICES
We support our clients in all countries globally.
SERVICES PROVIDED
Registration, evaluation and authorisation of chemicals (REACH)
OO
OO
OO
OO
socio-economic analyses
preparation of application for authorisation
REACH training/ REACH impact assessments
preparation of lead and member registration dossiers
Page 86
Partner of Cefic
ReachCentrum
CLIENTS
In the past five years we have worked for more than 70% of the Global
Fortune 100 and more than 50% of the Global Fortune 500 companies. TESTIMONIALS
"We have been working with the ERM team on REACH for a number of
years now, and there are very good reasons to continue and expand this
collaboration. Both on practical, communicative and technical-scientific
levels ERM has provided us with active, solid and high-quality support
for MSD's REACH programme. We are pleased to observe that our
collaboration has turned into a true partnership." – Frits Wielaard, REACH
programme manager, Merck Sharp & Dohme
CASE STUDY 1: Supporting the REACH team of Momentive
Performance Materials (MPM)
MPM required support for its REACH team using ERM’s REACH expertise,
including toxicologists, ecotoxicologists and chemists. The ERM REACH
project team was fully integrated into the MPM team and early identification
and discussions of issues encountered provided timely resolution of such.
Benefits and value:
OO
timely and successful submission of all registration dossiers in 2010;
OO
comprehensive documentation of approaches and work products to
enable MPM to demonstrate compliance to the ECHA/CAs;
OO
alignment of global teams with same company culture ensures highly
efficient 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.
CASE STUDY 2: Supporting a multinational pharmaceutical
company’s new chemical registration in China
An ERM client needed to register a new chemical product with high toxicity
(eg fish LC50(96h) < 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 could be successfully registered was necessary before
project commencement. Effective communication with different parties (eg the
client, ecotoxicological laboratory, government and experts) was essential.
Benefits and value:
OO
successfully registered the new chemical product with one submission;
OO
to facilitate the approval, full and comprehensive analysis, which was
not formally requested, was provided in addition to MEP;
OO
utilise the laboratory data, analysis results and ERM’s expertise
and experience to forego several expensive and time-consuming
laboratory tests, saving time and cost for the client.
Dominique Gangneux – Product Sustainability Lead UK
Post-master degree in environmental management with 16 years
Sustainability/ EHS consulting and assurance experience across the
areas of strategy, risk management, product sustainability, performance
improvement, supply chain management, reporting and assurance.
Dr Dave Best – Technical Director
PhD in microbial biochemistry, coordinating ERM’s global effort on the
provision of REACH. He has 18 years in the chemical industry as an
environment, health and safety manager.
Dr Steven Peterson – Senior Ecotoxicologist
PhD in biological sciences with 20 years of experience in risk
assessment, ecological research, environmental science with consulting
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
Has 20 years’ consulting experience in the fields of EHS compliance,
REACH and risk assessment.
Donna Morrall – Senior Project Manager
20 years of relevant expertise in both industry and consulting with a strong
focus on risk assessment, data analysis and computational modelling.
Dr Eckhard Schäfer
PhD in chemistry, with more than 20 years’ experience in chemical risk
assessment and preparation and implementation of safety plans. Health
and safety advisor of the Hoechst Corporation between 1986 and 1994.
Dr Elsie Millano
BSc in chemical eng and PhD in civil eng. environmental area. Supporting the
REACH team in the review and preparation of CSRs and safety data sheets,
and review of robust study summaries. Over 25 years of environmental
consulting experience in human health risk assessments, including exposure
assessments, fate and transport evaluations, and risk calculations. Extensive
expertise in contaminated site closures based on controlling exposures.
STAFF SELECTION
Carolyn Hammer – Senior Ecotoxicologist
ERM’s Global Product Stewardship TEAM (GPS)
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.
ERM has more than 50 professionals with extensive specific GPS
experience located at various offices worldwide. These consultants are
able to utilise the full resources of ERM globally to provide full back-up for
all GPS-related services.
Dianne Green – Senior Project Manager
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
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 Salvatore Giolando – Head of Global Product Stewardship Team
Tze Shin Goh – Principal Consultant
Dr Rudolf Wilden – Product Sustainability Lead Central Europe
BSc in chemistry and a PhD in environmental health, with 25 years
of global industry and consulting experience working for the Procter
& Gamble Company. Managing global product safety and regulatory
compliance for numerous brands and innovative technologies during
tenures in both Cincinnati and Brussels
More than 15 years of experience working in substance notification, EHS
compliance, management systems and performance improvement and
assurance projects in various European and Asian countries.
Page 87
PROFILE: ERM
“ERM have provided support and advice for us throughout the pre-registration
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
“ERM has been Momentive’s partner in the implementation of REACH
since the beginning and has always provided the expert support we
needed through the different stages of the project.” – Ralf Maecker,
Momentive Performance Materials
SERVICES PROVIDED
General REACH services
Exponent's consultants have significant experience in the provision of a
wide range of REACH support to our clients. These services include initial
work such as regulatory strategy and advice, data evaluation and the use
of intelligent testing strategies. 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 registrant or third party representative.
CONTACTS
Website
www.exponent.com
E-mail
[email protected]
PROFILE: Exponent
Head office The Lenz, Hornbeam Business Park, Harrogate, North
Yorkshire, HG2 8RE, UK
Tel
+44 (0)1332 868000
Fax
+44 (0)1332 868099
Contact
Julian Reddy
Ownership
Wholly owned subsidiary of Exponent Inc.
Locations
Derby, UK; Basel, Switzerland
Founded
2002
Preparation of REACH registration dossiers and chemical safety
reports
OVERVIEW
Exponent 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 unparallelled technical expertise
with the ability to focus this knowledge to meet our clients’ needs within
short timeframes. Our ability to create multidisciplinary teams of scientists,
regulatory consultants and project managers means that we can either
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
2011/12
Turnover, group
Est US$10m
Est US$3m
No. of offices
3
No. of countries represented
35
Staff, group
50
30
Training
Other
2%
3%
Information
5%
Global chemical notifications
Our consultants have considerable experience in compiling and
submitting chemical notifications worldwide; utilising our team of
specialists we are capable of preparing and submitting chemical
notifications to all countries that operate a relevant scheme. We can
prepare and submit dossiers for Australian, Canadian, New Zealand and
Swiss registrations and can act as sole representative notifier utilising
our Swiss office. We have a network of local agents to help with the
preparation and submission of regulatory documentation in China, Japan,
Korea, the 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, cosmetics and food regulatory
requirements. For agrochemicals and biocides we can assist with
regulatory strategy, data gap analysis, study monitoring, risk assessments
and completion of active substance and product registration dossiers.
This includes in-depth support such as managing compounds to Annex
I inclusion. For clients in the food industry we can develop strategies for
technical and regulatory challenges, develop food safety systems and
help meet regulatory requirements for food additives, contact materials,
novel foods and health claims. For cosmetics we provide general
regulatory strategy and can prepare the product information files and
cosmetic product safety reports.
Representation
& management
25%
Consultancy/
advisory
65%
GLOBAL OFFICES
Global head office (Exponent Inc): 149 Commonwealth Drive, Menlo
Park, CA 94025, USA
Other UK office: 1 Pride Point Drive, Pride Park, Derby, DE24 8BX,
United Kingdom
Switzerland office: Aeschenvorstadt 57, Basel, 4051, Switzerland
Page 88
Exponent has prepared in excess of 75 complete lead registrations
for phase-in substances and is currently working on approximately 50
more for the 2013 deadline. We can complete all aspects of the process
such as data evaluation and gap analysis, determination of substance
identification, use of intelligent strategies to address data gaps and study
monitoring. We can complete all components of the IUCLID 5 dossier and
the chemical safety report (CSR) including exposure assessments, using
Chesar and higher tier models if necessary, and risk characterisation.
Once the assessments have been completed we can produce the final
exposure scenarios and extended safety data sheets.
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
ACCREDITATIONS
ISO 9001 accreditation
CASE STUDY 3: REACH support for the 2013 deadline
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.
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 finishing the
dossiers for these eight substances including completion of CSRs. We
have added value as a service provider by managing all this work as one
project so that we can ensure that all necessary actions, for ourselves
and our client, are progressed within appropriate timeframes, using what
we have learnt from one substance to help with others where possible
and provide our client with confidence that they will meet their REACH
obligations ahead of the 2013 deadline.
CLIENTS
Exponent Inc has worked with more than 5,000 clients and Exponent
International has undertaken work for over 400 clients globally. Exponent
has provided regulatory support to a range of companies across many
industries; companies ranging from SMEs working in one industry to global
companies conducting business in all areas of the chemical industry.
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 has
been and is still responsible for the production of the registration dossiers in
IUCLID 5 including appropriate data waivers and testing proposals and for the
production of CSRs. To complete the CSRs, Exponent has the responsibility
of working with consortium members and external parties to identify
downstream uses that need to be considered and proposing use descriptor
codes for exposure assessments and the production of exposure scenarios.
Due to the properties of the substances, creative yet pragmatic solutions have
been necessary to demonstrate safe use. Exponent's technical capabilities
and support ensured that all 2010 consortium substances were registered
ahead of the deadline and it is anticipated the submissions for the 2013
substances will be completed in advance of that deadline.
CASE STUDY 2: Product stewardship service for a SME
Exponent has provided ongoing product stewardship support for a catalyst
manufacturer, covering REACH and all other global chemical regulatory
regimes for over five years. Taking a holistic approach, we provide global
regulatory strategy and advice to ensure that legislative requirements
from a number of countries can be effectively overlapped. Exponent also
provides more technical support by preparing and submitting regulatory
documentation for worldwide chemical notifications, preparing and
reviewing European safety data sheets and determining the classification
and labelling of the substances for GHS inside and outside of the EU. We
also act as a sole representative for their Swiss notifications. Following
the sale of part of this company’s business in 2011, we have handled all of
the necessary regulatory and administrative work to ensure that all parties
involved continued to maintain regulatory compliance for their products.
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 has almost 20 years of
experience working on global notifications of new chemical substances.
Mr Hislop has considerable experience in the preparation of regulatory
documentation, development of testing programmes for regulatory
purposes specialising in the use of an “intelligent approach” to safety
testing and is a leading advocate of the principle of the read-across
approach.
Dr Alec Willis – REACH Regulatory Specialist
Dr Willis leads Exponent’s capabilities for chemical safety reports,
exposure scenarios and Chesar. He has experience in Sief management,
production of registration dossiers and Sief and consortia representation
for clients. He has also helped clients across a range of industries
prepare for REACH by providing regulatory strategy and advice and
performing vulnerability analyses. Dr Willis is an experienced project
manager, managing a large number of multi-disciplinary REACH projects.
Page 89
PROFILE: Exponent
PARTNERS
VITAL STATISTICS
PROFILE: Harlan Laboratories
Turnover, group
-
-
No of offices
-
CONTACTS
Website
www.harlan.com/crs
E-mail
[email protected]
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. Understanding the
value of close relationships and collaboration with our costumers we act locally.
Stability, reliability, consistency, and quality are what Harlan Laboratories
offers with decades of proven expertise in both research models and
services, and contract research services.
As important as good customer service and relationships are, though, it’s
really all about scientific excellence. Today, research is increasingly being
outsourced, and researchers need to have confidence in their supplier
partners. Stability, reliability, consistency, and quality are all essential.
That’s what Harlan Laboratories offers with our passion for science and
decades of proven expertise in both research models and services, and
contract research services.
Products and services
Harlan is made up of two major business units offering local expertise,
presence, service, and state-of-the-art facilities in all of the countries it serves.
Contract Research Services provides non-clinical and pre-clinical
laboratory research services supported by state-of-the-art facilities
worldwide.
Our core capabilities are in:
OO
rodent and non-rodent toxicology;
OO
genetic toxicology;
OO
ecotoxicology;
OO
inhalation toxicology;
OO
reproduction toxicology;
OO
regulatory affairs, consulting, and programme management;
OO
analytical chemistry;
OO
environmental fate and modelling;
OO
in vitro alternative testing;
OO
pathology services ;
OO
drug metabolism and pharmacokinetics;
OO
discovery services.
Page 90
2012
12
Staff, group
2,800
800
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.
Alternative and in vitro toxicity
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.
STAFF SELECTION
Harlan Laboratories offers a complete range of genetic toxicology studies
to support the worldwide registration of pharmaceuticals, industrial
chemicals, and agrochemicals, meeting current guideline requirements.
We offer consulting services to review data already held, and to advise
on further testing requirements/strategies, if required. These services also
include access to in silico analysis to assist in hazard identification and
risk assessment.
John Handley, BSc MSc CBiol FSB – Global Vice President Operations
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.
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
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.
Page 91
PROFILE: Harlan Laboratories
Genetic toxicology
SERVICES PROVIDED
Socioeconomic analysis
Socioeconomic analysis (SEA) is a well-established method of weighing
the pros and cons of an action for society as a whole and plays an
important role in the authorisation process under REACH. For authorisation
applications, the applicant will need to determine, for each use of the
substance, whether the benefits of continued use outweigh risks to
human health and the environment. Based on our 40 years of experience
conducting SEAs on a wide range of issues, we have identified both
the practical steps and the key objectives for each stage of the process,
including analysis of alternatives, impact assessment, and monetisation of
impacts. We are currently contributing to an SEA for REACH authorisation.
PROFILE: ICF International
CONTACTS
Website
www.icfi.com
E-mail
[email protected]
Head office
9300 Lee Highway, Fairfax, VA 22031, USA
Tel
+1 703 934 3000
Fax
+1 703 934 3740
Contact
Stephanie Barrett (+32 2 888 01 28)
Directors
Sudhakar Kesavan, Chairman and CEO
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. ICF
also provides secure third-party management of confidential business
information to assist with communication up and down the value chain.
Science support
OVERVIEW
ICF International partners with commercial and government clients to deliver
professional services and technology solutions in the energy and climate
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 4,500 employees
serve these clients worldwide.
VITAL STATISTICS
2011/12
Turnover, group
2011 US$841m
-
No of offices
50
8
Staff, group
4,500
90
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.
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
Page 92
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.
2009
Software Engineering Institute (SEI) Capability Maturity
Model Integration (CMMI) Level 3 designation
2010
REACH outstanding project contributor by a major European
consortium
2011
Rank #80 on Forbes America’s Best small 100 companies
2011
Environmental Finance Market Survey – Best advisory/
consultancy North American markets (All)
2011
consultancy EU emissions trading
2012
consultancy North American markets (all)
2012
consultancy EU emissions trading
ACCREDITATIONS
STAFF SELECTION
CMMI Level 3 designation/ Project Management Institute global executive
council/ Project Management Institute registered education provider
Robert Hegner, PhD – Senior Vice President
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)
major trade associations in the metals and chemical industries
two major international chemical companies; and many more...
TESTIMONIALS
Recognised on REACH project as outstanding contributor by a REACH
consortium for a major European trade association in December 2010.
Recognised in December 2010 by a major REACH consortium for excellence
in operational management on the 2010 REACH registrations from 2008-2010.
CASE STUDY 1: REACH consortium operational and Sief support
ICF International has provided comprehensive programme management
and Sief management support for several major REACH consortia since
2008. These consortia represent hundreds of member companies and high
production volume substances. ICF’s operational support includes supporting
and managing communication among consortia members, providing meeting
support, managing consortia websites and data portals, and managing the
technical dossier production and consortium review and approval processes.
ICF also provides Sief management services, addressing thousands of
technical, policy, regulatory, and process enquiries from Sief participants.
ICF International also supported consortia in setting data sharing and data
access costs and policies. We communicated these costs as well as technical
information to Sief members for each substance within the scope of the
consortia and worked with the consortia legal teams and technology platforms
to provide, disseminate and collect revenues from letters of access.
CASE STUDY 2: IUCLID data entry and dossier preparation
ICF International has provided comprehensive technical support for dossier
preparation in advance of the 2010 substance registration deadlines for several
European-based chemical consortia. ICF managers, toxicologists and exposure
scientists worked collaboratively to produce hundreds of dossiers for REACH
registration in 2010. Each dossier included summary information on production,
use, physical and chemical properties, environmental fate, ecological effects,
human health effects, exposure, and risk management. ICF provided detailed
technical support for more than 100 dossiers and other support for more than
10% of the dossiers submitted for the 2010 REACH registration. ICF’s technical
responsibilities included data collection, literature review, data preparation
and entry into IUCLID, mapping of lifecycle stages for industrial chemicals,
identification of exposure scenarios, exposure modelling using ECETOC
TRA and other tools, risk characterisation, and preparation of various other
documentation needed for registration. We are currently updating IUCLID files to
incorporate changes introduced in the latest major version of IUCLID.
CASE STUDY 3: Classification and labelling
ICF International has made classification and labelling (C&L) recommendations
for hundreds of industrial chemicals for several European-based chemical
consortia and international chemical companies. ICF’s experience using readacross 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 US and Europe and have also been incorporated into REACH
chemical registration dossiers. ICF currently is tracking GHS implementation in
29 jurisdictions worldwide and is updating C&L recommendations in accordance
with how jurisdictions are implementing GHS. ICF also has developed a webbased, searchable database to facilitate access to this information.
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 management and
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 more than five years of experience in exposure analysis
and risk assessment. She led technical teams of toxicologists and exposure
assessors in the development of more than 70 registration dossiers in advance
of the REACH 2010 deadline. She is currently involved in human health impacts
assessments that are part of REACH authorisation applications. With expertise
in REACH hazard and exposure assessment, she specialises in designing
exposure algorithms for unique pathways of exposure. Dr Dederick has also
conducted multiple literature reviews and is familiar with toxicological literature
for multiple chemicals including nanomaterials and endocrine disruptors.
Nikki Maples-Reynolds – Senior Manager
Ms Maples-Reynolds has ten years of professional experience, where she
specialises in reviewing and analysing public health studies, conducting
toxicological risk assessments, and assessing environmental toxicological
risks. She is actively involved in several projects classifying chemicals
and substances in accordance with GHS as implemented in the European
Union and 28 other jurisdictions worldwide. Ms Maples also manages
human health and toxicology support to the U.S. Environmental Protection
Agency (EPA) National Center for Environmental Assessment.
Louise Assem, PhD – Senior Technical Specialist
Dr Louise Assem has more than six years’ of experience in chemical
toxicological hazard, exposure and risk assessment for human health.
She has a PhD in molecular toxicology and specific expertise in REACH,
global GHS-aligned regulatory systems, and metals toxicology. Dr Assem
has provided toxicology, exposure, regulatory, and project management
support to assist clients in their REACH registration and registration updates.
She also provides technical expertise on UN GHS-implementation in 29
jurisdictions worldwide in relation to classification and labelling of substances
and mineral ores and ore concentrates (mixtures). Dr Assem is also part of
a team which is currently preparing a socio-economic analysis for REACH
Authorisation. Dr Assem has recently published on the mutagenicity,
genotoxicity and carcinogenicity of inorganic manganese compounds,
vanadium and vanadium compounds and human biomonitoring.
Jonathan Hecht, PhD – Technical Specialist
Dr Hecht has more than 13 years of experience in economic and policy
analysis, research, and education. One particular area of Dr. Hecht’s
expertise is in the application of survey-based stated preference methods to
estimate the monetary value of “non-market” goods such as public health,
environmental quality, safety, and security. Dr Hecht also has extensive
experience in revealed preference methods, which use market data to infer
the value of a related non-market good or service, and benefit transfer
methods, which adapt previous valuation results to match a new analytical
context. Dr. Hecht has conducted and directed policy research on a variety
of issues, including public health, and drinking water quality, air quality,
hazardous waste recycling, and pricing of water services. Dr Hecht has coauthored several publications that have appeared in peer-reviewed journals.
Page 93
PROFILE: ICF International
PARTNERS
Dr Hegner has more than 35 years of experience in programme
management, risk analysis, and original research. His risk analysis
experience includes developing the Air Toxics Risk Assessment reference
library for the US EPA and assisting in the agency's initial efforts to
develop a framework for environmental risk assessments. He has
published more than 20 peer-reviewed research papers on the endocrine
and environmental regulation of complex vertebrate reproductive cycles.
GLOBAL OFFICES
Willoughby Road, Bracknell, West Berkshire RG12 8FB, UK
78 Shenton Way, Singapore
4777 Levy Street, St. Laurent, Quebec, Canada H4R 2P9
Oranjesingel 34, 6511 NV Nijmegen, The Netherlands
9 Monroe Parkway, Suite 150, Lake Oswego, Oregon 97035, USA
PROFILE: IHS
CONTACTS
SERVICES PROVIDED
Website
www.ihs.com/ehs-sustainability
E-mail
[email protected]
Head office
15 Inverness Way East, Englewood, Colorado 80112,
USA
Tel
+1 503 303 6544
Contact
Trish Jones
Directors
Jerre Stead, Chairman and CEO
Scott Key, President and Chief Operating Officer
Arshad Matin, Executive Vice President
Scott Lockhart, Vice President, EHS and Sustainability
Ownership
Publicly Traded Company (NYSE: IHS)
Locations
Worldwide
Founded
1959
IHS Product Stewardship Solution™
OVERVIEW
Information management solutions for EHS and sustainability
IHS is a global information company with leading experts in the pivotal
areas shaping today’s business landscape, including chemicals,
energy, economics, geopolitical risk, sustainability and supply chain
management. IHS is also the leading provider of information management
solutions – combining software, content and insight – for environmental,
health, safety and sustainability. In today’s business climate, corporate
executives are under pressure to reduce operational costs, avoid potential
disruptions, and meet escalating external demands from investors and
other external stakeholders for compliance with government regulations,
voluntary sustainability protocols and corporate policies.
IHS enables businesses to meet these challenges by adopting an
emerging information strategy called enterprise sustainability management.
Global industry leaders are increasingly focused on enterprise sustainability
management as a key factor in empowering a culture of operational
excellence and identifying a new competitive advantage.
VITAL STATISTICS
2011/12
Turnover, group
US $1.53bn
n/a
No of offices
193
31
Staff, group
More than 6,000
150
Training
5%
Consultancy/
advisory
20%
IT & software
40%
Information
35%
Page 94
The IHS Product Stewardship Solution™ helps your business maintain
access to existing markets while accelerating opportunities to introduce
products in new jurisdictions. Powered by industry-leading information
management products IHS Intelligent Authoring™, IHS Comply
Plus® and IHS DolphinRTK™, this comprehensive solution combines
software, content and industry expertise, enabling organisations to
efficiently monitor and manage product compliance with rigorous
regulatory mandates at every stage of the product lifecycle, from product
design through manufacturing. IHS supports your company’s compliance
programme with these powerful information management capabilities:
OO
SDS Authoring – Create product hazard communications
documents in nearly 50 languages, ensuring your employees and
customers will have the information they need to ensure safe use of
your products and continued access to global markets;
OO
Documentation and Labels – Simplify the process of producing
labels and regulatory documents while reducing your company’s
compliance-related risks across the enterprise;
OO
Product Compliance Analysis – Minimise risks to your company’s
go-to-market strategy by aligning regulatory compliance analysis with
your product lifecycle management plan. IHS helps you keep your
products compliant;
OO
Chemical Management – In order to identify opportunities to
reduce costs and optimise operational processes while maintaining
compliance with regional and national regulations;
OO
Supply Chain Communications – Improve communication
between your internal stakeholders and suppliers, so you can
maintain your access to key markets;
OO
Quality Risk Management – Leverage improved risk identification and
analysis so you can accurately understand your organisation’s risk profile.
IHS enables your business to make your product stewardship programme
part of a unified information management strategy for enterprise
sustainability management, and supported by a single world-class provider.
IHS managed regulatory content provides unparalleled support to our
solutions for environmental, health, safety and sustainability. IHS product
stewardship content consists of information on more than 300,000 chemical
substances, 15,000 regulatory phrases in nearly 50 languages, 7,500
proprietary rules, and 100 templates spanning more than 50 countries.
Enterprise sustainability management strategies
Companies are struggling to address escalating external demands from
investors and customers for transparency into a host of non-financial reporting
issues, including product stewardship, environment, health and safety, risk
management, natural resources, social responsibility and governance.
An enterprise sustainability management (ESM) information strategy
enables organisations to manage risk, drive workflow efficiency and
optimise resources – uncovering opportunities for innovation and growth.
ESM establishes a structure for managing sustainability performance by
collecting, aggregating and reporting information from the bottom up –
from the laboratory to the executive suite – as part of your big data and
analytics strategy.
Industry and domain expertise
IHS domain and technology experts possess a wealth of domain
knowledge and have proven experience at global implementations that
ensure alignment with our clients’ business requirements. IHS regulatory
Result: the single instance of a unified database eliminated the need
for repetitive support roles and reduced structural costs at multiple sites.
Dow was able to save $2m in redundant legacy systems and improve its
compliance reporting efficiency.
1959
IHS founded
STAFF SELECTION
2005
IHS becomes a publicly-traded company
Jeff Ladner, Senior Director, EHS and Sustainability Solutions
2007
IHS launches EHS & Sustainability Business
IHS acquires Environmax
2008
IHS acquires Environmental Software Providers
IHS acquires Dolphin Software
2009
IHS acquires Environmental Support Solutions
2010
IHS named Leader in Carbon and Energy Management
Software by independent analyst firm
IHS acquires Syntex Systems
IHS acquires Atrion International
IHS acquires Chemical and Energy Products
2011
IHS named Enterprise Sustainability Management Solution
Leader by leading research firm
IHS acquires Dyadem
2012
Analyst study names IHS a leader in environmental
management software
IHS acquires CyberRegs Business from Citation Technologies
IHS acquires GlobalSpec
PARTNERS
CH2MHill, Deloitte, E2 ManageTech, Environmental Resources
Management (ERM), EnVizTec, IBM, Kozo Keikaku Engineering (KKE),
Microsoft, MicroStrategy, OSIsoft, OSyS, SAP, Trinity Consulting, URS
CLIENTS
For more than two decades, IHS has been trusted by hundreds of
enterprise-level clients worldwide across a vast array of industries,
including chemicals, pharmaceuticals, energy, mining, manufacturing,
transportation, consumer goods, defence and government.
CASE STUDY 1: Americhem
Challenge: Americhem is a global organisation that brings polymer
products to life with custom-crafted colour and additive solutions.
Americhem needed to stay abreast of the ever-changing legislative
environment and maintain a high level of expertise in interpreting
legislative changes and their impact on the company.
Solution: Americhem implemented a global product stewardship solution
from IHS that enabled the company to streamline its processes and
support its globalisation efforts. This software and regulatory content suite
of products provides seamless raw materials management, auto creation
and authoring of SDS in nearly 50 languages.
Results: the IHS solution greatly improved Americhem’s ability to manage
compliance automatic data link updates providing the latest developments
on regulatory changes and requirements on all chemicals. This has enabled
the company to focus on its core business rather than compliance issues.
CASE STUDY 2: Dow Chemical
Challenge: Dow was looking to replace multiple legacy environmental
reporting systems. Previously, Dow used multiple legacy systems for
regulatory reporting, but those systems were no longer sustainable,
varied between sites, and required duplicate resources for support. The
company also was looking to develop and standardise best practices with
a single robust reporting system across 200 US facilities.
Solution: Dow implemented the IHS Environmental Performance Solution™.
Jeff Ladner oversees the development of unified information management
solutions that enable global organisations to proactively address EHS and
sustainability business challenges, as well as boost operational and financial
performance. Under Ladner’s leadership, IHS has established a strong
reputation for enabling corporations to develop and execute sustainability
strategies through a holistic, integrated view of operational performance.
He has nearly two decades of experience meeting market demand for
enterprise information management systems that efficiently manage
environmental, energy and carbon management, risk management, product
stewardship and corporate responsibility programmes.
Francis Trudeau, Solutions Manager
Francis Trudeau has worked for nearly 15 years in product compliance and
chemical management. Trudeau has significant experience in solutions
management and development, global regulations and industry standards
enforced worldwide. He has worked on a wide variety projects that support
IHS integrated information management solutions, and address legal
compliance challenges of environmental, health and safety professionals and
the implementation of regulations in databases and software applications.
Trudeau is a recognised industry expert, serving both as a featured
speaker at international conferences and leading multi-organisation task
forces in establishing industry best practices for regulatory compliance.
Mary Rudolph, Senior Manager – Global Content
Mary Rudolph has more than 25 years of international environmental,
health and safety experience, including technical and business
implementations of authoring services. She offers IHS customers an indepth and often sought after understanding of the needs of global EHS
departments. She has also managed the development of EHS-related
databases, including RTECS®, a recognised toxicology database.
Mark Blainey, Senior Regulatory Analyst
Mark Blainey has been involved in EU chemicals legislation for more than
15 years and is considered one of the foremost authorities on REACH
legislation. He is widely published and his work experience includes the
development of REACH from its inception to agreement, as well as the
myriad of guidance documents, reviews of the REACH annexes and
contributions to the European Commission’s CLP regulation. Prior to joining
IHS, he served as Director at the Policy Analysis and Chemical Evaluation
(PACE) SPRL, a consultancy expert in EU chemical policy during which he
helped a number of companies with their REACH registration submissions.
Carrie Decatur, Regulatory Analyst
Carrie Decatur is responsible for monitoring and analysing GHS
regulations around the world. She has nearly 15 years’ experience in
health and safety management programmes, managing compliance with
state and federal Osha, and US EPA regulations, ensuring product safety,
and supporting SDS authoring programmes.
Sue Barton, Senior Regulatory Analyst
Sue Barton brings more than 20 years’ experience in the regulatory
compliance arena to help IHS customers navigate ever-changing
chemical management regulations. Her expertise in research
and development, interpreting regulations and developing system
customisations, helps IHS customers meet their compliance challenges.
Page 95
PROFILE: IHS
experts continuously monitor and track legislation changes in order to
constantly refine our solutions, which support industry best practices that
enable organisations to contain costs while reducing business risks.
PROFILE: International Cosmetics & Chemical Services Ltd
SERVICES PROVIDED
Responsible person, product information files, and safety
assessment, cosmetic product safety report
We provide full regulatory services in Europe, including labelling
requirements.
Responsible person (RP) services. RP is responsible for:
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product information file (PIF) for each product;
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safety assessment;
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address on all product labelling;
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access for the competent authorities (27 countries) for PIFs;
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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
[email protected]
Head office
947 Manhattan Beach Boulevard, Suite A, Manhattan
Beach, CA 90266, USA
Tel
+1 310 545 3223
Fax
+1 310 546 6204
Contact
[email protected]
Directors
Janet Winter Blaschke
Georgia Boehm
Ownership
Private company
Locations
USA, UK
Founded
1997
Only representative (REACH), CLP notifications (sole
representative)
Only representative services for companies needing chemical
registrations for the EU scheme under REACH (Registration, Evaluation,
Authorisation and Restriction of Chemicals). Late pre-registration and full
registrations have already been successfully provided for many clients.
CLP notification services are also available, in addition to safety data
sheets to meet the requirements of REACH and CLP.
OVERVIEW
International Cosmetics and Regulatory Specialists LLC, a US
organisation and International Cosmetics and Chemical Services Ltd, a
UK entity are sister companies comprised of experienced professonals
in regulatory affairs, international product registration, and international
labelling compliance, with an emphasis on technical services for the EU,
USA, Canada, Asia, South America, and the Middle East. Please enquire
about your specific needs.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
2
28
Staff, group
6
3
US agent, cGMP audits and training, electronic US FDA
registrations
Products such as Acne and any product containing SPF ingredients
must be registered with the FDA. We can act as the US agent for foreign
manufacturers (which is mandated by FDA) and provide the mandatory
facility, distributor and product FDA electronic registrations.
FDA registrations must now be done electronically, which is a service we
provide. We provide cosmetic and over-the-counter drug label review,
training and cGMP facility and standard operating procedure audits.
Expert witness testimony services in many areas of product development,
product liability, and technical services are also available.
Training for GMPs and ISO manufacturing standards
A wide variety of experience facilitates custom services for international
needs with the intricacies of each individual organisation in mind. Focus
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
REACH
Training
20%
2007
Formed REACH Chemical Consulting, Ltd now known as
International Cosmetic and Chemical Services, Ltd.-UK
2008
Filed pre-registrations for US and international companies to
meet the EU regulation.
2009
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.
GLOBAL OFFICES
2010
USA: International Cosmetics and Regulatory Specialists LLC
UK: International Cosmetics and Chemical Services Ltd
Preparation of safety data sheets (SDS) to meet the REACH
and CLP requirements.
2011
Continuing with SDS creations, REACH late-preregistrations,
Sief coordination for clients and their chemicals, continue
with CLP notifications.
Information
10%
Consultancy/
advisory
60%
Representation
& management
10%
ISO
2006
Page 96
Designated expert in the Cosmetic ISO workgroup for TC217, Cosmetic GMP, Sunscreens and Microbiology in Paris.
Designated expert in Cosmetic GMP and Sunscreen
workgroup in Den Haag, The Netherlands.
2008
Designated expert Cosmetic GMP and Microbiology
workgroup in Paris.
2009
Designated expert Cosmetic GMP and Microbiology
workgroup in Baltimore, MD, USA.
2010
Designated expert Cosmetic GMP, Microbiology and
Sunscreens workgroup in London
2011
Designated expert Natural and Organic Terminology
workgroup in Kyoto, Japan
cGMP audit
ICRS continues to excel in meeting cGMP compliance
training and audits in the USA as well as internationally.
These activities are designed to meet the individual
companies and their unique cultures. Staff use ISO
GMPs, FDA cGMPs as well as country specific regulations
depending on the market and or country needs.
ACCREDITATIONS
OO
OO
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OO
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Personal Care Products Council (Formerly CTFA)
Society of Cosmetic Chemists (SCC)
Regulatory Affairs Professionals (RAPS)
American Society for Quality (ASQ).
Vrije University of Brussels (VUB), qualified safety assessor training
and certificate from the department of Pharmacology and Toxicology
Chartered biologist, Society of Biology, UK
PARTNERS
Manhattan Repro (graphic design for labelling)
CLIENTS
Georgia Boehm, AA Business Management, Glendale College
OO
OO
OO
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
OO
OO
OO
OO
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
specialist – product information file administrator
fluent in Cambodian
Alterna, Arbonne International, California Tan, CB Fleet Co, Circle of Friends,
Contem 1g (Brazil), Davi (Mondavi) Skin, Disney Consumer Products Inc,
Dermanew, Econet, Inc, Frederic Fekkai, Freeman Beauty, Giorgio Nardi
(Italy), Go Smile, Henkel Consumer Goods, ICN Pharmaceuticals (Valeant
Pharmaceuticals), Johnson and Johnson Consumer Products Inc, Jordana
Cosmetics Corp, Juvena/La Prairie (Switzerland, Germany), Laboratoire
Labothene Cosmetique GMbH (Germany), Leaf & Rusher, M&K (JK Mueller
& Myung Sun), Nu Skin, Ole Henriksen, Pental Soap Products (Australia),
Pierre Fabre Dermato-Cosmetique (France), Pola Cosmetics (Japan),
Procter and Gamble, Rock & Republic, Sexy Hair, Smashbox, TIGI (Toni and
Guy), Twincraft Soap Company, Zenyaku USA, and many others.
STAFF SELECTION
Janet Winter Blaschke, BA, Biology, University Redlands
OO
OO
OO
OO
OO
OO
OO
CEO of International Cosmetics & Regulatory Specialists LLC.
CEO and founder US, and managing director of International
Cosmetic and Chemical Services Ltd. in the UK, serving the
consumer products and chemical industries.
30 years of experience as a product formulator and regulatory
expert has given her unique expertise in both the European and US
regulatory schemes.
founder, instructor and lecturer for cosmetic science programme
at UCLA (University of California at Los Angeles). Topics include:
regulatory acceptance of cosmetic ingredients in individual countries;
R&D and manufacturing for the global market; microbiology and
quality control of cosmetic products.
past chairman, Society of Cosmetic Chemists; member, board of
directors, Society of Cosmetic Chemists; regulatory affairs chairman,
contributing author to SCC publications
chartered biologist, Society of Biology, United Kingdom
post graduate certificate in REACH management, University of Hull, UK
Page 97
PROFILE: International Cosmetics & Chemical Services Ltd
2006
SERVICES PROVIDED
Advisory – services to help you advance your business
Auditing – services to help you control operations
Certification – services to help you reach new markets
Outsourcing – services to help you focus on core activities
Quality assurance – services to help you meet expectations
PROFILE: Intertek
CONTACTS
Training – services to help you improve your performance
Website
www.intertek.com/green/chemicals/
E-mail
[email protected]
Testing – services to help you improve your performance
Head office
25 Savile Row, London W1S 2ES, UK
Tel
+44 0161 245 8071
Contact
Jeremy Ramsden
Directors
Sir David Reid, Chairman
Wolfhart Hauser, Chief Executive Officer
2004
ASG in Manchester, UK was acquired from Zeneca and Avecia.
2007
MSG in Wilton, UK was acquired from ICI.
2010
Intertek acquires CIBA Expert Services and Cantox Health
Sciences International.
Lloyd Pitchford, Chief Financial Officer
2011
Intertek acquires Moody International.
Ownership
Public
2011
Intertek acquires Analytical Sciences Americas (ASA).
Locations
Intertek is the industry leader with more than 33,000
people in 1,000 locations in over 100 countries.
2011
Intertek continued to expand and develop services in the 25plus industries it operates in.
Founded
The Intertek story starts at the inception of the modern
testing industry. The history of Intertek spans 126 years,
and evolved from the combined growth of a number of
innovative companies.
2011
Intertek is a partner to some of the 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.
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
OO
OO
2011/12
Turnover, group
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£1,374.2m
£151.5m
No of offices
1,000+
100+
Staff, group
30,000+
2,000+
Other
29%
Consultancy/
advisory
10%
Information
3%
Training
3%
Laboratory
55%
GLOBAL OFFICES
USA: 801 Travis, Suite 1500, Houston, TX 77002, USA, +1-877- 274-0181
Germany: Stangenstr 1, 70771 Leinfelden-Echterdingen, Germany, +49
711 27311 152
China: 4/F, Block B, JinLing Business Square, No. 801, Yi Shan Road,
Caohejing Development Zone, Shanghai, China 200233. Office: +86 021
6127 6132
Page 98
2012
Intertek acquires Laboratory Services International BV
(LSI) Mineral Laboratory.
Intertek wins UK National Business Awards for
exceptional leadership, customer focus, staff
engagement and innovation.
Intertek Group plc completes acquisition of NDT Services
Ltd.
ACCREDITATIONS
As a company Intertek believes that acquiring the appropriate quality
accreditations and maintaining membership (and in many cases) chairing
industry regulatory groups and standards organisations is key to not
only our development but to providing quality assurance and insight
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:
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Dr Naeem Mady – industry segment council board member and
a national board council member at the the Plastics Industry Trade
Association (SPI);
OO
Dr David Bechtel – diplomat of the American Board of Toxicology;
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Dr Paul Lambert – committee member of the European Structural
Integrity Society (ESIS TC4);
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Dr Ian Fletcher – member of the EPSRC ‘college’ for peer review;
OO
Dr Jeff Franks – Royal Society of Chemistry, Membership Affairs Board;
OO
Dr Neil Everall – European editor of Applied Spectroscopy journal.
CLIENTS
Our clients include: Behr, Bosch, BP, ChevronTexaco, Citgo,
ConocoPhillips, Haier, Lubrizol, Petrobas, Siemens
"Working with Intertek Group as our EU REACH only representative has
been a rewarding experience. Intertek has provided guidance to CITGO,
with respect to legal issues, suppliers, customers and changes of the
new EU legislation. CITGO has relied on Intertek's global knowledge
and assistance to meet each and every goal within the strict timeline
demanded by legislation, suppliers and customers. Intertek continues to
help CITGO develop and grow our markets." – Citgo
“I would like to let you know that I am surprised with the high speed and
high quality of the work you and your team have been doing to generate
e-SDS for Braskem. I am very thankful for your special support. You made
us feel important and we saw your special effort urgency sense dealing
with our requests. Your special effort last month was outstanding and
helped us a lot. I also wanted to inform you that Braskem Netherlands
BV were inpected by Dutch government in regards to OR scope for all
Braskem companies and all e-SDS checked were in compliance with
REACH / GHS rules. Thank you so much!” – Braskem SA
“NOVA Chemicals Corporation contracted with Intertek in Europe to provide
support as our only representative under REACH in Europe enabling us to
have the registration dossiers completed and submitted well in-time and
ahead of the 2010 deadline under the regulation. Intertek also represents
Nova Chemicals interests for certain chemicals having registration
deadlines 2013 and 2018 making it possible for us to continue selling our
products in Europe without interrupting the supply chain. In addition Intertek
provided a series of CLP submissions which fall under the new classification
and labeling regulation in Europe supporting us and our EU-customers
managing their legal obligations. We have had very good collaboration
with Intertek and would like to offer a special thank you for their support,
professionalism, and dedication. We look forward to a continued and long
excellent relationship with Intertek.” – NOVA Chemicals Corporation
CASE STUDY 1: Incorrect definition of substance can lead to
unnecessary registration
One of the first major hurdles to cross in the preparation of the technical
dossier for REACH is to ensure the registrant is certain that the substance is
well defined. The better the knowledge on the substance definition the easier
it is to decide on a registration strategy. In one case our client was uncertain
about the handling and interpretation of the product-by-process definition so
our expert spent several hours discussing the problem. As the descriptions
became quite complicated this led to the point that our expert was invited
to the plant and visit onsite to better define the case. After a few hours of
explanations onsite it became quite evident that the substance in question
was not eligible for registration and hence was exempted. Looking back it was
good money invested in thinking it through and well worth the trip to the site as
this was a minor investment compared to a full registration dossier; the client
easily saved € 50k in consulting charges and multiples thereof in testing costs.
CASE STUDY 2: Intertek: helping to reduce letter of access costs
Safer health and beauty products: recently the European Commission
concluded that REACH has improved the safe use of chemicals both
for human health and the environment. Various flavours and fragrances
companies are working with Intertek to meeting their REACH obligation
ensuring the safe use of their specialty chemicals in various applications,
including health and beauty products. Other legislations require that safety
assessments are performed on cosmetics and their ingredients and that
their packaging is correctly labelled. Intertek experts globally provide
safety solutions to ensure that cosmetic products can be used safely.
CASE STUDY 3: Intertek’s global network of experts helps clients
achieve cost-effective registrations worldwide
As most companies focus more and more on core competencies such as
R&D, marketing and production, it is our role as true service provider to help
our clients with exactly those support services no longer considered core.
For instance, our analytical, regulatory and environmental compliance
services focus on these competencies ensuring that our clients can draw
from our global network of experts, particularly in North America, Europe
and Asia/Pacific Rim. Due to our in-depth understanding of the regulatory
requirements locally we helped a multinational chemical company save
€80k by coordinating the testing requirements for China, Japan and Europe.
STAFF SELECTION
Dr Andrew Swift – Executive Vice President Chemicals and
Pharmaceuticals
Andrew Swift is executive vice president of Intertek's Chemicals and
Pharmaceuticals division, which role he assumed in January 2008. Prior to
this, he was vice president of global outsourcing within Intertek's Commodities
Division. Dr Swift joined Intertek in 2001 as business development manager of
the group's laboratory facilities at Sunbury (UK). Both of Andrew's degrees are
from UMIST and he is a chartered chemist of the Royal Society of Chemistry.
Dr Ruud Overbeek – Vice President, Global Health, Environmental
and Regulatory Services
Dr Ruud Overbeek manages Intertek’s Health and Environmental (H&E)
business which includes restricted substances, REACH, and climate 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.
Dr Marc Thouin – Vice President, Regulatory Services
Dr Thouin is vice president for regulatory services and bears the operational
responsibility globally. He studied natural sciences at the Swiss Federal
School of Technology in Zurich and obtained his PhD in toxicology in 1983,
followed by a postdoctoral study at GDSearle in Chicago, USA.
Torben Nörlem, Esq – Chief Counsel
Torben Nörlem, Intertek’s senior legal counselor, has a LLM in Law from
the legal faculty at Copenhagen University and 15 years’ experience
working with product related legislation and regulatory framework.
Torben has been working as chief counsel for health and environment
with Interek since 2008. Torben was responsible for legal affairs related
to the REACH legislative process and was a participant of the Danish
government negotiation team during the negotiations in the European
Union. He was also responsible for implementation and administration of
EU rules regarding chemicals in electronics in Denmark.
Dr Michael Leise – Senior Expert Consultant
Michael Leise is one of Intertek’s regulatory affairs senior expert
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.
Page 99
PROFILE: Intertek
TESTIMONIALS
SERVICES PROVIDED
Software solutions
Environmental product compliance and sustainability: ELV, IMDS, RoHS,
REACH/CLP, LCA, DfE, RRR, conflict minerals, GHG, sustainable open
innovation, SDS, dangerous goods management.
PROFILE: iPoint
CONTACTS
Consulting
Website
www.ipoint-systems.com
E-mail
[email protected]
Head office
Ludwig-Erhard-Straße 52-56, 72760 Reutlingen,
Germany
Tel
+49 7121 144 89 60
Fax
+49 7121 144 89 89
Contact
Christoph Junk
Directors
Jörg Walden, CEO
Hans-Gerhard Lang, Director Sales
Christoph Junk, Director Marketing
Ownership
Private (Germany: GmbH, US: Inc, GB: LLC)
Locations
Germany, Austria, Great Britain, France, China, USA
Founded
2001
Sustainability strategies, business and process analysis, impact analysis,
EH&S consulting, sustainable products and brands, sustainable supply
chain, sustainable manufacturing
Training
Training events in the field of environmental product compliance and
sustainability
Data care services
Sustainability services for handling data from companies’ supply chain
OVERVIEW
iPoint is an expert in environmental product compliance and sustainability,
specialising in software, consulting and training for managing, tracking
and reporting throughout the supply chain from product concept to
completion. iPoint delivers adaptive and comprehensive software
solutions that give the visibility and control customers seek in managing
sustainability.
Ensure compliance with requirements such as conflict minerals, ELV,
REACH, RoHS, or RRR, and at the same time increase the sustainability
of your products (LCA, DfE). Our solutions facilitate easy tracking of your
environmental impact, and implementation of your product sustainability
goals.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
7
6
Staff, group
2011: 55; 2012: 70
20
iPoint-systems gmbh founded in Reutlingen/Germany
2002
Sales office in Great Britain opened
2007
Office in North America opened
2008
Sales office in China opened
2010
Acquisition of KERP GmbH in Austria
2012
OO
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2012
Gartner recognises iPoint-systems as Cool Vendor
Quality seal “Top 100”: iPoint-systems is Innovator of the
Year 2012
Launch of iPoint Conflict Minerals Platform (iPCMP). iPCMP
is an on-demand software solution which enables companies
to fulfil the enormous challenge of collecting, managing,
aggregating and reporting conflict minerals information, and
meet the requirements of their customers and the regulatory
authorities.
PARTNERS
OO
AIAG, TetraTech,
CLIENTS
OO
OO
OO
OO
OO
OO
Training
10%
2001
OEM: Daimler, Jaguar/Landrover, Nissan, Renault, Honda, Hyundai/
KIA, GM
Supplier: Automotive Lightning, Johnson Controls, Mahle, Valeo,
Magna, Lear
Electronics: Bosch, ZUMTOBEL, Electrolux
Pharma: Roche, sanofi Aventis
Manufacturing: Rexroth, Voith
Other Industries: Tesa, Lavazza, HP, MTU, Sika
Consultancy/
advisory
20%
Representation
& management
5%
IT & software
55%
Information
10%
GLOBAL OFFICES
Reutlingen (Headquarters), Dortmund, Vienna, Manchester, Paris,
Southfield, Shanghai
Page 100
TESTIMONIALS
STAFF SELECTION
Gartner recognises iPoint-systems as Cool Vendor 2012: Why
cool?
OO
“Holistic solutions covering a sustainable supply chain management
remain absent from the marketplace.
OO
In existence since 2001, iPoint’s solutions however provide a robust
and well-tested technology platform for managing environmental
compliance and sustainability requirements in complex discrete and
increasingly regulated manufacturing environments.
OO
Central to their solution suite is their Compliance and Sustainability
Hub which acts as an integration platform for critical compliance,
materials and sustainability data”
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http://www.ipoint-systems.com/en/newsroom/news/news-details/
artikel/weltweit-fuehrendes-analystenhaus-waehlt-ipoint-systemszum-cool-vendor/
Quality seal “Top 100”: iPoint is one of the three main award
winners
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“With its integration and compliance solutions, the globally operating
software and consulting company has zeroed in on future issues
such as resource saving and health and safety.
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iPoint-systems convinces by its ability to react to changing
circumstances quickly. Due to its excellent monitoring processes, the
company can detect new market developments. Moreover, customers
are involved in the developing projects. Overall, the company’s
management level excels in its extraordinarily strong commitment in
innovation management.”
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http://www.ipoint-systems.com/en/newsroom/news/news-details/
artikel/ipoint-systems-ist-innovator-des-jahres-2012/
Management consulting
Chemical and material experts
Software engineering
Support and services
PROFILE: iPoint
Sales and marketing
CASE STUDY 1: Automotive Lighting
OO
OO
OO
iPoint-systems optimises global ELV processes at Automotive
Lighting with Compliance Agent’s IMDS Solutions.
closing the floodgates on data: AL has to create about 750 in-house
material datasheets (MDB) for annual average of 75 new products
– about two per day. This means that on top of our own MDB,
we receive about 20 times as many again from suppliers – which
makes for a flood of data. Finding the light at the end of the tunnel
by ensuring that delivered data was both on time and correct was
therefore the main priority for the new IT-solution
http://www.ipoint-systems.com/en/newsroom/brochures/#c1369
CASE STUDY 2: MagnaSteyr
Legally Compliant and Sustainable Designed Products for MAGNA
STEYR:
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main motivation for the project: use of a software tool that facilitates
compliance with regulations governing material recycling and
recovery. A steadfast commitment to the environment begins with the
development of green products while considering each individual life
cycle stage
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in a joint effort with MAGNA STEYR, we have successfully developed
iPoint RRR. This tool greatly reduces the time needed to calculate
recycling and recovery rates, allowing simulations of different
recycling scenarios while emulating novel recycling technologies.
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http://www.ipoint-systems.com/en/newsroom/brochures/#c1369
CASE STUDY 3: iPoint-systems equip Turkish household goods
sector leader with new software solution
OO
OO
OO
In the EU, housewares producers are faced with innumerable
regulations. In particular, surface properties and pure substances of
imported products are closely monitored.
In order to maintain profitability and ensure a complete overview of
the country-specific standards, the Turkish leader in the household
goods sector has chosen the iPoint Supplier Entry Portal (SEP) and
the Compliance Agent (module SAM-M).
www.ipoint-systems.com/en/newsroom/news/
Page 101
SERVICES PROVIDED
REACH services
JSC consultants have significant experience in all aspects of REACH.
We have prepared a large number of registration dossiers and chemical
safety reports (CSR’s) 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.
PROFILE: JSC International
CONTACTS
Website
www.jsci.co.uk
E-mail
[email protected]
Head office
Simpson House, Windsor Court, Clarence Drive,
Harrogate, North Yorkshire, HG1 2PE, UK
Tel
+44 (0)1423 520245
Fax
+44 (0)1423 520297
Contact
Dr Samantha Wright or Dr Richard Elsmore
JSC experts are able to assist with classification, labelling and safety
data sheet creation including the extended safety data sheet containing
exposure scenarios.
Directors
Lucy Croucher, Managing Director
DGSA
Denis Kaye, Finance Director
Ownership
Private company
Locations
UK
JSC can offer dangerous goods safety adviser services for the transport
of hazardous goods. Our experts can act as your company DGSA,
provide support, auditing and training.
Founded
1992
CLP/GHS
Biocidal products
OVERVIEW
JSC International Limited is a privately owned independent European
consultancy company predominantly providing regulatory support to the
chemical, agrochemical and biocides industries.
At JSC we have a dedicated team of highly motivated people with
backgrounds from government, industry and contract research. Our
integrated, cross-discipline working practices enable us to provide novel
and innovative approaches to problem solving, supported by our excellent
contacts with regulatory officials and scientific experts throughout the world.
VITAL STATISTICS
2011/2012
Turnover, group
-
-
No of offices
1
30+
Staff, group
26
23
Other
Training 5%
5%
Representation
& management
20%
Consultancy/
advisory
70%
JSC offers regulatory support for both active substances and biocidal
products. We have experience of submitting active substance dossiers
for a wide range of product types under the BPD. For biocidal products
we routinely submit national registrations and have good contacts with
regulatory authorities in all member states within the EU. We are also
active in submitting BPD/BPR product dossiers following Annex I inclusion.
We are able to offer support to a diverse range of biocidal products.
JSC can also offer more general regulatory support to biocide
manufacturers and formulators in areas such as scope issues, efficacy
testing, claim support and risk assessment and the impact of the new
Biocidal Products Regulation.
Agrochemical products
JSC has extensive experience in the preparation, submission and
regulatory support of EU dossiers and national draft registration
reports. We have an excellent track record of successful EUapprovals
and national authorisations, and are well placed to assist you in the
development of strategies to support your compounds in Europe.
1992
EU offices of JSC formed – 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
GLOBAL OFFICES
JSC International Limited, Simpson House, Windsor Court, Clarence
Drive, Harrogate, North Yorkshire, HG1 2PE, United Kingdom
Page 102
ACCREDITATIONS
STAFF SELECTION
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).
Lucy Croucher – Managing Director
Network of locally recognised contacts across the globe.
CLIENTS
Our clients range from large international companies to SMEs located
worldwide.
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. The project was a success culminating in the successful
submission of substance dossiers for the 2010 and 2013 deadlines.
During the development of these dossier and safety assessments JSC
has had to work with consortia members and downstream users to
identify relevant use patterns and in the development of appropriate RRM
and in the production of meaningful extended SDS.
CASE STUDY 2: REACH downstream user support
JSC has successfully provided support to downstream users. Through
training and consultations, JSC has provided the expertise and
knowledge for downstream users to determine their obligations under the
REACH Regulation, understand the implications of supply chains and
effectively plan their regulatory strategy and compliance.
CASE STUDY 3: New substance registration
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 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.
Dr Richard Elsmore – Regulatory Affairs: Biocides and REACH
Richard Elsmore has held a number of senior roles with speciality
chemical manufacturers and formulators and has experience of working
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
additionally sits on the BSi Technical Committee on disinfectant standards
(CH/216) and has represented BSi within CEN. He has also worked on
both method development and the assessment of individual chemicals in
the human and environmental risk assessments programme (HERA).
Dr Justine Weyman – Regulatory 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.
Page 103
PROFILE: JSC International
PARTNERS
Lucy Croucher has been working in the area of European agrochemical
regulatory affairs since 1994. She has managed large scale projects for
the preparation, submission and support of EU dossiers for existing active
substances, resubmissions and new active substances under Directive
91/414/EEC. To date, JSC has been involved in the successful Approval
of 17 active substances.
Lucy is currently advising Clients on Annex I renewals and the
implications of Regulation (EC) No 1107/2009.
SERVICES PROVIDED
Hazardous substance consulting
Safety data sheets
Generation of EU safety data sheets (SDS) in accordance with current
legislation (including GHS) for substances or compounds in all European and
other languages ie Turkish, Russian, Malay, Chinese Mandarin and Thai,
with particular consideration of national requirements MSDS for US/ Canada
according to current local legislation. A comprehensive concept of SDS
maintenance packages has been successfully introduced allowing customer’s
permanent updating of safety data sheets (SDS) pursuant to statutory
requirements. The total care service is completed by the latest innovation
KFT SDS Control & Care, covering the management of supplier SDS.
PROFILE: KFT Chemieservice
CONTACTS
Website
www.kft.de, www.kft-academy.com and www.KFTebook24.com
E-mail
[email protected]
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
Research
KFT Chemieservices’ business is its competence in regulatory and
product safety affairs. We ensure our customers’ legal compliance for
registrations, documentation as well as environmental exposures.
Key elements are our experienced and well trained staff, modern,
sophisticated software and fair compensation of our services. Our
responsiveness to individual customer needs is well recognised in the
market.
VITAL STATISTICS
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
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
12
8
Legal
IT & software 2%
2%
Laboratory
3%
Information
14%
Representation
& management
16%
Training
8%
Consultancy/
advisory
55%
Registration pursuant to §16e of the German Chemicals Act (ChemG),
the German Federal Institute for Risk Assessment (BfR), the German
Detergents and Cleaning Agents Act (WMRG) and product registrations in
Switzerland, Greece, the Netherlands, the US and other nations.
REACH
KFT Chemieservice has been working with REACH since 2001. Since
that time we have prepared a number of companies for REACH, devised
practical solutions by deploying task forces, and have carried out more
than 3,000 pre-registrations for our customers. We offer you:
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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:
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impact analysis, strategic and operative REACH consulting, portfolio
as well as supply chain communication consultation.
Our Sief management provides:
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project management, financial processing and settlement, trustee
services, conducting studies and organisation of data sharing ,
communication with customers, authorities and competitors.
Biocides
With an experienced team we handle registrations of biocide substances,
coordinate study generation, prepare the dossiers and do the authority
management.
Seminars,training and coaching
The very popular and much appreciated coaching support has been
continuously developed for a broad spectrum of seminars around the
compliance aspects of REACH, SDS, GHS / CLP and biocides. The
available selection can be found at [email protected]
In-house training and customised coaching are available on demand at
[email protected]. Monthly webinars can be accessed free of charge.
The launch of ebooks on legal aspects around Compliance has started 2013.
Page 104
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
2012
Introduction of SDS Control & Care
2013
Launch of KFT-Ebook 24 with legal information worldwide
ACCREDITATIONS
VCH (association of chemical suppliers) subsidiary of FECC (European
Association of Chemical Distributors)
Member of ENES (European Network on Exposure Scenarios)
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
Chemical manufacturers, distributors, importers of consumer goods,
biocide substances, pharmaceutical raw materials, hygiene products for
veterinary applications, household cleaner formulations and other products.
Dr Karl-Franz Torges is founder and managing partner of KFT
Chemieservice GmbH, heading the business unit REACH and
Registrations. Familiar with hazardous materials, hazardous cargo, MSDS
and registrations since 1989. Several years experience in working with
software companies focusing on compliance software (SAP EH&S). Since
2001 instrumental participation for the development of software tools for
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.
CASE STUDY 1: Marketability study
Angelika Torges – Member of the board
PARTNERS
Tradas Translations and Consulting Services (Flexible customised
solutions for linguistic and technical needs)
Laus GmbH (GLP certified testing laboratory)
CLIENTS
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:
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chemical legislation;
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Ordinance on Detergents;
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cosmetics regulations;
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biocide regulations;
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environmental regulations;
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commodities regulations;
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transport law (hazardous materials) etc;
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and ultimately issues approval for marketing.
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.
Page 105
PROFILE: KFT Chemieservice
SERVICES PROVIDED
Software
Website
http://the-ncec.com/
Chemdata® – clear and concise chemical hazard information on more
than 45 000 substances, at your fingertips
Pocket Chemdata® – Chemdata® for pocket PCs and smartphones
running Windows Mobile and Android operating systems
ChemeDox® – online, simple-to-use, chemical safety document
management system
E-mail
[email protected]
Emergency Response
Head office
Ricardo-AEA, The Gemini Building, Fermi Avenue,
Harwell, Didcot, UK, OX11 0QR
Tel
+44 (0)870 190 1900
Fax
+44 (0)870 190 6318
Contact
[email protected]
Directors
Daniel Haggarty
Ownership
Part of Ricardo-AEA
Locations
UK
Carechem 24 – for MSDS, labels and packaging – legal compliance and
the gold standard of responsible care
Carechem Marine – for transport by sea – guarding your cargo... and your
reputation
CERS – for keeping your business running – protect your employees and
reduce the risk of business downtime
Chemsafe – 24-hour support for the UK's emergency services
Haulsafe 24 – for UK road transport – guaranteed specialist advice to
keep your wagons on the road
Founded
1973
PROFILE: NCEC
CONTACTS
SDS Services
OVERVIEW
The National Chemical Emergency Centre (NCEC) offers a 24-hour
emergency response service that provides fast, trusted and up-to-theminute advice to emergency services dealing with chemical incidents.
NCEC also offers a number of other commercial emergency response
services.
Since 1973, NCEC’s exceptional products and services have set global
standards on emergency response and compliance, and have helped its
customers to manage risks associated with working with chemicals.
In addition, its commercial emergency response services have helped
companies to provide and obtain specialist advice and information when
dealing with chemical emergencies.
NCEC can help with all aspects of chemical risk management and
offers a number of services including training; REACH consultancy; and
SDS authoring.
VITAL STATISTICS
2011/12
Turnover, group
£307.7 million
£4.0 million
No of offices
21
11
Staff, group
2,300
Consultancy/
advisory
20%
Representation
& management
10%
IT & software
10%
Laboratory
10%
Training
Chemical training to help you comply with legislation and to help you and
your staff deal with chemical emergencies
Bespoke training courses – including Hazmat 1st Response and
Chemical Spill Response
Open training courses – including chemical hazard awareness and
making COSHH assessments
Consultancy
Classification, labelling, information and advice on chemical safety
legislation as well as chemical risk management
REACH services – help with your responsibilities under REACH and GHS
REACH Glossary – a list of REACH-related terms and abbreviations
2012
The NCEC receives over 4,500 calls per year, approximately
10% of these are through our Chemsafe role advising the UK
emergency services.
2012
Chemsafe – providing chemical emergency response
services to UK fire, police and ambulance for 39 years
through the Chemsafe scheme on behalf of UK government
2012
Chemdata – chemical emergency response software for
emergency responders around the globe from public and
private sector. Over 45,000 products listed and available on
laptops, PCs and Android phones.
27
Training
10%
NCEC's SDS authoring services and SDS management software
SDS authoring – keeping your safety data sheets legal and compliant with
REACH and GHS
ChemeDox® – online, simple-to-use, chemical safety document
management system
Information
20%
GLOBAL OFFICES
ACCREDITATIONS
Quality Assurance
As part of Ricardo-AEA, the NCEC is recognised via Lloyd's Register Quality
Assurance (LRQA) which has issued the certificate of approval to RicardoAEA for the environmental and quality management system standards below:
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BS EN ISO 9001: 2008
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ISO 14001: 2004
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The TickIT Guide Issue 5 (Overall business certificate), certificate
expiry: 30 November 2014
UK, China, Czech Rep, Germany, India, Italy, Japan, Korea, Russia, USA,
Malaysia
Page 106
NCEC is part of Ricardo-AEA, and also part of:
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REACH Consultant Network
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GCC Network
Supported by the Department for Transport (DfT) and the Chemical
Industries Association (CIA)
CLIENTS
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
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BASF
CPS Colour Group
Air Products
Flint Hills
Chemtura
Albemarle
Henkel Ltd
BP Chemicals
Nova Chemicals
Yara UK Ltd
Wincanton
Monsanto
BWA Water Additives
Leighs’ Paints
DKSH
TESTIMONIALS
Chemsafe “All requests for information and advice were handled quickly
and information explained concisely.” – group manager David Somerville,
Fife Fire and Rescue Service
Emergency Response “Carechem 24, like all the services provided by National
Chemical Emergency Centre [NCEC] at Harwell, is a robust solution for people
working with Dangerous Goods, be they consignors, consignees, transport
and warehousing operations, whether they use road, rail, air or sea traffic. With
the continual changes occurring in legislation as well as enhanced security
and environmental concerns, you need to be supported by credible and
internationally recognised technical specialists. NCEC is such an organisation,
and Carechem 24 in my opinion, the premier support service for those in the
sector. Their technical support is critical in managing The Hazchem Network
operation – the UK’s only specialist palletnetwork for the carriage of palletised
dangerous goods.” – Ali Karim, managing director, Hazchem Network Ltd
Training and compliance “This is the first time we have used the NCEC
for emergency response training and we found it really beneficial to
our employees. We had mock incidents planned where our employees
had to physically deal with the scenario. It made us think more of our
surroundings and the possible incidents we could be faced with - we are
going to continue this training with NCEC so that employees are kept
focused on their environment.” – Sue Clegg, UOP Ltd
CASE STUDY 1: Polyurethane foam manufacturing fire incident,
July 2012
NCEC recently received a call from a fire and rescue service station
manager who was dealing with a major fire at a factory where
polyurethane foams were manufactured. Police and ambulance service
personnel were also in attendance. The station manager was concerned
about the chemicals used in the process – isocyanate solutions,
polyols and solvents. He wanted advice about the hazards, thermal
decomposition products, personal protective equipment (PPE) and
decontamination.
Solution: our emergency responder advised the station manager that the
isocyanate solutions posed the greatest hazard and explained that they were
flammable, toxic, irritant, skin sensitising and hazardous to the environment,
and that they may be absorbed through the skin. Our emergency responder
also explained that hydrogen cyanide and nitrogen oxides were likely products
of thermal decomposition. The emergency action code for isocyanate solutions
is 2X. Therefore, the emergency responder advised the use of liquid-tight
chemical protective clothing with breathing apparatus and explained that soap
and water should be used for decontamination of equipment. In addition, our
emergency responder liaised directly with the manufacturer of the products to
provide the most up-to-date safety data sheets to the fire and rescue service.
Expertise: NCEC’s chemists work closely with the emergency services
and the chemicals industry to provide impartial expert advice in the event
of a chemical incident.
CASE STUDY 2: Overheated lithium battery incident, July 2012
A lithium battery measuring 25 x 20 cm was undergoing testing at an
electrical equipment testing company. It overheated on a workbench
and released smoke and fumes. The fire and rescue service was in
attendance and had evacuated the building. A firefighter contacted NCEC
for advice on the level of PPE required to enter the building and isolate
the battery, and the decomposition products.
Solution: the NCEC emergency responder explained that different
types of lithium battery would produce different decomposition products,
but inhalation of metal oxides can cause metal fume fever, which has a
delayed onset and causes flu-like symptoms. The emergency responder
recommended suitable PPE including breathing apparatus, in accordance
with the emergency action code (4W) for lithium batteries. Furthermore,
the emergency responder advised the firefighter that dry agents, such as
sand, should be used to smother the battery fire and that the area should be
thoroughly ventilated before employees were allowed back into the building.
Expertise: NCEC can provide guidance to companies on the safe handling
and transportation of lithium batteries, and offers an emergency telephone
advice service that is dedicated to providing advice on lithium batteries.
CASE STUDY 3: Barn fire incident, May 2012
NCEC recently received a call from a fire station manager who was
dealing with a barn fire late in the evening. The barn was constructed of
asbestos and contained two tonnes of ammonium nitrate fertiliser. The
station manager was concerned about the environmental impact of the
fire water due to the ammonium nitrate fertiliser.
Solution: the NCEC emergency responder advised the caller that
ammonium nitrate is not toxic to the aquatic organisms, but caused
eutrophication (an algal bloom that uses all of the oxygen in the water as it
decomposes, causing fish and other aquatic organisms to die). When asked
if ammonium nitrate was toxic in fire, the emergency responder explained that
nitrogen oxides would be produced, which pose a risk of pulmonary oedema,
and that firefighters should be monitored for 48 hours after exposure.
Expertise: NCEC emergency responders are available 24 hours a day,
365 days a year to provide chemical advice to the emergency services,
helping them to protect people, property, and the environment.
STAFF SELECTION
Maria Stearn – Chemdata/Hazmat Event
Bethan Davies – Chemsafe
Mike Kent – SDS Authoring
Rob Whiting – REACH Consultancy
Paul Rast-Lindsell – Training
Matt Hawes – Scalecards
Richard Davey – ChemeDox
Page 107
PROFILE: NCEC
PARTNERS
SERVICES PROVIDED
PROFILE: Pace Analytical – Regulator y Services
Supply chain data collection
Our proactive and streamlined approach to collecting, validating and
organising vital regulatory data is a tremendous time and cost savings
for our clients. The Pace Regulatory Data Management (RDM) maintains
hundreds of technical relationships with suppliers and compiles data
per customer specifications. The RDM team operates under an ISO
9001:2008 quality system ensuring consistent deliverables. Clients are
always provided with metrics so they can rest assured expectations are
met.
CONTACTS
Website
www.pacelabs.com/regulatory
E-mail
[email protected]
Head office
1800 Elm St SE, Minneapolis, MN 55414, USA
Tel
612-751-6986
Fax
612-656-1181
Contact
Lisa Rettinger
Directors
Todd Mitchell, General Manager
Angela Wutz, Regulatory Operations Manager
Lisa Rettinger, New Business Development
Ownership
Private Company, division of:
Pace Analytical Services, Inc.
Locations
USA
Founded
1998
Hazard communication
Our experts have authored thousands of safety data sheets for both
domestic (US) and international markets. Depending on client needs, we
can utilise our own software or work within the client’s system to author
documents and create label text. Pace can assist you with creation of new
SDSs or updating your current documents to meet new requirements.
Pace utilises highly skilled hazard communication specialists, AIHA/
SCHC registered authors, and toxicologists to create high quality, globally
compliant safety data sheets.
Product stewardship
OVERVIEW
The Product Regulatory Services division of Pace Analytical offers the
following primary services:
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supply chain data collection;
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hazard communication;
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product stewardship.
Our flexible custom solutions are based around the following models:
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process in-sourcing (at your location);
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process out-sourcing (at our location);
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staff augmentation;
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consulting/project-based expertise requests.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
85
85
Laboratory
1%
Consultancy/
advisory
55%
Information
44%
Our product stewardship services are extensive and include:
• Regulatory compliance – activities include verifications of status
and/or registrations of products on domestic and international
chemical inventory lists such as REACH and TSCA. We review
consumer and industrial products for compliance with state, federal
and international regulations including, but not limited to, REACH,
RoHS, FIFRA, CA Prop 65, CPSC, EU Detergent Regulation, etc.
Pace provides guidance on HAPS (Hazardous Air Pollutants) and
perform VOC calculations.
• Product assessments – aid in detection of unacceptable liability
risk due to potential impacts to public health or the environment.
They can also support sustainability goals. The types of
assessments we do include, but are not limited to:
–– chemical and raw material environmental hazard assessments;
–– product environmental hazard assessments;
–– product risk and life cycle assessments;
–– exposure scenarios;
–– robust summaries.
• Green label claims support – involves guidance through the
requirements involved to obtain desired green product labels.
Process in-sourcing/outsourcing, staff augmentation or
consulting
Pace offers flexible custom solutions based on the needs of our clients.
Our extensive in-house regulatory training system is the driver behind
Pace’s ability to offer such unique solutions, including:
• Business process outsourcing – Pace can offer dedicated
resources and manage the process at your location (in-sourcing) or
at our location (outsourcing).
• Staff augmentation – Pace employees of all levels are deployed
to our client locations and they have the support of our Minneapolis
staff and training systems.
• Consulting services – experts are available for project-based
work that is appropriate to do from our corporate office.
ACCREDITATIONS
ISO 9001:2008
AIHA/SCHC Registered SDS authors
CLIENTS
Our list of clients is confidential; however, they range from start-ups in
need of complete regulatory guidance to Fortune 50 companies looking
for effective strategies to manage their workload.
Page 108
John Hutchinson, PhD – Toxicologist
Our client retained Pace in order to offload a routine data management
process to allow their regulatory staff to focus core business activities.
This company values a proactive regulatory strategy and desired to
actively manage their supply chain regulatory data collection. It was
essential that the process be efficient, precise, and provide high quality
data. Pace worked closely with the client to define a customised
process to collect, validate and organise their data. We implemented
internal training programs through our ISO 9001:2008 quality system,
ensuring each staff member follows the same process. The result is an
ongoing, consistent programme that provides the customer with efficient,
validated data in an organised manner for use in downstream regulatory
compliance programmes. Pace also provides the client with monthly
metrics to ensure deliverables are met.
Dr John Hutchinson provides technical consulting support in the areas of
human and ecological toxicology. He holds a BS in biology and a PhD in
molecular and environmental toxicology from the University of WisconsinMadison. His graduate research focused on protein modification and
cellular signal transduction events resulting from genotoxic stress. With
extensive knowledge of toxicological principles, mechanisms, and human
health risk assessments, John helps clients interpret and evaluate
toxicological data in order to understand the regulatory implications of
their business decisions.
CASE STUDY 2: Mid-sized coatings company
With the implementation of OSHA HazCom 2012, it became clear to
this client they were in need of a more proactive regulatory strategy to
manage their raw materials and products. Pace worked with the client
to develop a strategic plan to meet their long term regulatory needs. We
aided in the selection of a chemical management software program and
then provided an onsite, knowledgeable user to populate their system.
Due to the short term nature of the project, the client also chose to
outsource the conversion of their SDSs to GHS compliant documents.
The client also utilised Pace’s Sr regulatory specialists to meet customer
specific regulatory inquiries.
CASE STUDY 3: Start-up green chemistry company with novel
chemistry
Our client developed novel chemistry for the green market, but did
not possess expertise necessary to meet regulatory requirements.
The client retained Pace to act as their regulatory compliance experts.
Pace provided SDS authoring and label text, new chemical registration,
testing recommendations, data interpretation, REACH preparation,
site permitting, DOT permitting, DHS support, etc. Confident in Pace’s
handling of their regulatory requirements; the client is able to focus
on core business activities such as product development, sales and
marketing.
Steve Ernst – Sr Regulatory Specialist
Steve Ernst has more than 20 years’ experience in the chemical
manufacturing and biotech industries. Steve has been responsible for
comprehensive portfolio of regulatory systems and EH&S programmes
spanning a variety product chemistries. He holds a degree in
chemical engineering from the University of Iowa. Steve is an expert
in both domestic and international chemical regulations and hazard
communication. His strong chemical industry background, places Steve in
a unique position to assess client needs, understand their challenges and
implement practical solutions.
Jody Hulne-Strege – Sr Project Manager
Jody Hulne-Strege has more than ten years of industry experience in a
variety of environmental and product regulatory capacities. She holds a
BS degree in geology as well as graduate level toxicology coursework.
Her expertise lies in regulations and issues concerning the development,
manufacture and sale of consumer products, including children’s
products, OTC monograph drugs, and insect repellents. Her past
experience in hazard communication, industrial hygiene, groundwater
modeling and remediation make her ideally suited to participate and
communicate effectively on cross functional teams. Jody has also been
instrumental in the continued development of Pace’s comprehensive
internal regulatory training system.
STAFF SELECTION
Todd Mitchell – General Manager
Todd Mitchell has more than 25 years’ experience in the environmental
chemistry sector. He holds a BS in microbiology from the University of
Minnesota and a MBA from the University of St Thomas. Over the course
of his career he has led a variety of environmental service programmes
including field sampling, contract laboratory, and regulatory consulting
services. At Pace Analytical, Todd is responsible for the professional
service business which provides creative in-sourcing and outsourcing
solutions to scientific based companies.
Angela Wutz – Regulatory Operations Manager
Angela Wutz has more than 10 years of direct industry experience in the
chemical regulatory field. She has authored thousands of (M)SDSs, and
has implemented multiple supply chain data collection programmes. She
holds a BS in medical microbiology and immunology from the University
of Wisconsin and has completed extensive graduate coursework in
environmental health and safety at the University of Minnesota. At
Pace Analytical, she manages the product regulatory operation and is
responsible for the delivery of customised solutions to customers.
Page 109
PROFILE: Pace Analytical – Regulator y Services
CASE STUDY 1: Fortune 50 conglomerate chemical manufacturer
SERVICES PROVIDED
REACH services
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PROFILE: REACh ChemAdvice GmbH
CONTACTS
Website
www.reach-chemadvice.com
E-mail
[email protected]
Head office
Am Marktplatz 5, D-65779 Kelkheim / Taunus, Germany
Tel/ Fax
+49 6195 96 199 0/ +49 6195 96 199 33
Contact
Dr Rudolf Staab
Directors
Dr Rudolf Staab, Managing Partner
Ownership
Privately owned company
Locations
Germany, USA, India, Portugal, Sweden
Founded
2007
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OO
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OVERVIEW
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REACh ChemAdvice GmbH is a sister company of ChemAdvice AG. It
was formed by a group of senior executives with decades of experience in
the chemical industry, in collaboration with a team of REACH specialists.
As an independent representative, with no direct involvement in the
production or trading of chemicals, REACh ChemAdvice can act on your
behalf without bias. This is very important, especially if you have multiple
agents, indirect exports, or want to alter your supply chain into Europe.
Founded to help non-EU manufacturers to comply with REACH as only
representative, the company now supports EU producers and importers
as consultant and/or third party representative, and downstream users as
consultant in all REACH matters. Unlike most advisors, we offer the complete
scope of REACH-related services: in-house and through our network.
REACh ChemAdvice would like to transfer the lessons learned from
REACH to the new European Cosmetics Regulation, where the challenge
for the cosmetic industry is implementing both regulations at the same time.
OO
VITAL STATISTICS
2011/12
Turnover, group
c €1.5m
c €1.5m
No of offices
5
5
Staff, group
10
10
Training
10%
Other
5%
GLOBAL OFFICES
REACh ChemAdvice GmbH, Germany
Regional offices: USA, India, Sweden, Portugal
Page 110
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CLP services
As your CLP-consultant REACH ChemAdvice we provide:
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identification of obligations under the CLP Regulation;
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implementation of strategy for CLP compliance;
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CLP workshops;
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CLP due diligence;
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customised training (adapted to your company’s needs);
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project management;
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classification and reclassification of substances and mixtures in
accordance with the CLP Regulation;
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safety data sheets (SDS) authoring and review;
OO
CLP notifications dossiers / CLP-group notifications dossiers;
OO
outsourcing of CLP services.
Cosmetics services
Information
20%
Representation
& management
5%
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Once you select REACH ChemAdvice as your REACH-consultant,
we will be pleased to provide a comprehensive range of services
customised exactly for your needs:
identification of obligations under the REACH Regulation;
implementation of strategy for REACH compliance;
only representative (Art 8 of the REACH Regulation);
third party representative (Art 4 of the REACH Regulation);
late pre-registration;
Sief communication management;
import certificates for REACH compliance;
creation and submission of IUCLID 5 dossiers (registration, inquiry,
PPORD notification, authorisation, substance in articles notification,
downstream user report) to ECHA in REACH-IT;
consortia management / consortia representation;
toxicological evaluation / studies / tests / reports;
SVHC inventory and monitoring;
SVHC testing and screening;
creation of chemical safety reports (CSR);
strategy development for the registration;
REACH and IUCLID 5 workshops;
REACH due diligence;
data gap analysis;
customised training;
project management;
authority relation management;
data vendor management (letter of access, LoA, purchase);
audits of suppliers concerning REACH compliance;
audits / REACH compliance verification (preparation for inspections
from the authorities);
creation and review of REACH-compliant SDS/ e-SDS (safety data
sheets) in all EU-member states languages;
analysis of exposure scenarios and implementation of risk
management measures;
CLP notifications/ CLP-group notifications;
outsourcing of REACH services.
Consultancy/
advisory
60%
Once you select REACH ChemAdvice as your consultant, we will be
pleased to provide a comprehensive range of services customised exactly
for your needs: regulatory workshops for the cosmetic industry.
2007
Start up in Frankfurt am Main, Germany
2007
Opening regional office in USA
2008
Opening regional office in India and Korea
2009
Relocation to new offices in Kelkheim/Taunus
2011
Start cosmetics consultancy
2011
Opening regional office Sweden
Expansion into the Iberian peninsula (Portugal and Spain)
2012
Opening regional office in Portugal
ACCREDITATIONS
REACH ChemAdvice GmbH is a member of ORO, the Only
Representatives Organisation in Brussels and complies with the quality
standards of this trade association.
REACH ChemAdvice, as an ERPA-member (European Cosmetics Responsible
Person Association), supports the cosmetic industry in all REACH-difficulties
during the whole complex cosmetics supply chain, as the cosmetic industry
needs to comply with the new Cosmetics Regulation and REACH.
PARTNERS
Our partners can be viewed on our website
CLIENTS
Our clients are located in Europe, United States of America, Latin
America, Africa, Middle East and Asia
TESTIMONIALS
Testimonials or references will be provided upon individual request
CASE STUDY 1:
The company started offering only representative services for NON-EU
Clients in 2007. We represent more than 100 companies with sizes ranging
from SME to multinational firms. We also represent European clients as
third party representatives and offer consultancy work under REACH.
Mr Fazendeiro is an expert in classification and labelling of chemicals,
safety data sheets (authoring, management and distribution). He worked
as a regulatory officer at INFOTOX in Portugal) where he dealt with
administrative issues related to REACH, assessment of test data reliability
under the biocidal products Directive and gave support to business
development activities.
He is a licentiate in industrial chemistry (five years degree, University
of Beira Interior, Portugal), and has practical education and training on
REACH, CLP/GHS, IUCLID 5, REACH-IT and SDS
Silvia Teige – Finance and Administration
Ms Teige’s experience includes working as a management assistant at
both ChemAdvice GmbH and to the head of regional business unit Europe,
NME, Africa, Clariant Masterbatches. She has been executive assistant to
head of division pigments and additives, Clariant, and executive assistant
to head of business unit additives, Hoechst AG and Clariant, fulfilling the
same role to the head of division chemicals, Hoechst AG.
Prof Dr Dieter Mayer – Toxicologist
Professor Mayer has extensive research experience having worked at the
Institutes of Human Genetics, University of Heidelberg, and Environmental
Health, University of California, Davis. He was scientific director at the
Centre International de Toxicologie, Evreux, France, and professor at
Frankfurt’s Johann Wolfgang Goethe University, Institute of Pharmaceutical
Technology. He has been a guest professor at Johannes Gutenberg
University, Mainz, Institute of Toxicology, Risk Assessment, Methods in
Modern Toxicology and also at the German Society of Pharmacology and
Toxicology. His industrial career includes having been a toxicologist, and
global head of toxicology Hoechst AG, Hoechst Marion Roussel, Aventis SA.
CASE STUDY 2: Consortia management
Dr Sebastian Hoffmann – Scientific Consultant
We successfully managed consortia or represented our clients in
consortia. We support our clients throughout the whole REACH
registration process from registration strategy development, data
generation, and dossier preparation to dossier submission.
Dr Hoffman has extensive experience as a REACH consultant (TÜV
Rheinland BioTech GmbH), as well as project management and scientific
consulting and hazard and risk assessment. He is an expert on human
health hazards and in vitro toxicological methods, having worked as a
scientific officer at the European Commission’s Joint Research Centre in
Italy). His speciality is assessment (validation) of in vitro test methods
and management of scientific projects. He is qualified to assess data
reliability and relevance, and has 25 peer reviewed publications to his
name.
CASE STUDY 3: Cosmetics industry
We are a member of cosmetics associations and are actively involved as
project managers for the development of guidelines. We help especially
SMEs in the cosmetics industry to manage the interface between REACH
and the new cosmetics Directive.
STAFF SELECTION
Dr Rudolf Staab – Managing Partner
Dr Staab has held many senior jobs in the industry including: senior
vice president Masterbatches Clariant International, responsible for
the reorganisation and re-engineering of business processes and the
introduction of new marketing approaches for key accounts. He was vice
president additives within Hoechst AG and Clariant International and vice
president specialty chemicals within Hoechst AG in charge of strategy
development and implementation, business re-engineering, efficiency
improvement activities and relocation efforts. He looked after the
development of new markets and applications M&A transactions, and has
been a member and chairman of the board of several companies within
the chemical, food ingredients and plastic processing industry. He has an
MSc in inorganic chemistry (Diplom-Chemiker – Saarbrücken, Germany,
and a PhD in inorganic chemistry (Dr rer nat – Saarbrücken, Germany).
Carlos Fazendeiro – Regulatory Affairs Consultant (Head Office
and Portugal)
Mr Fazendeiro has worked in regulatory compliance (CTR Lda, Portugal,
and has considerable experience of purchasing and sales of chemical raw
materials for coatings, classification,labelling and packaging of chemicals,
safety data sheets and giving regulatory support to clients and business
units (REACH, CLP and biocides). He has worked as a consultant (SGS
Portugal SA) and on REACH implementation (petrochemical industry), with
extensive experience of pre-registrations and REACH registration dossiers.
Jim DeLisi – Regional Head, North America
Jim DeLisi is a president of Fanwood Chemical, Inc, where he
looks after the sale of organic intermediates in North America, South
America and Europe, as well as tariff and trade affairs, monitoring of
imports and exports and REACH. He has been chairman of SOCMA’s
International Trade Committee, and chairman of the Industry Trade
Advisory Committee on Chemicals, Pharmaceuticals, Health/Science
Products and Services.
He has a BA in business administration (Rutgers College, USA), and an
MBA in chemical marketing (Fairleigh Dickinson, USA).
Barbara Fertl – Regional Head, Sweden
Barbara Fertl has extensive experience having worked at: the Institute
for Physical Biochemistry, Munich; Munich Municipal Hospital Group;
Linde AG, Munich; DQS Deutsche Gesellschaft zur Zertifizierung von
Managementsystemen, Frankfurt; Sasol, Hamburg. She has been
a chemical consultant for Kemikalierådgivare in Sweden and has
experience of safety data sheets, registrations, national and international
regulations on chemicals
Ms Fertl has an MSc in biology (Diplom-Biologin, Ludwig-MaximiliansUniversity, Munich, Germany), and is a certified auditor for quality
management systems
Page 111
PROFILE: REACh ChemAdvice GmbH
2012
SERVICES PROVIDED
General consulting services
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Supply chain communication
Importers and manufacturers, downstream users and manufacturers/
importers of article, are all responsible for the effective communication
flow of information. We provide all the necessary support by distributing
standard templates or customised forms to properly manage the
communication flow between customers and suppliers.
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Strategic implementation of European regulations
Participation to consortia, co-registrants agreements, data sharing,
deadline and tonnages for registration are decisions that are managed
in order to find the most cost-effective solution and the most convenient
choice on the market.
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Chemical management and product stewardship
The market will constantly change over time. Companies will face new
challenges to strategically select secure suppliers and to identify growing
sector markets. Our business development experts will support companies
with the right advice, in compliance with the provisions of the regulation.
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Implementation of IT systems to manage chemicals
Companies will internally develop new management systems to integrate
existing tools to monitor the presence of chemical substances, including
deadlines, total amounts, risk management measures etc.
PROFILE: REACH master y
CONTACTS
Web site
www.reachmastery.com
E-mail
[email protected]
Head office
Via Giovio 16, 22100 Como, Italy
Tel
+39 031 269513
Fax
+39 031 2756370
Contact
[email protected]
Directors
Monica Locatelli
Ownership
Private company
Locations
Italy
Founded
2008
OVERVIEW
REACH mastery is a provider of a wide range of services in the area
of chemical regulatory affairs. The staff are a highly motivated team,
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,
when applicable, alternatives to animal testing like in vitro and in silico
methods, through the high quality of our services and the expert support.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
7
7
Training
Legal 1%
Other
2%
5%
Information
2%
Representation
& management
15%
Consultancy/
advisory
75%
REACH services
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Consortia management
A lot of experience has been gained on consortia rules and management.
We will provide also legal advice, agreement documents, meeting
location, cost calculation, managing of LoAs.
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Data gap analysis and data collection
Gathering existing information is the first step in the preparation of any
registration dossier, but is not enough. All these data have to be really
collected, in respect to the right to use. The latter requires the negotiation
of the conditions for use according also to the quality of the data.
Each single study is evaluated and rated to check relevance and
adequacy to fill the requirements.
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Testing strategy development, in vitro strategies development,
QSAR modelling
An integrated testing strategy is the first step for cost reduction and
building rationale for waiving. International well known partners are
helping us in focusing on the right choice.
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Managing of analytical identification and inquiry dossiers
Our big expertise in analytics and experience in enquiries let us face
without problems one of the most critical aspect of REACH regulation.
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Tests monitoring
In case new tests are required, REACH mastery will take care of selecting
the most appropriate lab, will review the protocol and check the results.
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Dossier preparation (IUCLID compilation)
Dedicated expert persons are managing IUCLID compilation.
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Human health and environmental risk assessment
The focused experience and the support of high experienced toxicologists
let us make of the risk assessment the core part of the developing
registration dossier.
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CSA-CSR
REACH mastery is part of the consultation group of Chesar in ECHA.
We followed the development of the tool since the beginning and we are
among the first experts in Europe to use it.
CLP/GHS services
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OO
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data collection and assessment of classification and labelling
CLP notification
MSDS compilation
FEED and FOOD registration
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Page 112
dossier preparation
risk assessment
test monitoring
assistance to customer for Efsa calls for data
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full dossier preparation for active substances and placing a biocidal
product in the market
testing strategy development
study monitoring
risk assessment
finalisation and discussion with national and EU authorities.
post-submission support
PPP services
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support of existing substances in the context of the EU review
programme, re-submission of dossiers for active substances
Annex III dossiers for re-registration of products post-Annex I inclusion
Annex III dossiers for new products or to support label changes and/
or formulation changes
testing strategy development
study monitoring
risk assessment
finalisation and discussion with national and EU authorities.
post-submission support
EU cosmetic directive
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regulatory compliance support
product notifications
assistance in GMP certification
cosmetics ingredient profiles
product information files
clinical studies: design and monitoring
cosmetic product safety reports
product labelling review and support
2008
Foundation of REACH mastery within HBJ consultancy group
2009
Restructuring of REACH mastery as independent company
2010
About 120 successful registrations for the 2010 deadline
2011
Implementation of the group with operative members
2012
Implementation of the group to broaden the regulatory area
to Biocides and Plant Protection products
PARTNERS
RTC, QSAR group of Bicocca University, Vitroscreen,CAAT Europe as
preferred cooperations.
CLIENTS
We are working for about 50 customers around Europe; they are
manufacturers, distributors, downstream users, from SMEs to international
chemical companies distributed in many industrial fields: fertilisers, leather,
textile, pharmaceuticals, galvanic, food, cosmetic, polymers and many others.
CASE STUDY 1: First tier REACH registration and CLP notification
In 2010 we prepared about ten main dossiers on behalf of lead registrants,
complete with exposure scenarios above 1,000 tons and we submitted
more that 100 joint dossiers providing complete assistance in retrieving
lead registrant identity, letter of access costs, analytic development, inquiry
process for non phase-in substances and CSR adaptation.
In 2011 more than 1,000 substance have been notified on behalf of our
customers, after extensive bibliographic research, read-across approach
and computational predictions
CASE STUDY 2: EPA comments about flame retardant document
In 2012 REACH mastery participated in the public review of the
draft report An Alternatives Assessment for the Flame Retardant
Decabromodiphenyl Ether (DecaBDE), a document presented by the
US EPA (Environmental Protection Agency) within the Design for the
Environment (DfE) framework. REACH mastery commented upon and
improved the red phosphorus toxicological and ecotoxicological profile.
Final publication is forecast for winter 2013.
CASE STUDY 3: FOOD/ Feed authorisations of dyes
The dossiers for feed use authorisation of three dyes have been
followed according to Regulation 1831/2008. This was the beginning of
an effective communication flow with EFSA. Protocols for new studies
were all agreed together and in some cases we managed to change the
request for in vivo study into in vitro.
CASE STUDY 4: TIER 2 REACH registration
The group is preparing about 20 lead dossiers, many of them with a full
study plan ordered and monitored, three of them already submitted in
2012, 40 intermediate dossiers and actually about 40 joint registrations.
STAFF SELECTION
Dr ssa Monica Locatelli – Founder and Director
After a degree in chemistry, ten years in R&D and a specialisation in
toxicology applied to risk assessment, she has been working in regulatory
and implementation of REACH regulation since 2001, when it was still
a proposal. The cooperation with many specialists within international
companies and universities let her specialise in consortia management
and dossier preparation.
Dr ssa Costanza Rovida – REACH Regulatory Specialist
Graduated in chemistry, after 15 years’ experience in the field of analytical
chemistry, she worked for three years at the European Commission,
participating in two groups of RIP 3.3 (REACH Implementation Project,
Technical Guidelines to Industries) and as a leader of a work package
in a European project focused on integrated development of alternative
toxicological methods to animal testing. She is responsible for the
management of individual projects and global customer assistance.
Dr Leon Van der Wal – Eco toxicologist
Obtained a PhD in environmental toxicology and chemistry in 2003, and
has more than ten years’ experience in the risk assessment of chemicals.
He worked as a consultant on risk assessment and risk management
for national and international governmental agencies, and evaluated
active substances and product dossiers for governmental agencies, as
well as private national and multinational companies. For three years
he worked at the Joint Research Centre of the European Commission,
responsible for the regulatory environmental risk assessment of biocides,
the development of guidance documents and exposure scenarios, and
the harmonisation of risk assessment strategies between the various
EU legal frameworks. He is now responsible for the Biocides and Plant
Protection Product Unit and environmental risk assessment for all
regulatory frameworks.
Dr Daniele Ferrario – Toxicologist
Graduated in biological science, he earned a PhD in toxicology in 2009.
He gained knowledge in cellular and molecular biology techniques, as
well as having a strong background in metal toxicity on mammalian
immune and haematopoietic systems. While working for five years at the
laboratory of European Centre for The Validation of Alternative Method
of the European Commission he was actively involved in the validation of
CFU-GM as alternative to animal testing to evaluate immunotoxicity. He is
now responsible for the evaluation of toxicological outcomes of testing in
compliance with REACH Regulation
Page 113
PROFILE: REACH master y
BPD services
SERVICES PROVIDED
REACH business solutions
PROFILE: ReachCentrum
CONTACTS
Website
www.reachcentrum.eu
E-mail
[email protected]
Head office
Avenue E van Nieuwenhuyse 6, B-1160 Brussels,
Belgium
Tel/ Fax
+32 26767400/ +32 2 6767499
Contact
Francesca Furlan
Directors
Leo Appelman, Managing Director
Ownership
Private company
Locations
Brussels, Belgium
Founded
2006
OVERVIEW
ReachCentrum was created in June 2006 by Cefic (the European
Chemical Industry Council) to help companies all through the value
chain to prepare and implement REACH. ReachCentrum helps chemical
manufacturers and importers, as well as downstream users and
distributors to comply with all three aspects of the REACH legislation:
dossier preparation for registration and support through the phases of
evaluation and authorisation by providing our main services, namely
consortia, lead registrant and Sief leadership team support services,
consultancy and workshops.
Our services and support tools are designed for European and nonEuropean companies working on their own or in close collaboration with
other companies.
VITAL STATISTICS
2012/13
Turnover, group
-
-
No of offices
1
-
Staff, group
14
14
Training
20%
Information
2%
Admin, financial, data management, audit and legal support
Financial issues for a project are handled in-house. Support is backedup by our own financial department and flexible data management
system, letting us execute complex data-related cost sharing calculations.
Experienced staff analyse and process the data and an IT support team
runs the calculation. ReachCentrum has a powerful tool to manage the
sales of letters of access, the LoA shop. We provide tailor-made REACH
audit and legal advice and solutions for REACH and beyond, including
support in legal remedies and contract management.
Registration guidance including IUCLID 5 support
ReachCentrum has an extensive experience in assisting companies
in registering their substances, including dossier submission as coregistrants and lead registrants.
The service is conceived to answer to the needs of any registrants,
be it the lead registrant or any Sief member. It targets in particular coregistrants that need to get rid of the burden of a joint submission dossier.
For each registration submission, the company and ReachCentrum
project manager work together to compile the IUCLID 5 dataset, generate
the dossier and submit this to ECHA.
Training, workshops and e-learning solutions
Consultancy/
advisory
30%
Legal
13%
IT & software
5%
REACH requires strategic thinking to get your company ready to pass the
various phases of the legislation. ReachCentrum offers REACH expert
consultancy to support REACH implementation within companies and other
stakeholder groups, in order to help you adopt the most effective strategy.
ReachCentrum‘s approach is to listen to and carefully analyse each
customers’ needs, and then to find the best solution adapted to
their requirements and fine tune the support needed throughout the
registration, evaluation and authorisation phases of REACH.
ReachCentrum’s overall services are settled around six core fields of expertise:
OO
project management support
OO
strategic guidance and support
OO
financial and data management support
OO
Sief support and supply chain communication
OO
legal support; and audit management support.
OO
preparation of application for authorisation, including the SEA.
Moreover, ReachCentrum has set up a series of transversal services
beyond REACH regulation:
OO
DataCentrum (data brokerage)
OO
trustee service for indirect reports
OO
CLP for mixtures
OO
biocides support
OO
nanomaterial support
Representation
& management
30%
ReachCentrum organises a series of courses covering all aspects of
the REACH legislation by offering practical guidance – what to do, when
and how. ReachCentrum applies blended learning to its courses to offer
flexibility and convenience to the participants – classroom, web-based
virtual and e-learning. To increase awareness or show the business
opportunities of REACH, ReachCentrum can organise tailored workshops
for companies and trade associations. From 2012 ReachCentrum has
been accredited as a training centre delivering training courses to a
recognised standard established by the UK Learning and Performance
Institute. ReachCentrum also become an authorised training assessment
to offer internal trainers for chemical companies to deliver the same
standard of training.
GLOBAL OFFICES
EU, Asia-Pacific, US
Page 114
2006
Founded by Cefic (the European Chemical Industry Council)
2010
LoA e-shop successfully launched
2010
Through the LoA e-shop 342 the lead registrant allowed their
Sief members to access the registration dossier
2010
About 900 people attended ReachCentrum events (about 90
events)
2011
Partnership with TNO Triskelion and with Zieta Technologies
2011
Partnership with SCAS Europe
2011
Launch of REACH audit service
2012
Launch of virtual learning modules on IUCLID5 and Chesar
2012
Set up of three authorisation consortia
2012
Technical partnership with Environmental Resources
Management (ERM) for preparation of the application for
authorisation
ACCREDITATIONS
OO
OO
OO
OO
LPI accredited as authorised training assessment centre
LPI accredited as authorised training organisation
LPI certified online learning facilitator
certified lead auditor for environmental management systems
PARTNERS
Zieta Technologies for US and India; REACH Global Services (RGS) for
Turkey; national association services providers; TNO Triskelion; SCAS
Europe; LearningSpan, Environmental Resources Management (ERM)
CLIENTS
ReachCentrum offers its services to a wide range of chemical companies,
from all major multinationals to SMEs and only representatives (OR) from
all over Europe and beyond, including downstream users and distributors.
TESTIMONIALS
“The conference REACH registration 2013 – where should you be now –
showed an excellent mix of very good speakers. Good focus on practical
aspects. Well organised, a lot of practical advice and motivation for
working on 2013 registration” – Norbert Petereit, Sasol.
“My trainer is very forthcoming with his explanations and I find particularly
instructive when he makes examples of the possible mistakes that one
can make while working on IUCLID” – A participant of IUCLID5 virtual
online training.
"Having used the REACH auditing system of ReachCentrum, I can only
encourage other companies to conduct an auditing exercise for developing
internal REACH management processes. It provides a good overview of the
key issues in REACH implementation in various functions in a very concise,
cost-effective and inspiring manner. The results are easy to implement
and the review process fosters internal dialogue, which is essential for all
REACH implementation activities" – Helena Huttunen, Kemira Oyj.
CASE STUDY 1: An authorisation consortium case study
The authorisation process has now really started off and more and more
companies approached ReachCentrum in the quest for services around
authorisation. One example is a group of downstream users that have
combined forces in preparing an application for one particular use of a SVHC
as it became clear that their manufacturers are not going to apply for an
authorisation as the substance in question will certainly been used beyond the
sunset date as a potential alternative will not yet be available. The group is
hence now actively preparing the authorisation application and ReachCentrum
is supporting it with general consultancy, project management, finances,
communication, as well as all related legal matters, and acts as trustee for the
business confidential and competition law sensitive information.
CASE STUDY 2: Virtual learning for IT tools related to REACH
During 2012 ReachCentrum has been the first company to offer virtual
learning for IT tools related to REACH to the chemical industry. These
virtual courses are real-time training conducted by our experts through
an online environment, providing an ideal combination of flexibility and
knowledge transfer, in a convenient manner anywhere with an internet
connection. The virtual training has allowed many more people to attend
courses as they can stay in their countries and learn from their office or
from home. The participants were impressed by the fact they did not lose
any of the interaction, hands-on experience found in a classroom event.
One piece of significant feedback from the participants has been that they
have had more time to learn and use the tool by spreading the course
over several weeks.
CASE STUDY 3: Dossier registration: helping companies fill up
the dossier
ReachCentrum has assisted an international company to register their
substances. Together with the project manager, a plan was set out to
complete tasks over a given period. Tasks were divided between the
project manager to compile data from the company while ReachCentrum
investigated procedural queries with ECHA. For each registration
submission, the project manager and ReachCentrum consultant together
compiled the IUCLID 5 dataset, generated the dossier and submitted
this to ECHA. The company felt reassured that the advice and guidance
given by ReachCentrum was relevant and appropriate at each stage of
the process. A level of trust and reliability had been established over the
months of working together.
STAFF SELECTION
Leo Appelman – Managing Director
A toxicologist by profession, before joining ReachCentrum as managing
director in 2007, he had worked for nearly 17 years in a global paint
manufacturing company dealing with all health, safety and environmental
issues. He was the REACH facilitator for the coating business, and head
of the HSE department servicing its business units worldwide in their
marketing approach. He was also involved in the registration of biocidal
products and notifications for new chemical substances.
Mark Meesters – Manager Support Services
Mark worked as a regulatory affairs manager in the chemical industry for
seven years before joining ReachCentrum in 2007. He is a chemist and
lawyer by training. He joined ReachCentrum to head Support Services,
and he is currently in charge of coordinating the portfolio of tailored
business services ReachCentrum is offering to the market. His main
expertise is data and cost sharing. He regularly presents best practices to
a variety of audiences and is involved in advising companies in this field.
Vincenzo Girardi – Head of REACH Training and Workshops
Vincenzo has more than 20 years’ experience as a professional trainer,
with experience in the various industry sectors and since 2007 in REACH.
As a trainer, and certified online learning facilitator he has advised on,
managed and delivered numerous training projects. He is actively working
with companies to compile and submit their REACH registration dossiers.
Isaline van der Straten W – Legal Advisor
Graduated in law, she has several years of experience on contractual
aspects related to registration and on legal aspects and support of
evaluation and authorisation processes (tailored support, webinars,
workshops). In ReachCentrum she is also in charge of giving legal advice
and guidance, as for example on data sharing, consortia formation,
competition law and REACH, and legal remedies.
Page 115
PROFILE: ReachCentrum
GLOBAL OFFICES
Helsinki, Brussels, New Delhi and Istanbul
SERVICES PROVIDED
REACH and global compliance services
PROFILE: REACHLaw
CONTACTS
Website
www.reachlaw.fi
E-mail
[email protected]
Head office
Vanrikinkuja 3, 02600. Espoo. Finland
Tel/ Fax
+358 (0)9 412 3055/ +358 (0) 9 412 3049
Contact
Mr Stephen van Heerden, Sales Director
Directors
Mr Lasse Kurkilahti, Chairman of the Board
Mr Lasse Musakka, CEO-Partner
Mr Frederik Johanson, Head of Environmental ServicesPartner
Mr Jouni Honkavaara, CFO-Partner
Dr Mathias Berner, Partner
Mr Riku Rinta-Jouppi, Head of Global Compliance - Partner
Mr Stephen van Heerden, Sales Director
Dr Ying Zhu, COO-Partner
Ownership
Private company
Locations
Finland, Belgium, India, Turkey
Founded
2006
We support companies as their service provider or as their only
representative in fulfilling the REACH requirements. We manage
consortia, lead registrant projects, regular registrations and REACH
authorisations. Furthermore, for companies operating outside of the
European Union we assist them in managing the applicable market
access regulations by analysing their portfolio of products, monitoring
and assessing the impacts of upcoming changes in the regulations.
We also perform the required notifications and registrations as well as
the authoring of compliant SDSs and labels according to the market
requirements in question.
REACH authorisation services
Authorisation is one of the most complex challenges for companies
under REACH. REACHLaw combines the best expertise and deep
understanding of the business and regulatory requirements to provide
companies with a full set of services towards authorisation.Our support
covers the issues from defining the overall strategy and scope of
the authorisation to performing the work needed in all stages of the
authorisation process (eg analysis of alternatives, socio-economic
analysis, chemical safety report and full authorisation application).
www.compliantsuppliers.com
OVERVIEW
REACHLaw provides first class solutions in global regulatory compliance,
sustainability and EH&S.
We partner with our clients ensuring their global market access by
meeting regulatory requirements, but also by identifying their business
opportunities in the market place. This ensures that our clients achieve
competitive advantage, mitigate risks, global compliance, become more
capable organisations and improve internal processes.
In addition to our in-house expertise, we have local partners in Europe,
Asia, USA and Latin America to ensure that our clients get access to
specialised competencies and local market knowledge.
Having a multicultural team, REACHLaw is able to serve its clients in
the following languages: English, Finnish, French, German, Spanish,
Swedish, Chinese, Hindi, Russian and Turkish.
VITAL STATISTICS
www.compliantsuppliers.com connects buyers and suppliers of compliant
chemicals. The service provides suppliers with a way to benefit from
their investments in compliance by providing access to chemical buyers
searching for compliant products. For the buyers it reduces risks, number
of counterparties and costs by providing access a selection of suppliers
and chemicals verified as compliant. REACHLaw Ltd verifies the
compliance by validating chemicals per regulation per region and takes
care of all the required documentation.
2006
Established in Helsinki
2008
Partnerships with 20+ local partners in Asia, Europe, Latin
America, USA and India were established. 3000+ REACH
pre-registrations submitted
2009
REACHLaw received internationalisation award from the
president of Finland. Customers in 40+ countries. Brussels
and New Delhi offices opened. 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+
2011
Istanbul office opened. REACHLaw supported large companies
to ensure compliance with global chemical regulations.
2012
20+ REACH lead registrant cases. First authorisation cases.
Several global notifications were done. REACHLaw became
shareholder in eSpheres Ltd. REACHlaw established a business
partnership with BioSafe – Special Laboratories Services Ltd.
2013
REACHLaw launches www.compliantsuppliers.com
Currently supporting several REACH registrations, REACH
authorisation cases, 20+ lead registrant cases. Supporting
companies with Biocides Regulation
2011/12
Turnover, group
-
-
No of offices
4
40+
Staff, group
30+
25+
Legal
20%
Training
5%
IT & software
10%
Laboratory
5%
Information
5%
Page 116
Consultancy/
advisory
30%
Representation
& management
25%
ACCREDITATIONS
STAFF SELECTION
Internationalisation award from the president of Finland in 2009. AAA financial
rating in 2010. Innovative – Growth sustainable company by Europe Innova in
2011. Among 200 fastest growing companies in Finland by Kauppalehti in 2011.
Young Innovative Growth Company Programme by TEKES completed in 2012.
Mr Riku Rinta-Jouppi, MA (Law), MSc – Head of Global
Compliance – Partner
Selected partners: Chemtopia, ChemRisk, Chemitox, Dynamic Orbits,
Mourao Henrique Consultores Associados, AIDA, Chamber of Chemical
and Petrochemical Industry of Argentina – CIQyP, CICM, eSpheres,
BioSafe – Special Laboratory Services Ltd.
CLIENTS
More than 300 customers from 40+ countries, from Fortune 100 companies
to SMEs. Major industry sectors served: oil, chemicals, specialty chemicals
and metals. Our customers are manufacturers, importers, traders,
downstream users, retailers and governmental organisations.
TESTIMONIALS
“REACHLaw has provided excellent legal services to our REACH working
group. Their business approach and expertise in global compliance
have been of great help to our organisation. We are very satisfied with
REACHLaw service” – Petrochina.
“Over the years REACHLaw has advised OMG on several strategic
REACH and CLP issues and in the planning of our 2010 registrations.
For one substance REACHLaw managed the whole lead registrant
registration process in 2010. We are very pleased with REACHLaw
service” – Dr Thomas Slotte, OMG Kokkola Chemicals Ltd.
“REACHLaw assisted us in registering our substances as regular registrant
and as lead registrant in 2010. We are very pleased with REACHLaw’s
services” – Mr Ludo Schyvinck, Minerals Technologies Europe NV.
CASE STUDY 1: REACH – authorisation
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 Ying Zhu, PhD (Biochemistry), MSc in Economics, COOPartner
Dr Zhu has both a scientific and economic education background. She
has also worked in various management positions in industry for more
than ten years. Her unique educational background and work experience
are qualifications that enable her to act as a leading expert in the area of
REACH authorisation. Dr Zhu has advised companies from four different
continents on REACH compliance issues since 2008. In addition, she
also has also in-depth knowledge on global chemical regulations and
compliance issues.
Dr Kati Vaajasaari, PhD (Technology) – Project Director and
Specialist in Risk Assessment
REACHLaw acts as the service provider in several authorisation cases on
behalf of our customers. Many of the cases are still at an early stage when
strategy, participants, scope, uses and required organisational structures
have to be decided upon. Some of the cases have already proceeded into
a concrete application phase. From a customer perspective these concrete
authorisation cases can be extremely critical – the substance to be authorised
can form the basis of the customers whole industrial manufacturing process.
If the socio-economic route is the only possibility the authorisation projects
are even more demanding. REACHLaw has provided the full service
spectrum required in these cases; from analysis of alternatives to CSR
update to socio-economic analysis and project management
Dr Vaajasaari is working as a leader in REACH lead registrant projects
for REACHLaw. Her responsibilities include project management and
technical expertise in chemical safety assessment. She specialises in
environmental fate, pathways of substances, environmental exposure
assessment and risk characterisation of chemicals and products. She has
several years’ experience in these fields.
CASE STUDY 2: Lead registrant registration
Ms Sini Suomela, MSc (Organic Chemistry) – Technical Project
Manager
REACHLaw will be lead registrant for numerous substances in 2013 on
behalf of our customers. Compared to 2010 the substances are much
more complicated due to their specific nature. As an example in one
case REACHLaw acts as lead registrant for eight substances with similar
chemical characteristics such as high reactivity when in contact with
water or moisture. Thus there is a need to concentrate on more than 20
degradation products for these substances. Proving that substances that
will be registered in 2013 are more demanding and require more expertise
than in 2010. REACHLaw has provided the consortium, financial and project
management as well as the technical work required for the registration. Chemical Watch | Global Service Providers Guide 2013
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 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.
Page 117
PROFILE: REACHLaw
PARTNERS
Graduate of Cambridge university. He is widely recognised as one of
the leading European legal experts in chemicals regulations. In addition
to his legal qualifications he holds a masters degree in bio-information
technology. Mr Rinta-Jouppi is responsible for REACHLaw global
compliance services.
Training
5%
PROFILE: Risk & Policy Analysts (RPA)
CONTACTS
Website
www.rpaltd.co.uk
E-mail
[email protected]
Head office
1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK
Tel
+44 1508 528465
Fax
+44 1508 520758
Contact
Panos Zarogiannis
Directors
Pete Floyd
Meg Postle
Ownership
Private
Locations
UK
Founded
1990
Consultancy/
advisory
95%
GLOBAL OFFICES
UK
SERVICES PROVIDED
REACH – authorisations
RPA assists industry clients with the development of applications for
authorisation under REACH to be submitted to ECHA from 2013. These
studies can involve detailed analyses of supply chains, of alternatives and
the preparation of SEAs.
OVERVIEW
Risk & Policy Analysts Ltd (RPA) was established in 1990 as an
independent specialist consultancy. RPA has gained extensive experience in
undertaking impact assessments and evaluations, including the development of
quantitative and qualitative methodologies to assess policy impacts, chemicals
policy, chemical risk assessment and management. RPA is particularly proud of
its development and application of socio-economic analysis (SEA) to chemical
risk management and its reputation for excellence in this field.
RPA has been working with industry clients since 2001 on the implications
of the new EU regime for chemical risk management. RPA has also been
working closely with the European Commission (EC) and the European
Chemicals Agency (ECHA) on the development and implementation of
REACH and many other directives relating to chemical risk management.
Our experience covers a wide range of industry sectors including bulk
chemicals, ferrous and non-ferrous metals, paints and coatings, oil and gas,
speciality and novel chemicals (including nanomaterials), etc, and this has
resulted in detailed studies on over 50 high profile chemicals. Building on our
experience in preparing risk reduction strategies under the Existing Substances
Regulation, we are now advising a range of industry organisations on how to
respond to the threat of REACH authorisations and restrictions, and on the
scope and detail of the SEAs needed to justify continued use of a substance.
RPA’s multi-national staff routinely undertakes detailed analysis and
consultation with industry and regulators in most European languages.
VITAL STATISTICS
£1.4m
£0.8m
1
Focus on EU-27, EEA and
Candidate Countries
Staff, group
27
15
Page 118
RPA assists both industry clients and regulators with the collection and
analysis of use/exposure data of chemicals and their alternatives and the
preparation of SEAs, which may be used to inform the development of a
restrictions dossier.
REACH – registration/compliance
RPA provides advice on all aspects of REACH compliance to companies
of all sizes throughout the supply chain.
Regulations and impact assessment
RPA advises industry clients and regulators on the (potential) impacts of
regulations and regulatory change. Recent examples include work on
REACH, nanomaterials, OELs, mercury, CLP, CMRs at work, cosmetics,
biocides and WFD.
1992
RPA develops a risk-benefit analysis methodology for
chemical risk management for the UK authorities
1996
First (of over 40) projects for the EC on chemical risk
management
1998
RPA wins major framework contract for the UK authorities
on chemical risk management leading to numerous risk
reduction strategies
2000
OECD publishes guidance documents on SEA and chemical
risk management prepared by RPA
2001
RPA commences work with industry clients and with the EC
to assess the potential costs and benefits of the then EU
Chemicals Strategy which became the REACH Regulation
2004
RPA wins major framework contract for the EC on chemicals
2005
RPA works on REACH implementation projects including
leading RIP 3.9 on SEA
2008
RPA is a member of one of the consortia for ECHA REACH
framework contract
2009
RPA contracted by industry clients to support applications for
authorisation under REACH with a focus on SEA work
2011
RPA leads consortium for the second ECHA REACH
framework contract
2012
RPA completes three studies for DG Environment reviewing
the first years of REACH implementation
2011/12
Turnover, group
No of offices
REACH – restrictions
STAFF SELECTION
RPA works with FoBiG, DHI, TNO, RIVM, ARCHE, Hydrotox, Royal
Haskoning, Denehurst, ReachCentrum and EPPA amongst others.
Meg Postle – Director
CLIENTS
OO
OO
OO
OO
OO
EC (including DG Enterprise, DG Environment, DG Employment and
DG Sanco)
National authorities (including those in the UK, Germany, Denmark,
France and the Netherlands)
European Chemicals Agency
Numerous European/international industry/trade associations
(including AISE, APEAL, CEFIC, COLIPA, ETINSA, Eurocommerce,
Eurometaux, ICMM, IMnI, International Zinc Association, Lead
Development Association, Nickel Institute and UKWIR)
A range of companies (from multinationals to SMEs) and consortia.
CASE STUDY 1: Provision of analysis of alternative and socioeconomic analysis support services
RPA is currently providing REACH authorisation support to a consortium
of manufacturers of a SVHC substance. The work includes preparation
of an analysis of alternatives (involving an assessment of the technical
and economic feasibility of alternative chemicals and techniques),
supply chain communication to develop information on uses and users’
responses to the loss of the SVHC in question, and preparation of
socio-economic analyses of the impacts of the loss of the SVHC. As
part of this work, we are using the services of specialist toxicology and
risk assessment consultants to further up-date the chemical safety
assessment and to provide additional interpretation of toxicological data
for both the substance and the alternatives.
RPA will help the consortium submit an application for authorisation in
advance of the sunset date for the substance.
CASE STUDY 2: Assessing the health and environmental impacts
in the context of SEA under REACH
RPA led this DG Environment study, which was also overseen by ECHA.
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
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.
Meg is an environmental economist and policy analyst with more than
20 years’ experience of consultancy. She has led RPA’s work for the EC,
the UK government and a range of industry bodies on business, health
and environmental impact assessments of REACH and in relation to the
direct and indirect impacts of proposed restrictions and other controls on
the use of hazardous chemicals within the EU. She led the project for
DG Environment on the development of Logic Framework for SEA under
REACH and has conducted training on SEA to both RAC and SEAC
members of ECHA. More generally, she is overseeing preparation of
SEAs to support authorisation applications for a range of industry clients.
Dr Peter Floyd – Director
Risk assessment expert with more than 25 years’ consultancy experience.
He has led studies ranging from hazard and risk assessments relating
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 35
years’ experience in toxicology and risk assessment, and has
worked extensively on a wide range of chemical classes including
pharmaceuticals, agrochemicals, food additives, and industrial and
consumer chemicals. He is a registered toxicologist with the Society of
Biology/ British Toxicology Society/EUROTOX.
Panos Zarogiannis – Technical Director, Chemicals Policy
Chemist with extensive experience of developing risk reduction strategies
for chemical substances under the Existing Substances Regulation as
well as SEA-related studies and in the development of TGDs for REACH.
He has managed studies in support of the development of Annex XV
dossiers by ECHA and is leading our work for major industrial clients on
the development of authorisation dossiers.
Tobe Nwaogu – Principal Consultant, EU Policy
Tobe has degrees in biochemistry, pollution and environmental control as
well as an MBA. Since 2003, Tobe has been involved in EU chemicals
policy and chemical risk management. He has played a key role in the
development of the risk reduction strategies and has project managed
studies for the UK, Dutch, French and Danish authorities. Tobe has also
managed studies for the EC and ECHA to assess the impacts of (potential)
restrictions on chemicals and/or the development of Annex XV dossiers.
Paul Ylioja – Consultant, Chemical Science
Paul, who has recently joined RPA, has a background in organic
chemistry. After his MChem and experience in process chemistry
laboratories, Paul undertook a DPhil and postdoctoral research in organic
chemistry. He is currently working on REACH authorisation studies with a
focus on the risks associated with moving to alternatives.
Tom Persich – Researcher, Chemicals
Tom has a degree in environmental sciences. Since joining RPA, he
has worked on a range of projects both for the EC and for Industry.
He has collated and analysed information on the hazard profile and
physicochemical properties of various chemicals to inform REACH
authorisation studies.
Page 119
PROFILE: Risk & Policy Analysts (RPA)
PARTNERS
GLOBAL OFFICES
HaskoningDHV Nederland BV:
Barbarossastraat 35, 6522DK Nijmegen, Netherlands
Haskoning UK Ltd:
Rightwell House, Bretton, Peterborough, PE3 8DW, UK
Haskoning Belgium SA:
Schaliënhoevedreef 20D, B-2800 Mechelen, Belgium
PROFILE: Royal HaskoningDHV
CONTACTS
Website
www.royalhaskoningdhv.com
E-mail
[email protected]
Head office
HaskoningDHV Nederland BV, Laan 1914 nr. 35, 3818
EX Amersfoort
Tel
+31 24 328 41 35
Fax
+31 24 322 81 70
Contact
Mr Christiaan van Daalen/ Mr Tjeerd Bokhout
Directors
Mr Rob Schonk, Director Process and Chemical Industry
Ownership
Private company
Locations
100 Locations worldwide. Key locations Europe:
Nijmegen, Amersfoort (Nl), Peterborough (UK),
Mechelen (Be)
Founded
SERVICES PROVIDED
REACH
Compliance based engineering
As a result of REACH the risk management measures and operational
conditions of both manufacturers and downstream users may be
affected due to the changed insights in hazards and risks arising from
the use of their products and communications in the supply chain.
Royal HaskoningDHV provides a unique combination of knowledge on
chemicals management, safety and engineering to deliver lean and mean
organisational and technical solutions.
1881
OVERVIEW
The firm was founded in 1881 in the Netherlands. Our employees
combine a wide range of knowledge and experience. Rooted in a
technical background, our consulting services focus on the broad
field of the interaction between people and their environment. We
are committed to working enthusiastically with our clients to achieve
sustainable solutions in an increasingly complex society. The expertise
and experience of our professionals in a variety of disciplines allows
us to consider all technical, logistical, legal, organisational, social,
environmental and economic aspects of the projects of our clients, in
order to subsequently develop sustainable and practical solutions.
We have been working with the industry on chemicals management
for several decades and contributed to the implementation of many
legislative programmes. In 2012 Royal Haskoning and DHV merged to
the current organisation.
VITAL STATISTICS
Royal HaskoningDHV can assist you with services varying from technical
support to total solutions for implementation of GHS. The services
include, but are not limited to: regulatory consultancy and compliance
checks, GHS/CLP implementation, CLP notification, (re-)classification of
substances and mixtures, training on GHS/CLP.
Safety data sheets
Royal HaskoningDHV provides a full safety data sheet service including
the preparation of the annex of the extended SDS (eSDS). In addition
to these services advice is provided on the organisational and technical
implementation of information from the eSDS.
€312M and €434M
-
No of offices
100
35
Staff, group
7,900
80
IT & software
5%
Laboratory
2%
Information
15%
Representation
& management
15%
Storage of chemicals and (external) safety
Royal HaskoningDHV can assist you with assessing, designing and
permitting of storage facilities for hazardous chemicals, modelling of external
safety (SEVESO) and assessing aspects such as explosion safety (ATEX).
Other services
Royal HaskoningDHV provides a wide range of services that provide
solutions for multidisciplinary challenges to industry, such as engineering/
design of installations and buildings, responsible care and environmental
impact assessments.
Training
Legal
8%
5%
Page 120
GHS/CLP
2011/2012
Turnover, group (2011)
Royal HaskoningDHV provides a full range of REACH services, varying
from consortium management to preparation of the technical dossier and
the chemical safety report. Royal Haskoning experts prepare and submit
both lead and individual registration dossiers and support clients with both
their REACH strategy and day-to-day practical questions. Although Royal
HaskoningDHV does not provide laboratory services, it provides support
in laboratory selection and study monitoring. Royal HaskoningDHV has
good working relations with many laboratories.
Consultancy/
advisory
50%
1881
Founding fathers Johan van Hasselt and Jacobus de
Koning start their business in Nijmegen.
1917
Founding fathers Dwars, Hederik en Verheij start their
business in 's Gravenhage.
1981
Haskoning is granted the designation 'koninklijk' (Royal) at
its 100th birthday.
1991
EaSI is developed by Royal Haskoning: a database with
hazard information from legislation all over the world
1994
Royal Haskoning developed Rosetta, one of the first
programs able to produce multilingual safety data sheets.
STAFF SELECTION
2005
RIP 3.10 on characterisation and checking of substance
identity is prepared by Royal Haskoning.
2007
Royal Haskoning joins the organisation of ChemCon
Conferences
2012
Merge between Royal Haskoning and DHV
Froukje Balk is a biologist by training and a EUROTOX registered
toxicologist specialising in ecotoxicology and environmental fate and
behaviour of chemicals with more than 25 years of experience, including
seven years in the laboratory. She is involved in the risk assessment
(both effects and exposure) of chemical substances, mainly related to the
European chemicals legislation on existing chemicals and biocides.
ISO 9001
ISO 14001
OHSAS 18001
PARTNERS
ChemCon Conferences
CLIENTS
The clients of Royal HaskoningDHV are located in many different
industries. Because Royal HaskoningDHV provides many more services
than chemicals management alone, it has service relations with clients
covering a wide variety of solutions. Clients are, for example, in pharma,
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.
Dr Ingrid Sterenborg – Senior Expert Toxicology
Ingrid Sterenborg studied environmental hygiene and obtained her PhD
degree on the physiological mechanism of metal tolerance in springtails,
she started her career in environmental consulting, with particular expertise
in regulatory toxicology. Ingrid is a EUROTOX registered toxicologist. She
prepared several dossiers for biocidal and plant protection products as well
as REACH dossiers and prepared data gap analyses, proposed testing
strategies and prepared expert statements for several toxicological endpoints.
Conny Hoekzema Msc – GHS/CLP and SDS Expert
Conny Hoekzema has six 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.
Tjeerd Bokhout, MSc MBA – Consortium Manager
Tjeerd Bokhout is an experienced consultant and project manager on
environmental and chemicals management projects in Europe and
abroad (mainly Asia). Tjeerd holds both an MSc and MBA and has
a strong focus on the business case of his clients. Tjeerd has a vast
network in the global community on chemicals legislations. He has
experience in the support of chemical industry and governmental bodies
with requirements of REACH. Tjeerd manages several REACH consortia
and provides strategic advice on REACH implementation. Tjeerd is
also active as director of ChemCon Conferences, the world’s leading
conference on chemical control legislation and trade aspects.
ir. Leo van der Biessen Msc – Senior Expert Occupational Exposure
Leo van der Biessen has more than 20 years’ practical experience in
controlling and managing chemical exposure risk in the chemical process
industry and its downstream users. In 1990 he joined a leading health and
safety service provider in the Netherlands where he devised chemical risk
assessment and control strategies as well as worker protection regimes.
He joined Royal Haskoning in September 2002. Leo is a board member
for chemical safety of the Dutch Industrial Hygiene Association.
Christiaan van Daalen Msc – Project Manager
Christiaan van Daalen is trained as an environmental scientist, specialising
in both regulatory toxicology and business communication with a focus on
REACH. He has been involved in the production of several large dossiers
under REACH and advises on various REACH implementation processes.
Besides the preparation of technical dossiers Christiaan acts as project
manager in many REACH registration projects for individual companies
and consortia and he is teamleader of the advisory group in Nijmegen.
Page 121
PROFILE: Royal HaskoningDHV
ACCREDITATIONS
ir. Froukje Balk Msc – Senior Expert Ecotoxicology
SERVICES PROVIDED
Registration of chemicals – REACH
SCC has prepared hundreds of chemical notifications for new chemical
substances (including high volume products of more than 1,000 t/a) and
successfully filed over 100 lead dossiers for the 2010 deadline under
REACH. SCC has established a network for the competent authorities
within the entire EU and is recognised as a reliable and competent
partner by the authorities (eg ECHA) and EU industry organisations (eg
Cefic or Hera). SCC can provide you with:
OO
only representative support;
OO
support in the (pre/late pre) registration process;
OO
support in prioritisation/advice on required action in your company for
the upcoming deadlines;
OO
literature (re)search and evaluation;
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
support with uses, use categories, PROCs, (sp)ERCs;
OO
exposure modelling (eg EUSES, Risk of Derm, CONSEXPO, EASYTRA, ART);
OO
human and environmental risk assessments;
OO
preparation of the chemical safety report;
OO
submission/defence of the dossier at authority level;
OO
Sief and consortia support/management including trust account;
OO
C&L support (CLH dossier according to Annex XV, eSDS including
Annex);
OO
Scientific/regulatory support at EU expert meetings; and
OO
QSAR tools.
PROFILE: SCC
CONTACTS
Website
www.scc-gmbh.de
E-mail
[email protected]
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
OVERVIEW
Registration of consumer products
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.
Turnover, group
-
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 (SCCP, SCCNFP), and on cleansing ingredients or formulations
for industry associations, such as HERA.
-
Registration of agrochemicals and biopesticides
No of offices
2
2
The SCC agrochemicals and biopesticides department considers
current and future regulatory and legislative needs and developments
in the common agricultural policy of the EU, and stays up-to-date on the
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.
VITAL STATISTICS
2011/12
Staff, group
100
45
Information
10%
Representation
& management
18%
Registration of biocides
IT &
software
2%
Consultancy/
advisory
70%
GLOBAL OFFICES
Bad Kreuznach in Germany (HQ) and Tokyo in Japan
Page 122
The SCC biocides department has successfully submitted dossiers for
more than 20 existing biocidal active substances according to the Biocidal
Products Directive 98/8/EC, covering nearly all product types. We have
established good working relationships with many competent authorities
in the EU and have become an acknowledged partner of authorities and
industry. Currently, we are involved twofold: defending active substance
dossiers already submitted and preparing dossiers for biocidal products.
Registration of feed and food additives and veterinary medicine
The SCC feed and food additives and veterinary medicine department
successfully delivered 36 application dossiers for re-authorisation as a
feed additive for the 2010 deadline, which is about 10% of all dossiers
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.
Regulatory science
STAFF SELECTION
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.
Dr Werner Koehl – Head of the Chemicals, REACH, Consumer
Products Department
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.
Isabel Kirbach
Dr Charlotte Krone
1989
SCC GmbH founded
1989
Establishment of Agrochemical and Biopesticides
department
1989
Establishment of Regulatory Science department
1996
Establishment of Chemical and Consumer Products
department
2000
Establishment of Biocides department
2004
GLP archive certification
2007
Establishment of Liaison Office in Tokyo, Japan
2007
Establishment of Feed and Food Additives and Veterinary
Medicine department
Mrs Kirbach has a master’s degree in chemical engineering. She has
been with SCC since 2004 and her focus is on Sief and IUCLID 5.
Dr Krone has a PhD in geosciences. She has been with SCC since
2007, where she focuses on general regulatory affairs and consortia
management. Also, she is coordinator of all chemical issues involving our
Liaison Office in Tokyo, Japan.
Dr Ingo Walter
Dr Walter has a PhD in food chemistry. He has been with SCC since
2008, focusing on risk assessments, C&L and MSDSs.
Dr Albrecht Heidemann
Dr Heidemann has a PhD in biology. He has been with SCC since 1994
and is head of the Agrochemicals and Biopecticides department.
Dr Monika Hofer
ACCREDITATIONS
Dr Hofer has a PhD in chemistry. She has been with SCC since 1998 and
is head of the Regulatory Science department.
GLP archive (since 2004)
Dr Hans-Josef Leusch – Head of Biocides Department
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.
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
Dr Leusch has a PhD in agronomy. He has been with SCC since 2000
and is head of the Biocides department.
Ruud Huibers MSc – Head of Feed and Food Additives,
Veterinary Medicine Department
Mr Huibers has a master’s degree in agriculture and natural environment.
He has been with SCC since 2007 and is head of the Feed and Food
Additives and Veterinary Medicine department.
Dr Bernd Brielbeck – GLP Archive
Dr Brielbeck has a PhD in chemistry. He has been with SCC since 2001
and is responsible for our GLP-certified archive.
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.
Page 123
PROFILE: SCC
GLP archive
Dr Koehl has a PhD in food chemistry and is a certified expert for
toxicology. He has been with SCC since 2001 and is head of the
Chemicals, REACH, 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.
SERVICES PROVIDED
14C custom radiolabelling
PROFILE: Selcia
CONTACTS
Website
www.selcia.com
E-mail
[email protected]
Head office
Fyfield Business and Research Park, Ongar, Essex CM5
0GS, UK
Tel
+44 1277 367000
Fax
+44 1277 367099
Contact
David Carver
Directors
Simon Saxby, CEO
Dr Hans Fliri, Chairman
Ownership
Private
Locations
UK, USA
Founded
2001
OO
14C radiosynthesis including de novo development of synthetic
routes;
OO
synthesis of 14C radiolabelled API to GMP;
OO
rapid re-purification service;
OO
stock management of radiolabelled compounds;
OO
certificate of analysis and analytical profile;
OO
GLP analysis;
OO
safe and fast shipment worldwide to multiple destinations.
Our team of expert synthetic radiochemists can prepare C-14 labelled
small molecules of almost any complexity for use in pre-clinical and
clinical metabolism, distribution and mass balance studies, dermal
penetration, degradation/environmental fate and other studies.
All our products are delivered with a comprehensive analytical data
package, including full spectroscopic analysis and experimental
documentation. A certificate of analysis specifying chemical as well
as radiochemical purity by NMR, MS and HPLC accompanies each
compound.
GMP radiolabelled API
OVERVIEW
Selcia is a leading provider of 14C custom radiolabelling and produces
14C radiolabelled compounds and 14C GMP radiolabelled APIs for a
global customer base encompassing both the life sciences and chemical
industries. Applications of the radiolabelled products prepared by Selcia
include: preclinical and clinical drug metabolism, mass balance, and
microtracer studies; research and regulatory studies of cosmetic products;
and environmental fate studies of pharmaceutical, agricultural and
industrial chemicals. Selcia’s analytical laboratory is a member of the UK
GLP compliance monitoring programme and specialises in GLP NMR.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
2
Global
Staff, group
75
75
Laboratory
100%
Selcia is certified by the UK Medicines and Healthcare products
Regulatory Agency (MHRA) for the preparation and C-14 labelling of
active pharmaceutical ingredients (API) for clinical trials.
Whether you require a synthesis or re-purification under GMP, we
perform both in compliance with EMEA and the recent FDA Phase I
GMP guidance (IQCH Q7A Section 19: Single batches for investigational
drugs). We are certified by the UK's MHRA for preparation and 14C
labelling of APIs for clinical trials.
GLP analytical services and metabolite synthesis
We perform structural elucidation and impurity profiling, together with
synthesis and GLP characterisation of impurity, degradation product
and metabolite standards. Our analytical department is accredited by
the MHRA and we are a full member of the Good Laboratory Practice
programme in the UK and specialise in GLP NMR to support regulatory
submissions.
We provide specialist analytical services tailored to individual needs to
support regulatory studies and submissions:
OO
GLP analysis including mass spectrometry and infrared
spectroscopy;
OO
GLP NMR service;
OO
custom synthesis of metabolites, impurities and reference standards;
OO
custom synthesis of compounds labelled with stable isotopes such as
carbon-13, nitrogen-15, deuterium;
OO
all custom prepared products are available with a GLP certificate of
analysis;
OO
non-routine analytical studies including structural elucidation and
impurity profiling at microgram levels using capillary NMR;
Selcia can act as study director or principle investigator to support your
GLP regulatory study
Drug discovery
GLOBAL OFFICES
UK, USA
Page 124
Selcia Discovery provides integrated small molecule drug discovery to
pharmaceutical and biotech clients. Besides general medicinal chemistry
and biology capabilities applicable across all target classes, Selcia
Discovery has a particular strength in three unique and highly synergistic
technologies: (1) medicinal chemistry on complex natural products;
(2) capillary electrophoresis-based fragment and natural product
screening; (3) protein-protein interaction targets in particular peptidylprolyl isomerases (including cyclophilins, FKBPs, Pin1, together called
PPIases).
2012
Selcia celebrates 20 years of radiolabelling at Ongar
2010
Selcia’s radiochemistry facility is granted a Good
Manufacturing Practice (GMP) certificate for the preparation
of C-14 labelled active pharmaceutical ingredients (APIs)
following a successful inspection by the UK’s Medicines and
Healthcare products Regulatory Agency (MHRA).
2009
Expansion of radiochemistry laboratory increases
radiochemistry capacity to 30 fume cupboards.
2006
Selcia joins GLP compliance programme
2005
Following the management buyout of Scynexis Europe by
Dr Hans Fliri and the incumbent UK management team,
the company is renamed Selcia. The company is the only
dedicated provider of custom radiolabeling, chemistry and
analytics services worldwide. Dr Fliri is appointed managing
director.
2001
Aventis’s Ongar facility is acquired by Scynexis Inc. The new
subsidiary operation remains on the same site and is called
Scynexis Europe. In addition to the existing radiochemistry
expertise, Scynexis invests in automated high throughput
drug discovery facilities.
1992
Rhone Poulenc (renamed Aventis in 1999) establishes a
radiochemicals facility at what is now the Fyfield Research
and Business Park, Ongar.
ACCREDITATIONS
Selcia has been a full member of the GLP Compliance Monitoring
Programme in the UK since 2006.
Selcia holds a Good Manufacturing Practice (GMP) certificate for the
preparation and C-14 labelling of active pharmaceuticalingredients
(APIs) for clinical trials from the UK’s Medicines and Healthcare products
Regulatory Agency (MHRA).
Selcia is an approved service provider under the French Crédit Impôt
Recherche (CIR) scheme for the years 2012 to 2014.
CLIENTS
Client confidentiality is guaranteed. We work with a large portfolio of
clients of all sizes on five continents: manufactures of pharmaceuticals,
agrochemicals, biocides, veterinary medicines, chemicals as well as life
science research and development organisations and contract laboratories.
TESTIMONIALS
References can be provided on request.
STAFF SELECTION
Dr Hans Fliri – Chairman
Hans joined Selcia in 2003 as Managing Director and continued in this
position until May 2011 when he was appointed Chairman. During his time as
Managing Director he presided over the transformation of Selcia into a major
contract laboratory in both custom radiolabelling and integrated drug discovery
services. With more than 25 years’ experience in the healthcare sector,
Hans has held senior management positions in global pharmaceutical and
biotechnology companies. Before joining Selcia he was Vice President of drug
discovery at Cetek Corporation (2001-2002) in the US prior to which he was
Senior Director of anti-Infective drug discovery and lead generation at RhonePoulenc Rorer and later Aventis in Paris (1994-2000). He held research and
management positions at Sandoz (now Novartis) in Basel between 1977
and 1994. Hans has also served on scientific advisory boards for companies
in Europe and the US. He holds a PhD in chemistry from the University of
Innsbruck and is the author of approximately 50 scientific articles and patents.
Simon Saxby – Chief Executive Officer
Simon Saxby joined Selcia as CEO in April 2011 from RecipharmCobra
Biologics where he was Vice-President Biologics. His previous roles
as CEO include periods at Cobra Biomanufacturing PLC and at Alpha
Biologics Sdn Bhd. He has 13 years’ experience as a board director and
has led successful M&A activities for two companies. Mr Saxby has a
scientific background in immunology, and during his 31 years in the life
sciences industry he has been a founder and fundraiser for companies
in the UK, Malaysia and the USA where he spent five years leading the
development of a CMO business for Unisyn Technologies. Prior to that
he was a scientific founder of Murex Diagnostics, a founder director of
Quantum Biosystems Ltd, and held senior management positions with KS
Biomedix PLC, Xenova PLC and Scynexis Europe Ltd. He is a member of
the Institute of Directors’ Policy Voice forum, advising the IoD, legislators
and government, on business issues.
Dave Roberts – Business Development Director, Radiochemistry
Dave co-founded Scynexis Europe in 2001 and participated in the
subsequent management buyout which led to the creation of Selcia in
2005. For 20 years Dave has held various senior management positions
within life sciences R&D at Rhone-Poulenc and Aventis. At Rhone
Poulenc an early career as chemical research manager was followed by
roles in global project management for academic and internal research
programmes. Subsequently, at Aventis, projects included coordinating
external chemistry programmes and managing the sale of two former
Aventis research sites. Dave studied organic chemistry at King’s College
London. He is a co-inventor of the animal health insecticide Fipronil and
the maize herbicide Isoxaflutole.
Clive Cornell – Chief Operating Officer
Clive heads up Selcia’s Discovery division and is also responsible
for Operations. He previously held the positions of General Manager
and Head of Chemistry. Clive was a co-founder of Scynexis Europe
in 2001 and participated in the management buyout which led to the
creation of Selcia in 2005. Prior to this, Clive spent 25 years in the
life sciences industry with Aventis Cropscience, Schering and Fisons
where he led multidisciplinary teams progressing early stage research
leads into development. At Selcia, Clive has managed collaborative
research programmes with customer companies in large pharma, the
biotech industry and in academia. He is an active committee member
of the SCI Fine Chemicals Group and the co-author of over 20 scientific
articles and patents. Clive completed his first degree at the University of
Hertfordshire as a graduate of the Royal Society of Chemistry (Part II)
and subsequently obtained an MSc in synthetic organic chemistry. He is a
chartered chemist and member of the Royal Society of Chemistry.
Dr Gill Little – Director, Radiochemistry and Analytics
Gill has headed up Selcia’s 30-strong radiolabelling group and overseen
the group’s associated project portfolios since 2006. She was a cofounder of Scynexis Europe and was involved in the subsequent
management buyout that led to the formation of Selcia in 2005. With a
PhD in natural product chemistry from the University of Wales, she has
over 20 years of experience in chemistry initially with Rhone-Poulenc
and Aventis, both in the UK and France. She is the co-author of many
scientific papers, and patents, and is a co-inventor of the maize herbicide
Isoxaflutole.
Page 125
PROFILE: Selcia
SERVICES PROVIDED
Seminars and customised training
SGS dedicated REACH experts in the EU as well as our key trading
partners can offer seminars and tailor-made training to manufacturers,
importers, retailers and their suppliers at various levels (from elementary
to advanced) to suit the unique situation of the audiences.
PROFILE: SGS
CONTACTS
Consultancy/ impact analysis
Website
www.sgs.com/reach
E-mail
[email protected]
Head office
1, Place des Alpes, PO Box 2152, Geneva, 1211,
Switzerland
Tel
+41 22 739 91 11
Fax
+41 22 739 98 86
Contact
[email protected]
Directors
Chris Kirk, Chief Executive Officer
Malcolm Reid, Consumer Testing Services EVP
Ownership
Private company
Locations
Brazil, China, Finland, France, Germany, Hong-Kong,
Spain, UK, US, etc
Founded
1878
Our teams assess companies’ role and current compliance status to
define a specific REACH strategy.
Analysis
Laboratory testing: SGS can develop testing strategy and generate
required testing data according to the REACH requirements. Testing
services are available through our laboratory networks in Europe, Asia
and the Americas. Our labs can perform testing according to and in
compliance with Good Laboratory Practices (GLP) as required by the
regulation for toxicological and eco-toxicological studies.
Analysis of restricted substances and SVHC: SGS is a pioneer for
consumer products testing. We can meet all requests of product chemical
analysis enforced by regulations.
Data collection and volume tracking
OVERVIEW
SGS is the world’s leading inspection, verification, testing and certification
company. SGS is recognised as the global benchmark for quality and
integrity. With more than 75,000 employees, SGS operates a network of
over 1,500 offices and laboratories around the world.
Since 2006, SGS has offered a comprehensive suite of services to
help customers comply with their obligations under REACH, from initial
REACH registration to consulting, testing, auditing and verification
services to support ongoing compliance.
VITAL STATISTICS
2011/12
Turnover, group
5,578m CHF
-
No of offices
1,500
+100
Staff, group
75,000
-
SGS has an extensive network in EU and non-EU countries assisting EU
importers and retailers to collect substance data for registration as well as
SVHC notification. In cases where the importers and retailers do not have
their own internal IT system, SGS is able to provide alternative solutions
which enable effective consolidation of data that can be kept for ten years.
Sief participation and third party representative
Thanks to our large team of experts, including toxicologists, ecotoxicologist, chemists and in-house legal counsel, SGS is able to provide
you with valuable advice to negotiate data and cost sharing in the
Substance Information Exchange Forum (Sief).
Registration dossier
Further to the achievements of its Global REACH team for the first
REACH registration deadline, SGS can assist in preparing and submitting
to the ECHA a comprehensive and reliable registration dossier.
Chemical safety data sheet
SGS has many years of experience in preparing SDS and our services
are continuously evolving with regulatory development. We can draft SDS
under the Globally Harmonized System (GHS) format and according to
the location of import; we can prepare SDS in all European languages
and simplified Chinese.
Risk assessment and strategy consultation for SVHC notification
Consultancy/
advisory
10%
Laboratory
89%
SGS offers various solutions to identify and support SVHC notification
obligation.
REACH audit
Around the globe, we have specially trained inspection teams who excel in
system audit and have in-depth knowledge in the regulation. We conduct
REACH audits for manufacturers in EU as well as non-EU countries. Our
audit check list can be adjusted to the unique needs of our clients.
GLOBAL OFFICES
1878
Goldstück-Heinz & Co was founded in 1878 in Rouen as a
grain inspection company
1900s
Expanded beyond agriculture in early and mid 20th century to:
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minerals;
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oil, gas and chemicals;
OO
consumer goods;
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industrial sector.
1915
Headquarter in Geneva
Brazil, China, Finland, France, Germany, Hong-Kong, Spain, UK, US, etc
Page 126
The company adopted the name Société Générale de
Surveillance
1980s
Expanded our activities to:
OO
automotive;
OO
environmental;
OO
certification;
OO
governmental;
OO
and life science services.
1981
Publicly listed on the Swiss Stock Exchange
2001
By the start of the new millennium, a wide-ranging corporate
restructuring led to the formation of the ten businesses that
are now found at SGS.
ACCREDITATIONS
GLP accreditations for our labs in Rouen (France) and Taunusstein
(Germany).
TESTIMONIALS
“In 2010 we successfully submitted a REACH registration dossier as
lead registrant. We chose SGS as our REACH consultant and laboratory
service provider. SGS organised our kick-off consortium meeting and
communication throughout the process, developed an intelligent test
strategy, supported us regarding the necessary testing, handled confidential
business information, and prepared the technical IUCLID dossier and the
CSR. At no point during the process, did we regret having chosen SGS as
our service partner. In particular, we appreciated the smooth and prompt
communication with our SGS key contact and were pleased with the
expertise of the SGS staff involved in the project. In retrospect, we can say
that we would contract SGS again for the job.” – RUAG Ammotec GmbH
CASE STUDY 1:
A number of retailers positioned as importers of products and suppliers
of formulated products required to ensure they were in compliance with
REACH regulations. SGS was employed to obtain BOS information and
assess chemical substances in products and articles from numerous
suppliers many of whom are located outside of the EU. A tailor-made web
based data management system was used to collect information enabling
the clients registration and notification obligations to be evaluated.
Product testing in independently accredited test laboratories enabled
articles that were considered a high risk of containing SVHCs to be
evaluated, allowing the client to show a good level of due diligence. SGS
were able to reduce testing costs for the client by offering a package of
testing that selectively identified SVHC`s most likely to be present and not
unnecessarily testing SVHCs that had a low likelihood of being present.
The clients by using SGS`s services were able to reduce the level of
manpower that they were committing to REACH management whilst
maintaining a high level of regulatory compliance.
CASE STUDY 3:
Faced with the question of whether a read-across from the results gained from
toxicity studies conducted with a specific alkali metal salt could and had to be
applied to the corresponding alkali metal and alkali metal organyles, in absence
of the possibility to test the latter substances for their acute oral toxicity
potential based on their property of being corrosive, the client approached
SGS. By contracting SGS to assess the problem, our client was able to resolve
the issue with a consultancy report only and no further testing or classification
of the substance was needed. The SGS consultancy report was used by our
client for their official communication with the pertinent authority.
STAFF SELECTION
Céline Goulois
Ms Goulois is a regulatory (eco)toxicologist, specialist in REACH regulation.
She is in charge of SGS clients’ registration dossiers and also of training
and technical procedures.
Before joining SGS in 2008, Ms Goulois worked for six years at a
multinational chemical company where she was in charge of the
preparation and validation of technical documents (safety data sheets,
IUCLIDs dossiers, (eco)toxicological profile, HPV dossiers, customer
inquiries), classification (EU and GHS), and REACH (registration, risk
assessment, technical support).
Anne Kleinkauf
After receiving her PhD degree in the field of biomarkers for endocrine
disruption in wildlife, Anne Kleinkauf absolved two further degrees in
environmental auditing, impact assessment and management system and
in environmental law and economics, while working as an environmental
consultant and auditor. In addtion to her extensive knowledge regarding
the requirements under the EU REACH regulation, her experience covers
aspects of ecotoxicology, toxicology and risk assessment.
Mei Mei Sit
Senior Research Executive Dr Sit obtained her PhD degree in
organometallics. Her work focuses on REACH, CLP and POPs
regulations. Currently, she is developing chemical assessment service,
such as effective risk-control strategy for substances of very high concern
(SVHC) management and cost-effective restricted substance testing tool.
Tony Smith
Tony Smith is a Chartered Chemist with over twenty five years’ experience
in the environmental and regulatory fields. Ten years was spent working
in an analytical quality assurance laboratory developing new test methods
and client problem solving for the textile industry. He has been an active
member of many British standards committees and has represented the
UK at European and International level as the UK principle expert for
chemical and composition testing of textiles. A regular public speaker on
regulatory affairs to the UK industry and the retail sector providing up to
date and easily understood information on REACH and CLP.
CASE STUDY 2:
Jerome Vandenbroucke
Asked by a major player in the cycle industry to verify that their Indian
supplier was sufficiently ensuring that no SVHC list candidates were
contained in the products exported to Germany, SGS staff from Germany
and India carried out a training and site audit at the Indian supplier’s
facility. Despite being aware of the basic facts on REACH and having
implemented various compliance procedures, the staff of the Indian
company were found by SGS not to have fully grasped all measures
possible to comply with their customer’s expectations and EU SVHC
requirements. The service by SGS hence proved to not only be well
worth the investment for our client to ensure REACH compliance of their
imported products, but also turned out to be a valuable opportunity for the
Indian company to improve their quality standard procedures.
Jerome is a chemical engineer specialised in formulation. He worked
two years on chemical legislations applied to mixture: REACH, biocide,
classification and labelling of hazardous substances and mixtures and
formulation (repellents, firelighters, UV and PU resins).
Page 127
PROFILE: SGS
1919
PROFILE: Sustainability Support Services (Europe) AB
Training
20%
Legal
10%
CONTACTS
Website
www.reach-onlyrep.eu
E-mail
[email protected]
Head office
Markaskälsvägen 6, Lund – 22647, Sweden
Tel
+46 46 2850418
Contact
Shisher Kumra
GLOBAL OFFICES
Directors
Shisher Kumra and Mukta Kumra
Sweden, India, Hong Kong
Ownership
Locations
Sweden, India, Hong Kong
Founded
2008
IT & software
10%
Representation
& management
10%
SERVICES PROVIDED
Late pre-registration (LPR)
OVERVIEW
SSS was set up exclusively to provide technical assistance and
compliance required by non-European manufacturers and exporters of
chemicals and chemical containing products to the European Union for
compliance with the REACH Regulation (EC No 1907/2006). SSS has
an extensive network of European and Indian business intermediaries
and has been working to facilitate non-EU businesses to comply with
the requirements of REACH and various other European regulations
as well as the upcoming chemical regulations in other countries like
Turkey, China, Japan, South Korea, Malaysia, Canada, etc. SSS
has a memorandum of understanding (MoU) with two major industry
associations in China, namely:
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China Chamber of Commerce of Metals Minerals and Chemicals
(CCCMC); and
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China International Electronic Commerce Center (CIECC).
Through these MoU, as well as an exclusive Chinese team, SSS offers
the complete regulatory compliance services related to China, such as
preparation of Chinese compliant SDS as well as notification of new
substances to the Chinese inventory of existing chemical substances in
China (IECSC).
SSS has a client base of over 1,000 companies across the world and has
dealt with 9,000 pre-registrations, the successful registration of more than
35 substances by the first REACH registration deadline of 30 November,
2010 – including being the lead registrant. SSS is now working as lead
registrant on over 100 substances for 2013. SSS also:
OO
organised LPR for over 1500 substances;
OO
CLP notification of approximately 1,500 substances; and
OO
developed MSDS for 2,000 substances (including 500 MSDS
translation in various European languages).
VITAL STATISTICS
2011/12
Turnover, group
€2.5m
€2.0m
No of offices
3
20
Staff, group
30
25
Page 128
Consultancy/
advisory
50%
SSS offers LPR services to help non-European companies, either new
manufacturers or first time exporters of substances, to late pre-register
their substances that were not pre-registered during the June-December
2008 period. Since the pre-registration deadline, SSS has successfully
completed the LPR for 900+ substances, with many more in the pipeline.
CLP notification
SSS provides the CLP notification services to non-European companies
in the capacity of an importer for which the company has to furnish the
identity of the substance like the CAS Number, EC Number.
SSS has to date successfully completed over 1,000 CLP notifications.
Registration
Since 2011-12, SSS has been constantly working to help its client
companies successfully meet the second registration deadline of 31
May 2013. SSS has so far submitted over 70 lead dossiers and propose
to submit an additional 40 lead dossiers before the second deadline. In
addition, around 250 member dossiers are proposed to be submitted by
31st May 2013.
REACH compliant SDS
SSS is also engaged in compiling the 16 point REACH and CLP
compliant SDS for the chemical substances and preparations meeting the
criteria of classification as dangerous.
Extended SDS (e-SDS): SSS also provides e-SDS for the classified
registered substances with the relevant exposure scenarios that have to
be annexed to the SDS.
SDS translation: since it is obligatory for the exporter of chemicals to
provide to his buyer an SDS originally prepared in English, in the local
language, SSS also provides the service of translating the SDS into other
languages of European Member states (for example, German, French,
Spanish, Dutch, or Italian).
SSS has to date prepared over 2,000 REACH compliant SDSs.
SVHC applicability analysis
Companies exporting articles to European countries need to confirm the
presence or absence of substances of very high concern (SVHC) and
the REACH compliance obligations. SSS offers a very economical and
technically sound solution to these companies for fulfilling their REACH
obligations and certification requirement of their European buyers. This
solution is in line with the guidance provided by ECHA. So far, SSS has
provided around 75 companies exporting articles to Europe with the most
cost-effective REACH SVHC compliance certification
OO
OO
OO
OO
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Toys Safety Directive (TSD) Directive 2009/48/EC
Regulation (EU) No 528/2012 concerning the biocidal products
Turkish Inventory and Control of Chemicals Regulations
China REACH
Compliance with chemical management in Malaysia (EHSNR)
2008
Established and registered as a private limited company
2008
Successfully pre-registered over 7,000 substances within
REACH
2009
Professionals trained in IUCLID from REACH Centrum
2009
Trained over 100 industry professionals in use of IUCLID
2010
35 REACH registrations successfully completed
2010
Delivered 1,500 REACH and CLP compliant SDS
2011
Acquired capacity in Chesar and QSAR
2011
Mandated as lead registrant for 50 substances
2012
Mandated as lead registrant for over 60 additional substances
PARTNERS
OO
OO
OO
OO
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Confederation of Indian industry (CII), India
Apparel Export Promotion Council (AEPC), India
China Chamber of Commerce of Metals Minerals and Chemicals
Importers and Exporters (CCCMC), China
China International Electronic Commerce Center (CIECC), China
Tisamax Technical Co Ltd (Tisamax), Taiwan
CLIENTS
SSS has clients in the industrial and specialty chemical and petrochemical
industry, as well as the following industries: agrochemical, food colour,
cosmetic, electrical and electronics, automotive industry, leather, garment
and apparel, plastic and rubber, steel, writing instruments, polymers.
TESTIMONIALS
CASE STUDY 2: Successful REACH registration for CMR category 2
substance
Problem: with only a couple of months remaining to the first REACH
registration deadline of 30th November 2010, a company sought
assistance for successful registration within the deadline.
Solution: SSS took up the challenge and adopted a multi-pronged
strategy to successfully meet the deadline. It also made diligent use of
computational models for generating certain end points in a cost effective
way. SSS coordinated well with various agencies involved in completion
of the IUCLID dossier. Due to SSS’s diligence at each stage of the
registration process, the dossier was accepted by ECHA at the very first
attempt and the substance was successfully registered.
CASE STUDY 3: Providing guidance to a non-EU manufacturer
having own legal entity in Europe on preparation for a REACH audit
Problem: a non-European company sought the technical assistance of
SSS to guide them in their preparation for a REACH audit proposed by
one of REACH enforcement agency.
Solution: SSS provided guidance to the company in terms of the various
documentations and records that the European office of the non-EU
company should have in place before the audit, including compliance with
the CLP notification as well as provision of safety data sheets (SDS) and
translated safety data sheet (wherever applicable). Accordingly company
verified its compliance status prior to the Audit.
STAFF SELECTION
Mr Shisher Kumra – Executive Director
Area of expertise includes specialisation in regulatory affairs, legal
expertise, chemical assessment, toxicology.
Dr Rashmi Naidu
Area of expertise includes REACH data inventory, REACH registration
process, environmental toxicology, bio-assay and other regulatory affairs.
Mr Shrirang Bhoot
Area of expertise includes specialisation in the software’s like IUCLID,
QSAR, ECOSAR, dossier preparation, ecotoxicology.
On the service quality criteria, over 90% of our client companies have
rated the REACH compliance assistance services being offered by SSS
as very good.
Dr Chitralekha Datta
CASE STUDY 1: Technical support to a multinational company
Dr Shruti Ralegaonkar
Technical support provided to a multinational company having its
own European legal entity as their only representative for successful
submission of REACH registration dossier.
Problem: due to the registration dossier failing the technical
completeness check (TCC) at ECHA, the company had only one
opportunity for resubmission of the registration dossier without losing its
ECHA registration fee.
Solution: SSS (Europe) AB reviewed the TCC failure report as well as
the IUCLID registration dossier prepared by the company to identify the
reason for the registration dossier failure. Suitable modifications were
then incorporated into the dossier to remove the errors and when the
dossier was resubmitted, it cleared the ECHA TCC check resulting in the
company being allotted a REACH registration number. This saved the
company substantial Euros because it was a large sized company and
was registering in the highest tonnage band of greater than 1,000 tons
per annum.
Area of expertise includes REACH and articles, SVHC assessment and
REACH compliance verification.
Area of expertise includes chemical safety assessment (CSA), chemical
safety report (CSR), toxicology, software like IUCLID, Chesar and CLP.
Page 129
PROFILE: Sustainability Support Services (Europe) AB
SSS also provides compliance assistance for the following:
PROFILE: Swissi Instituto Suizo de Seguridad
GLOBAL OFFICES
Swissi Instituto Suizo de Seguridad: C Lope de Vega, 22-24. 08005
Barcelona, Spain
Swissi AG: Richtistrasse 15, 8304 Wallisellen, Switzerland
Swissi Process Safety GmbH: Schwarzwaldallee, 215 WRO-1055.5.24,
4002 Basel, Switzerland
Swissi Process Safety GmbH: An der Leiten 12, 82069 Hohenschäftlarn/
München, Germany
Swissi France SARL: 10, Place Charles Beraudier. Immeuble L’Orient.
69428 Lyon Cédex 03, France
Taiwan Sales Office: 13F, No 83, Jian Sing Rd, SanMin Dist, Kaohsiung
807, Taiwan, ROC
CONTACTS
Website
www.swissiesp.com
E-mail
[email protected]
Head office
C Lope de Vega, 22-24, 08005 Barcelona, Spain
Tel
+34 933 036 612
Fax
+34 933 036 612
Contact
Montserrat Fernández (REACH Business Group Leader)
Mr Kimmy Wu (Sales office in Taiwan)
Directors
Dr Alexis Pey (Director Swissi Instituto Suizo de
Seguridad, Spain)
Ownership
Swissi AG
Locations
Spain (Barcelona, Madrid, Murcia), Switzerland, France,
Germany, Taiwan
Founded
Swissi AG, 1945 – Swissi in Spain, 2004
SERVICES PROVIDED
Swissi Instituto Suizo de Seguridad is a subsidiary in Spain of Swissi AG.
Swissi works hand in hand with its clients to promote safety in the industry
and particularly in the industry dedicated to chemicals and chemical
processes. Our commitment to industrial, process and labour safety is
our top priority and, as part of it, we participate in research institutes,
international safety organisations and standardisation committees. Our
activities focus on three main areas: consulting, laboratory testing and
training.
2011/12
Turnover, group
€17m
€9m
No of offices
10
Global
Staff, group
143
55
Training
11%
Consultancy/
advisory
55%
Page 130
Swissi can offer more than 150 different tests in the fields of thermal
process safety, fire and explosion protection, electrostatics, REACH and
GHS and highly active and highly toxic materials. We also offer tests
for classification according to the Orange Book (UN Recommendations
on Transportation of Dangerous Goods) ie GHS (globally harmonised
system). We are certified in accordance with ISO/IEC 9001 and our test
laboratories are accredited under ISO/IEC 17025.
Process safety and loss prevention
We conduct audits and analyse risk in our fields of expertise: process
safety and reactions, ATEX, electrostatics, environment, thermal process
safety, occupational risk prevention and machine directive. We apply
recognised methodologies such as HAZOP, ZHA, FTA, LOPA and FMA
and propose cost-effective solutions. We belong to the EPSC - European
Process Safety Centre.
Environment consultancy
We perform environmental risk analysis, quantify the consequences
of possible damage, help companies to integrate their activities in the
environment, and perform administrative procedures associated to each
regulation and to environmental licenses. We also implement safety
management systems
Crisis management
Other
11%
Laboratory
23%
Swissi assists a number of companies outside the European Union
to comply with REACH regulation. We prepare registration dossiers
of their substances, submit them to ECHA and provide the necessary
documentation to their downstream users. We also act as third party
representative, offering consultancy services to European companies,
preparing their registration dossiers and SDS adapted to REACH
and CLP regulations. We are members of ORO (Only Representative
Organisation).
Laboratory testing
OVERVIEW
VITAL STATISTICS
REACH and product safety
We are accredited to prepare emergency plans and also help companies
to implement them with training and emergency exercises aimed at both
the companies’ management and staff. As part of the global services we
give to our clients, we develop crisis management and communication
manuals to minimise negative publicity.
1945
Company founded in Switzerland
2004
Company established in Barcelona, Spain
2008
REACH department is set up
2008
Sales company in Taiwan
2011
Delegation in Madrid, Spain
2012
Delegation in Murcia, Spain
2012
SVTI Group acquires Swissi AG
Swissi is certified in accordance with ISO/IEC 9001 and its test
laboratories are accredited under ISO/IEC 17025.
CLIENTS
Our clients are companies that produce or handle chemicals and
chemical products. They belong to the chemical, pharmaceutical,
petrochemical and agrifood sectors, among others. We work for all kinds
of companies, from multinationals to small and medium-sized local
companies.
CASE STUDY 1: REACH IT tool and Customer Care
Swissi developed in 2009 an IT tool for our REACH clients so that they
are able to manage all the information derived from the registration
process. The information is made available both to our clients and to their
respective supply chains. That way their European clients can access the
IT tool to download relevant documentation related to the substances they
import (only representative certificates, tonnage certificates, SDS, etc).
We also have a close relationship with our REACH clients in Asia. We
visit them on a yearly basis to provide them with updates on the latest
issues related with the registration process. We organise REACH and
product safety seminars and train them depending on their specific
needs.
CASE STUDY 2: Swissi HSE Management Platform
Swissi HSE Management Platform www.hseplatform.com allows
companies to manage all aspects related to health, safety and
environment with a single tool, and thus improve efficiency and
effectiveness. This IT tool, with customisable modules, integrates all
prevention measures, safety regulations and relevant documents. It is
a powerful database with integrated and related information from all
the modules, can be used to manage one or several sites, generates
reports automatically and can be hosted in the company’s own system to
guarantee confidentiality and data safety.
CASE STUDY 3: Tailor-made proceedings
Companies are increasingly concerned by safety, health and
environment. To meet its clients' needs, Swissi provides consultancy
services to develop tailor-made proceedings to help companies to
manage its procedures and thus increase effectiveness and reduce costs.
This service is the fruits of years of experience in consulting.
STAFF SELECTION
Dr Alexis Pey – Director of Swissi Instituto Suizo de Seguridad
Dr Alexis Pey started Swissi in 2004. He has a PhD in chemical
engineering and specialises in electrostatics, process safety, accident
investigation and risk analysis. He has also worked at the consumer care
Division of Ciba Specialty Chemicals. He is a member of the board of
Bequinor and a permanent member of EFCE.
Dr Otto Holzschuh – Consultant (REACH, Regulatory Affairs) and
Laboratory Manager.
Dr Otto Holzschuh, working at Swissi Process Safety GmbH in
Switzerland, is an experienced REACH specialist with a chemical
engineering and process safety background. He has had responsibilities
for safety and environment in leading chemical and pharmaceutical
companies. He has experience in laboratory testing for transport
classifications and REACH registration as well as in preparing safety data
sheets. He is coordinating Swissi’s collaboration with other laboratories to
offer one-stop services for REACH registration.
Dolors Vinyoles – Consultant (REACH, ORP and Environment)
Dolors Vinyoles has worked since 2008 at Swissi and holds a degree
in chemistry. She is a consultant specialising in REACH regulation,
environmental safety, safety management systems, and occupational risk
prevention.
Before joining Swissi, she worked at Clariant Spain, where she used to be
ESHA (Environment, Safety, and Health Affairs) country head.
Mariàngels Custal – Consultant (Environment)
Mariàngels Custal has worked since 2010 at Swissi and is a chemical
engineer. She is a consultant specialising in environmental safety,
explosive atmospheres (ATEX), and transport safety (ADR). Before
joining Swissi, she was responsible for the environment and the industrial
wastewater plant at various Clariant factories in Spain and Belgium.
Joan Marc Juncosa – Consultant (REACH and Machine Directive)
Joan Marc Juncosa has worked since 2009 at Swissi and is a chemical
engineer. He is a consultant specialising in REACH, classification,
labelling and packaging (CLP), explosive atmospheres (ATEX) and
machinery safety.
Berta Albaigés – Consultant (REACH and Thermal Process
Safety)
Berta Albaigés has worked since 2011 at Swissi and is a chemical
engineer. She is a consultant specialising in REACH and product safety
and thermal process safety. Before joining Swissi, she worked at RPN,
a consultancy for the pharmaceutical industry specialized in regulatory
affairs.
Ester Pellicer – Consultant (REACH and Crisis Management)
Ester Pellicer has worked since 2009 at Swissi and holds a degree
in communication science. She is a consultant specialising in
REACH (supply chain communications), crisis management – crisis
communication and emergency exercises.
Jordi Campos – Consultant (Emergency Plans and Major
Accidents)
Jordi Campos has worked since 2006 at Swissi and is a chemical
engineer. He specialises in emergency plans, major accidents (SEVESO)
and safety management systems. He has also worked for PQAT group of
IQS (Institut Químic de Sarrià).
Montserrat Fernández – REACH Business Group Leader
Montserrat Fernández has worked since 2009 at Swissi and holds
a degree in chemistry. She is a consultant specialising in REACH
regulation, safety data sheets (SDS), classification, labeling and
packaging (CLP) and transport safety (ADR). She also worked at the
R&D department of Clariant, where she held various positions.
Page 131
PROFILE: Swissi Instituto Suizo de Seguridad
ACCREDITATIONS
SERVICES PROVIDED
Risk assessment and chemicals management
Our focus is on REACH and its implementation. Besides registration,
authorisation and building exposure scenarios, we support the evaluation
of risk management options. We can audit your own implementation and
communication under REACH and its eSDS’s. Additionally ,we support
biocides and the safe use of nanoparticles. TNO and TNO Triskelion have
together developed a range of assessment tools to help evaluate human
exposure and to avoid and reduce health risks. Our expertise is available
to address regulatory issues as well as to solve day-to-day chemicals
management problems.
PROFILE: TNO Triskelion
CONTACTS
Website
www.triskelion.nl
E-mail
[email protected]
Head office
Utrechtseweg 48, PO Box 844, 3700 AV Zeist, The
Netherlands
Tel
+31 88 866 16 28
Fax
+31 88 866 69 70
Contact
[email protected]
Ownership
Private company, wholly-owned by TNO
Locations
Zeist, The Netherlands
Founded
TNO, 1933; TNO Triskelion, 1/1/2011
Experimental toxicology
OVERVIEW
TNO Triskelion is a new company born out of a rich history of TNO R&D
achievements.
Our chemical risk assessment services combine research-driven
excellence in the classical disciplines of toxicology and advanced
analytical chemistry, with new developments in risk assessment, in
order to produce intelligent testing strategies and thereby, cleaner,
safer, chemical products. We excel in worker exposure assessment, in
inhalation and in reproduction toxicology, including nanomaterials.
We offer our customers high quality registration and chemicals testing
and analysis services characterised by strong communication with a
personal touch that larger CROs cannot match.
VITAL STATISTICS
2011/12
Turnover, group
€650m
€30m
No of offices
20
5
Staff, group
4,500
200
IT & Training
software 5%
5%
Laboratory
45%
Analytical chemistry
TNO Triskelion’s analytical research centre, with its history of TNO R&D
excellence, has expertise in developing challenging analytical chemical
methods for a very broad range of substances including: organotins,
fluorocarbons, formaldehyde, biocides, pesticides, fragrance materials,
to name but a few. At the interface of the fields of toxicology and risk
assessment, our tailor-made services can make a difference, for example:
OO
test substance identification and characterisation;
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mechanistic studies of toxic compounds in vivo using sophisticated
analytical techniques;
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human and environmental exposure studies in various settings
(industrial, agricultural).
Food packaging petitions, migration testing and plastics recycling
TNO Triskelion offers regulatory affairs services, migration and toxicity
testing of food contact materials (FCM) for petitions to the European Food
Safety Authority (Efsa) and for food contact notifications (FCN) to the
US Food and Drug Administration (FDA). Examples are monomers and
additives used in plastics described in Directive 2002/72/EC. We sharpen
our knowledge by participating in the technical committees of the Efsa.
How we work
Consultancy/
advisory
30%
Representation
& management
10%
Information
5%
GLOBAL OFFICES
Headquarters group: TNO, Delft, The Netherlands,
Headquarters TNO Triskelion: Zeist, The Netherlands
Sales Office: Shin-Yokohama, Japan
Page 132
We offer high quality toxicology studies, specifically tailored to the needs
of REACH, biocides, pesticides and nanomaterials customers. Our
toxicological research centre provides new and improved methods in
toxicology, especially inhalation, reproduction, immuno-toxicology and (in
vitro) skin adsorption. We have been developing novel methods to reduce,
refine and replace animal testing for nearly two decades and are proud of
our performance record in this field, especially resource saving combined
in vivo studies such as repeat-dose (28/90d), repro screening and in vivo
gentox in the same study. We can offer the new OECD 443 guideline for an
extended one-generation reproduction toxicity (EOGRTS) study, already
validated in our laboratories, as well as the OECD 488 transgenic rodent
test.
Project management – your assignment with TNO Triskelion is always
led by one of our experienced project managers, your primary contact
person, who manages your project, interacts with the scientific team, and
ensures you that deadlines are met and that the assignment meets your
needs. Your project manager maintains contact with you during phone
and/or conference calls (scheduled as and when you require), and also
provides regular update reports.
Quality assurance and reporting – our GLP reports are consistently
subjected to the required auditing and control procedures to ensure
compliance. All the documentation you receive (proposals, reports,
analytical results, IUCLID files, chemical safety reports, eSDSs) is
reviewed by a senior staff member before being sent out to you.
Relationship management – in addition to strong project management,
our sales and account managers are also there to assist you. Our
customer services department is there to guide you to the correct technical
contacts within TNO Triskelion, who will help you find the right solution.
1932
TNO The Netherlands Organisation for Applied Scientific
Research is founded
1946
Founding of the Central Organic Chemistry Institute in Zeist
2004
Completion of five-year HPV programmes on various
chemical groups including organotins
2005
TNO Business Unit Quality and Safety formed to offer
safety services to the chemical industry
2006
Participated in REACH implementation projects (data
requirements, exposure assessment)
2007
Commenced REACH partnership with Sabic Europe
2010
Successful completion of 325 full and partial REACH dossiers
2011
Incorporation of TNO Triskelion as a private company
2011
ReachCentrum and TNO Triskelion join forces to offer
REACH workshops and training courses
2012
Extensive application of our exposure experience to the
evaluation of Risk Management Options for SVHC’s
ACCREDITATIONS
In compliance with GLP (toxicology and analytical chemistry); ISO 9001
certified; Some analytical services under ISO 17025.
PARTNERS
TNO Quality and Safety (R&D): we work together with TNO on development
of alternative toxicological methods and (bio)analytical methods.
ReachCentrum: workshops and training
Where needed we supply additional services like ecotoxicology,
physicochemical testing and special evaluations (as SEA) through our
network of co-operators.
CLIENTS
Three top-10 and 12 top-50 global chemicals manufacturers are our clients.
We have provided long-term chemical safety services to the following
chemical sectors: fluorochemicals, hydrocarbon distillates, organotins,
biocides, chlorinated solvents, fuel oxygenates, organic peroxides,
formaldehyde, amines, polyols and isocyanates, silicates and mineral
oxides (micro and nano grades), coal chemicals, fragrances.
TESTIMONIALS
“TNO Triskelion recently performed a comprehensive risk assessment
on behalf of our industry. As well as their knowledge and experience,
and their scientific integrity, we have been impressed by their skill in
communicating across the interfaces within the industry.” – Phil Hope,
Secretary General, Formacare.
"In the past three years TNO Triskelion has steered us safely through
the difficulties and uncertainties of REACH registration. It is a thorough,
scientifically reliable and pro-active partner for the risk assessment and
registration of chemicals." – Harrie Camps, SABIC.
CASE STUDY 1: Successful registration within REACH, post-2010
follow-up and 2013&2018 preparations
With Phase II REACH registration rapidly approaching in mid 2013, this
is another year in which to push ahead with the preparation of safety
dossiers. We have combined the necessary data searches, testing where
needed, chemical safety assessment, and exposure scenarios into
IUCLID 5, chemical safety reports and eSDS and all under the same roof.
It has also now become clear with the publication of a definition by the EC
of nanomaterials that they will ultimately fall under REACH and ECHA has
published its first advice on how that process may take shape on its website.
By 1 June 2013, companies should have completed the registration
of substances in the 100-1000 tonnage band. Based on the 2013
experience, TNO Triskelion can help you plan the registration, guide you
through the process, and work with you to ensure timely and successful
registration for 2018 as well. Grouping and read across will be needed to
keep costs down and has to be prepared early.
CASE STUDY 2: ECHA test proposal evaluations including EOGRTS
REACH requires that for substance volumes of 100-1,000t and >1,000t,
missing higher tier safety studies be included in the registration dossier
in the form of a test proposal. ECHA is in the process of evaluating these
proposals and (draft) decisions are being sent to lead registrants. Many
have already been published on the ECHA website and were open for
public comment for several weeks.
OO
Our advice to clients faced with an ECHA test-proposal that diverges
from their own, is to enter, as far as possible, into a dialogue with
ECHA. We can help develop and support the scientific arguments to
support your case to ECHA.
OO
Should testing be needed, TNO Triskelion is specialised in higher
tier testing with difficult test materials. Our inhalation toxicology skills
cover gases, volatile liquids, solids and nano-grade materials, while
our reproduction toxicology skills are second to none and include
the EOGRTS (OECD 443). We have validated OECD 443 in our
laboratory, gaining us the necessary experience.
CASE STUDY 3: Chemicals mamagement
Our experts can support you in your day-to-day management of
issues related to chemical safety. Our expertise can help you to avoid
compliance issues in the future that could affect your production of
chemical substances, mixtures and articles. For example, we can:
OO
assist you with the production and implementation of extended safety
data sheets (eSDS);
OO
prepare an audit of REACH readiness in preparation for government
inspections;
OO
evaluate current exposure of workers at your production sites;
OO
prepare answers to questions from ECHA and competent authorities/
rapporteurs regarding compliance of your dossiers;
OO
follow-up on any ongoing work on your substances in Siefs and
consortia;
OO
help you in answering questions from your clients regarding their
REACH obligations for the substances you supply to them;
OO
create and follow-up on watch lists of your substances as they
become impacted by regulatory measures in the future.
Solutions as outlined above are offered on a contract basis with a primary
contact point that becomes your personal advisor.
STAFF SELECTION
Our key staff members have long experience in the analysis, testing
and risk assessment of a wide diversity of substances for the chemical,
pharmaceutical and food industry. This solid background is applied to
your substances as well. A steady inflow of young academics ensures
that we remain vigorous and up to date.
Page 133
PROFILE: TNO Triskelion
SERVICES PROVIDED
The (eco)toxicology and regulatory experts of ToxMinds provide high
quality consulting and technical support services to a broad range of
industry clients that are subject to human and environmental health
legislation. All our senior consultants have long term industry experience
and therefore understand the specific needs of industry. Our services
are centred on our three competence areas: applied human health and
environmental risk assessment; EU regulatory strategy and compliance;
and science-based advocacy.
PROFILE: ToxMinds
CONTACTS
Website
www.toxminds.com
E-mail
[email protected]
Head office
116, Avenue de Broqueville, 1200 Brussels, Belgium
Tel
+32 (2) 762 91 45
Fax
+32 (2) 762 91 46
Contact
Daniéle van Haute
Directors
Dr Thomas Petry
Dr Francesca Tencalla
Ownership
Private company
Locations
Belgium, Germany
Founded
2006
Applied human health and environmental risk assessment
OVERVIEW
ToxMinds BVBA is a product safety and regulatory affairs firm located in
Brussels, Belgium. We provide scientific, regulatory and strategic support
to a broad range of industries. Human and environmental safety of
industrial and consumer products is essential for business sustainability
and growth. With our broad industry experience, we support our clients
in bringing safe, regulatory compliant and publicly acceptable products to
the market.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
2
4
Staff, group
10 - 25
10 - 25
Training
5%
Information
25%
Literature review: retrieval, organisation, analysis and presentation
of accurate information on the (eco)toxicological effects of chemical
substances.
Hazard assessment: in-depth evaluation of (eco)toxicological hazards,
target organ toxicity or species and characterisation of dose-response
relationships.
Environmental fate: determination of the fate of substances in soil,
water and air and derivation of predicted environmental concentrations
(PECs) according to the methodologies specific for the different types of
industries.
Data completion: evaluation of non-testing approaches to support
chemical and chemical-based product safety including grouping/readacross approaches, analogue identifications as well as the use of QSAR
methodologies; identification of intelligent testing strategies, design and
management of in vitro/vivo non-clinical and clinical safety programmes.
Risk assessment: comprehensive human health and environmental risk
assessments.
EU regulatory strategy and compliance
Chemicals and commodities: strategic consulting, technical
registration and post-submission support to ensure success under the
REACH as well as compliance with the CLP Regulation.
Biocides and agrochemicals: pre-registration/registration support
including literature search, data gap analysis, human and environmental
risk assessment as well as dossier assembly and post-submission
support.
Pharmaceuticals and OTC: strategic non-clinical programme planning
and conduct, eCTD dossier development, client representation to
authorities and post-marketing support.
Plant biotechnology: development of regulatory submissions as well
as scientific post-submission support (eg development of responses to
queries from regulatory authorities).
Science-based advocacy
Consultancy/
advisory
60%
Representation
& management
10%
GLOBAL OFFICES
Head office: Avenue de Broqueville 116, 1200 Brussels, Belgium
Strategy: develop and implement strategies to support products against
scientifically unjustified health- or environment-related allegations.
Authority review: support on science and regulatory matters in
discussions with regulatory authorities.
Communication: communicate (eco)toxicology and risk assessment
findings to diverse audiences (eg academia, authorities, consumer, and
non-governmental organisations).
Scientific review panels: addressing complex health or environmental
issues through organisation and management of independent
multidisciplinary peer review panels.
2006
Foundation of ToxMinds BVBA by Dr Thomas Petry
2009
Opening of ToxMinds office in Brussels in the direct vicinity of
the EU institutions
CLIENTS
ToxMinds is providing its (eco)toxicology, product safety and regulatory
compliance services to a wide range of multinational fortune 100
companies, SMEs, and industry associations from the chemical, metal/
mining, consumer product, biotechnology and pharmaceutical sector.
Page 134
TESTIMONIALS
STAFF SELECTION
“We have been working with ToxMinds BVBA for many years on
various complex toxicology, ecotoxicology and regulatory issues. The
professionals at ToxMinds are thorough, knowledgeable and always
meet the demands and difficult timelines required by our company. We continue to rely on ToxMinds as experts in the fields of toxicology,
ecotoxicology and regulatory compliance.” – Senior manager, Global
Product Regulatory Compliance, international specialty chemical
company
Thomas Petry, PhD, ERT, DABT
ToxMinds provides technical REACH support for a number of REACH
consortia and individual chemical companies covering more than
80 chemical substances, predominantly UVCBs. Our technical work
includes:
OO
desktop search and data gap analysis
OO
QSAR modelling and analysis
OO
design of intelligent testing strategies
OO
placement and monitoring of testing programmes
OO
development of Iuclid 5 registration dossiers, chemical safety
assessments and reports (CSR)
OO
strategy advice and support during registration and evaluation phases
OO
client representation in discussions with authorities
OO
applications for authorisation, strategic and technical support during
authorisation phase.
CASE STUDY 2: Human and environmental risk assessment
ToxMinds (eco)toxicology consultants have long experience in conducting
human and environmental risk assessments of commodity and specialty
chemicals for our clients as part of regulatory or voluntary industry
programmes or for internal safety assurance purposes. The human
health risk assessments considered human exposures to chemicals at
the workplace, in indoor/outdoor air or due to their release from consumer
products such as cosmetics, cleaning or pest control products. The
environmental assessments typically included environmental fate and
ecotoxicicty evaluations of chemical releases into the environment at
manufacturing or usage sites, field uses in the case of agrochemicals or
from “down the drain” consumer products.
Francesca Tencalla, PhD, ERT
Dr Tencalla is a (eco)toxicology and regulatory affairs consultant with 20
years’ of industry, consulting and research experience in the human and
environmental safety assessment of chemicals, metals, agrochemicals
and pharmaceuticals. She is a European registered toxicologist (ERT)
and earned her PhD in (eco)toxicology from the Institute of Toxicology of
the Swiss Federal Institute of Technology (ETH) of Zurich.
Nirmala Ranggasami, MSc, ERT
Ms Ranggasami is a toxicology and regulatory affairs consultant with
more than ten years’ of industry and consulting experience in the human
and environmental safety assessment of substances. She is a European
registered toxicologist (ERT) and earned her MSc in toxicology from the
University of Surrey, UK.
Ms Daniela Jeronimo Roque, MSc
Ms Daniela Jeronimo Roque has been a researcher at ToxMinds BVBA
since 2011. She supports the team in conducting thorough desktop
searches, (eco)toxicological hazard assessments, QSAR and exposure
modelling. Daniela has a biomedical license in life science and health/
biology with a specialisation in nutrition. She obtained a master’s degree
in health risk sciences at the University of Clermont-Ferrand in France
CASE STUDY 3: Science-based advocacy
ToxMinds has been supporting and advising global chemical and
consumer product companies whose main product categories were
subject to public discussion on potential human health effects in its
scientific external relation programmes. Our work involved the analysis
of the scientific basis of the claims on potential health impacts and the
evaluation of possible response strategies. On behalf of the industry,
ToxMinds presented its scientific views in discussions with the European
Commission, EU Member States as well as non-governmental
organisations leading to a less emotional and a more rational debate
supported by science.
Page 135
PROFILE: ToxMinds
CASE STUDY 1: Consortium management and technical support
to REACH consortia
Dr Petry is the founder and manager of ToxMinds BVBA. He is a product
safety and regulatory affairs consultant with 20 years’ industry, consulting
and research experience in the human safety assessment of chemical
exposures occurring at the workplace, through their use or presence in
consumer products, or via the environment. He is a European registered
toxicologist (ERT) as well as a diplomate of the American Board of
Toxicology (DABT) and earned his PhD in toxicology from the Institute of
Toxicology of the Swiss Federal Institute of Technology (ETH) of Zurich.
GLOBAL OFFICES
Japan, Singapore, China, India, Taiwan, Indonesia, Thailand, Vietnam,
Serbia, Russia, Ukraine, South Korea, USA
SERVICES PROVIDED
Only representative
Website
www.tuev-sued.de/technical_installations/reach
E-mail
[email protected]
Head office
TÜV SÜD Industrie Service GmbH, Westendstr 199,
D-80686 Munich, Germany
Tel
+49 / 89 / 5791-1004
Fax
+49 / 89 / 5791-1174
Contact
Dr Dieter Reiml
TÜV SÜD Industrie Service acts as reliable and impartial OR to numerous
manufacturers of substances established outside the community. The
obligations of an OR outlined in Art. 8 of the REACH regulation comprise
not only registration but also all obligations for importers under REACH.
Calling in an OR has the following advantages: importers need not
become active themselves, and manufacturers established outside the
EU can bundle notifications and do not have to address each importer
individually. We experience that often manufacturers address to us when
their previous OR failed to act to their satisfaction or did not fulfil its
obligations.
Ownership
TÜV SÜD Holding AG
REACH initiative for midsized and small companies
Locations
TÜV SÜD Group employs more than 17,000 people in
80 countries in ca. 800 locations
Founded
1866
All companies must register their chemicals by mid-2013 and by 2018 at
the very latest – which is especially challenging for small and midsized
businesses! TÜV SÜD aims to help these companies ensure that REACH
is not a threat, but a path to safeguarding business. With the special
needs of small and midsized companies in mind, TÜV SÜD has created
a service package that provides these companies with assistance in all
questions related to chemicals. The spirit of initiative: focus on your core
competences, not on REACH.
PROFILE: TÜV SÜD Industrie Service
CONTACTS
OVERVIEW
The principle of REACH, "No data, no market", may seem alarming.
Additionally, comprehensive obligations governing the provision of information
along the supply chain and to ECHA are gradually coming into effect.
As a globally recognised expert in all chemical law issues, TÜV SÜD
continuously pursues the reform process in the EU and supports
companies throughout all steps of REACH and GHS implementation.
To assist the companies affected by REACH, TÜV SÜD has established
an international REACH network. Our environmental experts are tracking
REACH implementation in the EU on an ongoing basis. And in addition,
we also help to maintain business secrets of our customers in spite of
mandatory data sharing provisions.
In view of the 2018 registration deadline TÜV SÜD developed a service
package custom tailored for small and medium enterprises (SME) as well
as for global players.
Our maxim is “REACH – Made easy with TÜV SÜD expertise.”
VITAL STATISTICS
2011/12
Turnover, group
€1,700m
-
No of offices
800
80
Staff, group
17,000
40
Training
10%
Laboratory
10%
Information
10%
Representation
& management
35%
Page 136
Consultancy/
advisory
35%
Authorisation
The authorisation procedure aims to assure that the risks from SVHC are
properly controlled and that these substances are progressively replaced
by suitable alternatives. SVHC may be included in the authorisation list
and become subject to authorisation. These substances cannot be placed
on the market or used after a given date, unless an authorisation is
granted for their specific use, or the use is exempted from authorisation.
Our support extends from the management of authorisation consortia to
supporting individual companies in fulfilling their duties in a costly and
effective manner.
In-house training and seminars
Companies affected by REACH or CLP are seeking advice on how to
deal with the challenges caused by REACH in a timely effective manner.
Desired training events vary depending on participants’ existing knowledge:
OO
introductory training courses to gain an overview of REACH and CLP;
OO
seminars on selected topics of REACH;
OO
workshops to create solutions under the guidance of an experienced
expert;
OO
in-house consulting for the ad-hoc solution of characteristic problems.
Any other activities concerning REACH and CLP
REACH and CLP shift most of the responsibility for the safe handling
of chemicals from the regulatory bodies to producers, importers and
downstream users and retailers. The relevant requirements and
consequences, however, are not clear at first sight. Consequently we offer
all kind of services related to REACH and CLP, from the starting point to
implement REACH via testing in our own GLP accredited laboratory to
long-term compliance with chemicals regulations.
1866
Established in Mannheim
1926
Introduction of the “TÜV SÜD mark / stamp” in Germany
1960
Establishing chemical services
1990
Conglomeration of TÜVs from the southern part of Germany
to form TÜV SÜD and the expansion of business operations
into Asia
2006
Expansion of services in ASEAN by acquiring Singaporebased PSB Group
2007
Establishing REACH services. Founder member of the
"BUSINESSEUROPE REACH Implementation Network”.
ACCREDITATIONS
GLP
CLIENTS
Due to client confidentiality individuals cannot be named. Our clients from
more than 30 countries are active in all fields of industry and professional
sectors. We support a network of chemical plants. Company size varies
from worldwide operating entities to SMEs. We support clients in all their
roles under the REACH regulation.
CASE STUDY 1: Consortium management
A consortium with representatives from five countries took over to register
a series of substances with registration deadlines from 2010 to 2018. The
duty to act as lead registrant was shared among the individual consortium
members. The main bodies of the consortium are the steering committee,
the technical committee and the secretariat. TÜV SÜD rendered
consortium management to all bodies. Technical REACH consultancy and
financial consultancy was part of the services to be delivered.
CASE STUDY 2: Support in REACH implementation
An EU manufacturer of articles and substances required support in
implementing a REACH system for the entire company. The tasks
focused on communication in the supply chain, registration, SVHC,
training and organisational building. A team was formed for continuous
assistance; the core team was fully integrated in the client’s activities onsite.
CASE STUDY 3: Complete service package for lead registrants
Several clients from the chemical industry lacked capacity to prepare lead
dossiers. TÜV SÜD prepared and submitted the lead dossiers on behalf
of the clients. Additionally, all accompanying steps were performed as
well: Sief communication, data-gap analyses, testing, expert statements,
QSAR modelling, communication within consortium, preparation of safety
data sheets, cost calculation of letter of access, handling of letter of
access.
CASE STUDY 4: Testing strategies and testing
The lead registrant of four substances had to conduct studies in order to
fulfil the information requirements under REACH. Two of the substances
were classified as hazardous according to CLP, the classification of the
others was not yet clarified. TÜV SÜD performed all steps to comply with
the information requirements.
All available information that had been gathered was assessed for
its adequacy for classification and labelling, determination of PBT or
vPvB status and the derivation of a dose descriptor to be used in the
chemical safety assessment (CSA). The information was evaluated for
its completeness and quality (relevance, reliability and adequacy). Cost
for data sharing is one of the crucial issues of negotiations in Siefs. High
quality data outsell a higher price than data of low quality.
Some data gaps were closed by QSAR and read-across. Other data
gaps had to be closed by testing. A thorough and meaningful test strategy
was set up in order to minimise cost and to comply with the registration
deadlines on one hand and to comply with REACH annexes VII to X on
the other hand.
TÜV SÜD operates its own GLP testing laboratory capable of performing all
testing required by REACH. The data gaps were closed by physico-chemical
properties testing, ecotoxicological studies as well as toxicological studies.
CASE STUDY 5: SVHC
A EU-based group with legal entities in several member states was
seeking support in making an inventory of SVHC of the articles put into
market, as well as in implementing a system to comply with the duties
to communicate information on SVHC in articles. The legal entities were
predominantly in the role of importers of articles or retailers of articles.
TÜV SÜD offered an integrated approach over all affected legal entities
in order to avoid duplication of work. Representative articles were
selected for chemical testing in case of uncertainty on the presence
or concentration of SVHC. Testing was performed in TÜV SÜD’s own
chemical laboratory.
As a result of the investigation and consulting, a unified system was
implemented in the entire group. The system ensured full compliance with
REACH Art. 33 to 36. Furthermore, supply contracts were amended to
increase legal certainty, to avoid the risk of lawsuits and to avoid image
problems.
CASE STUDY 6: Only representative
TÜV SÜD acts as OR for many non-EU manufacturers. In several
countries this is performed by involving local TÜV SÜD offices. This
approach guarantees direct contact to the end-client and avoids language
barriers where applicable. Thus, also smaller non-EU manufacturers
can benefit from OR services which are not sufficiently conversant with
English and technical terms.
STAFF SELECTION
Dr Fritz Prechtl
Fritz Prechtl is a chemist and certified REACH multiplicator with more
than 30 years' professional experience. His core activities are
OO
only representative
OO
preparing registration dossiers
OO
communication up and down the supply chain
OO
communication in Siefs and with authorities
OO
complex role analyses
OO
consultancy on REACH
Dr Dieter Reiml
Dieter Reiml is a molecular biologist and certified REACH multiplicator
with more than 30 years' professional experience. His core activities are
OO
OO
authorisation
OO
only representative
OO
preparing lead dossiers
OO
CSA / CSR
OO
consultancy on REACH and CLP
Other staff
The majority of the Munich REACH team of TÜV SÜD has gained the
qualification “Certified REACH multiplicator” from the Austrian Chamber
of commerce.
Page 137
PROFILE: TÜV SÜD Industrie Service
Best brand of technical services, testing, consulting, training,
certification in all industries worldwide – energy producers
and providers, nuclear power plants, chemical industry
GLOBAL OFFICES
Headquartered in the US, our main facility is in Ashland OH, with support
offices in Hillsborough NC, Skokie IL and Boothwyn PA. In Europe, our
main facility is in ‘s-Hertogenbosch NL with support offices in Switzerland
and UK. Additional support offices in Tokyo, Japan.
PROFILE: WIL Research
CONTACTS
SERVICES PROVIDED
Website
www.wilresearch.com
E-mail
[email protected]
Head office
1407 George Road, Ashland, Ohio, 44805
Tel
(419) 289-8700
Fax
(419) 289-3650
Contact
[email protected]
Ownership
Privately owned
Locations
Main offices: USA and The Netherlands. Support offices
in the UK, Japan and Switzerland
OVERVIEW
WIL Research consists of over 900 dedicated scientific, technical and
support personnel with locations in the United States, Europe and Japan.
The United States locations include Ashland OH, Skokie IL, Hillsborough
NC and Boothwyn PA. WIL Research provides regulatory affairs support
and programme management for the chemical industry, helping you
to focus on the core activity of your company and advancing your
compounds and products to the market. Our experts give advice on the
full range of regulatory and exploratory studies you will need. Importantly,
they are skilled experts and able to deliver relevant information to you
with full transparency.
WIL Research Europe specialises in personalised contract research
and expert consultancy for the registration of pharmaceutical products,
biocides and (agro)chemicals worldwide. More than 290 well-trained
and dedicated specialists and modern purpose built laboratories and
offices are available to perform your regulatory (eco)toxicology studies.
Our operations have been endorsed by the GLP monitoring authorities
(OECD/EPA/FDA/JMAFF certification).
VITAL STATISTICS
Our objective is to contribute to better human health, environmental
safety and industrial progress by accelerating the development process
of our client’s products. We support our clients by providing quality driven
contract research services. Our added value results from dedicated
staff working together with our client’s project team and enhancing the
processes through clear communication and scientific interpretation
of results. Our staff create the company’s value and this is enhanced
by continuous education, exciting career opportunities and personal
development. By these means the WIL Research team remains dedicated
and its objectives clear.
REACH compliance
REACH consultancy and Sief management and full testing
portfolio
REACH safety testing
To help you comply with the regulations WIL Research has set up a tenstep action plan which will cover all aspects of the registration needs for
both phase-in (EINECS materials) and the non-phase-in substances (new
chemicals). The different steps are given below. For each of these steps
we can provide more details on the activities within that step and the cost
estimation for completing that part of the work.
Full service portfolio for Annex 7-8-9-10
Registration chemicals worldwide
WIL Research provides regulatory affairs support and programme
management, helping you to focus on the core activity of your company
and advancing your compounds and products to the market.
Registration of agrochemicals and biocides
EDSP – endocrine disruptor screening programme (complete set of
assays) in conformity with EPA requirements.
2011/12
Safety testing including (eco) toxicology and risk assessment
Turnover, group
-
-
No of offices
8
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
40-50
Staff, group
900
-
Consultancy/
advisory
17%
Representation
& management
3%
Laboratory
80%
Page 138
OO
OO
OO
OO
OO
WIL Research has achieved Good Laboratory Practice (GLP)
compliance status for more than 20 years, with the most recent GLP
endorsement statement signed in May 2011.
WIL Research publication was referenced in the guidance document
117 for OECD 443 guideline.
WIL Research published article is referenced in the guidance
document 126 for the OECD 203 guideline.
We’re proud of our longstanding accreditation through the Association
for the Assessment and Accreditation of Laboratory Animal Care
(AAALAC).
We never get complacent about quality. Constantly striving to improve
it, we regularly analyse our processes and have established quality
improvement teams as part of our total quality management (TQM)
policy.
CLIENTS
Non-disclosure agreements prohibit this level of information.
CASE STUDY 1: WIL Research 10 steps to REACH compliance
We understand clearly that each situation is different and we therefore
advocate discussing this in a personal meeting going through the
following distinct steps:
OO
Step 1 - Inventory;
OO
Step 2 – (late) Pre-registration or inquiry Step 3 - Refinement of
inventory;
OO
Step 4 - Data evaluation;
OO
Step 5 - Determination of data gaps;
OO
Step 6 - Completion data requirements (Annex VII/VIII);
OO
Step 7 - Chemical safety assessment/report (CSA/CSR);
OO
Step 8 - Prepare a test proposal (> 100 t/y);
OO
Step 9 - Dossier preparation, finalisation and submission;
OO
Step 10 - Safety data sheet.
CASE STUDY 2: Biocidal registration
WIL Research’s regulatory affairs department provides a complete service
for the registration of biocides under the biocidal products Directive 98/8/
EC.
Our aim is to provide you with a high quality service which will help you in
achieving product registrations in a fast and efficient way.
We provide complete hazard characterisation and exposure assessments
for operators, workers, bystanders and consumers as well as for the
environment (groundwater, surface water, soil, air, non-target organisms).
These assessments are carried out using various modelling tools
(eg USES, EUSES, etc) and are based on the most up to date guidelines
and emission scenario documents.
WIL Research’s experienced team consists of regulatory experts in
chemistry, environmental fate and behavior, residues, ecotoxicology
and human toxicology. In addition to outstanding technical knowledge,
we have well-established contact with EU and national authorities
and a thorough understanding of the procedures involved in obtaining
registrations for biocides.
We assist you with dossier preparation at EU and Member state level.
We compile complete dossiers (Documents I, II, III and study reports) in
electronic format. Prior to dossier compilation, we assist you in identifying
data gaps and project management, outsourcing and study monitoring,
writing data waivers to save costs and time, and discussions with
authorities.
Our services are custom made to fit your needs and range from
assistance with single sections and smaller regulatory questions to the
preparation of complete dossiers.
CASE STUDY 3: Complete hazard and exposure assessments
WIL Research’s regulatory affairs department provides a complete service
for the registration of agrochemicals under the regulations 91/414/EC,
1107/2009.
We provide complete hazard and exposure assessments for operators,
workers, bystanders and consumers, as well as for the environment
(groundwater, surface water, soil, air, non-target organisms). These
assessments are carried out using various modelling tools and are based
on the most up to date guidelines.
WIL Research’s experienced team consists of regulatory experts in
chemistry, environmental fate and behavior, residues, ecotoxicology and
human toxicology. In addition to outstanding technical knowledge, WIL
Research has well established contact with EU and national authorities
and has a thorough understanding of the procedures involved in obtaining
registrations for agrochemicals. We assist you with dossier preparation at
EU (Annex II) and member state level (Annex III) – taking into account the
national dossier requirements.
Our services are custom-made to suit your needs. They include dossier
compilation (electronic submissions, CADDY), technical dossier writing,
data gap analysis and project management, outsourcing and study
monitoring, risk and exposure assessments and post-submission
support. We further assist you with classification and labelling issues,
import tolerance dossiers, and setting of MRLs or help you with complete
dossiers or single sections and smaller regulatory questions.
STAFF SELECTION
Wilbert Frieling, DVM – Managing Director
Wilbert Frieling graduated in veterinary science from the University of
Utrecht, The Netherlands, in 1991. From 1991 until 1996 he directed a
veterinary practice. He joined WIL Research as a supporting veterinarian
in December 1994. In April 1996 he was appointed as section head
General and Industrial Toxicology, in 1997 he was appointed as head
of Toxicology and in 2004 he was appointed director of Toxicology.
When WIL Research joined WIL Holding in 2005, he was appointed as
managing director of WIL Research BV.
Since 2000 he has been registered as a Eurotox board certified
toxicologist. He is also a board member of NVDEC (Dutch society
of animal ethical committees). He has presented various papers on
international meetings on toxicology (mini-pig in toxicology, continuous
infusion technology and preclinical safety testing strategies).
Steven D Barkyoumb, DVM, PhD – Sr Vice-President, Global
Operations – Nonclinical Safety Assessment
Steve has over twenty five years of non-clinical safety assessment
experience in the pharmaceutical and contract research industries. He
brings extensive experience in regulatory-driven toxicology, pathology
and laboratory sciences. Most recently, he served as Vice President,
Nonclinical Safety Assessment for Covance Laboratories and held
the role of Global Chief Scientific Officer, Pathology and Immunology
Services. He directed the growth of Covance’s toxicology business in
North America and managed the pathology and immunology services
across six sites in the United States, Europe and Asia. Clients describe
Steve as a leader with high integrity, strong principles and outstanding
operational skills with a sharp focus on scientific excellence and quality.
Prior to joining Covance, Steve served as the Executive Director for
Nonclinical Drug Safety at Quintiles and the Director of Regulatory
Toxicology and Safety Pharmacology for the Drug Safety Evaluation
unit at Abbott Laboratories. He began his career with a series of roles
with increasing responsibility with Hoechst Marion Roussel and its
predecessor companies. Steve holds a Doctor of veterinary medicine
degree and a PhD in veterinary pathology from Kansas State University.
He is a Diplomate, American College of Veterinary Pathologists (1984
– present) and previously a Diplomate, American Board of Toxicology
(1989-2004).
Page 139
PROFILE: WIL Research
ACCREDITATIONS
GLOBAL OFFICES
European Office of Wildlife International: Waterstraat 5, 7201 HM
Zutphen, The Netherlands
Japanese Agent: LSG Corporation; S&S Buildling 6-36 ShinOgawamachi; Shinjuku-ku, Tokyo 162-0814; Japan
a D i v i s i o n o f E aG , i n c.
E n v i R o n M E n Ta L faT E & E coToX i co Lo G Y T E s T i n G
SERVICES PROVIDED
PROFILE: Wildlife International
CONTACTS
Website
www.wildlifeinternational.com and www.eaglabs.com
E-mail
[email protected]
Head office
8598 Commerce Drive, Easton Maryland 21601, USA
Tel/ Fax
+1 410 822 8600/ +1 410 822 0632
Contact
Annegaaike Leopold
Directors
Mark Jaber, Managing Director
Jim Miraldi, Vice President Finance
Dave Palmer, Director of Business Services
Annegaaike Leopold, Director Global Business
Development
Ownership
Private company
Locations
USA, The Netherlands
Founded
1976
Biodegradability testing and environmental fate
Biodegradation screening and testing (OECD 301, 310, 314, 303 etc).
Environmental fate testing (OECD 307, 308, 309, 106). All these studies can be
performed including metabolite identification. Specific expertise in the context of
REACH is in the field of biodegradability screening and simulation testing. The
manure degradation study is another major area of specialisation at Wildlife.
Endocrine disruptor screening and testing
Further specific expertise lies in the field of endocrine disruption screening and
testing, We have in-house histopathology services to evaluate the potential of
chemicals to effect endocrine-sensitive tissues in fish, amphibians and frogs.
Sediment toxicity and terrestrial plant testing
We offer testing and study design expertise in terrestrial and aquatic plant
testing and evaluation of products to sediment dwelling organisms. A
9,000 m2 greenhouse provides ample space for testing multiple species
and advanced study designs. Sediment testing includes freshwater and
marine acute and chronic tests.
OVERVIEW
Ecotoxicology testing
Wildlife International is a leading contract research organisation
(CRO) specialising in ecotoxicology, environmental fate and chemistry.
Established in 1976, we serve, and provide support to, a global clientele
with GLP studies to meet global regulatory requirements for pesticides,
pharmaceutical and animal health products and industrial chemicals.
Wildlife leads in endocrine ecotoxicological testing and screening.
Bioaccumulation testing is one of our major areas of specialisation. Our
mass spectrometrist and Bruker maXis impact UHR-TOF instrument
completes our environmental fate capabilities. Wildlife International is a
part of the Environment Fate, Chemistry and Ecotoxicology Division of
EAG, Inc together with PTRL-West and PTRL-Europe. PTRL provides
specialised services in analytical chemistry and residue analysis,
environmental fate and metabolism helping us to complete our service
offerings.
Wildlife International Ltd maintains a modern aquatic toxicology laboratory. It
has been open since 1990. The facilities are designed to accommodate a wide
range of acute and chronic aquatic tests, and are capable of supporting a large
number of concurrent studies. Testing is performed in walk-in environmental
control chambers with built-in reconfigurable diluter systems (capable of
holding up to 64 replicate test tanks), or in smaller test systems each consisting
of an integrated temperature controlled water bath and diluter, enclosed in an
isolation chamber. The lab can run up to ten bioaccumulation studies per year.
VITAL STATISTICS
2012/13
Turnover, group
US$21
US$3.5m
No of offices
2
3
Staff, group
135
Other
Consultancy/
Training 2%
advisory
3%
5%
Laboratory
90%
Page 140
80
1976
Established as an avian toxicology facility with a staff of five
1983
Company acquired by current managing director and partner
1986
Opened laboratory designed for full service avian toxicology
testing
1990
Opened 2,800m2 aquatic toxicology and chemistry laboratory
1990
Expanded avian toxicology laboratory to 3,600m2
1992
Established biodegradation department to offer ready,
inherent and specialty biodegradation testing
1997
Opened the European office of Wildlife International Ltd in
The Netherlands
2000
Opened 1,300m2 environmentally controlled greenhouse facility
2006
Expanded biodegradation and e-fate department to include
300m2 of new laboratory space
2009
Completed in-house histopathology laboratory to evaluate
endocrine effects in fish, amphibians and birds
2010
Acquired by the Riverside Company
2011
Opened up 1,100m2 expansion designed to conduct aquatic
endocrine testing.
2012
Acquired a Bruker maXis impact UHR-TOF
Dec 2012
Merged with Evans Analytical Group (EAG, Inc) adding the
expertise of PTRL-West and PTRL-Europe to our range of
services.
Good laboratory practice (GLP) − multiple inspections by EPA with no findings
PARTNERS
Wildlife International works with many other contract laboratories and
consultancies with the aim of optimally serving our clients. Within the
Environment Fate, Chemistry and Ecotoxicology Division of EAG, Inc we
partner with PTRL-West and PTRL-Europe.
CLIENTS
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Agricultural chemicals: Dupont, Syngenta, DowAgro, BASF, Bayer,
Monsanto, Makteshim-Agan, Sumitomo, Nihon Nohyaku, Valent,
Gowan, Agrichem, Nufarm
Industrial chemicals: The Dow Chemical Company, Albemarle, ICL,
Arkema, Bayer, Dupont, Akzo Nobel, Procter and Gamble, RIFM
Pharmaceutical: Pfizer, Sanofi-Aventis, Eli Lilly, Merck & Co
Animal health: MSD (Intervet), Eli Lilly
TESTIMONIALS
"Wildlife International has always had a highly competent staff that
produces high quality reports with attention to detail. The reports meet
or exceed our needs for REACH and other regulatory requirements.
Wildlife is also flexible and will attempt to meet timelines on key projects
if at all possible. We have enjoyed working with Wildlife International Ltd
personnel for over 15 years and will continue to do so in the future." − The
Dow Chemical Company
“The European Office of Wildlife International brings the laboratory to the
doorstep of our clients.”– TNO-Triskelion.
CASE STUDY 1: Glyphosate: fish short term reproduction assay
(FSTRA) with the fathead minnow (Pimephales promelas) – a
paper presented at SETAC US 2012, S. Schneider et al, Wildlife
International
The objective of this assay was to determine if glyphosate might
impact the hypothalamus-pituitary-gonadal (HPG) endocrine axis resulting
in the disruption of reproduction in fish. Breeding groups of fathead minnows
(Pimephales promelas) were exposed to glyphosate under flow-through
conditions at mean measured concentrations of 0.046, 0.23, 1.2, 6.2 and
33 mg ae/L for 21 days. Endpoints that were evaluated for endocrine
disruption of the reproductive system included fecundity, fertility, secondary
sex characteristics (including tubercle and fatpad scores), gonadosomatic
index (GSI), histopathology of gonads, as well as plasma vitellogenin. Other
endpoints included survival, general observations of health, weight, and
length. There were no apparent effects on survival, growth, reproduction,
secondary sex characteristics, GSI, VTG or gonad histopathology in male
or female fish exposed to glyphosate for 21 days. Based on the endpoints
evaluated, glyphosate does not appear to impact the function of the
hypothalamuspituitary-gonadal (HPG) endocrine axis in fathead minnows.
CASE STUDY 2: E how a new builder in automatic dishwashing
detergent became ready biodegradable in the US: widespread
microbial adaptation in the field – work performed at Wildlife
International Ltd. Poster presented at SETAC US 2012, Itrich et al
L-GLDA (Glutamatediacetate) is a chelant that was introduced as a
phosphate replacement in a North America (NA) automatic dishwashing
(ADW) detergent gel in early 2010. Prior to ADW use, LGLDA failed
multiple biodegradation screening tests (OECD301B) in the NA region
and was not considered ready biodegradable in this geography. However,
results from a more realistic continuous activated sludge treatment test
(OECD 303A) predicted that a microbial population pre-exposed to
L-GLDA would extensively degrade it after a lag period. In this same time
frame, activated sludge inoculum from a single EU plant did degrade
L-GLDA and produced a bacterium that could utilise it as a sole
nitrogen, carbon and energy source. The market introduction of this
new ADW and the subsequent widespread distribution of L-GLDA in
wastewater offered a unique opportunity to monitor for potential microbial
adaptation in the field. After launch of the ADW, a series of OECD 301B
tests were conducted using inoculum collected from multiple WWTPs
in two NA regions. Within several months, WWTP inoculums that had
previously produced negative results, measuring 9-21% CO2 production,
demonstrated that L-GLDA was “ready biodegradable” (65-100% CO2).
Inoculum from additional WWTPs also showed positive ready test results
and a decrease in the measured lag period (< 10% CO2) was observed as
distribution of the ADW grew, indicating an increase in the field population
of competent degraders. This is the first systematic study showing how a
new chemical, that consistently failed ready biodegradation tests in the US
became ready biodegradable across a wide geographical region following
its introduction in a commercial product. The ready test is required under
most regulatory schemes for the registration of a new chemical and to
demonstrate a lack of persistence. However the use of pre-exposed
inoculum is strictly prohibited in some regions. This work demonstrates
that when pre-exposure occurs under realistic conditions, laboratory
tests can accurately predict ultimate real world behaviour indicating the
importance of considering potential adaptation in regulatory assessments.
STAFF SELECTION
Henry O Krueger, PhD – Director of Aquatic and Non-Target Plant
Testing
Director of aquatic toxicology since 1995. Responsible for all aspects of
the Wildlife International Ltd aquatic toxicology programme including fish
and amphibian endocrine disrupter studies. Expert aquatic toxicologist,
with specific expertise in bioaccumulation testing sediment toxicology
testing and endocrine test design, conduct and interpretation.
Timothy Springer, PhD – Director of Special Projects
Dr Tim Springer manages special projects and technical support. He
was responsible for the development of the abbreviated in vivo fish
bioconcentration test. Dr Springer has played a critical role in the revision
of the OECD guideline 305, and in development methods to estimate
BCF values using data from BMF studies.
Edward Schaefer – Director of Fate and Biodegradation
Mr Schaefer has more than 20 years of experience in the area of
degradation and environmental fate testing. Responsible for study design
and oversight of testing programmes. Key contributor to development of
EPA/OECD test guidelines – specifically OECD guideline 314.
Dr Timothy Blake – Metabolite Identification Specialist Dr Blake is a senior level scientist who has spent more than 25 years
performing definitive structure ID analysis. Dr Blake completes our ability
to conduct metabolite identification work using our UHR-TOF instrument.
Dr Alex Ponizovsky – Senior Scientist of Environmental Fate
Dr. Ponizovsky holds a PhD in physical chemistry from the Institute of
General and Inorganic Chemistry, Academy of Sciences, USSR, Moscow,
1981. He has 30 years of research experience and more than ten years
of environmental fate testing experience, specialising in adsorption/
desorption studies.
Page 141
PROFILE: Wildlife International
ACCREDITATIONS
SERVICES PROVIDED
REACH compliance
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PROFILE: WTConsulting
CONTACTS
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Website
www.wtconsulting.ch
E-mail
[email protected]
Head office
Weierweg 7, 4410 Liestal, Switzerland
Tel
+41 61 923 30 00
Fax
+41 61 923 30 02
Contact
Ulrich Wietschorke
Directors
Ulrich Wietschorke
Dr rer nat Andreas Tschech
Ownership
Private company
Locations
Switzerland
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Founded
2007
OO
OO
OO
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data gap analysis including scientific and monetary evaluation of data
(Klimisch etc)
literature search
development of intelligent test strategies
QSAR, read-across / bridging, waiving
compilation of technical dossier and chemical safety report in
IUCLID5
technical dossier submission, updates and follow-up
support on joint submissions
project management (initiation and scientific monitoring) of studies
(physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental
fate) at test laboratories
negotiations with regulatory agencies and scientific bodies
CLP / GHS notification, classification and labelling
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collection and assessment of data available
QSAR and read-across / testing proposal
classification according to CLP (1272/2008) and DSD (67/548/EEC)
submission of C&L notifications with ECHA (European Chemical
Agency)
OVERVIEW
Chemical notifications worldwide
WTConsulting is an independent and neutral full-service provider in
international regulatory affairs, environment, health and safety, offering
more than 25 years of sound knowledge and experience.
The regulatory disciplines covered include chemicals, food contact
substances/ food packaging, drinking water contact substances, direct
food additives, feed additives, medical devices, cosmetics and cosmetics
raw materials, toys and pharmaceutical packaging.
Geographic regions covered: Europe, North America, Japan, Korea,
China and Australia.
WTC staff are familiar with the requirements for the notification of new
chemicals to all notification schemes around the world. We cooperate
with local independent regulatory experts to ensure appliance of the very
latest expert information and direct access to regulatory agencies and test
laboratories, as needed.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
1
1
Staff, group
7
7
Food contact substances/ food packaging materials
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
OO
Cosmetics and cosmetic raw materials
Training
Information 5%
5%
OO
Representation
& management
10%
OO
Consultancy/
advisory
80%
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GLOBAL OFFICES
Page 142
safety evaluation of cosmetic raw materials, and cosmetics and
fragrances applying QSAR, read-across
compilation of registration dossier of cosmetic ingredients and
submission
Food additives and feed additives
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Covered by partner network.
review of existing data, gap analysis and test programme proposal
compilation of safety assessments, and depending on the country
environmental impact assessments
compilation and submission of registration dossiers, including follow-up
analytical method development and validation
migration calculation and migration studies
(migration, mutagenicity, toxicity) at test laboratories
compliance certification of plastic formulations (supply chain support)
preparation of compliance documentation according to Regulation
1935/2004
support on GMP
other countries upon request.
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review of existing data, gap analysis and test programme proposal
compilation and submission of registration dossiers, including followup
analytical method development and validation
(physical-chemical, mutagenicity, toxicity, eco-toxicity, environmental
fate) at test laboratories
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evaluation of biocompatibility in accordance with ISO 10993-1 / USP
literature search and data collection for safety assessment/ gap
analysis/ conception of test programme
(haemocompatibility, migration/ leaching, cytotoxicity, mutagenicity,
toxicity, ADME studies) at test laboratories
assessments reports
compliance certification
Toys
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evaluation of the chemical safety of toys in accordance with Directive
2009/48/EC
literature search and data collection for safety assessment/ gap
analysis/ conception of test programme
(migration/ leaching, cytotoxicity, mutagenicity, toxicity, ADME studies)
at test laboratories
assessments reports
compliance certification
compilation of technical information files according to EU Toys Directive
consulting on safety strategies
CASE STUDY 2: Time to market/cost savings
For a new chemical substance WTConsulting developed a test
programme for the global notification under chemical regulations
schemes and for the registration as an additive for food contact plastics in
Europe and in the USA. With the developed test programme the chemical
substance obtained global notification under chemical schemes, and it
became regulated / approved for food contact / packaging applications
“across the board” in Europe (EU-EFSA and German BfR) and in the
USA (FDA). The toxicological test programme was optimised to the extent
that also the eventual degradation products were covered, resulting in
significant cost- and time savings for the client. Market implementation for
food contact application could start 18 months early.
CASE STUDY 3: Business impact analysis and support
Industry is exposed to an increasingly growing regulatory and nonregulatory environment worldwide. At WTConsulting, we see this
development as a mega-trend. We support our companies taking these
developments into account and achieving sustainable global business,
growth and development.
WTConsulting successfully consulted and navigated a multi-national chemical
company through scientific, regulatory and non-regulatory negotiations
with agencies, NGOs and OEMs, demonstrating regulatory compliance,
environment and consumer safety of strategically important products.
2007
WTConsulting GmbH founded
CASE STUDY 4: Development of safety strategy and synergies
2008
Establish CRO network
2009
Establish global network of expert regulatory consultants
For a world-leading toy manufacturer WTConsulting successfully
developed a global safety strategy going beyond applicable toys
regulations. The strategy addresses the rapid developments in the
regulatory environment not limited to consumer safety, but also
addressing the product life cycle per se. As the evaluation of the raw
materials was part of the project, sensitive information was disclosed
– under a secrecy agreement. The safety strategy grants compliance
(beyond) toy regulations and directs permanent optimisation of raw
materials in view of life cycle aspects.
ACCREDITATIONS
WTConsulting staff is member of the Swiss Society of Toxicology and the
Swiss Society of Chemistry.
PARTNERS
Partner companies can be viewed on our website.
CLIENTS
In line with our confidentiality terms and the nature of our business,
WTConsulting does not release the identity of clients. WTConsulting
works for international companies covering the whole supply chain
including OEMs.
TESTIMONIALS
Testimonials will be provided upon individual request.
CASE STUDY 1: Overall experience
WTConsulting staff members experience is based on:
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more than 1,560 chemical notifications including testing and risk
assessment;
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more than 465 food contact substance notifications and registration
dossiers;
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more than 3,550 compliance evaluations of plastic formulations for
food contact use;
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more than 150 safety assessments for plastic formulations and
individual ingredients (including degradation products) for use in toys;
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over 80 safety assessments of cosmetic ingredients;
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over 650 evaluations of bio-compatibility of medical devices;
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active involvement in regulatory working groups.
STAFF SELECTION
Ulrich Wietschorke
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BSc in biology
founder of WTConsulting GmbH
26 years’ experience in the CRO industry as global senior regulatory
affairs professional, consultant and managing director
Dr rer nat Andreas Tschech
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PhD in biology
co-founder of WTConsulting GmbH
23 years’ experience in the CRO industry as global senior regulatory
affairs professional, consultant and regulatory toxicologist
Dr rer nat Birgit Seyfried
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PhD in biology
22 years' experience in the CRO industry as eco-toxicologist/ study
director and department head, and six years as regulatory affairs
manager
Page 143
PROFILE: WTConsulting
Medical devices
GLOBAL OFFICES
US: East Moline, IL (two locations); Woburn, MA; Des Moines, IA; St
Louis, MO; San Antonio, TX; Newark, CA; Princeton, NJ.
Brazil: São Paulo.
Europe: Walldorf, Germany; London, UK; Solna Sweden.
India: Indore, MP; Hyderabad, Madhapur (two locations); Pune, MH (two
locations); Bangalore, KA ; Mumbai, MH; Gurgaon (NCR).
Australia: Sydney, New South Wales .
PROFILE: YASH Technologies
CONTACTS
Website
www.yash.com
E-mail
[email protected]
Head office
841 Avenue of the Cities, East Moline, IL 61244, USA
Tel
847-903-2564
Fax
309-755-3742
Contact
Hari Vyakarnam, Vice President and Practice Director –
Sustainability Solutions
SERVICES PROVIDED
SAP EHS (and sustainability) services portfolio
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Directors
Paul Struck, SAP Practice Director
Yogesh Nagpal, REACH and SAP EH&S Program
Manager
Ownership
Privately held
Locations
North America, South America, Europe, Asia, Australia
Founded
1996
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MSDS and label authoring (and management)
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OVERVIEW
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YASH Technologies has been providing services and support around
environmental health and safety management to global customers for
years, helping them to cost-effectively meet various product, health
and safety, and environmental compliance. With the strong functional,
technical and business knowledge around the EHS and regulatory
compliance (REACH, RoHS, GHS, etc), YASH has brought together all of
its experience to bring in a holistic compliance approach which aligns to
address industry specific compliance needs.
VITAL STATISTICS
2011/12
Turnover, group
-
-
No of offices
21
7
Staff, group
2,500 total globally
100
Other
Training 2%
3%
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IT & software
70%
Page 144
REACH assessment, consulting and management
IUCLID dossier creation for REACH registration
robust summary preparation – per OECD/ REACH guidelines
substance and use-specific data collection
supporting data/system preparedness towards REACH
substance-specific exposure scenario, e-SDS generation
CSA and CSR creation and validation
literature search from authentic and reliable sources
guidance, training and orientation towards REACH
compliance process/ systems setup
Regulatory consulting and EHS support services
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Information
5%
MSDS authoring with various regions /regulatory requirements
MSDS conversion from other formats to country specific GHS
guidelines (CLP/ OSHA /others)
regular updates in SDS, labels as per the changes in the regulations,
business or customer requirement
classification and labelling of substances/ products
creation of various types of labels in WWI (SAP)
automatic report shipping, distribution,
label determination and management (in SAP)
MSDS help desk – for prompt support on MSDS requests
MSDS management – complete business outsourcing related to
entire MSDS operations
REACH compliance services
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Consultancy/
advisory
20%
business assessment
solution consulting and mapping
SAP product (module) implementation
application maintenance support
roll outs and upgrades
EHS data migration/ management
user/ business training
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compliance process/system evaluation and optimisation
compliance data collection and management
complete business process outsourcing for EHS data/ processes for
organisation wide compliance management
in-house organisational-wide training and consulting services
guidance and advisory workshops
IT application modernisation to meet the obligations from various
regulations such as RoHS, REACH, GHS, OSHA, TSCA, WEEE, etc
other ITES (MDM) support with regards to EHS compliance
1996
YASH Technologies is founded
2000
YASH establishes its first offshore development centre in India
2008
YASH starts its REACH and RC CoE with services focused
around REACH, GHS, OSHA and other regulatory compliance
2009
Gartner includes YASH in REACHing Downstream document
2010
inREACH, a proprietary solution by YASH, is launched
2011
YASH solutions around MSDS/ label management is
included into the SAP PLM –LoB Solutions portfolio
2011
YASH is recognised as the development and testing partner
for SAP – Chemical BP Solutions releases
2012
YASH opens offices in Germany and Sweden in Europe and
expands global reach to Australia
2012
YASH receives the Pinnacle award from SAP
ACCREDITATIONS
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chemicals industry best practices development with SAP (ChemOne
India V1 603 & V1 605)
product development/ testing partner for SAP EHS solutions
experienced professionals in providing solutions on regulatory
compliance for chemical, E&E, manufacturing industries
dedicated and established CoE on regulatory compliance to support
EHS (and regulatory) consulting and services
CLIENTS
Sampling of customers includes: DOW Chemical, Chemtura, Nova
Chemicals, Arch Chemicals, Quaker Chemicals, Red Spot, Gulbrandsen,
Cheminova, Asian Paints, Dr Reddy’s.
TESTIMONIALS
“[...] If you are looking for a system integration partner for your
implementation project, the SAP chemicals team highly recommends
YASH Technologies based on their deep experience in the chemical
industry and their proven success." – Frank Kochendoerfer, Director, SAP
IBU Chemicals
“[…] YASH had the deep chemical industry expertise we were looking
for in a partner. We felt really comfortable with the customer-centric and
flexible delivery options that a midsize company like YASH could provide.”
– Kevin Kolley, Corporate Director of IT, Red Spot
CASE STUDY 1: Chemtura Corporation
YASH was engaged as strategic partner for over four years to support
SAP landscape globally. YASH’s compliance services include:
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MSDS distribution/ management;
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data migration/ clean up;
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WWI labels creation;
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global support team with 24*7 availability;
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BoM-BoS transfer;
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property tree/ regulatory data update.
CASE STUDY 3: Dow Chemicals
Dow is a global leading manufacturer of specialty chemicals, advanced
materials, agro-sciences, and plastics to customers in 160 countries.
However its internal team could not keep pace with growing demand for
material safety data sheet (MSDS) creation, and was only able to produce
approximately 200 MSDSs a month
YASH was selected to provide MSDS “authoring” with a 100% accuracy
goal and shortened cycles. YASH’s involvement led to:
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refined process documents and training;
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extracted data relevant to standards and regulations;
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an average monthly MSDS output from YASH was 1500 MSDSs;
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Dow realising significant cost savings .
STAFF SELECTION
Hari Vyakarnam – Practice Director – Sustainability
Responsible for managing YASH’s services and solutions related to
environment, health and safety. Besides EHS, Hari focuses in offering
regulatory compliance services for a variety of regulations such as
REACH, RoHS, GHS etc. He has more than 21 years of experience in
product management, account management, practice management,
alliance management, business development and over six years’
experience in providing SAP EHS and regulatory solutions to global
large chemical companies. Hari has 15 years of experience working
with globally distributed teams and providing consolidated professional
services to Fortune 500 clients. He holds a Master’s degree in business
and systems management and is a certified quality analyst.
Yogesh Nagpal – Program Manager – SAP EH&S and REACH – is
the SME on EU-RoHS, REACH and SAP EHS business suite
Responsible for managing and driving various projects around EHS and
regulatory compliance with many reputed accounts. He brings more
than ten years of experience in EHS solution consulting and business
assessment from varied industry segments specifically focused around
the product compliance like RoHS, REACH, GHS, IMDS, WEEE. He
holds a Master’s degree in business management along with a PG
diploma in environmental sciences.
Paul Struck – Practice Director, Process Industries
Responsible for enhancing YASH's services and solutions portfolio to
directly address the business challenges of the process industry vertical.
Paul has more than 20 years of information technology and business
process consulting experience. Prior to joining YASH, Paul managed a
variety of SAP solution-based business transformation initiatives with
Fortune 500 clients including DuPont, BP, PepsiCo, and Microsoft. He has
18 years’ experience in consulting, including senior positions at Deloitte,
Accenture, and Hitachi Consulting.
CASE STUDY 2: Red Spot Paint and Varnish
This company provides high performance coatings for plastics, with
a focus in the automotive industry. They implemented YASH’s SAP
Business All-in-One ChemOne solution for ERP in 30 weeks. This
included:
OO
extensive, complex recipe management;
OO
leveraging SAP for reporting and dashboards for one version of the
truth;
OO
plans to implement warehouse management, quality management,
and mobility.
Page 145
PROFILE: YASH Technologies
CONTACTS
www.ag-hera.com
[email protected]
23 London Street, Faringdon, Oxfordshire SN7 7AG, UK
+44 (0) 1865 58 98 93/ 7805609296
Albania Grosso
Sole ownership
Spain, United Kingdom
2020
OVERVIEW
AG-HERA specialises in REACH, CLP, and chemical hazard, exposure and risk assessment.
The company, founded by Albania Grosso after 20 years of employment in environmental
consultancy firms and government agencies in the US and the UK, has extensive technical
and project management experience in the field of environmental legislation and compliance.
AG-HERA’s unique combination of technical and project management capabilities, plus
leading edge experience of REACH and CLP registrations, provides clients with seamless
solutions to any chemical risk assessment challenge. We can model worker and consumer
exposure to chemicals, exposure of the general population via the environment, and the
exposure of different environmental compartments. We are experienced in the use of
EUSES, Chesar, ART, IUCLID and ECETOC TRA. In collaboration with our associate
companies we provide the full range of technical, legal and administrative services required
for effective compliance with environmental regulations such as REACH and CLP.
SERVICES PROVIDED
Consortium management, dossier preparation and data management, pre-registration/
registration, risk assessment (environmental), risk assessment (human), testing
strategies, corporate strategy/advice.
CLIENTS
Lower Olefins and Aromatics (LOA) Consortium, Higher Olefins and Poly Alpha Olefins
(HOPA ) Consortium, Hydrocarbon Solvents REACH Consortium (HCSRC), CONCAWE,
International Lead Association (ILA), Frits Consortium, Precious Metals Consortium, Rutgers
Belgium, Penman Consulting, Regulatory Science Associates Ltd, wca environment ltd.
Website
E-mail
Head office
Tel/Fax
Contact
Ownership
Locations
Founded
www.big.be
[email protected]
Technische Schoolstraat 43A, 2440 Geel, Belgium
+ 32 14 58 45 47 / +32 14 58 35 16
Zita Snellinx
Non-profit organisation
Belgium
1979
OVERVIEW
BIG is an independent information and emergency call centre for dangerous chemical
substances. Information is gathered on physico-chemical and (eco)toxic properties, as well
as regulations on safety, health, environmental protection and transport related to hazardous
materials. Based on these data BIG delivers a large number of products and services to
clients from diverse sectors, including: industry, emergency services, governmental and
inspection services, healthcare and academia.
SERVICES PROVIDED
BIG offers expertise concerning information on hazardous substances. For REACH and
CLP this means assisting our clients in determining what their role and obligations are,
the complete registration process from A to Z (including data gap analysis, CSA/CSR/
ES), notifications and authorisations, communication up- and downstream (compilation of
ext-SDSs, CLP compliant labels), onsite training in REACH and/or CLP, onsite REACH
audits, only representative and third party representative services. BIG also specialises in
downstream user reports and DU CSA/CSR/ES for non-identified uses.
CLIENTS
BIG is only representative for many global players, providing customised services to large
international companies and SMEs. Our clients are in many sectors, such as: raw chemicals,
fine chemicals, polymers, adhesives, plastics, healthcare, pharmaceuticals, coatings and
paints, article manufacturers.
CONTACTS
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
CONTACTS
www.altox.dk
[email protected]
Tonsbakken 16-18, DK-2740 Skovlunde, Denmark
+45 3834 7798/ +45 3834 7799
Pernille Hjaltalin
Denmark
1992
OVERVIEW
ALTox is a consultative company that provides counselling and training within:
OO
REACH and CLP requirements of chemicals and articles (C&L, SDS, ECHA
registrations and communication)
OO
biocides
OO
cosmetics and toys
OO
other registration services (eco labelling, national product registers, COLIPA etc)
OO
general safety counselling for professional and private use (on-site handling,
storage etc in relation to regulations for occupational health and environment)
OO
Scandinavian regulations (eg MAL codes and order on carcinogenic substances).
SERVICES PROVIDED
At ALTox we assist private companies (SMEs as well as large companies), authorities and
trade organisations and work in collaboration with the client to find the most appropriate
result. We aim at finding practical solutions based on science and regulatory requirements.
ALTox is widely recognised for the development of helpful desk tools to ease implementation
of C&L and preparation of SDS. Being independent from software solutions (C&L, SDS) and
test laboratories (CRO) allows for a more flexible approach towards regulatory changes.
CLIENTS
Importers, downstream users and manufactures of chemicals primarily in Europe.
ALTox also provides counselling to trade organisations, universities and other
professionals within the chemical area.
Website
E-mail
Head office
www.calebgroup.net
[email protected]
The Stables, Somerset House, Church Road, Tormarton,
Badminton, Gloucestershire, UK
+44 (0)1454 269330/ +44 (0)1454 216030
John Yates
Tel/ Fax
Contact
Ownership
Private company
Locations
Founded
1994
UK, Germany, USA
OVERVIEW
Caleb Management Services Ltd is a policy and regulatory consultancy that has
been active in the field of chemical regulation since 1994. Caleb’s clients range from
governments, multi-national companies and worldwide consortia to small companies
with a single substance. Caleb tailors its support to take account of a client’s internal
resources in order to maximise the value of our contribution. The company has a
considerable track record in sustainable management recently adding a sustainable
procurement support service for our clients.
SERVICES PROVIDED
OO
OO
REACH dossier development and registration
OO
Sief management
OO
CLP compliance management
OO
SDS authoring and management
OO
OR and TPR services
OO
sustainable procurement support
CLIENTS
Caleb supports SMEs and large corporations, European and global industry
associations and task forces globally. Currently the company is OR or TPR for about 20
companies and provides consultancy support for many more. Caleb also supports more
than ten REACH consortia as managers and advisors.
Page 147
NICHE FIRM PROFILES
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
CONTACTS
CONTACTS
NICHE FIRM PROFILES
Website
E-mail
Head office
Tel/ Fax
Contact
Directors
Ownership
Locations
Founded
www.cfcs-consult.com
[email protected]
CFCS-Consult GmbH, Essen - Tübingen, Alfredstraße 68-72,
45130 Essen, Germany
+49 201 79870 191/ +49 201 79870 386
Dr Barbara Lohmann
Dr Barbara Lohmann (CEO), Dr Felix Endres (CEO)
Private company
Germany, Italy
2007
OVERVIEW
CFCS is a team of experienced: toxicologists, chemists, eco-toxicologists, biologists
and environmental chemists. Our experts are specialised in the areas of: regulatory
affairs, chemical assessments, chemical safety, risk assessment, environmental
protection and occupational safety. Our main focuses are: REACH services, project and
finance management, risk analysis, classification and labelling according to GHS/CLP,
authorisation of biocides and biocidal products, authorisation of pharmaceuticals and
veterinary drugs, assistance with the certification process for the ecolabel, workshops
for REACH, Ecetoc TRA, IUCLID 5, Chesar.
SERVICES PROVIDED
CFCS is a qualified partner offering services in various life science disciplines dedicated
to the assessment of the biological or chemical impact of substances on humans
and on the environment. We provide ample support on regulatory issues and project
management to our clients. Among our services, our clients can benefit from our network
of well renowned and certified scientific partners and institutions. Consequently, and
even for very complex projects, we are always available as your key reference partner.
CLIENTS
Manufacturers, importers or downstream users of industrial chemicals, veterinary drugs,
plant protection products or cosmetic ingredients.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Ownership
Locations
Founded
www.chemsw.com
[email protected]
4771 Mangels Blvd, Fairfield, CA 94534, USA
+1 707 864 0845/ +1 707 864 2815
Private
USA
1991
OVERVIEW
Founded more than two decades ago, ChemSW is the leading provider of chemical
and biochemical inventory management systems, MSDS systems and other chemistry
laboratory software and services. ChemSW’s products streamline laboratory processes
and reduce chemical purchasing and disposal costs. ChemSW supports over 15,000
customers in more than 40 countries throughout the world.
Our laboratory chemical inventory systems ensure user adoption, process efficiencies
and accurate, real-time data, enabling companies to: identify and optimise critical
inventory system components; optimise chemical safety and inventory data; streamline
lot tracking and qualification for process efficiencies; address regulatory requirements;
automate Tier II, Fire Code, GHS reporting; automate audit trails.
SERVICES PROVIDED
We offer a complete range of systems to meet the needs of diverse organisations
in both regulated and non-regulated environments. We provide laboratory chemical
inventory management and MSDS systems to meet the needs of the smallest desktop
application to the largest multinational enterprise. ChemSW maintains a comprehensive
R&D programme, coupled with rigorous usability testing and quality control processes.
We support all of our customers and systems with an experienced, dedicated customer
service staff.
CLIENTS
ChemSW serves major customers in the pharmaceutical, biotechnology, chemical,
petrochemical, food and environmental industries as well as colleges and universities.
Page 148
Website
E-mail
www.conusbat.com
[email protected] / [email protected]
Head offices
Tel
Germany: Kruppstr 18, D-52072 Aachen
+49 241 518 5 7790 (internet)/ +49 241 81987 (Germany)
Skype: steven.hanft
+49 241 81928
Dr Annelie Struessmann, Technical and Regulatory Director
Steven L Hanft, MA, President (private ownership)
Germany
1995; Aachen, Germany
Fax
Contact
Ownership
Locations
Founded
OVERVIEW
CONUSBAT specialises in EU/Global regulations for cosmetics, personal care and consumer
healthcare products, and fine chemicals. Our full service spectrum includes REACH-only
representative (OR), safety assessor-responsible person (RP), compliance analysis, CLP
review, strategic planning, online or onsite training on global regulations, and more. While
focusing internally on the EU frameworks, we cooperate worldwide with third parties (ASEAN,
China, S Korea, Brazil, USA, S Africa) in compliance approaches for our key industry sectors.
SERVICES PROVIDED
OO
EU cosmetic regulations (1223/2009): strategic consulting, dossier filing,
preparation and analysis, safety assessment
OO
REACH-only representative (OR): strategic consulting, dossier filing, preparation
and analysis
OO
Safety assessors-responsible person (RP) for cosmetic products in the EU:
strategic consulting, PIFs dossier preparation, notification to the CPNP, toxicology,
etc
OO
Global regulatory workshops (online/onsite) for the cosmetic, personal and
consumer health care products, fine chemicals: EU, ASEAN, China, S Korea,
Brazil, USA
OO
Global regulatory workshops (online/onsite) for the cosmetic, personal and
consumer health care products, fine chemical sectors: EU, ASEAN, China, S
Korea, Brazil, USA
OO
CLP: classification, labelling and notifications
OO
International regulations for cosmetics, food, fine chemicals: strategic consulting,
compliance analysis, implementation
OO
Product certificates: strategic consulting and application processing
CLIENTS
Fortune 500s, SMEs, academic or training institutes, governmental agencies in
cosmetics personal and consumer health care, fine chemicals, household products.
CONTACTS
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
www.crowell.com
[email protected]
Rue Joseph Stevens 7, Brussels, B-1000, Belgium
+32 2 282 4082
+32 2 230 6399
Laurent Ruessmann
Private company
Washington DC, New York, California, Anchorage, London and
Brussels
1979
OVERVIEW
Crowell & Moring is an international law firm with nearly 550 lawyers representing
clients in litigation and arbitration, regulatory and transactional matters. The firm is
internationally recognised for its representation of Fortune 500 companies in highstakes litigation, as well as its ongoing commitment to pro bono service and diversity.
SERVICES PROVIDED
Crowell & Moring provides legal services in relation to EU chemicals legislation
including REACH, CLP and WEEE.
CLIENTS
Representative clients include: AT&T, BAE Systems, BMW, Caterpillar, EI du Pont
de Nemours, Eastman Kodak, Hitachi, Lockheed Martin, Siemens and United
Technologies Ltd.
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
CONTACTS
www.dangerandsafety.it
[email protected]
Via Bugatti, 53, 56022 Castelfranco di Sotto (Pisa), Italy
+390571367427
+390571382829
Paola Ulivi
Private company
Italy
2000
OVERVIEW
With more than ten years of experience, Danger and Safety provides prompt and
professional services within the fields of risk assessment, environment, health and in
general for chemicals’ regulatory affairs (Reach-CLP-Dangerous goods transport). All
the staff are highly qualified (chemists and biologists).
SERVICES PROVIDED
OO
full regulatory support for REACH regulation (Sief and consortium management;
dossier development and submission; CSA and CSR)
OO
CLP compliance management
OO
SDS and e-SDS authoring for substances and mixtures
OO
risk and hazard assessment for health in working place
OO
specific training and workshops (generic and in-house)
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
www.ecotox.com.au
[email protected]
Unit 27, 2 Chaplin Drive, Lane Cove 2066, Australia
+61 2 9420 9481
+61 2 9420 9484
Dr Rick Krassoi
Australia
2001
OVERVIEW
Ecotox Services International (ESI) is the sister company of Ecotox Services Australasia
(ESA) formed in 2001. ESI was created specifically to provide contract ecotoxicity
testing services for chemicals and products for international regulatory assessment
purposes in compliance with the OECD Principles of Good Laboratory Practice (GLP).
These studies are used to satisfy international regulatory requirements for programmes
such as the REACH programme.
SERVICES PROVIDED
Ecotox Services International offers testing services in compliance with the OECD
Principles of Good Laboratory Practice (GLP). A wide range of acute and chronic
ecotoxicity tests are available, run with aquatic and terrestrial organisms.
CLIENTS
We serve a wide variety of clients, from very small to large enterprises, operating in
many fields as industrial chemicals, fragrance sector, pigments and dyes.
CLIENTS
Ecotox Services International works with companies that need to fulfil international
requirements for chemicals registration such as industrial chemical manufacturer/
importers and agrochemical companies. ESI also works with consultancies managing
REACH dossiers.
CONTACTS
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.mach-chemguide.com
[email protected]
Boernsener Str 16f, 21039 Hamburg-Boernsen, Germany
+49 40 729 10 933/ +49 40 729 10 934
Dr Bettina Mach
Private
Germany
2011
OVERVIEW
We guide you through REACH and CLP and the new cosmetic regulation 1223/2009.
We rely on more than 20 years of experience in product safety in the chemical and
cosmetic industry.
SERVICES PROVIDED
OO
identify your obligations
OO
prepare late preregistrations
OO
prepare ECHA inquiries
OO
prepare dossiers in IUCLID 5
OO
prepare all kinds of notifications
OO
represent your interests in Siefs and consortia
OO
monitor toxicological studies
OO
advise on classification and labelling and prepare C&L notification
OO
advice on the implementation of the new cosmetic regulation EC 1223/2009
OO
conduct safety assessments and prepare chemical safety reports for cosmetics
according to EC 1223/2009
CLIENTS
Dr MACH Chemical Compliance and Competence focuses on SMEs in the European
chemical and cosmetic industry: manufacturers, importers, distributors and downstream
users of chemicals and manufacturers of cosmetic products.
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.es4chem.eu
[email protected]
PO Box 8186, 6710 AD, Ede, The Netherlands
+31 636224088/ +31 318 846 538
Dr Evelyn Tjoe Nij
Private company
The Netherlands
2012
OVERVIEW
ES4chem is a dedicated service provider in the area of human exposure and risk assessment.
You can expect independent and objective advice on exposure related issues of substances
and mixtures in the workplace, consumer products and the environment. Many years of
experience in a scientific environment, a strong combination of expertise (occupational
hygiene and epidemiology), excellent communication skills and a problem solving attitude,
make ES4chem a highly valued partner in risk assessment issues related to REACH.
SERVICES PROVIDED
OO
chemical safety assessment, including first tier exposure assessment for workers
(ECETOC TRA), consumers (ConsExpo) and the environment (EUSES)
OO
higher tier exposure assessment (by models such as ART and Stoffenmanager,
and statistical analysis of measurement data)
OO
update of 2010 dossiers (chapters 9 and 10)
OO
preparation of exposure assessment field studies for compliance and risk
assessment
OO
derivation of OELs, DNELs/DMELs based on human data
OO
implementation of exposure scenarios (eSDS) down the chain
OO
advice on REACH compliance for all actors in the supply chain
CLIENTS
ES4chem offers its services related to chemical safety assessment to the chemical
industry and sector groups of downstream users in Europe and to other contract
research organisations.
Page 149
NICHE FIRM PROFILES
CONTACTS
CONTACTS
CONTACTS
NICHE FIRM PROFILES
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.espheres.com
[email protected]
Pères Blancs Street 4, 1040 Etterbeek, Brussels, Belgium
+ 32 (0)2 740 43 36/ + 32 (0)2 740 43 87
Charlotte Crauwels
Private
Belgium, France, Finland, Germany
November 2011
OVERVIEW
eSpheres, founded in 2011 as a Solvay spin-out. eSpheres is a global leader in
delivering cloud health, safety, environment (HSE) and corporate sustainability solutions
to organisations worldwide. Our in-depth IT solutions and HSE support services help
industrial companies in improving their management of safety, industrial hygiene, and
occupational health processes.
SERVICES PROVIDED
eSpheres supports responsible care all along the product’s life cycle. From industrial
hygiene and accident management, to air emissions and resource consumption – we
help companies automate and streamline compliance with HSE and sustainability
requirements with SAP® EHSM software. We host, secure and manage your HSE
data in a private cloud environment. SAP® EHSM software helps customers address
sustainability initiatives to reduce business risk, protect brands, manage scare
resources, and ensure compliance.
CLIENTS
We support global companies (Fortune 500s, SMEs) in a large number of industries:
(petro)-chemicals, pharmaceuticals, Iron, steel and alloys production, mining and
minerals and pulp and paper, but also at downstream users like polymers and polymer
transformation, electronic, cosmetic, and automotive industry.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.eupoc.de
[email protected]
Schlossblick 14, D-87748 Fellheim, Germany
+49-8335-987951/ +49-8335-987952
Dr Malte-Matthias Zimmer
Private company
Germany
2012
OVERVIEW
Eupoc was established to focus mainly on consortium management and representation
of interest. From the outset our business was driven by SMEs looking for partners able
to understand their specific needs. Together with the SMEs’ customers, Eupoc has
gained a lot of experience in managing different interests and corporate philosophies.
Combining knowledge with respect to the various visions of the future is making Eupoc’s
core business such successful: creating a future in Europe’s regulated markets.
SERVICES PROVIDED
Eupoc supports clients in communication – between each other (eg along supply chains) and
with customers, suppliers, associations, authorities, politicians and lawyers. This is the base
for successfully putting specific technological knowledge into regulative processes. Eupoc
combines technological expertise with successful interdisciplinary networking. Our main focus
is REACH, where Eupoc was the leading manager of one of the first authorisation consortia.
Our daily communication is fast, transparent and confidential. We always work towards being
practical, working together directly and establishing a cooperative sense inside the consortia.
CLIENTS
Eupoc began with an impressive number of SMEs in surface technology and engineering,
together with their customers. This is currently the core area of our business: our clients
are concerned by legal regulations, especially REACH registration, restriction and/or
authorisation. We are developing and will expand our activities in this field. Together with our
network of external experts we are able to handle European consortia.
Page 150
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
www.eurideastranslation.com
[email protected]
475 Avenue Louise, 1050 Brussels, Belgium
+32 (0)2 669 7701 / +32 (0)2 669 77 87
+32 (0)2 627 5655
Kristina Bitvai
Private company
Belgium
2007
OVERVIEW
Eurideas Linguistic Services provides professional translation and interpretation
services. We specialise in chemical, technical, medical translations, as well as in other
fields such as EU legislation, law, environment, health and many more. Our native
speaker chemical translators are experts on the REACH regulation and other related
EU legislation. We have great experience in translating MSDSs, exposure scenarios,
and other chemistry, environment and health related documents. We have developed
our own unique methodology through years of translating REACH documents, and are
therefore able to offer 60% discount for the repetitions.
SERVICES PROVIDED
Translation: translations are always done by a native speaker translator and
proofread by a second native speaker translator. This way we ensure the highest quality
of translation and that the correct terminology is used.
Interpretation: we provide simultaneous, consecutive and liaison interpretation in
Belgium, France, Germany, the Netherlands and the UK.
Typesetting: we prepare your ready-to-print publications based on a given artwork.
CLIENTS
We have worked on REACH related projects for Cefic, REACH Centrum, ISOPA, EuPC,
Glencore International Imports, Rio Tinto, ReachLaw, FEFCO, Codelco, Molymet, the
International Molybdenum Association, the International Lead Association, the Nickel
Institute, Aurubis AG, DonauChem, Euromines, EcoMundo, Chemtopia, and many more.
CONTACTS
Website
E-mail
Head office
Tel
Contact
Locations
Founded
www.finnreach.com
[email protected]
Itainen Pitkakatu 4B, FIN-20520 Turku, Finland
+358 2 4788 490 ; +358 40 747 3393/ +358 2 4788 120 (Fax)
Dr Jan Nylund
Finland
2009
OVERVIEW
FinnREACH provides chemical safety services to companies under REACH, the
Biocidal Products Regulation and the Cosmetic Products Regulation. We offer top
notch research and expert services to support our customers’ registration tasks. We
help you with the whole process starting from data acquisition, testing strategies and
data evaluation to preparation of the final registration documentation. We provide GLPcertified laboratory services, data and exposure assessments, dossier and document
preparation, IUCLID 5, Chesar and REACH-IT expertise. We have specialised in
services to assist customers comply with the CLP Regulation on classification, labelling
and packaging of chemical substances and preparations and to prepare appropriate
and correct safety data sheets (SDS) and other documents required by law. Our SDS
service also includes SDS translations to all EU and other languages. We offer qualified
dangerous goods safety adviser services including consultation and preparation of all
reports as required by the Transport of Dangerous Goods Regulation (Safety Adviser).
SERVICES PROVIDED
OO
REACH and biocide registration and consultancy
OO
testing strategy – planning and coordination
OO
data search and assessment
OO
human health and environment assessment
OO
cosmetics safety assessment
OO
CLP – classification and labelling
OO
safety data sheet preparation and translation
OO
R&D-services – formulation and substance replacement
OO
qualified dangerous goods safety adviser
OO
laboratory and testing – in vivo, in vitro, physico-chem
CONTACTS
www.fobig.com
[email protected]
Klarastraße 63, 79106 Freiburg, Germany
+49 761 38608-12/ +49 761 38608-20
Klaus Schneider
Private company
Freiburg, Germany
1992
OVERVIEW
FoBiG is a privately owned consultant institute specialised in toxicological risk assessment
with two decades of experience in exposure assessment and risk characterisation. FoBiG’s
REACH experience dates back to 2001 with participation in RIP projects, the Ceficsponsored SPORT project, the REACH baseline study and VCI projects on exposure-based
waiving and the “practical guide” on exposure assessment and communication in the supply
chain. FoBiG successfully prepared numerous registration dossiers for the first and second
REACH registration deadlines and supports companies with applications for authorisation.
SERVICES PROVIDED
FoBiG provides full-scale scientific support to meet industry’s REACH obligations:
OO
IUCLID 5 files (including literature searches, data gap analysis, evaluation of
reliability, application of read-across and category approaches and inquiry dossiers
for new substances)
OO
classification and labelling according to CLP Regulation
OO
chemical safety reports (including hazard assessment, derivation of DNELs,
DMELs and PNECs, exposure assessment and risk characterisation)
OO
support for preparing applications for authorisations under REACH
OO
support in Sief and consortium discussions and communications
OO
downstream user inquiries and communication
Other activities relate to cosmetics ingredients, safety evaluations and regulatory support in
the areas of food toxicology, environmental contaminants and occupational toxicology.
CLIENTS
FoBiG supports SMEs and large European chemical companies with their REACH
obligations and works for industry associations, European institutions and governmental
organisations in methodological projects and other areas of toxicological assessment.
GHS-expert
CONTACTS
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
Founded
www.GHSexpert.com and www.REACHexpert.eu
[email protected]
51 Haromszek str, 1194 Budapest, Hungary
+36202205737
Agnes Botos
Private company
Hungary
2010
OVERVIEW
We ensure 100% compliance with REACH and CLP (GHS) regulation. Together with an
IT firm – IQS co – we prepared a GHS-expert software aiming to help perform CLP
classification of substances and mixtures. This GHS- software is a platform-free web
application, which walks our clients through the optimal path of the classification in
order to make this complex process the most efficient possible.
SERVICES PROVIDED
GHS support: professional CLP (GHS) software for classification and labelling of
chemical substances and mixtures with 100% legal compliance with EU and US GHS
REACH support: lead registration dossier preparation; member registration dossier
preparation; only-representative services for non-EU companies; REACH and CLP
audit; training (IUCLID 5, Chesar, REACH, GHS, CLP).
CLIENTS
GHS-expert Ltd has a wide range of satisfied global customers for both GHS-expert
software and REACH services.
We have supported more than 70 Hungarian and foreign companies in completing the
REACH registration and CLP classification in a timely manner.
Countries of clients: Hungary, USA, Ukraine, Uzbekistan, Germany, UK
Please visit our website and click on References.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.grcci.com
[email protected]
Greenwich Chemical Consulting, Inc, 3300 PGA Boulevard, Suite
635, Palm Beach Gardens, FL 33410, USA
(561) 578-8110/ (561) 578-8120
Mr John V Massingale
Mr John V Massingale
Palm Beach Gardens, Florida, USA
1999
OVERVIEW
Greenwich Chemical Consulting provides environmental, chemical control, and regulatory
consulting assistance to a diverse array of US and international chemical companies.
SERVICES PROVIDED
Greenwich Chemical Consulting was established in 1999 and provides environmental
consulting assistance to US and international chemical companies. The firm specialises
in the Toxic Substances Control Act (TSCA) and the international chemical control
schemes of Australia, Canada, China, European Union, Japan, and South Korea.
The firm supports clients on TSCA new chemical notifications, (premanufacture notices
(PMNs), polymer exemption reviews, and low volume exemptions (LVEs)), TSCA
inventory and chemical identity issues, test rules and related negotiations, existing
chemical regulation, reporting and recordkeeping, import and export matters, and R&D
exemption matters. Greenwich Chemical Consulting also has significant experience
assisting clients with TSCA new chemical notifications (PMNs) on nanoscale materials
including TSCA Section 5(e) consent order negotiations with EPA.
Compliance assistance is also provided to clients in the related areas of the Osha
Hazard Communication Standard and the globally harmonised system of classification
and labelling of chemicals (GHS).
CLIENTS
US and international industrial chemical companies.
CONTACTS
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
Founded
www.igcon.nl
[email protected]
Booglaan 4, 5348JJ Oss, The Netherlands
+31 412854594/+1 9412660583
Ineke Gubbels
Private company
Netherlands
2011
OVERVIEW
Ineke Gubbels assists clients with services related to regulatory compliance. Extensive
knowledge of EU regulations, combined with years of experience in toxicology and risk
assessment, guarantee that you will receive high quality advice on REACH, biocides
and food. This will facilitate your access to the market and will lead to sustainable
business solutions. You do not need to gather knowledge on massive legislation like
REACH and the new Biocides Regulation or become a toxicologist yourself.
SERVICES PROVIDED
Strategic consultancy: regulatory impact on business case; independent trustee;
consortium management.
Technical consultancy: testing strategies; interpretation of (test) results;
alternatives to testing; risk assessment.
Toxicology: toxicological review; monitoring services; dossier preparation;
alternatives to animal testing.
REACH: Sief and consortium management; interpretation and strategic advice;
robust study summaries; CSR.
CLIENTS
Clients come mainly from the chemical industry, governmental organisations and
others. Identity of individual clients and the nature of the work performed will only
be disclosed after formal approval by the client. Confidentiality is key to the services
delivered.
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Website
E-mail
Head office
Tel/Fax
Contact
Ownership
Locations
Founded
CONTACTS
NICHE FIRM PROFILES
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
Founded
CONTACTS
www.jongeriusconsult.com
[email protected]
Begijnenhof 26, 6584 CW Molenhoek, The Netherlands
+31 615962071
Onno Jongerius
Private company
Netherlands
2009
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
Founded
www.linmarkconsulting.com
[email protected]
Bernoullistrasse 20, CH-4056 Basel, Switzerland
+41 79 500 9719
Dr Martin G Richards, Dr Al Wiedow
Private company
Switzerland, France, USA
2007
OVERVIEW
Jongerius Consult BV offers strategic and practical support to the various stakeholders
working towards a successful and efficient implementation of REACH, CLP and related EU
chemicals legislation. We combine our extended network, thorough legislative knowledge,
joy in strategic and practical consultancy, enthusiastic facilitation and training of group
processes, affinity for IT and creative, innovative and process oriented thinking (“out of the
box”) up to working solutions, good results and satisfied partners and customers.
OVERVIEW
Linmark Consulting is a consulting and service company engaged in regulatory affairs,
advocacy and communications for the chemical and life sciences industries. Linmark
Consulting is headquartered in Basel, Switzerland, a major European industrial centre with
good communications globally. Its French subsidiary, Linmark Consulting Europe SARL, offers
only representative services under REACH, for importers into Europe. Linmark Consulting
USA LLC specialises in US registration, advocacy using its strong links to EPA and FDA.
SERVICES PROVIDED
Sounding board for companies and partners such as Caesar Consult, Apeiron-team and
Baytouch. Organising efficient REACH compliance strategies and practical solutions in
companies. Providing specific training and workshops (generic and in-company).
Providing powerful support tools, eg practical (ext-)SDS assessment solution on site and
REACHsuite Advantage, a web based registration and Sief management tool that will
ease your lead registration and non-lead registration management towards 2013 and
2018 tremendously. Check our website for more detailed services and references!
SERVICES PROVIDED
Particular skills are in generating new business and protecting client businesses
through regulatory knowledge and practice, stakeholder analysis, problem-solving and
communications with stakeholders. Offerings based on over 25 years’ senior operational
experience in regulatory affairs management and product development functions in multinational chemical, agricultural biotechnology and biopharma companies in UK, USA and
Switzerland. Key European and USA strengths in consortium management and advocacy.
CLIENTS
Our clients are those companies that want to deal efficiently with REACH and related
legislation with focus on the added value for the organisation. We are pleased with
our satisfied partners, customers and many satisfied participants on our REACH
compliance training programme 2011-12. We’ll continue to focus on providing added
value and making REACH work for industry.
CLIENTS
Client confidentiality is guaranteed. Recent contracts include working as non-exclusive
sub-contractor to Cefic’s ReachCentrum in the management of six REACH consortia,
where 2010 registration deadlines were successfully met. Consortia support is
continuing to meet 2013 and 2018 deadlines. Linmark Consulting has successfully
managed global and EU chemical advocacy programmes for industrial chemical and
biocide clients. Operating as third party representative for non-EU clients in Europe.
CONTACTS
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.jrfonline.com
[email protected]
NH-08, Near Daman Ganga River, Valvada, Valsad, Gujarat, India
(+91) 260 654 0242, 329 1873/ (+91) 22 6646 6119 (Fax)
Dr Abhay Deshpande
Private company
India, USA, UK
1977
OVERVIEW
JRF Global is a regulatory contract research organisation, with a multinational presence
in India, the USA and the UK. JRF Global offers cost effective data generation, in
compliance with good laboratory practice (GLP) services in toxicology, ecotoxicology,
chemistry, environmental fate, metabolism, residues, and regulatory affairs. Studies are
conducted in accordance with global as well as Japanese regulatory guidelines. The
studies are well received by global regulatory authorities. JRF Global has professional
experience exceeding a few thousand man-years thanks to a combined life of 80
years in three continents. This expertise gives JRF Global, a competitive edge over the
competing CROs and establishes itself as a highly revered multinational brand.
SERVICES PROVIDED
Mammalian toxicology: acute toxicity, mutagenicity, developmental and reproductive
toxicity, repeated dose toxicity covering immunotoxicity and neurotoxicity parameters,
canine toxicity, endocrine disruptor screening tests (Tier-I), rodent ADME (oral and
dermal), etc. Ecotoxicology: acute toxicity to aquatic test systems, avian, earthworms
and honeybees. Environmental fate and metabolism: metabolism in soil and plant,
adsorption/desorption, photolysis and hydrolysis, C/N transformation, biodegradability,
covering identification / quantitation of degradates. Chemistry: product characterisation,
method development and validation studies, product stability and purity analysis, physicochemical studies, residue trials offering quantitation of residues and metabolites.
CLIENTS
JRF Global boasts of a strong sponsor base exceeding 800 companies, which include
leading multinationals for their pharmaceutical, biopharmaceutical, agrochemical,
biocidal and chemical products.
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Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.LKC-ltd.com
[email protected]
Postfach 167, Hauptstrasse, Fuellinsdorf, Switzerland
+41 61 906 8500 / +41 61 906 8509
Dr David Kane
Private company
Switzerland and UK
2001
OVERVIEW
LKC provides European registration and development services to the international
chemical industry. The LKC team is multifaceted, offering technical skills, regulatory
experience, project management proficiency and strategy planning expertise. Chemical
manufacturing clients can benefit from a full range of regulatory services to achieve the
successful registration of products in the fields of crop protection, biocides, veterinary
medicines and industrial chemicals.
SERVICES PROVIDED
Services for crop protection products, biocidal products, veterinary medicines and
industrial chemicals include:
Regulatory sciences: data gap analysis, data evaluation, contracting and managing
of higher tier studies, study monitoring of chemistry, analytical, toxicology, ecotoxicology,
environmental fate and efficacy studies, PEC-reports, GLP multi-site residue studies.
Conducting risk assessments and modelling for dietary, human and environmental exposures.
Dossiers: dossier preparation for active substance submissions for Annex I inclusion,
product dossiers for national registrations, provisional authorisations and mutual
recognition. CADDY-dossiers, IUCLID5-dossiers, re-registrations, renewals, label
extensions, import tolerance settings, REACH, CLP and JMAFF dossiers.
Regulatory support: pre and post submission meetings with regulatory authorities,
negotiation communications, estimating data package compensation for data-sharing
and product defence.
CLIENTS
LKC’s clients are specialty chemical manufacturers who benefit from technical support
in sectors that include crop protection, biocides, animal health and general chemicals.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
www.mckennalong.com
[email protected]
2 Avenue de Tervueren, 1040 Brussels, Belgium
+32 2 278 12 11/ +32 2 278 12 00
Ursula Schliessner
Partnership
USA, Brussels
OVERVIEW
Chemical regulation is one of MLA’s marquee practices. Lawyers in our Brussels
office counsel and litigate on all aspects of EU chemical regulation, including REACH,
biocides, pesticides and cosmetics.
MLA Brussels manages eight REACH registration consortia and two REACH
authorisation consortia. We handle issuance of REACH letters of access for more than
70 substances and substance groups for numerous lead registrants (see www.mlalaw.
eu). We advise on and handle ECHA Board of Appeal cases and are involved in several
testing proposal and compliance check decisions.
MLA has significant experience with REACH related issues concerning mergers and
acquisitions.
SERVICES PROVIDED
Anti-trust and unfair competition; chemicals, pesticides and product regulation;
corporate; energy; environment, energy and product regulation; EU competition; EU
environmental; EU food; financing and lending; government contracts; green chemistry;
hazardous waste management; litigation; mergers and acquisitions; private equity,
hedge funds and venture capital.
CLIENTS
Chromium Trioxide REACH authorisation consortium (CTAC); Ethyl Benzene REACH
consortium; Gluconic acid and its derivatives REACH consortium; Iron Oxides REACH
consortium; Maltitol/Sorbitol REACH registration group; Styrene REACH consortium;
TCPP REACH consortium; UPR/VER REACH consortium; 12-HSA REACH consortium
Miscellaneous Chromate Substances REACH authorisation consortium (CCST)
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.reachdelivery.com
[email protected]
Hamilton House, 111 Marlowes, Hemel Hempstead, Hertfordshire,
HP1 1BB, UK
+44 (0) 1442 450460/ +44 (0) 1442 450335
Malcolm Carroll
Part of the Mpower1 Group of Companies
Worldwide support
2009
OVERVIEW
The REACH Delivery service is used worldwide by manufacturers, importers, distributors and
downstream users. It supports the fully audited sending, receiving and automated update of
MSDS and associated documents for large and small companies alike both to their customers
and internal staff. It addresses the delivery and update requirements of REACH, EPCRA,
(HAZCOM) OSHA and other similar legislation in other countries. In addition, it automates,
simplifies and manages distribution, audit, archive, update and other compliance functions.
SERVICES PROVIDED
REACH Delivery is an electronic mail service that works seamlessly with email, yet:
OO
guarantees delivery and receipt of documents and messages;
OO
monitors and reports on delivery/acceptance status;
OO
generates automatic updates to all previous recipients of a document, with new
and latest versions;
OO
provides full audit trails and compliance reports to meet multiple legislative
requirements;
OO
works whenever confirmed delivery and audit is required – externally to other
companies and internally to your own staff;
OO
includes integral data repository, archiving and document management;
OO
simple to use app installed on your PC, can integrate with existing applications;
OO
the service is designed to dramatically reduce the time, risk and cost of
administration in maintaining compliance. A low cost multi language service
accessible world-wide.
Support, demonstration, installation and trial usage are all completely free
CLIENTS
Clients are from the chemical industry, and downstream users encompassing the entire supply
chain worldwide
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.ecotoxchem.co.uk
[email protected]
Saxon House, John Roberts Business Park, Pean Hill,
Nr Canterbury, Kent, CT5 3BJ, UK
+44 (0)1227 470901/ +44 (0)1227 765117
Dr Peter Fisk
Limited company
UK
Originally founded in 1995. Founded as a limited company in 2006.
OVERVIEW
Peter Fisk Associates offers specialist services to industry and regulatory organisations in
the fields of environmental chemistry, toxicology and risk assessment. We bring expertise
and high-level experience to chemical consultancy, tailored to our clients’ needs. We
collaborate closely with our clients to harness their insights into their own products.
SERVICES PROVIDED
PFA has the capability to undertake technical and commercial services in support of
compliance with all aspects of the REACH and CLP requirements, as well as other
chemical and related regulations and we have more than 15 years’ experience of
chemical regulatory compliance. We have worked on technical dossiers for more than 100
substances in Phase 1 of REACH and a similar amount for Phase 2. Working with partners,
we provide a comprehensive REACH service covering all areas including SEA, and other
areas of chemical regulation (including biocides and plant protection products). We have
also successfully provided REACH-related secretariat services, including consortium
management and Sief communications. Specific services include: REACH dossier
development – all technical aspects, chemistry, toxicology, ecotoxicology, quantitative
structure-activity relationships, exposure assessment and modelling, risk management
measures, consortium management, supply chain analysis and authorisation support.
CLIENTS
A wide variety of industrial clients including chemical manufacturers’ consortia from
several sectors, downstream users of chemicals and national competent authorities.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.reach-gs.eu
[email protected]
Rond Point Schuman, 6 Box 5, B-1040 Brussels, Belgium
+32 (2) 234 77 78/ +32 (2) 234 79 11
Mr Richard L Roden
Istanbul Chemicals and Chemical Products Exporters’ Association
(IKMIB) 95% and Steel Exporters’ Association (CIB) 5%. Two divisions
of Istanbul Minerals and Metal Exporter’s Association, a joint venture
between Turkish private industry and the Ministry of Economy.
Headquarters: Brussels, Belgium; Offices: Istanbul, Turkey.
Locations ideal for European and Turkish chemical industry and
proximity to the EU Commission and Cefic in Brussels and the
European Chemicals Agency (ECHA) in Helsinki.
2008
OVERVIEW
REACH Global Services SA (RGS) is a professional regulatory consulting company
advising private and public sector clients in the chemicals and allied industries to
comply with European Union and Turkish Republic chemicals legislation. RGS’s
experienced staff, based in Europe and Turkey consults to a diverse array of chemical
companies, international and Turkish operating across a range of industrial sectors.
SERVICES PROVIDED
REACH audit and related support services including Only Representation to non-EU
manufacturers. EU Cosmetics Regulation compliance services for Turkish exporters
to the EU. Turkish chemicals legislation compliance including by-law on chemicals
inventory and control, seveso II, food and biocides regulatory compliance.
CLIENTS
RGS’s client portfolio range from multinational blue chip and leading Turkish chemical
and allied industry companies to small and medium enterprises.
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CONTACTS
CONTACTS
NICHE FIRM PROFILES
CONTACTS
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
www.rorltd.com
[email protected]
Hippocampus House, Hulme Lane, UK
+44 (0)1565 724241
+44 (0)1565 723500
Client Services
Europe, local agents: Asia, Middle East
2006
OVERVIEW
Reach Only Representative Ltd (ROR) was one of the first commercial Only
Representatives established in Europe. UK based, assisting non-European chemical
manufacturers, and EU manufacturers and importers to comply with their REACH
obligations. ROR is recognised as one of the most competent specialist Only
Representative companies in Europe with the ability to provide compliance services to
all members of the supply chain.
SERVICES PROVIDED
Only Representative services for non-EU manufacturers to export to the EU. Third
party representative services for EU manufacturers, importers and internal Only
Representatives so they comply with their obligations. Lead registration representation
in consortia, within the Sief or on committees. Document preparation: IUCLID technical
dossier, chemical safety report (CSR), safety data sheet (SDS) authoring, provision and
distribution. Additionally we can offer auditing services to ensure your company remains
compliant with REACH.
CLIENTS
Countries of clients: China, India, USA, UK, Brazil, Qatar, Egypt, South Africa, South
America and other regions.
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
Founded
www.reachwise.eu
[email protected]
22, St Albans Avenue, London W4 5JP, UK
+44 (0)20 87470873
Peter Douben
Private company
UK, Netherlands, Germany
2007
OVERVIEW
With extensive knowledge of REACH and CLP, REACHWise provides tailor-made
services overseen by Peter Douben, formerly Director REACH, Cefic, and head
Environmental Protection, Unilever, before founding REACHWise. Our focus on
REACH and CLP means our efforts are targeted. We change complex situations into
manageable elements and processes, and provide solutions.
SERVICES PROVIDED
Impact of REACH and CLP: in finding comprehensive solutions for companies, we advise
you on the best way to approach your REACH and CLP “problem” and to remain compliant.
Sief support: we provide the whole spectrum of Sief and consortium management.
REACH registration: for individual and groups of companies, our REACH support covers
data evaluation and sharing, preparation of the technical dossier, use and exposure
requirements, chemical safety assessment and report, and exposure scenarios.
Safety data sheets: we prepare and update SDSs (body and annex ESs) including
translations.
Exposure scenarios: for individual substances as well as mixtures we ensure they are
comprehensive and communicable: you discharge your obligations and your customers find
them easy to understand.
Downstream user support: using specialist models we ensure that your conditions of use
are compliant even when they deviate from the registrant’s information.
CLIENTS
Satisfied customers from the ceramics industry, fertilisers and related industries, fragrance
sector, health care sector, home and personal care, lubricants manufacturers and suppliers,
metals sector, minerals sector, pigments and colorants sector, speciality chemicals industry.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.reachready.co.uk
[email protected]
Kings Buildings, Smith Square, London, UK
+44 (0)20 7901 1444/ +44 (0)87 1813 0304
Suzan Gunnee
Chemical Industries Association
London, UK
2006
OVERVIEW
REACHReady offers a dedicated one-stop shop for REACH and CLP services. A
wholly-owned subsidiary of the Chemical Industries Association, our strong reputation
and extensive experience of the chemical and downstream industries makes us the
best choice for REACH and CLP services. Our thorough understanding and knowledge
of the legislation stems from more than a decade of in-depth involvement in their
development at every stage. We offer a flexible, value-for-money service for all your
REACH and CLP compliance needs.
SERVICES PROVIDED
We offer a specialist helpdesk staffed by technical experts who can provide a rapid
response to your REACH and CLP questions. Our tailored consultancy service can
be used to develop or review a strategic approach to compliance, or deliver practical
help in tasks such as classification, IUCLID submissions or Sief support. Our free
Matchmaker service can match trusted suppliers of REACH and CLP services to your
particular need. There is also a comprehensive training programme of public or inhouse workshops to help you manage your own compliance.
CLIENTS
We have a global customer base with clients from all industries subject to the REACH
and CLP Regulations. Our services are used by businesses from individuals and SMEs
to global corporations. Recent clients include: British Adhesives and Sealants Association
(BASA), Eli Lilly & Co Ltd, FUJIFILM Imaging Colorants Limited, Minor Metals Trade
Association (MMTA), NEXT plc, The Body Shop International, WSP Environmental Limited.
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CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.refac.eu
[email protected]
Lyme Building, Westmere Drive, Crewe Business Park, Crewe,
Cheshire, CW1 6ZD UK
+44 (0)1270 258530/ +44 (0)1270 2584444
Ms Rachel Green, Dr Virginia Gretton
United Kingdom
2007
OVERVIEW
ReFaC is an independent privately owned organisation which provides regulatory assistance,
primarily to suppliers of industrial chemicals etc – both within Europe and from across the
world – who seek to comply with REACH. Our team of regulatory professionals provide
efficient and expert services to SME companies, multi-national organisations, industry
associations and consortia. Wherever possible ReFaC aims to reduce the burden imposed
by REACH and CLP and provides tailored support to clients in order to maximise the value of
our contribution. ReFaC delivers REACH compliance solutions using its own staff and a select
group of industry partners, including BIBRA, Harlan, Intertek and LSM Analytical Services.
SERVICES PROVIDED
ReFaC provide a complete range of services for those seeking compliance with REACH
and CLP regulation. Our services include: REACH dossier development and submission,
including data gap analysis, hazard and exposure scenario development and CSR authorship;
consortium and Sief management; consultancy and study services; PPORD notification; OR
and TPR services; SDS and eSDS authorship; CLP compliance management.
CLIENTS
ReFaC supports individual SMEs and large organisations from across the chemical
industry, both within Europe and worldwide, and assists industry associations and
consortia who require management, consultancy and study services.
CONTACTS
Tel/ Fax
Contact
Ownership
Locations
Founded
www.rsireg.com
[email protected]
P.O. Box 1280, Peterborough, PE2 2NG, Cambridgeshire,
United Kingdom
+44 (0)1223 969 972
Andy Burgess
China, UK, USA
2010
OVERVIEW
Regulatory Services International (RSI) is a multinational company primarily delivering
Chinese chemical regulatory services and strategic business impact assessments. Our
goals are to provide our clients with pragmatic business focused solutions to regulatory
compliance challenges and to guide them through the continually evolving regulatory
landscape. We have a highly experienced team with an in-depth practical knowledge of
the services we offer delivered through locally based contacts in the EU, USA and China.
SERVICES PROVIDED
Specialist Chinese chemical regulatory support: extensive experience and
expertise with all aspects of the New Chemical Notification Scheme in China (MEP
Order No 7). Compliance status determination, notification strategy development and
execution, registration preparation/translation, arranging in-country testing, submission/
post submission support and registration agent. Hazardous chemicals support under
SAWS Decree 591 and supporting legislation: compliance status determination,
notification/licensing strategy development and execution. Business focused
solutions to regulatory compliance challenges: we work alongside our client to
identify the major business impacts from regulatory compliance challenges and then
conduct analysis of product portfolios to specifically identify and address these impacts.
CLIENTS
We serve a wide range of clients from a broad range of industries, along with
consultants, CROs and law firms involved with manufacturing, developing and
marketing chemical substances and formulated products.
CONTACTS
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Founded
www.thewercs.com
[email protected]
The Wercs Ltd, 23 British American Blvd, Latham NY 12110, USA
+ 1 800 572 6501 / +1 518 229 3489
+1 518 640 9299
Steffan Kilmer
Private
1984
OVERVIEW
The Wercs provides software tools and services to help advance the health and safety
of the environment in which people live and work. For almost 30 years The Wercs has
partnered with clients to develop innovative solutions that go beyond global regulatory
and sustainability compliance. Key areas of support include (M)SDS authoring software
and services, management and distribution software and services, retail supplier
compliance, and green chemistry and sustainability solutions. In addition, we offer GHSand REACH-compliant solutions for all types of companies, regardless of size or location.
SERVICES PROVIDED
OO
(M)SDS authoring software and services
OO
Retail supplier compliance
OO
Green chemistry and sustainability solutions
CLIENTS
Manufacturing including: adhesives and sealants; agro-chemical; automotive;
chemical; consumer products; distributors; flavours and fragrances; paints and resins;
coatings, inks and colours; petroleum; pharmaceutical, healthcare and life sciences;
plastics, polymers; specialty chemicals; tyre and rubber; etc.
Retail including: big-box; auto parts; grocers; home improvement; pharmacy;
warehouse club; specialty retailers; etc. Government
CONTACTS
CONTACTS
Website
E-mail
Head office
Tel
Fax
Contact
Ownership
Locations
Founded
www.steptoe.com
[email protected]
1330 Connecticut Avenue, NW, Washington, DC 20036, USA
+32 2 626 0500/ +1 202 429 3000
+32 2 626 0510/ +1 202 429 3902
Seth Goldberg/ Darren Abrahams/ Dr Anna Gergely
Limited liability partnership
Belgium, China, UK, US
1945
OVERVIEW
To operate in these fast-evolving regulatory fields requires not only mastery of the law,
but also the underlying science. Our integrated team of legal, regulatory and science
professionals located in the EU, US and China, along with our network of contacts in
other jurisdictions, provide the breadth of expertise and geographic reach to enable our
clients to accomplish their commercial objectives. We have the experience to leverage
the investments our clients have made, and knowledge of their products across a range
of regulatory fields and jurisdictions.
SERVICES PROVIDED
Our practice has a particular focus on the full breadth of legal and commercial issues arising
under the regimes on biocides (antimicrobials), plant protection products (agrochemicals),
food contact materials, nanotechnologies, REACH (where we act as OR and TPR) and CLP.
We have a strong body of experience in the following additional areas: agricultural and
industrial biotechnology, chemicals (commodity and speciality), cosmetics, electronics,
feed and seeds, flavours and fragrances, functional foods, medical devices and waste.
CLIENTS
Our clients are national and multinational companies, in sectors including: automotive,
chemicals, food, metals, mining, plastics, textiles and waste. We work with European
and international trade associations, public institutions, agencies and bodies at the
regional and national levels.
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.toxfocus.com
[email protected]
3016 Shenandoah Valley Drive, Little Rock, AR 72212, USA
+1 501 351 4389
Barbara Vogt, PhD, DABT
Private company
USA
2008
OVERVIEW
Tox Focus, LLC is a specialty consulting practice providing the toxicologic and scientific
content for REACH, the Cosmetics Regulation, and other regulatory programmes. Principal
Barbara Vogt, PhD Toxicology, DABT, has more than 15 years’ experience in corporate and
clinical toxicology. The consultancy has authored numerous REACH registration dossiers,
classification and labelling harmonisation dossiers, weight-of-evidence positions and
REACH evaluation responses to ECHA/member states. Tox Focus LLC is a qualified risk
assessor for cosmetics, supporting premarket notification for the EU Cosmetics Regulation.
SERVICES PROVIDED
REACH: high-quality toxicology assessments and strategic planning for compliance with data
requirements, including data gap filling, adaptations to data requirements, identification of
analogues and categories, computer modelling and support (QMRF, QPRF), laboratory test
monitoring, robust study authoring, construction of IUCLID 5 files with completeness reports,
chemical safety reports, risk assessments, classification, labelling and packaging (CLP), and
evaluation support and dossier defence. EU Cosmetic Regulation: product risk assessment
certificates and cosmetic product safety reports as part of the product information file.
CLIENTS
Cytec Industries Inc, The Redstone Group, Unilever, Mayer Brown International LLP,
Lucite International, Ineos Europe Ltd, The Cyanide Council, Evonik-DeGussa GmbH,
Air Products and Chemicals Inc, Vertellus Specialties Inc, Arch Chemicals Inc, Gerber
Scientific International, AW Chesterton Company, Calumet Specialty Products Partners
LP, Gulf Bayport Chemicals LP, Shepherd Chemical Company, Connecticut Business
and Industry Association, United States Department of Commerce.
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Website
E-mail
Head office
CONTACTS
CONTACTS
NICHE FIRM PROFILES
Website
E-mail
Head office
Tel
Contacts
Ownership
Locations
Founded
www.toxcel.com
[email protected] / [email protected]
PO Box 93, Ledbury, HR8 9JE, UK
+44(0)1531 638999 (UK) / +1 703 754 0248 (USA)
Christine McAlinden (UK) / Alan Katz (USA)
Limited company
UK, USA
1999
OVERVIEW
toXcel’s European and North American offices work closely together to provide a
coordinated regulatory resource for seamless development and execution of strategies,
designed for cost-effective regulatory approvals, leading to domestic, regional, and
global export market expansion.
SERVICES PROVIDED
toXcel provides a full range of services to support obtaining marketing approvals by
governmental agencies, with emphasis on regulatory strategy development and all aspects
of preparing applications and dossiers. toXcel advises companies about compliance with
REACH, the Biocidal Products Regulation, the Cosmetics Directive, the Plant Protection
Products Regulation, and other EU registration requirements. We can provide you with a full
REACH registration service (including only representative function), or we can support your
in-house activities as required. Our experts provide FIFRA, TSCA, and FDA services to our
global clientele in our US office. toXcel has global experience in the performance of exposure
and risk assessments, environmental assessment, safety and toxicological evaluations, and
the design and management of GLP analytical chemistry, residue, efficacy, environmental
fate, mammalian toxicity, metabolism/pharmacokinetics (ADME), and ecotoxicity studies.
CLIENTS
Our leading consultants focus their collective professional talents on assisting chemical
manufacturers, formulators, pharmaceutical companies, personal care/consumer product
manufacturers and suppliers, trade associations, law firms, and the food industry.
www.verdantlaw.com
[email protected]
1025 Connecticut Ave, NW, Suite 1000, Washington, DC 20036, USA
+01 202 828 1233
Philip A Moffat, Esq
Private – professional limited liability company (PLLC)
USA with an international network of affiliated providers
2009
OVERVIEW
Verdant Law, PLLC is a boutique environmental law firm located in Washington,
DC. Although located in the United States capital, the firm has a global perspective,
providing high-quality services to domestic and foreign clients on matters at the federal,
state, and local levels, as well as those arising internationally. Verdant specialises
in product risk management with an emphasis on sustainability, environmental, and
related challenges. The firm’s principal practice areas include green chemistry and
chemicals management, right-to-know, and nanotechnology, among others.
SERVICES PROVIDED
Through a combination of in-house expertise and a network of jurisdiction-specific
experts, Verdant is well-positioned to assist companies manufacturing, importing, using,
or marketing chemicals and other affected products in major markets around the globe.
Verdant’s services include new product/chemical registrations; compliance advice,
auditing, and enforcement defence; data rights negotiation; product defence; protection
of confidential information; transactional due diligence; and consortium management.
CLIENTS
Verdant provides services to clients in many different industries, but has particular
expertise with respect to the following: coatings, consumer products, electronics, industrial
chemicals, medical devices, personal care products and pharmaceuticals, among others.
CONTACTS
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.toxservices.com
[email protected]
1367 Connecticut Avenue NW, Suite 300, Washington, DC 20036, USA
202-429-8787/ 202-429-8788
Margaret H Whittaker, PhD, MPH, CBiol, FSB, ERT, DABT
Limited Liability Company
USA
2003
OVERVIEW
ToxServices is a scientific consulting firm that excels at providing toxicology, regulatory,
third-party auditing and risk assessment consulting services to corporations, certification
and testing laboratories, government agencies, and law firms.
SERVICES PROVIDED
We specialise in evaluating potential human health and ecological hazards and risks
from industrial chemicals, pharmaceuticals cleaning products, cosmetics, dietary
supplements, food additives, and pesticides. We provide third-party auditing services
to ensure that contract laboratories and food, pharmaceutical, and dietary supplement
manufacturing facilities adhere to current good manufacturing practices (cGMPs) and
current good laboratory practices (cGLPs). We help clients comply with applicable
international, federal, state, and local environmental health and safety regulations, and
provide clients with strategic assistance in instances when products are claimed to be
associated with adverse effects.
Key areas of ToxServices expertise comprise: US EPA Design for the Environment
(DfE) evaluations; CleanGredients® evaluations; GreenScreen™ evaluations; Cradle
to Cradle® assessments; product safety and regulatory evaluations; study design,
coordination, and data analysis; third party GMP, GLP, and GCP audits; regulatory
compliance and expert witness support.
Website
E-mail
Head office
Tel
Contact
Ownership
Locations
www.wca-environment.com
[email protected]
Brunel House, Volunteer Way, Faringdon, Oxon, UK SN7 7YR
01367 246026
Dean Leverett
Limited company
England, Scotland, Italy
OVERVIEW
Wca-environment provides independent and objective advice on the sources, fate and
effects of chemicals in the natural and industrial environments.
Our staff of environmental scientists, ecotoxicologists, toxicologists and chemists
provide quality assured advice and consultancy for clients in commercial and
governmental organisations worldwide.
SERVICES PROVIDED
We help our clients meet their obligations under regulations such as REACH, CLP/
GHS, the Water Framework Directive, the Priority Substances Daughter Directive, the
Landfill Directive, EMEA and give VICH guidance on environmental risk assessment
of human and veterinary medicines, the Biocidal Products Directive, and the Plant
Protection Products Directive. We also help them identify and deal with new or
emerging chemical and technological issues that might threaten their business.
CLIENTS
The Environment Agency (England and Wales), States of Jersey Environmental
Protection, Environment Canada, Alberta Environment (Canada), United Kingdom
Water Industry Research, Cefic, European Environment Agency, ECMA, Nickel
Institute, Syngenta, Defra, European Commission, ERGTC, European Copper Institute,
the chemical industries.
CLIENTS
Located across the US, Europe,and Asia.
Page 156
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.thewercs.com
[email protected]
23 British American Blvd, Latham, NY 12110
+1 518 640 9283/ +1 518 640 9299
Bob Sheehan
Private
USA, Belgium, Germany, China, Japan
2004
OVERVIEW
Since 2004, WERCS Professional Services (WPS) has been providing expert SDS and
hazard label authoring and translation services to companies large and small.
Today WPS has authored and translated SDS and other hazard communication documents
for over 4,000 companies around the world. Our regulatory experts come from a diverse
group of international companies in the chemical manufacturing, consumer product,
lubricants, paints and coatings and pharmaceutical/ biotech industries, among others.
Due to the increasing demands on companies, WPS has continued to invest in technology,
tools, and experienced personnel to provide comprehensive, cost-effective solutions to
a variety of clients. From authoring product SDS and hazard labels for small and large
chemical companies, to building and maintaining a regulatory compliance reporting system
for 19 of the top 25 US retailers (and growing), WPS is equipped to deploy whatever is
necessary to address and satisfy each customer’s unique regulatory requirements.
SERVICES PROVIDED
WPS provides: SDS/ hazard label authoring to any region of the world; SDS/ hazard
label translation – currently support 40+ languages; MSDS to SDS conversion services
– convert existing product MSDS to GHS-compliant SDS; e-SDS authoring/ translation
services; regulatory consulting services, sustainability scoring.
CLIENTS
WPS clients come from industies including: adhesives; agrochemical; chemical;
consumer products; flavour/ fragrance; inks; paints/coatings; pharmaceutical / biotech;
retail; specialty chemical.
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.wspenvironmental.com
[email protected]
70 Chancery Lane, London, UK
0161 886 2400/ 0161 886 2401
Stuart Burrow/ Dr Stephen Bounds
Private company
UK, Europe, worldwide
8 April 1997
OVERVIEW
WSP Environment & Energy provide a wide range of environmental, health and safety,
and regulatory consultancy services. Our global REACH Group includes chemical
industry professionals experienced in all aspects of chemical regulation and includes
registration specialists, toxicologists and ecotoxicologists experienced in dealing with
REACH projects for a wide range and size of clients. We are part of WSP and GENIVAR,
a leading global design and engineering firm with about 15,000 staff around the world.
SERVICES PROVIDED
We offer a complete range of services to deal with all our client’s REACH requirements
including: identifying a client’s REACH registration obligations and developing the
registration strategy; Sief and consortium management; all aspects of substance
registration dossier preparation and submission; joint registration submission; socioeconomic analysis; authorisation of a substance; classification,labelling and packaging
(CLP) management and compliance; only representative and third party representative
services; safety data sheet preparation and management; REACH compliance checks.
CLIENTS
WSP assists a large group of companies to fulfil their REACH obligations ranging from
SMEs through to large corporations. Our clients include manufacturers, importers
and downstream users. We act as only representative for about 20 companies and
provide support over and above the basic service as required. We specialise in helping
companies with compliance problems.
CONTACTS
Website
E-mail
Head office
Tel/ Fax
Contact
Ownership
Locations
Founded
www.wrcplc.co.uk
[email protected]
Frankland Road, Swindon, UK
01793 86 5000/ 01793 86 5001
Ian Johnson
Private company
UK
1927
OVERVIEW
WRc’s REACH team consists of experienced mammalian and environmental
toxicologists, risk assessment analysts, chemists, QSAR and exposure scenario
modellers and REACH legislation experts. WRc has extensive experience of dealing
with national and European regulators and industrial clients.
SERVICES PROVIDED
OO
Identification of registration requirements. OO
Arrangement of toxicological and ecotoxicological testing. OO
Compilation and evaluation of physico-chemical, environmental, fate, toxicological
and ecotoxicological data packages.
OO
Substance grouping, QSAR and read across for data gap filling and test
replacement for some endpoints. OO
Exposure modelling and derivation of exposure scenarios. OO
Reviews of epidemiological data and health monitoring studies. OO
Hazard classification and labelling (CLP).
OO
Preparation of technical dossiers in IUCLID 5, chemicals safety reports (CSRs)
and safety data sheets (SDSs).
OO
Validation of registration dossiers prior to agency submission.
CLIENTS
A wide variety of clients ranging from single industrial chemical manufacturers to multinational consortia.
Page 157
NICHE FIRM PROFILES
CONTACTS
Page Headquarters
Other locations
Global
staff
Chemical
staff
Representation/management
Legal services
Laboratory services
Training
Other(s)
 24-7 Response
36
UK
Australia
50-100
50-100
 3E Company
38
USA
Denmark, Canada,
Asia
100-500
100-500
gg
2-5
1
5,000 plus
5,000 plus
25-50
25-50
25-50
10-25
5-10
5-10
2-5
2-5
Organisation
3S-Safely Serving Science
Greece
Accenture
Belgium
A-Z LISTING
 ACTA
40
Actio Corporation
USA, China
USA
Aegis Regulatory Inc
 AG-HERA
UK
Canada
147
UK
Spain
Alberi EcoTech
USA
1
1
Alchemy Compliance Ltd
UK
1
1
Alemare Solutions
UK
2-5
1
Denmark
2-5
2-5
 ALTox
147
AMEC
UK
Antea Group
USA
APC
UK
Apeiron-Team NV
Belgium
 ARCADIS
42
 ARCHE
44
The Netherlands
Belgium
Belgium, The
5,000 plus
Netherlands,
Germany, Italy, USA,
Canada
The Netherlands,
5,000 plus
France, Belgium,
Colombia, Africa,
Germany
France, Spain, Poland10-25
10-25
10-25
UK
100-500
25-50
1
1
1
Beveridge & Diamond, P.C.
USA
50-100
10-25
10-25
2-5
 bibra toxicology advice & consulting
46
UK
10-25
10-25
 BIG vzw
147
Belgium
25-50
25-50
 Bioagri
48
Brazil
France, China
1,000-2,000
100-500
France
Japan, Thailand, USA 25-50
Burges Salmon LLP
 Caleb Management Services
5-10
5-10
Belgium
1
1
Finland
100-500
5-10
UK
50-100
50-100
France
UK
147
10-25
UK
USA
56
UK
Cambridge Environmental Assessments
UK
Cardno ENTRIX
USA
 CEHTRA
58
France
 Centro Reach
60
Italy
 CFCS-Consult
148
Germany
Worldwide (140
countries)
Germany, USA
50-100
1,000-2,000
5,000 plus
100-500
500-1000
2-5
10-25
5-10
gg
ga
me
e
ge
gge
i
e
ig
g
ii
me
aea
iee
m
mg
www.buckman.com
eg
5,000 plus
50-100
50-100
50-100
e
mg
m
e www.calebgroup.net
www.cea-res.co.uk
e
www.cardnoentrix.com
aee
me
m
ge
meee
m
www.bureauveritas.com
www.burges-salmon.com
m
mg
mee
Key: Icons above represent the percent breakdown of services provided by each firm as follows:
m >60% i 40-60% g 20-40% e 5-20% a <5%
e
geee
5-10
1
www.brixham-lab.com
egegeee
2-5
1
www.big.be
e www.merieuxnutrisciences.com
www.bioquanta.net
m
2-5
Ireland
www.bibratoxadvice.co.uk
e
5-10
ChemHaz Solutions
www.austenbusinesssolutions.co.uk
www.bioservice.com
Italy
2-5
www.atoutreach.fr
m
mea
2-5
www.aschem.waw.pl
www.borenius.com
m
25-50
Finland
www.arche-consulting.be
www.argentumenvironment.se
ge
25-50
Chemest Ltd.
www.arcadis.com
a www.bluefrogscientific.com
www.boeijeconsulting.com
e
mg
25-50
USA
ege
m
10-25
UK
www.apeiron-team.eu
www.bdlaw.com
m
ee
www.apc.eu.com
www.assentcompliance.com
gg
1,000-2,000
ChemADVISOR, Inc
e
ge
gg
100-500
Charles River
Page 158
gg
South America,
Canada
Belgium, UK, India,
Canada
Belgium
www.ag-hera.com
g g www.alberieco.com
www.alchemycompliance.com
i
g e a www.alemare.co.uk
i
eeee
25-50
2-5
Buckman
e
mg
5,000 plus
UK
 Bureau Veritas
me
e
Belgium, United
States, Switzerland
Representatives in 100-500
Switzerland, Japan,
India, Poland,
Scandinavia, Italy and
other countries
2,000-5,000
www.aegisreg.com
m
a
France
Germany
m
me
Austen Business Solutions Ltd
 BSL BIOSERVICE Scientific Laboratories GmbH 54
e e e e www.actagroup.com
www.actio.net
ggg
m
10-25
ATOUT REACH
52
www.accenture.com
10-25
Canada
Borenius & Kemppinen, Attorneys at law Ltd
www.3s-chem.gr
e e e e www.anteagroup.com
Poland
 Brixham Environmental Laboratory
e
me
Assent Compliance
Boeije Consulting
iee
100-500
ASCHEM Chemical Consulting
50
g
ge
i g a www.altox.dk
e e i www.amec.com/reach
Sweden
BioQuanta
ie
ge
Argentum Environment
 Blue Frog Scientific
e
10-25
10-25
USA, Germany, UK, 100-500
Taiwan, India, Kenya
2-5
Further information
g g g www.24-7response.org
em
e www.3ecompany.com
www.cehtra.com
www.centroreach.it
ee
e e e www.cfcs-consult.com
www.criver.com
iee
ee
e
www.chemadvisor.com
www.chemest.fi
www.chemhazsolutions.com
Information
IT solutions
Laboratories
Training
Antea Group
  
APC
   
Apeiron-Team NV
           
ARCADIS
                    
ARCHE
           
Argentum Environment
                    
ASCHEM Chemical Consulting
 
Assent Compliance
    
ATOUT REACH
           
 
           
Austen Business Solutions Ltd
  
 

 
Beveridge & Diamond, P.C.
   
      

   
bibra toxicology advice & consulting
 
BIG vzw
          
Bioagri
                
BioQuanta
  


      
   
                
 
      
  



                            

 

 
    
  
  


 
       
           
 
Lobbying/advocacy
Insurance
                     
Bespoke/in-house training
          
AMEC
 
SVHC testing
ALTox
 
Exposure testing
  
Alemare Solutions
 
  

Ecotoxicology
  
 
Consortia/registration solutions
Laboratory management solutions
      
Alchemy Compliance Ltd
Supply chain management
Alberi EcoTech


EH&S solutions

        
   
            
 
Substance inventory management
        

Legal representation
   
       
       
 
 
   
      
GHS notification
CLP notification

AG-HERA
Dossier preparation
Aegis Regulatory Inc
   
 
                     
Actio Corporation
Representation
Management (Sief, Consortium etc)
ACTA
               
                    
Chemical transport/warehousing
  
Accenture
3S-Safely Serving Science
                
  
Testing strategies
                                      
3E Company
Organisation
24-7 Response
     
        

        
 


   
   
 
    
    

 

        

     
        

 
 
        
               
 

            
  
        

      

 
   
 

 
      
  

 

          
    
   

  


        


      
 

Blue Frog Scientific
      
   
Boeije Consulting
     
        
 
Borenius & Kemppinen, Attorneys at law Ltd
      
                             
 
Brixham Environmental Laboratory
 
BSL BIOSERVICE Scientific Laboratories 
GmbH

 
   

 
  
   

       
      
   
      
Buckman
            
Bureau Veritas
           
Burges Salmon LLP
  
Caleb Management Services
           
Cambridge Environmental Assessments
                     
Cardno ENTRIX
   
CEHTRA
                        
Centro Reach
           
                  
CFCS-Consult
      
   
Charles River
 
ChemADVISOR, Inc
                    
Chemest Ltd.
 
ChemHaz Solutions

 

   
 
   
   
 

   
            
        
   

   

  
 

 
 
    


 
 
      


      
 
  



          
 


      
                  

        

 
       

 
Key: Icons above represents the extent to which the company provides the service as follows:
 Core service  Service that isoccasionallyprovided  Service provided by partners and third parties
Page 159
A-Z LISTING
Repre./management
Guidance on regulatory interpretation
Product compliance
A-Z LISTING
Page Headquarters
Other locations
Global
staff
Chemical
staff
Legal services
Laboratory services
Training
Other(s)
Organisation
i
ChemPharmaServe Ltd
UK
2-5
2-5
Chemphex
Finland
1
1
ChemRegs (UK) Ltd
UK
2-5
2-5
ChemRisk
USA
50-100
50-100
10-25
5-10
 Chemsafe
62
Italy
Qatar
 Chemservice
64
 ChemService Srl Controlli e Ricerche
66
Germany,
Luxmbourg
Italy
South Korea, Turkey, 25-50
France
Agent in China
25-50
 ChemSW
148
USA
 Chilworth – a DEKRA Company
68
UK
25-50
25-50
25-50
80+ globally
5,000 plus
100-500
Chris Braun Consultancy
The Netherlands
1
1
CJV Consulting Ltd
UK
1
1
Clariant
Italy
5,000 plus
100-500
Compliance & Risks
Ireland
USA, UK, Belgium
25-50
10-25
Compliance Footprint AG
Switzerland
global offices
5-10
5-10
Compliance Services International
USA
UK
10-25
10-25
compliance2business
Italy
1
1
Consortia Management GmbH
Germany
5-10
5-10
 CONUSBAT
148
CRAD Ltd. Sti
Germany
5-10
2-5
Turkey
10-25
10-25
 Crowell & Moring
148
USA
1,000-2,000
25-50
 CS Regulatory Ltd
70
UK
5-10
5-10
China
100-500
100-500
CTT
UK, Belgium
 CURRENTA GmbH & Co.OHG
72
Germany
100-500
25-50
 Danger and Safety srl
149
Italy
5-10
5-10
DanGoods Training & Consultancy Ltd
UK
1
1
Datalab
USA
2-5
1
David Ryberg
Norway
10-25
2-5
Defense Logistics Agency
USA
1,000-2,000
10-25
Denehurst Chemical Safety Ltd
USA
5-10
2-5
 DHI
74
DIPHEX Ltd
Denmark
27 worldwide offices 500-1,000
UK
Dr. Andrea Volpato
Italy
 Dr. Knoell Consult GmbH
76
Germany
 DR. MACH Chemical Compliance &
Competence
Dr. Philipp Langenbach GmbH
149
Germany
 EBRC Consulting
78
50-100
5-10
2-5
1
1
UK, Switzerland,
100-500
China, The
Netherlands, Thailand
1
100-500
5-10
Ecolab
USA
5,000 plus
50-100
Ecomatters
The Netherlands
5-10
2-5
EcoMundo
France
Belgium
25-50
25-50
Norway
Sweden, Finland,
50-100
Denmark, Switzerland
5-10
USA
UK
Elemica
USA
Emveo
Enthone B.V.
 ENVIRON
82
5-10
5-10
1
1
10-25
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www.cttlab.com
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Belgium
The Netherlands
UK
2,000-5,000
85+ offices worldwide 1,000-2,000
10-25
50-100
e
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www.knoell.com
1
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2-5
2-5
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EnviroPlanning AB
Sweden
5-10
2-5
m
www.ecoonline.com
www.ehsstrategies.com
www.elc-group.com
e e a www.emveo.be
www.cooksonelectronics.com
www.environcorp.com
ig
me
www.ecomundo.eu
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m
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www.EggCentris.com
m
m
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m www.ecetoc.org
m www.ecolab.com
www.ecotox.com.au
m
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100-500
Environmental Science Limited
Page 160
m
5-10
5-10
Czech Republic,
50-100
India, Romania
Germany, UK, The 100-500
Netherlands, Japan,
Singapore, China,
South Korea
1
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www.dr-langenbach.de
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EHS Strategies, Inc
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ECETOC
Australia
m
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10-25
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149
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Further information
i www.chempharmaserve.com
www.chemphex.com
e
i
e
www.esldatasheets.com
0
          



Lobbying/advocacy
Insurance
SVHC testing
Training
Exposure testing
Ecotoxicology
Laboratories
EH&S solutions
IT solutions
GHS notification
CLP notification
Dossier preparation
Representation

Information
 
 

ChemRegs (UK) Ltd
 
ChemRisk
      
Chemsafe
                       
             
Chemservice
                      
 
ChemService Srl Controlli e Ricerche
 


  
     
   
    
   

 

ChemSW
 


                
Chris Braun Consultancy
      
         
CJV Consulting Ltd
      

Clariant
   
Compliance & Risks
 
  
Compliance Footprint AG
 
 
Compliance Services International
           
compliance2business
                           

    


          
               
 

 
                 
 





     
Consortia Management GmbH

 
 
 
 

    
Chilworth – a DEKRA Company
    
 
        
   
 

        
      

 


     

CONUSBAT
      
CRAD Ltd. Sti
                                       
Crowell & Moring
 
CS Regulatory Ltd
                  
        

CTT
                    
   
 
CURRENTA GmbH & Co.OHG
      
   
Danger and Safety srl
           
DanGoods Training & Consultancy Ltd

Datalab
 
   
       
 

 

    

       


 
  

 
  



        

 


 
David Ryberg
Defense Logistics Agency

Denehurst Chemical Safety Ltd
DHI
  
  

 


 
           
       
    
    
   
Dr. Andrea Volpato
         
        
Dr. Knoell Consult GmbH
           
    

Dr. Mach Chemical Compliance &
Competence
Dr. Philipp Langenbach GmbH
 
   

EBRC Consulting
 

 
Ecolab
 

      
Ecomatters
                    
      
  
EcoMundo
                    
      
 
ECOonline
                    
                
DIPHEX Ltd
 
   
   
                    
  
ECETOC
   
 

  


    
      
      




        


  
        
 

       

Ecotox Services International
 

 
  
EggCentris
 
EHS Strategies, Inc
  
elc group
                                     
Elemica
         
Emveo
      
Enthone B.V.
ENVIRON
  
       
           
       
       
      
   


Environmental Science Limited
         
       
      
  
   
EnviroPlanning AB
         
       
 

 

 
 
 
   


 


 
   
 
 
   
     
 
 

 



 



Page 161
A-Z LISTING
Chemphex
Testing strategies
      
Organisation
ChemPharmaServe Ltd
Repre./management
Product compliance
 Equitox
Page Headquarters
Other locations
Global
staff
Chemical
staff
Legal services
Laboratory services
Training
Other(s)
Organisation
84
Switzerland
5-10
2-5
50-100
5-10
ig
2,000-5,000
50-100
1
1
25-50
25-50
A-Z LISTING
ERA Technology Ltd
France
UK
 ERM
86
UK
 ES4chem
149
The Netherlands
 eSpheres
150
Belgium
ETC
Slovakia
Worldwide offices
France, Finland,
Germany
10-25
5-10
 Eupoc
150
Germany
1
1
 Eurideas Linguistic Services
150
Belgium
5-10
2-5
2-5
2-5
Euro Safety and Health
UK
Eurofins Air Toxics
USA
Eurofins Product Testing A/S
Denmark
Euromines
Eversheds LLP
Belgium
UK
Denmark, Germany, 5,000 plus
France, China
Belgium, China,
5,000 plus
France, Germany,
Italy, The
Netherlands, Spain,
Sweden, USA
5-10
Offices throughout 2,000-5,000
Europe, Middle East
and Singapore
10-25
2,000-5,000
USA, Switzerland,
China
Germany
500-1,000
25-50
2-5
2-5
Finland
2-5
2-5
Italy
10-25
5-10
Germany
10-25
5-10
Foresite Systems, Ltd.
USA
25-50
5-10
Gain Claude
France
1
0
Gentrochema BV
The Netherlands
2-5
1
Hungary
2-5
2-5
Gillies Associates Ltd
UK
2-5
2-5
GlobalMSDS
UK
5-10
5-10
Golder Associates
Italy
GreenSoft Technology, Inc
USA
Exitss
 Exponent International Limited
Belgium
88
Fanwood Chemical, Inc
 FinnREACH
USA
150
Flashpoint srl
 FoBiG
 GHS Expert Ltd.
 Greenwich Chemical Consulting
151
151
151
H2 Compliance
Hangzhou RUIO Technology Co. Ltd
 Harlan Laboratories
UK
2-5
50-100
USA
Ireland
USA
10-25
5-10
50-100
50-100
USA
France, Germany,
2,000-5,000
Israel, Italy, Japan,
Korea, Mexico, The
Netherlands, Spain,
Switzerland, UK, USA
UK
25-50
1
500-1,000
Israel
herbert smith llp
UK
2,000-5,000
2-5
HFL Risk Services Ltd
UK
10-25
10-25
IBACON GmbH
Germany
100-500
100-500
92
USA
 IGCON
151
 IHS
94
 International Cosmetics & Chemical Services 96
 Intertek
98
IOM
IPO O/Pszczyna
 iPoint
10-25
ee
gie
ee
g
m
e
m
ge
me
e
m
i
5,000 plus
1,000-2,000
100-500
10-25
50-100
50-100
m >60% i 40-60% g 20-40% e 5-20% a <5%
1
www.globalmsds.co.uk
ii
www.greensofttech.com
www.golder.com
www.grcci.com
m
ii
e
em
ee
g
m
mg
e
ee
me
e
m
ige
me
e
www.hazmat.co.il
www.herbertsmith.com
www.hflrisk.com
www.ibacon.com
www.icfi.com
ee
g
www.h2compliance.com
e e www.reach24h.com
www.harlan.com
m
5-10
www.GHSexpert.com
www.gilliesassociates.co.uk
gg
mg
5-10
110+ Countries
e
e
i
UK
Singapore
www.gentrochema.nl
i
m
USA
UK
e www.finnreach.com
www.flashpointsrl.com
g
www.fobig.com
ee
www.foresitesystems.com
m
0
g
iiee
mg
Japan
g
m
50-100
South Korea
www.fanwoodchemical.com
m
1
Japan Chemical Safety Institute
e e e e www.exitss.eu
e a a www.exponent.com
mg
5,000 plus
Austria, France, USA, 50-100
China, UK
China, Vietnam
50-100
www.euromines.org
www.eversheds.com
gge
Worldwide
www.eupoc.de
www.eurofins.com/galten
m
USA
www.ekotox.sk
m www.eurideastranslation.com
www.eurosh.com
e
www.airtoxics.com
me
The Netherlands
UK
www.espheres.com
ig
me
m
Jaehak Jung
Page 162
ee
50-100
Germany
www.ES4chem.eu
ii
Belgium, Brazil,
2,000-5,000
China, Russia, India
1
Poland
100
mg
50-100
HAZMAT Ltd
 ICF International
m
2-5
25-50
Offices in over 20
5,000 plus
countries
Taiwan, Japan, China, 50-100
Spain
1
China
90
100-500
Further information
a e a www.equitox.eu
www.era.co.uk
eaee
www.erm.com
e
eg
i
meeee
www.igcon.nl
www.ihs.com/ehs-sustainability
www.Intlcosmetics.com
a a g www.intertek.com
www.iom-world.org
m
www.ipo-pszczyna.pl
10-25
ge
2-5
g e e g e e e e www.kotiti.re.kr
0
eee
eme
1
iee
www.ipoint-systems.com
Lobbying/advocacy
Insurance
SVHC testing
EH&S solutions
 


   
 
 
 
  
    





    
        

  




        



 
Eurideas Linguistic Services
Euro Safety and Health
  
                
     
  
 
Eurofins Air Toxics
Eurofins Product Testing A/S
      
 

Euromines
Eversheds LLP
 

  
  
 
  

Exitss
         
Exponent International Limited
           
    
Fanwood Chemical, Inc

 

FinnREACH
 

   

Flashpoint srl
 
   
FoBiG
      
  
Foresite Systems, Ltd.
  
 
Gain Claude
 

       


 
      

  
  

        


    
    

    

  

 


           
    
  

      



        

        

 
 

 

               


Gentrochema BV
GHS Expert Ltd.
           
       
Gillies Associates Ltd
          
   

GlobalMSDS

Golder Associates
           
    

GreenSoft Technology, Inc
         
       
Greenwich Chemical Consulting
 
H2 Compliance
 
Hangzhou RUIO Technology Co. Ltd
           
       
  
        
Harlan Laboratories
           
   

   
HAZMAT Ltd
                     
herbert smith llp
                     
HFL Risk Services Ltd
 
  


  
 


   
   

        
 
 
  

          
        

 

 
          
    
       
 
   

IGCON
      
IHS
  
    



 
      

               
        



 
   
IBACON GmbH
ICF International
 

   
    
 
International Cosmetics & Chemical
Services
Intertek
                           
    
IOM
            
      
IPO O/Pszczyna
 
iPoint
      
Jaehak Jung
                                        
Japan Chemical Safety Institute
  


  
  
     

 
      
   


    


 

  
       
    
                    
 

Page 163
A-Z LISTING


GHS notification
CLP notification
                    
Eupoc
Dossier preparation
ETC
  
                        
  
Representation
eSpheres
  
  
                           
ES4chem
ERM
    
Testing strategies
      
ERA Technology Ltd
Organisation
Equitox
Training
Exposure testing
Laboratories
IT solutions
Information
Ecotoxicology
Repre./management
Product compliance
Page Headquarters
A-Z LISTING
Jean Warshaw, Esq.
Other locations
USA
Global
staff
Chemical
staff
2-5
2-5
1
1
100-500
100-500
 Jongerius Consult BV
152
The Netherlands
 JRF Global
152
India
 JSC International
102
UK
25-50
10-25
K J Bray & Associates
UK
1
1
K&L Gates LLP
Belgium
1,000-2,000
25-50
Kathrin Lanz
Germany
10-25
10-25
Keller and Heckman LLP
USA
100-500
10-25
Belgium, China
Germany
10-25
10-25
Konica Minolta Business Expert, Inc
Japan
2,000-5,000
10-25
LAUS
Germany
10-25
10-25
LG CNS
South Korea
 KFT Chemieservice
104
USA, UK
LGC
 Linmark Consulting
152
Linnunmaa Oy
 LKC Switzerland Ltd
50-100
UK
Japan, China, India, 5,000 plus
Brazil, Indonesia,
Europe, USA, Middle
East
1,000-2,000
Switzerland
USA, France
2-5
2-5
Finland
152
LSR Associates
MB Research Laboratories
10-25
5-10
UK
10-25
10-25
UK
USA, Japan
25-50
10-25
25-50
25-50
100-500
10-25
USA
153
Belgium
Mercer
USA
Miami Chemical
USA
Asia-Pacific, EMEA, 100-500
Americas
10-25
Micromeritics Analytical Services
USA
MSDS Europe
Hungary
 National Chemical Emergency Centre (NCEC) 106
UK
Neuralog, LP
USA
Noerr LLP
Germany
NovaTox Inc
Canada
Oil Recruitment
UK
5-10
1
10-25
2-5
1
Belgium
5-10
5-10
UK
10-25
10-25
Pinnacle Associates
UK
2-5
2-5
Polgar ACRO
Hungary
Pöyry Finland Oy
Finland
Prosacon GmbH
Germany
UK, Netherlands
Belarus, Kazakhstan, 10-25
Moldova, Russia,
Ukraine
2,000-5,000
5-10
10-25
5-10
5-10
The Netherlands
Global presence
2,000-5,000
25-50
Germany
USA, India
5-10
5-10
Germany
UK
5-10
5-10
 REACH Delivery
153
UK
USA, Japan
25-50
0
 REACH Global Services
153
Belgium
Turkey
10-25
10-25
 REACH mastery
112
Italy
5-10
5-10
REACH Monitor
Spain
2-5
2-5
2-5
50-100
Reach Registration Services
UK
Reach24H Consulting Group
China
Canada, Ireland
Belgium
EU, Asia-Pacific, USA 10-25
114
UK
10-25
Agents: Asia, Middle 5-10
East
10-25
 ReachCentrum
154
m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 164
e www.qualisys.eu
www.khlaw.com
gm
m
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www.laus.de
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www.linnunmaa.fi
www.LKC-ltd.com
e
a a e www.lsr-associates.com
www.mbresearch.com
m
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e www.lgc.co.uk
www.linmarkconsulting.com
m
a
m
www.mckennalong.com
www.mercer.com
www.miamichemical.com
em
www.particletesting.com
m
5-10
Penman Consulting
 Reach Only Representative Ltd
e
10-25
50-100
REACh ChemConsult GmbH
www.klgates.com
m
Slovakia, Hungary, 1,000-2,000
Romania, Ukraine,
Russian Federation,
Czech Republic,
Poland
2-5
1
110
ii
g e g e e g e a the-ncec.com
50-100
PwC
e e www.jsci.co.uk
www.kjba.talktalk.net
mg
25-50
1
 REACh ChemAdvice
m
www.jongeriusconsult.com
www.jrfonline.com
eieaege
USA
153
g
10-25
UK
 Peter Fisk Associates
g
France, Germany,
10-25
Poland, Italy, Spain
China, Czech Rep, 100-500
Germany, India, Italy,
Japan, Korea, Russia,
USA, Malaysia
Canada
25-50
Paul Illing Consultancy Services Ltd
 Pace Analytical - Regulatory Services
108
2-5
10-25
iee
e
Further information
0
m
50-100
Switzerland
USA
 McKenna Long & Aldridge LLP
Legal services
Laboratory services
Training
Other(s)
Organisation
50-100
10-25
www.msds-europe.com
www.neuralog.com
m
www.noerr.com
m
www.novatox.ca
m
i
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www.paceregulatoryservices.com
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www.ecotoxchem.co.uk
www.pinnacleassoc.com
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www.polgar-acro.eu
m
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www.poyry.com
e e e www.prosacon.eu
g www.pwc.nl/nl/reach
me
ii
g e e www.reach-chemadvice.com
www.reach-chemconsult.com
me
me
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www.reachdelivery.com
www.reach-gs.eu
a a e www.reachmastery.com
www.reachmonitor.org
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www.rorltd.com
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e e e e e www.reach24h.com/en
gge
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www.reachcentrum.eu



      
 
 
 

Lobbying/advocacy
Insurance

    
 
  
        
      
    
   
SVHC testing
Training
Exposure testing
Ecotoxicology
Laboratories
EH&S solutions
IT solutions
Information
GHS notification
CLP notification
Dossier preparation
Representation
 
K J Bray & Associates
           

JSC International
JRF Global
      
Testing strategies
  
Jongerius Consult BV
Organisation
Jean Warshaw, Esq.
Repre./management
Product compliance

 
   


Kathrin Lanz
 
Keller and Heckman LLP
  
KFT Chemieservice
                     
Konica Minolta Business Expert, Inc
           
LAUS
   
LG CNS
                
LGC

Linmark Consulting
                
Linnunmaa Oy
                                      
LKC Switzerland Ltd
           
          
LSR Associates
           
    
MB Research Laboratories
     
      
 
       
        

 
Mercer



 

        
                        
       

 

McKenna Long & Aldridge LLP
Miami Chemical
 

      
      

  
    
   


  

   
        

        

     















Micromeritics Analytical Services
MSDS Europe
                  
National Chemical Emergency Centre
(NCEC)
           
Neuralog, LP


       

       
     
 

Noerr LLP
 
NovaTox Inc
   
     


 
 
   
 


       

         
Oil Recruitment
Pace Analytical - Regulatory Services
         
Paul Illing Consultancy Services Ltd
 
Penman Consulting
                
Peter Fisk Associates
      
Pinnacle Associates
             
   
Polgar ACRO
   

Pöyry Finland Oy
           
                       
Prosacon GmbH
      

 
     
PwC
  

 
 
REACh ChemAdvice
      
         
REACh ChemConsult GmbH
      
   
   


REACH Delivery

 
 
 
 
 


      

    


  

        


 
   
 
 
 
  



      

 

 
 


     
        



        





REACH Global Services
  
REACH mastery
                           
REACH Monitor
                            
Reach Only Representative Ltd
                  

     
        
Reach Registration Services
                  

     
          
Reach24H Consulting Group
 
ReachCentrum
      
      
        

       
             
 

 
 

               
              
Page 165
A-Z LISTING
K&L Gates LLP
Other locations
 REACHLaw
116
Belgium, India, Turkey25-50
 REACHReady
154
Finland
Chemical
staff
Further information
25-50
gggeeee
www.reachlaw.fi
UK
5-10
2-5
ReachSpektrum, s.r.o.
Czech Republic
2-5
2-5
ReachSuite Ltd
UK
5-10
5-10
2-5
2-5
100-500
5-10
2-5
2-5
10-25
10-25
 REACHWise
A-Z LISTING
Global
staff
Page Headquarters
Legal services
Laboratory services
Training
Other(s)
Organisation
154
Redeker Sellner Dahs Rechtsanwälte
UK
Germany
 ReFaC
154
UK
 Regulatory Services International
155
China
The Netherlands,
Belgium, North
America
The Netherlands,
Germany
Belgium
UK
Regulatus
UK
1
1
Ricerca Biosciences, LLC
USA
500-1,000
500-1,000
RimaOne
Germany
25-50
25-50
UK
25-50
10-25
Riskchem
South Africa
2-5
1
Rivendell International
Ireland
10-25
10-25
1
1
 Risk & Policy Analysts
118
Roisin McEneany
Ireland
The Netherlands
100 offices worldwide 5,000 plus
50-100
SAFENANO
UK
Singapore
100-500
25-50
Safety Data Services
UK
1
1
Safeware Quasar Ltd
UK
SAP AG
Germany
SAP Japan Co., Ltd.
Japan
1,000-2,000
5-10
SATRA Technology Centre
UK
0
0
 Royal HaskoningDHV
 SCC
120
USA, Spain and
Japan
122
Science & Environnement
SciVera LLC
Turkey, USA, Japan, 25-50
The Netherlands,
Greece, Ireland
5,000 plus
10-25
5,000 plus
Germany
Japan
50-100
25-50
Switzerland
France
5-10
5-10
5-10
5-10
50-100
50-100
USA
 Selcia
124
UK
USA
 SGS
126
Switzerland
China, France,
5,000 plus
Germany, Hong Kong,
UK, USA
2,000-5,000
0
ShawCor
Canada
Shridhar Rajappanavar
India
2,000-5,000
50-100
SIEF-IT
Poland
5-10
5-10
Siletz SPRL
Belgium
2-5
1
SiteHawk
USA
25-50
25-50
Sitmae Reach Services
The Netherlands
2-5
2-5
Smithers Viscient
USA
UK
100-500
5-10
Spetsinterproject Oy
Finland
Russia, Ukraine
5-10
2-5
2-5
2-5
25-50
10-25
1
1
Spinnaker Coating, LLC
 SSS (Europe) AB
USA
128
Stefanie Merenyi
 Steptoe & Johnson LLP
Sweden
India, Hong Kong
Germany
155
USA
Stewardship Solutions Ltd
UK
Sumika Chemical Analysis Service Ltd (SCAS)
Belgium
Surface Science Western
Canada
SustChem Engineering
Greece
Japan, China,
Singapore
25-50
2-5
2-5
1,000-2,000
25-50
10-25
1
5-10
5-10
Switzerland, Taiwan 100-500
50-100
Syska Voskian Consulting
Denmark
USA
2-5
2-5
TEI Analytical, Inc
USA
5-10
5-10
Telematic srl
Italy
10-25
5-10
Tenviro
Sweden
The Netherlands
1
1
Tetra Tech
USA
Canada, Japan
5,000 plus
50-100
The REACH Centre Ltd
UK
Italy, Japan
10-25
5-10
m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 166
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Spain
 Swissi Instituto Suizo de Seguridad
130
Belgium, China, UK 1,000-2,000
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www.tetratech.com
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


 
  
     


     


      
    
 
 
 
      
 
  
Riskchem
 
Rivendell International
                                  
Roisin McEneany
 
Royal HaskoningDHV
                 
SAFENANO
          
Safety Data Services
 
Safeware Quasar Ltd
 
SAP AG
  
SAP Japan Co., Ltd.
         
SATRA Technology Centre
         
SCC
           
          
Science & Environnement
      
   
    
SciVera LLC
  
 
 
 
      
  




 
 

 

 

         
  
 
      
 
 

   

  



  

                 
ShawCor
       


 


  
SGS
 
  
           
 
Selcia
      
    

                  



 
        
 
 

    
      

  


 

   
  
             


  

      
Risk & Policy Analysts
 


 
       
 
Lobbying/advocacy
Insurance
 
    
   
   
SVHC testing

                  
RimaOne
  


                
           
 

Shridhar Rajappanavar
SIEF-IT
Siletz SPRL
SiteHawk
  
 
      
   

 
 
       


   


 
   
   
Sitmae Reach Services
  
Smithers Viscient
   
Spetsinterproject Oy
      
Spinnaker Coating, LLC
    
SSS (Europe) AB
                 
Stefanie Merenyi
  
Steptoe & Johnson LLP
                                     
Stewardship Solutions Ltd
                                        
 

 

    
 

 
  
  

 
 
 

 

   
 
  
  

Swissi Instituto Suizo de Seguridad
           
Syska Voskian Consulting
          
TEI Analytical, Inc
 
Telematic srl
  
Tenviro
          
     
Tetra Tech
           
       
The REACH Centre Ltd
                    
                
     
 
     
   
  
    
 

     

 


   

    


      

  

  
 

SustChem Engineering


           
  

             
             

Sumika Chemical Analysis Service Ltd (SCAS)      
Surface Science Western
 
            
   
   
    
  
 
   
 
                
     
  
   

Page 167
A-Z LISTING

 

 
Ricerca Biosciences, LLC
 
EH&S solutions
      
   
      
Regulatus

   
        
                   
    
    
Regulatory Services International
 
   
 
GHS notification
CLP notification
  
ReFaC
Dossier preparation
Redeker Sellner Dahs Rechtsanwälte
           
REACHWise
Representation
    
                    
           
ReachSuite Ltd
ReachSpektrum, s.r.o.
    
   
      
Testing strategies
                           
REACHReady
Organisation
REACHLaw
Training
Exposure testing
Laboratories
IT solutions
Information
Ecotoxicology
Repre./management
Product compliance
Page Headquarters
A-Z LISTING
The Sapphire Group
USA
 The Wercs
155
USA
 TNO Triskelion
132
The Netherlands
 Tox Focus, LLC
155
USA
 toXcel International Ltd
156
UK
Toxikon
100-500
5-10
Germany
10-25
10-25
25-50
10-25
TSGE
UK
TUV Rheinland Hong Kong Ltd.
Hong Kong
TÜV Rheinland LGA Products GmbH
Germany
Germany
TUV SUD Japan
Japan
UL
UK
France
USA
Von Roll REACH GmbH
Germany
VRS Regulatory
UK
UK
ge
ieee
me
e
ii
e
e
m
me
www.thewercs.com
www.triskelion.nl
aa
www.toxfocus.com
ge
www.toxminds.com
e a a www.toxcel.com
www.toxikon.be
e e e www.toxservices.com
www.trasys.be
m
e
m
100-500
China, India,
500-1000
Bangladesh, Turkey
Germany, Japan,
2,000-5,000
Singapore, China,
India
100-500
50-100
ie
USA, Switzerland,
Bangladesh
5,000 plus
500-1000
500-1,000
100-500
Global network of
affiliated providers
2-5
2-5
e e e g e e e e www.u-bordeaux2.fr
www.verdantlaw.com
gem
ee
2-5
2-5
5-10
2-5
me
25-50
25-50
1
1
50-100
10-25
1,000-2,000
100-500
100-500
50-100
Italy
 WIL Research
138
USA
 Wildlife International, a division of EAG
140
USA
The Netherlands
e
eeee
ii
www.TSGEurope.com
www.chn.tuv.com
www.tuv.com
25-50
gg
e
e e a www.tuev-sued.de/technical_
installations/reach
2-5
em
e
aa
e
m
Switzerland
1
1
 WRc plc
157
UK
100-500
10-25
 WSP Group
157
UK
 WTConsulting
142
e
m
me
a
m
m
m
e
m
m
www.vonroll.com
www.vrs-regulatory.net
www.wca-environment.com
0
www.thewercs.com
g
ea
www.tuv-sud.jp
e e e ul.com/consumer-products
www.wilresearch.com
a a www.wildlifeinternational.com
www.reachwilmer.com
e
ee
www.wrcplc.co.uk
me
e e e www.wspenvironmental.com
me
ee
www.wtconsulting.ch
ii
50-100
Switzerland
Africa, Asia, Europe, 5,000 plus
Middle East, Oceania
5-10
China
USA
100-500
100-500
USA
Europe, Asia,
Australia
2,000-5,000
50-100
e e e i e e e a www. hach.com
g
m e a a www.yash.com
2-5
1
ee
UK
m >60% i 40-60% g 20-40% e 5-20% a <5%
Page 168
e
me
Belgium, Germany,
China, Japan
The Netherlands
Zanos Limited
i
25-50
USA
144
i
g
157
 YASH Technologies
ee
25-50
 Wercs Professional Services, LLC
Xiaodan Pei
e
France, Greece,
500-1000
Luxembourg, Spain,
UK
Germany, Spain,
50-100
Slovenia, Poland,
USA, Canada
5,000 plus
USA
Wilmer Tox Consulting
50-100
100-500
Belgium
Weeset Advisors
France, Belgium, UK, 50-100
Italy, Germany, Japan
Japan (sales office) 2,000-5,000
Belgium
TRASYS
156
www.thesapphiregroup.com
USA
USA
 wca environment
m
10-25
Belgium
156
5-10
10-25
156
Universit Bordeaux Segalen
Further information
5-10
USA
134
 Verdant Law, PLLC
Chemical
staff
2-5
 Toxservices LLC
136
Global
staff
2-5
 ToxMinds
 TÜV SÜD Industrie Service GmbH
Other locations
Legal services
Laboratory services
Training
Other(s)
Organisation
5-10
m www.zanos.co.uk
Information
IT solutions
Laboratories
Training
  
Lobbying/advocacy
Insurance
SVHC testing
Exposure testing
Ecotoxicology
EH&S solutions
            
        
         
     
      
Toxservices LLC
ToxMinds
GHS notification
CLP notification

Dossier preparation
        
   
           
Toxikon
     
toXcel International Ltd
Representation
          
                    
      
Tox Focus, LLC
TNO Triskelion
    
                 
  
Testing strategies
                    
The Wercs
Organisation
The Sapphire Group
 

        
        


      
 


 
 

        
TRASYS
TSGE
      
TUV Rheinland Hong Kong Ltd.
 

  
TÜV Rheinland LGA Products GmbH
 


TÜV SÜD Industrie Service GmbH
           
 

        
TUV SUD Japan
           
       
        
          

 
 
  



 




  



UL
Universit Bordeaux Segalen
                    
Verdant Law, PLLC
  
  
 
Von Roll REACH GmbH
  
 
  

VRS Regulatory
wca environment
Weeset Advisors

   
               

  




 
 
 
WIL Research
      
Wildlife International, a division of EAG  

 

 
 


 
 
  
   



   
   
WRc plc
      
   
     
WSP Group
                      
WTConsulting
                     
 

    
         



 
        
      
  

      

Xiaodan Pei

  
   

         
      

Wilmer Tox Consulting
Zanos Limited


Wercs Professional Services, LLC
YASH Technologies
 



             

              


 
 
     
 

 
 

Page 169
A-Z LISTING
Repre./management
Product compliance
IUCLID
Nano
Notification
REACHPolymers
Biocides
GHS WEEE CLP
ROHS
TSCA
GPS
COMPLIANT
SUPPLIERS

Global Service Providers Guide 2013

Transcription

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