Community Spotlight
Andrew
Fasey and REACH
MCS
Would you share something about yourself and your background? I have been working on international regulatory chemicals issues for almost 20 years. I am currently advising companies and other stakeholders on the implications of REACH (The Registration, Evaluations, Authorisation and restriction of CHemicals Regulation) and the GHS (Globally Harmonised System for the classification and labeling of chemicals) and how to address compliance issues. I have two main ‘claims to fame’. First, I was one of the authors of the European Commission’s proposal for REACH and subsequently acted as a Special Advisor on REACH to the Government of Finland during their Presidency of the EU when they brought negotiations in the EU on REACH to a successful conclusion. Second, whilst working for the UK Government I was part of the IOMC (Inter-Organisation Progamme for the Sound Mangement of Chemicals) drafting group that prepared the GHS.
Do you feel that industrial
chemicals have been effectively governed around the world?
No. Whilst the
authorities have largely ‘done their best’ it is clear that the management of
chemicals has been inadequate globally. The
development of legislation is always to an extent incremental but progress has
been too slow. There is insufficient data on the
properties of the vast majority of chemicals in use, the communication of
information in the supply chain on the properties of chemicals, and how
chemicals can be used safely. The
promotion of chemical innovation and the encouragement of safer processes is
poor. The old EU legislation did not encourage
innovation and may even, inadvertently, have discouraged it.
What is the new chemical
regulatory system in the European Union known as REACH?
REACH is the Eurpean
Union’s (UN) attempt to correct some of the shortcomings of the old regulatory
regime. It is a complex legal, technical and
scientific piece of legislation and will be supported by many thousands of
pages of guidance. It will lead to a data-set being
established for all substances manufactured in, or imported into, the EU in
quantities of 1 metric tonne or more per year per
manufacturer or importer; the data required increasing in proportion to the
tonnage. This process is known as Registration and
will in the cases of all registrations over the 10 tonne
threshold also require risk management measures to be identified for the uses
of the substance. ‘Substances of very high concern’
(SVHC) will potentially be subject to authorisation; this is a system whereby all uses of chosen SVHCs
will need to be specifically authorised. It is hoped that the authorisation
process in particular, and REACH as a whole, will lead to the substitution of SVHCs with safer alternatives and processes. There are many other important components of REACH but the
Registration and Authorisation elements are perhaps
the most important.
How did you become involved in
REACH?
I have been working in the international regulatory chemicals field for
many years. I had been involved in the development and
implementation of many pieces of EU chemicals legislation and international
development programmes and had seen at close hand the
strengths and limitations of the various pieces of legislation and programmes. I was therefore well
placed to work for the European Commission when they asked for support to turn
the White Paper ‘A future EU chemicals policy’ into legislation. Once I left the Commission after publication of the REACH
proposal I was in a very good position to help other stakeholders such as the
Government of Finland to progress the REACH proposal through the complicated EU
negotiating process and industry to understand the implications of REACH and
prepare for its introduction.
What process will REACH require
for evaluation of chemicals before they are registered?
Manufacturers and importers of substances (on their own and in mixtures)
should pre-register their substances (second half of 2008) in order to take
account of the tonnage related registration deadlines. Following
pre-registration, all potential registrants of the same substance need to
cooperate to share data to develop a single hazard data-set per substance and
to make proposals for testing if needed to complete the data-set; the
requirements of the data-set are prescribed in the legislation and are tonnage
dependent. The potential registrants can then prepare
their own risk assessment (known in REACH as a chemical safety assessment) to
identify appropriate risk management measures or cooperate with each other to
do this. The registration itself is the hazard
data-set and the chemicals safety assessment (if required).
Will REACH be banning any
current chemicals?
Existing bans and restrictions on chemicals will be carried forward under
REACH. The restrictions process under REACH will lead
to further bans and restrictions being introduced over time. The
authorisation process will mean that only certain
uses, if any, of authorised substances will be
allowed. REACH will also lead to chemicals being
‘deselected’ and withdrawn from the market once there is greater information
available on their properties and safe use.
I understand that authorisation will be required for the use of certain
chemicals. What does this mean?
All SVHCs
(broadly speaking CMRs, PBTs,
vPvBs and other substances with properties of
equivalent concern) are potentially subject to authorisation;
a list will be published and other SVHCs added over
time as they are identified. The idea is that a few of
these substances will be selected every year and all those using these
substances will need to submit a case demonstrating that they can be used
safely for each individual use or, failing that, there is a socio-economic
reason why the use of the substance should be allowed to continue. All unauthorized uses would de facto be banned.
Who will be the governing
authority to carry out REACH?
The operation of REACH will be managed by
the new European Chemicals Agency in
Will REACH encourage more
research studies on chemical?
It is hard to say. However,
as all stakeholders become more aware of the risks posed by chemicals the
pressure to research new and better ways of doing things may increase. I think it is likely that REACH will encourage research
into the development of new approaches to identify the properties of chemicals;
this may include computer modeling approaches ((Q)SARs)*,
toxicogenomics, and non-animal test methods. REACH covers the whole life cycle of chemicals; I expect
increasing emphasis to be given to environmental fate assessment for chemicals after
they are used. I would hope that greater resources
will be given to the development of safer chemicals than those currently used
but with the same use characteristics. The principles
of green chemistry should be further developed so that a wider range of
companies can apply these principles in practice.
How do you think REACH will
affect those with multiple chemical sensitivity (MCS) and ?
REACH does not specifically address MCS. However,
over time we will have a far better understanding of the effects of individual
substances and we will be able to apply this knowledge to the issue of MCS; for
example, we may be able to make a link between chemical structure and/or
effects and the incidence of MCS. If there is a known
issue with MCS and a registered substance it would be good practice to address
this in the chemical safety assessment and in the relevant hazard and risk
assessment tools (e.g. safety data sheets).
What can we do to establish
similar chemical regulation the
It is not up to Europeans to advise the
Are there any problems with
REACH?
This remains to be seen, however, I do have some concerns.
The authorisation process may be overly slow
and cumbersome to deal with the perhaps 1500 SVHCs,
and could conversely lead to the withdrawal of substances which are needed and
for which there are no adequate replacements. Many
companies will struggle to cope with the scope and complexity of REACH which
may lead to poor business decisions being made. The
data-set for low volume substances is limited (for good competitiveness
reasons), but this could perhaps be addressed in REACH 2. The
requirement for all potential registrants to share data to prepare a single
hazard data-set may sound like a good idea but the practical implications (e.g.
agreeing on the data to be used, how the costs will be attributed, holding
discussions in up to 20 languages, SMEs having to
‘hold their own’ with large multi-nationals) are going to make this process a
nightmare. Resolving these data sharing issues and
then preparing a registration dossier by the end of 2010 will be challenging to
say the least. Enforcement is the responsibility of
the individual EU Member States; it is certain that there will be some
difference in interpretation and enforcement of the law, despite the best
efforts of the agency, resulting in an un-level ‘playing field’.
Andrew Fasey can be contacted at:
Copyrighted © 2008
MCS