http://mcs-america.org/January2008pg9101112.htm
MCS America News, Volume 3, Issue 1, January 2008.
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 Helsinki. The European Commission will continue to have powers to
introduce new, or amend the existing, legislation. All the EU Member States
will have enforcement responsibilities within their boundaries.
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 United States?
It is not up to Europeans to advise the US on its regulatory requirements
and/or the deficiencies in its existing legislation! Indeed, the EU can
learn a lot from the US in the area of computer modeling of effects. The US
has to consider whether chemicals are sufficiently well managed, for both
human health and the environment, and whether innovation and the replacement
of dangerous chemicals and processes by safer ones is encouraged
sufficiently. If the answer to either of these questions is no then you
should perhaps consider revising or replacing existing legislation. It is
however vitally important that the various national and international
programs are compatible and that information generated under one system can
be shared with another. Whilst the EU hopes that REACH will improve the
management of chemicals the US would be well advised to monitor its
successes and failures to help ensure that the same mistakes are not
repeated.
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:
andrew.fasey@ptkltd.com
Copyrighted © 2008 MCS America
