APPENDIX 10
Memorandum from the Royal Society of Chemistry
The European Commission White Paper Strategy
for a Future Chemicals Policy was published in February 2001
outlining proposals for the future regulatory control of chemicals.
This initiative, now known as REACH (Registration, Evaluation,
Authorisation, and Restriction, of Chemicals) is arguably the
most significant development in European legislation with regard
to controlling chemicals with far reaching implications for the
science and practice of chemistry within the European Union.
One of the key aims of the chemicals policy
is to introduce laws that will provide a faster, more efficient
approach to managing chemicals of high concern. Since its publication
the strategy has undergone many modifications and amendments,
resulting in submission of a proposal for legislation to the Council
and the European Parliament in October 2003.
The Royal Society of Chemistry Charter obliges
it to serve the public interest by acting in an independent advisory
capacity. It is in this capacity that the Society has made an
input into official UK and EC consultations and inquiries with
an interest in the proposed policy and legislation.
The RSC finds the latest version setting out
the proposed regulations to be more balanced and more pragmatic
than earlier versions. However, we still have significant concerns
about the workability of some aspects of the proposal, and we
believe that more information and guidance is required if it is
to achieve its intended objectives. The Society is aware that
the process of developing the proposals into legislation has only
just begun and hopes that further improvements will be made to
ensure the effectiveness and workability of the eventual legislation.
The current EU system is fragmented and cumbersome.
In principle the Royal Society of Chemistry would welcome a single
harmonised regime for assessing and controlling the effects of
chemicals on health and the environment.
However the Society would like to stress that:
1. IT IS
VITALLY IMPORTANT
THAT REACH IS
BASED ON
RISK
Substances should generally not be banned on
the basis of intrinsic hazard alone. Intrinsic hazard is not a
good measure of the actual threat that a substance poses to humans
or the environment. Risk is a better measure because it is based
on the likelihood that an intrinsic hazard associated with a substance
will cause actual harm. Using tonnage to trigger the REACH process
is not ideal although it offers a pragmatic solution for new substances.
There is a need for improved prioritization procedures for existing
substances.
The Society would have preferred prioritisation
(to identify and deal with substances of high concern) on the
basis of risk to be built in at the Registration stage. Exposure
scenarios required for registration will differ on the basis of
use and this will have a key impact on the risk that a chemical
(substance) poses. By focusing on the volume of chemical produced
or imported, the danger exists that effort may be misdirected
on high volume but low toxicity substances such as sodium chloride—common
table salt, rather than on substances of high concern used in
smaller quantities. In this regard it may also be appropriate
to revise Annex II which provides for exemptions from the obligation
to register (in accordance with Article 6(a)).
2. REACH SHOULD
BE COMPATIBLE
WITH EXISTING
AND PROPOSED
INTERNATIONAL INITIATIVES
ON THE
CONTROL OF
CHEMICALS
Efforts must also be made to minimise duplication
with other legislation.
REACH will replace about 40 Directives and regulations
on chemicals but leave more than 20 others in place. The Commission
when implementing REACH should recognise and where appropriate
incorporate the outputs of the Intergovernmental Forum on Chemical
Safety (IFCS), the UNEP strategic approach to chemicals management,
the OECD cooperative programme for testing and assessing High
Production Volume (HPV) chemicals (ie the ICCA HPV programme),
the Rotterdam convention on Prior Informed Consent (PIC) regulating
trade in certain dangerous substances and the Stockholm Convention
on Persistent Organic Pollutants (POPs), which came into force
this year. REACH should also be compatible with the proposed Global
Harmonised system for classification and labelling of substances.
3. THE SOCIETY
FULLY SUPPORTS
THE PRINCIPLE
OF TRANSPARENCY
UNDER REACH
Transparency is vital to enhance public confidence
in chemistry. The challenge is to create a balance between transparency
and commercial confidentiality.
All aspects of the REACH process need to be
transparent so that interested parties can see how decisions are
made. However this should not extend to providing detailed commercially
sensitive information that would impact on competitiveness without
providing any useful benefit, such as on the intermediates used
in pharmaceutical syntheses, or on details of formulations that
would allow competitors to copy mixtures or articles (finished
products). Commercial enterprises should only have an obligation
to declare hazardous components of mixtures and articles that
could have public safety implications. The Society recognises
the need for, and wishes to promote, dialogue between the chemical
industry and other stakeholders to discuss information needs in
the context of mutually desired outcomes.
4. REACH SHOULD
ONLY REQUIRE
DATA THAT
HAS REAL
VALUE
This is particularly true for "existing
chemicals" that have been in use for many years with no apparent
adverse effects.
Production and importation levels are not ideal
indicators of potential harm or exposure. Therefore testing thresholds
should, where practicable, take account of estimated actual exposure
and potential impact.
Furthermore, there should be greater acceptance
of scientifically reliable historical data gathered for other
toxicological assessments required under other regimes. In addition,
data in dossiers produced to meet the requirements of other chemical
evaluation programmes such as the US High Production Volume challenge
should be mutually acceptable for REACH. There is a need for European
Chemicals Agency guidance on using read across toxicity data and
advice on what level of information is required at the Registration
stage to enable a move away from a tick box approach.
There is concern that if dossiers will only
be checked for completeness, prior to being placed on the database,
that this will encourage registrants to generate comprehensive
datasets and thus the use of experimental animals for toxicity
testing is likely to increase unnecessarily. Testing on animals
should be minimised. It would be unethical to require animal testing
simply to complete a bureaucratic box ticking exercise.
For low volume chemicals (1-10 tonnes/year/manufacturer
or importer) the European Commission has recognised the need to
avoid animal testing as far as is possible.
For higher volumes animal testing may be necessary
if existing information and validated alternative methods are
not sufficient.
Even though the Commission is proposing to allow
the maximum use of existing non-animal test methods and encourage
the development of new tests that do not use animals, this may
not reduce the use of experimental animals in the short and medium
term.
New test methods will take time to develop,
validate and gain acceptability by regulators. The regime should
also be flexible enough to adapt to developments in toxicology,
such as those resulting from the fast developing area of genomic
science. In general companies prefer to use test methods that
don't involve animals. However a company cannot use alternative
tests until legislators and regulatory agencies have confirmed
that they will accept the results. In the past it has taken many
years of international validation studies before legislators and
regulatory agencies would accept the results from alternative
test methods.
There tends to be more information about chemicals
of high concern. Consequently, data waivers should be allowed
where there are good surrogate measures. Provision is made for
this in Annex IX (rules for adaptation of standard testing regime)
which also covers the need for additional standard information
requirements for substances in excess of 100 tonnes (Annexes V
to VII ). The Society also recognises that the revised proposals
also make provision for data sharing between enterprises but it
is not clear on how this will be achieved in practice without
excessive bureaucratic interference.
The Society is also concerned about the practicalities
of the Registration of 30,000 or so substances, including the
1,500 substances of high concern requiring Evaluation and Authorization
within the 12 years of REACH coming into force. In addition to
these substances, 40,000 intermediates will also need to be registered
even though the requirements for registering these will be significantly
lighter. In view of the number of chemicals that will fall within
the REACH process it seems unlikely the Competent Authorities
will have the resources to devote sufficient time to chemicals
of lower concern, ie those requiring Registration and Evaluation
but not Authorisation.
5. THE SOCIETY
WELCOMES THE
SIMPLIFIED AND
REDUCED REGISTRATION
REQUIREMENTS BUT
HAS SERIOUS
CONCERNS ABOUT
THE RESOURCES
AND EXPERTISE
WITHIN THE
EUROPEAN CHEMICALS
AGENCY, COMPETENT
AUTHORITIES IN
MEMBER STATES
AND IN
TESTING LABORATORIES
FOR COPING
WITH REACH
There is a need for people with the necessary
skills and experience to be available throughout all three stages
of the REACH process in order to avoid Registration being downgraded
to a box ticking exercise.
Expert judgement is required in specifying what
data (including existing data) and which tests are acceptable
in the first instance. Then there is a need to be able to go beyond
the completeness to check validity of dossier contents. The Registration
process also needs to be enhanced by instituting a sampling regime
to ensure that harmful substances classified into categories not
intended for rapid evaluation do not slip through because the
data is not properly scrutinised. This requires a level of expertise
to counter the ability of registrants to finesse a dossier that
could hide issues requiring more careful scrutiny.
With regard to the Evaluation of dossiers and
substances by the Competent Authorities in Member States, the
European Chemicals Agency will have to provide guidance to ensure
consistency and a level playing field. This guidance needs to
address both registrants and Member States.
Differences in interpretation by Member States
must be minimised. As registrants will not know which Member State
will be conducting the evaluation, clear guidance should be given
as to what data is required, because without it registrants will
be likely to generate the maximum amount of test data that any
Member State might require, to ensure that applications are successful.
This in turn is will create an unnecessary amount of work and,
possibly, unnecessary animal testing.
6. ONE PARTICULAR
CONCERN IS
THAT REACH COULD
LEAD TO
USEFUL CHEMICALS
CEASING TO
BE AVAILABLE
DUE TO
THE HIGH
COST OF
TESTING
Any chemicals that are withdrawn should be those
that are least desirable for health, safety or environmental reasons.
The "best" or "safest" substances
should not be withdrawn simply because they generate insufficient
profit to cover the cost of testing.
The Commission estimates that 1-2% of substances
currently on the market will be lost. The Society and others believe
that this may be a significant underestimation. This situation
is likely to arise in those cases where a producer would have
to spend a large amount of money to test a low economic value
substance for the purposes of Registration. In such cases economic
sense dictates that the producer/importer drop that substance
rather than pay for the tests. A similar situation has resulted
in a loss of around 60% active substances in plant protection
products and probably an even larger proportion of active substances
in biocidal products.
It is difficult to quantify cost of compliance
with REACH. However the current cost estimate from the Commission
for complying with the proposals is 2.8 billion euros with most
of this being for testing and Registration. It is likely however
that the biggest costs will be incurred downstream in the supply
chain due to mixture and article reformulation and this in turn
will depend on the number of substances that will be taken off
the market. It is important to note that the quantity of material
does not relate to value of a component in a formulation which
may not be possible to reformulate in some cases.
Whatever the figures turn out to be it is already
clear that implementing REACH will place significant costs on
industry and there are fears that this could be a factor when
industry decides whether to remain in the EU.
The Commission should therefore consider developing
options for allowing some, generic substances that do not have
sponsorship to continue to be manufactured within the Community.
Enforcement of REACH may be a serious problem when dealing with
downstream users, and proper enforcement also represents a significant
cost.
7. REACH SHOULD
NOT INHIBIT
INNOVATION
Innovation is essential to achieving sustainable
development, and chemistry can provide a range of "solutions"
to support sustainable development. The Society welcomes the exemptions
on registration for the purposes of research and development together
with lower registration costs to facilitate the introduction of
new substances aimed promoting innovation. There is some concern
that innovation as envisaged by the Commission is primarily focused
on substitution. Although substitution can lead to environmental
benefits it is unlikely to lead to truly innovative articles (products)
which contribute to the economic profits needed to underpin sustainable
development.
The Royal Society of Chemistry is the UK Professional
Body for chemical scientists and an international Learned Society
for the chemical sciences with 46,000 members world-wide. It is
a major international publisher of chemical information, supports
the teaching of the chemical sciences at all levels and is a leader
in bringing science to the public.
January 2004
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