PROPOSALS FOR REFORM
6. The White Paper proposes a new regime, to be known
as REACH, with three main elements: Registration, Evaluation and
Authorisation. It seeks to overcome the deficiencies that have
been identified by requiring industry to submit much more data
than are currently required, including preliminary risk assessments.
The idea is that the same sort of data that are provided for the
2,700 chemicals marketed since 1981 will be made available for
30,000 or so older chemicals marketed in quantities of more than
1 tonne per annum. Manufacturers will have a powerful incentive
to submit a complete registration dossier because a failure to
do so may result in marketing being banned.
7. The proposed system places much reliance on the
preliminary risk assessment that industry is required to provide.
The authorities are likely to evaluate only some of these assessments.
The White Paper estimates that 80 per cent of the 30,000 substances
"would only require registration", with evaluation being
limited to chemicals where production has exceeded 100 tonnes
per annum and, at lower tonnages, to chemicals identified as being
of concern. Authorisation will be required for chemicals identified
as of very high concern and the onus will be on industry to justify
the use of such chemicals. These will be banned unless a particular
use is authorised.
HOW PRACTICAL ARE THE PROPOSALS?
8. The White Paper programme is highly ambitious.
While, in our opinion, it is right to set deadlines by which relevant
information must be made available, the timetables set for a great
deal of the work that is proposed are unrealistic. We have received
much evidence of the need for prioritisation to focus attention
on chemicals of greatest concern and in order to minimise the
amount of testing on animals that will result. It may be a mistake
to move at the outset to a single system that seeks to combine
the arrangements for new and existing chemicals, since the information
obtainable for new and existing chemicals is necessarily different.
The new legislation that will be needed will be extremely complicated
and contentious, and the Commission will be adding to the difficulties
of having the legislation adopted quickly if it tries to reform
everything at once. Its priority must be the reform of the regime
for existing chemicals.
9. We agree with many of the conclusions of the Environment
Council of 7 June 2001 and, in particular, with the need for "streamlined,
pragmatic and effective procedures" which are "realistically
achievable". The failure of the present Existing Substances
Regulation arises in part because there is no pressure on industry
to conduct tests and assessments. We therefore agree with the
Council that a chemical should not be marketed or used "if
the information required under the REACH system is not provided
by the industry within the reasonable time periods to be set within
10. Many of our witnesses agreed that it would not
be possible to provide the amount of data that the White Paper
wishes to have available at the registration stage by the intended
deadlines, and that the target of 2012 for completion of the testing
programme is not achievable. Furthermore, some witnesses doubt
whether testing facilities in Europe have the capacity to meet
the deadlines even if animal testing on that scale were acceptable
to public opinion. It is, therefore, important that definitions
should be provided of the minimum amount of hazard data required
that will enable prioritisation of those chemicals needing risk
assessment and risk management measures. We welcome the fact that
the Commission has established task forces to study the matter.
11. The proposal to transfer responsibility to industry,
including downstream users, to conduct preliminary risk assessments
is a centrepiece of the White Paper. The authorities, who previously
did these assessments, will not have the resources to undertake
so many and we therefore support the proposed transfer. But given
the difficulty and uncertainty of the risk assessment process,
and that confidence in the system will depend on their quality,
we believe the Commission should provide guidance and detailed
rules on how industry should conduct and present risk assessments.
12. Downstream users have hitherto had no formal
role in the existing EU regimes but will now have to contribute
to the risk assessment process. The complexity of the supply chain
and the very large number of uses of chemicals, often unknown
to manufacturers, pose real problems for the preparation of risk
assessments, which we do not believe are reflected in the White
Paper. A solution may be to limit them to chemicals meeting certain
THE PRIORITYCHEMICALS OF VERY
13. We believe that a main aim must be to ensure
that action is taken on chemicals of very high concern. It has
not been established that an authorisation system will achieve
speedy results, because positive approval schemes can be slow
and resource-intensive. There may be a continued role for action
on specific uses under a revised Marketing and Use Directive.
The White Paper proposes that authorisation would apply to CMRs
(carcinogenic, mutagenic and reprotoxic substances) and those
with POP characteristics (persistent organic pollutants as defined
in the Stockholm Convention).
14. A vigorous debate is taking place involving,
among others, the European Commission, the Council and the European
Parliament as to whether the list should include PBT (persistent,
bio-accumulative and toxic) and VPVB (very persistent, very bio-accumulative)
chemicals (and possibly endocrine disrupters). We think that PBT
and VPVB chemicals should be regarded as of very high concern
and be subject to authorisation, and we support the Council's
position against the current position of the Commission and the
RESOURCES, PARTICULARLY FOR DEVELOPING ALTERNATIVES
TO ANIMAL TESTING
15. The success of the regime proposed in the White
Paper will in two crucial respects be dependent on adequate resources
being made available. We find it impossible to accept the White
Paper's optimistic view that the substantial extra regulatory
effort that will be required can be provided with no net increase
in public resources. We agree with the Council that "Member
States and the Commission must commit themselves fully to an effective
implementation of the new system by ensuring sufficient resources
at all levels and through Community measures to facilitate the
implementation by Member States".
16. We also agree with the Council that adequate
resources must be provided for research, development and validation
of globally accepted test guidelines for alternatives to the existing
techniques of animal testing. Animal testing is an extremely sensitive
subject. Concerns have been expressed by many of our witnesses
that the White Paper proposals will lead to a big increase in
animal testing; and the majority of those witnesses believe that
finding acceptable alternatives will take much longer than the
deadlines that the White Paper proposes for the implementation
of the new regime. The British Union for the Abolition of Vivisection
provided arguments that alternatives could be found and was more
optimistic than other witnesses about the timescales.
17. In our view the White Paper provides a rare opportunity
to generate the political will in the EU to promote non-animal
testing. The United Kingdom Government must take a lead in this
and should make it clear in the Council that it cannot accept
a new chemicals strategy that leads to significantly increased
animal testing. This would be unacceptable to the public and could
well cause the strategy to fail. The EU chemicals strategy must
therefore be linked to an EU strategy for minimising animal testing.
All witnesses agreed that the search for acceptable alternatives
would require the commitment of substantial additional resources.
The United Kingdom Government is more likely to be successful
in pressing this argument if it has its own well-funded programme
for finding alternatives.
THE DEBATE CONTINUES
18. Our report covers many other aspects of what
is a complex subject and includes our initial conclusions on the
responsibilities of the proposed "central entity" that
would administer the system; the need for transparency and stakeholder
involvement; the need for post-marketing surveillance; difficult
issues involving imported products; and the manner in which the
White Paper proposals relate to other international arrangements.
We refer to extremely important and sensitive matters still to
be decided in relation to the political process and the manner
in which decisions are to be reached.
19. Following the guidance given by the Environment
Council in June 2001 the Commission has established a number of
task forces to work on problem areas and the numerous unresolved
issues. It is not now expected to come forward with its legislative
proposals before the middle of 2002. In these circumstances this
can only be seen as an interim report. The Committee will, no
doubt, have to return to the subject again when those proposals