4 EVALUATION
55. The Proposals outline two types of Evaluation,
to be carried out by the competent authority in the Member State
of production:
a) Dossier Evaluation (where the principal
aim of preventing unnecessary animal testing would be achieved
by Proposals being examined in advance) and
b) Substance Evaluation (which would enable an
authority to require more information from industry).
56. Dossier Evaluation has two stages: a mandatory
review of testing proposals and a voluntary compliance check of
registrations. The Proposals suggest that the review of testing
proposals will be carried out by Member States in order to assess
whether the test proposed is necessary and, if so, whether the
proposed test conditions are appropriate.[70]
This is intended to avoid unnecessary animal testing. In addition,
the Member State Competent Authority may check that any Registration
complies with the registration requirements. The location of the
registering company dictates which Member State will conduct the
Dossier Evaluation.
57. For substance evaluation, the ECA would be required
to develop guidance on the prioritisation of substances, in order
to promote a consistent approach. Member States would then prepare
rolling plans of the substances which they wished to evaluate.
As with Registration, the new arrangements would be phased in,
with testing for substances above 1,000 tonnes having to be completed
within five years of the Regulation entering into force, and testing
for those above 100 tonnes within seven years.
58. While the CBI welcomes the distinction between
dossier and substance Evaluations, it regards the Evaluation system
as "unnecessarily complex and burdensome". Particular
concerns are the freedom of Member States to undertake Evaluation
over and above criteria set by the ECA and the need to harmonise
the approach across the EU. The CBI is also concerned that the
Evaluation process has no clear end point.[71]
59. A driving principle for the Commission has been
the abolition of the distinction between "old" and "new"
chemicals. The Scientific Alliance argues that the distinction
could still have some value in the Evaluation process: "the
Evaluation process for pre-1981 chemicals should be more reactive
than proactive. A full Evaluation process should only be enacted
to investigate the chemicals where evidence exists that they cause
harm".[72] Greenpeace
rejects this position: Mark Strutt told us that "history
has shown us that chemicals that will be perceived to be safe
at one point have subsequently proved to be risky; that exposure
has taken place when it was denied that it would take place, and
that exposure has had health or environmental impact".[73]
We agree. Treating old and new chemicals the same is one of the
strengths of the REACH Proposals.
60. Despite Dr Delbeke's insistence that the Evaluation
process was risk-based, the Government describes concern that
"the European Commission's proposal may not in practice result
in all evaluations which are needed being carried out".[74]
As drafted, the Proposals indicate that Member States are responsible
for drawing up a rolling programme of Evaluation, although the
ECA will develop criteria and propose priorities for Evaluation.[75]
The UK Environment Agency argues that it will "be crucial
to develop a system of prioritisation which will enable a quick
screen of the information supplied at Registration to identify
chemicals which may be of concern and for which Evaluation should
be prioritised".[76]
The WWF is concerned that the Proposals would allow some Members
States to carry out no Evaluations at all and argues that each
country should have to undertake a minimum number of Evaluations.[77]
61. While there are merits in leaving the Evaluation
process with the competent authorities in Member States, it is
naïve to think that this will result in the rapid identification
of substances of concern unless the rolling programmes are subject
to ratification by the Commission of the ECA. It is unclear what
incentive there is for Member States to either develop or implement
their rolling programmes. Member States, protective of their chemical
industries, could easily be tempted to move at a pedestrian pace
when more energetic progress is required. The Government says
it is "considering whether the obligation to conduct substance
evaluations should be moved from the Member States' Competent
Authorities to the European Chemicals Agency".[78]
While this has its attractions, we feel that expertise in Member
States' Competent Authorities should be utilised. What is missing
from the Proposals, we believe, is strong oversight by the ECA
to ensure that a speedy and risk-based approach to Evaluation
is employed by all Member States. We recommend that Substance
Evaluation remain the responsibility of Member States but their
rolling programmes be subject to oversight by the European Chemicals
Agency to ensure that Evaluations of chemicals are prioritised
according to risk and rapidly undertaken.
70 Article 43. This only applies to Annexes VII and
VIII. Back
71
Ev 96 Back
72
Ev 102 Back
73
Q 14 Back
74
DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 94, Q 136 Back
75
Article 38 Back
76
Ev 62 Back
77
Ev 76-77 Back
78
DEFRA, UK Consultation paper on the New EU Chemicals Strategy
- REACH, March 2004, para 95 Back
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