1 Registration, evaluation
and authorisation of chemicals (REACH)
| (25115)
15409/03
COM(03) 644
| Draft Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) [on Persistent Organic Pollutants]
Draft Directive amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) concerning the registration, evaluation, authorisation and restriction of chemicals
|
| Legal base | Article 95 EC; co-decision; QMV
|
| Department | Environment, Food and Rural Affairs
|
| Basis of consideration | SEM of 17 April 2004
|
| Previous Committee Report | HC 42-ix (2003-04), para 2 (4 February 2004)
|
| To be discussed in Council | May 2004
|
| Committee's assessment | Politically important
|
| Committee's decision | For debate in European Standing Committee A (decision reported on 4 February 2004)
|
Background
1.1 It has long been recognised that certain chemicals can cause
serious damage to human health and the environment. Consequently,
their production, marketing and use within the Community is governed
by a number of legal instruments, which regulate their testing,
determine risk reduction measures, and establish duties regarding
the safety information provided to users. However, concerns that
these measures do not provide sufficient protection led the Commission
to review the situation in February 2001, in a White Paper[1]
which identified a number of major problems.
1.2 In particular, it pointed out that the present
system distinguishes between existing substances (declared to
be on the market in September 1981) and new substances (placed
on the market since that date), and that there was a general lack
of knowledge about the properties and uses of those substances
in the former category, due to the slowness and resource-intensive
nature of the risk assessment process, and the fact that, although
manufacturers and importers are required to provide information
about them, this obligation does not apply to downstream users.
The White Paper also highlighted two major procedural flaws.
First, industry can be asked to carry out further testing of
a substance only after the relevant authorities have demonstrated
that it may present a serious risk, but, without test results,
it is almost impossible to provide such proof. Secondly, current
liability regimes are insufficient to remedy any problems found,
as they require a causal link, which is often impossible to establish.
1.3 The White Paper therefore suggested that both
existing and new substances should become subject to a new system
called REACH, based upon the registration of the basic
information which manufacturers would be required to provide;
an evaluation of those substances whose production exceeds
100 tonnes, as well as of those of a lower tonnage where there
is cause for concern; and the special authorization of
substances giving rise to very high concern. In the case of existing
substances, the White Paper envisaged this new system being phased
in over a period, but with provisions enabling it be applied more
quickly where there is cause for concern. The main aim would
be to provide a reliable basis for deciding on adequate safety
measures, based on a chemicals hazardous properties and potency,
and the exposure arising from its use, thus enabling chemicals
to be classified, and decisions to be taken on the appropriate
labelling and other measures needed to protect consumers and the
environment.
1.4 The White Paper was debated in European Standing
Committee A on 12 June 2002, but, following the circulation last
summer of draft legislative proposals, the Commission brought
forward in October 2003 the current document, which it says takes
account of reactions to the draft proposals. Although the document
is immensely long, it contains two key elements, set out in our
Report of 4 February 2004: first, that both existing and new
substances should become subject to the REACH system, along the
lines outlined in the White Paper, and secondly, that a European
Chemicals Agency should be established to manage the technical,
scientific and administrative aspects of the system, and ensure
consistency of decision-making at Community level.
1.5 The proposals were accompanied by an extended
impact assessment, in which the Commission sought to identify
the potential benefits and costs. This suggested that, although
benefits will eventually extend to improvements to human health
and the environment, it is not possible at this stage to give
a quantitative assessment, since much of the information needed
to provide this will only become available once the proposals
have come into operation. However, purely as an illustration
of the potential scale, it suggested that even a 0.1% reduction
in the disease burden as a result of REACH would give rise to
benefits of around €50 billion over the next 30 years. The
assessment said that the costs of testing and registration envisaged
over the next 11 years would be (in net present value terms) €2.3
billion, of which €1.25 billion would arise from testing,
€500 million from registration, and €300 million from
fees payable to the new Agency. It added that the indirect costs[2]
falling on downstream users are more difficult to quantify, but
might be €2.8-5.2 billion, depending on the assumptions made,
and the extent to which these costs could be passed on.
1.6 We noted that the Government strongly supported
the principles set out in the White Paper, and the overall objective
of REACH; that it believed that the proposals could be made to
work in a cost-effective way; and that the UK had three key objectives
in the negotiations on them — to develop a workable process
to assess chemicals and tackle those of most concern first; to
minimise animal testing; and to maintain or enhance the competitiveness
of the chemicals industry and downstream users. We also said
that, although the Commission's White Paper on the subject had
been debated, we had no hesitation in recommending that the current
proposal should also be considered in European Standing Committee
A, even though we had yet to receive the partial Regulatory Impact
Assessment which the Government had said it was preparing. We
added that we hoped that, in addressing the issues identified
by the Minister, the Assessment would also touch upon a number
of other aspects of the proposal, on which we understood concerns
had been raised, including the extent to which prioritisation
is based on the intrinsic hazard of a chemical, as opposed to
a risk-based approach; the precise rules governing the substitution
of chemicals of known toxicity; whether a one-substance-one-registration
approach would give rise to problems of confidentiality and cost-sharing;
and the obligations to be placed on retailers.
Supplementary Explanatory Memorandum of 17 April
2004
1.7 We have now received a supplementary Explanatory
Memorandum of 17 April 2004 from the Minister of State (Rural
Affairs and Local Environmental Quality) at the Department for
Environment, Food and Rural Affairs (Mr Alun Michael), enclosing
a copy of the consultation document issued by his department at
the end of March, and on which it has invited comments by 25 June.
This covers in considerable detail the various aspects of the
proposals, and sets out the Government's initial views on these,
the intention being to finalise the UK's negotiating position
in the light of the comments received.
1.8 The consultation document also incorporates a
partial Regulatory Impact Assessment, which the Minister says
is an integral part of the policy-making process. However, the
Assessment stresses the considerable uncertainties involved, and
the consequent difficulties of quantifying the impact of the proposals,
particularly as regards the benefits, where it does no more than
estimate that, for the proposals to "break even", between
18 and 37 occupational deaths from cancer would need to be prevented
each year. It also seeks to relate these figures to the potential
costs of the proposals in the UK, which depend on the assumptions
made as to their relative impact in this country as compared with
other Member States and the extent to which companies form consortia
in order to apply the REACH principles to particular products.
However, the Assessment suggests that, with an 85% participation
by consortia, the direct costs — excluding costs to downstream
users — to the Community chemical industry over the 11-year
phase-in period could lie between £1.24 billion and £4.64
billion, with a "central" figure of £2.40 billion,
the latter giving rise to a "central" UK figure of £515
million (which would fall to £505 million if a "one
substance, one registration" approach were to be adopted).
These estimates are therefore markedly higher than those contained
in the Commission's own impact assessment.
Conclusion
1.9 Since the consultation document covers ground
similar to that in our earlier Report, we think it sufficient
simply to draw it —
and the tentative figures in the Regulatory Impact Assessment
—
to the attention of the House as being relevant to the debate
we have recommended in European Standing Committee A (which we
understand is currently scheduled to take place on 12 May).
1 (22212) 6671/01; see HC 28-xii (2000-01), para 1
(25 April 2001). Back
2
Arising from the higher price of chemicals, the need to find substitutes
for those which have been withdrawn, and the increased market
power which remaining suppliers might temporarily exploit. Back
|
