12 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
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Legal base | Article 95 EC; co-decision; QMV
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Department | Environment, Food and Rural Affairs
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Basis of consideration | Minister's letters of 26 October 2005 and 4 November 2005
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Previous Committee Reports | HC 42-ix (2003-04), para 2 (4 February 2004) and HC 42-xviii (2003-04), para 1 (28 April 2004)
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To be discussed in Council | 28 November 2005
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Committee's assessment | Politically important
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Committee's decision | Cleared following debate in European Standing Committee A on 16 June 2004
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Background
12.1 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[40]
which identified a number of major problems.
12.2 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.
12.3 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.
12.4 The White Paper was debated in European Standing
Committee A on 12 June 2002, but, following the circulation of
draft legislative proposals, the Commission brought forward in
October 2003 the current document, which contains two key elements,
set out in our predecessors' Report of 4 February 2004. First,
both existing and new substances would become subject to the REACH
system, along the lines outlined in the White Paper, and secondly,
a European Chemicals Agency would be established to manage the
technical, scientific and administrative aspects of the system,
and ensure consistency of decision-making at Community level.
The proposals were accompanied by an extended impact assessment,
in which the Commission suggested that, although benefits would
eventually extend to improvements to human health and the environment,
it was not possible at that stage to give a quantitative assessment,
since much of the information needed to provide this would only
become available once the proposals had come into operation.
12.5 Our predecessors 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.[41]
They also said that, notwithstanding the earlier debate on the
Commission's White Paper, the current proposal should be considered
as well in European Standing Committee A. That debate duly took
place on 16 June 2004.
Recent developments
12.6 We recently received two letters
one dated 5 October 2005 from the Parliamentary Under-Secretary
of State (Sustainable Farming and Food) at the Department of Environment,
Food and Rural Affairs (Lord Bach), and the other dated 20 October
2005 from the UK Metals Industry Reach Group (Annex A). The Minister
said that the European Parliament was expected to give the proposal
a First Reading on 14-17 November, and that the UK Presidency
would be seeking to reach a political agreement at the Competitiveness
Council on 28 November on the basis of a text aimed at finding
a workable compromise which protects public health, the environment
and industrial competitiveness. In particular, this aimed to rationalise
the registration process, and to focus first on substances of
concern; to redefine the division of responsibility between the
Member States and the proposed Agency; and to make all authorisations
subject to a review, which would enable consideration to be given
in the future to the availability of alternatives. However, the
Metals Industry Research Group drew to our attention its concerns
about the impact of the proposal on minerals, ores and concentrates,
and in particular the fact that, although the Government had responded
to these by exempting them from registration and evaluation, this
had not extended to authorisation. The Group claimed that this
would damage unnecessarily, not only the competitiveness of the
UK and the Community, but also that of many developing countries
heavily dependent on export revenues from their mining sector.
12.7 In view of these concerns, we wrote to the Minister
on 26 October, inviting him to comment. We have now received his
reply of 4 November. This stresses the benefits to the industries
concerned from the proposed exemptions from the registration and
evaluation requirements, but says that, because certain minerals
and ores could contain carcinogenic compounds above a certain
level, they could meet the criteria requiring their authorisation.
He adds that the Government appreciates that substitutes for these
compounds are not easily found, which is why the proposal allows
for a pragmatic and proportionate approach to authorisation, and
provides for the most dangerous substances to be dealt with first.
He also says that uses and categories of uses may be exempt from
the authorisation process, and that the Presidency text enables
the establishment of exemptions to take account of the proportionality
of the risk to human health and the environment, for example,
where it is modified by the physical form. He suggests that this
could apply to metals in "massive form" if appropriate.
Conclusion
12.8 Given that this proposal was debated in June
2004, and that the UK Presidency is seeking to reach political
agreement on it in the Council at the end of this month, we can
probably do little more at this stage than draw the attention
of the House to the present position, including the representations
we have received from the UK Metals Industry Reach Group (and
the Government's response to these). We would, however, be glad
if the Government could continue to keep us informed of developments,
and, in particular of any indication that the Commission may be
considering revising its original proposal in the light of either
the views reached by the Council or any amendments proposed by
the European Parliament at its First Reading.
Annex: Letter to Chairman from the UK Metals Industry
REACH Group (MIRG)
REACH and the Metals Industry
Since I first wrote, on behalf of the UK Metals Industry
REACH Group (MIRG), to the European Scrutiny Committee in February
this year, MIRG has been actively engaged in dialogue with the
UK Government, seeking to secure their broader understanding of
the likely impact of REACH on the UK and EU metals industry.
MIRG fully supports the drivers behind REACH, but
to be workable for metals, the proposal must be amended to reflect
the special properties of metals and alloys. Without amendment
it will have the unintended effect of hindering the effective
use of metals compared to less sustainable alternatives. This
discrimination will result in socio-economic harm to the UK metals
and alloys industries, with no net benefit to the EU environment
and health. In its current form, REACH will also distort international
trade, undermine EU competitiveness, hamper African development,
and that of other developing nations.
One clear illustration of how REACH directly creates
competitive market distortion is that the current proposal exempts
the raw material feedstock for the plastics industry (oil, coal,
natural gas, and polymers) from Registration & Evaluation
under REACH, but does not exempt the raw material feedstock for
the metals industry (minerals, ores and concentrates). Taking
this one step further, it stigmatises metals versus plastics because
only metals will require a Chemicals Safety Report. Users will
therefore see metal and mineral products as hazardous, but not
the competing plastics. Is REACH intended to promote plastic containers
over (recyclable) steel and aluminium?
UK Government has partially taken on board this issue,
by proposing, in its Sept 05 REACH Compromise Text, that ores
and concentrates be exempt from Registration and Evaluation, but
not from Authorisation. In the original Commission proposal,
Authorisation is a risk-based policy, intended to ensure
proper control of the risks associated with certain hazardous
substances OR encouragement of eventual substitution. The UK Government
however, is strenuously promoting a hazard-based approach
to Authorisation, seeking eventual substitution on the basis of
hazard, even if the risks are properly controlled. Recent proposals
by the EU Environment Committee go further, stipulating "proper
control and progress towards phase-out after a single non-renewable
5 year authorisation period".
Intrinsic hazard classification alone is an inadequate
indicator of actual risk for metals and alloys. It is important
for future value-added innovation in the metals sector that REACH
adopts a policy on authorisation that is practical and risk-based.
The driver should be net risk reduction, not simply hazard.
If ores and concentrates remain liable to Authorisation,
it will prejudice against the development of future metal-based
enabling technologies for society such as fuel cells,
photovoltaic energy systems, advanced telecommunications, bio-fuel
plants, pollution control and remediation equipment, etc. The
current inadequately sophisticated Authorisation policy must be
re-designed to ensure that these innovative technologies, which
support the EU wider global sustainable development objectives,
are encouraged, not destabilised.
Both the Commission and UK Government have advised
us not to be unduly concerned, as ores, concentrates and metals
are not the prime target of the legislation and it would be many,
many years before Authorisation may be sought to apply. This provides
no comfort, as the stigmatisation of our products would be immediate.
It suggests that our industries are to be targeted and prejudiced,
as described above, for no tangible benefit, or reduction in risks
to society, other than compliance with tick-box bureaucracy.
Persisting with an inadequate Authorisation policy
for metals will unnecessarily damage not only UK and EU competitiveness,
but also those of many developing nations, such as those of South
Africa and Chile. The Heads of State of those nations have recently
directly appealed to Prime Minister Blair to take action on the
fact that metals don't fit within the simple regulatory concepts
of REACH. The social and infrastructure development programmes
of developing countries, heavily dependent upon mining sector
export revenues, will be needlessly prejudiced by an EU Regulation
for which no credible evidence has been advanced to show that
including minerals and metals will bring any benefit to human
health and the environment over and above already existing legislation.
REACH threatens to disrupt global trade flows of
key materials for the still present strategic European industries
(i.e. aerospace, automobile, electronics, engineering, etc). Europe
will have to compete even more aggressively for its raw material
feedstock in a world marketplace with markedly more severe entry
barriers for Europe. The majority raw material source for the
metals sector is outside the EU. Non-EU suppliers will simply
desist from supplying into the EU because they have multiple customers
for their raw materials elsewhere (i.e. China, India, etc).
In summary, to be workable for both the Authorities
and the metals industry REACH must properly accommodate the special
nature of metals and alloys anything less will be a huge
disservice to UK competitiveness and global trade flows. The Authorisation
issue described above, plus the other key concerns indicated
in Annex I [not printed], must be adequately reflected
in REACH to permit metals and alloys to continue to play vital
roles in further EU sustainable development policies, e.g. long-life
products, increased recycling, efficient resource use, whilst
still remaining internationally competitive and value-adding businesses
based in Europe. Much is at stake.
To conclude on Authorisation, the appropriate treatment
for ores and concentrates under REACH is:
- Exemption from Registration
and Evaluation
- Exemption from Authorisation
(The above does not totally place ores and concentrates
outside the Scope of REACH, because they remain liable to the
restriction clauses)
MIRG greatly appreciates the continuing concern shown
by the House of Commons European Scrutiny Committee to properly
address these issues, and the opportunity you represent to convey
this matter to the attention of UK Members of Parliament.
Members of the UK Metals Industry REACH Alliance
Anglo American
BHP Billiton
Corus
Inco Europe
Johnson Matthey
Rio Tinto
Aluminium Federation
British Non-Ferrous Metals Federation
British Stainless Steel Association
Cast Metals Federaton
Cobalt Development Institute
UK Steel
| European Powder Metals Association (UK Chapter)
Galvanisers Association
International Molybdenum Association
International Tungsten Industry Association
Lead Development Association International
London Metal Exchange
Metals Forum (UK)
Minor Metals Trade Association
Nickel Institute
Non-Ferrous Alliance
Society of British Aerospace Companies
Zinc Information Centre
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40 (22212) 6671/01; see HC 28-xii (2000-01), para 1
(25 April 2001). Official Report, European Standing Committee
A (12 June 2002). Back
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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. Back
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