After two years
of intense debate, the Competitiveness Council
reached a political agreement on the draft regulation
for the registration, evaluation, authorisation
and restriction of chemicals (REACH) on 13 December.
The new EU REACH regulation will replace 40 existing legal acts and create
a single integrated system for the registration, evaluation, authorisation
and restriction of chemicals. REACH will ensure that the gaps in existing
information on the hazardous properties of some 30,000 chemicals are
filled, and that the necessary information on the safe use of substances
is transmitted along the industrial supply chain leading to reduced risks
for workers, for consumers, and for the environment. REACH will reverse
the burden of proof so that industry, both producers and importers of
substances, rather than public authorities, will have to assume responsibility
for providing the necessary information and taking effective risk management
The Council has backed the compromise adopted by the European Parliament
on the registration procedures, which will reduce the number of chemicals
needing to be tested from 30,000 to nearer 12,500. Ministers also supported
the sharing of data, in order to minimise the duplication of tests, including
tests on animals.
At the centre of the debate were 'authorisation' and 'substitution'.
Whereas some delegations stressed the importance of providing for strong
incentives or even obligations for substitution of dangerous substances,
other delegations were worried by the impact on industry if excessive
conditions for authorisation were to be adopted. The agreement by the
Council aimed at striking a balance between these different views.
The proposal provides that authorisations should not be granted on the
grounds of adequate control in the case of substances that are persistent,
bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative
(vPvB). On amendments regarding authorisation - the Parliament had proposed
a revision within five years - the ministers said reviews should be set
on a individual case-by-case basis. The ministers also said that companies
seeking authorisation for dangerous substances would have to prove that
the risks could be adequately controlled and provide information on possible
The Council also approved the establishment of a new European Chemicals
Agency, to be located in Helsinki, Finland. The agency will manage the
registration of substances through the setting up of a database. It will
also play an important role in the evaluation and authorisation of substances.
The European Commission has welcomed the Council's political
agreement. Commission Vice-President Günter Verheugen, responsible
for enterprise and industry, said: 'This agreement puts an end
to a long period of uncertainty for industry and helps them plan
for the very challenging task of meeting the new requirements.
The Council's agreement is a reasonable compromise. We have succeeded
in making REACH more effective and more workable. And we have
succeeded in maintaining the competitiveness of EU industry and
- a crucial point - reducing the burden for small and medium-sized companies.'
Environment Commissioner Stavros Dimas added: 'This agreement will represent
a marked improvement in the protection of health and the environment.
It will reduce chemical related disease and will allow users and consumers
to make informed choices about the substances they come in contact with.
It will also encourage innovation and give a strong incentive to industry
to replace dangerous chemicals with safer ones.'
But not everyone is so pleased. Environmental groups are accusing the
Member States of watering down the conditions for the authorisation of
toxic chemicals set by European Parliament: the text approved in the
first reading required the substitution of hazardous chemicals with safer
alternatives whenever possible, whilst the text approved by the Council
merely says companies should be encouraged to do so.
In a joint communiqué issued on 13 December, environmental, women's,
health and consumer organisations expressed disappointment that EU ministers
had 'failed to seize a unique opportunity to protect people and the environment
from the threat of toxic chemicals'. They underline that the strengthened
substitution requirements approved by the Council for PBT and vPvB represent
only a fraction of all hazardous chemicals, and that other carcinogen
chemicals that can harm reproduction and hormone-disrupting substances
will be not affected, even though safer alternatives exist. Another point
of discord concerns the proposed reduction on safety data that chemical
producers would be obliged to supply, particularly for substances produced
in low quantities (i.e. produced or imported in the range of one to ten
tonnes). The communiqué urges the European Parliament to reaffirm
its support for 'mandatory substitution' at the second reading, in 2006.
It seems that industry is also not entirely satisfied. UNICE (the European
Community's Union of Industries) has welcomed an agreement which goes
'halfway towards the fully risk-based approach advocated by the industry'.
And while satisfied with the reduction of information requirements for
low-volume substances that will make REACH more cost-efficient for small
and medium sized enterprises (SMEs), the employers' confederations represented
by UNICE think that appropriate control of the use of the most dangerous
substances should be a sufficient condition for unlimited authorisation.
As the agreed text differs from the proposal adopted by the European
Parliament on 17 November, the formal Common Position of the Council,
to be approved under the Austrian Presidency in May 2006, will have to
go back to the European Parliament for a second reading under the co-decision
procedure. It is expected that a final decision on REACH will be made
by the European Parliament and Council in autumn 2006. The Commission
expects the following Regulation to enter into force in spring 2007,
and the operational requirements of REACH are expected to be applied
from 2008 onwards.