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Commission Vice-President Günter Verheugen
responsible for enterprise and industry policy 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.”
Commissioner Stavros Dimas responsible for
environment policy said: “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. Today’s
agreement presents to our citizens a chance for a healthier life and a
safer environment.”
REACH stands for Registration, Evaluation
and Authorisation of Chemicals. This new EU regulation will
replace 40 existing legal acts and create a single system for all
chemical substances. It will introduce a new European Chemicals
Agency to be established in Helsinki, Finland, which will manage
the registration of substances, through the setting up of a database.
It will play an important role also in the evaluation and
authorisation of substances.
REACH will require manufacturers and importers to
gather comprehensive information on properties of their substances
produced or imported in volumes over 1 tonne per year and to submit
the necessary information to demonstrate their safe use in a
registration dossier to the European chemicals agency. Failure to
register will mean the substance cannot be manufactured or imported to
the EU market.
Member States’ public authorities will examine
registration dossiers and substances of concern. They will also
scrutinise all proposals for animal testing to keep it to the minimum
absolutely necessary. Use-specific authorisations will be required for
chemicals that cause cancer, mutations or reproduction problems, or
that accumulate in our bodies and in the environment. Authorisation
will be granted only to companies that can show that the risks are
adequately controlled or if social and economic benefits outweigh the
risks and suitable alternative substances do not exist. This will
encourage substitution of unsafe substances by safer ones.
Existing system not working
REACH will improve the current EU chemicals
legislation, which distinguishes between so-called “existing” and
“new” chemicals. All chemicals that were put on the market before 1981
are called “existing” chemicals. They amount to around 100,000.
Chemicals introduced after 1981 (around 4,300) are called “new”
chemicals. While new chemicals have to be tested, there are no
systematic provisions for the existing substances. Consequently, in
volume terms, safety information is sketchy for around 99% of these
existing chemicals.
As national competent authorities are responsible
for the risk assessment of new chemicals, the process is slow,
cumbersome and resource-intensive. For example, since 1993, 140
high-volume chemicals have been singled out for risk assessment, of
which only a very limited number have completed the process. In
addition, the existing system discourages the introduction of new and
possibly safer chemicals – thereby giving no incentives for innovation.
Next steps
It is expected that the final decision on REACH
will be reached by the European Parliament and Council in autumn 2006.
The Commission expects entry into force of the Regulation for spring
2007. Thereafter it will take about a year for the REACH Agency to be
operational. Accordingly the operational requirements of REACH are
expected to start to be applied from 2008 onwards. |
