More about the new EU chemicals legislation - REACH
In October 2003 the European Commission adopted a legislative proposal for
implementing a new EU chemicals policy that aims at maintaining and enhancing
the competitiveness of the EU chemicals industry as well as at the protection of
human health and the environment. According to the new regulatory system, known
as REACH (Registration, Evaluation and Authorization of Chemicals), all
chemical substances produced or imported into the European Union have to be
registered for all intended uses.
Registration. The registration is required for all chemical
substances placed on the market in quantities of 1 ton or above per year.
Manufacturers and importers of substances will need to obtain information on the
substances they manufacture or import and use this information to assess the
risks arising from the uses and to ensure that the risks which the substances
may present are properly managed. Registration documents the performance of this
duty and requires manufacturers and importers to submit:
-
a technical dossier - this contains information on the
properties, uses and on the classification of a substance as well as guidance on
safe use;
-
a chemical safety report, for substances in quantities of 10
tonnes or more.
Evaluation. The aim of Evaluation is to prevent unnecessary
testing. The competent authorities will evaluate testing
proposals provided by industry and will check compliance of information with the
registration requirements. Evaluation also enables authorities to investigate
chemicals with potential risks by asking industry for further information.
Authorization. The authorization system addresses substances of
very high concern. Applicants will have to demonstrate that risks associated
with uses of these substances are adequately controlled. In this case the
Commission will grant an authorization. Otherwise,
authorization may be granted if it is shown that the socio-economic benefits
outweigh the risks to human health or the environment and if there are no
suitable alternative substances or technologies.
REACH will implement the objectives set out in the
“White paper: Strategy
for a Future Chemicals Policy”. It will give industry the responsibility for
ensuring and demonstrating the safe manufacture, use and disposal of chemicals.
This represents a shift of responsibility to demonstrate risks associated with
the use of chemicals from authorities to the actors in the chemical supply
chain. As a result, manufacturers and importers of chemicals are required not
only to control risks present during those stages of a substance’s life cycle
under their direct control but also to give guidance to downstream users on the
safe handling and use of the substance. The new legislation also aims at
reducing testing on vertebrate animals, data sharing is required for studies on
such animals.
More information about REACH can be found at the
European Commission webpage.
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