and Authorisation of Chemicals)
is a proposal for a new EU regulatory framework for
chemicals, launched by the European Commission in
October 2003, which is currently under legislative
review in the European Parliament. Under the proposed
new system, enterprises that manufacture or import
more than one tonne of a chemical substance per year
would be required to register it in a central database.
The aims of the proposed new Regulation are to improve
the protection of human health and the environment,
while maintaining the competitiveness and enhancing
the innovative capability of the EU chemicals industry.
Furthermore, REACH would give greater responsibility
to industry to manage the risks from chemicals and
to provide safety information on the substances.
An authorisation system for uses of substances and
the placing on the market of substances for such uses
is established for the substances of very high concern.
Substances of very high concern are defined as: substances
that are category 1 and 2 carcinogens or mutagens;
substances that are toxic to the reproductive system
of category 1 and 2; substances that are persistent,
bioaccumulative and toxic or very persistent and very
bioaccumulative; and substances such as endocrine
disrupters, which are demonstrated to be of equivalent
concern. The authorisation provisions require those
using or making available substances with properties
of very high concern to apply for an authorisation
of each use within deadlines set by the Commission.
The burden of proof is placed on the applicant to
demonstrate that the risk from the use is adequately
controlled or that the socio-economic benefits outweigh
the risks. Downstream users may use a substance for
an authorised use provided they obtain the substance
from a company for whom an authorisation has been
granted and that they keep within the conditions of