Commission Regulation (EC) No 642/2005 of 27 April 2005 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substancesText with EEA relevance
Date: 2005-04-27
Institutions: European Commission
Subjects: chemical product, dangerous substance, exchange of information, health risk, scientific report, toxicology

L 107/14

EN

Official Journal of the European Union

28.4.2005

COMMISSION REGULATION (EC) No 642/2005

of 27 April 2005

imposing testing and information requirements on the importers or manufacturers of certain
priority substances in accordance with Council Regulation (EEC) No 793/93 on the evaluation
and control of the risks of existing substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 793/93 of
23 March 1993 on the evaluation and control of risks of
existing substances (1), and in particular Article 10(2) thereof,

Whereas:

The protocols
to the
Commission should be used for performing those tests.

submitted by the rapporteurs

(4)

The provisions of this Regulation are in accordance with
the opinion of the Committee established pursuant to
Article 15 of Regulation (EEC) No 793/93,

HAS ADOPTED THIS REGULATION:

Article 1

(1)

(2)

(3)

The rapporteurs designated by the Member States in
accordance with Article 10(1) of Regulation (EEC) No
793/93 have evaluated the information submitted by
the manufacturers and importers in respect of certain
priority substances. After consultation of those manufac-
turers and importers, the rapporteurs have determined
that it is necessary for the purposes of the risk evaluation
to require those manufacturers and importers to submit
further information and carry out further testing.

The information needed to evaluate the substances in
question is not available from former manufacturers or
importers. The manufacturers
and importers have
checked that
tests on animals cannot be replaced or
limited by using other methods.

The manufacturers and importers of the substances listed in the
Annex, who have submitted information in accordance with the
requirements of Articles 3, 4, 7 and 9 of Regulation (EEC) No
793/93, shall provide the information and perform the tests
indicated in the Annex and shall deliver the results to the
relevant rapporteurs.

The tests
specified by the rapporteurs.

shall be performed according to the protocols

The results shall be delivered within the time limits laid down in
the Annex.

Article 2

It is therefore appropriate to request manufacturers and
importers of priority substances to submit further infor-
mation and carry out further testing of those substances.

This Regulation shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 April 2005.

For the Commission

Stavros DIMAS
Member of the Commission

(1) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

28.4.2005

EN

Official Journal of the European Union

L 107/15

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