Commission Directive 2004/94/EC of 15 September 2004 amending Council Directive 76/768/EEC as regards Annex IX(Text with EEA relevance)
Date: 2004-09-15
Institutions: European Commission
Subjects: animal experimentation, approximation of laws, cosmetic product, industrial research

L 294/28

EN

Official Journal of the European Union

17.9.2004

COMMISSION DIRECTIVE 2004/94/EC

of 15 September 2004

amending Council Directive 76/768/EEC as regards Annex IX

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS DIRECTIVE:

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 76/768/EEC of 27 July 1976
on approximation of the laws of the Member States relating to
cosmetic products (1), in particular the second subparagraph of
Article 4a(1) thereof,

After consulting the Scientific Committee on Cosmetic products
and Non-food Products intended for consumers,

Whereas:

(1)

(2)

(3)

(4)

(5)

The contents of Annex IX to Directive 76/768/EEC
should be established for the purpose of listing those
alternative methods to animal
testing that have been
validated by the European Centre on Validation of Alter-
native Methods (ECVAM) of the Joint Research Centre
and that are not listed in Annex V to Council Directive
67/548/EEC of 27 June 1967 on the approximation of
laws, regulations and administrative provisions relating to
the classification, packaging and labelling of dangerous
substances (2).

As animal testing may not be replaced completely by an
alternative method, it should be mentioned in Annex IX
whether the alternative method fully or partially replaces
animal testing.

Directive 76/768/EEC should therefore be amended
accordingly.

There are at present, no alternative methods validated by
ECVAM, other than those listed in Annex V to Council
Directive 67/548/EEC.

The measures provided for
accordance with
opinion
Committee on Cosmetic Products,

the

in this Directive are in
Standing
the

of

Article 1

The text in the Annex to this Directive is inserted in the Annex
IX to Directive 76/768/EEC.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 21 September 2004 at
the latest. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

2. When Member States adopt those provisions, they shall
contain a reference to this Directive or be accompanied by such
a reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

3. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 15 September 2004.

For the Commission

Olli REHN
Member of the Commission

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2004/88/EC (OJ L 287, 8.9.2004, p. 5).
(2) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive

2004/73/EC (OJ L 152, 30.4.2004, p. 1).

17.9.2004

EN

Official Journal of the European Union

L 294/29

ANNEX

The following text is inserted in Annex IX to Directive 76/768/EEC:

‘ANNEX IX

LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING

This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM)
of the Joint Research Centre available to meet the requirements of this Directive and which are not listed in Annex V to
Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances. As animal testing may not be replaced completely by an
alternative method, it should be mentioned in Annex IX whether the alternative method fully or partially replaces animal
testing.

Reference number

Validated alternative methods

A

B

Nature of replacement full or partial
C’