Commission Directive 2000/41/EC of 19 June 2000 postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products (Text with EEA relevance)
Date: 2000-06-19
Institutions: European Commission
Subjects: animal experimentation, approximation of laws, consumer protection, cosmetic product, public health

20.6.2000

EN

Official Journal of the European Communities

L 145/25

COMMISSION DIRECTIVE 2000/41/EC

of 19 June 2000

postponing for a second time the date after which animal tests are prohibited for ingredients or
combinations of ingredients of cosmetic products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 76/768/EEC of 27 July
1976 on the approximation of the laws of the Member States
relating to cosmetic products (1), as last amended by Commis-
sion Directive 2000/11/EC (2), and in particular Article 4(1)(i)
thereof,

After consulting the Scientific Committee on cosmetic products
and non-food products intended for consumers,

Whereas:

(1)

(2)

(3)

(4)

The main objective of Directive 76/768/EEC is to protect
public health. To this end it is indispensable to carry out
certain toxicological
tests to evaluate the safety for
human health of ingredients and combinations of ingre-
dients used in cosmetic products.

to Article 4(1)(i) of Directive 76/768/EEC
Pursuant
Member States
the marketing of
cosmetic products containing ingredients or combina-
ingredients tested on animals after 30 June
tions of
2000 in order to meet the requirements of the Directive.

should prohibit

The second subparagraph of this provision also provides
that the Commission should submit draft measures to
postpone the date of implementation of this provision if
there has been insufficient progress in developing satis-
factory methods to replace animal testing, and in partic-
ular in those cases where alternative methods of testing,
despite all reasonable endeavours, have not been scientif-
ically validated as offering an equivalent level of protec-
tion for
taking into account OECD
toxicity test guidelines.

the consumer,

In the absence of any scientifically validated alternative
methods
to animal experiments and any pertinent
toxicity test guidelines in the field of alternative methods
adopted by the OECD, it was necessary to postpone the
date provided for in Article 4(1)(i) of Directive 76/
768/EEC for the first time by Commission Directive

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 65, 14.3.2000, p. 22.

(5)

(6)

(7)

(8)

(9)

(10)

(11)

97/18/EC in compliance with the second subparagraph
of this provision.

Three alternative methods have been validated in Europe
to date. It is unlikely that the scientific state of the art
will change significantly before 30 June 2000. Therefore,
the date provided for in Article 4(1)(i) of Directive 76/
768/EEC should be postponed for a second time in
compliance with the second subparagraph of this provi-
sion and Article 2 of Directive 97/18/EC.

These
three methods are being incorporated into
Community law through their entry onto 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 (3), as last amended by
Commission Directive 2000/33/EC (4).

Council Directive 86/609/EEC (5) of 24 November 1986
on the approximation of laws, regulations and adminis-
trative provisions of the Member States regarding the
protection of animals used for experimental and other
scientific purposes (6) provides that an animal test shall
not be carried out if an alternative method is available.

These methods are therefore mandatory for use in all
sectors including that of cosmetics.

The Commission has proposed a Directive amending for
the seventh time Directive 76/768/EEC in order to solve
definitively the issue of experiments on animals in the
cosmetic products sector. Such a proposal should be
adopted by co-decision procedure involving the Euro-
pean Parliament and the Council.

Taking into account that it can be expected that vali-
dated alternative methods will become available for
other tests in the next two years and that the proposed
Directive shall be adopted by that point of time, it is
appropriate to postpone for the last time the date to 30
June 2002.

The measures provided for in this Directive are in
accordance with the opinion of the Committee on the
adaptation to technical progress of the Directives on the
removal of technical barriers to trade in the cosmetic
products sector,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The date of ‘30 June 2000’ shall be replaced by ‘30 June 2002’
in the first sentence of Article 4(1)(i) of Directive 76/768/EEC.

(3) OJ L 114, 1.5.1997, p. 43.
(4) OJ L 196, 16.8.1967, p. 1.
(5) OJ L 136, 8.6.2000, p. 90.
(6) OJ L 358, 18.12.1986, p. 1.

L 145/26

EN

Official Journal of the European Communities

20.6.2000

Article 2

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 29 June 2000 at the latest. They shall forthwith
inform the Commission thereof.

those provisions,

When Member States adopt
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.

2. Member States shall communicate to the Commission the
in the field
provisions of national
covered by this Directive.

law which they adopt

This Directive shall enter into force on the third day following
that of its publication in the Official Journal of the European
Communities.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 19 June 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission