Proposal for a directive of the European Parliament and of the Council amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
Date: 2000-04-05
Institutions: European Commission
Subjects: animal experimentation, approximation of laws, consumer protection, cosmetic product, marketing

C 311 E/134

EN

Official Journal of the European Communities

31.10.2000

Proposal for a Directive of the European Parliament and of the Council amending for the seventh
time Council Directive 76/768/EEC on the approximation of the laws of the Member States
relating to cosmetic products

(2000/C 311 E/06)

(Text with EEA relevance)

COM(2000) 189 final (cid:151) 2000/0077(COD)

(Submitted by the Commission on 6 April 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) Council Directive 76/768/EEC (1), as

last amended by
Commission Directive 2000/11/EC (2), has comprehensively
harmonised the national laws relating to cosmetic products.
The main objective of the Directive is to protect public
health. To this end it is indispensable to carry out certain
toxicological
to evaluate the safety of cosmetic
products for human health.

tests

(2) In accordance with Directive 76/768/EEC, it is essential that
the aim of abolishing animal experiments be pursued and
that the prohibition of such experiments becomes effective
on the territory of the Member States.

(3) The safety of finished cosmetic products can already be
assessed from knowledge about the safety of the ingredients
which they contain and by methods which do not involve
the use of animals. Therefore animal tests with finished
cosmetic products should be prohibited.

(4) It will progressively but slowly be possible to ensure the
safety of the ingredients and combinations of ingredients
used in cosmetic products, at least for the acute effects,
without recourse to animal experiments, by using alter-
or
native methods
the
validated,
approved
the Validation of Alternative
European Centre

at Community

scientifically

level,
by

validated

being

for

as

the

consulting

(ECVAM). After

Methods
Scientific
Committee on Cosmetic Products and Non-Food Products
intended for Consumers (SCCNFP) as regards the applica-
bility of the validated alternative methods to the field of
cosmetic products, the Commission will have immediately
to publish the validated or approved methods recognised as
being applicable to such ingredients. In order to achieve the
highest possible degree of animal protection, a deadline has
to be foreseen, when a definitive prohibition should be
introduced. However, the date of implementation of this
prohibition should be postponed if there has been insuf-
to
ficient progress
in developing satisfactory methods
replace animal
testing scientifically validated as offering
an equivalent level of protection for the consumer.

(5) All efforts must be made to ensure that

the ethical
requirement of animal welfare is recognised world-wide.
To this end, the Commission should endeavour to obtain
the rapid acceptance by the Organisation for Economic
Co-operation and Development
(OECD) of alternative
in
methods validated at Community level. Furthermore,
the framework of bilateral agreements with third countries,
the Commission should make efforts to obtain recognition
of the results of tests carried out in the Community using
alternative methods so as not to obstruct the export of
cosmetic products for which such methods have been used.

(6) It should be possible to claim on a cosmetic product that
no experiment on animals was ever carried out on the
finished cosmetic product and/or its ingredients and combi-
nations of ingredients including for the purposes outside
the scope of Directive 76/768/EEC. The Commission,
in
consultation with the Member States,
should produce
guidelines with the aim of providing clarity and practical
guidance to the cosmetic industry, European regulators and
above-all the consumer with respect to claims relating to
animal testing within the cosmetic sector. These guidelines
should aim to ensure that common criteria are applied in
the use of claims and that an aligned understanding of the
claims is reached, and in particular that such claims do not
mislead the consumer.

(7) Since the measures necessary for the implementation of
this Directive are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC
of 28 June 1999 laying down the procedures for the
conferred on the
exercise of
Commission (3), they should be adopted by use of the regu-
latory procedure provided for in Article 5 of that Decision,

implementing powers

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

(3) OJ L 184, 17.7.1999, p. 23.

31.10.2000

EN

Official Journal of the European Communities

C 311 E/135

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Council Directive 76/768/EEC is hereby amended as follows:

1. Article 4(1)(i) is deleted.

2. The following Article 4a is added:

(cid:145)Article 4a

only take advantage, on the product packaging or in any
document, notice,
label, ring or collar accompanying or
referring to the product, of the fact that no animal tests
have been carried out provided neither
finished
the ingredients
its prototype, nor any of
product, nor
contained in it have ever been the subject of such tests
including for purposes outside the scope of this Directive.
The Commission, in consultation with the Member States,
shall for this purpose publish guidelines on the implemen-
tation of this principle.(cid:146).

the

1. Member States shall take all necessary measures to
prohibit the performance on their territory of animal tests
in order to meet the requirements of this Directive:

(a) for tests performed on finished cosmetic products (from

1 December 2001);

(b) for tests performed on ingredients or combinations of
ingredients, as soon as an alternative method has been
published by the Commission, after endorsement of its
scientific validity by the European Centre for the Vali-
dation of Alternative Methods (ECVAM) and the ECVAM
Scientific Advisory Committee, following consultation of
the Scientific Committee on Cosmetic Products and
Non-Food Products intended for Consumers, and in any
case (from 1 December 2004). However, if there has been
insufficient progress in developing satisfactory methods to
replace animal testing scientifically validated as offering an
equivalent
the
Commission shall, by (1 June 2004),
submit draft
measures to postpone the date of implementation of this
provision for a sufficient period, and in any case for no
more than two years, in accordance with the procedure
laid down in Article 10.

level of protection for the consumer,

For the purposes of this Directive, (cid:147)finished cosmetic
intended to be

2.
product(cid:148) means
supplied in its existing state to the final consumer.

the cosmetic product

3.
The Commission shall present an annual report to the
European Parliament and the Council on progress in the devel-
opment, validation and legal acceptance of alternative
methods to those involving experiments on animals until
the entry into force of
the prohibition referred to in
paragraph 1(b). That report shall contain precise data on the
number and type of experiments relating to cosmetic products
carried out on animals. The Member States shall be obliged to
collect that information in addition to collecting statistics as
laid down by Directive 86/609/EEC on the protection of
animals used for experimental and other scientific purposes.
The Commission shall pay particular attention to the devel-
opment, validation and legal acceptance of experimental
methods which do not use live animals.(cid:146).

3. Article 6(3) is amended as follows:

(a) The last sentence of Article 6(3) is deleted.

(b) The following second subparagraph is added:

4. In Article 8(2) and Article 8a(3),

the title (cid:145)Scientific
Committee on Cosmetology(cid:146)
title
(cid:145)Scientific Committee on Cosmetic Products and Non-Food
Products intended for Consumers(cid:146).

replaced by the

is

5. In Article 9(1), the title (cid:145)Committee on the Adaptation to
the Directives on the Removal of
to Trade in the Cosmetic Products
is replaced by the title (cid:145)Standing Committee on

Technical Progress of
Technical Barriers
Sector(cid:146)
Cosmetic Products(cid:146).

6. Article 10 is replaced by the following text:

(cid:145)Article 10

1.

The Commission shall be assisted by the Committee.

2. Where reference is made to this paragraph, the regu-
latory procedure laid down in Article 5 of Decision
1999/468/EC shall apply, in compliance with Article 7(3)
and Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.(cid:146).

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive no later
than (1 December 2001). They shall
forthwith inform the Commission thereof.

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

the time of

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

law which they adopt

Article 3

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

(cid:145)Furthermore, the manufacturer or the person responsible
for placing the product on the Community market may

Article 4

This Directive is addressed to the Member States.