Commission Recommendation of  7 June 2006  Establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC   (Text with EEA relevance)
Date: 2006-06-10
Institutions: European Commission
Subjects: consumer information, cosmetic product, cosmetics industry, labelling, testing

L 158/18

EN

Official Journal of the European Union

10.6.2006

COMMISSION RECOMMENDATION

of 7 June 2006

Establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to
Council Directive 76/768/EEC

(Text with EEA relevance)

(2006/406/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HEREBY RECOMMENDS:

Having regard to the Treaty
Community,

establishing the European

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), and in particular the second sentence
of the second subparagraph of Article 6(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Article 6(3) of Directive 76/768/EEC provides that the
manufacturer or the person responsible for placing a
cosmetic product on the Community market may 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 only if the manufacturer and his
suppliers have not carried out or commissioned any
animal tests on the finished product, or its prototype
or any of the ingredients contained in it, or used any
ingredients that have been tested on animals by others
for the purpose of developing new cosmetic products.

It is thus possible to claim on a cosmetic product that no
animal
in relation to its
carried out
development.

testing was

It is necessary to establish guidelines aimed at ensuring
that common criteria are applied in the use of such
claims, that an aligned understanding of the claims is
reached and in particular
such claims do not
mislead the consumer or lead to unfair competition on
the market between manufacturers.

that

Moreover, a general understanding of the provision set
out
in the second subparagraph of Article 6(3) of
Directive 76/768/EEC within the framework of good
administrative cooperation would facilitate a common
authorities. This would
implementation by control
prevent, for instance, distortions in the internal market.

The measures provided for in this Recommendation are
in accordance with the opinion of
the Standing
Committee on Cosmetic Products,

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).

For the purposes of the application of the second subparagraph
of Article 6(3) of Directive 76/768/EEC, Member States should
use the following guidelines.

1. Main principles

The use of claims on a cosmetic product should not mislead
the consumer. The consumer should obtain the real benefit
of being able to make an informed choice as a result of the
‘not
labelling claim. The information
should be useful for the consumer.

tested on animals’

The use of claims should not lead to unfair competition on
the market between manufacturers and/or suppliers who use
such claims as marketing tools.

2. Voluntary use of claims

Under the second subparagraph of Article 6(3) of Directive
76/768/EEC the manufacturer or the person responsible for
placing the product on the market may use a claim to
indicate that no animal
testing has been carried out.
Therefore it is not mandatory, neither for the manufacturer
nor for the person responsible for placing the product on
the market, to use such a claim. It is a possibility which is
offered to those persons if the requirements in the second
subparagraph of Article 6(3) of Directive 76/768/EEC, taking
into account the present guidelines, are met.

3. Interpretation of the requirements set out in the second
subparagraph of Article 6(3) of Directive 76/768/EEC

The definitions of certain terms used in the context of the
present guidelines are repeated below for clarity purposes:

— ‘cosmetic product’ means ‘cosmetic product’ as defined in

Article 1 of Directive 76/768/EEC,

— ‘finished cosmetic product’ means

‘finished cosmetic
product’ as defined in Article 4a(3)(a) of Directive
76/768/EEC,

10.6.2006

EN

Official Journal of the European Union

L 158/19

— ‘ingredients’ means

any

chemical

substance

or
preparation of synthetic or natural origin,
including
perfume and aromatic compositions used in composition
of cosmetic products (see in that respect Article 5a(1) of
and
Directive76/768/EEC which excludes
aromatic compositions’ only for the purpose compiling
of an inventory of ingredients),

‘perfumes

— ‘prototype of the cosmetic product’ means ‘prototype’ as
defined in Article 4a(3)(b) of Directive 76/768/EEC,

suppliers

should not have used ingredients

cosmetic products’ means that
the manufacturer and
his
for
which data resulting from animal tests made by others
for the purpose of developing a new cosmetic product
are available for instance in scientific literature. In this
‘the development of new cosmetic product’
context
means either the reformulation of product already on
the market or
the development of a totally new
product
(innovation). A new packaging can not be
considered as a new cosmetic product.

— ‘animal’ means ‘animal’ as defined in Article 2(a) of

4. Burden of proof

Council Directive 86/609/EEC (1),

— ‘testing’ means any tests performed in relation to the
development or safety evaluation of the product or its
ingredients
respect Article 7a(1)(h) of
Directive 76/768/EEC),

(see in that

— ‘re-testing’ means testing a product or its ingredients

another time.

The requirements in the second subparagraph of Article 6(3)
should be interpreted as follows:

(a)

‘no animal tests have been carried out’ means that no
animal test whatsoever was carried out in relation to the
development or safety evaluation of a cosmetic product
or its ingredients. Only the full replacement of
the
animal
tests by an alternative method, and therefore
not a reduction or a refinement of animal tests, allows
the claim to be made. Furthermore, it does not matter
where the test (including re-testing) is performed (in the
Community or in third countries) or when the test has
been performed.

(b) ‘the manufacturer and his suppliers have not carried out
or commissioned any animal tests […]’ means that the
manufacturer and his suppliers, including all suppliers in
the supply chain:

— have not directly carried out the animal tests,

— have not commissioned animal tests, which means
they have not requested or paid for animal
sponsorship of
instance of

that
tests by means
research by academic institutions.

for

that no
Any person who claims on a cosmetic product
animal testing was carried out in relation to its development
should be responsible for the claim and should be able to
prove the relevance of the claim with regard to Directive
76/768/EEC.

In that context it is recalled that all relevant information for
control purposes has to be readily accessible in accordance
with Article 7a(1) of Directive 76/768/EEC and in particular
points (d) and (h) thereof, which read as follows:

the safety for human health of

the

‘(d) Assessment of

finished product.

[…]

agents or

(h) data on any animal testing performed by the manu-
to the
facturer, his
development or safety evaluation of the product or its
ingredients,
including any animal testing performed to
meet the legislative or regulatory requirements of non-
member countries’.

suppliers,

relating

5. Wording of claims

Any person who wishes to use a claim to indicate that no
animal testing has been carried out is free to choose the
wording of the claim and/or to use any pictures, figurative
or other signs, as long as all the relevant requirements in
Directive 76/768/EEC are fulfilled.

Done at Brussels, 7 June 2006.

(c) The fact that the manufacturer and his suppliers should
not have ‘used any ingredients that have been tested on
animals by others for the purpose of developing new

For the Commission

Günter VERHEUGEN
Vice-President

(1) OJ L 358, 18.12.1986, p. 1.