10.6.2006   

EN

Official Journal of the European Union

L 158/18

(1)

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.

(2)

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

(3)

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 that such claims do not mislead the consumer or lead to unfair competition on the market between manufacturers.

(4)

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 implementation by control authorities. This would prevent, for instance, distortions in the internal market.

(5)

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

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‘cosmetic product’ means ‘cosmetic product’ as defined in Article 1 of Directive 76/768/EEC,

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

—

‘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 Directive76/768/EEC which excludes ‘perfumes and aromatic compositions’ only for the purpose compiling of an inventory of ingredients),

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

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‘animal’ means ‘animal’ as defined in Article 2(a) of Council Directive 86/609/EEC (2),

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

—

‘re-testing’ means testing a product or its ingredients another time.

(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:

(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 cosmetic products’ means that the manufacturer and his suppliers should not have used ingredients 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 context ‘the development of new cosmetic product’ 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.

‘(d)

Assessment of the safety for human health of the finished product.

[…]

(h)

data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the 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’.