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Directive relating to Cosmetic Products – 76/768/EEC and its amendments – EU Directive relating to cosmetic products

The main objective of the European Cosmetics Directive 76/768/EEC, adopted in 1976, is to safeguard public health. The Directive primarily attributes this responsibility to the cosmetic manufacturer. The Directive represents the European cosmetic regulatory "bible", and literally serves as a model for global harmonisation.

Summary of the main requirements of the Directive 76/768/EEC and its amendments

i) Cosmetic products shall not contain any substance listed in Annex II of the Directive

ii) Cosmetic products can contain the substances listed in Annex III of the Directive, provided that they are within the specified limits

iii) Cosmetic products shall not contain any Coloring Agents that are not listed in Annex IV of the Directive, unless for products for coloring hairs. Annex IV also sets out conditions for compliance to the substance listed in this Annex.

iv) Cosmetic products shall not contain any Preservatives that are not listed in Annex VI of the Directive. Annex VI also sets out conditions for compliance to the substance listed in this Annex.

v) Cosmetic products shall not contain any UV filters that are not listed in Annex VII of the Directive. Annex VII also sets out conditions for compliance to the substance listed in this Annex.

vi) Cosmetic products shall not contain any substances classified as carcinogenic, mutagenic or toxic for reproduction of category 1,2,3 under Annex I of the Directive. However, category 3 may be used if the addressed substances have been evaluated by SCCNEP and found acceptable for use in cosmetics.

vii) Cosmetic products shall comply with the labeling requirements in the Directive.

Related organization in EU

· European Cosmetic Toiletry and Perfumery Association: Coli

· UK Cosmetics Organization: The Cosmetic Toiletry & Perfumery Association

· German Cosmetics Organization: The Industrieverband Körperpflege- und Waschmittel e.V.

· Netherlands Cosmetics Organization: NCV

Definition of cosmetic products

"Cosmetic products are any substances or preparations intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition".

Labelling

Cosmetic products may only be marketed if the container and packaging bear specific information. Examples (but not limited to) of aspects that should be mentioned are:

The name and address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is established within the EU;
The nominal content at the time of packaging, given either by weight or volume;
The date of minimum durability;
Particular precautions to be observed in use;
The batch number of manufacture or the reference for identifying the goods;
A list of ingredients in descending order of weight at the time they are added.

Availability of a dossier with readily accessible information

This should be available either at the manufacturers, his agents or at the persons responsible for placing the imported product onto the market. The name and address should be indicated on the product label in such a way that it is generally possible to identify the undertaking. Examples of aspects that should be mentioned in this documentation are:

The qualitative and quantitative composition of the product;
Physico-chemical and microbial specifications of the raw materials;
The obligation to keep a technical dossier available for every cosmetic product marketed in the EU. This should contain a safety evaluation of the finished product taking into consideration the general toxicological profile of the ingredient, chemical structure and exposure levels.

This information should be provided in either the national language or languages of the member state concerned, or in a language readily understood by the competent authority. The information described in the Cosmetics Directive should be available for control purposes.