Introduction to Cosmetics

"'Cosmetic product' means any substance or mixture intended to be placed in contact with the 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, protecting them, keeping them in good condition or correcting body odours" (art. 2.1.a) 1223/2009/CE regulation

There is no prior authorisation to place cosmetic products on the market although the products must be notified on a community site (information and traceability principle). Article 3 of the regulation forsees that “A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use”. It is therefore the responsibility of the manufacturers to guarantee that their products comply with the regulatory requirements and that they do not present any danger for human health. Manufacturers must have respected the correct practice during a products manufacturing (art.8 of the regulation) in which the references have been published in The Official Journal of the European Union.

In order to ensure the highest level of human health protection, the « person responsible » for launching the product on the market (the manufacturer or the third party) establishes a report on the cosmetic product’s security (explained in the Annex I of the regulation) and makes it available to the authorities. This dossier includes the quantitative and qualitative formulae of the cosmetic product: the characteristics, the toxicological profile of the substances, and information on the packaging materials.

There are lists of substances that are also forbidden or restricted in cosmetic products (Annex II and VI).

Source : Agence nationale de sécurité des médicaments et des produits de santé (ANSM)

Introduction to Cosmetics

Within the European Union, cosmetic products are currently subject to the Directive No. 76/768/EEC of 27 July 1976. Unlike drugs, pesticides or biocides, no prior authorisation is needed for placing cosmetics on the market. Only the absence of harm to human health is required by European regulations.

Since its entry into force, the Directive 76/768/EEC has undergone numerous amendments established by the Council and European Parliament. Hence this directive will be replaced definitely by the regulation n°1223/2009 (CE) from July 11, 2013. Certain provisions are already being applied.

Since 1 December 2010, the use of CMR category 1 and 2 in cosmetic products is prohibited. However, the incorporation of these substances is permitted within a well defined framework, in an exceptional way and after an evaluation by the Centre de Soins et de Santé Communautaire (Healthcare community centre).