Cosmetic product

A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, such as the 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. The definition is laid down by Regulation (EC) No 1223/2009, which is directly applicable and is supplemented by the Public Health Code on the points left to the Member States.

The responsible person and placing on the market

A cosmetic product is not subject to any prior authorisation, but each product must have a responsible person established in the Union, in principle the manufacturer or the importer. That person ensures the product’s compliance, draws up a safety report based on the assessment of a qualified professional, keeps a product information file available to the authorities and notifies the product on the European portal before it is placed on the market. The annexes to the Regulation prohibit or restrict certain substances, and animal testing is banned for finished products and for their ingredients, as is the marketing of products so tested.

Claims and the boundary with medicinal products

Claims must comply with common criteria laid down by Regulation (EU) No 655/2013, including truthfulness and support by adequate evidence. A product presented as treating a condition, or whose composition exerts a significant pharmacological action, may be reclassified as a medicinal product, following the logic of borderline products. Cosmetovigilance also requires serious undesirable effects to be reported to the authorities.

Intellectual property protection

Cosmetic formulations and processes are patentable, and purely cosmetic treatment methods escape the exclusion of methods of treatment, provided they can be separated from any therapeutic effect. The Court of Cassation, however, refuses copyright protection for the fragrance of a perfume, which is then protected as know-how and through secrecy. The sector therefore relies heavily on trade marks, on designs for bottles and on parasitism actions against lookalike products and smell-alike comparison lists.

Key points

A cosmetic product reaches the market without authorisation, under the responsibility of a person established in the Union who guarantees its safety and notifies it before marketing. Its claims may not assert any therapeutic effect. To protect a perfume, the secrecy of the formula, the trade mark, the bottle design and an action for parasitism should be combined, since copyright in the fragrance is refused in France.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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