October 2, 2023. Here is an overview of the national requirements for cosmetic products sold in France. If you plan to sell your cosmetics on the French market, you should be aware of the specificities of the French regulatory framework.
Applicable laws and competent authorities
In France, cosmetic products are regulated by Regulation (EC) 1223/2009 and the Code de la santé publique (CSP).
The authorities responsible for cosmetic products in France are the Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the Direction générale de la concurrence, de la consommation et de la répression des fraudes (DG CCRF). Considering there is no pre-market authorisation for cosmetic products, competent authorities exercise in-market controls through the following:
- Inspections of Product Information Files (PIF)
- Physical checks
- Laboratory testing on samples
Language requirements and safety assessor qualification
Loi 94-665 (also known as Law Toubon) on the use of the French language establishes that all information on the labels of cosmetics sold in France must be in French. Furthermore, the ANSM confirmed that PIF documents held in France by the Responsible Person should be preferable in French, but English is acceptable.
Regarding safety assessments, EU Cosmetics Regulation Article 10.2 provides that a qualified person must do them with a diploma in pharmacy, toxicology, medicine, or a similar discipline. An arrêté from February 25, 2015, clarifies which qualifications are recognised as equivalent in France. They are veterinary diploma, doctorate research in toxicology or ecotoxicology, Master’s degree with a least 60 ECTS in the field of toxicology, ecotoxicology, or risk assessment, DEA (diplôme d’études approfondies) or DES S (diplôme d’études supérieures) in toxicology or ecotoxicology.
Notifications
All establishments based in France that manufacture or distribute cosmetic products must register with the ANSM via an online portal. The registration is done by each establishment, and the ANSM must be informed about changes or termination of the activity. Importers are not subject to the declaration of establishment.
French manufacturers, importers, and distributors of products with nanomaterials, including cosmetics, must submit an annual declaration to the R-Nano register with information on the characteristics of nanomaterials, their use and quantity.
Other requirements
On August 30, 2023, Décret 2023-837 establishes that cosmetic products requiring a challenge test can be sold in bulk only via assisted service.
Other peculiarities of the French regulatory framework for cosmetic products concern the interpretation of the definition of nanomaterials and certain environmental labelling requirements, such as the Triman logo.
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References
- ANSM. (2021). Règlementation des produits cosmétiques. Retrieved on 19/09/2023
- Légifrance. (2023). Code de la santé publique. Retrieved on 19/09/2023
- Légifrance. (2022). Loi n° 94-665 du 4 août 1994 relative à l’emploi de la langue française. Retrieved on 19/09/2023
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