Title III: Other regulated pharmaceutical products and substances

Cosmetic product means any substance or mixture intended to be placed in contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and the external genital organs) or with the teeth and oral mucous membranes, 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 opening and operation of any establishment for the manufacture or packaging, even on an ancillary basis, of cosmetic products, as well as the extension of the activity of an establishment to include such operations, are subject to a declaration to the Agence nationale de sécurité du médicament et des produits de santé. The Agency is notified of any changes to the information contained in the declaration. The qualified persons…

Cosmetic products imported or made available on the market shall comply with the provisions of the aforementioned Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009. The competent authority referred to in paragraph 5 of Article 6, paragraph 3 of Article 11, paragraph 5 of Article 13 and Articles 23 to 30 of the same regulation is the Agence nationale de sécurité du…

The Agence nationale de sécurité du médicament et des produits de santé publishes the principles of good laboratory practice applicable to non-clinical safety studies intended to assess the safety of cosmetic products for the implementation of Article 10 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, mentioned above, as well as the rules applicable to the inspection and verification of good…

I. – In addition to their obligations under Article 23 of the above-mentioned Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, any responsible person and any distributor of cosmetic products may report other adverse reactions to the French National Agency for the Safety of Medicines and Health Products. II. – Any healthcare professional who is aware of a serious adverse reaction, within…

In the event of serious doubt as to the safety of a substance used in the composition of a cosmetic product, the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to the person responsible for the product to provide it with the information referred to in Article 24 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30…

A decree in the Conseil d’Etat shall determine the procedures for applying this chapter, in particular : 1° The presentation and content of the declaration provided for in Article L. 5131-2 ; 2° The labelling procedures for the cosmetic products mentioned in paragraph 4 of Article 19 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, referred to above, after obtaining the…