Section 5: National cosmetovigilance system

Cosmetic products are subject to vigilance designed to monitor all undesirable effects and misuse resulting from their use. This vigilance is applied to all these products once they have been placed on the market.

For the purposes of this section, : “Misuse” means use which does not comply with the intended purpose of the product, its normal or reasonably foreseeable use or its instructions for use, or with the special precautions for use referred to in point d of paragraph 1 of Article 19 of Regulation (EC) No 1223/2009 of 30 November 2009. “Adverse reaction” means a reaction which is harmful to human health…

The national cosmetovigilance system comprises : 1° The National Agency for the Safety of Medicines and Health Products ; 2° The Directorate-General for Consumer Affairs, Competition and Fraud Control; 3° The responsible person as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products and distributors of cosmetic products as defined in Article 2(1)(e) of the…

The responsible person as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products and distributors of cosmetic products as defined in Article 2(1)(e) of the same Regulation : 1° Must report without delay to the Agence nationale de sécurité du médicament et des produits de santé the serious adverse reactions mentioned in Article 23 of…

Health professionals, in application of the first paragraph of II of Article L. 5131-5: 1° Must report without delay to the Agence nationale de sécurité du médicament et des produits de santé any serious adverse reactions of which they are aware ; 2° May report to the aforementioned agency any other adverse reactions of which they are aware and any reactions likely to result from misuse of the product.

Professional users and consumers, in accordance with the second and third paragraphs of II of Article L. 5131-5, may report to the Agence nationale de sécurité du médicament et des produits de santé any undesirable effects and any effects likely to result from misuse.

The vigilance exercised over cosmetic products by the Agence nationale de sécurité du médicament et des produits de santé includes : 1° Receiving and recording serious adverse reaction reports sent by the parties mentioned in Articles R. 5131-9 to 11 and transmitting the information reported under the conditions set out in paragraphs 2 to 4 of Article 23 of Regulation (EC) No 1223/2009 of the European Parliament and of the…

The Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes communicates to the Agence Nationale de Sécurité du Médicament et des Produits de Santé the declarations of serious undesirable effects brought to its attention as part of its mission to monitor the cosmetics market.

The competent authorities referred to in Article L. 5131-3 may use the information referred to in Articles R. 5131-9 to 11 for the purposes of market surveillance, market analysis, evaluation and consumer information under Articles 25, 26 and 27 of the Regulation referred to in Article R. 5131-12.

The declarations provided for in Article L. 5131-5 shall be made in accordance with the procedures and standard form laid down by order of the Minister for Health on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products.