Cosmetovigilance: definition, regulation and use "in practice"

Abstract

Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance (Revidal-Gerda), whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigilance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories. Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market.

Keywords: European regulation; PPD; causality assessment; cosmetic adverse effects; cosmetovigilance; peer surveillance.