The undesirable effect management procedure or cosmetovigilance procedure is an essential part of the Product Information File. It is compulsory for cosmetics manufacturers to regularly review the adverse effects observed (and/or absent). It must be recorded and accessible to the supervisory authorities. Advice from Estelle Dehier, from Labosphère.
Cosmetovigilance is necessary for consumer safety. And the safety assessment carried out by the toxicologist before the product is placed on the market can be reviewed on the basis of feedback from cosmetovigilance.
The regulations do not say when a safety report should be reconsidered, or how many cases of cosmetovigilance should trigger an “alert”. It is the Responsible Person who must set the objectives and implement the appropriate management tools (recording, monitoring, traceability, consequences, etc.).
However, we have to admit that most of the time, when we have to draw up a Product Information File for a customer, we rarely have the references of a real cosmetovigilance procedure.
Cosmetovigilance: definitions and reporting procedures
Cosmetovigilance is a system for monitoring and recording undesirable effects associated with the use of cosmetics in humans.
It therefore complements the tolerance tests carried out before the product is placed on the market, in order to guarantee the safe use of the product by consumers.
It covers any undesirable effect, serious or otherwise, which has occurred under normal or reasonably foreseeable conditions of use of a cosmetic product or which is likely to result from misuse.
It concerns all products meeting the definition of European …
