WHAT IS MEANT BY COSMETOVIGILANCE?

Cosmetic products are largely used, but they can cause undesirable effects, defined as “adverse reactions to human health attributable to normal or reasonably foreseeable conditions of use of a cosmetic product”.

In the moment when, through the report of a client, a doctor or a pharmacist, the RESPONSIBLE PERSON becomes aware of such adverse reactions, it must do something to retrieve as much useful information as possible to verify the existence of a causal link between the use of the product and the adverse reaction.

We can affirm that cosmetovigilance is the responsible person’s commitment of conveying to the competent authorities all the undesirable effects that a cosmetic product can cause.

The Responsible Person must archive all documentation relating to the undesirable effect and report all known undesirable effects in the PRODUCT INFORMATION FILE (PIF). Constantly updating these information will benecessary to eventually reevaluate the cosmetic product’s safety, assuming, if necessary, a modification of the formula.

In the case of a serious undesirable effect it is necessary to take particular measures.

WHAT ARE THE “SERIOUS UNDESIRABLE EFFECTS”

Serious undesirable effects are the ones that “induce temporary or permanent functional incapacity, disability, hospitalization, congenital abnormalities, immediate fatal risks or death”.

In order to reduce risks, the European Union has provided for the creation of a cosmetovigilance system, with EC Regulation No. 1223/2009, in force since July 11 ͭ ͪ  2013.

In order to guarantee compliance with the requirements of this Regulation, it is required an effective market surveillance. For this purpose, serious undesirable effects should be notified. The competent authorities should have the possibility to ask to the responsible a list of the cosmetic products which contain substances for which there are serious safety concerns.

In accordance with the regulation, manufacturers and suppliers are required to report serious undesirable effects, presumably associated with the use of cosmetics, to the competent authority, which is the Ministry of Health in Italy.