What is cosmetovigilance?

Cosmetic treatments, whether intended for use on the skin or hair, are likely to cause adverse effects after application. Most often, these are redness, heat, itching, or a breakout of pimples. In very rare cases, the adverse effects can be more significant and manifest as a more impressive skin reaction. Before they are put on the market, the marketed treatments are indeed evaluated via various tests, but their sensitizing risk differs from one user to another.

In order to protect consumers and prevent issues related to the use of cosmetics, it is therefore crucial to ensure a monitoring of adverse effects after the skincare products are put on the market. This monitoring is known as "cosmetovigilance". Cosmetovigilance is quite similar to pharmacovigilance, the system of surveillance, evaluation, prevention, and management of the risk of adverse effects resulting from the use of medications.

Cosmetovigilance can also be defined as the recording system that allows for the listing of potentially risky cosmetics. This practice is part of the European regulation (EC) No. 1223/2009 of the European Parliament and Council, which governs the use of cosmetics within the European Union. In France, the monitoring of this market is jointly ensured by the ANSM (National Agency for the Safety of Medicines and Health Products) and the DGCCRF (General Directorate for Competition Policy, Consumer Affairs and Fraud Control). The cosmetic regulation stipulates that any serious adverse effect resulting from the use of a cosmetic product must be reported without delay to the ANSM by the responsible person. For your information, it is mandatory to designate a responsible person when a cosmetic product is placed on the market. This could, for example, be the manufacturer or the distributor. The responsible person is charged with ensuring that the cosmetic product under their supervision complies with regulation 1223/2009 and its amendments.

When the responsible person reports a side effect to the authorities, they are obligated to mention all serious adverse effects they are aware of, the name of the concerned cosmetic product, allowing its specific identification, as well as any corrective measures that have been taken, if applicable. It is also possible to specify whether the adverse effect occurred under normal usage conditions or reasonably foreseeable conditions of the cosmetic product, or if it is likely to result from misuse. It should be noted that Regulation 1223/2009 provides the following definitions:

• An adverse effect is a harmful reaction to human health attributable to the normal or reasonably foreseeable use of a cosmetic product.

• A serious adverse effect is an adverse effect that results in temporary or permanent functional disability, impairment, hospitalization, congenital abnormalities, immediate life-threatening risk, or death.

• Misuse refers to the use that does not comply with the instructions provided on the packaging or the product. For instance, it could be the application of a cosmetic intended for the body to the area around the eyes.

Once a report is received by the ANSM, the agency evaluates it and may need to take preventive or corrective measures. These can range from simple recommendations to suspending the sale of a brand's products, or even requesting a reformulation. However, the withdrawal of a product's right to sell is quite rare and usually follows very serious adverse effects or a legal fault committed by the brand, such as failing to declare products on the Cosmetic Product Notification Portal (CPNP), a lack of product safety reports, or an incomplete Product Information File (PIF).