What is cosmetovigilance?

Cosmetic treatments, whether intended for use on the skin or hair, are likely to cause adverse effects after application. Most commonly, these are redness, heat, itching or a breakout of spots. 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 sensitising 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 have been put on sale. 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 medicines.

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 occurring following 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 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 responsibility complies with regulation 1223/2009 and its amendments.

When the responsible person reports a side effect to the authorities, they are obliged to mention all serious adverse effects they are aware of, the name of the cosmetic product in question, 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, hospitalisation, 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 a failure to declare products on the Cosmetic Product Notification Portal (CPNP), a lack of product safety reports, or an incomplete Product Information File (PIF).

Consumers have an active role to play in the process of cosmetovigilance. Indeed, as users of cosmetic care, they are the first to be affected by the potential adverse effects of these products. Their active involvement in the cosmetovigilance process contributes to ensuring the safety and continuous improvement of cosmetic products available on the market. When they experience an adverse effect, consumers are encouraged to report it to the cosmetic brands. In addition to making manufacturers aware of potential improvements to their products, this allows users to receive advice on how to better manage the discomfort they have encountered. However, the ideal is still to prevent adverse effects.

By adhering to certain best practices, consumers can minimise the risk of reactions.

One of the most crucial elements when applying a cosmetic product is to meticulously follow the instructions provided on the packaging or the treatment. For instance, if the product advises to avoid the eye contour, it's potentially because it could cause eye irritation. By adhering to the usage guidelines, we reduce the risk of adverse effects related to misuse.

Another habit to adopt systematically when using a cosmetic product for the first time is: to test it on a small part of the body (such as the crook of the elbow or wrist) before applying it to the entire skin. This simple practice allows for the detection of an allergic sensitisation caused by an ingredient that the skin does not tolerate, thus preventing a widespread reaction. Testing your cosmetics is not only for those with particularly sensitive skin: all skin types are likely to react to a cosmetic product at some point.

• Regulation (EC) No 1223/2009 of the European Parliament and the Council.

• Regulation (EC) No 1545/2023 of the European Parliament and Council.

• ANSM - Regulation pertaining to cosmetics (2021).

• DGCCRF - Market surveillance of cosmetic products and reporting of adverse effects (2021).