Regulation

Cosmetovigilance & adverse-event reporting

Cosmetovigilance is the systematic surveillance of undesirable effects of cosmetic products. Under Article 23 of Regulation (EC) No 1223/2009, responsible persons and distributors must report serious undesirable effects to national authorities, who collate the information at EU level.

What cosmetovigilance covers

Cosmetovigilance is the cosmetic-product equivalent of pharmacovigilance, although it sits within a different legal framework. It covers two categories of event, defined in Article 2 of Regulation (EC) No 1223/2009:

• Undesirable effect — an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.
• Serious undesirable effect (SUE) — an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk, or death.

The system is built around the responsible person identified on the product label, who is the primary point of contact for collecting and reporting adverse-event information.

Article 23 reporting obligations

Article 23 of the Regulation requires the responsible person and distributors to notify, without delay, serious undesirable effects of which they are aware or can reasonably be expected to be aware, to the competent authority of the Member State where the SUE occurred. The notification must include all available information: the SUE itself, the cosmetic product concerned (with its identification), the responsible person's identification, and the corrective measures, if any, taken by the responsible person.

Distributors are subject to the same notification obligation: when a distributor (which can include a parapharmacy retailer) becomes aware of a SUE, it must notify the competent authority of the Member State where the SUE occurred; that authority then transmits the information to the responsible person (Article 23(2)).

The receiving competent authority then transmits the information to the other Member States' competent authorities, providing a route by which information about serious effects can be shared across the EU even when the product is sold in multiple Member States by different distributors.

Non-serious undesirable effects

For non-serious undesirable effects, there is no specific Article 23 reporting obligation, but they are part of the safety information that the responsible person must collect, evaluate and document in the Product Information File. Where a pattern of non-serious effects suggests a safety issue, the responsible person is expected to take appropriate action.

Consumer reporting channels

Consumers and health professionals can report undesirable effects in two ways: directly to the responsible person identified on the label, or to a national authority. Several Member States operate consumer-facing reporting portals for cosmetics. In France, ANSM hosts a dedicated portal for the signalement of undesirable effects, including cosmetics. In Italy, the Ministero della Salute operates a cosmetovigilance system. Similar arrangements exist in Belgium (FPS Public Health), Spain (AEMPS) and Portugal (INFARMED). The exact procedure varies by country; the national authority listings on this site link to each agency.

This site does not provide medical advice. A person experiencing a suspected adverse reaction to a cosmetic product should seek the advice of a pharmacist or physician for the management of the reaction; the regulatory reporting described above is a separate process aimed at collecting information for population-level surveillance.

What happens after a report

The national competent authority assesses incoming reports and decides whether further action is needed: requests for additional information from the responsible person, on-the-ground inspection, market-surveillance testing of product samples, or formal action such as ordering withdrawal or recall. Information is shared between competent authorities through the EU's general administrative cooperation mechanisms and through SCCS scientific opinions, which can lead to amendment of Annexes II to VI of the Regulation where a substance is shown to require restriction or prohibition.

Cosmetovigilance and the wider safety system

Cosmetovigilance interlocks with the safety assessment carried out before a product is placed on the market (Articles 10 and 11 of the Regulation; the Product Information File and the Cosmetic Product Safety Report). Pre-market assessment is forward-looking and aims to anticipate undesirable effects from known toxicological data; cosmetovigilance is post-market and captures real-world experience. Both feed into the Commission's process of updating the substance Annexes through the SCCS opinion mechanism.

Frequently asked questions

What is cosmetovigilance?

The collection, assessment and monitoring of reports of undesirable effects observed during or after normal or reasonably foreseeable use of cosmetic products, with the aim of protecting consumers.

Since when has cosmetovigilance been mandatory in the EU?

EU-wide reporting of serious undesirable effects has applied since Regulation (EC) No 1223/2009 became applicable on 11 July 2013. Some countries, such as France, had national cosmetovigilance systems before that.

What is the difference between an undesirable effect and a serious undesirable effect?

A serious undesirable effect results in functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk or death. Other adverse reactions are undesirable effects. See serious undesirable effects.

How is cosmetovigilance different from pharmacovigilance?

Pharmacovigilance covers medicinal products and is governed by medicines legislation. Cosmetovigilance covers cosmetics under Regulation (EC) No 1223/2009. Medical devices (materiovigilance) and food supplements (nutrivigilance) have their own systems.

Last reviewed: October 2026.