Regulation

Serious undesirable effects (SUE) from cosmetics

The EU Cosmetics Regulation obliges responsible persons and distributors to notify serious undesirable effects to the national authority "without delay". This page explains the definitions, the reporting chain and the related obligations. It complements the broader page on cosmetovigilance.

Definitions

Article 2(1) of Regulation (EC) No 1223/2009 distinguishes two levels:

• 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.

Most cosmetic reactions — transient redness, stinging, mild contact dermatitis — are undesirable effects but not SUEs. They must still be recorded and taken into account in the product's safety assessment.

Who reports, to whom

Under Article 23, where a serious undesirable effect occurs, the responsible person and distributors must notify the competent authority of the Member State where the effect occurred, without delay. The notification covers:

• all serious undesirable effects that are known to them, or that may reasonably be expected to be known to them;
• the name of the product concerned, enabling its specific identification;
• the corrective measures taken, if any.

The competent authority passes the information on to the authorities of the other Member States. Where the notification comes from a distributor, it also passes it to the responsible person. Reports from end users and health professionals to the authority are handled in the same way. Consumers and health professionals can usually report directly to the national authority — for example ANSM in France, the Ministry of Health in Italy, AEMPS in Spain, INFARMED in Portugal and the FPS Public Health in Belgium.

How quickly

The Regulation itself says "without delay" and sets no number of days. The European Commission's SUE reporting guidelines, agreed with national authorities, interpret this as a notification within 20 calendar days of the responsible person or distributor becoming aware of the case. Follow-up information is to be sent as it becomes available. The guidelines also provide standard notification forms and a method for assessing causality. They are guidance rather than law, so check the current version on the Commission's website.

Link with the product information file

The product information file required by Article 11 must contain existing data on undesirable effects and serious undesirable effects of the product (Annex I, Part A). The safety report must be kept up to date in the light of new information. Under Article 21, the responsible person must also make the existing data on undesirable effects and serious undesirable effects easily accessible to the public. Under Article 24, if there is a serious doubt about the safety of a substance, the competent authority may ask the responsible person for a list of all their products containing it and its concentration.

Special situations

Pregnancy. The Regulation does not create a dedicated system for monitoring exposure during pregnancy. A congenital anomaly attributable to a cosmetic would, however, fall within the SUE definition and be reportable.

Other vigilance systems. Cosmetovigilance is separate from pharmacovigilance (medicinal products), materiovigilance (medical devices) and nutrivigilance (food supplements, organised nationally — in France, for example, by ANSES). A reaction to a product is reported under the system that matches the product's legal classification.

Frequently asked questions

What is a serious undesirable effect under the Cosmetics Regulation?

An undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, an immediate vital risk or death (Article 2(1)(p) of Regulation (EC) No 1223/2009).

Within what timeframe must a SUE be notified?

Article 23 requires notification "without delay". The Commission's SUE reporting guidelines interpret this as within 20 calendar days of the responsible person or distributor becoming aware of the case.

Who must notify a serious undesirable effect?

The responsible person and distributors must notify the competent authority of the Member State where the effect occurred. Consumers and health professionals may also report to that authority.

Is there a requirement to monitor pregnancy exposure in cosmetovigilance?

There is no dedicated pregnancy-exposure monitoring obligation in the Cosmetics Regulation, but a congenital anomaly attributable to a cosmetic is a serious undesirable effect and must be reported.

Last reviewed: October 2026.