Communication of Serious Undesirable Effects

Changed on: 22.02.2021
beautiful woman hands with cream

Article 2 of Regulation (EC) No 1223/2009 defines the following terms:

An ‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.

A ‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.

Article 23 states that “in the event of serious undesirable effects, the person responsible and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred.” Consumers and doctors also have the opportunity to report serious undesired effects.

Report forms  For whom?

Report Form A        

For the person responsible and distributors; to the competent authorities
Notification Form AT For consumers and health professionals, to report to the competent food safety agency.
Each form comes with instructions on how it should be completed.
The form sent must be used for both first notifications and any updates (follow-ups, final conclusions).

The guidelines for communicating serious undesired effects provide exact details on the procedure and the causality assessment.

In addition, information on serious undesired effects and undesired effects must be provided in the safety information (product information file) (Article 11).

Furthermore, the person responsible ensures that the existing data on undesirable effects and serious undesirable effects resulting from the use of the cosmetic product is made easily accessible to the public by any appropriate means (Article 21).

The BMG homepage provides more detailed information on the communication of serious undesired effects and contact information of the competent food safety agency in your province.
Further information on serious undesired effects can be found on the website of the European Commission on cosmetics