Reporting serious undesirable effects (SUE) caused by cosmetics
- Permit or other obligation
- Public service
Although cosmetic products are required by law to be safe, they can have unwanted effects on human health. In some cases these can be serious, such as serious allergic reactions. A serious undesirable effect is categorised as an adverse effect that causes temporary or permanent functional incapacity, disability, hospitalisation, birth defects, immediate risk of death, or death. Serious undesirable effects must be reported to the national authorities responsible for enforcement of cosmetics legislation in the country where the serious undesirable effect occurred. The authorities in this country forward the information to the authorities in other EU Member States who are responsible for enforcement of cosmetics legislation. Standardised SUE forms (Serious Undesirable Effect) are used for reporting. In Finland, serious undesirable effects of cosmetic products are reported to Tukes, which processes the notifications and passes the information to other authorities in the EU.
Do the following
The EU Cosmetics Regulation obliges those responsible for cosmetic products (usually the manufacturer or EU / EEA importer) and distributors to report any known serious undesirable effects to Tukes without delay by submitting a SUE-notification. This must be done within 20 days of the date on which it became aware of the SUE. The distributor of a cosmetic product may first report a SUE to the manufacturing company. The distributor and the manufacturer can cooperate to prepare a SUE notification for the authority (this is recommended). Please use the English SUE Form A where possible. The SUE Form A is designed for recording the initial notification and submission of information as well as for follow-up and final conclusions. Not all information requested in the form may be available when the first serious undesirable effect is reported. However, the initial notification, which may be supplemented at a later stage, should be submitted if the following minimum information is available:
- An identifiable reporter (Form A: Sections 1, 2 and 4)
- Nature of the alleged SUE and date of its occurrence (Form A: item 7)
- The full name of the cosmetic product concerned, which enables identification (Form A: item 6a)
Health professionals and end-users of cosmetics (e.g. hairdresser, cosmetologist or consumer) are advised to report any serious undesirable effects of cosmetics directly to the responsible person or distributor of the product. Contact details of the responsible person or manufacturer can be found on the packaging of the cosmetic product. The distributor is the party who sold the product. The cosmetics regulation continues to oblige the responsible person or the distributor to submit a SUE to the national competent authority.
A health professional or an end user can also directly notify Tukes.
To whom and on what terms
Only serious undesirable effects are reported. Before reporting a serious undesirable effect, the responsible person or distributor must ensure that the incident in question meets the severity criteria.
The service is free of charge.
The responsible person and the distributor must process SUE notifications within 20 days of becoming aware of the serious undesirable effect.
Period of validity
no expiration date