The obligation to notify authorities only applies to serious undesirable effects, such as effects that have resulted in sick leave. The abbreviation ‘SUE’ is commonly used for serious undesirable effects.
When is an effect a serious undesirable effect?
The criteria for seriousness are met if a cosmetic product causes one of the following:
- temporary or permanent functional incapacity,
- disability
- hospitalisation
- congenital anomalies,
- immediate vital risk or
- death.
Temporary functional incapacity affects quality of life or ability to perform work or other activities. Effects that result in interruption of work or sick leave are examples of temporary functional incapacity. Changes in appearance that significantly affect quality of life, such as strong allergic reaction on the face, can also be considered serious.
Effects of permanent functional incapacity are permanent. For example, a person may need to change employment due to permanent functional incapacity. A professional who uses cosmetic products in his/her work may become sensitised to certain ingredients and can no longer work in the same profession.
SUE notification by the responsible person or distributor
The responsible person or distributor of a cosmetic product must submit a SUE notification to the competent authorities without delay, within 20 days from the date on which it becomes aware of the SUE. The responsible person and distributor must ensure that the criteria for seriousness are met.
The distributor of a cosmetic product may first report a SUE to the responsible person. The distributor and responsible person can cooperate to prepare a SUE notification for the competent authority.
Causality assessment
The responsible person should carry out a causality assessment and include the results in the SUE notification. The aim of the causality assessment is to determine the probability that the reported SUE is attributable to the reported cosmetic product.
SUE notifications submitted by distributors should also include a causality assessment, if possible. The distributor should always gather all the available information on the case. Based on this information, the responsible person or an authority may perform a causality assessment, if needed.
Instructions for responsible persons and distributors on reporting a SUE that has occurred in Finland
When you notify Tukes about a SUE that has occurred in Finland, take the following into account:
Make sure that the criteria for seriousness are met.
- Use SUE Form A for the notification. SUE Form A is available in all the official EU languages. Please use the English form when possible.
- Instructions for completing SUE Form A are available at the European Commission website.
- Please provide all the available information on the case.
- You do not necessarily have all of the information that is requested in SUE Form A. However, the initial notification should be submitted if the following minimum information is available:
- an identifiable reporter;
- the nature of the alleged SUE and the date of its onset; and
- the name of the cosmetic product concerned enabling its specific identification.
- Your notification can be supplemented later.
- Detailed instructions for SUE reporting are available at the European Commission website.
- Include a causality assessment in the SUE notification, if possible. Instructions for causality assessment are available in all the official EU languages at the European Commission website.
- Send your completed SUE Form A to Tukes at [email protected].
- Further information on communication related to a serious undesirable effect caused by a cosmetic product is available at the European Commission website.
SUE notifications submitted by health professionals and cosmetics end users
Health professionals and cosmetics end users do not have an obligation to submit a SUE notification. It is important for the person responsible for a product to receive information about all SUEs caused by the product.
If a professional, such as a cosmetologist or a hairdresser, who uses cosmetic products, also resells cosmetic products the professional is a distributor of the sold products.
What to do if you are a health professional or an end user of cosmetic products and you notice a serious undesirable effect caused by a cosmetic product:
- Notify the responsible person or distributor of the product. You can find the contact details of the responsible person on the packaging of the cosmetic product. The distributor is the party who sold the product. OR
- Directly notify the competent authority. In Finland the competent authority is Tukes. Use the form intended for this purpose, which is available here.
- Please use the SUE notification to report all the available information on the case.
The role of Tukes in processing SUE notifications
Tukes shall process SUE notifications related to cases that have occurred in Finland without delay, within 20 days of receiving a notification.
Tukes checks
- that the notification contains sufficient information on the case and the suspected product;
- whether the criteria for seriousness are met; and
- the causality assessment and carries out a causality assessment, if necessary.
Tukes may request additional information from the reporter of the SUE notification.
Tukes transmits information about the SUE to the competent authorities responsible for enforcement of cosmetics legislation in other EU Member States. If the initial SUE notification was submitted by a distributor, health professional or end user, Tukes shall also transmit the information to the responsible person.
Tukes uses forms SUE B and SUE C to further communicate SUE cases. Forms SUE B and SUE C are intended for use by authorities only.
