Notification by health professionals or end users of serious undesirable effect caused by cosmetics

It is recommended that a health professional or end user (e.g. a consumer or cosmetics professional such as a hairdresser or cosmetologist*) reports a serious undesirable effect to the responsible person for the product concerned (responsible company; contact details available on the  packaging of cosmetic product) or the distributor (party from whom the product was purchased). They are required by legislation to complete a SUE notification concerning the matter to the authority of the country where the serious undesirable effect occurred. In Finland, the notifications are to be submitted to Tukes. However, a health professional or end user can also submit a SUE notification directly to Tukes by using the form below.

 

The form is used to gather information as exhaustively as possible on the resulting serious undesirable effect. The aim is to use the information to determine the probability that the reported serious undesirable effect is attributable to the reported cosmetic product. The information is also required for Tukes to transmit information on the SUE to other EU authorities and the responsible person for the cosmetic product.

 

Inquiries concerning the SUE notification can be sent by e-mail to: kosmetiikka_sue@tukes.fi

 

*) Professionals who use cosmetic products in their work are end users. The legislation does not obligate professionals acting as end-users to notify the authorities if a cosmetic product causes a serious undesirable effect in their work. A professional should, however, always report all undesirable effects caused by cosmetics and serious undesirable effects to the company (i.e. responsible person or distributor) who sold the cosmetic product concerned. Legislation obliges responsible persons and distributors to report serious undesirable effects that have come to their knowledge to an authority. If a professional resells cosmetic products, they act as a distributor of these products. If a cosmetics professional subsequently becomes aware of a serious undesirable effect caused by a cosmetic product sold by them, they are required by the legislation to submit a SUE notification either independently or in collaboration with the responsible person.  Collaboration is recommended, as a hairdresser, for example, may not have all the necessary information on a product, or they may not know how to complete the notification as required by the legislation. Notification of a serious undesirable effect caused by cosmetics by a distributor to  authority is done on SUE Form A here.

 

 

 
(Maximum allowed total size of files is 9.77MB)










1. REPORTER



 
2. HAS THE REPORTED INFORMATION BEEN CONFIRMED BY A MEDICAL PROFESSIONAL?


 
3. HAS THE SERIOUS UNDESIRABLE EFFECT CAUSED BY COSMETICS BEEN REPORTED ELSEWHERE?


 
4. INFORMATION ON THE PERSON AFFECTED BY THE SERIOUS UNDESIRABLE EFFECT
Age (at time of SUE):
 
Sex:


 
Country of residence:
 
Country of occurrence of SUE:
 
5. SUSPECTED COSMETIC PRODUCT AND ITS USE
Full name of suspected product:
You can add a product image in the box at the top
 
Manufacturer/importer:
 
Batch number (if known):
 
Date of first ever use (dd/mm/yyyy):
 
Frequency of use (how many times per day/week/month/year):
 
Application site(s):
 
Professional use:


 
Product use stopped:



 
Other cosmetic products used concomitantly (full name of product, manufacturer/importer):
 
6. DESCRIPTION OF SERIOUS UNDESIRABLE EFFECT
Date of onset (dd/mm/yyyy):
 
Time from the beginning of use to onset of first symptoms:
 
Time from last use to onset of first symptoms:
 
Description of resulting symptoms/effects (describe in as great detail as possible):
 
Diagnosis established by a medical practitioner:


 
Location of serious undesirable effect:









 
Location of serious undesirable effect :


 
Has the suspected product been re-used:



If you replied yes to the previous question, did the serious undesirable effect recur as a result of re-exposure?



 
7. STATUS OF SERIOUS UNDESIRABLE EFFECT(S)






 
8. OTHER POSSIBLY RELEVANT UNDERLYING CONDITIONS







 
Additional concurrent use of other products (drugs, food supplements, etc.):
 
9. TREATMENT OF SERIOUS UNDESIRABLE EFFECT
Details on any medication used for the treatment of the serious undesirable effect (name of drug, active substance, dose, duration of treatment):
 
Other treatment (describe in as great detail as possible):
 
10. SERIOUSNESS OF UNDESIRABLE EFFECT




 



 
Hospitalisation; describe in as great detail as possible: reason; duration; medication (drug/dose/duration) and other treatment received during hospitalisation; hospital name and address; treatment and measures taken after hospitalisation:
 
Immediate vital risk; in the box below, describe in as great detail as possible: reason, medication (drug/dose/duration) and other treatment/measures
 
11. COMPLEMENTARY INVESTIGATIONS






In the box below, specify 1) Name of the products tested 2) Methods used 3) Readings on 4) Results
 
12. CONTACT DETAILS OF THE REPORTER (Required only in case the reporter needs to be contacted. The reporter’s name and contact details will not be disclosed to third parties. Tukes will not use this information to create a personal data register.)
Name:
Address:
Postal code and city:
Telephone number:
E-mail:
 
If you wish to print the completed form before sending it, click the pink 'Print' button at the bottom right of the page. Only then click the 'Send form' button.