Notification by a responsible person or distributor of serious undesirable effect caused by cosmetic product

Responsible persons and distributors shall, before submitting a notification on a serious undesirable effect to the competent authority of a Member State, ensure that the case in question fulfils the seriousness criteria. The competent authority shall also ensure, upon receiving the SUE notification, that the seriousness criteria are fulfilled before informing other authorities of the EU countries. A SUE notification by a distributor is also reported to the responsible person for the cosmetic product.

 

SUE Form A: The responsible persons or distributors shall notify of serious undesirable effects caused by cosmetic products occurring in Finland to the competent authority (Tukes) by using SUE Form A. The form is available in all the official EU languages (including Finnish, Swedish and English).It is recommended to use the English form. This will facilitate the transmission of information on SUE cases among the authorities in the EU countries. The instructions for completing SUE Form A are only available in English.

 

The notification is submitted primarily by e-mail to: kosmetiikka_sue@tukes.fi

or by post to the following address (Please write ”Cosmetics SUE” on the envelope):

Finnish Safety and Chemicals Agency (Tukes)

PO Box 66
FI-00521 Helsinki

 

SUE Form A is designed not only for the initial notification or transmission of information, but also for the follow-up and final conclusions of the case. Not all the information listed on the form may be available at the time of submission of the initial notification of a serious undesirable effect. The initial notification, which can be supplemented at a later date, should be carried out if the following minimum information is available:

 

1) An identifiable reporter (Form A: sections 1, 2 and 4)
2) The nature of the alleged serious undesirable effect and the date of its onset (Form A: section 7)
3) The full name of the cosmetic product concerned, enabling its specific identification (Form A: section 6a)

 

The ”SUE reporting guidelines" describe the procedures related to the notification obligation regarding serious undesirable effects caused by cosmetic products in more detail. You should follow these instructions for completing notification of SUE. The instructions are available in all the official EU languages; see here.

 

Causality assessment of serious undesirable effect

Causality assessment is of key importance in SUE notification. The aim of the causality assessment is to determine the probability that a reported serious undesirable effect is attributable to the reported cosmetic product. SUE notifications by the responsibleperson should include a causality assessment (Form A: section 13c). Notifications by the distributor should also include a causality assessment, if possible. In any event, the distributor should gather all the available information on the case in order to allow the responsible person and/or competent authority to make the causality assessment.

 

The competent authority reviews the causality assessment made by the responsible person or distributor. If there is disagreement between the reporter and the competent authority regarding the assessment of the probability of causality, this should be noted in the transmission of the SUE to the other EU authorities. Annex 1 of the "SUE reporting guidelines" describes the standardised causality assessment method which should be used to assess the probability of the causality of a serious undesirable effect.

 

 

Cosmetic Products Notification Portal (CPNP)

 

Legislation

  • Regulation on cosmetic products (EC) No 1223/2009 (consolidated version 12.5.2016)
  • Commission Regulation (EU) No 344/2013 amending Annexes II, III and VI Commission Regulation (EU) No 483/2013 amending Annex III
  • Commission Regulation (EU) No 658/2013 amending Annexes II and III 
  • Commission Regulation (EU) No 1197/2013 amending Annex III 
  • Commission Regulation (EU) No 358/2014 amending Annexes II and V
  • Commission Regulation (EU) No 866/2014 amending Annexes II, V and VI 
  • Commission Regulation (EU) No 1003/2014 amending Annex V 
  • Commission Regulation (EU) No 1004/2014 amending Annex V to Regulation on cosmetics products
  • Comission Regulation (EU) 2015/1190 amending Annex III
  • Comission Regulation (EU) 2015/1298 amending Annexes II and IV
  • Comission Regulation (EU) 2016/314 amending Annex III
  • Comission Regulation (EU) 2016/621 amending Annex VI
  • Comission Regulation (EU) 2016/622 amending Annex III
  • Comission Regulation (EU) 2016/1120 amending Annex IV
  • Comission Regulation (EU) 2016/1121 amending Annex V
  • Comission Regulation (EU) 2016/1143 amending Annex VI
  • Comission Regulation (EU) 2016/1198 amending Annex V
  • Comission Regulation (EU) 2017/237 amending Annex III
  • Comission Regulation (EU) 2017/238 amending Annex VI

 

  • Directive 76/768/EEC on cosmetic products (repealed)

 

Claims used to cosmetic products

 

Cosmetic products safety report

  • Commission Implementing Decision (2013/674/EU) on Guidelines on Annex I to Regulation on cosmetic products
  • The SCCS's notes of guidance for the testing of cosmetic substances and their safety evaluation, 8th revision SCCS/1501/12

 

CMR-substances (substances classified as carcinogenic, mutagenic or toxic for reproduction)

 

Other related links to cosmetic products