Notification of serious undesirable effect (SUE) caused by cosmetics

Cosmetic products must be safe for their intended purposes of use or under reasonably foreseeable conditions of use. A comprehensive safety assessment shall be conducted for all cosmetic products. The responsibility for safety lies with the responsible person for the cosmetic product, whose name and contact details shall be indicated on the packaging of the cosmetic product. The term ‘responsible person’  is a legal term, and the responsible person is almost invariably the company responsible for the cosmetic product, and only in rare cases a natural person.

 

Although cosmetic products must be safe according to the legislation, they may nevertheless have undesirable effects on human health, which in some cases may be serious (such as serious allergic reactions). According to the EU Regulation on cosmetic products (No 1223/2009) (‘Cosmetics Regulation’), undesirable effect means an adverse reaction for human health. A Serious Undesirable Effect (SUE) means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death. According to Article 23 of the Cosmetics Regulation, only serious undesirable effects shall be notified to the authority responsible for cosmetic products in the Member State where the serious undesirable effect occurred. The authorities of this country shall transmit the information to the authorities responsible for the surveillance of cosmetic products in the other Member States. Harmonised SUE (Serious Undesirable Effect) forms are used for submitting the notification. Additional information is available on the website of the European Commission.

 

Serious undesirable effects attributable to cosmetics that occur in Finland shall be notified to the Finnish Safety and Chemicals Agency (Tukes), which processes the notifications and transmits the information to the authorities of the other Member States.

 

Instructions for the responsible person and distributor of cosmetic products 

The EU Cosmetics Regulation (applicable as of 11 July 2013), requires the responsible persons (usually the manufacturer or EU/EEA importer) and distributors of cosmetic products to notify without delay (within 20 calendar days of receiving of the notification) serious undesirable effects known to them (SUE notification) to the competent authority of the Member State where the serious undesirable effect occurred. As the distributor may not have the same level of information concerning the product as is available to the responsible person, the distributor can also inform the responsible person (=responsible company)  of a serious undesired effect known to him, so that they can collaborate on the SUE notification (this is recommendable). In the case that the distributor notifies the serious undesirable effect to the authorities himself, it is recommended that distributor also inform the company responsible for the product, even though this is not required by the legislation.

 

The responsible persons and distributors should submit the notification by using SUE Form A; further details can be found here.


 

Instructions for health professionals and end users 

It is recommended that health professionals and end users of cosmetics (such as hairdressers, cosmetologists and consumers) make notification of serious undesirable effects primarily to the responsible person for the product (contact details can be found on the packaging of cosmetic product) or the distributor (party from whom the product was purchased), who are obligated by the Cosmetics Regulation to further submit a SUE notification to a competent national authority. If the cosmetic product causes an undesirable effect, the end user or distributor should always also inform the responsible person of this.  Only serious undesirable effects shall be reported to the authorities, in Finland to Tukes, who shall transmit information on received SUE notifications on to the competent authorities of the other Member States.

 

Health professionals or end users can also notify authority directly here.

 

 

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