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Market surveillance

EU countries are responsible for the surveillance of their own markets for cosmetics. In order to ensure a coherent approach to consumer products issues, the market surveillance authorities of all EU countries established the platform of European market surveillance authorities for cosmetics (PEMSAC).

The aim of this network is to facilitate cooperation by

  • coordinating activities
  • exchanging information
  • developing and implementing joint projects
  • exchanging expertise and best practices in cosmetics market surveillance

The members of PEMSAC are the representatives of market surveillance authorities in all EU countries. They meet twice a year in plenary and in 2 technical groups dealing with market surveillance and analytical methods.

Communication of serious undesirable effects (SUE)

One area where EU countries should cooperate and exchange information is on serious undesirable effects attributable to cosmetics use. EU Regulation (EC) No 1223/2009 on cosmetic products ('Cosmetics Regulation') created the basis for a uniform approach for the communication of serious undesirable effects (SUE). It provides for

  • notification of SUEs to national authorities where the effect in question occurred
  • notification of any corrective measures taken by the responsible person or distributor

Data on SUEs forms part of the cosmetics product safety report (CPSR). The communication of SUEs has been mandatory since 11 July 2013.

Guidelines

To facilitate the implementation of the Cosmetics Regulation and to establish a harmonised communication and management system on SUE throughout the EU, the Commission, in cooperation with EU countries and industry, established special guidelines. The aim of these guidelines is to help ensure harmonised notification of SUE by the responsible person or distributor, and to ensure that SUE notifications are followed-up by national authorities, responsible persons, or distributors.

3 different forms were drawn up for the structured and harmonised submission of all important factors related to SUE

  • SUE form A (85 kB) – A (85 kB): To be filled in by responsible persons or distributors that are made aware of a SUE in order to transmit it to the national authorities of the country where the SUE occurred.
  • SUE form B (62 kB) – B (62 kB): To be filled in by a national authority and attached to SUE form A to transmit the information on SUE to the authorities of other EU countries when the information was reported by a responsible person or distributor; or to transmit the information on SUE to the responsible person, when the information was initially reported by a distributor.
  • SUE form C (2 MB) – C (2 MB): To be filled in by a national authority to transmit the information on SUE which has been reported by health professionals and/or end users to the authorities of other EU countries and to the responsible person.