The aim of this network is, in particular, to facilitate cooperation by:
developing and implementing joint projects;
exchanging expertise and best practices in the field of cosmetics market surveillance.
The members of PEMSAC are the representatives of market surveillance authorities of all the Member States and they meet twice a year in plenary and in two technical groups dealing with market surveillance and analytical methods.
Communication of serious undesirable effects (SUE)
One of the areas where Member States should cooperate and exchange information is information on serious undesirable effects attributable to the use of cosmetics.
EU Regulation (EC) No 1223/2009 on cosmetic products ('Cosmetics Regulation') created the basis for a uniform approach to the communication of Serious Undesirable Effects (SUE). It provides for:
notification of SUEs to the Competent Authorities of the Member State where the effect in question occurred without delay;
notification of any corrective measures taken by the Responsible Person or Distributor.
Data on SUE as well as on any undesirable effect become part of the Cosmetics Product Safety Report (CPSR).
The communication of SUE is mandatory since 11 July 2013.
In order 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 Member States and industry, established special guidelines. The aim of this document is to ensure harmonized notification of SUE by the Responsible Person or Distributor and follow-up on SUE notifications by Competent Authorities, Responsible Persons or Distributors.
Three different forms were drawn up, enabling a structured and harmonised submission of all important factors related to the SUE:
SUE Form B - B : To be filled in by a Competent Authority and attached to SUE Form A in order to transmit the information on SUE to the Competent Authorities of other Member States, when the information was reported by a Responsible Person or Distributor; or in order to transmit the information on SUE to the Responsible Person, when the information was initially reported by a Distributor.
SUE Form C - C : To be filled in by a Competent Authority in order to transmit to the Competent Authorities of other Member States and to the Responsible Person the information on SUE which has been reported by health professionals and/or end users.