SUE Reporting Guidelines

EU Regulation (EC) No 1223/2009 (the Cosmetic Regulation) created the basis for a uniform approach for the communication of serious undesirable effects (SUE). It provides for the notification of SUEs to national authorities where the effect in question occurred, as well as the notification of any corrective measures taken by the responsible person or distributor. 

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.