Cosmetic Compliance
Intelligence & Solutions
SUE Reporting Guidelines
Local Title:
/
Country/Region:
EU
Competent Authority:
European Commission
Type:
Regulation
Status:
In force
Release Date:
2013-07-11
Implementation Date:
2013-07-11
Document
Language Source Title Access
EN
Official SUE Reporting Guidelines
Summary

EU Regulation (EC) No 1223/2009 on cosmetic products (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.