Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

• Main Authors: Andreas Butschke, Astrid Droß, Katja Dünnebier, Ines Laube, Ariane Weiler
• Format: Article
• Language: English
• Published: MDPI AG 2016-07-01
• Series: Cosmetics
• Subjects: serious undesirable effects; cosmetics; statistical evaluation; cosmetic legislation; Regulation (EC) 1223/2009
• Online Access: http://www.mdpi.com/2079-9284/3/3/25

The Council of Europe created an outline for a vigilant system of undesirable effects of cosmetic products in 2006. In 2013, some of those aspects were included in the European Cosmetics Regulation (EC) 1223/2009. Since then, serious undesirable effects (SUEs), which are the tip of the iceberg of all undesirable effects of cosmetic products, have to be reported to competent authorities. Neglecting the first phase of establishing the system, we have about two years of experience regarding the notification of SUEs. This notification system is based on a huge amount of cases that allow us to identify occurring problems at an early stage through a signal of increased reported cases for a certain product. It has already been shown that the system is able to identify products that have the potential to cause health risks even if they seem to comply with the legal requirements and the safeguard clause was applied. Until May 2016, 680 cases of SUEs were shared in the EU. The statistics of SUEs indicate that hair dyes and skin care products are the product types that cause the most SUEs. Almost 80% of all SUEs occurred in the head area, especially the skin of the face was affected.