Regulatory Toxicology in the European Union
CHAPTER 11: Cosmetic Products
Published:21 Feb 2018
In Europe, cosmetic products are regulated under the Cosmetic Products Regulation (Regulation (EC) No 1223/2009), which was implemented in 2013 and applies to manufacturers, retailers, distributors and importers placing products on the European Union market. The Regulation replaced previous legislation and included a specific aim of strengthening the safety requirements for cosmetic products. Among other aspects, the Regulation introduced the Cosmetic Product Safety Report (CPSR), which must be provided for all products placed on the market; it introduced the concept of a ‘Responsible Person’, with legal responsibility for any cosmetic products placed on the market, and also established the Cosmetics Products Notification Portal (CPNP). This chapter provides insight into the toxicology data which are required to be compiled by a suitably qualified Safety Assessor in order to demonstrate product safety. The Regulation also established a ban on the animal testing of cosmetic products and their ingredients; the difficulties involved in demonstrating product safety without the availability of validated alternative methods are also discussed.