New factsheet on the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation – 10th revision

The Scientific Committee on Consumer Safety (SCCS) Notes of Guidance provide relevant information about the safety evaluation process for the Annex substances and the testing procedures that can be applied. They are regularly updated according to the latest scientific and technological advances. The last revision took place in April 2016. While attention was then given to the general requirements of the new Cosmetic Regulation and the use of alternative methods, the focus is now entirely on non-animal methodologies and strategies. Indeed, in the light of the full implementation of the animal testing and marketing bans, only non-animal replacement methods are legally allowed for the testing of cosmetics and their ingredients. Non-animal techniques, termed New Approach Methods (NAMs), are thus increasingly being used. Therefore, the general structure of the Notes of Guidance, as well as the content, has been updated in the 10th Revision. Priority has been given to the updated non-animal methods, followed by the older in vivo techniques. A section on Weight of Evidence (WoE) and the use of a ‘toolbox’ strategy for genotoxicity testing has been included. As the safety assessment of cosmetic ingredients is exposure-driven, the section on exposure has been significantly extended. External and internal exposure, a tiered approach and aggregate exposure have been considered separately and a literature overview of consumer exposure data has been included in the Appendix. More guidance has also been provided for the submission of a safety dossier to the SCCS and re-submission in case of rejection.

EU Scientific Committees, 12 November 2018 ;