The SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation – 11th Revision - SCCS/1628/21

International audienceIn the present update, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. New methodologies for risk assessment of chemicals without using animal experimentation are worldwide being explored. Attention is given here to Next-Generation Risk Assessment (NGRA) as a possible framework for the safety evaluation of cosmetic ingredients and the NAMs that would fit into this structure (Rogiers et al., 2020). Risk assessment of cosmetics and their ingredients is shifting towards a strategic combination of NAMs and new technology with historical animal data, if available, to come to a Weight of Evidence (WoE) decision making approach. Although the "Notes of Guidance" are concerned with the testing and safety evaluation of the cosmetic substances listed in the Annexes of Regulation (EC) No 1223/2009 and those for which safety concerns have been expressed, they could be also of interest for all substances intended to be incorporated in a cosmetic product. Even though the "Notes of Guidance" have not been written for the latter purpose, they can indeed be of practical use in making a Product Information File (PIF) for a finished cosmetic product as currently required by Regulation (EC) No 1223/2009