Monday, April 26, 2021SCCS

Safety assessment: 11th revision of the SCCS' Notes of Guidance

Évaluation de la sécurité : 11e révision des lignes directrices du CSSC

At its plenary meeting on 30-31 March 2021, the SCCS adopted the 11th revision of its Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. Compared to the previous version, a focus was made on exposure and the application of alternative methods, more specifically on non-animal methods/new approach methodology (NAM).

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The “Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS” is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS, replacing the former SCCP, SCCNFP and SCC).
The document contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products.
It is designed to provide guidance to public authorities and to the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation. An important development in recent years was the full implementation of the cosmetic legislation, Regulation (EC) No.1223/2009, meaning that the animal testing and marketing bans fully apply from 2013 onwards: no in vivo testing of finished products after 11 March 2004; no in vivo testing for local toxicity after 11 March 2009 and no in vivo testing for repeated dose toxicity (including sensitisation) toxicokinetics and developmental toxicity from 11 March 2013 onwards for the purpose of cosmetics.
For this reason, the SCCS has closely followed the progress made with regard to the development and validation of alternative methods, with emphasis on replacement methodology.

The “Notes of Guidance” are regularly revised and updated in order to incorporate the progress of scientific knowledge in general, and the experience gained, in particular in the field of testing and safety evaluation of cosmetic ingredients.
The previous revision of the Notes of Guidance took place in 2018 (SCCS/1602/18). Since then, several new addenda, opinions and memoranda of importance to the content of this guidance document have been adopted and they form the basis of this new revision.
Focus is on exposure and the application of alternative methods, more specifically on non-animal methods/new approach methodology (NAM).

Main changes in 11th revision of the SCCS Notes of Guidance (NoG)

The whole NoG have been revised and updated with a particular emphasis on the following:
• Inhalation models
In silico methodology for genotoxicity/carcinogenicity
• General updating of NAMs
• Scientific concerns for the safety of the nanomaterials
• Update of ED (Endocrine disruptors) section
• Discussion on uncertainty factors
• Updating of references in general
• Appendix 1: complying with the testing & marketing bans
• Appendix 9: guidelines on microbiological quality of the finished product
• Appendix 10: free access to in silico mutagenicity/genotoxicity databases
• Appendix 11: inhalation parameterisation
• Appendix 12: Lifetime Cancer Risk Approach
• Appendix 13: PoD (Point of Departure) used for TTC (Thresholds of Toxicological Concern) derivation

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