SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers (Rapporteur), Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
SCHEER member: R. Krätke
SCCS external experts: E. Benfenati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1647/22
Adopted on: 15 May 2023

The corrigendum 1 on Table 3A page 27 (footnote added under deo non-spray) was adopted on 26 October 2023 and the corrigendum 2 on Tables 3A and 3B was adopted on 21 December 2023

Conclusion of the opinion:

The NoG have been revised and updated with emphasis on the following:
• Importance of systematic literature review
• Updating of animal-free alternative methods: NAM (New Approach Methodology), changes introduced for acute inhalation, skin irritation testing, eye irritation testing with DAL (Defined Approach for eye irritation, Liquid), DASS (Defined Approaches for Skin Sensitisation), new in vitro methods for genotoxicity testing (3D skin Comet; in vitro micronucleus)
• Importance of AOP (Adverse Outcome Pathway), DAs (Defined Approaches), IATA (Integrated Approaches to Testing and Assessment), NGRA (Next Generation Risk Assessment) with definition of BER (Bioactivity/Exposure Ratio), TTC (Threshold of Toxicological Concern), iTTC (internal TTC)
• Updating of in silico prediction possibilities
• Exposure data reviewed (models, parameters specific for inhalation, aggregate exposure)
• Exposure of children to different cosmetic product categories according to age
• Sun protection by sunscreen products: rationale behind exposure data
• Human biomonitoring (HBM) and differences with SCCS approach for risk assessment
• CMRs reporting requirements
• Endocrine active substances, introduction of non-monotonic dose response, reporting requirements
• Templates for PBTK (Physiologically Based ToxicoKinetics) model description and parameter verification and analysis

Keywords:

SCCS, SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision, SCCS/1647/22, corrigendum

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 12th revision, 15 May 2023, corrigendum 1 on 26 October 2023, corrigendum 2 on 21 December 2023, SCCS/1647/22.