European Commission Publishes SCCS Notes of Guidance for Cosmetic Ingredients.

On 15 May 2023, the European Commission adopted the 12th revision of The SCCS Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation. The SCCS Notes of Guidance (NoG) are revised and updates by the European Commission’s Scientific Committee on Consumer Safety (SCCS) approximately every 3 years, to incorporate the progress in the field of testing and safety evaluation of cosmetic ingredients. The NoG aim to provide guidance to public authorities and the cosmetic industry in order to improve harmonised compliance with the current cosmetic EU legislation (Regulation (EC) No. 1223/2009). The notes contain information on the different aspects of testing and safety evaluation of cosmetic substances with the emphasis on cosmetic ingredients, although some guidance is also indirectly given for the safety assessment of finished products.

The updates in the 12th revision of the Notes of Guidance have emphasis on the following aspects:

• 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

• Reporting requirements for cancerogenic, mutagenic and reprotoxic substances (CMRs)

• Introduction of non-monotonic dose response, reporting requirements for endocrine active substances

• Templates for PBTK (Physiologically Based ToxicoKinetic) model description and parameter verification and analysis

The full text of the NoG can be found here: https://health.ec.europa.eu/system/files/2023-05/sccs_o_273.pdf