SCCS Updates the Cosmetic Safety Assessment Guidelines

On May 16, 2023, the European Union Scientific Committee on Consumer Safety (SCCS) published the "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation – 12th revision" (SCCS/1647/22).

MAIN CHANGES IN THE 12TH REVISION OF THE SCCS NOTES OF GUIDANCE (NoG)

The NoG has 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 the 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: the rationale behind exposure data;
• Human biomonitoring (HBM) and differences with the SCCS approach for risk assessment;
• CMRs reporting requirements;
• Endocrine active substances, the introduction of non-monotonic dose response, reporting requirements; and
• Templates for PBTK (Physiologically Based ToxicoKinetics) model description and parameter verification and analysis.

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