The SCCS has just adopted (on 15 May 2023 by written procedure) the 12th revision of its Notes of Guidance (NoG) for the testing of cosmetic ingredients and their safety evaluation. Like the previous ones, it has been carried out to integrate new scientific and toxicological knowledge, to update on alternative methods to animal testing and to take into account regulatory developments.
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
