Sccs Notes of Guidance-12th Revision
The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their safety evaluation are now in its 12th revision.
The SCCS guidance notes are a basic requirement for industry to meet the criteria of Article 3 of the Cosmetics Regulation: every cosmetic product must undergo a safety assessment procedure before being placed on the market.
Why have we reached the 12th revision?
Guidelines evolve accordingly to the scientific knowledge about individual ingredients and test methods progresses.
Let’s see together what changes have been introduced in this revision:
- 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
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