SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision - Final Opinion – SCCS/1647/22 - Corrigendum 2 - Archive ouverte HAL Accéder directement au contenu
Ouvrages Année : 2023

SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision - Final Opinion – SCCS/1647/22 - Corrigendum 2

U. Bernauer
  • Fonction : Auteur
Q. Chaudhry
  • Fonction : Auteur
P.J. Coenraads
  • Fonction : Auteur
M. Dusinska
  • Fonction : Auteur
J. Ezendam
  • Fonction : Auteur
C. L. Galli
  • Fonction : Auteur
E. Panteri
  • Fonction : Auteur
V. Rogiers
  • Fonction : Auteur
M. Stepnik
  • Fonction : Auteur
T. Vanhaecke
  • Fonction : Auteur
S. Wijnhoven
  • Fonction : Auteur
E. Benfentati
  • Fonction : Auteur
N. Cabaton
  • Fonction : Auteur
E. Corsini
  • Fonction : Auteur
A. Koutsodimou
  • Fonction : Auteur
H. Louro
  • Fonction : Auteur
W. Uter
  • Fonction : Auteur
N. Von Goetz
  • Fonction : Auteur
R. Krätke
  • Fonction : Auteur

Résumé

SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision - Final Opinion – SCCS/1647/22 - Corrigendum 2 U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz, R. Krätke The SCCS adopted this guidance document by written procedure on 15 May 2023Adopted 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 (203 pages) Published on 22 December 2023 https://health.ec.europa.eu/publications/sccs-notes-guidance-testing-cosmetic-ingredients-and-their-safety-evaluation-12th-revision_en https://health.ec.europa.eu/document/download/32a999f7-d820-496a-b659-d8c296cc99c1_en?filename=sccs_o_273_final.pdf Details Publication date : 22 December 2023 Author : Scientific Committee on Consumer Safety (SCCS) Description 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-SCCS@ec.europa.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.
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Dates et versions

hal-04367448 , version 1 (30-12-2023)

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  • HAL Id : hal-04367448 , version 1

Citer

U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, et al.. SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision - Final Opinion – SCCS/1647/22 - Corrigendum 2. Scientific Committee for Consumer Safety (SCCS, EC). , 2023, Scientific Committee for Consumer Safety (SCCS, EC). ⟨hal-04367448⟩
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