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The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2.
Συγγραφείς: Rogiers V; Department of In Vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Brussels, Belgium., Benfenati E; Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Bernauer U; German Federal Institute for Risk Assessment (BfR), Berlin, Germany., Bodin L; Alternative Energies and Atomic Energy Commission (CEA), Saclay, France., Browne P; Organisation for Economic Co-operation and Development - OECD, Paris, France., Cabaton N; French National Research Institute for Agriculture, Food and the Environment (INRAE TOXALIM), Toulouse, France., Chaudhry Q; University of Chester, Chester, UK., Coenraads PJ; University of Groningen, Groningen, The Netherlands., Corsini E; Università degli Studi di Milano, Milan, Italy., Dent M; Unilever Safety, Environmental and Regulatory Science, Colworth Science Park, Sharnbrook, Bedfordshire, MK44, UK., Ellison C; The Procter & Gamble Company, Cincinnati, OH, USA., Ezendam J; National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands., Gaffet E; Institute Jean Lamour (UMR 7198 CNRS Université de Lorraine), Nancy, France., Galli CL; Faculty of Pharmaceutical Sciences, University of Milan, Milan, Italy., Katsanou E; European Commission, Joint Research Centre (JRC), Ispra, Italy., Koutsodimou A; General Chemical State Laboratory, Athens, Greece., Louro H; National Institute of Health Dr. Ricardo Jorge (INSA), Lisbon, Portugal., Najjar A; Department Global Toxicology, Beiersdorf AG, Beiersdorfstraße 1-9, 22529, Hamburg, Germany., Paini A; European Food Safety Authority (EFSA), Parma, Italy., Panteri E; Faculty of Pharmacy, Laboratory of Pharmaceutical Analysis, National and Kapodistrian University of Athens, Panepistimiopolis - Zografou, 157 71, Athens, Greece., Rousselle C; French Agency for Food, Environmental and Occupational Health & Safety (Anses), European and International Affairs, Maison-Alfort, France., Sadekar N; Research Institute for Fragrance Materials - RIFM, Mahwah, NJ, USA., Schepky A; International Collaboration on Cosmetics Safety - ICCS, Mt. Royal, USA., Stępnik M; Qsar Lab Ltd., Gdańsk, Poland; Department of Toxicology, Faculty of Pharmacy, Medical University of Łódź, Łódź, Poland., Uter W; University of Erlangen-Nürnberg, Erlangen and Nuremberg, Germany., Vanhaecke T; Federal Office of Public Health (FOPH), Bern, Switzerland., von Goetz N; Federal Office of Public Health (FOPH), Bern, Switzerland., Wijnhoven S; RIVM, Centre for Safety of Substances and Products (VSP), Centre for Substances and Integrated Risk Assessment (SIR), Bilthoven, The Netherlands.
Συλλογικό Έργο: SCCS - Scientific Committee on Consumer Safety
Πηγή: Archives of toxicology [Arch Toxicol] 2026 Apr; Vol. 100 (4), pp. 1637-1655. Date of Electronic Publication: 2026 Jan 08.
Τύπος έκδοσης: Journal Article
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Springer-Verlag Country of Publication: Germany NLM ID: 0417615 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0738 (Electronic) Linking ISSN: 03405761 NLM ISO Abbreviation: Arch Toxicol Subsets: MEDLINE
Imprint Name(s): Original Publication: Berlin, New York, Springer-Verlag.
Ιατρικοί όροι (MeSH): Cosmetics*/toxicity , Cosmetics*/adverse effects , Toxicity Tests*/methods , Consumer Product Safety*, Risk Assessment/methods ; Humans ; European Union ; Animals ; Animal Testing Alternatives
Περίληψη: Under the European Cosmetic Regulation, safety assessments of cosmetics and their ingredients must be conducted without the use of animals. This regulatory requirement poses a number of challenges, as validated alternative methods are only available for some of the toxicological endpoints that are typically considered in standard human health risk assessments. Despite significant progress since the ban in 2013, particularly in the development of New Approach Methodologies (NAMs) for local and acute toxicity, and for mutagenicity/genotoxicity, there remains an urgent need for non-animal test methods to assess systemic toxicity, which often becomes evident after repeated or long-term exposure. Currently, no validated animal-free alternatives are available for assessing sub-acute, sub-chronic and chronic toxicity, carcinogenicity, developmental/reproductive toxicity, or for a major part of toxicokinetics. In response to these challenges, the Methodology Working Group of the Scientific Committee on Consumer Safety organised a dedicated workshop in December 2024 to discuss advances in the application of Next Generation Risk Assessment (NGRA) as a strategic animal-free approach for the safety assessment of cosmetic ingredients. The workshop focused on a number of important key issues for the practical application of NAMs and NGRA, their regulatory acceptance and identification of possible (partial) solutions to overcome existing limitations.
(© 2025. The Author(s).)
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Contributed Indexing: Keywords: Alternative method; Animal-free method; Cosmetics; NAM; NGRA; New approach methodology; Next generation risk assessment; Replacement method; SCCS; Safety assessment; Safety evaluation; Scientific Committee on Consumer Safety
Substance Nomenclature: 0 (Cosmetics)
Entry Date(s): Date Created: 20260107 Date Completed: 20260625 Latest Revision: 20260625
Update Code: 20260626
PubMed Central ID: PMC13043536
DOI: 10.1007/s00204-025-04275-x
PMID: 41501514
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1432-0738
DOI:10.1007/s00204-025-04275-x