The way forward for assessing the human health safety of cosmetics in the EU - Workshop proceedings. (30th April 2020)

• Record Type: Journal Article
• Authors: Rogiers, Vera; Benfenati, Emilio; Bernauer, Ulrike; Bodin, Laurent; Carmichael, Paul; Chaudhry, Qasim; Coenraads, Pieter Jan; Cronin, Mark T.D.; Dent, Matthew; Dusinska, Maria; Ellison, Corie; Ezendam, Janine; Gaffet, Eric; Galli, Corrado Lodovico; Goebel, Carsten; Granum, Berit; Hollnagel, Heli Miriam; Kern, Petra S.; Kosemund-Meynen, Kirstin; Ouédraogo, Gladys; Panteri, Eirini; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; von Goetz, Natalie; Worth, Andrew
• Is Part Of: Toxicology. Volume 436(2020)
• Publication Date: 2020-04-30
• Subjects: ADME Absorption, Metabolism, Distribution and Excretion -- ANSA Agencies Network on Scientific Advice -- AOP Adverse Outcome Pathway -- AR Androgen Receptor -- AUC Area Under the Curve -- CC Cramer Class -- Cmax Maximal blood Concentration -- CMR Carcinogen, Mutagen, Reproductive toxic -- Css Blood concentration at steady-state -- DB Data Base -- EAR Exposure: Activity Ratio -- ER Estrogenic Receptor -- ECHA European Chemicals Agency -- EFSA European Food Safety Authority -- EMA European Medicines Agency -- EPA Environmental Protection Agency -- GI Gastro-Intestinal -- HBA Hydroxy Benzoic Acid -- hERG human Ether-à-go-go Related Gene -- IATA Integrated Approaches to Testing and Assessment -- IC Inhibitory Concentration -- ICCR International Cooperation on Cosmetics Regulation -- IRIS Integrated Risk Information System -- IVIVE Vitro to in vivo Extrapolation -- JRC Joint Research Centre -- LOAEL Lowest Observed Adverse Effect Level -- LRSS Long Range Science Strategy -- MIE Molecular Initiating Event -- MoA Mode of Action -- MoS Margin of Safety -- MOIE Margin Of Internal Exposure -- NAM New Approach Methodology -- NGRA Next Generation Risk Assessment -- NOAEL No Observed Adverse Effect Level -- NOEL No Observed Effect Level -- NOTEL No Observed Transcriptional Effect Level -- OECD Organisation for Economic Cooperation and Development -- PBK Physiologically Based Kinetics -- PBT Persistent, Bioaccumulative, Toxic -- PBPK Physiologically Based Pharmaco Kinetics -- PBTK Physiologically Based Toxico Kinetics -- PCA Principal Component Analysis -- PK Pharmacokinetic -- POD Point Of Departure -- PTD Para Toluene Diamine -- PPD Para Phenylene Diamine -- (Q)SAR (Quantitative) Structure-Activity Relationship -- RIFM Research Institute of Fragrance Materials -- 3Rs Replacement, Reduction, Refinement (Principle of Russell and Burch) -- SAR Structure Activity Relationship -- SCCS Scientific Committee on Consumer Safety -- SED Systemic Exposure Dose -- SCHEER Scientific Committee on Health, Environmental and Emerging Risks -- THR Thyroid Hormone Receptor -- (i)TTC (internal) Threshold of Toxicological Concern -- UBA German Environmental Agency -- US EPA US Environmental Protection Agency -- WHO World Health Organization -- WoE Weight of Evidence; Cosmetics -- New approach methodology -- Animal-Free method -- Replacement method -- Alternative method -- Next generation risk assessment -- Safety assessment; Toxicology -- Periodicals; Chemicals -- Physiological effect -- Periodicals; 615.9005
• DOI: 10.1016/j.tox.2020.152421
• Languages: English
• ISSNs: 0300-483X

Abstract

Highlights: In the EU only animal-free methods may be used for safety assessment of cosmetics. Next Generation Risk Assessment (NGRA) offers a suitable framework for safety assessment. NGRA makes use of animal-free New Approach Methodologies (NAMs). NAMs consist of in chemico, in silico, in vitro and ex vivo methods. Abstract: Although the need for non-animal alternatives has been well recognised for the human health hazard assessment of chemicals in general, it has become especially pressing for cosmetic ingredients due to the full implementation of testing and marketing bans on animal testing under the European Cosmetics Regulation. This means that for the safety assessment of cosmetics, the necessary safety data for both the ingredients and the finished product can be drawn from validated (or scientifically-valid), so-called "Replacement methods". In view of the challenges for safety assessment without recourse to animal test data, the Methodology Working Group of the Scientific Committee on Consumer Safety organised a workshop in February 2019 to discuss the key issues in regard to the use of animal-free alternative methods for the safety evaluation of cosmetic ingredients. This perspective article summarises the outcomes of this workshop and reflects on the state-of-the-art and possible way forward for the safety assessment of cosmetic ingredients for which no experimental animal data exist. The use and optimisation of "New Approach Methodology" that could be useful tools in the context of the "Next Generation Risk Assessment" and the strategic framework for safety assessment of cosmetics were discussed in depth.