Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
| Autor: | Valérie Zuang, Alicia Paini, Stephanie K. Bopp, Pilar Prieto, Elisabet Berggren, Silvia Casati, Andrew Worth, Sharon Munn, Elise Grignard, Anna Bal-Price, Federica Madia, Francesca Pistollato, Raffaella Corvi |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
European level International Cooperation Health Toxicology and Mutagenesis Pharmacology toxicology Alternatives to animal testing Cosmetics Review Article 010501 environmental sciences Animal Testing Alternatives Toxicology Risk Assessment Cosmetic products 01 natural sciences 3Rs 03 medical and health sciences Human health Toxicity Tests Animals Humans EU regulatory requirements European Union Animal testing 0105 earth and related environmental sciences Cosmetic products regulation Alternative methods Industrial chemicals General Medicine Directive 030104 developmental biology Risk analysis (engineering) REACH Cosmetic ingredients Business |
| Zdroj: | Archives of Toxicology |
| ISSN: | 1432-0738 0340-5761 |
| DOI: | 10.1007/s00204-021-03034-y |
| Popis: | The EU Directive 2010/63/EU on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is conducted. Whilst the Cosmetic Products Regulation bans animal testing altogether, REACH aims for a progressive shift from in vivo testing towards quantitative in vitro and computational approaches. Several endpoints can already be addressed using non-animal approaches including skin corrosion and irritation, serious eye damage and irritation, skin sensitisation, and mutagenicity and genotoxicity. However, for systemic effects such as acute toxicity, repeated dose toxicity and reproductive and developmental toxicity, evaluation of chemicals under REACH still heavily relies on animal tests. Here we summarise current EU regulatory requirements for the human health assessment of chemicals under REACH and the Cosmetic Products Regulation, considering the more critical endpoints and identifying the main challenges in introducing alternative methods into regulatory testing practice. This supports a recent initiative taken by the International Cooperation on Alternative Test Methods (ICATM) to summarise current regulatory requirements specific for the assessment of chemicals and cosmetic products for several human health-related endpoints, with the aim of comparing different jurisdictions and coordinating the promotion and ultimately the implementation of non-animal approaches worldwide. Recent initiatives undertaken at European level to promote the 3Rs and the use of alternative methods in current regulatory practice are also discussed. |
| Databáze: | OpenAIRE |
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