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Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies

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,...

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Autores principales: Pistollato, Francesca, Madia, Federica, Corvi, Raffaella, Munn, Sharon, Grignard, Elise, Paini, Alicia, Worth, Andrew, Bal-Price, Anna, Prieto, Pilar, Casati, Silvia, Berggren, Elisabet, Bopp, Stephanie K, Zuang, Valérie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166712/
https://www.ncbi.nlm.nih.gov/pubmed/33851225
http://dx.doi.org/10.1007/s00204-021-03034-y
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author Pistollato, Francesca
Madia, Federica
Corvi, Raffaella
Munn, Sharon
Grignard, Elise
Paini, Alicia
Worth, Andrew
Bal-Price, Anna
Prieto, Pilar
Casati, Silvia
Berggren, Elisabet
Bopp, Stephanie K
Zuang, Valérie
author_facet Pistollato, Francesca
Madia, Federica
Corvi, Raffaella
Munn, Sharon
Grignard, Elise
Paini, Alicia
Worth, Andrew
Bal-Price, Anna
Prieto, Pilar
Casati, Silvia
Berggren, Elisabet
Bopp, Stephanie K
Zuang, Valérie
author_sort Pistollato, Francesca
collection PubMed
description 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.
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spelling pubmed-81667122021-06-03 Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies Pistollato, Francesca Madia, Federica Corvi, Raffaella Munn, Sharon Grignard, Elise Paini, Alicia Worth, Andrew Bal-Price, Anna Prieto, Pilar Casati, Silvia Berggren, Elisabet Bopp, Stephanie K Zuang, Valérie Arch Toxicol Review Article 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. Springer Berlin Heidelberg 2021-04-13 2021 /pmc/articles/PMC8166712/ /pubmed/33851225 http://dx.doi.org/10.1007/s00204-021-03034-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Review Article
Pistollato, Francesca
Madia, Federica
Corvi, Raffaella
Munn, Sharon
Grignard, Elise
Paini, Alicia
Worth, Andrew
Bal-Price, Anna
Prieto, Pilar
Casati, Silvia
Berggren, Elisabet
Bopp, Stephanie K
Zuang, Valérie
Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title_full Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title_fullStr Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title_full_unstemmed Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title_short Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
title_sort current eu regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8166712/
https://www.ncbi.nlm.nih.gov/pubmed/33851225
http://dx.doi.org/10.1007/s00204-021-03034-y
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