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Francesca Pistollato, Federica Madia, Raffaella Corvi, Sharon Munn, Elise Grignard, Alicia Paini, Andrew Paul Worth, Anna Bal‐Price, Pilar Prieto, Silvia Casati and 3 more
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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Pistollato, F., Madia, F., Corvi, R., Munn, S., Grignard, E., Paini, A., Worth, A. P., Bal‐Price, A., Prieto, P., Casati, S., Berggren, E., Bopp, S. K., & Zuang, V. (2021). Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies. Archives of Toxicology, 95(6), 1867–1897. https://doi.org/10.1007/s00204-021-03034-y
Pistollato, Francesca, et al. "Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies." Archives of Toxicology, vol. 95, no. 6, 2021, pp. 1867–1897, https://doi.org/10.1007/s00204-021-03034-y.
Pistollato, Francesca, Federica Madia, Raffaella Corvi, Sharon Munn, Elise Grignard, Alicia Paini, Andrew Paul Worth, et al. "Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies." Archives of Toxicology 95, no. 6 (2021): 1867–1897. https://doi.org/10.1007/s00204-021-03034-y.
Pistollato F., Madia F., Corvi R. [и др.] Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies // Archives of Toxicology. — 2021. — Vol. 95, № 6. — P. 1867–1897. — URL: https://doi.org/10.1007/s00204-021-03034-y
@article{pistollato2021current,
title = {{Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies}},
author = {Francesca Pistollato and Federica Madia and Raffaella Corvi and Sharon Munn and Elise Grignard and Alicia Paini and Andrew Paul Worth and Anna Bal‐Price and Pilar Prieto and Silvia Casati and Elisabet Berggren and Stephanie K. Bopp and Valérie Zuang},
journal = {Archives of Toxicology},
year = {2021},
volume = {95},
number = {6},
pages = {1867--1897},
doi = {10.1007/s00204-021-03034-y},
url = {https://doi.org/10.1007/s00204-021-03034-y}
}TY - JOUR AU - Pistollato, Francesca AU - Madia, Federica AU - Corvi, Raffaella AU - Munn, Sharon AU - Grignard, Elise AU - Paini, Alicia AU - Worth, Andrew Paul AU - Bal‐Price, Anna AU - Prieto, Pilar AU - Casati, Silvia AU - Berggren, Elisabet AU - Bopp, Stephanie K. AU - Zuang, Valérie TI - Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies JO - Archives of Toxicology VL - 95 IS - 6 SP - 1867 EP - 1897 PY - 2021 DA - 2021/04/13 DO - 10.1007/s00204-021-03034-y UR - https://doi.org/10.1007/s00204-021-03034-y ER -
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