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dc.contributor.authorKnight, Derek J.
dc.contributor.authorDeluyker, Hubert; orcid: 0000-0002-3490-8661
dc.contributor.authorChaudhry, Qasim
dc.contributor.authorVidal, Jean-Marc; orcid: 0000-0002-4422-5880
dc.contributor.authorde Boer, Alie
dc.date.accessioned2020-11-29T01:34:07Z
dc.date.available2020-11-29T01:34:07Z
dc.identifier.citationKnight, D. J., Deluyker, H., Chaudhry, Q., Vidal, J. M., & de Boer, A. (2021). A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU–A short communication. Regulatory Toxicology and Pharmacology, 119, 104837.
dc.identifier.doi10.1016/j.yrtph.2020.104837
dc.identifier.urihttp://hdl.handle.net/10034/624021
dc.descriptionFrom Elsevier via Jisc Publications Router
dc.descriptionHistory: accepted 2020-11-24, issue date 2020-11-26
dc.descriptionArticle version: AM
dc.descriptionPublication status: Accepted
dc.description.abstractSafety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a long-standing ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources. This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.
dc.publisherElsevier
dc.rightsLicence for AM version of this article starting on 2020-11-25: http://creativecommons.org/licenses/by/4.0/
dc.sourceissn: 02732300
dc.titleA call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication
dc.typearticle
dc.date.updated2020-11-29T01:34:07Z
dc.date.accepted2020-11-24


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