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    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

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    Authors
    Knight, Derek J.
    Deluyker, Hubert; orcid: 0000-0002-3490-8661
    Chaudhry, Qasim
    Vidal, Jean-Marc; orcid: 0000-0002-4422-5880
    de Boer, Alie
    
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    Abstract
    Safety 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.
    Citation
    Knight, 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.
    Publisher
    Elsevier
    URI
    http://hdl.handle.net/10034/624021
    DOI
    10.1016/j.yrtph.2020.104837
    Type
    article
    Description
    From Elsevier via Jisc Publications Router
    History: accepted 2020-11-24, issue date 2020-11-26
    Article version: AM
    Publication status: Accepted
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.yrtph.2020.104837
    Scopus Count
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    Clinical Sciences and Nutrition

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