Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment

EFSA Supporting PublicationsVolume 19, Issue 6 7341E External scientific reportOpen Access Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment Sylvia E. Escher, Corresponding Author Sylvia E. Escher [email protected] Fraunhofer ITEM Correspondence:[email protected]Search for more papers by this authorFalko Partosch, Falko Partosch Fraunhofer ITEMSearch for more papers by this authorSebastian Konzok, Sebastian Konzok Fraunhofer ITEMSearch for more papers by this authorPaul Jennings, Paul Jennings Vrije Universiteit AmsterdamSearch for more papers by this authorMirjam Luijten, Mirjam Luijten National Institute for Public Health and the EnvironmentSearch for more papers by this authorAnne Kienhuis, Anne Kienhuis National Institute for Public Health and the EnvironmentSearch for more papers by this authorVictoria de Leeuw, Victoria de Leeuw National Institute for Public Health and the EnvironmentSearch for more papers by this authorRosmarie Reuss, Rosmarie Reuss Eura AGSearch for more papers by this authorKatrina-Magdalena Lindemann, Katrina-Magdalena Lindemann Eura AGSearch for more papers by this authorSusanne Hougaard Bennekou, Susanne Hougaard Bennekou The National Food Institute DenmarkSearch for more papers by this author Sylvia E. Escher, Corresponding Author Sylvia E. Escher [email protected] Fraunhofer ITEM Correspondence:[email protected]Search for more papers by this authorFalko Partosch, Falko Partosch Fraunhofer ITEMSearch for more papers by this authorSebastian Konzok, Sebastian Konzok Fraunhofer ITEMSearch for more papers by this authorPaul Jennings, Paul Jennings Vrije Universiteit AmsterdamSearch for more papers by this authorMirjam Luijten, Mirjam Luijten National Institute for Public Health and the EnvironmentSearch for more papers by this authorAnne Kienhuis, Anne Kienhuis National Institute for Public Health and the EnvironmentSearch for more papers by this authorVictoria de Leeuw, Victoria de Leeuw National Institute for Public Health and the EnvironmentSearch for more papers by this authorRosmarie Reuss, Rosmarie Reuss Eura AGSearch for more papers by this authorKatrina-Magdalena Lindemann, Katrina-Magdalena Lindemann Eura AGSearch for more papers by this authorSusanne Hougaard Bennekou, Susanne Hougaard Bennekou The National Food Institute DenmarkSearch for more papers by this author First published: 03 June 2022 https://doi.org/10.2903/sp.efsa.2022.EN-7341Citations: 2 Question number: EFSA-Q-2022-00231 Disclaimer: The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. Amendment: This version was revised by adding information on the Terms of Reference of the contract, as requested by the EFSA template for external scientific reports (page 5). This editorial correction does not materially affect the contents or outcome of this scientific output. To avoid confusion, the original version of the output has been removed from the EFSA Journal but is available on request. Appendices A, B, C and D are available under the Supporting Information section. Appendix E (NAMs roadmap slide show) is available on the YouTube EFSAchannel;https://youtu.be/BxSZrdrVxyY. AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract While whole animal studies have their place in risk assessment of food and feed components, it is thought that more modern approaches such as human focused new approached methodologies (NAMs) would bring advantages including a greater focus to the human species, a focus on molecular mechanism and kinetics and the possibility of addressing susceptible populations. This report outlines the thinking from the authors and culminates in activity proposals in seven distinct but interacting scientific areas i.e. development of additional AOPs/AOP networks (AOPs), advanced cell culture models including Organ on a chip (OoC), toxicokinetic assessment with a focus on physiological based kinetic modelling (PBK), exposome, human susceptibility, data integration and new concepts in human risk assessment. Furthermore, the development of a Forum is proposed to facilitate the implementation of new approaches and concepts in risk assessment. The report was compiled by the project team, renowned experts in the various areas, and recommendations were discussed with EFSA and further refined following consultation with external experts via a dedicated workshop. The authors are convinced that if the recommendations are taken up, there will be a significant impact in the field, resulting in increasing the uptake and utilisation of these emerging technologies by all stakeholders involved. References Abdelsalam NA, Ramadan AT, et al. 2020. Toxicomicrobiomics: The Human Microbiome vs. Pharmaceutical, Dietary, and Environmental Xenobiotics. Front Pharmacol, 11, 390. https://doi.org/10.3389/fphar.2020.00390. Adami Hans-Olov, Berry Sir Colin L, Breckenridge Charles B, Smith Lewis L, Swenberg James A, Trichopoulos Dimitrios, Weiss Noel S and Pastoor Timothy P 2011. 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