Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments

Abstract This Opinion assesses the biological relevance of the non‐monotonic dose responses (NMDR) identified in a previous EFSA External Report (Beausoleil et al., 2016) produced under GP/EFSA/SCER/2014/01 and the follow‐up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on the in ...

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Autores principales:	EFSA Scientific Committee, Simon More, Diane Benford, Susanne Hougaard Bennekou, Vasileios Bampidis, Claude Bragard, Thorhallur Halldorsson, Antonio Hernandez‐Jerez, Kostas Koutsoumanis, Claude Lambré, Kyriaki Machera, Ewen Mullins, Søren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Jose Tarazona, Maged Younes
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233
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spelling	oai:doaj.org-article:71f15f72c9644c07a79127ec9b5b22332021-11-23T08:30:50ZOpinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments1831-473210.2903/j.efsa.2021.6877https://doaj.org/article/71f15f72c9644c07a79127ec9b5b22332021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6877https://doaj.org/toc/1831-4732Abstract This Opinion assesses the biological relevance of the non‐monotonic dose responses (NMDR) identified in a previous EFSA External Report (Beausoleil et al., 2016) produced under GP/EFSA/SCER/2014/01 and the follow‐up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on the in vivo data sets fulfilling most of the checkpoints of the visual/statistical‐based analysis identified in Beausoleil et al. (2016). The evaluation was completed with cases discussed in EFSA assessments and the update of the scientific literature. Observations of NMDR were confirmed in certain studies and are particularly relevant for receptor‐mediated effects. Based on the results of the evaluation, the Opinion proposes an approach to be applied during the risk assessment process when apparent non‐monotonicity is observed, also providing advice on specific elements to be considered to facilitate the assessment of NMDR in EFSA risk assessments. The proposed approach was applied to two case studies, Bisphenol A and bis(2‐ethylhexyl phthalate (DEHP) and these evaluations are reported in dedicated annexes. Considering the potential impact of NMDRs in regulatory risk assessment, the Scientific Committee recommends a concerted international effort on developing internationally agreed guidance and harmonised frameworks for identifying and addressing NMDRs in the risk assessment process.EFSA Scientific CommitteeSimon MoreDiane BenfordSusanne Hougaard BennekouVasileios BampidisClaude BragardThorhallur HalldorssonAntonio Hernandez‐JerezKostas KoutsoumanisClaude LambréKyriaki MacheraEwen MullinsSøren Saxmose NielsenJosef SchlatterDieter SchrenkDominique TurckJose TarazonaMaged YounesWileyarticlenon‐monotonic dose response (NMDR)statistical analysisprobabilistic analysisbiological relevancereference dosehuman health risk assessmentNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185
spellingShingle	non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply TX341-641 Chemical technology TP1-1185 EFSA Scientific Committee Simon More Diane Benford Susanne Hougaard Bennekou Vasileios Bampidis Claude Bragard Thorhallur Halldorsson Antonio Hernandez‐Jerez Kostas Koutsoumanis Claude Lambré Kyriaki Machera Ewen Mullins Søren Saxmose Nielsen Josef Schlatter Dieter Schrenk Dominique Turck Jose Tarazona Maged Younes Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
description	Abstract This Opinion assesses the biological relevance of the non‐monotonic dose responses (NMDR) identified in a previous EFSA External Report (Beausoleil et al., 2016) produced under GP/EFSA/SCER/2014/01 and the follow‐up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on the in vivo data sets fulfilling most of the checkpoints of the visual/statistical‐based analysis identified in Beausoleil et al. (2016). The evaluation was completed with cases discussed in EFSA assessments and the update of the scientific literature. Observations of NMDR were confirmed in certain studies and are particularly relevant for receptor‐mediated effects. Based on the results of the evaluation, the Opinion proposes an approach to be applied during the risk assessment process when apparent non‐monotonicity is observed, also providing advice on specific elements to be considered to facilitate the assessment of NMDR in EFSA risk assessments. The proposed approach was applied to two case studies, Bisphenol A and bis(2‐ethylhexyl phthalate (DEHP) and these evaluations are reported in dedicated annexes. Considering the potential impact of NMDRs in regulatory risk assessment, the Scientific Committee recommends a concerted international effort on developing internationally agreed guidance and harmonised frameworks for identifying and addressing NMDRs in the risk assessment process.
format	article
author	EFSA Scientific Committee Simon More Diane Benford Susanne Hougaard Bennekou Vasileios Bampidis Claude Bragard Thorhallur Halldorsson Antonio Hernandez‐Jerez Kostas Koutsoumanis Claude Lambré Kyriaki Machera Ewen Mullins Søren Saxmose Nielsen Josef Schlatter Dieter Schrenk Dominique Turck Jose Tarazona Maged Younes
author_facet	EFSA Scientific Committee Simon More Diane Benford Susanne Hougaard Bennekou Vasileios Bampidis Claude Bragard Thorhallur Halldorsson Antonio Hernandez‐Jerez Kostas Koutsoumanis Claude Lambré Kyriaki Machera Ewen Mullins Søren Saxmose Nielsen Josef Schlatter Dieter Schrenk Dominique Turck Jose Tarazona Maged Younes
author_sort	EFSA Scientific Committee
title	Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
title_short	Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
title_full	Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
title_fullStr	Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
title_full_unstemmed	Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
title_sort	opinion on the impact of non‐monotonic dose responses on efsa′s human health risk assessments
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233
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Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments

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