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

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Title: Opinion on the impact of non‐monotonic dose responses on EFSA's human health risk assessments
Authors: European Food Safety Authority (EFSA), Scientific CommitteeMore, Simon JohnBenford, DianeHougaard Bennekou, Susanneet al.
Permanent link: http://hdl.handle.net/10197/13101
Date: Oct-2021
Online since: 2022-08-29T14:38:16Z
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.
Type of material: Journal Article
Publisher: Wiley
Journal: EFSA Journal
Volume: 19
Issue: 10
Copyright (published version): 2021 European Food Safety Authority
Keywords: Non-monotonic dose response (NMDR)Statistical analysisProbabilistic analysisBiological relevanceBiological relevanceReference doseHuman health risk assessment
DOI: 10.2903/j.efsa.2021.6877
Language: en
Status of Item: Peer reviewed
ISSN: 1831-4732
This item is made available under a Creative Commons License: https://creativecommons.org/licenses/by-nc-nd/3.0/ie/
Appears in Collections:Veterinary Medicine Research Collection
CVERA Research Collection

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