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

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Author(s)
European Food Safety Authority (EFSA), Scientific Committee 
More, Simon John 
Benford, Diane 
Hougaard Bennekou, Susanne 
et al. 
Uri
http://hdl.handle.net/10197/13101
Date Issued
October 2021
Date Available
29T14:38:16Z August 2022
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 re...

  • Statistical analysis

  • Probabilistic analysi...

  • Biological relevance

  • Biological relevance

  • Reference dose

  • Human health risk ass...

DOI
10.2903/j.efsa.2021.6877
Language
English
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/
Owning collection
Veterinary Medicine Research Collection
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6
Acquisition Date
Jan 28, 2023
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