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

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


Title: Opinion on the impact of non-monotonic dose responses on EFSA′s human health risk assessments
Author: EFSA Scientific Committee
Date: 2021-10
Language: English
Scope:
Department: Faculty of Food Science and Nutrition
Series: EFSA Journal; 19(10)
ISSN: 1831-4732
DOI: https://doi.org/10.2903/j.efsa.2021.6877
Subject: Áhættugreining; Tölfræði; Örverufræði; Matvælafræði; NMDR; NMDR; biological relevance; human health risk assessment; non-monotonic dose response (NMDR); probabilistic analysis; reference dose; statistical analysis; Parasitology; Food Science; Microbiology; Animal Science and Zoology; Veterinary (miscellaneous); Plant Science
URI: https://hdl.handle.net/20.500.11815/2818

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Citation:

EFSA Scientific Committee 2021 , ' Opinion on the impact of non-monotonic dose responses on EFSA′s human health risk assessments ' , EFSA Journal , vol. 19 , no. 10 , e06877 . https://doi.org/10.2903/j.efsa.2021.6877

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.

Description:

Funding text The Scientific Committee wishes to thank the following for the support provided to this scientific output: the hearing experts Laurent Bodin and Richard Sharp; the EFSA Staff Maria Chiara Astuto, Bernard Bottex, Anna Castoldi, Irene Cattaneo, Arianna Chiusolo, Andrea Terron, and Katharina Volk for the support provided to this scientific output. Publisher Copyright: © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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