
Opinion on the impact of non‐monotonic dose responses on EFSA ′s human health risk assessments
Author(s) -
More Simon,
Benford Diane,
Hougaard Bennekou Susanne,
Bampidis Vasileios,
Bragard Claude,
Halldorsson Thorhallur,
HernandezJerez Antonio,
Koutsoumanis Kostas,
Lambré Claude,
Machera Kyriaki,
Mullins Ewen,
Nielsen Søren Saxmose,
Schlatter Josef,
Schrenk Dieter,
Turck Dominique,
Tarazona Jose,
Younes Maged
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6877
Subject(s) - library science , environmental health , political science , medicine , computer science
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 NMDR s in regulatory risk assessment, the Scientific Committee recommends a concerted international effort on developing internationally agreed guidance and harmonised frameworks for identifying and addressing NMDR s in the risk assessment process.