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

DC FieldValueLanguage
dc.contributor.authorEuropean Food Safety Authority (EFSA), Scientific Committee-
dc.contributor.authorMore, Simon John-
dc.contributor.authorBenford, Diane-
dc.contributor.authorHougaard Bennekou, Susanne-
dc.contributor.authoret al.-
dc.date.accessioned2022-08-29T14:38:16Z-
dc.date.available2022-08-29T14:38:16Z-
dc.date.copyright2021 European Food Safety Authorityen_US
dc.date.issued2021-10-
dc.identifier.citationEFSA Journalen_US
dc.identifier.issn1831-4732-
dc.identifier.urihttp://hdl.handle.net/10197/13101-
dc.description.abstractThis 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.en_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.rightsThis is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.en_US
dc.subjectNon-monotonic dose response (NMDR)en_US
dc.subjectStatistical analysisen_US
dc.subjectProbabilistic analysisen_US
dc.subjectBiological relevanceen_US
dc.subjectBiological relevanceen_US
dc.subjectReference doseen_US
dc.subjectHuman health risk assessmenten_US
dc.titleOpinion on the impact of non‐monotonic dose responses on EFSA's human health risk assessmentsen_US
dc.typeJournal Articleen_US
dc.internal.authorcontactothersimon.more@ucd.ieen_US
dc.statusPeer revieweden_US
dc.identifier.volume19en_US
dc.identifier.issue10en_US
dc.citation.otherArticle Number: e06877en_US
dc.identifier.doi10.2903/j.efsa.2021.6877-
dc.neeo.contributorEuropean Food Safety Authority (EFSA)|Scientific Committee|aut|-
dc.neeo.contributorMore|Simon John|aut|-
dc.neeo.contributorBenford|Diane|aut|-
dc.neeo.contributorHougaard Bennekou|Susanne|aut|-
dc.neeo.contributoret al.||aut|-
dc.date.updated2021-10-21T14:25:04Z-
dc.rights.licensehttps://creativecommons.org/licenses/by-nc-nd/3.0/ie/en_US
item.fulltextWith Fulltext-
item.grantfulltextopen-
Appears in Collections:Veterinary Medicine Research Collection
CVERA Research Collection
Files in This Item:
 File SizeFormat
Downloadj.efsa.2021.6877.pdf6.57 MBAdobe PDF
Show simple item record

Page view(s)

194
Last Week
1
Last month
9
checked on Dec 5, 2022

Download(s)

18
checked on Dec 5, 2022

Google ScholarTM

Check

Altmetric


If you are a publisher or author and have copyright concerns for any item, please email research.repository@ucd.ie and the item will be withdrawn immediately. The author or person responsible for depositing the article will be contacted within one business day.