Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments
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 ...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
EFSA Scientific Committee [verfasserIn] Simon More [verfasserIn] Diane Benford [verfasserIn] Susanne Hougaard Bennekou [verfasserIn] Vasileios Bampidis [verfasserIn] Claude Bragard [verfasserIn] Thorhallur Halldorsson [verfasserIn] Antonio Hernandez‐Jerez [verfasserIn] Kostas Koutsoumanis [verfasserIn] Claude Lambré [verfasserIn] Kyriaki Machera [verfasserIn] Ewen Mullins [verfasserIn] Søren Saxmose Nielsen [verfasserIn] Josef Schlatter [verfasserIn] Dieter Schrenk [verfasserIn] Dominique Turck [verfasserIn] Jose Tarazona [verfasserIn] Maged Younes [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2021 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 19(2021), 10, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:19 ; year:2021 ; number:10 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2021.6877 |
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| Katalog-ID: |
DOAJ071522433 |
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| 520 | |a 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. | ||
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10.2903/j.efsa.2021.6877 doi (DE-627)DOAJ071522433 (DE-599)DOAJ71f15f72c9644c07a79127ec9b5b2233 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Scientific Committee verfasserin aut Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply Chemical technology Simon More verfasserin aut Diane Benford verfasserin aut Susanne Hougaard Bennekou verfasserin aut Vasileios Bampidis verfasserin aut Claude Bragard verfasserin aut Thorhallur Halldorsson verfasserin aut Antonio Hernandez‐Jerez verfasserin aut Kostas Koutsoumanis verfasserin aut Claude Lambré verfasserin aut Kyriaki Machera verfasserin aut Ewen Mullins verfasserin aut Søren Saxmose Nielsen verfasserin aut Josef Schlatter verfasserin aut Dieter Schrenk verfasserin aut Dominique Turck verfasserin aut Jose Tarazona verfasserin aut Maged Younes verfasserin aut In EFSA Journal Wiley, 2018 19(2021), 10, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:19 year:2021 number:10 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 kostenfrei https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2021 10 n/a-n/a |
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10.2903/j.efsa.2021.6877 doi (DE-627)DOAJ071522433 (DE-599)DOAJ71f15f72c9644c07a79127ec9b5b2233 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Scientific Committee verfasserin aut Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply Chemical technology Simon More verfasserin aut Diane Benford verfasserin aut Susanne Hougaard Bennekou verfasserin aut Vasileios Bampidis verfasserin aut Claude Bragard verfasserin aut Thorhallur Halldorsson verfasserin aut Antonio Hernandez‐Jerez verfasserin aut Kostas Koutsoumanis verfasserin aut Claude Lambré verfasserin aut Kyriaki Machera verfasserin aut Ewen Mullins verfasserin aut Søren Saxmose Nielsen verfasserin aut Josef Schlatter verfasserin aut Dieter Schrenk verfasserin aut Dominique Turck verfasserin aut Jose Tarazona verfasserin aut Maged Younes verfasserin aut In EFSA Journal Wiley, 2018 19(2021), 10, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:19 year:2021 number:10 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 kostenfrei https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2021 10 n/a-n/a |
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10.2903/j.efsa.2021.6877 doi (DE-627)DOAJ071522433 (DE-599)DOAJ71f15f72c9644c07a79127ec9b5b2233 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Scientific Committee verfasserin aut Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply Chemical technology Simon More verfasserin aut Diane Benford verfasserin aut Susanne Hougaard Bennekou verfasserin aut Vasileios Bampidis verfasserin aut Claude Bragard verfasserin aut Thorhallur Halldorsson verfasserin aut Antonio Hernandez‐Jerez verfasserin aut Kostas Koutsoumanis verfasserin aut Claude Lambré verfasserin aut Kyriaki Machera verfasserin aut Ewen Mullins verfasserin aut Søren Saxmose Nielsen verfasserin aut Josef Schlatter verfasserin aut Dieter Schrenk verfasserin aut Dominique Turck verfasserin aut Jose Tarazona verfasserin aut Maged Younes verfasserin aut In EFSA Journal Wiley, 2018 19(2021), 10, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:19 year:2021 number:10 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 kostenfrei https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2021 10 n/a-n/a |
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10.2903/j.efsa.2021.6877 doi (DE-627)DOAJ071522433 (DE-599)DOAJ71f15f72c9644c07a79127ec9b5b2233 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Scientific Committee verfasserin aut Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply Chemical technology Simon More verfasserin aut Diane Benford verfasserin aut Susanne Hougaard Bennekou verfasserin aut Vasileios Bampidis verfasserin aut Claude Bragard verfasserin aut Thorhallur Halldorsson verfasserin aut Antonio Hernandez‐Jerez verfasserin aut Kostas Koutsoumanis verfasserin aut Claude Lambré verfasserin aut Kyriaki Machera verfasserin aut Ewen Mullins verfasserin aut Søren Saxmose Nielsen verfasserin aut Josef Schlatter verfasserin aut Dieter Schrenk verfasserin aut Dominique Turck verfasserin aut Jose Tarazona verfasserin aut Maged Younes verfasserin aut In EFSA Journal Wiley, 2018 19(2021), 10, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:19 year:2021 number:10 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 kostenfrei https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2021 10 n/a-n/a |
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10.2903/j.efsa.2021.6877 doi (DE-627)DOAJ071522433 (DE-599)DOAJ71f15f72c9644c07a79127ec9b5b2233 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Scientific Committee verfasserin aut Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. non‐monotonic dose response (NMDR) statistical analysis probabilistic analysis biological relevance reference dose human health risk assessment Nutrition. Foods and food supply Chemical technology Simon More verfasserin aut Diane Benford verfasserin aut Susanne Hougaard Bennekou verfasserin aut Vasileios Bampidis verfasserin aut Claude Bragard verfasserin aut Thorhallur Halldorsson verfasserin aut Antonio Hernandez‐Jerez verfasserin aut Kostas Koutsoumanis verfasserin aut Claude Lambré verfasserin aut Kyriaki Machera verfasserin aut Ewen Mullins verfasserin aut Søren Saxmose Nielsen verfasserin aut Josef Schlatter verfasserin aut Dieter Schrenk verfasserin aut Dominique Turck verfasserin aut Jose Tarazona verfasserin aut Maged Younes verfasserin aut In EFSA Journal Wiley, 2018 19(2021), 10, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:19 year:2021 number:10 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 kostenfrei https://doi.org/10.2903/j.efsa.2021.6877 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2021 10 n/a-n/a |
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EFSA Scientific Committee @@aut@@ Simon More @@aut@@ Diane Benford @@aut@@ Susanne Hougaard Bennekou @@aut@@ Vasileios Bampidis @@aut@@ Claude Bragard @@aut@@ Thorhallur Halldorsson @@aut@@ Antonio Hernandez‐Jerez @@aut@@ Kostas Koutsoumanis @@aut@@ Claude Lambré @@aut@@ Kyriaki Machera @@aut@@ Ewen Mullins @@aut@@ Søren Saxmose Nielsen @@aut@@ Josef Schlatter @@aut@@ Dieter Schrenk @@aut@@ Dominique Turck @@aut@@ Jose Tarazona @@aut@@ Maged Younes @@aut@@ |
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Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments |
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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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
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Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments |
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https://doi.org/10.2903/j.efsa.2021.6877 https://doaj.org/article/71f15f72c9644c07a79127ec9b5b2233 https://doaj.org/toc/1831-4732 |
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Simon More Diane Benford Susanne Hougaard Bennekou Vasileios Bampidis Claude Bragard Thorhallur Halldorsson Antonio Hernandez‐Jerez Kostas Koutsoumanis Claude Lambré Kyriaki Machera Ewen Mullins Søren Saxmose Nielsen Josef Schlatter Dieter Schrenk Dominique Turck Jose Tarazona Maged Younes |
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