Update of the risk assessment of brominated phenols and their derivatives in food
Abstract
The European Commission asked EFSA to update its 2012 risk assessment on brominated phenols and their derivatives in food, focusing on five bromophenols and one derivative: 2,4,6‐tribromophenol (2,4,6‐TBP), 2,4‐dibromophenol (2,4‐DBP), 4‐bromophenol (4‐BP), 2,6‐dibromophenol (2,6‐DBP), tetrabrominated bisphenol S (TBBPS), tetrabromobisphenol S bismethyl ether (TBBPS‐BME). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of 2,4,6‐TBP to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6‐tribromophenol (2,4,6‐TBP) in studies in rats. A BMDL10 of 353 mg/kg body weight (bw) per day for kidney papillary necrosis in male rats was identified and was selected as the reference point for the risk characterisation. The derivation of a health‐based guidance value was not considered appropriate due to major limitations in the toxicological database. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Around 78,200 analytical results for 2,4,6‐TBP in food were used to estimate dietary exposure for the European population. Considering the resulting MOE values, all far above an MOE of 6000 that does not raise a health concern, and accounting for the uncertainties affecting the exposure and hazard assessments, the CONTAM Panel concluded with at least 95% probability that the current dietary exposure to 2,4,6‐TBP does not raise a health concern. Due to lack of occurrence data, no risk assessment could be performed for breastfed or formula‐fed infants. No risk characterisation could be performed for any of the other brominated phenols and derivatives included in the assessment, due to lack of data both on the toxicity and occurrence.
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BibTeX
@article{knutsen2026update,
title = {{Update of the risk assessment of brominated phenols and their derivatives in food}},
author = {Helle Katrine Knutsen and Agneta Åkesson and Vasileios Bampidis and Margherita Bignami and Laurent Bodin and James Kevin Chipman and Gisela Degen and Antonio Hernández-Jerez and Tim Hofer and Stefano Landi and Jean‐charles Leblanc and Kyriaki Machera and Evangelia Ntzani and Guido Rychen and Salomon Sand and Tanja Schwerdtle and Katharina Vejdovszky and Barbara Viviani and Diane Benford and Andy Hart and Martin Rose and Henri Schroeder and Christiane Vleminckx and Martine Vrijheid and Eleni Gkimprixi and Eirini Kouloura and Francesca Riolo and Luisa Ramos Bordajandi and Christer Hogstrand},
journal = {EFSA Journal},
year = {2026},
month = oct,
doi = {10.2903/j.efsa.2024.9034},
url = {https://hal.univ-lorraine.fr/hal-05839120v1},
note = {CC BY-ND},
}
RIS
TY - JOUR
TI - Update of the risk assessment of brominated phenols and their derivatives in food
AU - Helle Katrine Knutsen
AU - Agneta Åkesson
AU - Vasileios Bampidis
AU - Margherita Bignami
AU - Laurent Bodin
AU - James Kevin Chipman
AU - Gisela Degen
AU - Antonio Hernández-Jerez
AU - Tim Hofer
AU - Stefano Landi
AU - Jean‐charles Leblanc
AU - Kyriaki Machera
AU - Evangelia Ntzani
AU - Guido Rychen
AU - Salomon Sand
AU - Tanja Schwerdtle
AU - Katharina Vejdovszky
AU - Barbara Viviani
AU - Diane Benford
AU - Andy Hart
AU - Martin Rose
AU - Henri Schroeder
AU - Christiane Vleminckx
AU - Martine Vrijheid
AU - Eleni Gkimprixi
AU - Eirini Kouloura
AU - Francesca Riolo
AU - Luisa Ramos Bordajandi
AU - Christer Hogstrand
PY - 2026
DA - 2026/10/26
JO - EFSA Journal
DO - 10.2903/j.efsa.2024.9034
UR - https://hal.univ-lorraine.fr/hal-05839120v1
AB - The European Commission asked EFSA to update its 2012 risk assessment on brominated phenols and their derivatives in food, focusing on five bromophenols and one derivative: 2,4,6‐tribromophenol (2,4,6‐TBP), 2,4‐dibromophenol (2,4‐DBP), 4‐bromophenol (4‐BP), 2,6‐dibromophenol (2,6‐DBP), tetrabrominated bisphenol S (TBBPS), tetrabromobisphenol S bismethyl ether (TBBPS‐BME). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of 2,4,6‐TBP to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6‐tribromophenol (2,4,6‐TBP) in studies in rats. A BMDL10 of 353 mg/kg body weight (bw) per day for kidney papillary necrosis in male rats was identified and was selected as the reference point for the risk characterisation. The derivation of a health‐based guidance value was not considered appropriate due to major limitations in the toxicological database. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Around 78,200 analytical results for 2,4,6‐TBP in food were used to estimate dietary exposure for the European population. Considering the resulting MOE values, all far above an MOE of 6000 that does not raise a health concern, and accounting for the uncertainties affecting the exposure and hazard assessments, the CONTAM Panel concluded with at least 95% probability that the current dietary exposure to 2,4,6‐TBP does not raise a health concern. Due to lack of occurrence data, no risk assessment could be performed for breastfed or formula‐fed infants. No risk characterisation could be performed for any of the other brominated phenols and derivatives included in the assessment, due to lack of data both on the toxicity and occurrence.
SN - 1831-4732
SN - 1831-4732
ER -