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), tetr...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-10-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.9034 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850248248368824320 |
|---|---|
| author | EFSA Panel on Contaminants in the Food Chain (CONTAM) Helle Katrine Knutsen Agneta Åkesson Vasileios Bampidis Margherita Bignami Laurent Bodin James Kevin Chipman Gisela Degen Antonio Hernández‐Jerez Tim Hofer Stefano Landi Jean‐Charles Leblanc Kyriaki Machera Evangelia Ntzani Guido Rychen Salomon Sand Tanja Schwerdtle Katharina Vejdovszky Barbara Viviani Diane Benford Andy Hart Martin Rose Henri Schroeder Christiane Vleminckx Martine Vrijheid Eleni Gkimprixi Eirini Kouloura Francesca Riolo Luisa Ramos Bordajandi Christer Hogstrand |
| author_facet | EFSA Panel on Contaminants in the Food Chain (CONTAM) Helle Katrine Knutsen Agneta Åkesson Vasileios Bampidis Margherita Bignami Laurent Bodin James Kevin Chipman Gisela Degen Antonio Hernández‐Jerez Tim Hofer Stefano Landi Jean‐Charles Leblanc Kyriaki Machera Evangelia Ntzani Guido Rychen Salomon Sand Tanja Schwerdtle Katharina Vejdovszky Barbara Viviani Diane Benford Andy Hart Martin Rose Henri Schroeder Christiane Vleminckx Martine Vrijheid Eleni Gkimprixi Eirini Kouloura Francesca Riolo Luisa Ramos Bordajandi Christer Hogstrand |
| author_sort | EFSA Panel on Contaminants in the Food Chain (CONTAM) |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5ee2fd2252eb48fb9a5e2c34c1bd4d96 |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-5ee2fd2252eb48fb9a5e2c34c1bd4d962025-08-20T01:58:45ZengWileyEFSA Journal1831-47322024-10-012210n/an/a10.2903/j.efsa.2024.9034Update of the risk assessment of brominated phenols and their derivatives in foodEFSA Panel on Contaminants in the Food Chain (CONTAM)Helle Katrine KnutsenAgneta ÅkessonVasileios BampidisMargherita BignamiLaurent BodinJames Kevin ChipmanGisela DegenAntonio Hernández‐JerezTim HoferStefano LandiJean‐Charles LeblancKyriaki MacheraEvangelia NtzaniGuido RychenSalomon SandTanja SchwerdtleKatharina VejdovszkyBarbara VivianiDiane BenfordAndy HartMartin RoseHenri SchroederChristiane VleminckxMartine VrijheidEleni GkimprixiEirini KoulouraFrancesca RioloLuisa Ramos BordajandiChrister HogstrandAbstract 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.https://doi.org/10.2903/j.efsa.2024.90342,4,6‐TBPbrominated phenolsfoodhuman exposureoccurrencerisk assessment |
| spellingShingle | EFSA Panel on Contaminants in the Food Chain (CONTAM) Helle Katrine Knutsen Agneta Åkesson Vasileios Bampidis Margherita Bignami Laurent Bodin James Kevin Chipman Gisela Degen Antonio Hernández‐Jerez Tim Hofer Stefano Landi Jean‐Charles Leblanc Kyriaki Machera Evangelia Ntzani Guido Rychen Salomon Sand Tanja Schwerdtle Katharina Vejdovszky Barbara Viviani Diane Benford Andy Hart Martin Rose Henri Schroeder Christiane Vleminckx Martine Vrijheid Eleni Gkimprixi Eirini Kouloura Francesca Riolo Luisa Ramos Bordajandi Christer Hogstrand Update of the risk assessment of brominated phenols and their derivatives in food EFSA Journal 2,4,6‐TBP brominated phenols food human exposure occurrence risk assessment |
| title | Update of the risk assessment of brominated phenols and their derivatives in food |
| title_full | Update of the risk assessment of brominated phenols and their derivatives in food |
| title_fullStr | Update of the risk assessment of brominated phenols and their derivatives in food |
| title_full_unstemmed | Update of the risk assessment of brominated phenols and their derivatives in food |
| title_short | Update of the risk assessment of brominated phenols and their derivatives in food |
| title_sort | update of the risk assessment of brominated phenols and their derivatives in food |
| topic | 2,4,6‐TBP brominated phenols food human exposure occurrence risk assessment |
| url | https://doi.org/10.2903/j.efsa.2024.9034 |
| work_keys_str_mv | AT efsapaneloncontaminantsinthefoodchaincontam updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT hellekatrineknutsen updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT agnetaakesson updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT vasileiosbampidis updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT margheritabignami updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT laurentbodin updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT jameskevinchipman updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT giseladegen updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT antoniohernandezjerez updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT timhofer updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT stefanolandi updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT jeancharlesleblanc updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT kyriakimachera updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT evangeliantzani updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT guidorychen updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT salomonsand updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT tanjaschwerdtle updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT katharinavejdovszky updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT barbaraviviani updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT dianebenford updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT andyhart updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT martinrose updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT henrischroeder updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT christianevleminckx updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT martinevrijheid updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT elenigkimprixi updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT eirinikouloura updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT francescariolo updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT luisaramosbordajandi updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood AT christerhogstrand updateoftheriskassessmentofbrominatedphenolsandtheirderivativesinfood |