Risks to human and animal health from the presence of bromide in food and feed
Abstract The European Commission mandated EFSA to assess the toxicity of bromide, the existing maximum residue levels (MRLs), and possible transfer from feed into food of animal origin. The critical effects of bromide in experimental animals are on the thyroid and central nervous system. Changes in...
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2025-01-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9121 |
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| author | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Thorhallur Halldorsson Laurentius (Ron) Hoogenboom Helle Knutsen Konstantinos Koutsoumanis Claude Lambré Søren Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Vasileios Bampidis Jacqueline Castenmiller Marie‐Christine Chagnon Bruce Cottrill Keyvin Darney Jürgen Gropp Secundino Lopez Puente Martin Rose Marco Vinceti Maria Bastaki Petra Gergelová Luna Greco Matteo Lorenzo Innocenti Judit Janossy Anna Lanzoni Andrea Terron Diane Benford |
| author_facet | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Thorhallur Halldorsson Laurentius (Ron) Hoogenboom Helle Knutsen Konstantinos Koutsoumanis Claude Lambré Søren Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Vasileios Bampidis Jacqueline Castenmiller Marie‐Christine Chagnon Bruce Cottrill Keyvin Darney Jürgen Gropp Secundino Lopez Puente Martin Rose Marco Vinceti Maria Bastaki Petra Gergelová Luna Greco Matteo Lorenzo Innocenti Judit Janossy Anna Lanzoni Andrea Terron Diane Benford |
| author_sort | EFSA Scientific Committee |
| collection | DOAJ |
| description | Abstract The European Commission mandated EFSA to assess the toxicity of bromide, the existing maximum residue levels (MRLs), and possible transfer from feed into food of animal origin. The critical effects of bromide in experimental animals are on the thyroid and central nervous system. Changes in thyroid hormone homeostasis could result in neurodevelopmental toxicity, among other adverse effects. Changes in thyroid hormone concentrations and neurophysiological parameters have also been observed in experimental human studies, but the evidence was limited. Dose–response modelling of decreased blood thyroxine concentrations in rats resulted in a reference point of 40 mg/kg body weight (bw) per day. The Scientific Committee established a tolerable daily intake (TDI) of 0.4 mg/kg bw per day and an acute reference dose (ARfD) of 0.4 mg/kg bw per day to protect against adverse neurodevelopmental effects. The TDI value is supported by the results of experimental human studies with a NOAEL of 4 mg/kg bw per day and 10‐fold interindividual variability. The TDI and ARfD are considered as conservative with 90% certainty. Insufficient evidence related to the toxicological effects of bromide was available for animals, with the exception of dogs. Therefore, the reference point of 40 mg/kg bw per day was extrapolated to maximum safe concentrations of bromide in complete feed for other animal species. Bromide can transfer from feed to food of animal origin, but, from the limited data, it was not possible to quantify the transfer rate. Monitoring data exceeded the current MRLs for some food commodities, generally with a low frequency. A conservative safety screening of the MRLs indicated that the TDI and ARfD are exceeded for some EU diets. Dietary exposure assessment for animals was not feasible due to insufficient data. The Scientific Committee recommends data be generated to allow robust dietary exposure assessments in the future, and data that support the risk assessment. |
| format | Article |
| id | doaj-art-3aa8c35ade3c41d1812871c9e00968f2 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
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| series | EFSA Journal |
| spelling | doaj-art-3aa8c35ade3c41d1812871c9e00968f22025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9121Risks to human and animal health from the presence of bromide in food and feedEFSA Scientific CommitteeSusanne Hougaard BennekouAna AllendeAngela BearthJosep CasacubertaLaurence CastleTamara CojaAmélie CrépetThorhallur HalldorssonLaurentius (Ron) HoogenboomHelle KnutsenKonstantinos KoutsoumanisClaude LambréSøren NielsenDominique TurckAntonio Vicent CiveraRoberto VillaHolger ZornVasileios BampidisJacqueline CastenmillerMarie‐Christine ChagnonBruce CottrillKeyvin DarneyJürgen GroppSecundino Lopez PuenteMartin RoseMarco VincetiMaria BastakiPetra GergelováLuna GrecoMatteo Lorenzo InnocentiJudit JanossyAnna LanzoniAndrea TerronDiane BenfordAbstract The European Commission mandated EFSA to assess the toxicity of bromide, the existing maximum residue levels (MRLs), and possible transfer from feed into food of animal origin. The critical effects of bromide in experimental animals are on the thyroid and central nervous system. Changes in thyroid hormone homeostasis could result in neurodevelopmental toxicity, among other adverse effects. Changes in thyroid hormone concentrations and neurophysiological parameters have also been observed in experimental human studies, but the evidence was limited. Dose–response modelling of decreased blood thyroxine concentrations in rats resulted in a reference point of 40 mg/kg body weight (bw) per day. The Scientific Committee established a tolerable daily intake (TDI) of 0.4 mg/kg bw per day and an acute reference dose (ARfD) of 0.4 mg/kg bw per day to protect against adverse neurodevelopmental effects. The TDI value is supported by the results of experimental human studies with a NOAEL of 4 mg/kg bw per day and 10‐fold interindividual variability. The TDI and ARfD are considered as conservative with 90% certainty. Insufficient evidence related to the toxicological effects of bromide was available for animals, with the exception of dogs. Therefore, the reference point of 40 mg/kg bw per day was extrapolated to maximum safe concentrations of bromide in complete feed for other animal species. Bromide can transfer from feed to food of animal origin, but, from the limited data, it was not possible to quantify the transfer rate. Monitoring data exceeded the current MRLs for some food commodities, generally with a low frequency. A conservative safety screening of the MRLs indicated that the TDI and ARfD are exceeded for some EU diets. Dietary exposure assessment for animals was not feasible due to insufficient data. The Scientific Committee recommends data be generated to allow robust dietary exposure assessments in the future, and data that support the risk assessment.https://doi.org/10.2903/j.efsa.2025.9121animal healthbromidefeedhealth‐based guidance valuehuman healthmode of action |
| spellingShingle | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Thorhallur Halldorsson Laurentius (Ron) Hoogenboom Helle Knutsen Konstantinos Koutsoumanis Claude Lambré Søren Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Vasileios Bampidis Jacqueline Castenmiller Marie‐Christine Chagnon Bruce Cottrill Keyvin Darney Jürgen Gropp Secundino Lopez Puente Martin Rose Marco Vinceti Maria Bastaki Petra Gergelová Luna Greco Matteo Lorenzo Innocenti Judit Janossy Anna Lanzoni Andrea Terron Diane Benford Risks to human and animal health from the presence of bromide in food and feed EFSA Journal animal health bromide feed health‐based guidance value human health mode of action |
| title | Risks to human and animal health from the presence of bromide in food and feed |
| title_full | Risks to human and animal health from the presence of bromide in food and feed |
| title_fullStr | Risks to human and animal health from the presence of bromide in food and feed |
| title_full_unstemmed | Risks to human and animal health from the presence of bromide in food and feed |
| title_short | Risks to human and animal health from the presence of bromide in food and feed |
| title_sort | risks to human and animal health from the presence of bromide in food and feed |
| topic | animal health bromide feed health‐based guidance value human health mode of action |
| url | https://doi.org/10.2903/j.efsa.2025.9121 |
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