食品中溴化酚及其衍生物的风险评估更新

Update of the risk assessment of brominated phenols and their derivatives in food.

作者信息

Knutsen Helle Katrine, Åkesson Agneta, Bampidis Vasileios, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Degen Gisela, Hernández-Jerez Antonio, Hofer Tim, Landi Stefano, Leblanc Jean-Charles, Machera Kyriaki, Ntzani Evangelia, Rychen Guido, Sand Salomon, Schwerdtle Tanja, Vejdovszky Katharina, Viviani Barbara, Benford Diane, Hart Andy, Rose Martin, Schroeder Henri, Vleminckx Christiane, Vrijheid Martine, Gkimprixi Eleni, Kouloura Eirini, Riolo Francesca, Bordajandi Luisa Ramos, Hogstrand Christer

出版信息

EFSA J. 2024 Oct 23;22(10):e9034. doi: 10.2903/j.efsa.2024.9034. eCollection 2024 Oct.

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-dibromophenol (), 4-bromophenol (), 2,6-dibromophenol (), tetrabrominated bisphenol S (), tetrabromobisphenol S bismethyl ether (). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6-tribromophenol () in studies in rats. A BMDL 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 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 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.

摘要

欧盟委员会要求欧洲食品安全局更新其2012年对食品中溴化酚及其衍生物的风险评估,重点关注五种溴酚和一种衍生物:2,4,6-三溴酚()、2,4-二溴酚()、4-溴酚()、2,6-二溴酚()、四溴双酚S()、四溴双酚S双甲基醚()。基于总体证据,CONTAM专家组认为其体内遗传毒性不太可能。在大鼠研究中,肝脏和肾脏的影响被认为是2,4,6-三溴酚()的关键影响。确定雄性大鼠肾乳头坏死的每日基准剂量下限(BMDL)为353毫克/千克体重(bw),并将其选作风险特征描述的参考点。由于毒理学数据库存在重大局限性,认为得出基于健康的指导值不合适。相反,采用暴露边际(MOE)方法评估可能的健康问题。约78200份食品中该物质的分析结果用于估计欧洲人群的膳食暴露量。考虑到由此得出的MOE值均远高于6000这一不会引发健康问题的MOE值,并考虑到影响暴露和危害评估的不确定性,CONTAM专家组得出结论,当前该物质的膳食暴露导致健康问题的概率至少为95%。由于缺乏发生数据,无法对母乳喂养或配方奶喂养的婴儿进行风险评估。由于缺乏毒性和发生数据,无法对评估中包含的任何其他溴化酚及其衍生物进行风险特征描述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6204/11496907/c18848e06765/EFS2-22-e9034-g001.jpg

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