Schrenk Dieter, Bignami Margherita, Bodin Laurent, Chipman James Kevin, Del Mazo Jesús, Grasl-Kraupp Bettina, Hogstrand Christer, Hoogenboom Laurentius Ron, Leblanc Jean-Charles, Nebbia Carlo Stefano, Nielsen Elsa, Ntzani Evangelia, Petersen Annette, Sand Salomon, Schwerdtle Tanja, Wallace Heather, Benford Diane, Fürst Peter, Rose Martin, Ioannidou Sofia, Nikolič Marina, Bordajandi Luisa Ramos, Vleminckx Christiane
EFSA J. 2021 Mar 8;19(3):e06421. doi: 10.2903/j.efsa.2021.6421. eCollection 2021 Mar.
The European Commission asked EFSA to update its 2011 risk assessment on hexabromocyclododecanes (HBCDDs) in food. HBCDDs, predominantly mixtures of the stereoisomers α-, β- and γ-HBCDD, were widely used additive flame retardants. Concern has been raised because of the occurrence of HBCDDs in the environment, food and in humans. Main targets for toxicity are neurodevelopment, the liver, thyroid hormone homeostasis and the reproductive and immune systems. The CONTAM Panel concluded that the neurodevelopmental effects on behaviour in mice can be considered the critical effects. Based on effects on spontaneous behaviour in mice, the Panel identified a lowest observed adverse effect level (LOAEL) of 0.9 mg/kg body weight (bw) as the Reference Point, corresponding to a body burden of 0.75 mg/kg bw. The chronic intake that would lead to the same body burden in humans was calculated to be 2.35 μg/kg bw per day. The derivation of a health-based guidance value (HBGV) was not considered appropriate. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Over 6,000 analytical results for HBCDDs in food were used to estimate the exposure across dietary surveys and age groups of the European population. The most important contributors to the chronic dietary LB exposure to HBCDDs were fish meat, eggs, livestock meat and poultry. The CONTAM Panel concluded that the resulting MOE values support the conclusion that current dietary exposure to HBCDDs across European countries does not raise a health concern. An exception is breastfed infants with high milk consumption, for which the lowest MOE values may raise a health concern.
欧盟委员会要求欧洲食品安全局更新其2011年关于食品中六溴环十二烷(HBCDDs)的风险评估。HBCDDs主要是立体异构体α-、β-和γ-HBCDD的混合物,曾是广泛使用的添加型阻燃剂。由于HBCDDs在环境、食品及人体中的出现,人们对此表示担忧。其毒性的主要作用靶点是神经发育、肝脏、甲状腺激素稳态以及生殖和免疫系统。污染物毒理学委员会得出结论,对小鼠行为的神经发育影响可被视为关键影响。基于对小鼠自发行为的影响,该委员会确定最低观察到有害作用水平(LOAEL)为0.9毫克/千克体重(bw)作为参考点,相当于体内负荷为0.75毫克/千克bw。计算得出,导致人体出现相同体内负荷的慢性摄入量为每天2.35微克/千克bw。基于健康的指导值(HBGV)的推导被认为不合适。相反,采用暴露边际(MOE)方法来评估可能的健康问题。利用6000多项食品中HBCDDs的分析结果,对欧洲人群不同饮食调查和年龄组的暴露情况进行了估算。食品中慢性膳食低剂量暴露于HBCDDs的最重要来源是鱼肉、蛋类、禽畜肉。污染物毒理学委员会得出结论,由此得出的MOE值支持以下结论:欧洲各国目前通过膳食接触HBCDDs不会引发健康问题。母乳喂养且奶量摄入高的婴儿是个例外,他们的最低MOE值可能引发健康问题。