欧洲食品安全局（EFSA）2015年科学意见-综合简介
本科学意见是对与双酚A（BPA）暴露相关的公众健康风险评估。暴露评估是按不同的人群组以三种不同的方式进行的：（1）外暴露（通过饮食、饮用水、呼吸、皮肤接触化妆品和热敏纸）；（2）总BPA内暴露（BPA的吸收剂量、结合态和非结合态BPA的总和）；（3）暴露总和（来自饮食、灰尘、化妆品和热敏纸），表示为人类口服当量剂量（HED）仅指非结合态的BPA。BPA膳食摄入量估计值最高的是婴儿和学步儿童（最高达每天0.875μg/kg bw）；育龄妇女和同龄男性的膳食暴露量相当（最高每天0.388μg/kg bw）。青少年的总暴露量估计值最高，达每天1.499μg/kg bw。各种来源的总BPA内暴露量估计值与生物监测数据相符合。BPA的毒性通过证据权重法评估。对动物肾脏和乳腺“可能的”不良影响进行了基准剂量（BMDL10）反应进行模拟。根据小鼠的两代毒性试验中肾脏平均相对重量的变化推算得到BMDL10的值为每天8960μg/kg bw。但通过乳腺的效应无法推算出BMDL10。利用毒理动力学的数据，可以将这一基准剂量值转化为人类当量剂量值为每天609μg/kg bw。CEF专家组采用了150作为总的不确定因子（包含物种内和物种间的差别，以及乳腺、生殖、神经行为、免疫和代谢系统的影响）建立了每天4μg/kg bw的临时可耐受每日摄入量（t-TDI）。将这一t-TDI值与暴露量估计值进行比较，CEF专家组得出的结论是：BPA的膳食暴露和总暴露量对任何人群组的健康都不构成隐患。CEF专家组注意到非膳食来源的暴露量估计有相当大的不确定性，而膳食暴露的不确定性相对较低。ABSTRACTThis opinion describes the assessment of the risks to public health associated with bisphenol A (BPA) exposure. Exposure was assessed for various groups of the human population in three different ways: (1) external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper); (2) internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA); and (3) aggregated (from diet, dust, cosmetics and thermal paper), expressed as oral human equivalent dose (HED) referring to unconjugated BPA only. The estimated BPA dietary intake was highest in infants and toddlers (up to 0.875 µg/kg bw per day). Women of childbearing age had dietary exposures comparable to men of the same age (up to 0.388 µg/kg bw per day). The highest aggregated exposure of 1.449 µg/kg bw per day was estimated for adolescents. Biomonitoring data were in line with estimated internal exposure to total BPA from all sources. BPA toxicity was evaluated by a weight of evidence approach. “Likely” adverse effects in animals on kidney and mammary gland underwent benchmark dose (BMDL10) response modelling. A BMDL10 of 8 960 µg/kg bw per day was calculated for changes in the mean relative kidney weight in a two generation toxicity study in mice. No BMDL10 could be calculated for mammary gland effects. Using data on toxicokinetics, this BMDL10 was converted to an HED of 609 µg/kg bw per day. The CEF Panel applied a total uncertainty factor of 150 (for inter- and intra-species differences and uncertainty in mammary gland, reproductive, neurobehavioural, immune and metabolic system effects) to establish a temporary Tolerable Daily Intake (t-TDI) of 4 µg/kg bw per day. By comparing this t-TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure and low health concern from aggregated exposure. The CEF Panel noted considerable uncertainty in the exposure estimates for non-dietary sources, whilst the uncertainty around dietary estimates was relatively low.
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