Gradient, Seattle, Washington 98101, USA.
Gradient, Boston, Massachusetts 02108, USA.
Toxicol Sci. 2024 Mar 26;198(2):185-190. doi: 10.1093/toxsci/kfad136.
The European Food Safety Authority (EFSA) recently derived a tolerable daily intake (TDI) for bisphenol A (BPA) of 0.2 ng/kg bw/day. There are several issues with EFSA's hazard assessment review process, including that it was based on a limited subset of relevant studies. Multiple public commenters on EFSA's draft evaluation of BPA, including several European regulatory agencies, noted these issues, yet they were not adequately addressed by EFSA in the final evaluation. The TDI for BPA was based on an intermediate immunotoxicity endpoint in mice that has not been observed in other species; there is no evidence that it is a precursor event to any downstream pathological outcome. The TDI is several orders of magnitude lower than estimates of safe doses of BPA established by agencies worldwide, including EFSA's temporary TDI (t-TDI) for BPA established in 2015. Overall, the EFSA hazard assessment review process has led to a conclusion that there are low-dose effects of BPA based on very few, lower quality experimental animal studies. This conclusion is not supported by the totality of the available evidence, which includes multiple high-quality studies not considered by EFSA and indicates that the t-TDI established in 2015 is protective of human health.
欧洲食品安全局 (EFSA) 最近为双酚 A (BPA) 制定了可耐受每日摄入量 (TDI)，为 0.2ng/kg bw/day。EFSA 的危害评估审查过程存在几个问题，包括它基于相关研究的有限子集。包括几个欧洲监管机构在内的 EFSA 对 BPA 的草案评估的多位公众评论员指出了这些问题，但 EFSA 在最终评估中并未充分解决这些问题。BPA 的 TDI 基于在其他物种中未观察到的小鼠中间免疫毒性终点；没有证据表明它是任何下游病理结果的前体事件。TDI 比包括 EFSA 于 2015 年制定的临时 TDI(t-TDI)在内的全球各机构确定的 BPA 安全剂量估计值低几个数量级。总体而言，EFSA 的危害评估审查过程得出的结论是，BPA 存在低剂量效应，依据的是极少数低质量的实验动物研究。这一结论与现有证据的总体情况不符，其中包括 EFSA 未考虑的多项高质量研究，这表明 2015 年制定的 t-TDI 可保护人类健康。
