FDA Proposes Expanding Threshold of Regulation Exemption to Permit Direct Food Additives Without Safety Review

美国食品药品监督管理局（FDA）提出一项拟议规则，计划扩大“法规阈值”（TOR）豁免范围，允许浓度低于十亿分之零点五（0.5 ppb）的非致癌化学物质直接添加至食品中，而无需通过正式的上市前安全审查。该拟议规则已提交至《联邦公报》（Federal Register）。此前，该豁免政策仅适用于包装等间接接触食品的材料，而新规将豁免范围延伸至调味剂、防腐剂和乳化剂等直接成分。此举引发了公共卫生倡导人士的批评，他们指出，高氯酸盐、邻苯二甲酸酯及全氟和多氟烷基物质（PFAS）等内分泌干扰物即使在极低剂量下，也会对儿童及人体发育构成严重危害。倡导人士还指责包括小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）在内的卫生官员违背了先前的食品安全承诺，在旨在封堵“公认安全”（GRAS）漏洞的审查条例修订中，借机塞入扩大TOR豁免的内容。

The US Food and Drug Administration has proposed expanding the Threshold of Regulation (TOR) exemption, allowing non-carcinogenic chemical compounds below 0.5 parts per billion to be added directly into food products without formal pre-market safety reviews. Previously restricted to indirect food-contact materials such as packaging, the proposed rule submitted to the Federal Register extends the exemption to direct ingredients, including flavorings, preservatives, and emulsifiers. Public health advocates criticized the proposal, arguing that low-dose endocrine disruptors like perchlorate, phthalates, and PFAS pose severe risks to children and human development. Advocates also accused health officials, including Robert F. Kennedy Jr., of undermining stated food safety pledges by embedding the TOR expansion inside revisions aimed at closing the generally recognized as safe loophole.