食品药品管理局撤销二氯甲烷等物质的色素用途授权 2027 年 1 月 11 日生效
华盛顿 — 美国食品药品管理局（FDA）11 月 9 日在华盛顿宣布两项撤销行动，撤销某些物质作为色素添加剂、或用于生产色素添加剂的授权，撤销自 2027 年 1 月 11 日起生效。
第一项行动撤销二氯甲烷用作成品果蔬标记油墨稀释剂的授权。第二项行动撤销二氯甲烷、二氯乙烷与三氯乙烯用于生产三种色素添加剂的授权，这三种色素添加剂是红木提取物（annatto extract）、辣椒油树脂（paprika oleoresin）与姜黄油树脂（turmeric oleoresin）。食品药品管理局说，上述物质作为色素添加剂、或用于生产色素添加剂，已没有任何仍然有效的授权用途。
第一项撤销是应环境保护基金（Environmental Defense Fund）、乳腺癌预防伙伴、环境健康中心、环境工作组与 Lisa Lefferts 提交的色素添加剂请愿作出的。请愿援引《联邦食品、药品和化妆品法》的 Delaney 条款：依该条款，一种会被摄入的色素添加剂，如已被发现会在人或动物身上诱发癌症，就必须被认定为不安全。实验显示，二氯甲烷会在实验动物身上致癌。
第二项撤销是应国际色素制造商协会（International Association of Color Manufacturers）提交的请愿作出的，该协会证明，业界已经弃用上述用途。
（来源：美国食品药品管理局）
FDA Revokes Authorizations for Methylene Chloride and Two Other Substances Used in Color Additives, Effective January 11, 2027
WASHINGTON — The U.S. Food and Drug Administration (FDA) announced two separate actions in Washington on November 9 to revoke the authorizations of certain substances used as color additives or in the production of color additives, with the revocations taking effect on January 11, 2027.
In the first action, the FDA is revoking the authorization for the use of methylene chloride as a diluent in inks for marking fruit and vegetables. In the second, the agency is revoking the authorizations for the uses of methylene chloride, ethylene dichloride and trichloroethylene in the manufacture of three color additives: annatto extract, paprika oleoresin and turmeric oleoresin. The FDA said these substances have no remaining authorized uses as color additives or in the production of color additives.
The first revocation responds to a color additive petition from the Environmental Defense Fund, Breast Cancer Prevention Partners, the Center for Environmental Health, the Environmental Working Group and Lisa Lefferts. The petition invoked the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, under which a color additive that is ingested must be deemed unsafe if the substance has been found to induce cancer in humans or animals. Methylene chloride has been shown to cause cancer in laboratory animals.
The second revocation responds to a petition from the International Association of Color Manufacturers, which demonstrated that these uses have been abandoned by industry.
(Source: U.S. Food and Drug Administration)
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品管理局总部大楼（GSM 固定图库）。 / Photo: U.S. Food and Drug Administration headquarters (GSM asset library).
GSM Global · 本篇英文版 English edition of this story
