2005年9月6日

摘要：美国食品药品管理局颁布了几项2004年7月的暂行最终法规的修正提案，“人类食品和化妆品中使用牛源物料，”允许人类食品和化妆品中使用某些牛源物料。法规禁止人类食品，食物补充剂，和化妆品中携带可能会传染的牛海绵状脑病（疯牛病）制剂的牛源物料的使用。基于科学的信息资料，在暂行最终法规评议期间，提供证实了从小肠的其他部分一向被去除的叫做末梢回肠的牛消化管的部分，从而把整个小肠都作为是禁止的牛物料是没有必要的。美国食品药品管理局正在修订允许人类食品和化妆品中小肠使用的法规，。美国农业部出版了有关疯牛病的暂行最终法规的类似修正案。修正案同时阐明了在人类食品和化妆品中，牛奶和奶类产品，兽皮和源自兽皮的产品，源于牛脂的产品是不被禁止的。暂行最终法规的修正案于2005年10月7日生效。

FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Food and Cosmetics"

September 6, 2005

The U.S. Food and Drug Administration today published several amendments to the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human Food and Cosmetics," that will allow the use of certain cattle-derived material in human foods and cosmetics.

The rule prohibits the use of cattle-derived materials that can carry the infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease, in human foods, dietary supplements, and in cosmetics. Based on the scientific information provided during the interim final rule's comment period, which demonstrates that a part of the cow's digestive tract called the distal ileum can be consistently and effectively removed from the other sections of the small intestine, it is no longer necessary to designate the entire small intestine as a prohibited cattle material.

As a result, FDA is amending the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The U.S. Department of Agriculture is publishing today a similar amendment to its interim final rule on BSE.

The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.

Finally, FDA has reconsidered the recommended method for determining insoluble impurities in a type of solid fat known as tallow, in response to information submitted to the agency, to cite a method that is less costly to use and requires less specialized equipment.

FDA issued the interim final rule to minimize human exposure to materials that studies have demonstrated are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.

The amendments to the interim final rule are effective on October 7, 2005 and comments are being are accepted on the amendments through November 7, 2005.