2005年9月6日

摘要：美國食品藥品管理局頒布了幾項2004年7月的暫行最終法規(guī)的修正提案，“人類食品和化妝品中使用牛源物料，”允許人類食品和化妝品中使用某些牛源物料。法規(guī)禁止人類食品，食物補充劑，和化妝品中攜帶可能會傳染的牛海綿狀腦?。ǒ偱２。┲苿┑呐Ｔ次锪系氖褂谩；诳茖W的信息資料，在暫行最終法規(guī)評議期間，提供證實了從小腸的其他部分一向被去除的叫做末梢回腸的牛消化管的部分，從而把整個小腸都作為是禁止的牛物料是沒有必要的。美國食品藥品管理局正在修訂允許人類食品和化妝品中小腸使用的法規(guī)，。美國農業(yè)部出版了有關瘋牛病的暫行最終法規(guī)的類似修正案。修正案同時闡明了在人類食品和化妝品中，牛奶和奶類產品，獸皮和源自獸皮的產品，源于牛脂的產品是不被禁止的。暫行最終法規(guī)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.