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FDA BSE Rule Permits Tallow With .15% Hexane-Insoluble Impurities

This article was originally published in The Rose Sheet

Executive Summary

FDA's 1interim final rule prohibiting certain bovine risk materials in cosmetics, dietary supplements and foods to minimize exposure to bovine spongiform encephalopathy will be effective immediately upon publication in the Federal Register, slated for July 14

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FDA Releases Final Recordkeeping Rule For Cosmetics With Bovine Material

Manufacturers and processors of cosmetic ingredients and finished products that contain cattle material must maintain records that demonstrate their products do not contain prohibited bovine matter, according to an FDA final recordkeeping rule published in a Federal Register 1notice Oct. 11. The rule is effective Jan. 9

FDA Releases Final Recordkeeping Rule For Cosmetics With Bovine Material

Manufacturers and processors of cosmetic ingredients and finished products that contain cattle material must maintain records that demonstrate their products do not contain prohibited bovine matter, according to an FDA final recordkeeping rule published in a Federal Register 1notice Oct. 11. The rule is effective Jan. 9

BSE interim final rule

Cosmetic, Toiletry and Fragrance Association requests FDA further clarify that all tallow derivatives are exempt from the interim final rule governing use of cattle-derived ingredients in food and cosmetics in comments submitted to the agency Oct. 12. Rule states that FDA believes tallow has a "negligible risk of transmitting BSE," a position with which CTFA concurs. However, manufacturers must document that tallow does not contain prohibited materials and no more than .15% insoluble impurities (1"The Rose Sheet" July 12, 2004, p. 10). CTFA also asks FDA to clarify milk and its byproducts are not included as prohibited cattle materials, noting the prohibition of milk for use in cosmetics is believed to be an "unintended result" of the regulation...

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