[Code of Federal Regulations] |
[Title 21, Volume 6] |
[CITE: 21CFR570.245] |
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CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS |
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PART 570 -- FOOD ADDITIVES
Subpart E - Generally Recognized as Safe (GRAS) Notice
Sec. 570.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958.
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If the statutory basis for your conclusion of GRAS status is through experience based on common use in animal food, in Part 5 of your GRAS notice you must include evidence of a substantial history of consumption of the notified substance for food use by a significant number of animals of the species to which the substance is intended to be fed prior to January 1, 1958, and evidence of a substantial history of consumption by humans consuming human foods derived from food-producing animals prior to January 1, 1958.
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