GroundRules
21 CFR 570.245: Part 5 of a GRAS notice: Experience based on common use in food before 1958.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 570—FOOD ADDITIVES
- Subpart E—Generally Recognized as Safe (GRAS) Notice
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON