C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 170—FOOD ADDITIVES › Subpart E—Generally Recognized as Safe (GRAS) Notice

21 C.F.R. § 170.240

Part 4 of a GRAS notice: Self-limiting levels of use

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In circumstances where the amount of the notified substance that can be added to food is limited because food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical, in Part 4 of your GRAS notice you must include data and information on such self-limiting levels of use.