21 CFR § 170.240
Part 4 of a GRAS notice: Self-limiting levels of use
June 25, 2020
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.