Safe and suitable
Safe and suitable means that the ingredient:
(1) Performs an appropriate function in the food in which it is used.
(2) Is used at a level no higher than necessary to achieve its intended purpose in that food.
(3) Is not a food additive or color additive as defined in section 201 (s) or (t) of the Federal Food, Drug, and Cosmetic Act as used in that food, or is a food additive or color additive as so defined and is used in conformity with regulations established pursuant to section 409 or 721 of the act.