170.39 - Threshold of regulation for substances used in

FOOD-contact articles;Pf

or

(b) 21 CFR 178 - Indirect FOOD Additives: Adjuvants, Production

Aids, and Sanitizers as regulated for use as a FOOD ADDITIVE with

conditions of safe use, Pf

or

46

(c) A determination of generally recognized as safe (GRAS). Partial

listings of substances with FOOD uses that are GRAS may be found

in 21 CFR 182 - Substances Generally Recognized as Safe, 21 CFR

184 - Direct FOOD Substances Affirmed as Generally Recognized as

Safe, or 21 CFR 186 – Indirect FOOD Substances Affirmed as

Generally Recognized as Safe for use in contact with FOOD, and

in FDA’s Inventory of GRAS Notices, Pf

or

(d) A prior sanction listed under 21 CFR 181 – Prior

Sanctioned FOOD Ingredients,Pf

or

(e) a FOOD Contact Notification that is effective,PF and

(3) Be applied only to hands that are cleaned as specified under