Color Additive Certification

The information collection implements section 721(a) of the Federal Food Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a) providing that a color additive shall be deemed unsafe unless it meets the requirement of a listing regulation including any requirement for batch certification. FDA lists color additives that have been shown to be safe for their intended uses in Title 21 of the Code of Federal regulations.( CFR). FDA requires batch certification for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80.

The latest form for Color Additive Certification expires 2023-10-31 and can be found here.

Request for certification

Federal Enterprise Architecture: Health - Consumer Health and Safety