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Color Additive Laws, Regulations, and Guidance

Laws

FDA regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

Guidance for Industry

Regulations Related to Color Additives 

FDA-regulated products must comply with the color additive regulations; otherwise they are adulterated and/or misbranded. Color additive violations are common reasons for warning letters and import detentions. 

Color additives are required to be pre-approved by FDA and listed in the color additive regulations before they may be used in food, drugs, cosmetics, and medical devices. Each color additive is permitted only for the intended use stated in its listing regulation. Some are also subject to the FDA certification process.

Here are links to FDA’s color additive regulations and related resources. 

Links to the Electronic Code of Federal Regulations (eCFR)

21 CFR Part 70 - Color Additives - These regulations address general provisions for color additives, their packaging and labeling requirements, and the fees for filing a color additive petition to list a new color additive or a new use for a listed color additive.

21 CFR Part 71 - Color Additive Petitions - These regulations describe how to submit a color additive petition to FDA as well as the information FDA requires in order to evaluate the petition.

CFR Part 73 - Listing of Color Additives Exempt from Certification - These regulations list the FDA-approved color additives that are exempt from FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 74 - Listing of Color Additives Subject to Certification - These regulations list the FDA-approved color additives that are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives.

21 CFR Part 80 - Color Additive Certification - These regulations state the fees for color additive certification and describe the certification procedures and requirements.

21 CFR Part 81 - General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics - These regulations include the provisional lists of color additives and the color additives whose provisional listings have been terminated.

21 CFR Part 82 - Listing of Certified Provisionally Listed Colors and Specifications - These regulations list the provisionally listed color additive lakes, which are subject to FDA’s certification process. The regulations state the permitted uses, specifications, and restrictions that apply to each of these color additives. (All color additives were provisionally listed in response to the 1960 color additive amendments to the Federal Food, Drug, and Cosmetic Act. Only lakes, which are insoluble pigments formed from color additives listed in 21 CFR part 74, remain provisionally listed.)

Related Resources