Color Additives
Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except for coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. The following resources are related to the use of color additives in FDA-regulated products.
Information on Specific Color Additives
- FD&C Red No. 3
- Titanium Dioxide
- Letter to Additive Manufacturers on Certification of Irradiated Colors
Color Additive Inventories
- Regulatory Status of Color Additives (formerly Color Additive Status List)
- Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices
- Color Additives Permitted for Use in Cosmetics
- Food and Color Additives Final Rules
Color Additive Petitions
- Preparing a Color Additive Petition for Color Additives Used in or on Contact Lenses
- More Resources on Color Additive Petitions
Color Certification
- Quarterly Reports on the Certification of Color Additives
- Companies Requesting Color Certification Within the Last Two Years
- More Resources on Color Certification
Compliance & Enforcement
Laws
FDA regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.
Proposed & Final Rules
- Proposed Rule: Color Additive Certification - Increase in Fees for Certification Services (November 2022)
Guidance for Industry
- Guidance for Industry: Colored Sea Salt (September 2015)
- Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives (June 2014)
- Guidance for Industry: Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products That Contain These Color Additives; Small Entity Compliance Guide (April 2009)
Petitions
- Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (January 1997; Revised July 2009)
- Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses (May 2006)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety
- See also: Centralized Online Submission Module (COSM)
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.)
FDA scientists conduct a variety of activities to ensure the safety of color additives listed for use in FDA-regulated products. These activities include:
- Analyzing samples of color additives sent to FDA for batch certification, to determine whether they meet the specifications required in the regulations that list permitted color additives
- Developing and updating analytical methods used for color additive certification
- Developing analytical methods to identify and quantify potentially harmful ingredients and impurities in color additives
- Developing analytical methods to identify and quantify color additives in FDA-regulated products
- Providing scientific and technical support within FDA on color additives
- Providing guidance to regulated industry and others on color additives
- Evaluating chemistry data in petitions for new color additives and new uses for currently permitted color additives
To find scientific publications by FDA scientists on the topic of color additives, visit "Scientific Publications by FDA Staff" and enter "color additives" in the search field.
- Color Additives in Foods
- How Safe Are Color Additives?
- Redbook 2000 Table of Contents: Guidance for Industry and Other Stakeholders
- Summary Table of Recommended Toxicological Testing for Additives Used in Food
- Everything Added to Food in the United States (EAFUS)
- FDA Advises Home and Commercial Bakers to Avoid Use of Non-Edible Food Decorative Products
- Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration, Final Rule, January 5, 2009
- Color Additives Listed for Use in Food: Exempt from Certification (21 CFR 73, Subpart A)
- Color Additives Listed for Use in Food: Subject to Certification (21 CFR 74, Subpart A)
- Color Additives and Cosmetics: Fact Sheet
- How Safe Are Color Additives?
- Color Additives Permitted for Use in Cosmetics (Table)
- Color Additive Petitions: Information on the Color Additive Approval Process
- Import Alerts Related to Cosmetics
- Untitled Letter to BASF Regarding Mica-Based Pearlescent Pigments
- Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration, Final Rule, January 5, 2009
- Color Additives Listed for Use in Cosmetics: Exempt from Certification (21 CFR 73, Subpart C)
- Color Additives Listed for Use in Cosmetics: Subject to Certification (21 CFR 74, Subpart C)
- Color Additives For Medical Devices
- Listing of Color Additives Exempt From Certification (Title 21 CFR Part 73, Subpart B)
- Listing of Color Additives Subject to Certification (Title 21 CFR Part 74, Subpart B)
- Declaration of Presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in Certain Drugs for Human Use (21 CFR 201.20)