Color Additive Petitions

FDA Guidance on Submitting Chemical and Technological Data for Color Additives in Food, Drugs, Cosmetics, and Medical Devices

The U.S. Food and Drug Administration (FDA) provides recommendations for submitting the chemical and technological information needed to evaluate petitions requesting authorization to use new color additives in food, drugs, cosmetics, or medical devices. These recommendations are intended to help petitioners seeking approval for a color additive not currently permitted for the proposed use. They supplement, but do not replace, requirements established in the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21 of the Code of Federal Regulations (CFR).

Statutory and Regulatory Requirements

Statutory Requirements

Under Section 721(a) of the Act, a color additive used in or on food, drugs, cosmetics, or medical devices is considered unsafe unless:

1. A regulation lists the color additive; 
2. The regulation allows the proposed use; and 
3. The additive and its use conform to that regulation.

Color additives used in or on medical devices fall under this section only when they are in direct contact with the human or animal body for a significant period.

Parts 70 and 71 of Title 21 CFR, issued under section 706(b) of the Act, describe the required format, administrative procedures, data, and information needed for a complete color additive petition.

Regulatory Requirements for Chemical and Technological Data (21 CFR 71.1)

(1) 21 CFR 71.1(c)(A)

• Identity – The petition must identify the color additive by name and provide all relevant information on its chemical identity and composition. It must also include the chemical and physical tests used to characterize the additive.
• Physical, Chemical, and Biological Properties – Information describing relevant physical, chemical, and biological characteristics must be included.
• Chemical Specifications – Specifications must list the components of the color additive and establish acceptable limits for impurities and reaction byproducts.
• Manufacturing Process – The petition must describe in detail the manufacturing methods, facilities, and controls used to ensure the additive has a consistent and reproducible composition. Alternative methods and controls may be included when they do not affect the additive’s characteristics.
• Stability – Stability data must be provided. When necessary, expiration dating, packaging requirements, and labeling precautions must also be included to protect product stability.

(2) 21 CFR 71.1(c)(B)

• Uses and Restrictions – The petition must specify the intended amount and purpose of the color additive, including instructions and recommendations for use. If color may transfer from packaging, the petition must explain how this can occur and provide supporting residue data.
• Labeling – Draft labeling must be submitted with the petition. Final printed labeling, matching the draft content, must be submitted before marketing.

(3) 21 CFR 71.1(c)(C)

• Analytical Methods for Enforcing Specifications – The petition must describe practical analytical procedures to identify the pure color additive and its intermediates, subsidiary colors, and other components.
• Determining the Additive in Products – Methods must be provided to measure the amount of the color additive in raw, processed, or finished foods, drugs, or cosmetics.
• Identification of Substances Formed in Products – Analytical methods must also be included to detect and quantify substances formed as a result of using the color additive.

(4) 21 CFR 71.1(c)(E)

• Estimate of Probable Exposure – The petition must include comprehensive exposure data, including expected consumption or use levels and cumulative exposure from related substances such as other food additives or pesticides with established tolerances.

(5) 21 CFR 71.1(c)(F)

• Proposed Tolerances and Limitations – If necessary for safety, the petition must propose appropriate tolerances or restrictions for the color additive.

(6) 21 CFR 71.1(c)(G)

• Exemption from Batch Certification – If requesting exemption from batch certification, the petition must justify why certification is unnecessary and provide supporting safety data.