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FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices

Food and Drug Administration (FDA) provides guidance for the submission of the chemical and technological data that FDA’s Office of Food Additive Safety considers necessary for its evaluation of petitions requesting the listing of color additives for use in food, drugs, cosmetics, or medical devices. These recommendations are provided to assist petitioners who propose to impart color to a food, drug, cosmetic, or medical device that is subject to federal regulation by use of a substance (color additive) that is currently not permitted for that use. These recommendations are not substitutes for the Federal Food, Drug, and Cosmetic Act (the Act) or Title 21 of the Code of Federal Regulations (CFR), sections that are cited in this document.

Statutory and Regulatory Requirements

Statutory Requirements

Section 721(a) of the Food Act defines that a color additive used in or on a food, drug, cosmetic or medical device shall be deemed unsafe unless

(1) there is a regulation listing such color additive,

(2) the regulation allows that particular use, and

(3) the color additive and its use conform to the regulation.

A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animal for a significant period of time.

Parts 70 and 71 of Title 21 of the Code of Federal Regulations, which were promulgated under the authority of section 706(b) of the Act, describe in greater detail the format, the administrative requirements, and the information and data required for color additive petitions.

Regulatory Requirements for Chemical and Technological Data in Color Additive Petitions (21 CFR 71.1)

      (1) 21 CFR 71.1(c) A.

• Identity: The petition must include the name and all pertinent information concerning the color additive, including chemical identity and composition and a description of the chemical and physical tests relied upon to identify the color additive. (21 CFR 71.1(c) A.)
• Physical, Chemical, and Biological Properties: The petition must include information on physical, chemical, and biological properties. (21 CFR 71.1(c) A.)
• Chemical Specifications: The petition must include specifications prescribing the color additive component(s) and identifying and limiting the reaction byproducts and other impurities. (21 CFR 71.1(c) A.)
• Manufacturing Process Description: The petition must include a full description of the methods used in, and the facilities and controls used for, the production of the color additive. These shall establish that it is a substance of reproducible composition. Alternative methods, controls, and variations in methods and controls, within reasonable limits, that do not affect the characteristics of the substance or the reliability of the controls may be specified.
• Stability Data: The petition must include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the color additive, the expiration period that will be employed as well as any packaging and labeling precautions needed to preserve stability. (21 CFR 71.1(c) A.)
  
  (2) 21 CFR 71.1(c) B.
• Uses and restrictions: The petition must include the amount of the color additive proposed for use and the color effect intended to be achieved, together with all directions, recommendations, and suggestions regarding the proposed use. If the color effect results or may reasonably be expected to result from use of the color additive in packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated.
• Labeling: The petition must include specimens of the labeling proposed for the color additive. Typewritten or other draft-labeling copy will be accepted for consideration of the petition provided final printed labeling identical in content to the draft copy is submitted as soon as available, and prior to the marketing of the color additive.

(3) 21 CFR 71.1(c) C.

• Analytical Methods for Enforcing Chemical Specifications: The petition must include a description of practical methods to determine the pure color and all intermediates, subsidiary colors, and other components of the color additive. (21 CFR 71.1(c) C. 1.)
• Qualitative and Quantitative Determination of the Color Additive in Products: The petition must include a description of practicable methods to determine the amount of the color additive in any raw, processed, and/or finished food, drug, or cosmetic in which use of the color additive is proposed.
• Identification and Determination of Any Substance Formed in or on Products Because of the Use of the Color Additive: The petition must include a description of methods for identification and determination of any substance formed in or on such food, drug, or cosmetic because of the use of the color additive.

 (4) 21 CFR 71.1(c) E.

• Estimate of Probable Exposure: The petition must include complete data which will allow the Commissioner to consider, among other things, the probable consumption of, and/or other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in the diet including, but not limited to food additives and pesticide chemicals for which tolerances or exemptions from tolerances have been established. (21 CFR 71.1(c) E.)

(5) 21 CFR 71.1(c) F.

• Proposed Tolerances and Other Limitations: The petition must include proposed tolerances and other limitations on the use of the color additive, if tolerances and limitations are required in order to ensure its safety. (21 CFR 71.1 (c) F.)

(6) 21 CFR 71.1(c) G.

• Exemption from Batch Certification: The petition must include, if exemption from batch certification is requested, the reasons why it is believed such certification is not necessary (including supporting data to establish the safety of the intended use). (21 CFR 71.1 (c) G.)