FDA Food Color Additives Application

Food color can directly affect the consumer's desire to buy. Therefore, the modern food industry commonly uses color additives to improve the color of food. In the U.S., color additives must be approved by the FDA before being used in food. In this article, we introduce the FDA's food color additive regulations, classification, application and certification procedures.

Introduction of Food Color Additives

A pigment additive is any dye, pigment, or other substance that, when added or applied to food, medicine, cosmetics, or the human body, confers color either alone or by reaction with other substances. The U.S. FDA regulates all color additives used in foods, drugs, cosmetics (except coal tar hair dyes), and certain medical devices to ensure that they meet FDA safety standards and are accurately labeled.

Before a color additive can be used in food, evidence must be provided to FDA that the color additive is safe at the intended level of use. Reasons for using color additives in foods include:

• Correcting natural variations in color
• Enhancing naturally occurring colors
• Providing color to colorless foods to enhance appetite through visual enjoyment
• Counteract color loss due to exposure to light, air, temperature extremes, humidity and storage conditions

Color Additives Regulations

Before a new food color additive, or an approved color additive, can be used in a new application, the manufacturer must apply for approval from the FDA. The FDA promulgates regulations that specify the types of foods in which color additives may be used, the maximum allowable additive levels, and how to properly label color additives.

(1) 21 CFR parts 70-82 formulate the color additive regulations.

(2) 21 CFR parts 73, 74, and 82 identify each of the listed color additives, provide chemical specifications for the color additives, and identify uses and restrictions, labeling requirements for listed color additives, and certification requirements.

(3) 21 CFR parts 70 and 71 provide definitions and describe the premarket approval process for new color additives or new uses of listed color additives.

(4) 21 CFR part 80 relates to the certification of color additives.

Classification of Color Additives

Request for certification

Color additives requiring lot certification are generally synthetic organic colorants, color deposits, or pigments, i.e., "artificial colors".

Food color additives are classified as azo, xanthene, triarylmethane, and indigo dyes. There are seven certified color additives approved for use in food, known as "FD&C" color additives, including FD&C Blue Nos. 1 and 2, FD&C Green No. 3, FD&C Green No. 2, FD&C Green No. 3, and FD&C Green No. 3. FD&C Green No. 3, FD&C Red Nos. 3 and 40, and FD&C Yellow Nos. 5 and 6.

Exempted from certification

Color additives exempt from certification typically include those from plant or mineral sources, known as "natural colors". One such additive is cochineal extract (and its colorant, carmine), which is derived from insects. Carmine and cochineal extracts should be pasteurized or otherwise destroyed of all salmonella.

Certification-exempt color additives must meet the labeling, purity specifications, and restrictions on use described in their listing regulations. Manufacturers using these color additives are responsible for ensuring that the color additives comply with the listing regulations.

Food color additives exempt from certification are listed in 21 CFR Part 73.

Application and Review of Color Additives

Applicants are required to submit a Color Additive Petition to FDA providing evidence that the color additive is safe and suitable for the proposed use.Upon receipt of the petition, FDA evaluates the data contained in the petition, public comments, and other pertinent data in FDA's records. FDA will consider possible uses, cumulative effects in the diet, safety factors, and analytical methods used to determine purity and acceptable levels of impurities.

Any interested person may apply to FDA for a new color additive or a new use of an approved color additive. An applicant for a new color additive must provide the following information:

• Properties of the color additive being applied
• Physical, chemical, and biological properties
• Chemical specifications
• Description of the manufacturing process
• Stability data
• Intended uses and limitations
• Labeling
• Tolerances and limitations
• Methods of analysis for performing chemical specifications
• Methods of analysis for color additives
• Identification and determination of any substances formed within or on the surface of the product as a result of the use of color additives
• Safety studies
• Estimation of potential exposure
• Regulatory legislation
• Proposed exemption from batch certification
• Environmental assessment or categorical exclusion statement

Color Additive Certification Process

Certain color additives require batch certification prior to use, and manufacturers are required to send samples of the color additive and a Request for Certification to FDA's Color Certification Branch.

FDA tests batch samples of color additives to ensure that they meet FDA's regulatory requirements. In 2022, FDA certified batches totaling 281,000 pounds of color additives, most of which are used in food.

Decisions about the need for batch certification are made during FDA's review of color additive petitions. Some color additives may contain toxicological impurities that can adversely affect human health. FDA requires batch certification when ingredient control is needed to protect public health.

Upon receipt of a sample, an FDA reviewer evaluates its physical appearance and performs a chemical analysis. FDA will conduct a minimum of 10 analyses, including purity (total pigment content), moisture, residual salts, unreacted intermediates, colored impurities other than the primary color (secondary colors), any other specified impurities, and the heavy metals lead, arsenic, and mercury.

Evaluation and analysis usually take less than five working days. If the sample meets the requirements, the FDA issues a certificate for the batch that identifies the color additive, the batch weight, the purpose for which the color additive is certified, the name and address of the owner, and other required information.

FDA color additive certification fees

FDA charges a fee for color additive certification based on lot weight.

• Pure colors (including color deposits)

0.35 per pound, but the fee cannot be less than $224.

• Repackaged certified color additives and color additive blends

(1) 100 pounds or less: $35.

(2) Over 100 pounds but not more than 1,000 pounds: $35 plus $0.06 per pound over 100 pounds.

(3) Over 1,000 pounds: $89, plus $0.02 per pound over 1,000 pounds. ‍

Other Requirements

Manufacturer registration

Domestic and foreign manufacturers of color additives for use in food in the U.S. are required to register with the FDA.

Compliance and enforcement

After an investigation, if FDA determines that there is a color additive violation, FDA can take a variety of steps to enforce the FD&C Act and protect public health, including issuing a warning letter, detention, issuing an import alert, and forfeiture actions.

Label requirements

Color additives must be properly declared on food product labels in accordance with 21 CFR 101.22(k). For example, certification-exempt color additives may be declared as "artificial color" or "artificial coloring" (21 CFR 101.22(k)(2)), whereas certified color additives must be declared by their listed name or appropriate abbreviation (e.g., FD&C Red No. 40 or Red 40) (21 CFR 101.22(k)(1)).

Food color additive applications in the U.S. need to comply with FDA regulations or face potentially severe penalties. Proregulations helps food manufacturers complete compliant FDA color additive applications and certifications, and provides U.S. agency services to assist manufacturers with the process of applying for batch certifications, sending samples, and more. If you need to apply to the FDA for food coloring additives, please feel free to contact us.