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  1. Food Chemical Safety

FDA Reminds Manufacturers of Color Additives Exempt from Certification to Comply with Identity and Purity Requirements

February 5, 2026

Dear Manufacturer,

The Food and Drug Administration (FDA) reminds manufacturers that, while certain color additives do not require FDA batch certification, all authorized color additives must meet the identity and specifications (including purity specifications) described in their listing regulations, and comply with other applicable legal and regulatory requirements.1 As FDA encourages the transition away from the use of certified colors in food, it is important that manufacturers of non-certified colors take all possible measures to ensure the safety and purity of the color additives they produce.  

Color additive manufacturers should limit impurities, including heavy metal contaminants, solvent residues, and microbial contaminants. Stringent heavy metal limits for substances added to the food supply are important for reducing dietary exposure to environmental contaminants to as low as possible, including under FDA’s Closer to Zero Initiative.2 A color additive containing  levels of heavy metal contamination which exceed specifications in the color additive listing  for heavy metals would be considered adulterated.3

One resource to aid manufacturers is the United States Pharmacopeia’s recently-finalized “Food Chemicals Codex (FCC)- Appendix XXI: Guidelines for the Control of Contaminants in Food Colors from Natural Sources.” The document addresses approaches to support consistent definitions and quality control and product safety specifications for certain authorized food colors. The FCC contains resources that may assist manufacturers of authorized color additives for which the listing regulations do not include specifications. In particular, FCC monographs for color additives include specifications for impurities (e.g., heavy metal and microbial limits). In addition, Appendix XXI of the FCC contains general standards and specifications that may be useful for industry when specifications under a color additive’s listing regulation or an FCC monograph for the color additive are not available. The composition of authorized color additives that are addressed in Appendix XXI may be subject to differences in plant cultivars, environmental conditions, handling procedures, and production methods. As such, manufacturers may find it useful to apply appropriate controls and specifications to ensure quality and safety of these substances.

FDA recommends that manufacturers consult all available resources to identify the most stringent specifications achievable when manufacturing color additives.  

Sincerely,

/S/
Kyle A. Diamantas, J.D.
Deputy Commissioner for Human Foods

  1. 1See 21 CFR parts 70-82; see also section 721 of the Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 379e. Any colors derived from natural sources must be approved by FDA under FDA’s color additive petition process. See 21 CFR part 71.
  2. 2See U.S. Food and Drug Administration, “Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods.” Available at https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods.
  3. 3See section 402(c) of the FD&C Act, 21 U.S.C. 342(c) and section 721 of the FD&C Act, 21 U.S.C. 379e.
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