COFEPRIS Evaluates the Use of FDC Red No. 3 in Food Beverages and Pharmaceuticals

The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) is currently conducting a risk analysis regarding the use of FD&C Red No. 3 in food, beverages, and pharmaceuticals. As Mexico’s national health authority, COFEPRIS continually evaluates food and pharmaceutical additives to ensure public safety and compliance with scientific and regulatory advancements.

International Considerations and Regulatory Review

COFEPRIS is actively assessing the impact of international regulatory decisions, including the recent revocation by the U.S. Food and Drug Administration (FDA) of FD&C Red No. 3 for certain uses. Taking these developments into account, COFEPRIS is performing a thorough risk assessment under the framework of Annex III, which governs colorants with an established Acceptable Daily Intake (ADI) in accordance with the Agreement on Food and Beverage Additives.

The ongoing review will determine whether modifications should be made to the existing list of permitted additives, considering scientific evaluations and international best practices. The process follows Article Fourteen of the Additives Agreement, which allows for the addition, exclusion, or extension of use of additives based on risk assessments conducted by multinational expert bodies. These include the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the Codex Alimentarius, and relevant regulations from the European Union and the United States.

Assessment of FD&C Red No. 3 in Pharmaceuticals

In addition to its use in food and beverages, COFEPRIS is evaluating the presence of FD&C Red No. 3 in pharmaceuticals. The agency has directed its scientific advisory body, the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM), to analyze the inclusion of this colorant within the FEUM’s chapter on pharmaceutical additives. The findings of this analysis will contribute to regulatory decisions regarding the continued use of this dye in medications.

Commitment to Public Health and Regulatory Transparency

COFEPRIS remains committed to safeguarding public health by continuously updating its regulatory framework based on scientific research and international developments.  COFEPRIS will implement any necessary regulatory adjustments following the conclusion of its risk assessment in the coming weeks. You can find the press release in Spanish here.