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.

In a move aimed at enhancing environmental protection and regulating the import and export of hazardous substances, Mexico has amended its regulatory framework for the Control of Pesticides, Fertilizers, and Toxic Substances (CICOPLAFEST). These amendments, published in the Official Gazette of the Federation on March 14, 2024, came into effect 30 days after the publication and represent a significant change in Mexico's environmental regulatory landscape.

The revised agreement introduces several modifications and additions to various articles and annexes, notably impacting the classification, verification, and exportation procedures for substances falling under CICOPLAFEST. Below are the key highlights of the amendments:

1. Updated Definitions:

• The inclusion of the acronym for PROFEPA (Federal Attorney for Environmental Protection) broadens the range of regulatory entities involved in overseeing environmental compliance.

• The refinement of the "Regulation" description now includes references to the "Verification Registry," in addition to existing authorization and permit requirements, reflecting a more comprehensive regulatory approach.

2. Enhanced Verification Requirements:

• Addition of the mandate for verification and compliance with the PROFEPA verification registry for goods listed in Annex I underscores the government's commitment to ensuring adherence to environmental standards at entry and exit points.

• The requirement for attaching digital or electronic documentation to customs declarations streamlines verification processes and enhances transparency in regulatory compliance.

3. Goods Subject to Compliance with CICOPLAFEST:

• Annex I now incorporates a new homoclave system, introducing a standardized method for identifying substances subject to regulatory oversight.

• The classification of goods into distinct categories, including pesticides, toxic substances, and fertilizers, facilitates targeted regulatory measures tailored to specific environmental risks associated with each category.

4. Clarified Exportation Procedures

• Export procedures for substances outlined in Article Four, Annex II are clearly outlined, ensuring exporters are aware of their compliance obligations, minimizing regulatory ambiguities.

• Specific mention of goods not covered in Annex I underscores the necessity for export authorization, eliminating potential loopholes in oversight mechanisms.

These regulatory amendments represent a significant step forward in Mexico's efforts to strengthen environmental protection measures and promote sustainable development practices.

Stakeholders across affected industries are urged to familiarize themselves with the amended regulations and take proactive steps to ensure compliance within the stipulated timeframe.