New Agreement on Additives and Processing Aids in Food, Beverages and Dietary Supplements: Update of the Sanitary Regulatory Framework

Executive Summary

• Publication: Official Gazette of the Federation, August 21, 2026.
• Validity: November 13, 2026
• Abrogates: Additives Agreement of 2012 and its amendments of 2013 and 2016.
• Reach: Determine the permitted, restricted and prohibited additives and processing aids in food, beverages and food supplements.
• Dynamic Update: The Annexes will be updated every three months on the COFEPRIS website and every six months through publication in the DOF.

On August 21, 2026, it was published in the Official Gazette of the Federation (“DOF") he “Agreement determining the additives and processing aids in food, beverages and food supplements, their use and sanitary provisions” (he "Agreement 2026“), issued by the Secretary of Health, David Kershenobich Stalnikowitz, based on the General Health Law and the Regulations for Sanitary Control of Products and Services (“RCSPS“), and through the Comisión Federal para la Protección against Riesgos Sanitarios ( "COFEPRISThe 2026 Agreement updates and repeal the previous one published on July 16, 2012 and its amendments of September 2013 and May 2016 (the “Agreement 2012“), consolidating in a single text the regulatory framework applicable to the use of food additives in Mexico.

Significant Changes: Comparison of the 2012 Agreement vs. the 2026 Agreement

Although the 2026 Agreement maintains the basic structure of the 2012 Agreement (11 Annexes, definition of GMP, reference to the RCSPS), it introduces fundamental adjustments that directly impact the operation of the industry.

1. Permitted, restricted and prohibited additives

The 2012 Agreement already grouped additives into eleven Annexes; the 2026 Agreement updates and expands those lists (in particular Annexes I, III and VII), incorporating new substances (e.g.

 sweeteners such as advantame, neotame, aspartame-acesulfame combinations, new preservatives and emulsifiers) and specifying in a more granular way their categories of use and maximum limits.

Regarding restrictions and prohibitions, both instruments rely on articles 201, 203 and 205 of the RCSPS: only additives free from alterations and without evidence of serious health risk are permitted.

 Agreement 2026 reinforces the regulatory consequence: when an additive shows confirmed evidence of carcinogenic, teratogenic or mutagenic effects, its import, production, storage and sale are prohibited, and the corresponding lists must be modified.

2. New functional classes and technological precision

Both agreements identify functional classes based on the International Numbering System (INS).

 Text 2026 maintains the logic and expands and details the technological functions: for example, it expressly recognizes functions such as “inert substances carrying nutrients”, “flavor or aroma modifiers” or “bulk enhancers” for certain polymers and resins, which aligns the Mexican framework with the most recent terminology of the Codex and JECFA and facilitates the classification of new complex products (supplements, encapsulated mixtures, functional matrices).

3. Maximum limits for pollutants

The 2012 Agreement already included limits on pollutants; the 2026 Agreement consolidates and makes them explicit in general provisions:

• Additives in general: arsenic (≤ 3 mg/kg), heavy metals (≤ 40 mg/kg), lead (≤ 10 mg/kg).
• Colorants (Annexes III and IV): mercury (≤ 1 mg/kg), residual solvents (≤ 50 mg/kg), in addition to complying with JECFA monographs.

This clarification strengthens traceability and analytical verification, forcing the industry to more accurately review its raw material specifications and quality control.

4. Dynamic update mechanisms

The 2012 Agreement already provided, based on articles 208 and 208 Bis of the RCSPS, that the lists of additives could be modified at the request of the party and that the approved substances could be used once they were published on the COFEPRIS website.

The 2026 Agreement institutionalizes this scheme as a permanent policy, incorporating two key elements:

• Mandatory update frequency:
• Annexes updated on the COFEPRIS website every 3 months.
• Consolidated publication in the Official Gazette of the Federation (DOF) every 6 months.

Express anchoring to international standards: it is centrally recognized that incorporation or modification may be supported by assessments from JECFA, Codex, the EU and/or the United States.

In practice, this reduces the regulatory gap with respect to global innovations, but it also imposes on companies the burden of continuously monitoring the COFEPRIS website.

5. Procedures before COFEPRIS

The 2012 Agreement already allowed for the use of additives not included in the list. The 2026 Agreement systematizes the minimum content of the application (Codex provisions, US, Canadian, and EU regulations, exposure calculations, and consumption data for the Mexican population) and clarifies that COFEPRIS can impose provisional measures during the evaluation.

For the industry, this means that:

• The reports must incorporate more robust exposure analyses adapted to the national consumption pattern.
• The regulatory strategy should consider harmonization with international frameworks from the product design stage, not just at the time of application.

In practical terms, the 2026 Agreement obliges companies to:

• Map all current formulations that use:
  • Colorants with ADI from Annex III whose uses were under GMP,
  • Additives in categories not listed in Annexes I, III and VII, and
  • Gold, silver and aluminum colorants.
• Define a transition plan to:
  • Adjust concentrations to the new numerical limits (24-month deadline).
  • Prepare and submit complete notifications to COFEPRIS (12-month deadline).
  • Reformulate products in case of unfavorable resolutions (24 months from the resolution).
  • Replace metallic colorants if their inclusion is not obtained (up to 24 months effective after entry into force).

Overall, the new 2026 framework maintains the structural logic of 2012 but It strengthens traceability, international alignment, and the predictability of compliance deadlines., imposing a more technical and proactive regulatory management on the industry.