The agreement, published in the Official Gazette of the Federation on Aug. 21, determines which additives and processing aids are authorized, the product categories in which they may be used and the applicable conditions of use. Like its predessor, it is provided as a “positive list” of substances—a common regulatory practice in Latin America—that serves as an oversight mechanism to ensure quality, efficacy and consumer safety.
The move is expected to trigger formulation reviews across brands, contract manufacturers and ingredient suppliers serving the Mexican market.
“For importing companies and multinationals, the update to the agreement confirms that marketing authorization in their countries of origin does not grant automatic approval or authorization in Mexico; in other words, any formulation introduced to the Mexican market must undergo a formal evaluation against the categories, maximum dosage levels and technological functions outlined in the 11 annexes of the new agreement,” said Yury Caldera, a regulatory affairs consultant for Latin America.
Definition of an additive in Mexico
- "Any substance not normally consumed as food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage stages results, or may reasonably be expected to result (directly or indirectly), in it or its by-products becoming a component of such foods or otherwise affecting the characteristics of such foods (including organoleptic properties). This definition does not include ‘contaminants’ or substances added to the product to maintain or improve nutritional qualities.”
Eleven annexes bring tighter category-by-category controls
The update organizes permitted substances across eleven technical annexes covering categories including colorants, sweeteners, enzymes, processing aids and flavoring agents.
“The new agreement in general remains similar but incorporates some important changes including establishing maximum usage limits for certain colors, which were previously permitted under Good Manufacturing Practices (GMPs) without a numerical limit, and expanding labeling requirements,” explained David Pineda, managing director at DPE International Consulting. “Sweeteners have additional requirements, including the concentration per serving and the applicable Acceptable Daily Intake (ADI).”
If the specific product, product category or applicable maximum limit is not expressly addressed in the annexes, the manufacturer must request an evaluation from the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Submissions should include international regulatory references, an exposure calculation and evidence of consumption within the Mexican population to demonstrate the safety of the proposed use.
The update to the agreement also requires blends containing two or more additives to be supported by detailed technical data sheets that include the name, quantity and function of each component, along with a compliant suggested method of use.
Another significant provision is the setting of maximum contaminant limits for additives including tolerances of no more than 3 mg/kg for arsenic and 10 mg/kg for lead.
Specific to dietary supplements
- The framework establishes specific quantitative limits for additives used in dietary supplements, including 1,000 mg/kg for benzoates; 400 mg/kg for certain antioxidant combinations of BHA, BHT, TBHQ and propyl gallate, calculated on the basis of fats and oils and, where specified, in the product as prepared for consumption; and, for supplements in tablet and capsule form, 840 mg/kg for methylparaben and 170 mg/kg for propylparaben. The framework also establishes additive-specific maximum levels for high-intensity sweeteners and artificial colorants.
- If the applicable additive entry for a dietary supplement specifies a maximum level “en producto listo para consumo,” that maximum applies to the supplement in its ready-to-consume form, including where the supplement is supplied as a powder or concentrate that is subsequently reconstituted according to its directions.
Compliance timeline and obligations
The regulation will enter into force 60 business days after publication in the official gazette, providing companies with a phased timeline that starts the clock for regulatory gap assessments, label and formula reviews, supplier documentation checks and potential product reformulation.
The agreement grants a 12-month window to notify the authority of the certain uses that are not currently listed and allows six months to request inclusion of gold, silver and aluminum colorants, where applicable. Should companies fail to request inclusion of these colorants, an 18-month phase-out period will apply.
For colorants listed in Annex III with an established ADI that were previously permitted under GMPs but are now subject to a specific maximum limit, companies have 24 months to comply with the new requirements.
What’s more, the COFEPRIS website will be updated with modifications to the annexes every three months, and the agreement will be published in the official gazette every six months. Caldera describes this as a more dynamic approach to regulatory updates.
“This shifts away from static reference frameworks and compels companies to maintain continuous monitoring of their product formulations,” he said. “Specifically, economic operators must anticipate changes to their supply chain operations, quality control processes and technical records.”
He highlighted that companies will require regulatory monitoring systems for product-by-product formulation review and harmonization, supplier and product technical data validation, implementation of a reformulation plan and transition schedule, and label compliance to declare additives using their common names or recognized official synonyms.
COFEPRIS will use this additives agreement in tandem with its June 2026 Non-Regulatory Guide for the Classification of Products as Food Supplements, which evaluates a product’s additive profile as part of the criteria for determining whether it is a dietary supplement rather than a drug, herbal remedy or prohibited item.
