n August 21, 2026, the Agreement determining food additives, processing aids and other substances in food, beverages and food supplements, their uses and sanitary provisions (hereinafter, the “Agreement”) was published in the Official Journal of the Federation (hereinafter, the “DOF”). This regulation abrogates the previous version published on July 16, 2012, and its subsequent amendments, and will enter into force 60 business days following its publication.
The purpose of this new regulation is to update the catalogue of permitted, restricted, or prohibited substances in the manufacture of food, beverages, and food supplements, based on international standards and the most recent scientific evidence.
The Agreement organizes the authorized substances into eleven annexes, which are divided according to the level of risk and the applicable type of sanitary control.
Annexes I, III, and VII contain additives, colorants, and sweeteners with specific numerical limits (expressed in mg/kg or mg/L), determined based on the Acceptable Daily Intake (hereinafter, “ADI”) established by the Joint FAO/WHO Expert Committee on Food Additives (hereinafter, “JECFA”).
Annexes II, IV, and VIII include substances that may be used in accordance with Good Manufacturing Practices (hereinafter, “GMP”), i.e., without a specific numerical limit, but applying the minimum amount necessary to achieve the desired technological effect, without altering the nature, substance, or safety of the product.
Annexes V, VI, IX, X, and XI contain, respectively, purified chewing substances, enzymes, specific rules for infant formulas and special nutrition formulas, processing aids, and authorized flavourings (the latter with their FEMA and IUPAC nomenclature).
For substances not included in Annexes I, III, or VII, the Agreement provides a specific authorization procedure before the Federal Commission for the Protection against Sanitary Risks (hereinafter, “COFEPRIS”).
The corresponding application must demonstrate the safety of the substance based on recognized international standards, such as the Codex Alimentarius, the U.S. FDA, the regulations of Canada, or the European Union.
Additionally, the Agreement establishes a periodic update mechanism, whereby COFEPRIS may amend the lists of additives on a quarterly basis through its website, and every six months through publication in the DOF.
This provision allows the catalogue to remain current based on new scientific evidence or at the request of any interested party, in accordance with evaluations by JECFA, Codex Alimentarius, the European Union, or the United States.
Similarly, COFEPRIS reserves the right to restrict or prohibit additives by means of an official notice served to the interested party, without the need to await a formal amendment, and will publish such determinations on its electronic portal for general information.
In the same vein, when there is knowledge, based on recognized scientific research, that an additive show confirmed evidence of carcinogenic, teratogenic, or mutagenic effects, or any other health risk, its import will not be permitted and its manufacture, storage, and sale will be prohibited.
At the same time, the Agreement prohibits the use of additives in fresh foods such as fresh milk, fresh meat, eggs in shell, whole grains, spices, and fruit juices, unless a specific Official Mexican Standard authorizes it.
With respect to labelling, the Agreement requires that additives be declared in the ingredient list by their common name or synonym, with the exception of enzymes, processing aids, and flavourings.
For sweeteners, the following specific warnings must be included: (i) products containing aspartame must state “PHENYLKETONURICS: CONTAINS PHENYLALANINE”; (ii) table‑top sweeteners based on polyols (sorbitol, xylitol, mannitol, among others) must warn of possible laxative effects from excessive consumption; and (iii) table‑top sweeteners must indicate the concentration per serving and, where applicable, their corresponding ADI.
Colorants must also comply with specific contaminant limits for arsenic, lead, mercury, and residual solvents, and must also meet JECFA monograph specifications.
Finally, the Agreement establishes staggered transition periods to allow manufacturers to comply with the new provisions without disruptions in the supply chain:
- For colorants that were previously used in accordance with GMP and are now subject to a numerical limit, a 24‑month period is granted to reformulate the products.
- For products that were already using additives under the previous regime, a 12‑month period is granted to notify their use under the new procedure; if the evaluation is unfavorable, an additional 24‑month period is granted for reformulation.
- For colorants such as gold, silver, and aluminum that are not included in the text, a 6‑month period is granted to request their inclusion; if no request is submitted, an additional 18‑month period will be allowed to remove them from formulations.
Should you require further information regarding the content of this note or legal assistance, please contact:
Guillermo Solórzano Leiro – Partner
GUILLERMO.SOLORZANO@S-L.MX
Phone: +52 55 50015409
Alan Osorio Aragón – Associate
ALAN.OSORIO@S-L.MX
Phone: +52 55 50620074
