New Agreement regarding Additives and Adjuvants in Foods, Beverages, and Dietary Supplements
August 26, 2026
On August 21, 2026, the Secretary of Health published the new Agreement establishing additives and adjuvants in foods, beverages, and dietary supplements, their use and health regulations in the Official Gazette of the Federation. The regulatory health framework applicable to these substances, including technological functions, conditions, and maximum use limits, has been updated as a result.
The new Agreement replaces the agreement published on July 16, 2012, and its amendments dated September 5, 2013, and May 16, 2016. The regulation keeps the eleven annexes that classify additives and adjuvants according to their characteristics and conditions of use, including colorants, sweeteners, enzymes, adjuvants, and flavorings.
One of the important updates concerns acceptable daily intake for additives, colorants, and sweeteners; they are listed, respectively, in Annexes I, III, and VII. When an annex does not expressly address a product, a product category, or applicable maximum limits, the manufacturer must request an evaluation from the Federal Commission for Protection Against Health Risks (COFEPRIS). The manufacturer must submit international regulatory references, an exposure calculation, and evidence of consumption among the Mexican population to demonstrate the safety of the proposed use.
The Agreement permits the use of flavorings recognized by leading international organizations or authorities, provided that authorized products and limits are respected and the COFEPRIS is notified in advance of their use, as well as those established by the Secretary of Health based on the Commission’s evaluation. For naturally occurring flavorings, exclusions and limits are established for certain substances.
Additives on labeling must use their common names or a synonym established in the Agreement, with the exception of enzymes, adjuvants, and flavorings. Products containing sweeteners must indicate milligrams or grams per 100 grams of the product, and in the case of table-top sweeteners, the concentration per serving and acceptable daily intake, when applicable.
Maximum limits of arsenic, heavy metals, and lead are established for additives, as well as additional limits for mercury, residual solvents, and other contaminants in colorants.
Additives, colorants, and sweeteners permitted under good manufacturing practices—as listed in Annexes II, IV, and VIII—are prohibited in fresh milk, fresh meat, shell eggs, whole or crushed grains, spices, and fruit juices, as well as in any other product expressly prohibited by an Official Mexican Standard.
Finally, manufacturers of mixtures containing two or more additives must provide a technical data sheet indicating the name, quantity, and technological function of each component, as well as the suggested method of use, which must ensure compliance with applicable specifications.
Key points:
• The lists, categories, conditions, and maximum limits for additives and adjuvants have been comprehensively updated.
• The Agreement published in 2012 and its amendments from 2013 and 2016 will be repealed.
• Product formulations and labels must be updated in accordance with the new annexes.
• A procedure has been established with the COFEPRIS for the use of certain additives in products or categories that are not expressly addressed in the Agreement.
• Specific requirements for flavorings, sweeteners, and additive mixtures are incorporated.
• The general contaminant limits applicable to additives and colorants have been updated.
• The annexes modifying additives will be updated every three months on the COFEPRIS website. Likewise, updated versions of the Agreement will be published every six months in the Official Gazette of the Federation.
Specific deadlines for bringing certain products into compliance are established in the transitory articles:
| Condition | Deadline |
| General entry into force of the Agreement | 60 business days following its publication |
| Compliance with colorant formulations listed in Annex III that previously were permitted for use in accordance with good manufacturing practices, but now have a numerical maximum limit. | 24 months from the date of publication |
| Notification of the use of additives in products or categories not included in Annexes I, III, and VII that were used under the previous Agreement | 12 months |
| Reformulation when COFEPRIS determines that a previously submitted application is not admissible | 24 months from the date of the decision |
| Application for the inclusion of gold, silver, and aluminum colorants | 6 months from the effective date |
| Removal of gold, silver, and aluminum colorants if their inclusion is not requested in a timely manner | 18 months after the expiration of the previous deadline |
The Agreement will enter into force on November 17, 2026, 60 business days following its publication in the Official Gazette of the Federation. As of this date, the Agreement published on July 16, 2012, along with its amendments from September 5, 2013, and May 16, 2016, will be repealed.
At Arochi & Lindner, we are analyzing the Agreement and its annexes to identify the primary implications to assist clients in implementing the required actions within the applicable transition periods.
The full text is available here: DOF—Official Gazette of the Federation.
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