New Agreement on Additives and Processing Aids in Food, Beverages and Food Supplements

The purpose of this note is to inform you that, on August 21^st, 2026, the Ministry of Health (the “Ministry”) published in the Federal Official Gazette (the “DOF”) a new Agreement that determines the additives¹ and processing aids² permitted in food, beverages and food supplements, as well as their use and applicable health provisions (the “Agreement”). The Agreement fully replaces the framework in force since 2012 and sets out a compliance calendar with several relevant dates for the industry, the first of which falls in mid-November of this year.

Relevant Amendments

We highlight below six changes applicable to the activities regulated by the Agreement:

1.- New numerical limits on colorants (Annex³ III). Several colorants that were previously permitted under Good Manufacturing Practices⁴, with no specific cap, are now subject to a maximum quantitative limit per food category. Affected parties have 24 months to adjust their formulations.

2.- Periodic update mechanism for the annexes. The Agreement provides that the Federal Commission for the Protection against Sanitary Risks (the “COFEPRIS”) will publish quarterly updates to the annexes on its website, in addition to a republication of the full Agreement in the DOF every six months.

3.- Notification procedure for unlisted uses. When a product or category is not expressly included in Annexes I, III or VII, there is a 12-month period to notify such use to the authority, with an additional 24-month period to reformulate if the request is denied.

4.- Special regime for gold, silver and aluminum colorants. Parties using these colorants where they are not contemplated in the text of the Agreement have 6 months to request their inclusion, and if they do not, an additional 18 months to remove them from their formulations.

5.- Full replacement of the prior framework. The Agreement does not amend, but instead fully repeals the agreement published on July 16^th, 2012, and its amendments of September 5^th, 2013, and May 16^th, 2016, consolidating the entire subject matter into a single updated instrument.

6.- Content organized into eleven technical annexes. The Agreement groups permitted substances into eleven specialized annexes (for example, colorants, sweeteners, enzymes and flavorings), each with its own food categories and use limits, making it easier to pinpoint exactly which substances apply to each type of product.

Effective Dates

In general terms, the Agreement will enter into force on November 17^th, 2026; however, it sets out a phased implementation timetable for certain obligations.

Recommendations

We recommend that our clients review the additives and processing aids currently used in their formulations against the limits and categories set out in the updated annexes, paying particular attention to colorants that moved from a Good Manufacturing Practices scheme to a specific numerical limit. We further suggest monitoring the quarterly updates that COFEPRIS will publish on its website and confirming the exact effective date against the official business-day calendar before setting internal compliance deadlines. We remain available to analyze the specific application of the Agreement to your operations.

[1] Under the Agreement and article 215, section IV, of the General Health Law (Ley General de Salud), an additive is any substance not normally consumed as a food by itself, but intentionally added to a product during its manufacturing, packaging or storage for a technological purpose (for example, to preserve, color or thicken it), affecting one of its characteristics.

[2] A processing aid (coadyuvante de elaboración) differs from an additive. It is used during manufacturing to achieve a technical effect but is not consumed as an ingredient of the final product, although it may leave unintended but unavoidable residues.

[3] The annexes are the Agreement’s technical lists (eleven in total) that specify, substance by substance, in which foods each additive or processing aid may be used and, where applicable, the maximum permitted dose.

[4] Permitting an additive “under Good Manufacturing Practices” means the law does not set an exact maximum amount in milligrams but instead requires using only the minimum dose necessary to achieve the intended effect, without altering the nature or safety of the product.