Mexico’s food additive regulatory framework received important updates in 2026. Two documents are particularly important for businesses that wish to introduce a new food additive or extend the permitted use of an existing one. It’s the FF-COFEPRIS-37 application form, published on September 18, 2026. There’s also COFEPRIS’s October 2026 guide for estimating dietary exposure to food additives with an established Acceptable Daily Intake (ADI).
The two documents serve different purposes. FF-COFEPRIS-37 is an application form, while the October 2026 exposure guide is a non-binding technical resource. Continue reading to know this update.
Food Additives and Processing Aids Regulatory Framework in Mexico
Mexico regulates food additives and processing aids through the following:
- General Health Law
- Regulation of Sanitary Control of Products and Services (RCSPS)
- The Ministry of Health’s Agreement
They regulate additives and processing aids in food, beverages, and food supplements. It covers their uses, sanitary provisions, lists, and conditions that govern additive use in the covered products. Companies must check the substance, food category, technological function, and permitted use level before they include an additive in a formulation.
Articles 201–203 of the RCSPS say that additives must be used only in the amount needed so they can achieve the intended effect. Their limits must not go over those established by the Agreement. They must also satisfy the safety and functional requirements that are relevant.
Article 203 particularly is about clarifying that additives must be harmless at the permitted use level. They should have a useful function and not be used to conceal defects in sanitary quality. They must also not be used when good manufacturing practices can solely help achieve the desired effect. An analytical method must also be available, as it can control the additive’s use. Its inapplicability must be justified. The applicable rules also provide warning labels for products with additives. Companies should check the labeling rules for their particular product.
What are Food Additives and Processing Aids?
Food additives are substances added to food or beverages. They perform specific technological functions. The functions can be any of the following:
- Preserving freshness
- Improving texture
- Maintaining color
- Enhancing flavor
- Extending shelf life
Processing aids are substances used during food processing. They help achieve a particular technical purpose. They are not intended to have a technological effect on the final food. However, their residues may remain.
COFEPRIS FF-COFEPRIS-37: What Changed in September 2026?
September 18, 2026, was the publication date for FF-COFEPRIS-37, “Format for Incorporating Substances or Elements into the List.” The form gives a standardized way to submit a request to modify specified lists. It covers three categories:
- Additives and processing aids for food, beverages, and food supplements
- Permitted or restricted ingredients for perfumery and beauty products
- Plants banned or allowed for teas, infusions, and edible vegetable oils
Applicants should select the first category for a request about food additives or processing aids.
Information Requested in the Form
The three-page form requests the following information:
- Procedure details: The procedure code and name.
- Owner or applicant details: Identification and contact information for an individual or legal entity.
- Legal representative info: Information about the person submitting the request on behalf of the owner.
- Tax address: Postal code, road name, exterior and interior numbers, settlement, nearby roads, locality, municipality or borough, and federal entity.
- Authorized persons: Names and contact details for connected & authorized individuals.
- Reasons for the request: A brief description of the requested change. Also, the facts or reasons supporting it.
- Email for notifications: An email address for receiving notifications concerning the procedure. It’s a mandatory field.
- Declaration and signature: Truthful and verifiable information must be ensured. The form is signed by the owner or legal representative.
The form also asks about the accompanying information. There may be confidential data that can be provided to the public. Be careful in choosing questions when submitting supporting material.
COFEPRIS instructs applicants to complete the form legibly. It can either be by hand in block letters or electronically. Erasures or alterations to the information will invalidate it. Additional legal representatives or authorized persons can be listed by reproducing the corresponding section as many times as necessary.
Important: FF-COFEPRIS-37 records the application and applicant details. It does not replace the scientific evidence needed to support a requested change.
Technical and Scientific Requirements Under Article 208
Article 208 of the RCSPS describes the information required to request changes to the lists of permitted, prohibited, or restricted additives. The October 2026 guide reproduces these requirements. It explains how dietary exposure calculations can support a request. The principal information includes the following:
1. Identification of the Additive
Applicants must provide the generic name and best-known synonym for a chemical substance. The genus and species should be known for a substance derived from a plant or animal. Provide the condensed and structural chemical formulas where proper and known
2. Justification of the Technological Function
The applicant should explain the function of the additive in the food or beverage. The justification should recognize the intended technological purpose. It should explain why the substance is proposed for the requested use.
3. Toxicological Evidence and Safety Assessment
Article 208 calls for short- and long-term toxicological studies of national or foreign origin. It specifically refers to the LD50 in laboratory mammals. Also, it calls for the acceptable daily intake used to evaluate safety. This includes assessment of cancer-related and teratogenic effects where applicable. The supporting evidence should provide a scientific basis for assessing the proposed use and the potential risk to consumers.
4. Analytical Methods
Applicants must provide analytical methods to determine the additive’s identity, purity, and contaminants. These methods help establish that the substance can be recognized and its quality and use controlled.
5. Proposed Products and Use Levels
The applicant must detect the products in which the additive is proposed to be used along with the proposed quantity or concentration. The information must assess whether the use it is for stays within the relevant safety margins. The technical submission should be in line with the requested change.
Can International Evaluations Support a Request?
Yes. The guide also reproduces provisions that a request to modify the lists may be supported by evaluations. It also takes approval support from the following:
- Joint FAO/WHO Expert Committee on Food Additives (JECFA)
- The Codex Alimentarius
- European Union
- United States of America
It is submitted to the Secretariat for consideration.
Article 208 Bis: Use of Evaluated and Published Additives
Article 208 Bis of the RCSPS provides a route. Under this, additives and processing aids evaluated and approved by the health authority may be used before the Additives Agreement is updated. This happens when the substances are published on the COFEPRIS website. The October 2026 guide also reproduces the provision stating that the Agreement must be updated every six months. This provision is important because the publication of an approved substance and the subsequent updating of the Agreement are connected but distinct steps.
COFEPRIS Guide to Dietary Exposure Assessment
In October 2026, COFEPRIS published its Guidelines for Estimating Exposure to a Food Additive with an Established ADI. It is for manufacturers, formulators, importers, and distributors of food, beverages, and food supplements. They prepare requests under Article 208 of the RCSPS or the matching provisions of the Additives Agreement.
The guideline intends to explain a method for estimating dietary exposure to an additive with an accepted ADI. Applicants can also present their calculations to COFEPRIS in a standardized format. The guide can substantiate requests to include a new additive in the lists. Or, it can extend the authorized uses of an existing additive. It is particularly useful when the proposed use could change the amount of the additive consumers receive from their overall diet.
The guide is non-binding. It has no independent legal validity. It does not certify that you are compliant. There’s no replacement of current regulations or removal of the need to submit the required procedure. The guide draws on the FAO/WHO document. Its name is Guidelines for a Simple Evaluation of Dietary Exposure to Food Additives (CAC/GL 3-1989).
How COFEPRIS Estimates Dietary Exposure to an Additive?
The October 2026 guide describes a simple screening method called the theoretical maximum daily intake method (IDMT in the guide). It estimates the amount of an additive that could be consumed through different food categories and compares the total with the established ADI.
The method uses food-consumption figures and the additive’s maximum use levels. It provides a conservative first estimate.
Step 1: Compute the Acceptable Daily Amount Per Person
The guide uses the following formula: C = A × B
Here,
- C = Acceptable daily amount per person, in mg/person/day.
- A = Established ADI, in mg/kg body weight/day.
- B = Reference body weight, in kg.
Step 2: Estimate Exposure from Each Food Category
The guide uses the following calculation: G = F × D. Here,
- G = Estimated contribution to theoretical maximum daily intake, in mg/person/day.
- F = Per capita daily consumption of the food, in kg or liters per person per day.
- D = Maximum use level of the additive, in mg/kg of food or mg/liter of beverage.
The calculation is carried out separately for each food category included in the assessment.
Step 3: Add the Food-Category Contributions
The estimated contribution from each category is added to calculate the total theoretical maximum daily intake. The total is then compared with the acceptable daily amount calculated from the ADI and reference body weight. Consistent units should be used throughout the calculation.
Why is this a Conservative Estimate?
The screening method can overestimate actual intake. That’s because it may assume the following:
- Every food in which the additive is permitted contains it at the maximum use level.
- Consumers eat the foods included in the calculation.
- Processing, storage, or preparation doesn’t lead to additive loss.
These assumptions and initial estimates may not show actual consumption or the concentration of an additive in every food.
What Data Is Needed for an Exposure Calculation?
The reliability of an exposure estimate is based on the quality and suitability of used data. The guide discusses the information required to estimate dietary exposure. It includes food consumption and the concentration of the additives in food. The following are some critical inputs:
- Food-consumption data: The amount of each food or beverage consumed by one person over a defined time.
- Additive use levels: The maximum permitted level or the proposed level for each food category.
- Food categories: The additive is currently allowed along with any additional categories covered by the request.
- Additive concentrations: Information about actual or expected concentrations in foods when a more refined estimate is needed.
- ADI and body weight: Used for the calculation.
If the starting screening estimate goes over the ADI, more specific data may help decide if the conservative assumptions have overstated likely exposure.
What if the Estimated Exposure Exceeds the ADI?
It does not automatically establish that actual consumer exposure will be greater than the ADI. Conservative assumptions are being used in the screening calculation. So, the guide describes ways to refine the estimate. The suggested steps are mentioned below:
1. Review the Food Categories
See if all categories included in the first calculation are correct for the proposed use.
2. Detect Actual Use Patterns
Decide whether the additive is used in all permitted foods. Or, they are only added in specific products or subcategories.
3. Use More Specific Concentration Data
Consider the maximum effective use levels reported by the food industry where they are available. Or, have their average concentrations measured in foods.
4. Recalculate Exposure
Use the refined data. Estimate the contribution that comes from every food category as well as the total exposure. Assess the refined result against the established ADI. Also, see the conditions of the proposed use. Clearly explain any assumptions or limitations in the data.
COFEPRIS Exposure-Calculation Format and Database
There’s a standardized format for presenting exposure calculations. COFEPRIS also provides a database intended to support these calculations. The format has two main parts.
Part 1: Additive Identification and Acceptable Daily Amount
The applicant enters the additive name, INS number, and established ADI. The format then calculates the acceptable daily amount per person using the reference body weight.
Part 2: Food-Category Exposure Calculations
The applicant records the food categories in which the additive is currently used or permitted. It covers the additional categories included in the request, where applicable. The format also records the maximum use limits and per-capita consumption figures.
The contributions from the individual food categories are combined to calculate the total theoretical maximum daily intake. The guide states that the database contains preloaded information for additives. There are established ADIs in Annex III of the Additives Agreement, and it provides a blank format for a request involving a new additive.
The guide also links the use of the Annex III database with the beginning of the new Agreement. So, companies should check the current status of the Agreement, the database, and the relevant annexes before they use the data in a submission.
When does the 2026 Additives Agreement Take Effect?
August 21, 2026, was the date of the Additives Agreement publication in the Official Gazette of the Federation. Its transitional provision states that it enters into force 60 business days after publication.
Conclusion
Mexico’s 2026 food additive updates provide a clearer process for requesting changes to the lists of permitted, prohibited, or restricted substances. FF-COFEPRIS-37 standardizes the application details. Article 208 provides scientific information supporting a request. The October 2026 COFEPRIS guide practically provides for estimating dietary exposure to additives with official ADIs. It explains how to combine food-consumption figures and additive use levels and compare the estimate with the ADI. Also, refine the calculation when conservative assumptions produce a high result.
Businesses should keep the legal requirements distinct from the guide’s recommendations. Before introducing a new additive or extending an existing use, they should verify the current regulatory lists, prepare the required evidence, and check the effective status of the 2026 Agreement and its supporting database.
For businesses seeking support with food additive compliance, ingredient assessments, and regulatory requirements in Mexico, Artixio offers nutrition regulatory services in Mexico, including regulatory planning and COFEPRIS coordination.
FAQs
1. What is FF-COFEPRIS-37?
FF-COFEPRIS-37 is a COFEPRIS form for requesting the incorporation of substances or elements into specified lists. It covers food additives and processing aids, some cosmetic ingredients, and specific plants used for teas, infusions, and edible vegetable oils.
2. Is the October 2026 guide legally binding?
No. COFEPRIS recognizes the document as a non-binding guide without independent legal validity. It provides a calculation of methodology and recommendations but does not replace the applicable legislation or required procedures.
3. Does completing FF-COFEPRIS-37 authorize the use of a new additive?
No. The form records the request and applicant information. The request must be supported by the scientific and technical information required under the applicable provisions, and the substance’s use must be assessed under the Mexican regulatory framework.
