RAUpdate: Prohibition of Erythrosine (Red 3 FD&C) in the Mexican Food Industry
The Mexican Ministry of Health (Secretaría de Salud) has issued an Agreement to eliminate the use of the coloring agent Erythrosine and its lakes (Red 3 FD&C) in food, beverages, and dietary supplements. This measure responds to a risk analysis that determined that the population's exposure exceeds internationally established safety limits. This RAUpdate is essential for quality directors, formulators, and regulators in the dietary supplements, food, and beverage industry, as it establishes a 24-month transition period for product reformulation and inventory depletion.
UPDATE
On May 28, 2026, the Agreement prohibiting the use of Erythrosine (SIN 127, Food Red 14) was published in the Official Gazette of the Federation (DOF). This regulatory update arises after a sanitary surveillance process initiated by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in January 2025.
The importance of this measure lies in the protection of the human right to health, especially for the child population, identified as the group with the highest consumption of products containing this additive, such as gummies, gelatins, and candies. The industry now faces a technical and logistical challenge to replace a coloring agent that, although it had limited uses, was present in a wide range of commercial categories under previous regulatory interpretation criteria.
REGULATORY FRAMEWORK
The regulatory framework that supports this decision is based on the Ministry of Health's authority to regulate substances that represent a sanitary risk. The legal foundations include:
Political Constitution of the United Mexican States: Article 4, which enshrines the right to health protection.
General Health Law: Articles that empower sanitary control over the processes, import, and export of additives.
Regulation for Sanitary Control of Products and Services: Articles 201, 203, and 205, which stipulate that additives must not exceed permitted limits and must be suspended if there is evidence of health risks.
Key Points of the Risk Assessment
COFEPRIS and its Scientific Council determined the inviability of keeping Erythrosine on the market based on the following technical findings:
Exceedance of the acceptable daily intake (ADI): The FAO/WHO Joint Expert Committee on Food Additives (JECFA) establishes an ADI of 0.1 mg/kg body weight per day. The analysis in Mexico detected that current exposure exceeds this limit by up to two times.
Theoretical maximum daily intake (TMDI): A value of 0.231 mg/kg bw/day was estimated, which represents an unacceptable risk.
Toxicological evidence: Studies (Borzelleca et al., 1987) are cited showing that this coloring agent can induce thyroid tumors in animal models (rats), a scientific basis that supports the current ADI.
Changes in consumption: The use of Erythrosine was identified in categories not originally foreseen in the 2012 Accord, but permitted by generality clauses, which increased population exposure.
EFFECTS FROM RAUPDATE
The delisting of Red 3 FD&C from Annex III of the Additives Accord generates a profound and multifactorial impact on the industry. Manufacturers must consider the following scenarios:
1. Implementation and transitional deadlines
The Agreement enters into force the day after its publication (May 29, 2026). However, Transitional Article Two grants a 24-month period for companies to carry out two critical actions:
Product reformulation: Technical substitution of the coloring agent.
Inventory depletion: Removal of products already manufactured with Erythrosine from the market.
2. Technical reformulation challenges
Substituting Erythrosine is not a trivial process. Companies must perform:
Shelf-life studies: To ensure the new coloring agent maintains visual stability during the commercialization period.
Process and equipment adjustments: Some substitutes may require different mixing or temperature conditions.
Maintenance of sensory attributes: Ensuring the consumer does not perceive a degradation in the product's appearance or acceptability.
About IPS
At IPS, we support manufacturers and distributors of dietary supplements in strategically complying with COFEPRIS regulations. Our goal is to minimize the regulatory risks of their products by facilitating consultation processes for classification, labeling, and technical reformulation. Contact us to learn more about how we can help you: info@insumosparasalud.com