COFEPRIS has published updated lists of additives and adjuvants, which are essential reference documents for the formulation of dietary supplements.
UPDATE
In July 2024, the commissioner of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS, by its acronym in Spanish) shared the updated lists of authorized additives for their use in food and dietary supplements.
Included the following lists:
Annex I: Food additives with diverse functional classes and an established ADI (Acceptable Daily Intake).
Included polyacrylic acid for use in solid, semisolid, and liquid dietary supplements. The functionality in the formula is stabilizer and thickener.
Annex III: Colorants with an established ADI (Acceptable Daily Intake).
Included class III caramel color for use in dietary supplements.
REGULATORY FRAMEWORK
By article 168 of the Regulation of Sanitary Control of Products and Services in the manufacturing of dietary supplements has to ensure compliance with the list of authorized food additives.
The use of those additives depends on the product type and purpose of use in the formula (preservative, colorant, emulsifier, gelling agent, antioxidant, pH regulator, and others).
So it is important to consider this information for the product's analysis and classification.
EFFECTS FROM THE RA UPDATE
To classify a product as a dietary supplement, it is important to check the ingredients versus authorized lists of additives and adjuvants for use in. Therefore, it is important to be aware of any updates.
If the dietary supplement includes an ingredient that is not declared in those lists, you have to consider other regulatory strategies.
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