5. Claim Requirements

Infant, Follow-up, Young Child Formula
Mexico

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

5.1.1 Types & Definitions

According to Item 10.3.9 of Mexican Official Standard NOM-131-SSA1-2012, Formulas must not include any nutrition or health claims. However, the regulation foresees some exceptions regarding the declaration of the presence of some nutrients/ingredients and indications linked to a medical condition. These are the following:

a. To include the presence of optional nutrients or ingredients in the product name, other than vitamins, minerals, choline, myoinositol, L-carnitine, taurine, DHA, nucleotides, chromium, and molybdenum. These products can bear claims such as “with probiotics", "with prebiotics", "with lutein" if they comply with 7.6.3.6.1, 7.6.3.6.3.3, 7.6.3.6.5 and 10.3.8.2 of the Mexican Official Standard NOM 131. These conditions are the following: 

1. Scientific evidence demonstrating the usefulness of the optional nutrients/ingredients used must be available to the Secretariat upon request.
2. Only cultures that produce L(+) lactic acid may be used, for infant formulae for infants with special nutritional needs, and follow-on formulae for special nutritional needs may be used provided they have been proven to be safe and suitable for these vulnerable populations, and support must be available to the Secretariat upon request.
3. The nutrition labeling must show the total amount in the appropriate units of vitamins and inorganic nutrients (minerals), choline, and any other nutrients declared in the list of ingredients per 100 kcal.

c. According to Item 10.3.5 formulas for infants with special nutritional needs and follow-on formulas for special nutritional needs must state in appropriate descriptive terms as part of the name the essential characteristic of the formula, but not the specific disorder, disease, or medical condition for which it is intended, e.g., "hydrolyzed protein", "lactose-free". The only specific medical condition that may be included is the use of the terms "preterm" or "low birth weight".

5.1.2 List of Prohibited Claims

Infant Formula and Follow-up Formula

From NOM-131-SSA1-2012: [1]

Terms such as "humanized" (“humanizado”), "maternized" (“maternizada”), or similar should not be used. 

They may not include any type of declaration of nutritional or healthy properties. 

They must not display images or texts that suggest infant formulas and formulas for infants with special nutritional needs as identical and superior to breast or human milk, in accordance with the recommendations of the World Health Organization for marketing breastmilk substitutes.

5.2 Nutritional Claims

5.2.1 Permitted Claims

Infant Formula, Follow-up Formula, and Young child formula [1]

It is prohibited to include any type of nutrition and health claims.

• In the case of formulas that contain nutrients or optional ingredients, different from those established in Tables No. 3, No. 4, No. 6, and No. 7, it is allowed to include their presence within the denomination, as long as they comply with the conditions below. For example “with probiotics” (“con probióticos”), “with prebiotics” (“con prebióticos”), “with lutein” (“con luteína”).
• In formulas for infants, other nutrients/ingredients normally present in the breast or human milk may be added in sufficient quantity in order to achieve the nutritional or physiological effect of the latter, on the basis of the amounts present in human milk and to ensure that it is suitable as a sole source of nutrition for the infant. Its suitability and safety must be scientifically proven.
• There must be scientific evidence that demonstrates the usefulness of the optional nutrients/ingredients used and be available to the Secretariat upon request.
• Only cultures that produce L(+) lactic acid may be used.
• The total amount in the corresponding units of vitamins and inorganic nutrients (minerals), choline, and any other nutrient declared in the list of ingredients per 100 kcal.

5.2.2 Nutritional Claim Registration 

There is no registration of claims for these products. Only those exceptions referred to in section 5.1.1 must be considered the following: 

Since formulas are not subject to registration in Mexico, there is no formal procedure to verify the compliance of the above-mentioned conditions, thus, to get a kind of “authorization” to include their presence in the name of the product, a case-by-case assessment called in Spanish “Escrito libre” shall be applied. This is a free letter addressed to the Federal Commissioner that shall be submitted at COFEPRIS requesting the evaluation of the product and the corresponding mention of the optional nutrient in the product's name. The letter must include:

1. Name of the company interested.
2. Name of the legal representative in Mexico, if applicable, attaching the documents proving their identity.
3. Address of the applicant.
4. The administrative body to which it is addressed.
5. The express request being made should include any information or documentation that you consider necessary to support your request, for example:

- A description of the product 

- Composition/formula

- Intended use

- Mechanism of action (if applicable)

- Scientific support of efficacy and safety for human consumption

- Physicochemical and microbiological test methods

- Label (or its draft version)

This procedure is free of cost. COFEPRIS is currently taken about 12 months to answer, but this may vary depending on the complexity of the substance and the quality of the information submitted. 

Although the “Escrito libre” is not a formal procedure described in the Mexican regulation, the answer received is considered an official opinion useful to support the corresponding prior import procedures avoiding rejections or refusals to import the product.

There is no possibility of getting approval for claims different from the exceptions for these products. 

For the exception referred to in section 5.1.1 (c), the procedure to verify the compliance of the statement used is the same as above described.

5.3 Health Claims

5.3.1 Permitted Claims

Infant Formula, Follow-up Formula, Young Child Formula [1]

N/A. Health claims are not allowed for infant formula and follow-up formula.

5.3.2 Health Claim Registration

Infant Formula, Follow-up Formula, Young Child Formula [1]

There is no registration of claims for these products. 

There is no possibility of getting approval for claims different from the exceptions for these products. 

Note: Due to nutritional and food policies in favor of breastfeeding, Mexico is a very restrictive market regarding the use of nutritional and health claims on formulas. On several occasions, the industry has submitted requests for revision of the Mexican Official Standard NOM-131-SSA1-2012 [1] indicating the need to remove this prohibition in order to favor and align national production with international evidence-based rules, however, both COFEPRIS and the Mexican government have decided to maintain it and position breastfeeding over the use of formulas.

5.4 Other Notes or Requirements for Claims

None.

5.5 References

1. NORMA Oficial Mexicana NOM-131-SSA1-2012, Productos y servicios. Fórmulas para lactantes, de continuación y para necesidades especiales de nutrición. Alimentos y bebidas no alcohólicas para lactantes y niños de corta edad. Disposiciones y especificaciones sanitarias y nutrimentales. Etiquetado y métodos de prueba

Official Mexican Standard NOM-131-SSA1-2012, Products and Services. Formulas for infants, follow-up formulas, and for special nutrition needs. Food and non-alcoholic beverages for infants and young children. Health and nutritional provisions and specifications. Labeling and test methods

https://www.sinec.gob.mx/SINEC/Vista/Normalizacion/BusquedaNormas.xhtml

2. COFEPRIS' Procedures and services

https://www.gob.mx/cofepris/acciones-y-programas/tipo