3. Compositional Aspects

Infant, Follow-up, Young Child Formula
Mexico

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

Infant, Follow-up and Young Child Formula 

In NOM-131-SSA1-2012, 7.6.3 Nutrition: [1]

• For Vitamins, see Table 3
• For Minerals, see Table 4 
• See also, Reference Nutritional Values in Table 14
• See also the permitted forms of vitamins and inorganic nutrients (minerals) in Appendix A
• For essential nutrients such as Choline, Taurine, and DHA, see Table 6
• For Proteins, see Table 8
• For Fatty Acids, Lipids, or Fats, see Table 9
• Carbohydrates content must be 9 g/100 kcal - 14 g/100 kcal
  

In NOM-086-SSA1-1994: [2]
See Appendix B, of the Recommended Daily Intake for Children, established by the National Institute of Medical Sciences and Nutrition "Salvador Zubirán".

3.2 Raw Material Requirements

Infant, Follow-up and Young Child Formula [1][3][4][5][6]

Products and raw materials must comply with the Regulation for the Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios). In addition, raw materials:

• Must be safe and harmless.
• Must not exceed the maximum residue limits of pesticides established in the Official Pesticides Catalogue (CICOPLAFEST) nor contain any pesticide forbidden by this Catalogue per raw material's nature.
• Must comply with the corresponding Official Mexican Standards (e.g. NOM-040-SSA1-1993 Salt; NOM-243-SSA1-2010 Milk and products thereof, NMX-F-003-SCFI-2004 Sugar Refined, NOM-159-SSA1-2016 Egg and products thereof, NOM-247-SSA1-2008 Cereals and products thereof, etc).

Products and raw materials must not be irradiated.

Commercially sterile products must comply with the provisions of the Official Mexican Standard NOM-130-SSA1-1995.

3.3 Fortification

Infant, Follow-up and Young Child Formula

From NOM-086-SSA1-1994: [2]

The minimum and maximum limits allowed for the addition, fortification, and enrichment of food and non-alcoholic beverages will be from 5 to 100% per serving of the recommended daily intake (Appendix B, Of the Recommended Daily Intake for Children, established by the National Institute of Medical Sciences and Nutrition "Salvador Zubirán"), as long as the nutrient contribution under normal conditions or usual consumption, do not exceed the recommended daily intake.

3.4 Other Permitted Ingredients

Infant, Follow-up, and Young Child Formula

From NOM-131-SSA1-2012, 7.6.3.6 Optional nutrients or ingredients: [1]

• 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.
•  In the follow-up formulas, in addition to the vitamins and minerals indicated, other nutrients/ingredients may be added, when necessary to ensure that the product is suitable to form part of a mixed feeding plan, intended to be used after the sixth month of age.
• There must be scientific evidence that demonstrates the usefulness of the optional nutrients/ingredients used and be available to the Secretariat upon request.
• For follow-up formulas, the concentrations of sodium and potassium derived from the vitamin and mineral ingredients must be adjusted to the limits established for sodium and potassium in Table No. 4.
• Only cultures that produce L(+) lactic acid may be used.

3.5 Permitted Additives

Infant, Follow-up and Young Child Formula

See Annex IX: Additives allowed in infant formulas, follow-up formulas, and formulas for special nutritional needs from references [7][8][9][10].

3.6 Permitted Flavours and Colours 

Infant Formula, Follow-on formula, Young child formula[7][8][9][10]

No authorized flavorings.

3.7 Permitted Processing Aids 

N/A.

3.8 Additional Notes 

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

To validate elements not listed in the "Agreement establishing the additives and processing aids in food, non-alcoholic beverages, and dietary supplements, the use thereof and health provisions", COFEPRIS validates their addition through the following procedure: 

COFEPRIS-05-041-A Request to add elements to the lists. Modality A.- Additives and adjuvants for food, beverages and food supplements. (COFEPRIS-05-041-A Solicitud de incorporación de elementos a las listas. Modalidad A.- Aditivos y coadyuvantes para alimentos, bebidas y suplementos alimenticios). 

For the corresponding requirements, refer to the link provided [10].

3.9 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. NORMA Oficial Mexicana NOM-086-SSA1-1994 Bienes y Servicios. Alimentos y bebidas no alcohólicas con modificaciones en su composición. Especificaciones nutrimentales

Mexican Official Standard NOM-086-SSA1-1994 Goods and Services. Food and non-alcoholic beverages with modifications in their composition. Nutritional Specifications. 

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

3. Reglamento de Control Sanitario de Productos y Servicios./ Regulation for the Sanitary Control of Products and Services

http://transparencia.cofepris.gob.mx/index.php/es/marco-juridico/reglamentos

4. National Catalogue of Standards

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

5. Official Pesticides Catalogue

http://www.siicex.gob.mx/portalSiicex/SICETECA/Acuerdos/Regulaciones/SSA/cicoplafest.htm

6. NORMA Oficial Mexicana NOM-082-SAG-FITO/SSA1-2017. Límites máximos de residuos de plaguicidas en alimentos. / Official Mexican Standard NOM-082-SAG-FITO/SSA1-2017 Maximum Residues Limits of pesticides in foods

http://dof.gob.mx/nota_detalle.php?codigo=5499806&fecha=04/10/2017

7. ACUERDO por el que se determinan los aditivos y coadyuvantes en alimentos, bebidas y suplementos alimenticios, su uso y disposiciones sanitarias

Agreement establishing the additives and processing aids in food, non-alcoholic beverages and dietary supplements, the use thereof and health provisions, published in the Official Gazette on July 16, 2012Original publication on July 16, 2012

https://www.dof.gob.mx/nota_detalle.php?codigo=5259470&fecha=16/07/2012

8. Modification published on September 5, 2013

https://www.dof.gob.mx/nota_detalle.php?codigo=5312987&fecha=05/09/2013

9. Modification published on May 16, 2016

https://www.dof.gob.mx/nota_detalle.php?codigo=5437267&fecha=16/05/2016

10. Amendments not published in the Official Gazette but official. July 11, 2019

https://www.gob.mx/cofepris/documentos/aditivos-alimentarios-anexo-ix?state=published

11. COFEPRIS-05-041-A

https://catalogonacional.gob.mx/FichaTramite?traHomoclave=COFEPRIS-05-041-A