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Selling infant formula and baby food in Mexico

In Mexico, infant formula, follow-on formula and food for infants and young children follow NOM-131-SSA1-2012 and the Reglamento de Control Sanitario de Productos y Servicios. Formula labels may make no nutrition or health claims, must state that breast milk is the best food for babies, and may not suggest the formula equals or betters it.

Updated · Each section links to the official source it comes from

Main NOM
NOM-131-SSA1-2012, DOF 10 September 2012
Regulator
COFEPRIS, for the Secretaría de Salud
Claims on formula
No nutrition or health claims
Mandatory notice
"Aviso Importante" on the superiority of breastfeeding
Front-of-pack seals
Formula exempt under NOM-051, 4.5.3.3
Complementary food
Not from earlier than six months of age

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it infant formula, follow-on formula, formula for special needs, or food for infants and young children? Read more
  2. 2Does the composition meet the NOM and the Regulation? Read more
  3. 3Does the label carry the name, age range, preparation instructions and the "Aviso Importante"? Read more
  4. 4Is the label free of claims and of images that idealise formula? Read more
  5. 5How does it come into Mexico, and who answers for it there? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Scope and composition

Which products the NOM covers, and the rules for what goes into them.

  • NOM-131-SSA1-2012 sets sanitary, nutritional and labelling requirements for infant formula, infant formula for special nutritional needs, follow-on formula, follow-on formula for special needs, and food and non-alcoholic drinks for infants and young children; it binds those who process or import them.
  • Under the Regulation, ingredients for infant and young-child food must be clean, safe and fit for infants; additives are those in the Agreement on additives and processing aids (Article 137).
  • These products may not contain residues of hormones, antibiotics or pharmacologically active substances, and may not be irradiated (Articles 138 and 139).
  • Formula is milk-based where at least 90% of its protein comes from milk or whey; a non-milk formula states "No contiene leche" or an equivalent (Article 140).

How we help: Compliant Always reads your formula specifications and certificates of analysis against the NOM and the Regulation, and keeps them with each lot. Ask about this

Labelling of formula

What a formula label shows.

  • Labels also meet the Regulation and NOM-051-SCFI/SSA1-2010 where these do not conflict with NOM-131 (10.1); formula carries an expiry date (10.2).
  • Terms such as "humanizado" or "maternizada" may not be used; non-milk formula includes "no láctea" in its name (10.3.2 and 10.3.3).
  • Nutrients are declared per 100 kcal, with the amount of product equal to 100 kcal as consumed (10.3.8).
  • Infant formula gives written and pictorial preparation instructions that do not discourage breastfeeding, a statement to use water boiled for five minutes and cooled, and a warning not to heat it in a microwave (10.3.10).
  • The label carries "Aviso Importante" followed by a statement on the superiority of breastfeeding, such as "La leche materna es el mejor alimento para el bebé", and that the product is used under medical guidance (10.3.14).
  • The age range appears near the name; follow-on formula states that it is part of complementary feeding and is not introduced before six months (10.3.12 and 10.3.16).

How we help: Compliant Always sets your formula label beside each clause of NOM-131, including the legends and their placement. Ask about this

Claims and images

What formula labels may not say or show.

  • Formula may carry no nutrition or health claims (10.3.9).
  • Infant formula may not show images or text suggesting it is identical or superior to breast milk, following the WHO recommendations on marketing breast-milk substitutes (10.3.11).
  • Formula for special nutritional needs carries "UTILICESE BAJO SUPERVISION MEDICA", and breast-milk fortifiers carry "EXCLUSIVAMENTE PARA USO HOSPITALARIO" (10.3.18 and 10.3.19).
  • Infant and follow-on formulas, and foods for infants and young children with nutritional specifications for fat, sugars or sodium, are exempt from the NOM-051 front-of-pack information (4.5.3.3).

How we help: Compliant Always reads your label and artwork against the claims and image rules, with the clause beside each finding. Ask about this

Food for infants and young children

The labelling of cereals, purées and other food for babies and young children.

  • The name states the age group, such as "cereal seco para lactantes" (10.4.1); iodised salt is declared as such (10.4.2).
  • Products for complementary feeding may not give a starting age earlier than six months, and the label says the decision on when to start is taken with a health professional (10.4.5).
  • Products containing beetroot or spinach carry "Para niños de más de doce semanas de edad" (10.4.6).
  • Cereals to be prepared with milk or another liquid carry "Utilícese leche o fórmula pero no agua" or an equivalent (10.4.8).

How we help: Compliant Always checks the age statements and legends on each product, and keeps the label version on file. Ask about this

Packaging, import and control

How these products are packed, how they come into Mexico, and who checks them.

  • Products are packed in containers of safe, resistant materials that do not react with or alter them (11.1).
  • Food for infants and young children is under sanitary control for processing, import and export (Article 194, General Health Law).
  • The importer must be domiciled in Mexico; COFEPRIS may sample imported products, and products new to Mexico are sampled before entry (Articles 285 and 286 Bis).

How we help: Compliant Always keeps the certificates and import documents with each shipment, and shows what is missing before it leaves. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe label, its legends and the absence of claims.Labels checked against NOM-131, with the evidence behind them.
ManufacturerComposition, microbiological and contaminant specifications, and packaging.Certificates of analysis kept by lot and read against the NOM.
ImporterBeing domiciled in Mexico, and the import documents.Supplier documents read and dated before the goods arrive.

Federal rules and the states

Product rules in Mexico are federal: the General Health Law, the Federal Consumer Protection Law and the Normas Oficiales Mexicanas apply across the national territory.

Health surveillance is shared. Under the General Health Law, a notice of operation (aviso de funcionamiento) goes to the Secretaría de Salud or to the government of the state (entidad federativa), and several sanitary NOMs are enforced by COFEPRIS and the state governments together.

Questions businesses ask

Which NOM covers infant formula in Mexico?
NOM-131-SSA1-2012, which sets sanitary, nutritional and labelling requirements for infant and follow-on formula, formula for special needs, and food and drinks for infants and young children.
Can infant formula make health claims in Mexico?
No. Formula may carry no nutrition or health claims (NOM-131, 10.3.9).
What must the "Aviso Importante" on formula say?
A statement on the superiority of breastfeeding, such as "La leche materna es el mejor alimento para el bebé", and that the product is used under medical guidance, or for follow-on formula under a health professional's guidance.
Can formula be called "humanised" in Mexico?
No. Terms such as "humanizado" or "maternizada" may not be used (NOM-131, 10.3.2).
Does infant formula carry front-of-pack warning seals?
No. NOM-051 exempts infant and follow-on formulas, and foods for infants and young children with nutritional specifications for fat, sugars or sodium, from the front-of-pack information.
From what age can complementary foods be labelled?
Not earlier than six months. Follow-on formula states it is not introduced before the sixth month of life (NOM-131, 10.3.16 and 10.4.5).
What preparation warnings must formula carry?
Written and pictorial instructions, a statement to use water boiled for five minutes and cooled, and a warning not to heat it in a microwave (NOM-131, 10.3.10).
Can a non-milk formula be sold in Mexico?
Yes. It includes "no láctea" in its name and states "No contiene leche" or an equivalent (NOM-131, 10.3.3; Article 140 of the Regulation).
Must baby food be free of hormone and antibiotic residues?
Yes. Food for infants and young children may not contain residues of hormones, antibiotics or pharmacologically active substances (Article 138 of the Regulation).
Who must comply with NOM-131?
Anyone who processes or imports the products it covers for sale in Mexico (NOM-131, 1.2).
How does Compliant Always help with selling in Mexico?
Our team reads the rules for the markets you sell in, including the Normas Oficiales Mexicanas and COFEPRIS requirements. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Mexico and what your paperwork needs to show.

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