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Selling infant formula and baby food in Brazil

In Brazil, infant formula, follow-on formula, transition foods and cereal-based foods for young children follow ANVISA's RDC 976/2025. Formulas are registered with ANVISA before sale; transition and cereal foods are notified. Law 11.265/2006 bans promotion of infant formula and sets the label warnings, and no functional or health claims are allowed.

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

Regulator
ANVISA
Composition and labelling
RDC 976/2025, with lists in IN 367/2025
Formulas
Registration with ANVISA (IN 281/2024, Annex I)
Transition and cereal foods
Notification to ANVISA (IN 281/2024, Annex II)
Marketing
Law 11.265/2006: no promotion of infant formula
Claims
No functional or health claims

Before a product goes on sale

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

  1. 1Which product type is it: infant formula, follow-on formula, transition food or cereal-based food? Read more
  2. 2Does it need registration or notification with ANVISA? Read more
  3. 3What must the label say, and what may it not show? Read more
  4. 4May the product be promoted at all? Read more
  5. 5How are quality deviations and recalls reported? Read more

The rules, by area

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

Product types and composition

The names and composition rules for formulas and foods for infants and young children.

  • RDC 976/2025 covers infant formulas, transition foods and cereal-based foods for infants and young children, enteral formulas and formulas for inborn errors of metabolism; it revoked RDC 43/2011 and RDC 44/2011.
  • Names of sale are "Fórmula infantil para lactentes" (infant formula, 0 to 6 months), "Fórmula infantil de seguimento para lactentes" (follow-on formula, 6 to 12 months) and "Fórmula infantil de seguimento para crianças de primeira infância" (follow-on formula for young children, 1 to 3 years) (Article 6).
  • The lists of permitted ingredients and composition values are in IN 367/2025.
  • Products for infants and young children, and their constituents, may not be irradiated (Article 48).
  • Companies have 24 months to adapt products already on the market (Article 58).

How we help: Compliant Always reads your formulation and specifications against the RDC 976 rules and keeps the evidence with the product. Ask about this

Registration and notification

How each product type is put on record with ANVISA before sale.

  • Infant formulas, follow-on formulas, formulas for specific dietary needs and nutrient formulas for high-risk newborns need registration with ANVISA (IN 281/2024, Annex I).
  • A registration is granted by publication in the official gazette, sale may start only after publication, and it is valid for 5 years, renewed 12 to 3 months before expiry (RDC 843/2024, Articles 12 and 13).
  • Transition foods and cereal-based foods for infants and young children are notified to ANVISA (IN 281/2024, Annex II); sale can start once the notification is filed (RDC 843/2024, Article 21).
  • Documentation behind the product must be available to the health authority (RDC 976/2025, Article 50).

How we help: Compliant Always keeps the registration or notification with the product and shows when a renewal window opens. Ask about this

Labelling

What formula labels must say, and what they may not show.

  • The label states the protein sources and, where probiotics are added, a warning that the product should not be given to premature or immunocompromised infants or those with heart disease (RDC 976/2025, Article 9).
  • Infant formula for 0 to 6 months gives preparation with boiled water cooled to not less than 70 °C; reconstituted formula is kept refrigerated below 5 °C for no more than 24 hours (Article 9).
  • Functional and health claims are not allowed on formulas, transition foods or cereal-based foods (Articles 11, 17 and 23).
  • Infant formula labels may not show pictures of babies or phrases suggesting the product is like breast milk (Law 11.265/2006, Article 10).
  • They carry the warning "AVISO IMPORTANTE: Este produto somente deve ser usado na alimentação de crianças menores de 1 (um) ano de idade com indicação expressa de médico ou nutricionista. O aleitamento materno evita infecções e alergias e fortalece o vínculo mãe-filho." (important notice: only for children under one year on the express advice of a doctor or nutritionist; breastfeeding prevents infections and allergies and strengthens the mother-child bond) (Article 10 §1).

How we help: Compliant Always reads your label against the RDC 976 particulars and the Law 11.265 warnings and bans, and shows what is missing or not allowed. Ask about this

Marketing

Law 11.265/2006 limits how food for infants and young children, bottles, teats and dummies are promoted.

  • The law covers infant and follow-on formulas, milks, transition foods, and feeding bottles, teats and dummies.
  • Commercial promotion of infant formula, follow-on formula for infants, nutrient formula for high-risk newborns, and bottles, teats and dummies is prohibited (Article 4).
  • Promotion of other products in scope carries the phrase "O Ministério da Saúde informa: o aleitamento materno evita infecções e alergias e é recomendado até os 2 (dois) anos de idade ou mais" (the Ministry of Health advises: breastfeeding prevents infections and allergies and is recommended up to 2 years of age or more) (Article 5).

How we help: Compliant Always keeps the promotional material for each product with the article it was read against. Ask about this

Monitoring and recall

What happens after the product is on sale.

  • Companies monitor their products permanently and notify ANVISA of quality deviations and adverse events within 15 working days (RDC 976/2025, Article 51).
  • Recalls follow RDC 655/2022: ANVISA is notified immediately, with a report within 48 hours.

How we help: Compliant Always ties each document to the lot it belongs to, so a quality deviation can be traced to its supplier and batch records. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ManufacturerComposition, registration or notification, labelling and post-market monitoring.Formulations, filings and batch records kept with each product and lot.
ImporterRegularising imported formulas and foods and their Portuguese labels.The foreign supplier's documents read and dated before the goods arrive.
Brand ownerLabels and promotion, within RDC 976/2025 and Law 11.265/2006.Artwork read against the bans and warnings, with the article for each.
RetailerNot promoting products whose promotion the law bans.Questionnaires answered from the record of each product.

States and municipalities

Under the Consumer Defence Code, the federal government, the states and the Federal District make concurrent rules on production, distribution and consumption, and together with the municipalities they oversee and control production, distribution and advertising (Article 55).

Health surveillance is shared: state, Federal District and municipal health authorities license food establishments and receive the communication of start of manufacture for many foods, and INMETRO's delegated state bodies (IPEMs) inspect regulated and pre-packaged products on the market.

Questions businesses ask

Does infant formula need registration in Brazil?
Yes. Infant and follow-on formulas are in Annex I of IN 281/2024 and need registration with ANVISA, granted by publication in the official gazette. Sale may start only after publication (RDC 843/2024, Article 12).
Do baby cereals and purées need registration in Brazil?
No. Transition foods and cereal-based foods for infants and young children are notified to ANVISA (IN 281/2024, Annex II), and sale can start once the notification is filed.
Which ANVISA rule covers infant formula now?
RDC 976 of 5 June 2025, which revoked RDC 43/2011 and RDC 44/2011. IN 367/2025 holds the lists. Products have 24 months to adapt (Article 58).
What are the names of sale for formula in Brazil?
"Fórmula infantil para lactentes" (0 to 6 months), "Fórmula infantil de seguimento para lactentes" (6 to 12 months) and "Fórmula infantil de seguimento para crianças de primeira infância" (1 to 3 years) (RDC 976/2025, Article 6).
Can infant formula be advertised in Brazil?
No. Law 11.265/2006 prohibits commercial promotion of infant formula, follow-on formula for infants, nutrient formula for high-risk newborns, and feeding bottles, teats and dummies (Article 4).
Can a formula label show a picture of a baby?
No. Law 11.265/2006 bans images of babies and phrases suggesting the product is like breast milk on infant formula labels (Article 10).
What warning goes on infant formula labels in Brazil?
An "AVISO IMPORTANTE" stating that the product should be used only for children under one year on the express advice of a doctor or nutritionist, and that breastfeeding prevents infections and allergies (Law 11.265/2006, Article 10 §1).
Can baby food make health claims in Brazil?
No. Functional and health claims are not allowed on formulas, transition foods or cereal-based foods (RDC 976/2025, Articles 11, 17 and 23).
What preparation instructions must infant formula give?
For 0 to 6 months, preparation with boiled water cooled to not less than 70 °C, and refrigeration of reconstituted formula below 5 °C for no more than 24 hours (RDC 976/2025, Article 9).
How quickly must quality problems be reported to ANVISA?
Within 15 working days for quality deviations and adverse events (RDC 976/2025, Article 51). Recalls follow RDC 655/2022.
How does Compliant Always help with selling in Brazil?
Our team reads the rules for the markets you sell in. 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.

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