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Selling food in Brazil

In Brazil, ANVISA sets the food rules. A packaged food is registered, notified or communicated before sale, depending on its category under RDC 843/2024. Labels are in Portuguese, with a nutrition table under RDC 429/2020 and, above set limits, the front-of-pack "ALTO EM" mark. State and municipal health authorities enforce.

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

Regulator
ANVISA (Agência Nacional de Vigilância Sanitária)
Before sale
Registration, notification or communication, by category (RDC 843/2024)
Label language
Portuguese (Consumer Defence Code, Article 31)
Nutrition labelling
RDC 429/2020 and IN 75/2020, in force since 9 October 2022
Front-of-pack
"ALTO EM" magnifying-glass mark above set limits
Recall
RDC 655/2022: notify ANVISA immediately

Before a product goes on sale

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

  1. 1Which regularisation route does the food's category take: registration, notification, communication or exemption? Read more
  2. 2What has to be on the label, and in Portuguese? Read more
  3. 3What does the nutrition table show, and does the food need the front-of-pack mark? Read more
  4. 4Are the additives authorised, and are contaminants within the limits? Read more
  5. 5Is there a recall plan, and can each lot be traced one step back and one forward? Read more
  6. 6How does an imported food clear ANVISA's checks at the border? Read more

The rules, by area

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

Regularisation before sale

How a food is put on record with the health authorities before it is sold, and who does it.

  • Before sale, a food is regularised by registration with ANVISA, notification to ANVISA, or communication of the start of manufacture or import to the state, Federal District or municipal health authority; some categories are exempt (RDC 843/2024, Article 3).
  • IN 281/2024 sorts categories by route: infant and enteral formulas need registration (Annex I); supplements, foods with functional or health claims and transition foods for infants need notification (Annex II); most everyday foods, such as biscuits, sauces, confectionery and ready meals, need communication (Annex III).
  • Regularisation is done by the head office of the manufacturer, its legal representative, or the importer (Article 4).
  • A registration is granted by publication in the official gazette (DOU); the label then carries "Alimento registrado na Anvisa:" and the number, and the registration is valid for 5 years (Article 12).
  • A notification is automatic, without prior assessment; sale can start once it is filed, and the label carries "Alimento notificado na Anvisa:" with the process number (Article 21).
  • Documents behind the regularisation must be available to the health authority on request (Article 9).

How we help: Compliant Always records which route each product took, keeps the filing and its number with the product, and shows when a registration or notification is due for renewal. Ask about this

Label particulars and language

What the label must show under the basic food law and the Consumer Defence Code.

  • Decree-Law 986/1969 (Normas básicas sobre alimentos) requires, in perfectly legible characters, the nature and type of food, the name or brand, the manufacturer and factory location, the registration number where there is one, additives, a lot or date, and the net weight or volume (Article 11).
  • Words in a foreign language must be translated (Article 11 §1), and a misleading label is prohibited (Article 21).
  • The Consumer Defence Code requires correct, clear, precise and prominent information in Portuguese on characteristics, quantity, composition, price, guarantee, expiry, origin and risks to health and safety (Article 31).
  • Industrialised foods must state "contém Glúten" or "não contém Glúten" (Law 10.674/2003).
  • ANVISA's labelling page lists ingredients, shelf life, nutrition information and household measures among the mandatory items, and bans misleading information.

How we help: Compliant Always reads your Portuguese label against these particulars, with the article beside each, and shows what is missing. Ask about this

Nutrition and front-of-pack labelling

The nutrition table, the "ALTO EM" warning mark and the nutrition claims a pack may carry.

  • A nutrition table is mandatory and declares energy, carbohydrates, total sugars, added sugars, protein, total fat, saturated fat, trans fat, dietary fibre and sodium (RDC 429/2020, Articles 4 and 5).
  • The table sits on one continuous surface, on the same panel as the ingredients list (Article 14).
  • The front-of-pack mark is required where added sugars, saturated fat or sodium reach the IN 75/2020 limits: added sugars 15 g per 100 g (7.5 g per 100 ml for liquids), saturated fat 6 g per 100 g (3 g per 100 ml), sodium 600 mg per 100 g (300 mg per 100 ml).
  • The mark is black on white, in the upper half of the main panel, following the models in Annex XVII (Article 21); it is optional on packs whose main panel is under 35 cm².
  • Nutrition claims are in Portuguese (Article 26), and may not sit in the upper half of the main panel when the front-of-pack mark is shown (Article 30).
  • The rules have applied since 9 October 2022; a breach is a health infraction under Law 6.437/1977 (Article 48).

How we help: Upload the specification and Compliant Always reads the nutrient values against the IN 75 limits, so you see whether the front-of-pack mark applies before the artwork is final. Ask about this

Additives and contaminants

What may be added to the food, and how much of an unwanted substance it may contain.

  • Only the additives and processing aids listed in IN 211/2023, with their functions, maximum limits and conditions of use, may be used (RDC 778/2023, Article 9).
  • RDC 722/2022 sets the maximum tolerated limits of contaminants in food and IN 160/2022 lists the limits; RDC 724/2022 and IN 161/2022 set the microbiological standards (ANVISA contaminants page).
  • Decree-Law 986/1969 requires an artificially coloured food to say "Colorido Artificialmente" (Article 13).

How we help: Compliant Always reads your formulation and lab reports against the additive and contaminant lists, and keeps the results with the lot they came from. Ask about this

Traceability and recall

What a food business must have ready, and do, when a lot puts health at risk.

  • Food businesses keep a recall plan (RDC 655/2022, Article 4) and trace products one step back and one step forward (Article 6).
  • Lots that pose a risk are recalled (Article 8), and ANVISA can order a recall (Article 9).
  • ANVISA is notified immediately, at recolhimento.alimentos@anvisa.gov.br (Article 21), with a report within 48 hours (Article 22).
  • Consumers are warned by an alert message whose content ANVISA agrees first (Articles 29 and 30); ANVISA publishes the recalls (Article 20).

How we help: Compliant Always ties each document to the lot and the supplier it came from, so the step back and the step forward are on record when a lot is questioned. Ask about this

Import

How ANVISA consents to imported food, and what the pack must show on arrival.

  • Foods under non-automatic licensing need ANVISA's consent through the import licence (LI) in SISCOMEX (RDC 81/2008).
  • On entry the pack must show at least the trade name, the manufacturer and its location, the lot and the expiry date.
  • ANVISA may require a translation of the label; for food it may be signed by the importer.
  • Where the Portuguese label does not conform, goods may be released with a reservation under a custody term (Termo de Guarda) until it is corrected.
  • Products of animal origin are inspected by MAPA's Federal Inspection Service (Serviço de Inspeção Federal, SIF).

How we help: Compliant Always keeps the import documents and the Portuguese label with each shipment, and shows what is missing before the goods leave. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ManufacturerRegularising the food (RDC 843/2024, Article 4), the label and the recall plan.Filings, specifications and labels kept together, by product and lot.
ImporterRegularising imported food, the import licence and the Portuguese label.The foreign supplier's documents read and dated before the goods arrive.
Brand ownerWhat the label and claims say, under the Consumer Defence Code.The label read against the particulars, with the source for each.
RetailerSelling only regularised, correctly labelled food, and acting on recalls.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

Do I need to register food with ANVISA before selling in Brazil?
It depends on the category. IN 281/2024 lists which foods need registration (such as infant formula), notification (such as supplements) or communication to the local health authority (most everyday foods), and which are exempt, such as raw materials and fresh produce.
What is the difference between notification and communication?
Notification is filed with ANVISA and is automatic, without prior assessment. Communication of the start of manufacture or import goes to the state, Federal District or municipal health authority (RDC 843/2024, Article 3).
Who can regularise a food in Brazil?
The head office of the manufacturer, its legal representative, or the importer (RDC 843/2024, Article 4).
Do food labels in Brazil have to be in Portuguese?
Yes. The Consumer Defence Code requires information in Portuguese (Article 31), and Decree-Law 986/1969 requires foreign words on a food label to be translated.
What is the "ALTO EM" front-of-pack label?
A black-on-white mark with a magnifying glass that says a food is high in added sugars, saturated fat or sodium. It is required when the food reaches the limits in Annex XV of IN 75/2020.
What are the front-of-pack limits in Brazil?
Added sugars 15 g per 100 g or 7.5 g per 100 ml; saturated fat 6 g per 100 g or 3 g per 100 ml; sodium 600 mg per 100 g or 300 mg per 100 ml (IN 75/2020, Annex XV).
Which nutrients go in the Brazilian nutrition table?
Energy, carbohydrates, total sugars, added sugars, protein, total fat, saturated fat, trans fat, dietary fibre and sodium (RDC 429/2020, Article 5).
Must a food label in Brazil say whether it contains gluten?
Yes. Industrialised foods must state "contém Glúten" or "não contém Glúten" under Law 10.674/2003.
Which additives can I use in food sold in Brazil?
Only those listed in IN 211/2023, for the functions and within the limits and conditions set there (RDC 778/2023, Article 9).
What do I do if a lot of food is unsafe?
Recall it under RDC 655/2022: notify ANVISA immediately, report within 48 hours, and warn consumers with an alert message ANVISA has agreed. ANVISA can also order a recall.
What must an imported food's pack show when it arrives in Brazil?
At least the trade name, the manufacturer and its location, the lot and the expiry date (RDC 81/2008). ANVISA may ask for a label translation.
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.

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

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