Private label supplements for Brazil: Anvisa notification and import

Short answer

Can a supplement made in the EU be sold in Brazil?

Yes, as a suplemento alimentar under Anvisa rules. Since 1 September 2024 a supplement needs no registration in Brazil, but a Brazilian company must notify it to Anvisa before the first sale (RDC 843/2024 and IN 281/2024). Pharma Manufacture manufactures the product in Latvia from 150 units and supplies the documents; the Brazilian holder files the notification.

Brazilian law treats supplements as food. RDC 243/2018 defines the category, and IN 28/2018 lists the permitted ingredients, their limits, the permitted claims and the extra labelling. Anvisa announced that the adaptation period to RDC 243/2018 ended in July 2023.

Registration and import

Anvisa notification of food supplements: RDC 843/2024 at a glance

The notification is filed in Brazil by a Brazilian company. Our part is the product and the paperwork behind it.

A claim authorised in the EU under Regulation (EU) No 432/2012 does not carry over to Brazil. Anvisa accepts claims only in the wording of its own approved list in IN 28/2018, with minimal changes to the text. Write the Brazilian label from that list and keep the EU label for EU shelves.

Steps

Steps to your first shipment to Brazil

1. The Brazilian company that will hold the notification, the manufacturer’s head office, its representative or the importer, works in Anvisa’s Solicita system; the importer also holds an alvará or licença sanitária from the local health service (Brazilian company; the licence term depends on the municipal or state service).
2. You choose a ready-made formula or send your own; Pharma Manufacture returns formula options, a price and the full formula with quantities, so the holder can check it against the IN 28/2018 lists (you and Pharma Manufacture; first reply within 24 hours).
3. The holder pays the TFVS and files the notification under the subject code for suplementos alimentares, with the documents listed in Annex X of IN 281/2024 (Brazilian holder; automatic, with no prior assessment, and the product may be sold once the protocol is issued).
4. Pharma Manufacture makes the batch and prints the artwork the holder approved, with “SUPLEMENTO ALIMENTAR” and the notification number (from 4 weeks, about 8 weeks for a typical run; the order can be booked while the notification is filed, and the label goes to print once the number is known).
5. For each shipment the importer obtains a Siscomex import licence reviewed by Anvisa, quoting its sanitary licence number, and clears the goods (Brazilian importer and its broker).

Procedure as described by Anvisa on gov.br, checked 30 October 2026. Anvisa can check the documents at any time after the notification (RDC 843/2024).

What you pay. The holder pays Anvisa the TFVS (Taxa de Fiscalização de Vigilância Sanitária), which depends on the size of the company and the type of request; Anvisa gives the amount in its Consulta de Assuntos, and it was not found on 30 October 2026. Import duty depends on the tariff code and the EU-Mercosur preference, checked in Access2Markets. The Pharma Manufacture quote covers the product under your brand, made to the agreed formula and volume; help with the label artwork is part of the service, and every batch leaves with a Certificate of Analysis. Prices are sent on request.

Demand

What is known about demand for supplements in Brazil

No official statistics on supplement sales by category were found in Anvisa or other government sources on 30 October 2026.

Shipping

How to import supplements from Latvia into Brazil

The factory is in Mārupe, 2 minutes from Riga Airport and close to the Free Port of Riga, so air and sea freight both start next to the plant. The buyer’s forwarder chooses the mode and the Brazilian port or airport.

Clearance in Siscomex belongs to the Brazilian importer, whose licence number goes into the import licence, so delivered duty paid terms do not fit. Two Incoterms do: FCA, with the goods handed to the buyer’s forwarder in Latvia, and DAP, delivered to the agreed port or warehouse with duties and clearance left to the buyer.

Lead time starts at 4 weeks, and a typical run takes about 8 weeks from confirmed order and specification to despatch.

From the factory

Contract manufacturing (terceirização): what the EU factory supplies

• The product under your brand: tablets, hard capsules, softgels, effervescent tablets, powder sachets, liquids or sports powders, from a catalogue of 350 ready-made formulas or developed for you.
• A Certificate of Analysis for every batch. A sample of each batch is kept for at least three years.
• The full formula with quantities per serving, so the holder can check it against the IN 28/2018 lists before notifying.
• Copies of GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384. Their scope is the manufacturing and packaging of food supplements: tablets, capsules and powders.
• Label design help as part of the service, with the wording your Brazilian holder approves.

Frequently asked questions

Common questions about exporting supplements to Brazil

How do you register a supplement with Anvisa?

No registration is needed for a suplemento alimentar, but it must be notified to Anvisa before it goes on sale. The notificação under RDC 843/2024 and IN 281/2024 is automatic, with no prior assessment; the product may be sold once the protocol is issued, and Anvisa can check the documents at any time afterwards.

Who files the Anvisa notification, and what does Pharma Manufacture supply?

A Brazilian company files it: the manufacturer’s head office, its representative or the importer, which then holds the product. Pharma Manufacture, the manufacturer in Latvia, supplies the factory documents the holder needs for the file.

What are the requirements to import food supplements into Brazil?

The importing company needs an alvará or licença sanitária from the local health service, the product must be notified to Anvisa, and each shipment goes through a Siscomex import licence reviewed by Anvisa. Pharma Manufacture supplies the factory documents for the holder’s dossier.

Does the Brazilian importer need an AFE from Anvisa?

No. Anvisa does not issue an AFE (Autorização de Funcionamento) for food, and supplements are food. The importer needs a sanitary licence, alvará or licença sanitária, from the municipal or state health service, and quotes its number in the Siscomex import licence.

Can I use EU health claims on a supplement for Brazil?

Only where Anvisa’s list has the same claim. Brazil works from IN 28/2018, with its own wording and conditions, and not from the EU register under Regulation (EU) No 432/2012. Pharma Manufacture prints the artwork your Brazilian holder approves, so the claim text should come from the Brazilian list.

What changed for supplements in Brazil on 1 September 2026?

The transition for older products ended. Supplements reported to a local health service before 31 August 2024 had to be notified to Anvisa by 1 September 2026, and stock made before that date may be sold until it expires. A new product from the EU follows the normal notification route.

How do you create a supplement brand in Brazil?

With an EU factory it takes three steps: choose a ready formula or order your own, name the Brazilian company that will hold the Anvisa notification, and approve the label artwork using the claims listed in IN 28/2018. Pharma Manufacture manufactures from 150 units in tablets or capsules and supplies the factory documents.

What is the minimum order for a supplement for Brazil?

Pharma Manufacture starts at 150 units for a ready-made formula in tablets or capsules. Powder sachets start at 80,000, a figure set by the print run of the laminate, and a formula developed from scratch has a higher minimum.

How long does production for Brazil take?

From 4 weeks from order to despatch, and about 8 weeks for a typical run from confirmed order and specification. The Anvisa notification and the import licence run on the Brazilian side, outside that time.

Does the EU-Mercosur agreement remove the import duty for Brazil?

The preference depends on the tariff code of each product. The European Commission announced on 23 March 2026 that the EU-Mercosur interim trade agreement would apply provisionally to Brazil from 1 May 2026, and it points exporters to its Access2Markets tool, where the rate for a specific code can be checked before the landed price is calculated.