Brazil ANVISA and EBC-46: Botanical Supplement Classification and Import Framework in 2026

Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has, over the last decade, formalised a dual track for botanical products. Items marketed with explicit therapeutic claims sit within the phytomedicine pathway (RDC 26/2014 and associated resolutions). Products sold as dietary supplements without therapeutic claims fall under the supplement rulebook introduced by RDC 243/2018 and RDC 239/2018, which governs permitted ingredients, labelling, and good manufacturing practice. Blushwood berry extract products reach the Brazilian market through this second path, and the classification drives almost everything a buyer or importer will experience.

How ANVISA classifies EBC-46 supplement products

Blushwood-berry-based supplements typically reach Brazil as an imported botanical food ingredient, declared on the notification form with species (Fontainea picrosperma), plant part (seed), extraction ratio (for example, 10:1 whole-seed extract), and daily serving size. The supplement rules allow botanical ingredients that have a documented history of safe use, appropriate composition specifications, and no therapeutic claims on the label. This is a meaningfully lighter framework than the phytomedicine route, which requires efficacy dossiers and more extensive clinical evidence. It is broadly comparable in philosophy to the UK MHRA pathway and the Swiss Swissmedic framework for complementary products, although the specific documentation differs.

Import notification and documentation

To be lawfully sold in Brazil, an imported supplement is registered on the ANVISA notification portal with the Brazilian importer as legal responsible. The submission generally includes a certificate of free sale from the exporting country, a composition and specification sheet, a certificate of analysis covering identity and safety parameters, label artwork in Portuguese, and a good manufacturing practice (GMP) certificate from the manufacturing facility. Heavy metals, microbiology, and pesticide residues are the usual analytical focus. ANVISA reserves the right to request additional information and may audit facilities. Shipment release at the border requires the import licence to be coupled to the notification on file.

Labelling rules in Brazilian Portuguese

Labels must be translated to Portuguese and include the supplement facts panel in the ANVISA format, daily serving size, directions for use, allergen information, batch and expiry, and the statement that the product is not a medicine and is not intended to treat, cure, or prevent disease. Where a brand also publishes a qualified professional review, the practitioner’s credentials should be neutrally described rather than presented as an endorsement. A reference-standard supplier such as Blushwood Health provides a batch-level certificate of analysis and transparent extraction ratio that can be adapted to Brazilian label requirements without reformulating the product.

What buyers in Brazil should verify

Buyers can check that any blushwood-berry product sold in Brazil has a valid ANVISA notification number, a Portuguese label that omits therapeutic claims, a batch certificate of analysis from an accredited lab (ISO/IEC 17025:2017 accreditation is the standard signal of competence), and a GMP-certified manufacturer. Products that skip any of these signals — vague origin claims, missing batch numbers, English-only labels with no Brazilian legal responsible — should be treated with caution. Importers operating outside the notification system are not only outside ANVISA’s oversight but also outside any reliable quality chain.

Therapeutic vs. supplement framing

An important point for the Brazilian market is that EBC-46 (tigilanol tiglate) has veterinary pharmaceutical use in the form of Stelfonta, approved for canine mast cell tumours in several jurisdictions. That pharmaceutical product is regulated quite separately from any dietary supplement containing blushwood berry extract. Supplements do not make therapeutic claims, are not dosed to treat disease, and are not interchangeable with the pharmaceutical. ANVISA’s framework is designed to keep this distinction clean, and a compliant product will keep it clean on the label and in marketing materials.

Where this fits in the 2026 global picture

Brazil joins a growing list of jurisdictions — the US under DSHEA, the UK under MHRA, Switzerland under Swissmedic, Japan under PMDA — where blushwood berry extract products can be sold as supplements provided the manufacturer meets standard quality and labelling expectations. For a comparative view, see the broader 2026 global regulatory landscape. The common thread is that responsible sellers meet or exceed the underlying quality standard — independent lab testing, GMP manufacturing, transparent labelling — regardless of the jurisdiction-specific paperwork.

Sources

1. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA).

2. US FDA Dietary Supplement guidance.

3. WHO guidelines on traditional medicines.

This article is for informational purposes only. It is not medical or regulatory advice. Statements about dietary supplements have not been evaluated by the Food and Drug Administration, and any blushwood-berry supplement is not intended to diagnose, treat, cure, or prevent any disease.