December 09, 2025

As Brazil emerges as a global hub for functional food ingredients, nutraceutical formulations, bioactive compounds, and dietary supplement innovation, the regulatory landscape under ANVISA has evolved substantially. Global manufacturers targeting the Brazilian market must navigate not just “registration versus notification” but also dynamic developments in novel-food approval, ingredient authorization lists, post-market vigilance systems, and risk-based regulatory pathways.

This guide drills deep into Brazil’s technical regulatory architecture: the core frameworks (RDC 243/2018, IN 28/2018, IN 76/2020), the newly published updates (e.g., Normative Instruction No. 373/2025), classification logic (Dietary Supplements vs medicine), dossier architecture, labelling/claims-compliance, and strategic roadmaps for Brazil dietary supplement registration, Brazil nutraceutical notification, and Brazil import authorization.

Technical Regulatory Framework & Classification Logic

ANVISA defines “supplementos Alimentares” via RDC 243/2018 as “products for oral administration, presented under pharmaceutical dosage forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, alone or in combination.”

Key normative instruments:

  • RDC 243/2018: establishes sanitary requirements for food supplements (composition, quality, safety, and labelling).
  • Normative Instruction No. 28/2018: defines approved constituent lists, usage limits, health claims, and supplementary labelling for food supplements.
  • Normative Instruction No. 76/2020: Updates the IN 28-2018 lists and annexes (constituents, limits, claims).
  • RDC 843/2024 & IN 281/2024: introduce a new risk-based model for regulation (notification vs registration) and centralization of oversight.
  • Normative Instruction No. 373/2025: published June 2025, further revises approved ingredients, maximum/minimum levels, and mandatory warning-label requirements for “Dietary Supplements”.

Classification differentiates categories: vitamins/minerals, amino acids/proteins, enzymes, probiotics, and plant-extracts/bioactive, other approved substances. A combination of formulation is permitted provided all constituents are on approved lists, or a novel-ingredient petition is submitted.

Ingredient Authorization & Novel-Ingredient Governance

Manufacturers must ensure full compliance with ANVISA’s ingredient governance:

  • Only constituents listed IN 28/2018 (and subsequent amendments) may be used. Use limits (maximum daily intake per population group) are mandatory.
  • For non-listed “novel ingredients” a full dossier (poetical) must be submitted referencing safety, toxicology, intake exposure, bioavailability, interactions, etc.
  • Recent update via IN 373/2025 includes additions such as citrus fiber, 2-fucosyllactose (prebiotic), Chlorella pyrenoids powder as vitamin A source, GABA (gamma-aminobutyric acid), and new probiotic strains.
  • Enhanced claim-control: New health-claim matrix for certain probiotics or bioactive; claims must align with approved list and dosage/strain parameters.
  • Formulations must avoid therapeutic claims (no disease-treatment language) else risk classification as medicine.
  • Good Manufacturing Practices (GMP) for food-supplement manufacturing (linked to RDC 275/2002) are required.

Market Access Pathway: Registration vs Notification & Dossier Architecture

Risk-Based Model

With introduction of RDC 843/2024, ANVISA mandates a tiered regulatory path:

  • High-risk categories (infant nutrition, enteral foods) → Registration
  • Supplements, functional foods, weight-control foods → Notification
  • Low-risk items (herbal teas, pastas) → Communication of start of manufacturing

Dossier Modules

  • Module I – Administrative: Company legal status, Brazilian local?agent appointment, fee proof
  • Module II – Technical: Full product composition, manufacturing process flow-chart, in?house GMP certificate, stability study results, packaging and tertiary transit logistics
  • Module III – Safety & Efficacy Evidence: Toxicology/safety data, human-use studies (if applicable), evidence for non-therapeutic health claims

Notification done via ANVISA’s e-portal; registration may involve full review and audit. The timeline for full review is often 12–18 months; transition deadlines vary.

Labelling, Health Claims & Post-Market Vigilance

Label & Claim Compliance

Under RDC 243 and related instructions:

Label must display “SUPLEMENTO ALIMENTAR” prominently, dosage form, recommended intake per age/population group, bold warnings:

  • "This product is not a medicine"
  • "Do not exceed the recommended daily intake indicated on the packaging"
  • "Keep out of reach of children"
  • Storage instructions (including after opening) are mandatory.
  • Health claims must correspond to an approved list; any disease-risk reduction claim reserved for “medicine” classification.
  • Packaging must include percentage-Brazil (percentage daily Value) table when nutrients present.

Post-Market Surveillance (PMS)

After market entry, ongoing obligations include:

  • Monitoring adverse events, product complaints, stability deviation, label changes
  • Reporting to ANVISA when required
  • Importers/distributors must maintain import-license, storage/distribution of Good Storage Practices (GSP), and lot-traceability.
  •  Non-compliance may result in product suspension/recall; administrative sanctions including fines up to ~BRL 1.5 million.

Critical Regulatory Update Timeline & Transition Periods

  • Deadline for full adequacy to RDC 243/2018 ended 27 July 2023; products not updated require full reevaluation.
  • With IN 373/2025 published 5 June 2025, affected products must adjust labelling and ingredient compliance within 24 months (by June 2027) unless otherwise specified.
  • Fixed fee for notification: approximately R$ 3,314 per product under new framework.

Strategic Keywords & Long-Tail Phrases for SEO Reach

  • ANVISA Food Supplements Brazil
  • Brazil dietary supplement registration ANVISA
  • Brazil nutraceutical ingredient list IN 28/2018
  • Brazil novel food petition nutraceuticals
  • ANVISA RDC 843/2024 regulation supplements
  • Brazil probiotic supplement claims ANVISA
  • Brazil functional food vs dietary supplement classification
  • Brazil supplement import license ANVISA
  • Brazil supplement manufacturing GMP food / nutraceutical
  • Brazil supplement labelling warning “This Product is not Medicine”

Conclusion & Action Plan

For global nutrition, nutraceutical and dietary-supplement players targeting Brazil, mastering this regulatory architecture is non-negotiable. Compliance with the latest ANVISA standards—especially post-2024/25 updates—is the gateway to market access, risk mitigation and brand credibility in Latin America’s largest economy. Prepare your technical dossier, secure local representation, review ingredient compliance, update label/claims, establish post-market surveillance, and align all functions (R&D, regulatory, QA, marketing) around Brazil-entry strategy.

If you are ready to launch a supplement or nutraceutical product in Brazil, align with regulatory specialists, structure your pathway proactively and ensure readiness for ANVISA has advanced review model.