Brazil regulates health supplements under ANVISA’s food regulations, with rules covering ingredients, dosage limits, labelling, health claims, and imports. Even if approved in the U.S. or EU, supplements will need to be reformulated or relabeled before being marketed in Brazil. This guide provides an overview of Health Supplement Registration Brazil, labelling regulations, GMP requirements, import requirements, timeline and costs.
Regulatory Authority for Health Supplements in Brazil
In Brazil, health supplements are regulated by ANVISA (RDC 243/2018 and IN 28/2018). These rules establish the ingredients allowed, dose limits, labelling conditions and approved health claims for supplements marketed in Brazil.
What Are Health Supplements Under Brazilian Regulations?
According to RDC 243/2018, health supplements are products that are meant to be used as dietary supplements by healthy people to provide a supplemental source of nutrients and/or bioactive substances.
There are several different kinds of health supplements available in Brazil, and they include:
- Vitamins and minerals
- Amino acids and proteins
- Probiotics and enzymes
- Botanical extracts
- Sports nutrition products
Unapproved ingredients or therapeutic claims in products can lead to the classification of the product as a medicine rather than a supplement.
Health Supplements Registration Process in Brazil
Prior to the beginning of the registration process, companies should consider whether the product is exempt from registration or if it needs the approval of ANVISA due to the ingredients used, claims and risk profile.
Here is the step-by-step approval process.
Step 1: Verify Ingredient Compliance Under IN 28/2018.
Companies should verify:
- Permitted ingredients
- Dosage limits
- Approved claims
- Restricted substances
- It is not known whether the product is a medicine.
The non-compliant formulas typically need to be restructured for submission.
Step 2: Apply for a Brazilian Legal Entity / Importer.
It is not possible for foreign manufacturers to register supplements with ANVISA directly by foreign manufacturers. A Brazilian company is required to come in two forms:
- Registration holder
- Importer of record
- Legal representative
The Brazilian entity is responsible for compliance, importation and post-market duties.
Step 3: Obtain Company and Licensing Documents.
The Brazilian company should include:
- CNPJ registration
- Local sanitary license
- Allow for import authorisation, if applicable
Step 4: Prepare the Technical Dossier.
The dossier will usually contain:
- Product formulation
- Ingredient specifications
- Manufacturing process
- Certificate of analysis
- Stability data
- Portuguese label artwork
- GMP documents
- Scientific evidence for health claims (if applicable),
Additional scientific data may be needed for products containing probiotics, enzymes, herbals or novel ingredients. Probiotic, enzyme, botanical or novel products may need more scientific information.
Step 5: Submit the Application on ANVISA’s Solicita Portal
The owner of the registration shall:
- Create a company account
- Choose the supplement category for the selection
- Create a GRU fee slip
- Attach necessary documents
ANVISA portal:
https://www.gov.br/anvisa/pt-br/sistemas/peticionamento
Step 6: Pay the ANVISA Fees and Submit the Application.
The TFVS fee must be paid prior to the technical review of the application.
Step 7: Answer ANVISA Technical Questions
ANVISA may request:
- Additional safety data
- Formula clarification
- Label corrections
- Claim substantiation
- GMP documents
Step 8: Get Permission and Start Importing.
Upon approval, the supplement can be imported and commercialised in Brazil.
Adjustments in the formula, the claims, manufacturer, packaging or labelling may be subject to ANVISA notification or approval.
Documents Required for Health Supplements Registration in Brazil
ANVISA may require:
- Power of attorney of the Brazilian representative
- CNPJ registration
- Local sanitary license
- The proof of payment of the ANVISA fee must be presented.
- Complete product formulation
- Ingredient specifications
- Manufacturing process description
- Certificate of analysis (CoA)
- Stability data
- Microbiological and contaminant test reports
- GMP certificate
- Portuguese label artwork
- Health claims are substantiated by scientific evidence.
- Safety information for probiotics, enzymes, botanicals or novel ingredients (if available)
ANVISA Labelling Requirements for Health Supplements in Brazil
ANVISA must have supplement labels written in Portuguese and contain:
- Product name and category
- Ingredient list
- Recommended daily intake
- Nutrition information table
- Manufacturer and importer information
- Batch number and expiration dates
- Storage instructions
- Restrictions and warnings that must be adhered to
Claims must comply with IN 28/2018 requirements. No claims for disease prevention, treatment or cure.
Typical problems where the compliance is not met include:
- Missing warnings
- Unauthorized claims
- Incorrect ingredient names
- Non-compliant nutrition tables
- Using US/EU brands without adaptation
ANVISA Licensing Requirements for Health Supplements in Brazil
Foreign companies are not allowed to register or import supplements directly in Brazil without having a legal entity in Brazil or an importer.
The Brazilian company must have:
- CNPJ registration
- Local sanitary license
- Import authorisation (where applicable),
The owner of the car in Brazil is responsible for:
- ANVISA submissions
- Product importation
- Label compliance
- Post-market surveillance
- Product recalls
GMP Requirements for Health Supplements in Brazil
ANVISA requires supplement manufacturers to have GMP controls of product quality and traceability.
Companies should maintain:
- Qualification records of raw materials.
- Batch manufacturing records
- Quality control procedures
- Stability data
- Procedures for cleaning and sanitation
- Product traceability systems
In the case of imported supplements, it is necessary that GMP evidence is provided by the foreign manufacturing site at ANVISA review or import inspection.
Health Claims and Advertising Regulations in Brazil
Nutritional and functional claims are only permitted in Brazil by approval under IN 28/2018.
No supplement can make a claim to:
- Prevent diseases
- Treat diseases
- Cure medical conditions
- Replace medicines
For functional claims, particularly for probiotics, botanicals and bioactive substances, ANVISA may request scientific evidence.
Import Regulations for Health Supplements in Brazil
Before the importation of supplements in Brazil, there are regulations established by ANVISA.
Typically, the following conditions are required for imports:
- Brazilian importer/legal representative
- Regularisation of the product with ANVISA (if applicable)
- Import License (LI) registration via Siscomex
- Portuguese-compliant labeling
- Commercial invoice and shipping documents.
- Batch and traceability records should be kept.
Labelled products that don’t meet the approval standards, don’t include authorised ingredients, or don’t have an approval or permit may be held or refused.
Health Supplement Registration Timelines in Brazil
The registration period varies according to the product category and ANVISA pathway.
Typical timelines include:
- The notification pathway will take around 30-90 days.
- Full ANVISA registration (Approval): 6–18 months.
- Novel food ingredients, probiotics, enzymes, and functional foods: extended review periods.
The following are typical reasons for delays:
- Non-compliant ingredients
- Missing documents
- Incorrect labeling
- Responses that were incomplete to the queries raised by ANVISA
- Product classification issues
Health Supplement Registration Costs in Brazil
Costs of registration depend on the product category, ingredients, claims and regulatory pathway.
Common costs include:
- ANVISA application fees
- Legal representative and/or importation of the goods, fees paid in Brazil.
- Portuguese label adaptation
- Stability and laboratory testing.
- GMP documentation
- Notarization fees and translation fees.
Full technical review and novel ingredient assessment products tend to be more expensive.
Conclusion
Under the rules of ANVISA, Brazil has extremely demanding requirements for ingredients in supplements, claims, labelling, import and GMP compliance. Businesses that conduct formulation and labelling assessments at an early stage can minimise the risk of importation, delays in approval and reformulation costs for accessing the Brazilian market.
Looking for support with ANVISA health supplements registration and market entry in Brazil? Artixio supports global supplement companies with Brazil regulatory affairs services, including product compliance, registration, labelling, and commercialisation requirements. Get in touch with us at info@artixio.com.
FAQs
Are all health supplements registered in Brazil?
No. Some lower-risk supplements may proceed by notification or exemption, and certain products containing probiotics, enzymes, novel ingredients or functional or health claims will require ANVISA review.
Can foreign companies register supplements directly with ANVISA?
No. Foreign companies need to be represented by a Brazilian legal entity or importer for registration and importation.
Do supplements that are approved by the US FDA automatically meet the requirements in Brazil?
Brazil adheres to its own rules regarding ingredients, dosage, labelling and claims for Brazil, per ANVISA regulations.
