Proven Experience
With extensive experience in the Brazilian market, we have successfully developed and delivered food supplements that comply with the stringent regulations set forth by the National Health Surveillance Agency (ANVISA). Our expertise encompasses every stage, from formulation to delivery, ensuring adherence to Resolution RDC No. 243/2018, which governs the composition, quality, safety, and labeling of food supplements in Brazil.
Definition of Food Supplements
In Brazil, food supplements are defined as products intended for oral administration, presented in pharmaceutical dosage forms, and designed to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes, or probiotics, either alone or in combination.
Registration Process.
To market food supplements in Brazil, companies must follow these steps:
1. Company Registration:
Foreign companies must partner with entities legally established in Brazil, which will be responsible for importing and distributing the products within the country.
The local partner must register with ANVISA to gain access to the petitioning system required for product registration.
2. Product Registration
The following documentation is required for product registration:
Cover Sheet:
Completed application form.
Petition Forms 1 and 2:
Detailed information about the product and manufacturing process.
Label Copy:
Proposed labeling that complies with Brazilian regulations.
Company Registration Form:
For companies not previously registered with ANVISA.
Sanitary Permit:
Valid document equivalent to a sanitary permit.
Scientific Evidence:
Technical-scientific reports demonstrating the efficacy of any proposed health claims.
Safety Documentation:
For new ingredients, proof of safety in accordance with ANVISA guidelines.
Labeling Requirements
Labels must adhere to specific regulations, including:
- Product Name: The descriptor “Suplemento Alimentar” (food supplement) followed by its form and the names of nutrients or substances included.
- Usage Instructions: Recommended daily intake and target population groups.
- Warnings: Mandatory statements such as “This product is not a medicine,” “Do not exceed the recommended daily consumption,” and “Keep out of the reach of children.”
- Nutritional Information: A table detailing energy value and amounts of all nutrients, bioactive substances, and enzymes added to the product.
Labels must not suggest that a balanced and varied diet cannot provide appropriate quantities of nutrients, nor attribute properties of preventing, treating, or curing human diseases to the product. All claims must adhere to Regulation 1924/2006.
Claims
Nutrition and health claims are permitted but must conform to the authorized list provided in Annex V of Normative Instruction IN No. 28/2018. Textual variations of authorized claims are not allowed unless combining identical claims for different substances into a single sentence.
Recent Regulatory Updates
ANVISA has revised regulations governing food supplements, as published in Normative Instruction IN No. 318, which amends IN No. 28. These updates include modifications to the lists of constituents, usage limits, declarations, and supplementary labeling requirements for dietary supplements.
We’re Certified.
Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.
Multi-language Labelling
To enhance product appeal in Brazil’s diverse market, we offer assistance in creating labels in Portuguese, ensuring compliance with regional language requirements.