Food Supplements Regulatory Support in Brazil

Overview

Brazil is the only country in Latin America (LATAM) to have a well-defined legislation for functional and health claims for the nutrient and non-nutrient components. The Brazilian Regulatory framework for these components has been developed by the National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) based on safety and efficacy of the products. These products are defined as Food & Food Supplements. ANVISA follows strict regulations for Food Supplement registration in Brazil.

The Food supplement category was created in 2018 to guarantee the access to safe and quality products. The term “Supplement” applies only to minerals, vitamins, or a combination of both. ANVISA has established the guidelines for these products with the scientific advice of the committee - Technical and Scientific Committee on Functional Food and Novel Ingredients (CTCAF).

Freyr assists in food product classification, food product registration, formulation/ingredient assessment, label & claims review, technical dossier compilation, and submission & follow up with ANVISA.

Classification of Food Supplements

Food supplements are intended to provide nutrients, bioactive substances, enzymes, or probiotics in addition to food.

If a Food Supplement is classified as established in Annex II, the food supplement will be subjected to the product registration. If not, the Food Supplement is exempt from the product registration.

The following categories of foods require a pre-market approval from the ANVISA, as established in Annex II of Resolution RDC 240/2018:

  • Novel foods and novel ingredients 
  • Food with functional claims and/or health properties claims
  • Food for infants and young children
  • Enteral nutrition products
  • Food contact materials with new technologies (recycled) (PET-PCR food grade)
  • Bioactive substances and probiotic supplements with functional claims and/or health properties claims

Registration of Food Supplements

Market Authorizations

Only the Food Supplements classified under Annex II are subject to the product registration. It is necessary to submit the scientific technical dossier to the ANVISA for obtaining Market authorization.

Pre-market approvals are valid for five (5) years from the date of their publication in the Brazilian Official Gazette and may be renewed for equal and successive periods.

To make administrative arrangements for issuing market authorizations with the ANVISA, it is mandatory for the foreign companies to have partner companies legally constituted in Brazil. These local partners will be legally responsible for the products imported to and distributed in the Brazilian territory.

Supplement Food Notification

Food Supplements not classified under Annex II of the RDC 240/2018 are exempted from the product registration because the ingredients used in them already have a history of safety and efficacy and follow current requirement trends that describe the limits of use of the ingredients and packaging. So, these products must be notified to the Health Authority by the manufacturing or importing company established in Brazil.

Product Maintenance & Compliance

Sl. No

Validity of Registration Certificate

Renewal

Post-approval Changes (Variations)

01

Five (5) years

The renewal application must be submitted six (6) months before expiration of the existing registration certificate, along with documents mentioned in the current regulation.

Any change of notified or registered supplement Food must be submitted to the ANVISA with relevant documents according to the current requirements.

Freyr Expertise

  • End-to-end Food product Registration
  • Legal representation
  • Strategic Regulatory Guidance during Product development and Regulatory Affairs Support
  • Carrying out Gap Analysis, Reviewing, Compiling & Submitting the Dossier to ANVISA
  • Representing as RA CMC in Health Authority Meetings
  • Interacting with ANVISA
  • Handling HA Queries Strategically and Preparing Response Packages
  • Providing Product Compliance & Maintenance
  • Managing Artwork & Labeling requirements

 

Quick Inquiry
x