Publicado em 29/10/2020 16h26

Market authorizations

The following categories of foods require a pre-market approval by 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 with functional claims and or health properties claims 

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

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

Applicable regulations

These are the main regulations issued by Anvisa applicable to food exported to Brazil: