Food
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:
- Resolution 16/1999 and Resolution 17/1999: Novel foods and novel ingredients
- Resolution 18/1999 and Resolution 19/1999: Food with functional claims and or health properties claims
- Resolution RDC 42/2011, Resolution RDC 43/2011, Resolution RDC 44/2011, Resolution RDC 45/2011, Ordinance 34/1998, Ordinance 36/1998, Law 11.265/2006, Decree 8.552/2015 and Resolution RDC 222/2002: food for infants and young children
- Resolution RDC 21/2015 and Resolution RDC 22/2015: Enteral nutrition products
- Resolution RDC 20/2008: Food contact materials with new technologies
- Resolution RDC 27/2010: Categories of foods and packaging that require a pre-market approval by Anvisa
- Resolution RDC 240/2018: Amends RDC 27/2010