New Food Ingredient Application in Brazil

The following categories of foods require a pre-market approval by ANVISA (Agência Nacional de Vigilância Sanitária), 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 regulation

RESOLUÇÃO DA DIRETORIA COLEGIADA - RDC Nº 839, DE 14 DE DEZEMBRO DE 2023

(RDC 839/2023: Regarding the Safety Certification and Authorization for the Use of New Foods and New Ingredients)

Application materials

1. Technical and scientific documentation proving that the imported product meets safety and efficacy requirements;
2. Labels, including usage instructions;
3. Description of the production process, including flowcharts;
4. Information on the product’s raw materials and ingredients, research and development background, and function description;
5. Product quality specification test reports;
6. Clinical data (if applicable);
7. Efficacy and toxicology data (if applicable);
8. Certificate of Free Sale or equivalent certificate, legalized by the Brazilian consulate in the country of origin (i.e., proof of approval/clearance from the country of origin); and
9. Letter of Authorization, legalized by the Brazilian consulate in the country of origin.

Application procedure

The following steps will be conducted in order to obtain the registration of your products:

Step 1: CIRS Group will begin compiling the technical files, translating the relevant information into

Portuguese as we compile the submission;

Step 2: CIRS Group will submit the completed technical files to ANVISA for products application

review;

Step 3: CIRS Group and your company will work to provide responses to ANVISA as required; and

Step 4: ANVISA will approve the products for import and your company can begin shipping.

Application timeline

Based on experience, the preparation of the dossier and official approval from ANVISA for standard substances typically takes between six months to one year.