ZMUni Compliance Centre

Our Services

• Feasibility analysis for novel food application in Brazil
• Novel food application in Brazil
• Testing services
• Other customized compliance services

Regulatory Approach of Novel Food in Brazil

According to Annex II of Resolution RDC 240/2018 of the Brazilian National Health Surveillance Agency (ANVISA), the following categories of food (including new food) require official approval before being marketed:

Foods with functional claims and/or health claims
Infant and baby foods
Enteral nutrition foods
Food contact materials using new technologies (recycled)
Novel foods and novel ingredients
Dietary supplements containing enzymes or probiotics

According to Regulation RES 16/1999 of the National Health Surveillance Agency (ANVISA) (Registration of New Foods), novel food refers to food or substances without a consumption history in the country or food containing substances that have been consumed but at levels significantly higher than those currently used in regular diets. If a substance is considered a novel food, the applicant for the registration of novel food must submit the corresponding scientific and technological reports to ANVISA. ANVISA conducts safety assessments and decides whether to approve the new food.

Applicant for Novel Food in Brazil (Entity)

The applicant should be a company based in Brazil.

Documentation for Novel Food Application in Brazil

1. Company registration form (FCE) - applicable to unregistered companies
2. Novel food registration application form
   1 Applicant information, including name, address, CNPJ (Brazilian company registration number), email address
   2.2 Manufacturer information of the new food, including name, address, CNPJ, email address
   2.3 Common name, synonyms, and trademarks (if applicable) of the new food
   2.4 Intended use and conditions of use
3. Scientific and technological report
   1 Ingredient characteristics
   3.2 Hazard characteristics
   3.3 Risk characteristics
   3.4 Assessment and approval information from international regulatory agencies.