Application for Novel Food Ingredients in Brazil

I.Definition of a Novel Food in Brazil

According to the regulation RES 16/1999 (Registration of Novel Food) of the ANVISA, novel food refers to those that have no consumption history in the country or substances that have been consumed before but are added or used at levels far higher than those currently used in conventional diets.

If a substance is considered a novel food, the applicant must submit the corresponding scientific and technical report to ANVISA. ANVISA will conduct a safety assessment and decide whether to approve this novel food.

II. Requirement for an Applicant

The applicant has to be a company within Brazil.

III.Application Time Frame

ANVISA's review process usually takes up to one year, but the time varies depending on the each individual case.

The whole application usually takes 2-3 years from document preparation to completion of the registration.

IV. Application Documents

The following documents are required for a novel food registration application in Brazil:

1. Company registration form (FCE) - applicable to unregistered companies;

2. novel food registration application form;

2.1 Applicant information, including name, address, CNPJ (Brazilian business registration number), and email address;

2.2 novel food manufacturer information, including name, address, CNPJ, and email address;

2.3 Common name, synonyms, and trademark (if applicable) of the new food;

2.4 Intended use and conditions of use;

3. Scientific and technical report;

3.1 Ingredient characteristics;

3.2 Hazard characteristics;

3.3 Risk characteristics;

3.4 Evaluation and approval information from international regulatory Institutes.

V. Our Services

ZMUni can provide enterprises with related services for Brazilian food, including:

- Feasibility analysis of novel food registration in Brazil

- Registration application for novel food in Brazil

- Testing services for novel food in Brazil

- Other customized compliance consulting services