ANVISA Novel Food Application in Brazil - South America - Food & Food Contact Materials

What is ANVISA?

The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. ANVISA’s role is to promote the protection of the population’s health by:

Executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies;
Executing import/export supervision at ports, airports and borders.

Why ANVISA?

ANVISA certification constitutes a statutory prerequisite for the market release of food products in Brazil. As the regulatory authority, ANVISA is responsible for the scientific evaluation and registration approval of food products. Food registration approvals must be published in the Brazilian Official Gazette (Diário Oficial da União - DOU) to authorize legal marketing and distribution. Registrations remain valid for 5 years from the DOU publication date. Prior to expiration, a revalidation request must be submitted to maintain market authorization.

Applicable Regulation

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

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

Definition of Novel Foods (Novos Alimentos e Novos ingredients) in Brazil

Any food or food ingredient lacking a documented history of safe consumption in Brazil is classified as novel and must undergo mandatory premarket evaluation by ANVISA. This regulatory understanding has been established since the issuance of ANVISA Regulation RES 16/1999. On December 14, 2023, Regulation RDC 839/2023 revoked the Regulation RES 16/1999 and refined the regulatory framework for novel foods, providing clearer definitions.

According to RDC 839/2023, novel foods are defined as:

Foods and food ingredients without a documented history of safe consumption in Brazil, derived from plants, animals, minerals, microorganisms, fungi, algae, or synthetic sources, including but not limited to those that:

Exhibit novel or intentionally modified molecular structures;
Consist of or are produced from cell cultures or tissue cultures;
Have undergone production processes resulting in significant compositional modifications;
Are manufactured using non-traditional food production techniques;
Are obtained through fermentation, extraction, or selective concentration for technological purposes to alter the physical, chemical, biological, or sensory properties of foods—provided they are not listed as food additives in Normative Instruction (IN) 211/2023 or any replacement regulation;
Are composed of engineered nanomaterials;
Serve as sources of nutrients or non-nutrient compounds for use in conventional foods;
Are ingredients for food supplements not specified in IN 28/2018 or any replacement regulation;
Consist of nutrients and other substances for enteral nutrition formulations not covered by RDC 22/2015 or any replacement regulation;
Contain nutrients intended for infants and young children not cover by RDC 42/2011 or any replacement regulation;
Are components authorized exclusively for food supplements and foods for special purposes, if intended for use in other food categories; or
Are botanical species for preparation of tea or spices not listed in IN 159/2022, or any replacement regulation.

Purpose of ANVISA's Safety Assessment

The safety assessment conducted by ANVISA constitutes a regulatory administrative procedure to evaluate the safety of novel foods based on technical-scientific dossiers submitted by applicants. During safety assessment, ANVISA verifies that the manufacturing process does not introduce or concentrate substances with potential adverse health effects, and confirms that the intended conditions of use do not exceed the established safety thresholds.

Eligibility for ANVISA Certification Applications

The request for ANVISA safety assessment is typically submitted the companies responsible for producing novel foods. For foreign companies, submissions must be made through locally established representatives in Brazil.

Note: Foreign companies cannot directly engage with ANVISA for administrative approval of market authorization. Foreign companies must partner with a legally established Brazilian company. The Brazilian partner company shall assume full legal liability for products imported into and commercially distributed within Brazilian territory.

Application Materials

Regulation RDC 839/2023 defines the documentation required for safety evaluation applications. Applications for the safety assessment of novel foods must include a Technical-Scientific Report (Relatório Técnico-Científico, RTC) written in Portuguese, containing the following information:

Executive summary;
Description of the claim;
Applicant’s details: Name, CNPJ, address and email address;
Manufacturer’s details: Name and address of the novel food’s manufacturer (including CNPJ for domestic manufacturers);
Identification and characterization of the novel food;
Specifications of the novel food, including analytical methods used;
Production process description of the novel food;
Consumption history of the novel food;
Safety assessment studies;
Allergenicity of the novel food;
Bioavailability of nutrients and bioactive compounds provided by the novel food;
Methodology used to derive the proposed safety value;
Intended use and conditions;
Exposure assessment
Risk assessment
Evaluations and authorizations published by equivalent foreign regulatory authorities; and
Justification for any omitted information, demonstrating that its absence does not compromise safety assessment or ANVISA’s decision making (if applicable).

Note:

*The Resolution provides detailed explanations and regulatory requirements for the required documentation. Applicants may also access a compliance checklist within the application system that outlines the mandatory documents necessary for preparing the technical-scientific report, based on the subject of the safety evaluation request.

*Additional reference documents for application materials:

Guideline No. 23/2019 (GUIA Nº 23, DE 23 DE JULHO DE 2019 - VERSÃO 1) provides guidance on the information required to substantiate safety evaluation petitions. The guideline outlines the information considered relevant for conducting the process of proving safety level of use, bringing recommendations on the documentation and information that must be instructed in the process. This guide will be updated to align with the requirements established by RDC 839/2023, but may still be used to assist in dossier preparation.
Guideline No. 35/2020 (GUIA Nº 37, DE 2 DE SETEMBRO DE 2020 - VERSÃO 1) clarifies the essential elements for product specification, particularly for ingredients and foods that lack established specifications in ANVISA-recognized reference standards.

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 dossier;
Step 2: CIRS Group will submit the completed dossier to ANVISA for 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.

Administrative Workflow for ANVISA Safety Evaluation

Application Timeline

Based on experience, the ANVISA official review process for novel foods typically requires 12-18 months from dossier submission to publication in DOU. However, pre-assessment phases (including queue time and preliminary screening) exhibit significant variability, primarily depends on ANVISA’s internal workload.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.