Brazilian FDA (ANVISA) adopts a new regulatory framework for the food industry

by | Mar 11, 2024 | Client Alert, Life Sciences, Regulatory

On February 28th, the Brazilian regulatory agency ANVISA published the Resolution RDC 843/2024 and the Normative Instruction 281/2024, which provide for the regularization of food and packaging under the competence of the National Health Surveillance System (SNVS) intended for supply in the national territory.

The main goal of these measures is to reduce the regulatory burden for the food sector in cases of lower risk, and to maintain or increase the rigor in cases of high-risk products or those with a history of complaints. In return, ANVISA will be able to act more effectively on the most relevant risks, without imposing unnecessary barriers for access to products.

The new regulatory food framework provides three forms of regularization:

  1. Registration with ANVISA;
  2. Notification to ANVISA and
  3. Notification to local health surveillance bodies at the start of manufacturing or import.

Registration with ANVISA

Registration with ANVISA is compulsory for the categories of foods listed in Annex I of the Normative Instruction 81/2024, which are considered high risk. Thus, formulas for infants, young children, or those with specific dietary needs; formulas for enteral nutrition and dietary formulas for inborn errors of metabolism must be registered before being marketed.

These products must be registered by the manufacturer’s head office, the manufacturer’s representative, or the importer. The application for registration is made through a petition accompanied by i) a completed application form; ii) a copy of the valid health license of the manufacturer(s); iii) information on the label; iv) qualitative and quantitative information on the ingredients; v) an analytical report on the ingredients; vi) an analytical report on the final product and vii) a report on stability studies that guarantee that the nutritional properties of the product are maintained during the declared shelf life.

In addition to these mentioned documents, others may be requested depending on the characteristics of the product to be registered. Once the requirements have been met, the registration will be published in the Federal Official Gazette and only then can the product be marketed. It is important to note that the labeling of these products must indicate that they have been registered with ANVISA, in accordance with the provisions of RDC 727/2022. The registration will be valid for five (5) years from publication in the Federal Official Gazette and may be renewed.

Notification to ANVISA

For products considered to be of intermediate risk, registration was waived, and a new form of regularization was created: Notification to ANVISA. According to Annex II of Normative Instruction 281/2024, products such as desalinated seawater, food supplements, cereals for infant feeding, foods with claims of functional and/or health properties, weight control, or transition to infant feeding are considered intermediate risk.

As with products that require registration, notification must be made by the manufacturer’s head office, the manufacturer’s representative, or the importer. The notification must be filed with ANVISA accompanied by the necessary documents for each type of product. In general, all products must submit i) a notification form and ii) a copy of the manufacturer’s valid health license. However, other documents may be required, depending on the product to be regularized by notification. For example, the notification request for desalinated water must be accompanied by i) a notification form; ii) a copy of the manufacturer’s valid health license; iii) a product calculation report or memorial proving compliance with the composition requirements and iv) a copy of the authorization to collect the water and licenses issued by the competent environmental bodies, in accordance with Annex X of Normative Instruction 281/2024.

In the case of Notification, the product will be ready for marketing as soon as the application with the documentation is filed, without the need to wait for any publication in the Federal Official Gazette. Although the product can be marketed as soon as the notification protocol is filed, it can be subject to evaluation by ANVISA at any time.

Notification to local health surveillance bodies at the start of manufacture or import.

Finally, the products that must be notified to local health surveillance bodies at the start of manufacturing or import are listed in Annex III of Normative Instruction 281/2024 and include sugar, bread, flour, spices, food additives, biscuits, processed or whole cereals, edible mushrooms, oils and fats, mineral water, iodine-enriched salt, among others.

The notice of the start of manufacturing or import must be filed with the competent Health Surveillance body, using the specific form provided in Normative Instruction 281/2024. The notification of manufacture or import is valid indefinitely and its protocol is sufficient to make the product available on the market. It is worth noting that after receiving the notification, the competent health authority may carry out a health inspection at the units that manufacture or store the food or packaging.

The new rules will come into force on September 1, 2024; however, Resolution 843/2024 sets deadlines for products to be readjusted to their new categories until 2025 or 2026, depending on the case. If you have any questions or would like to get more information, do not hesitate to get in touch with our regulatory team. We will be glad to assist you.


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