Food

Market authorizations

What regulations govern the authorization of food and packaging?

The regulatory framework for the authorization of food and packaging within the scope of the National Health Surveillance System (SNVS) comprises Collegiate Board Resolution (RDC) No. 843/2024 and Normative Instruction (IN) No. 281/2024, both of which entered into force on September 1, 2024.

What are the regulatory pathways for food and packaging under the SNVS?

RDC No. 843/2024 establishes three regulatory pathways for food and packaging:

1. Registration with Anvisa
2. Notification to Anvisa
3. Communication to the competent local health authority (state, Federal District, or municipal) of the start of manufacturing or importation

IN No. 281/2024 specifies in its Annexes I, II, and III, respectively, the categories of food and packaging that are subject to registration with Anvisa, notification to Anvisa, and communication of the start of manufacturing or importation to the local health authority.

Which categories of food and packaging are exempt from authorization under the SNVS?

Annex IV of IN No. 281/2024 establishes the categories exempt from authorization under the SNVS:

1. Food raw materials
2. Fresh foods
3. Food equipment, including those intended for domestic use
4. Food products and ingredients, including food additives and processing aids, prepared in compliance with technical standards that establish their composition, quality, safety, and labeling requirements, provided they are used exclusively in the manufacturing of industrialized foods
5. Food products handled and prepared in food services for direct sale to the final consumer, such as bakery, pasta, confectionery, dessert, rotisserie, ice cream, bar, restaurant, canteen, institutional food and nutrition units (e.g., schools, health services), daycare, among others

Which categories of food and packaging must be registered with Anvisa?

Annex I of IN No. 281/2024 lists the categories subject to registration with Anvisa:

• Dietary formula for inborn errors of metabolism (RDC No. 460/2020)
• Follow-up infant formula for infants and young children (RDC No. 44/2011)
• Infant formula for specific nutritional needs (RDC No. 45/2011)
• Infant formula for infants (RDC No. 43/2011)
• Standard enteral nutrition formula (RDC No. 21/2015)
• Modified enteral nutrition formula (RDC No. 21/2015)
• Pediatric enteral nutrition formula (RDC No. 21/2015)
• Enteral nutrition modules (RDC No. 21/2015)

Which categories are exempt from registration but must be authorized through notification to Anvisa before being placed on the market?

Annex II of IN No. 281/2024 defines the categories subject to notification to Anvisa:

• Desalinated potable seawater (Decree-Law No. 7,841/1945 and RDC No. 717/2022)
• Foods with functional and/or health claims (Resolution No. 19/1999)
• Transitional foods for infant feeding (Ordinance No. 34/1998)
• Weight control foods (RDC No. 715/2022)
• Infant cereals (Ordinance No. 36/1998)
• Food-grade PET-PCR resin (Resolution No. 105/1999)
• Food-grade PET-PCR precursor or final packaging (RDC No. 20/2008)
• Food supplements (RDC No. 243/2018)

Which companies are eligible to request product authorization?

According to IN No. 281/2024:

a) Products subject to registration (Annex I): the headquarters of the manufacturer, the manufacturer’s legal representative in Brazil, or the importer
b) Products subject to notification (Annex II): the headquarters of the manufacturer, the manufacturer’s legal representative in Brazil, or the importer
c) Products subject to communication of the start of manufacturing or importation (Annex III): the manufacturing or importing company

In accordance with §2 of Art. 4 of RDC No. 843/2024, the requesting company must be the product owner.

When should the holder request an amendment to the authorization?

An amendment must be requested whenever the product undergoes modification initiated by the manufacturer, due to regulatory updates, or by determination of the health authority.

When should the holder request cancellation of the authorization?

Cancellation must be requested when the company no longer intends to market the product.