Brazil Implements a New Regulatory Framework for Food Products

The newly implemented regulatory framework governing food safety and quality in Brazil took effect on September 1st, 2024.

The Collegiate Board Resolutions (RDC) No. 843/2024 as well as the Normative Instruction (IN) No. 281/2024, introduce improvements to the pre-market control of food, based on risk criteria. These regulations establish clear and uniform guidelines for the registration and notification processes of food products, as well as defining the requirements for labeling, the precautions to be observed in marketing, and the control of food additives.

The new legal framework outlines three distinct forms of regularization:

– Registration with Anvisa (Chapter III, Article 11 et seq. of RDC 843/2024)

– Notification with Anvisa (Chapter IV, Article 21 et seq. of RDC 843/2024)

– Communication with the health surveillance authorities at the start of manufacture or import (Chapter V, Article 26 et seq. of RDC 843/2024)

Within the revised regulatory framework, lower-risk food products are subject to less stringent controls and administrative burdens, streamlining the processes for both regulatory agencies and the regulated food industry. In alignment with this approach, intermediate-risk products such as weight-management foods, infant cereals, and dietary supplements have been exempted from the registration requirement, now it is only required a notification with Anvisa, expediting market entry by eliminating the need for prior approval.

Normative Instructions 281/2024 delineates the specific categories of food products that fall under each regulatory pathway, as well as the corresponding documentation that must be submitted to the relevant authorities.

Consider the deadlines for companies to comply with the new rules below:

• September 1^st, 2025:

Application for registration of dietary formulas intended for individuals with inborn errors of metabolism, which have been subject to a notification of commencement of manufacture or importation to the competent health authority prior to September 1, 2024 (the date of entry into force of RDC 843/2024).

Notification of foods specifically designed for weight control or as food supplements, which have been subject to a notification of commencement of manufacture or importation to the competent health authority prior to September 1, 2024 (the date of entry into force of RDC 843/2024).

• September 1^st, 2026:

Deadline for requesting the adaptation of foods falling into the categories listed in Annex I of IN No. 281/2024, whose registration is mandatory with Anvisa. Among them: infant formulas.

• Until the expiration date of the registrations:

The notification of the products categorized as food and packaging listed below that have been registered until September 1^st, 2024, must be filed until the expiration date of their registration and concurrently with the request for cancellation of registration:

I – desalinated, potable and bottled seawater;

II – foods with functional or health claims;

III – transition foods for infant feeding;

IV – cereals for infant feeding;

V – resin, precursor article or final packaging of food-grade PET-PCR; and

VI – food supplements containing probiotics or enzymes.

It is imperative to note that, as a general principle, the regularization of food and packaging must be completed prior to the introduction of products to the consumer market.

Non-compliance with ANVISA’s new food standards constitutes a health violation, subjecting offenders to penalties.

If you would like to know more about this and other topics related to health and regulatory law, contact our team: regulatorio@kasznarleonardos.com.