Anvisa Establishes New Regulatory Framework for Food Regularization: Learn about the Main Changes and Deadlines for Compliance
- Piva Advogados
- Mar 6, 2024
- 2 min read
In the food sector, the National Health Surveillance Agency (Anvisa) coordinates, supervises and controls registration, inspection, surveillance and risk control activities, and is responsible for establishing norms and standards of quality and identity to be observed.
Anvisa has announced the publication of two regulations aimed at regularizing food: Collegiate Board Resolution (RDC) 843/2024 and Normative Instruction (IN) 281/2024.
RDC 843/2024 deals with the regularization of food and packaging under the jurisdiction of the National Health Surveillance System (SNVS), intended for sale in the national territory. IN 281/2024 complements this regulation, establishing the procedures for regularizing the different categories of food and packaging, including the documentation required by the competent authorities.
These regulations were the result of Public Consultations conducted by Anvisa in 2022 and represent a new regulatory framework for the food sector, replacing the previous resolution, which had been in force for 24 years (RDC 22/2000).
The new regulation establishes three ways of regularizing food in Brazil:
Registration with Anvisa (Registro);
Notification to Anvisa (Notification);
Communication to local health surveillance bodies (VISA Local) of the start of manufacture or import (Communication).
One of the main new features is the introduction of regularization through Notification, applicable to food products considered to be of intermediate risk, as defined in Annex II of IN 281/2024. This includes transition foods and cereals for infant feeding, recycled packaging, foods with functional and/or health claims, among others. These products have been exempted from the Registration procedure for marketing and must submit the documents described in Annex X of IN 281/2024 for regularization.
Food supplements and foods for weight control, previously regulated by communication to local VISAs, have been included in the categories subject to the Notification procedure. Products subject to Registration include infant formula and formula for enteral nutrition, as well as dietary formula for inborn errors of metabolism.
In addition, some foods are required to report the start of production, such as sugar, cocoa powder, chocolate, molasses, rapadura, tabletop sweeteners and diet sweeteners, coffee, among others.
The aim of the new regulations is to reduce the administrative burden for Anvisa and the food sector, especially in cases of lower risk, while maintaining or increasing the rigor for high-risk products or those with a history of complaints.
The deadlines for regularizing and adapting food products and packaging to the new rules established by Anvisa vary from approximately 18 to 31 months, as specified in RDC 843/2024, depending on the product category.
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