The new regulatory framework for access (registration, notification and communication) to the market for supplements and foods, published by the National Health Surveillance Agency (ANVISA), will come into force as of September 1. According to the authority, RDC 843/2024 and Normative Instruction (IN) 281/2024 aim to improve the pre-marketing control of foods, based on risk criteria.

The measure reduces the administrative burden for both the regulatory agency and the food sector, in cases of lower risk; and maintains or increases the rigor, in the case of high-risk products or those with a history of complaints and denunciations.

The new rules define three forms of regularization. These are registration with ANVISA, notification to the agency and, finally, communication to local health surveillance bodies at the start of manufacture or import.

According to the regulatory framework for supplements, products with mandatory registration require ANVISA approval prior to marketing. In this group, infant formulas and enteral nutrition formulas were maintained, and diethotherapeutic formulas for inborn errors of metabolism were included.

For products considered intermediate risk, such as desalinated seawater, transitional foods and cereals for infant feeding, recycled packaging and foods with claims, registration was waived and a new form of regularization was created.