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ANVISA revises pre-market control system


Feb 28, 2024

The National Health Surveillance Agency (ANVISA in Portuguese) has published the new regulatory framework for the regularization of food in the National Health Surveillance System (SNVS). The Collegiate Council Resolution (RDC) 843/2024 and Normative Instruction (IN) 281/2024 improve the pre-marketing control of food, based on risk criteria.    

Main changes are:

  • Products with mandatory registration requiring ANVISA's approval prior to marketing: in this group, infant formulas and enteral nutrition formulas are maintained, and diethotherapeutic formulas for inborn errors of metabolism have been included.
  • For products considered to be of intermediate risk, such as desalinated seawater, cereals for infant, recycled packaging, and foods with claims, registration has been waived and a "Notification to ANVISA" is now required: these types of products will now enter the market more quickly, as they will not require prior approval, although companies will maintain the obligation to submit information to the Agency.
  • Food supplements and weight control foods, whose regularization was carried out directly by the local Health Surveillance, will now be notified to ANVISA. The notification will allow the Agency to structure a database on these products, facilitating the organization of post-marketing control actions, such as follow-up, inspections and audits.  

For further information (in Portuguese), click on the Link

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