ANVISA Extends Danone's Formula Registrations in Brazil Until 2030
The Brazilian Health Regulatory Agency, ANVISA, has formally renewed the registrations of several Danone nutrition formulas, extending their validity in the Brazilian market. This extension is seen as a significant step in providing regulatory certainty for products aimed at specialized nutrition.
The renewal was officially documented through Resolution-RE No. 2,286, which was issued by ANVISA's General Food Management on June 3, 2026. This resolution approved Danone Ltda.'s applications concerning the registration of food products designed for specific nutritional needs.
Among the approved registrations is an infant formula with extensively hydrolyzed protein and lactose restriction, offering an energy density of 1 kcal/mL. This product's registration is valid until March 2028. The approved packaging includes both metal and plastic primary containers, with a shelf life of 18 months.
Additionally, ANVISA has revalidated the registration of a modified formula intended for enteral and oral nutrition. This product's regulatory validity is extended until December 2030, utilizing cellulose and plastic packaging and having a nine-month shelf life.
The resolution also involved the cancellation of certain infant formula registrations intended for export, as noted in the annex of the resolution. This cancellation is part of the operational adjustments to ensure compliance with regulatory frameworks.
Operationally, this decision maintains the authorization for the sale of products targeting specific segments of infant and clinical nutrition. It also clarifies the regulatory timelines under which these products will continue to be available in the Brazilian market, offering transparency on the status of registrations covering both infant formulas and solutions for enteral nutrition.
With the publication of this resolution, the authorizations for the sale of the mentioned products remain valid within the timeframes established by ANVISA for each registration.
