ANMAT Disposition No. 11632/2024
Health Law – Life Sciences and Administrative Law Report | ANMAT Disposition No. 11632/2024
On December 26 of this year, Disposition 11632/2024 (the “Disposition”) was published in the Official Gazette, through which the National Administration of Drugs, Food, and Medical Technology (“ANMAT”) updated its regulatory framework for Law 27.642 on the Promotion of Healthy Eating (the “Law”) and its Regulatory Decree 252/2022 (the “Regulatory Decree”).
It is worth remembering that through Disposition 2673/22, ANMAT had created the Seal and Nutritional Warning Declaration System, a tool aimed at managing the procedures established by the Law, offering clear guidelines for the implementation of current regulations.
Through this new Disposition, the “services” for sworn declarations, extension management, and the search tool within the Seal and Nutritional Warning Declaration System, which was part of the Federal Food Control Management Information System, have been removed. Instead, from the date of the Disposition’s entry into force, the “Seal Calculator” will be the only official tool within the Seal and Nutritional Warning Declaration System, thus enabling the official calculation of critical nutrient profiles and the corresponding warning seals applicable to food and non-alcoholic beverages regulated by the Law and its Regulatory Decree.
Furthermore, the Disposition approved the Manual for the Application of the Law and the Regulatory Decree (the “Manual”), developed by the National Food Institute (INAL), which details the specific requirements that labels must meet. Finally, the Disposition establishes that ANMAT, through INAL, may grant authorizations for the exhaustion of remaining label stock derived from the implementation of the Manual.
The Disposition comes into force today.
We remain at your disposal to provide the necessary advice regarding the implementation of this Disposition.
Sincerely,