The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has issued Disposition 537/2025, introducing modifications to the regulatory framework for food imports and exports in Argentina. The new measures aim to streamline administrative processes, enhance efficiency, and reinforce compliance with national and international food safety regulations.

Background and Legal Framework

The regulation is based on a series of national laws and decrees, including Law No. 18.284, which established the Argentine Food Code (Código Alimentario Argentino:CAA), and Decree No. 1490/92, which created ANMAT as an autonomous regulatory body. The updated procedures align with existing frameworks such as the Sistema de Información Federal para la Gestión del Control de los Alimentos (SIFeGA) and international trade agreements.

Key Provisions

1. Implementation of a New Food Importation Procedure

The Instituto Nacional de Alimentos (INAL) will oversee the Registro Nacional de Establecimientos (RNE) and Registro Nacional de Productos Alimenticios (RNPA), along with the authorization of packaging materials and utensils in contact with food. Importers must now complete the following steps:

• Submit an Import Authorization request via SIFeGA.

• Provide documentation, including commercial registration, sanitary approvals, product composition details, and compliance certificates from the country of origin.

• Obtain a unique RNE and RNPA number for tracking purposes.

• Ensure compliance with labeling requirements as per the Argentine Food Code (CAA)

For imports from designated countries (listed in Annex II of Decree 2126/71), the Notification of Import declaration replaces prior authorization, allowing immediate entry of goods based on foreign certifications. However, ANMAT retains the authority to conduct post-entry inspections.

2. Changes in the Exportation Process

The regulation simplifies the export process by eliminating prior authorization for food exports. However, exporters requiring official certification for registration or market entry in foreign countries may request such documentation from INAL. The process includes:

• Filing an online request through Argentina’s Trámites a Distancia (TAD) platform.

• Specifying the destination country and required certifications.

• INAL’s issuance of the necessary export documentation.

3. Strengthened Regulatory Oversight

To ensure food safety compliance, ANMAT will implement:

• Post-market surveillance, including inspections of food storage facilities and manufacturing sites.

• Random sampling and risk-based inspections for imported food items.

• Enhanced digital tracking of food imports and exports via Argentina’s Ventanilla Única de Comercio Exterior Argentino (VUCEA) and the Sistema Informático Malvina (S.I.M.).

Repeal of Previous Regulations

Disposición 537/2025 replaces and revokes various past resolutions, including:

• Disposición ANMAT No. 14023/2016 (Guidelines for Establishment Authorization)

• Disposición ANMAT No. 1307/2017 (Guidelines for Food Product Authorization)

• Disposición ANMAT No. 10174/2017 (Import Authorization for Industrial Use Foods)

• Disposición ANMAT No. 10100-E/2017 (Export Notification Requirements)

• Disposición ANMAT No. 10088/2017 (Packaging and Utensil Authorization for Food Contact)

• Disposición ANMAT No. 2953/2021 (Mandatory Re-registration for Establishments)

Conclusion

The updated regulations reinforce Argentina’s commitment to food safety, trade facilitation, and regulatory efficiency. By consolidating procedures, implementing digital platforms, and streamlining certification requirements, ANMAT aims to reduce administrative burdens while maintaining high sanitary standards for food products circulating in both domestic and international markets.

The full text of Disposition 537/2025 and its annexes is available here (in Spanish)

Under Resolution 1081/2024, published on September 13, 2024, the National Service of Agri-food Health and Quality (SENASA) has introduced an significant update that grants greater flexibility to those involved in the agricultural sector, allowing them to choose freely laboratories for conducting the analytical tests required for product registrations. This move is part of SENASA's broader effort to streamline operations, improve the efficiency of the regulatory process,  to enhance competitiveness and access to quality services for stakeholders across the agricultural and food sectors. 

The resolution authorizes producers, manufacturers, and other stakeholders in the agricultural and food industries to freely select any qualified national or international laboratory for the required analytical testing. All chosen laboratories must comply with the necessary technical conditions set forth by the relevant regulations. The laboratories are required to guarantee the quality and traceability of the results they provide, ensuring the integrity of the registration process.

This resolution builds on Law No. 27.233, which emphasizes the national interest in animal and plant health, as well as food safety. It also reflects the principles of Law No. 27.742, which aims to improve the transparency and efficiency of public administration. SENASA's decision to update its procedures aligns with these legal frameworks to ensure faster, more transparent responses to the needs of both citizens and businesses.

Resolution 1081/2024 took effect upon its publication in the Official Gazette on September 13, 2024. SENASA will oversee the implementation of this measure, ensuring that all involved laboratories meet the required technical standards.

For further details, stakeholders are encouraged to consult the Official Gazette or reach out to SENASA for guidance on complying with the new procedures.