Argentina Regulatory News

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the m...

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the minimum shelf life required for imported medical devices from one year to six months, effective immediately.

The change was made official through the Disposition 2565/2025 issued on April 15, 2025, which replaces Disposición N° 1655/1999, a long-standing rule that prohibited the import of medical devices with less than 12 months before expiration. The updated regulation aims to align ANMAT’s oversight with technological advances in medical devices, and to ease restrictions that stakeholders argued were limiting access to innovative products.

According to ANMAT, the review process was initiated following requests from industry representatives involved in the manufacturing, importation, and distribution of medical devices. These groups expressed concern that the original one-year requirement restricted imports and delayed the arrival of critical healthcare technologies.

Under the new framework:

• Medical devices and their accessories must now have at least six (6) months of shelf life remaining at the time of importation.

• Devices with a total approved shelf life of six months or less are exempted, provided they are not expired upon entry.

• Single-use sterile products—whether imported or locally manufactured—may not be re-sterilized, reused, or have their original packaging altered, unless specifically authorized by regulatory resolution.

• Falsifying expiration dates on packaging is explicitly prohibited and may lead to sanctions under Law No. 16.463 and possible criminal charges.

The revised policy reflects ANMAT’s intention to improve regulatory efficiency without compromising safety. The agency emphasized that shorter shelf lives should not translate into lower standards, and all products must still comply with the established quality and safety benchmarks. This update is expected to enhance the flexibility of Argentina’s healthcare supply chain, enabling hospitals and clinics to access a wider range of medical technologies while maintaining oversight to ensure patient safety. For further details, you can consult the Disposition (in Spanish) here.

The Argentine Ministry of Health has issued Resolution 915/2025, updating existing regulations on lead content in paints, lacquers, and varnishes. The new resolution introduces significant changes aim...

The Argentine Ministry of Health has issued Resolution 915/2025, updating existing regulations on lead content in paints, lacquers, and varnishes. The new resolution introduces significant changes aimed at streamlining import procedures while maintaining strict health and safety standards.

The original regulation, established in Resolution 7/2009, prohibited the manufacture, import, commercialization, and free distribution of paints containing more than 0.06% lead by mass in non-volatile content. The latest update replaces and clarifies certain provisions to enhance compliance measures and improve trade facilitation.

Key Updates in Resolution 915/2025

1. Pre-Import Declaration Requirement:

   • Importers must now submit a sworn declaration confirming that their products comply with the lead limit before import clearance.

   • This declaration will be sufficient for customs clearance, provided all other import requirements are met.

2. Post-Market Compliance Checks:

   • The Instituto Nacional de Tecnología Industrial (INTI) will be responsible for verifying compliance after importation through market inspections and factory audits.

   • If an infraction is detected, the violator will bear the cost of laboratory testing.

3. Scope of Prohibition Defined:

   • The restrictions continue to apply to paints used in homes, healthcare facilities, schools, furniture, children’s toys, and playground equipment.

   • Exemptions have been granted to industrial-use paints, including those for automobiles, aircraft, bridges, agricultural equipment, and traffic markings, which will no longer require the sworn declaration.

4. Labeling Requirements for Lead-Containing Paints:

   • Products that exceed the permitted lead levels must display a mandatory health warning:
     ADVERTENCIA: Este producto contiene plomo. Su ingestión provoca daño a la salud. Producto de uso exclusivo para...” (WARNING: This product contains lead. Ingestion may cause health damage. Product for exclusive use in...)

   • The label must specify the approved applications for the product.

5. Enhanced Customs Control:

   • The Dirección General de Aduanas (DGA), under the Agencia de Recaudación y Control Aduanero (ARCA), will implement selective import control mechanisms in line with risk assessment protocols.

Impact on the Industry

The resolution is expected to simplify import procedures and remove bureaucratic barriers while ensuring that health risks remain controlled. The regulation also brings clarity to businesses by explicitly defining which products fall under the restriction and ensuring that industrial-use paints are excluded from unnecessary compliance burdens.

Next Steps

Resolution 915/2025 has been formally communicated to the relevant regulatory agencies, including the Customs Authority (DGA) and INTI, which will oversee implementation. The changes take immediate effect following their official publication in Argentina’s Boletín Oficial.

For further details, stakeholders are encouraged to review the full resolution text as published by the Ministry of Health, here (in Spanish).

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 export...

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 t...

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.

The Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) has taken a significant step toward updating national cosmetic regulations by incorporating the latest MERCOSUR...

The Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) has taken a significant step toward updating national cosmetic regulations by incorporating the latest MERCOSUR standards into its legal framework. The move is formalized in Disposición 8067/2024, published on September 6, 2024, in the Official Gazette of Argentina, marking a crucial alignment with regional regulatory norms.

This regulatory update follows the approval of Resolution GMC No. 18/23, which establishes a new technical regulation for the classification of personal hygiene products, cosmetics, and perfumes within the MERCOSUR region. This resolution replaces the previous Resolution GMC No. 07/05, which had been in force since its incorporation into Argentine law in 2006 via ANMAT’s Disposición No. 345/2006. As a result of the new update, Disposición No. 345/06 has been officially revoked.

The new regulation provides an updated classification system for personal hygiene products, cosmetics, and perfumes, ensuring they meet current safety and efficacy standards. This aims to harmonize regulations across the MERCOSUR region, enhancing trade and compliance.

Under the Ouro Preto Protocol, the new MERCOSUR rule will take effect simultaneously in all member states. The regulation will enter into force 30 days after MERCOSUR’s Secretariat confirms that all member states have incorporated it into their respective legal systems.

The ANMAT has involved its Directorate for Monitoring Health Products, Directorate of Institutional Relations, and Directorate of Legal Affairs in the process. The relevant sectoral board and international relations programs will also be notified, ensuring that stakeholders are fully informed about the upcoming changes.

The new classification framework is expected to offer clearer guidelines for manufacturers and distributors in Argentina and throughout the MERCOSUR region. To this extent, Argentina positions itself in closer alignment with international standards, fostering smoother international trade and protecting consumers more effectively.

The full details of Resolution GMC No. 18/23 and its annexes are available on: Resolution GMC No. 18/23

This update highlights ANMAT’s commitment to maintaining rigorous standards in the health, safety, and efficacy of products in the marketplace while facilitating regional cooperation under MERCOSUR agreements. The cosmetics and personal care sectors can now look forward to improved regulatory clarity and market access across Argentina and its neighboring countries.

Aiming at enhancing efficiency in the agrochemical importation process, Argentina has introduced a new policy that will recognize the equivalency of active substances approved by several leading inter...

Aiming at enhancing efficiency in the agrochemical importation process, Argentina has introduced a new policy that will recognize the equivalency of active substances approved by several leading international authorities. This development, announced through Resolution 694/2024 and published today in the Official Gazette, marks a pivotal shift in the country’s approach to managing agrochemical imports.

A New Era for Agrochemical Imports

The Argentine National Service of Agrifood Health and Quality (Senasa) has formally accepted equivalencies from countries including the United States, Mexico, the European Union, the United Kingdom, Australia, New Zealand, and Brazil. This decision aligns with Argentina’s ongoing efforts to streamline regulatory processes and reduce bureaucratic barriers for businesses.

Under the new resolution, active substances that meet the technical grade criteria and have been approved by the aforementioned authorities will be recognized, provided they come from the same manufacturing establishment and have equal or higher purity levels compared to those registered in these countries. This move is expected to facilitate quicker and more efficient importation of agrochemicals, benefiting both importers and agricultural stakeholders.

Simplification and Deregulation: A Strategic Approach

The adoption of this policy is part of a broader plan to deregulate and simplify the regulatory framework governing agrochemicals in Argentina. Senasa’s initiative is designed to address the challenges faced by the industry and to enhance the overall efficiency of the importation process. By acknowledging international equivalencies, Argentina aims to align its standards with global practices, making it easier for businesses to comply with regulations while ensuring the safety and quality of agrochemical products.

“This is a significant first step in our ongoing efforts to modernize and streamline our regulatory processes,” said a Senasa spokesperson. “We are committed to working closely with the Secretariat of Simplification of the Cabinet of Ministers to further refine and enhance our regulatory framework. Our goal is to clarify regulations, improve efficiency, simplify procedures, and reduce processing times.”

Looking Ahead: Future Developments

The new policy is expected to be the initial phase of a broader regulatory reform process. Senasa has indicated that future steps will involve additional areas of the agency and further collaboration with other governmental bodies. This comprehensive approach is aimed at consolidating the regulatory framework, ultimately benefiting both the agricultural sector and consumers.

As Argentina embarks on this transformative journey, the recognition of international equivalencies represents a crucial advancement in the country’s agrochemical regulation landscape. It not only promises to streamline operations but also reinforces Argentina’s commitment to global standards and practices.

Argentina has taken a significant step towards expediting its pesticide registration procedure by recognising technical equivalence with seven key countries: the United States, Mexico, the European Un...

Argentina has taken a significant step towards expediting its pesticide registration procedure by recognising technical equivalence with seven key countries: the United States, Mexico, the European Union, the United Kingdom, Australia, New Zealand, and Brazil.

Resolution 694/2024: Key Details

The new Resolution 694/2024, published in 2024, stipulates that equivalency will be granted only if the technical grade active substance to be registered comes from the same manufacturing facility and has ‘the same or higher purity level’ as the product approved in the countries listed above.

By accepting equivalence from countries with strong regulatory regimes, Argentina hopes to speed up the pesticide registration process, lower business costs and increase access to critical agricultural supplies. The decision is anticipated to promote tighter coordination between Argentina and the listed nations on pesticide control, as well as facilitate trade in agricultural goods.

Establishment of National Registry and Regulatory Oversight

The legislation establishes the National Registry of Plant Therapeutics and mandates stringent controls over the production, import, export, and marketing of phytosanitary products used in agriculture.

Key provisions of the legislation include:

National Registry: The creation of a centralized registry to monitor and regulate phytosanitary products.

Industry Responsibility: Strict accountability for those involved in the production and trade of these products.

International Standards: Adoption of global best practices and recognition of equivalence for technical grade active substances based on guidelines from organizations like the World Trade Organization.

Regulatory Alignment: Acknowledgment of leading regulatory bodies such as the US EPA and EU's EFSA for phytosanitary product evaluation.

National Oversight: The designation of SENASA (National Service of Agri-Food Health and Quality) as the authority responsible for registration, trade, and quality control of agri-food products.

Compliance Focus: A strong emphasis on adhering to international standards for health, safety, and quality in agri-food production.

Impact on the Agri-Food Chain

Argentina's dedication to protecting consumers and maintaining global standards in the agri-food industry is evident in this extensive regulatory reform. The legislation aims to protect public health and ensure the quality of agricultural produce. It covers a wide range of products within the agri-food chain, including food, raw materials, additives, animal feed, and fishery products.

*Source