Argentina Regulatory News

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

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the proce...

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the process of changing formulations and labeling required under Provision 5978 / 2023 will expire.

The Provision was released by the ANMAT on 4 August 2023. The article prohibits the use of certain substances in cosmetics, personal hygiene, and perfume products, including 4-Amino-3-hydroxytoluene, 1,2,4-Trihydroxybenzene, and 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid.

The EU’s Scientific Committee on Consumer Safety (SCCS) has already issued opinions on the safety of these ingredients when used in hair and eyelash dyes. The SCCS found that 4-amino-3-hydroxytoluene and 1,2,4-Trihydroxybenzene are genotoxic, while 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid is mutagenic. According to the findings, the use of these chemicals in cosmetics is not safe. Based on the quality of the scientific evidence provided, the European Commission modified Annex II of Regulation No. 1223/2009 to include these compounds in the list of substances restricted for use in cosmetics. ANMAT cites the EU's findings as the proof required to ban the chemicals in Argentina.

Provision 5978 / 2023 also forbids the marketing of cosmetic products containing these chemicals. Companies that own, produce, or import cosmetic items affected by this clause have 90 calendar days (until 2 November 2023) to make required revisions and commence the process of changing formulations and labeling. Penalties for non-compliance will be imposed in accordance with Law 6.463 and Decree No. 341/92. The Provision entered into force on the day of its publication in the Official Gazette, and it must be filed with the National Directorate of the Official Registry, the Argentine Chamber of the Industry of Personal Hygiene, Cosmetics, and Perfumery Products, and other organizations.

Argentina has introduced fresh technical guidelines for the storage of mercury in line with the Minamata Convention. The issued Resolution delineates the particulars concerning storage and management,...

Argentina has introduced fresh technical guidelines for the storage of mercury in line with the Minamata Convention. The issued Resolution delineates the particulars concerning storage and management, encompassing explicit stipulations for labeling. These updated regulations are applicable to any entity or individual within Argentina who is in possession of mercury under the following conditions:

Those who have sought exemption in accordance with Resolution MAyDS No. 299/21;

Those who have had their Reconversion Plans approved under the Minamata Convention on Mercury as per Resolution MAyDS No. 503/22;

Those subject to the provisions of Law No. 24,051. 

The Argentinian government has published the fees for registration, importation, notification, fines and tariffs for 2023 regarding the Registry of Chemical Precursors created by Law 26.045 of 8 June ...

The Argentinian government has published the fees for registration, importation, notification, fines and tariffs for 2023 regarding the Registry of Chemical Precursors created by Law 26.045 of 8 June 2005. The fees are summarized in the following table: 

To make the payment there are several options available. The first option is to make a transfer or deposit that corresponds to the fee that needs to be paid or the value of the tariff that is required for the compensation of tariffs that were acquired before the Resolution 647/2021 of 30 December 2019 (Procedures within the National Registry of Chemical Precursors) came into effect. 

Another option is to complete the form found on the website www.entecooperador.org.ar/informar-pago.html. Once the payment has been made, it is necessary to wait for the receipt of an electronic invoice, which will be emailed within 48 hours of the next business day after the transfer or deposit was made. 

If the invoice has not been received after 72 business hours, it is important to inform the National Registry to the email: pedidos@entecooperador.org.ar.