Argentina’s Updated Approach to New Breeding Techniques
This post is written by Florencia Goberna, Secretary of Agriculture, Livestock and Fisheries at the Secretariat of Agriculture, Livestock and Fisheries of the Argentine Nation.
Argentina is promoting New Breeding Techniques (NBTs) as tools to add value to agricultural products and processes, contributing to sustainability while respecting biodiversity and addressing the challenges of climate change.
Since 2015, the country has implemented a robust regulatory framework for NBT-derived products, based on case-by-case assessments to determine whether they fall within the scope of Genetically Modified Organisms (GMOs). This approach has been continuously refined through practical experience and developer consultations.
In 2020, Argentina undertook a comprehensive review of its regulatory system for both GMOs and NBTs. As NBT provisions were originally embedded within GMO regulations, they were separated and updated to improve clarity and specificity. This process led to the development of tailored submission forms for plants, animals, and microorganisms, and enabled the submission of products still under development. These updates were formalized in 2021 under [Resolution No. 21/2021](https://magyp.gob.ar/sitio/areas/biotecnologia/conabia/_pdf/Resolution_N21-2021_3 annexes.pdf).
As technologies evolve, regulatory frameworks must evolve accordingly. In this context, Argentina initiated a new update process in 2024, which culminated in March 2026 with the adoption of Resolution No. 24/2026. This updated framework introduces several improvements aimed at enhancing clarity, accessibility, and efficiency.
A key structural change is the incorporation of an Annex I, which serves as a detailed guidance document. It includes definitions, submission requirements, timelines, and evaluation criteria, clearly separating legal provisions from operational aspects and improving usability for both developers and regulators.
The regulation establishes procedures to determine whether an organism obtained through NBTs—or other modern biotechnology techniques—should be considered genetically modified under Resolution No. 763/2011. At the same time, it explicitly excludes organisms that clearly fall within the scope of that resolution, avoiding unnecessary regulatory overlap and enabling developers to seek clarification for a broader range of products. Key definitions have been consolidated and expanded in Annex I, including concepts such as “genomic intervention,” “insertion,”
“line/product/development,” and “technical responsible party.” This improves conceptual clarity and helps reduce delays by facilitating more precise and consistent submissions.
The Pre-Consultation Instance (ICP) is now described in detail within Annex I, addressing common questions raised during the submission process. The updated framework removes the requirement for prior registration in the National Registry of GMO Operators or equivalent accreditation, facilitating access for smaller developers. It also allows the submission of multiple lines within a single application without redundant information, reducing preparation time and improving data organization.
Procedures for handling Confidential Information have also been updated. The regulation clearly specifies which types of information cannot be treated as confidential and establishes transparent procedures for managing sensitive data, providing greater predictability for developers.
Importantly, the regulation defines the criteria used to determine whether an organism constitutes a GMO. A “new combination of genetic material” is considered to exist when a genomic intervention results in a stable insertion and meets specific conditions: the genotype cannot be obtained through conventional breeding or occur naturally, and the intervention leads to a novel expression product within the species’ genetic pool. By clearly defining these criteria, the framework enhances transparency and allows developers to better anticipate regulatory outcomes.
Further reading
- New Improvement Techniques (NBT), Argentina.
- Whelan & Lema (2015), Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina.
- Goberna et al. (2022), Genomic Editing: The Evolution in Regulatory Management Accompanying Scientific Progress.
- Goberna et al. (2023), Gene Editing Regulation in Argentina. En: Global Regulatory Outlook for CRISPRized Plants 1st Edition.
- Fernández Ríos et al. (2024), Regulatory landscape for new breeding techniques (NBTs): insights from Paraguay.
- Fernández Ríos et al. (2025), Naturally transgenic plants and the need to rethink regulatory triggers in biotechnology.
- Fernández Ríos et al. (2025), Regulatory challenges and global trade implications of genome editing in agriculture.
About the author
Florencia Goberna is a biotechnologist specialized in regulatory affairs, biosafety, and risk assessment of GMOs and New Breeding Techniques (NBTs). She has extensive experience in policy development, international regulatory harmonization, and capacity building for governmental and regulatory authorities. She is actively engaged in science communication, public dialogue, and advising policymakers on biotechnology governance.