Argentina Updates Regulatory Procedures for GMO Classification of New Biotechnology Techniques

By Estudio Chaloupka

Argentina's Secretariat of Agriculture, Livestock and Fisheries has issued Resolution 24/2026, establishing updated consultation procedures to determine whether organisms developed through New Breeding Techniques (NBTs) or other modern biotechnology methods qualify as Genetically Modified Organisms (GMOs) under Argentine law. 

Under Argentine regulatory definitions, Modern Biotechnology encompasses the application of in vitro nucleic acid techniques — including recombinant DNA, direct nucleic acid injection into cells or organelles, and cell fusion beyond taxonomic family boundaries — that overcome barriers of reproduction or recombination not achievable through traditional breeding and selection methods. New Breeding Techniques (NBTs) are classified as tools within this broader Modern Biotechnology category.

Resolution 24/2026 establishes a prior consultation mechanism through which developers can submit organisms obtained via NBTs or other modern biotechnology techniques to a formal determination process, resulting in a ruling on whether the organism constitutes a GMO and is therefore subject to the applicable GMO regulatory framework.

Organisms that clearly and unambiguously fall within the existing GMO regulatory scope are excluded from this consultation pathway and must proceed directly to evaluation under the applicable GMO resolutions.

The resolution approves four annexed instruments: an instructional guide (Annex I) and three separate prior consultation submission forms for animals (Annex II), microorganisms (Annex III), and plants (Annex IV), which are published in the web edition of the Official Gazette. 

All documentation submitted under the consultation procedure — including submissions, evaluations, and conclusions — is classified as reserved and may not be disclosed or used outside the context of the consultation. The confidentiality regime invokes exceptions under articles 8(c) and 8(l) of Law No. 27,275, Argentina's Access to Public Information Act, to protect commercially sensitive information submitted by developers.