On November 6, 2025, Resolution No. 512/2025 of the National Seed Institute (INASE) (hereinafter, the “Resolution”) was published in the Official Gazette. The Resolution approves the new regulations governing the operation of laboratories dedicated to the identification of plant varieties using optical markers.
The purpose of this measure is to establish the technical, administrative, and authorization criteria and requirements applicable to laboratories engaged in varietal identification of seeds, ensuring genetic quality and varietal identity within the framework of Seed and Plant Breeders’ Rights Law No. 20,247.
The Resolution will be mandatory for laboratories providing varietal identification services to INASE, while it will be optional for those offering services to third parties. In all cases, the National Seed Institute will be the competent authority to define the species, validated operating systems, and corresponding versions that may be used for varietal identification.
The authorization regime established by the Resolution requires interested laboratories to submit to the Quality Evaluation Directorate (hereinafter, the “QED”) technical information about the laboratory, a commitment letter from the Technical Director, a list of analysts, and details of the available equipment. They must also demonstrate the implementation of procedures that ensure sample traceability, proper use of equipment, and adequate preservation of materials before and after analysis. In addition, they must participate in interlaboratory tests organized by INASE and undergo authorization audits and periodic inspections by the QED.
In this regard, any modification to the scope of the authorization, address, facilities, equipment, or the appointment of the Technical Director must be formally notified to the Institute within thirty days of its occurrence, and such modification will not take effect until approval is granted by the QED.
According to the regulations, once technical authorization has been obtained, laboratories must register with the National Registry of Seed Trade and Control (RNCyFS) within thirty days of receiving notice of approval, under penalty of the sanctions established in Article 41 of Law No. 20,247, including suspension or revocation of the authorization.
Finally, the Resolution provides that INASE will be empowered to issue warnings, reprimands, suspend, or revoke technical authorization and/or registration, depending on the severity of the infringements detected, which may include non-compliance with regulatory obligations, obstruction of audits, persistence of unresolved irregularities, or the submission of false information.
