Plant Gene-Editing Regulation Roundup

In this Roundup, the MoFo Food & Ag team aims to help our clients proactively track plant gene-editing regulation to inform business strategy.

This edition provides updates on the continued streamlining of approval for modern gene-edited crops. Argentina, one of the world’s leaders in growing genetically modified organisms (GMOs) and gene-edited crops, is streamlining its approval process. The European Union has passed legislation differentiating new gene-editing techniques from GMOs. Pakistan is poised to make that same distinction.

Regulation in the Americas

Argentina

Argentina’s Ministry of Economy’s Resolución 255/2026 was published in March, replacing Resolución 763/2011, the framework that established the country as a leader in permitting gene-edited plants.

Argentina’s Ministry of Economy stated that the new resolution streamlines the approval processes of the previous permitting regime. Environmental safety, food safety, and commercialization impact reviews are now streamlined into a single three-step procedure, handled by three evaluation bodies: Comisión Nacional Asesora de Biotecnología Agropecuaria (CONABIA), Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA), and the Dirección Nacional de Políticas de Mercados, respectively. This new process avoids administrative overlap while maintaining the substantive scientific content of gene-editing evaluation.

Key Takeaway

Applicants should expect a transition period as the three evaluation bodies coordinate the new processes. After the transition period, the process will be further simplified for applicants.

Regulation in Europe, the Middle East, & Africa

European Union

At long last, the European Parliament has adopted new rules around New Genomic Techniques (NGTs). The new rules represent a shift away from regulating plants according to the techniques used to create them and toward regulation based on their final characteristics. The new regulations entered into force July 16, 2026 and will be fully applied by July 17, 2028.[1]

Under the new regulation, gene-edited plants are characterized into two categories.

• Category 1 NGT plants can have small targeted genetic changes (substitutions or insertions of less than 20 nucleotides), deletions, or other changes that could have been made through traditional breeding. Category 1 plants will now be treated like conventionally bred plants and will be exempted from GMO regulations.
• Category 2 NGT plants include all other gene-edited plants that do not fall under Category 1. These plants will continue to be treated as GMOs and will be subject to risk assessment and authorization procedures.

Key Takeaway

The new rules will allow some plants developed using modern biotechnology tools to be treated similarly to conventionally bred crops.

Regulation in Asia – Pacific

Pakistan

Approval of the National Agriculture Biotechnology Policy

Pakistan approved the National Agriculture Biotechnology Policy of Pakistan 2025 in June 2026. Gene-edited crops will now be categorized as:

• Site Directed Nuclease (SDN)-1 plants, which do not contain any foreign nucleotide sequences;
• SDN-2 plants, which do not contain foreign sequences other than those from a sexually compatible donor; or
• SDN-3 plants, which contain foreign DNA from a non-sexually compatible donor.

SDN-1 and SDN-2 products (plants or plant parts meant for cultivation, food, feed, and processing) will not be regulated as GMOs. Products containing foreign DNA from non-sexually compatible donors (SDN-3) will still be treated as GMOs. These new regulations represent a significant shift from the previous regulations, which did not distinguish between gene-edited and genetically modified plants.

Key Takeaway

Pakistan has adopted policies that treat some modern gene-edited crops like conventionally bred crops.

[1] Articles 29, 30, and 31 are directed to formalities and planning and enter into force July 16, 2027.