The European Parliament has given final approval to a landmark regulation on plants developed through New Genomic Techniques (NGTs), marking one of the most significant changes to European biotechnology legislation in more than two decades. The new regulation establishes a dedicated framework for genome-edited plants and is expected to provide greater regulatory predictability, foster innovation, and create new opportunities for the development and commercialization of improved crop varieties.
The regulation introduces a two-tier system for NGT plants. Category 1 plants, considered equivalent to conventionally bred varieties, will follow a simplified regulatory pathway and be exempt from the EU’s existing GMO risk assessment requirements. Category 2 plants, which involve more complex modifications, will remain subject to the current GMO regulatory framework, including authorization, traceability, and labeling requirements.
The legislation also includes provisions on patent transparency, coexistence measures, and restrictions on certain traits, including herbicide tolerance and known insecticidal effects, from qualifying under the simplified Category 1 pathway.
Following Parliament’s approval, the regulation will proceed to formal signature and publication in the Official Journal of the European Union, after which a two-year implementation period will begin. The European Commission will develop the necessary implementing measures and guidance documents during this period.
The decision signals a growing global trend toward developing fit-for-purpose regulatory frameworks for genome-edited products and may influence ongoing policy discussions in other regions, including Africa, where seven countries (Nigeria, Ghana, Burkina Faso, Ethiopia, Kenya, Malawi, and Zambia) have already adopted differentiated regulatory approaches for certain genome-edited products.