Council Adopts Regulation on New Genomic Techniques

The Council of the European Union has adopted a regulation on new genomic techniques (NGTs), following years of discussions on sustainability and patenting. The text will now proceed to the European Parliament for a plenary vote scheduled between 18 and 21 May, where some Members of the European Parliament (MEPs) are expected to challenge the outcome of the negotiations. 

The regulation sets out a revised framework for NGTs, which are used to design or enhance traits in plant species, such as improving nutritional profiles or increasing resistance to disease and climatic conditions. It follows earlier efforts to adjust the EU approach after a 2018 ruling by the Court of Justice of the EU classified gene editing under existing rules for genetically modified organisms (GMOs). In 2023, the European Commission proposed easing these rules to harness the potential of gene editing for competitiveness and food security. 

Under the agreed framework, NGT plants are divided into two categories. Category 1 includes plants considered equivalent to conventionally bred varieties. These are exempt from GMO legislation, are not subject to labelling requirements except for seeds and other reproductive material, and their offspring do not require further checks. However, plants with certain intended traits, such as herbicide tolerance or the production of known insecticidal substances, are excluded from this category. Category 2 covers plants with more complex modifications and remains subject to GMO rules, including authorisation, traceability and labelling requirements. 

The regulation also introduces transparency measures on patenting. Developers of Category 1 plants must submit patent information to a public database and may voluntarily indicate licensing intentions. The European Commission is expected to establish a code of conduct on patents and to set up an expert group to examine the effects of patent law and implementation practices on access to modified genetic resources, the transparency of the patent landscape, and innovation in the field of NGT plants. The European Patent Office will participate in this group. At the same time, concerns remain among some MEPs regarding the absence of a clear legal approach to the patentability of genetic traits. 

Additional provisions clarify that Member States may opt out of cultivating Category 2 plants on their territory. These plants will also be excluded from organic production. The use of Category 1 plants in organic farming is subject to further consideration and will remain prohibited until such assessment is completed. The Council anticipates that the new framework will apply from mid-2028.