On December 4, 2025, the Council of the European Union (EU) reached a provisional agreement with the European Parliament (EP) on rules establishing a legal framework for new genomic techniques (NGT). According to the Council’s press release, the provisional agreement “guarantees a simplified process for NGT plants equivalent to conventional plants and addresses concerns regarding intellectual property and access to seeds.” There would be two ways for NGT plants to be placed on the market:

• Category 1 NGT (NGT-1) plants: The provisional agreement maintains the principle that NGT-1 plants are equivalent to conventional plants, in line with the Council’s negotiating mandate and the European Commission (EC) proposal. National authorities would have to verify that NGT plants belong to category 1, but their offspring would not need subsequent verification. NGT-1 plants and products would not be labeled, with the exception of seeds and other plant reproductive material of NGT-1 plants that should be labeled. The Council states that “[t]his would not entail a disproportionate burden for plant breeders, but it would allow operators to ensure a NGT-free chain, if they wish to do so.” The Council notes that it agreed with the EP on an exclusion list of intended traits that would be excluded from the NGT-1 category. The Council and the EP concurred that tolerance to herbicides and ‘production of a known insecticidal substance’ would be on the exclusion list and cannot be one of the intended traits for category 1 NGT plants. According to the Council, this change to the EC proposal “will ensure that such plants are classed as NGT-2 and therefore remain subject to authorisation, traceability and monitoring.”
• Category 2 NGT (NGT-2) plants: Plants with more complex or less “natural-equivalent” genomic modifications would be classified as category 2. For NGT-2 plants, both the Council and the EP agreed with the EC’s proposal to maintain the existing genetically modified organism (GMO) legislation requirements, including mandatory labeling of products. According to the Council, if the label includes information on the traits that were modified, it must cover all the relevant traits. The Council and the EP agreed to allow EU member states to opt out from the cultivation of NGT-2 plants on their territory. The agreement also includes optional coexistence measures, meaning that EU member states would be able to take measures to avoid the unintended presence of NGT-2 plants in other products.

Although the EU’s Biotech Directive governs patent rules, the NGTs regulation addresses concerns voiced by plant breeders and farmers on patenting. In particular, according to the Council, when applying to register an NGT-1 plant or product, companies or breeders would be required to submit information on all existing or pending patents, and the patenting information must be included in a publicly available database. Companies or breeders would also provide information on a voluntary basis on the patent holder’s intention to license the use of a patented NGT-1 plant or product, under equitable conditions.

The Council and the EP agreed on the creation of a patenting expert group to focus on the effect of patents on NGT plants, composed of experts from all EU member states, the European Patent Office, and the Community Plant Variety Office. One year after the entry into force of the regulation, the EC would be required to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The EC would identify any necessary measures or publish a legislative proposal to address any issues found in the study.

The Council and the EP must endorse the provisional agreement before it can be formally adopted. According to the EC’s December 3, 2025, press release, the regulation will be published in the Official Journal of the EU “in the course of 2026 and will start applying two years later.”