Regulatory Framework for NGTs and GMOs

At present, plants developed through NGTs are regulated under EU genetic modification (GMO) legislation. However, unlike GMO plants, plants bred using NGTs can be very similar or even identical to products generated with conventional breeding techniques or to plants occurring naturally, according to the Commission. 

The new EU rules aim to give legal clarity on new breeding methods that do not use foreign DNA, while NGT plants containing foreign genetic material continue to be regulated under GMO legislation. Conventional breeding falls outside the scope of GMO legislation.

Rules for NGTs in Practice

On December 4, 2025, the European Council reached a provisional agreement with the European Parliament on rules that establish a legal framework for NGTs. The rules would require all NGT plants to be listed in a public database and banned from organic production.

Additionally, two categories of plants would be established, with different rules:

• Category 1: Plants equivalent to conventionally bred or naturally mutated plants. Category 1 plants would be verified as such by national authorities and the Commission before being placed on the market. Seeds and reproductive material must be labeled as NGT in origin, but plants would not need to be labeled. Herbicide-tolerant plants would be excluded from Category 1. Companies or breeders would have to submit information on patents, and the Commission would conduct a study on the impact of patenting on NGT plant innovation, access, and competitiveness. Category 1 plants would be exempt from GMO legislation, but existing EU legislation on food and feed, novel foods, and environmental liability and conservation would apply.
• Category 2: Plants with more complex modifications. Category 2 plants would have to be authorized for use by national authorities and the Commission, including risk and safety assessments, before being placed on the market. These products would have to bear a label providing information about the traits that resulted from the genetic modification. Regulatory incentives could be offered to producers of plants with traits that could improve sustainability, except for herbicide-tolerant traits. Category 2 plants would have to comply with existing GMO legislation, adapted by the new NGT rules. Individual EU countries could restrict or prohibit the cultivation of category 2 plants within their jurisdiction, or take measures to ensure that these plants are not unintentionally present in non-NGT products.

The Impact of Patenting on Plant Breeding

Additionally, one year after the entry into force of the regulation, the Commission will publish a study on the impact of patenting on innovation, the availability of seeds to farmers, and the competitiveness of the EU plant breeding sector. The Commission will then indicate if any follow-up measures are necessary or publish a legislative proposal to address any issues found through the study.

Agri-Food Uses for NGTs

According to the Commission, NGTs have the potential to contribute to sustainable agri-food systems and help respond to challenges such as global food insecurity and climate change. NGTs can help breed plants that:

• Are climate-resilient or pest-resistant
• Require fewer fertilizers and pesticides
• Can ensure higher yields
• Have fewer allergens
• Use water and other natural resources more efficiently.

For example, NGTs have led to the development of low-gluten wheat, pathogen-resistant potatoes, and drought-tolerant maize.