The Council has adopted new rules on genomic techniques (NGTs), establishing a framework to support a more competitive and sustainable EU agrifood sector.
The regulation is designed to enhance food security, reduce external dependencies and ensure a level playing field for European operators, while maintaining high standards for human and animal health and environmental protection. It also supports EU sustainability objectives by enabling the development of more resilient and resource-efficient crops.
Our farmers need practical solutions to adapt to climate change and remain competitive. These new rules give them access to innovation while ensuring clarity, fairness and high standards across the EU.
Maria Panayiotou, Minister of Agriculture, Rural Development and Environment of the Republic of Cyprus
NGTs are modern techniques that make precise, targeted changes to plant DNA to develop improved varieties more quickly, including those better able to withstand drought, floods and other climate-related challenges.
Two categories of NGT plants
The regulation distinguishes between two categories:
- Category 1 (NGT-1):
Plants considered equivalent to conventional varieties. National authorities will verify their status, but their offspring will not require further checks.
NGT-1 plants and products will not be labelled, except for seeds and other reproductive material, allowing operators to maintain NGT-free supply chains if desired.
Certain traits, including herbicide tolerance and the production of known insecticidal substances, are excluded from this category.
- Category 2 (NGT-2):
Plants with more complex genetic modifications. These remain subject to existing EU GMO legislation, including authorisation, traceability and mandatory labelling. Member states may opt out of cultivating NGT-2 plants and can introduce coexistence measures to prevent unintended presence in other products.
Addressing intellectual property concerns
While patent rules remain governed by the EU Biotech Directive, the regulation introduces new transparency measures. Developers of NGT-1 plants must provide information on relevant patents in a public database and may voluntarily indicate licensing intentions under fair conditions.
An expert group will be established to assess the impact of patents on NGT plants. Within one year of the regulation’s entry into force, the Commission will publish a study on patenting effects on innovation, seed availability and sector competitiveness, and propose follow-up actions if needed.
Next steps
The text still needs to be formally adopted by the European Parliament. Once adopted, the regulation will enter into force 20 days after publication in the Official Journal of the EU. Most provisions will apply after a 24-month transition period, allowing time to adopt implementing rules. The new framework is expected to apply from mid-2028.
Background
NGTs have emerged over the past decade as a result of advances in biotechnology. Those new technologies did not exist in 2001, when the EU legislation on GMOs was adopted. That is why plants obtained through NGTs are currently subject to the same rules as GMOs.
The new framework aligns regulation with scientific progress, ensuring that NGT plants placed on the EU market are as safe as conventionally bred varieties, while keeping existing GMO legislation unchanged.
Fonte: Conselho Europeu
