EU council adopts new NGT regulation for gene edited crops
The EU council has formally adopted new rules on new genomic techniques (NGTs), with the draft text submitted to a plenary vote by the European Parliament on 18 May. These steps mark the final stages of the EU in approving its new framework for NGT authorisation and market entry. If adopted, the regulation will enter into force 20 days after publication in the Official Journal of the EU.
The new NGT rules were adopted by the European Parliament's Environment, Climate and Food Safety Committee (ENVI) in January, with encouragement for the EU plenary to accept the rules without amendment.
For context the proposed regulatory changes distinguish gene editing products between two categories:
- Category 1 NGT plants: Those which could occur naturally or by conventional breeding will not be considered as GMOs. They will only have to undergo a verification procedure, and will not need to be risk-assessed and authorised. 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. Notably, the Council and Parliament have have excluded certain traits from inclusion in NGT1, such as herbicide tolerance and the production of known insecticidal substances.
- Category 2 NGT plants: Plants with more complex genetic modifications (cisgenic or mutagenic changes that exceed the equivalence thresholds for Category 1) which could not happen naturally or through conventional breeding. 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.
NGTs of both categories are banned from organic production, although presence of NGT-1 plants in organic production shall not constitute non-compliance.
The EU Council backed the new rules on several arguments. These include:
The need to modernise regulations
An overarching argument is that the 2001 GMO framework is no longer fit for purpose to govern the precise changes and potentially transgene-free products made possible through use of gene editing technologies. A new regulatory approach is therefore required.
Gene edited products were ruled to fall under this 2001 GMO framework after a 2018 European Court of Justice decision. Under the 2001 legislation, transgene-free gene-edited plants with changes that could have arisen through conventional breeding would still undergo the same regulatory process as transgenic GMOs.
The NGT framework offers a newer approach to the 2001 GMO framework, to more accurately and fairly govern the review and release of transgene-free products. This ensures regulation based on managing transgenic material is not applied to transgene-free GE products.
Competitiveness
The regulatory change is made to improve competitiveness of EU agribusiness. With the 2018 ruling that gene editing products uniformly fell under GMO legislation, the EU became the only major agricultural jurisdiction in the world to apply full GMO regulation to CRISPR techniques which produce no transgenic material. Conversely, Argentina, Australia, Brazil Canada, Japan the US and, more recently, England, adopted lighter touch frameworks for transgene-free (or 'precision-bred') products.
The EU's legislative stance of classifying gene-edited plants as GMOs risked threatening the competitiveness of the bloc's plant breeders and agri-food businesses, and the related flow of expertise and innovation through EU institutions. This constraint was particularly concerning given the EU's role as a major agricultural trader, where the current regulations risked excluding EU actors from import and export of emerging GE products. The decision to adopt the the new ruling therefore prevents this constraint to EU actors to engage with the developing market opportunities around GE products.
Climate adaptation and food security
The legislative change is hoped to improve food security by permitting the use of improved products across the EU which also reduce the dependency on other suppliers.
GE crops offer an approach to improve speed and precision of development of climate-resilient varieties. The Council therefore argues that NGT crops will be important for climate adaptation and food security efforts, and therefore support the European Green Deal and Farm to Fork strategy.
Examples such as the war in Ukraine showed the EU's dependence and vulnerability to concentrated supply chains across food and agricultural inputs. Gene edited technologies are framed as part of a wider response to developing products that require fewer inputs, and therefore an important tool to help reduce the EU's reliance on externally sourced inputs.
Patents and intellectual property
A concern during negotiations was that larger seed companies would use NGT patents to outcompete smaller EU breeders. In response, the Council and the Parliament agreed on the creation of a patenting expert group, focusing on the effect of patents on NGT plants.1
One year after the regulation comes into force, the Commission will 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. Based on this study, the Commission will indicate what follow-up measures or legislative proposals are needed to to protect EU breeders.
Labelling
One area where there continues to be contrasting views between those of the EU Council and Parliament are on the instances for labelling.
The European Commission's original proposal in July 2023 established the template that NGT-1 plants would carry no consumer-facing product label, abandoning the mandatory labelling that applied under the 2001 GMO regulations. Instead, all NGT plants will be listed in a public database, their seeds labelled, and information on reproductive material listed in the EU plant variety catalogues.
The non-labelling argument is that if NGT-1 plants are indistinguishable from those arising natural or through conventional breeding, then a label implies a material difference that the science cannot provide.
The Parliament's ENVI Committee took a different position. They proposed mandatory labelling for all NGT products. This position was argued (i) to support the right of European citizens know whether their food has been subject to genetic modification and (ii) to protect the premium, identity-preserved supply chains for European organic and GMO-free sectors.
The debate around labelling has developed over the last few years, and particularly during four trilogues held between May and December 2025. The final compromise sided with the Council position, where EU Parliament's ENVI Committee accepted the no-labelling position in January 2026. As such, NGT-1 plants and products will not be labelled, but that seeds and other plant reproductive material of NGT-1 plants would be labelled - allowing actors the ability to ensure an NGT-free supply chains, if wanted.
Next steps
The final EU Parliament vote is expected to take place on 18 May, or shortly after. Should the vote approve the NGT regulations, most provisions will apply after a 24-month transition period, with the new framework applying from mid-2028.
Further reading
- New genomic techniques: Council adopts new rules to boost sustainable and competitive EU food systems
- Council adopts regulation on new genomic techniques
Composed of experts from all member states, the European Patent Office and the Community Plant Variety Office.↩