What the EU’s New Genomic Techniques (NGT) Regulation Means for Plant Innovators

This week, the European Parliament will cast its final vote on the EU’s new regulatory framework for plants developed using New Genomic Techniques (NGTs). This vote follows the provisional agreement reached between the Council and Parliament in December 2025, establishing a two‑tier structure for NGT plants.

How we got to the final vote

Prior to trilogue negotiations, the European parliament proposed strict regulations for NGT1 plants, requiring strict labelling and a ban for all patents for NGT plants, irrespective of whether they were NGT1 or NGT2. This proposed patent ban was ostensibly to “avoid legal uncertainties, increased costs and new dependencies for farmers and breeders”. However, many doubted whether the proposed approach would actually achieve this. Furthermore, without the possibility of protection, there were concerns that innovator companies would avoid investing in these technologies in the EU, leading to a stifling of innovation in this area.

In contrast, the European Council proposed a more deregulated and ‘user friendly’ approach to NGT plants, with fewer labelling and registration requirements, and no patent ban. Instead, the council proposed implementing a requirement for applicants to declare relevant patents (or the absence thereof) when applying for NGT1 status, where this patent information will be published on a publicly available database.

A side-by-side comparison of the proposals demonstrates where the Commission and Parliament’s proposals differ – particularly with regard to the diverging approaches to labelling and patenting.

The agreed proposal and its benefits

The Council’s prevailing proposal closely aligns with the European Council’s proposal and creates a two‑tier system distinguishing “conventional‑like” NGT plants (Category 1 – NGT1) from more complex gene‑edited plants (Category 2 – NGT2). This proposed pathway would create two distinct pathways to the EU market for NGT plants. This marks a positive step forward for European agriculture, moving toward the more permissive genome-edited plant regulations of the US and South America.

The EU Council declared that the agreed-upon approach supports competitiveness, food security, and sustainability in European agriculture. However, there is still some way to go before EU regulations of NGT2 plants fall in line with the ‘innovation-friendly’ models adopted elsewhere.

Category 1 (“NGT1”)

NGT1 plants are those obtained by targeted mutagenesis or cisgenesis, but which could also have been obtained naturally or by conventional breeding techniques.

The justification for this change in regulation is that targeted mutagenesis or cisgenesis mimic changes that could occur naturally or via traditional breeding techniques, enabling higher precision and faster introduction of desired characteristics, with no specific risks associated with these mutagenesis techniques. In fact, such methods reduce the potential for unintended effects as compared to conventional breeding. However, we note that NGT1 plants are likely to be indistinguishable on a technical level from plants obtained by conventional breeding techniques, and it remains to be seen what the impact on infringement on patents relating to such plants will be.

Under the provisional agreement, NGT1 plants (which meet the verification criteria and are not excluded from category 1 under the exclusion criteria (see below)) are treated as equivalent to conventional plants, benefitting from:

• A simplified approval process with only an initial verification required as performed by national authorities. NGT1 plants are exempted from GMO legislation requirements and only subject to ‘conventional plant’ provisions.
• No product‑level labelling, aside from seed‑level identification.
• Faster development cycles, as breeders can place NGT1 varieties on the market through a less cumbersome regulatory route.

However, the present proposal includes a list of plants which are excluded from category 1, such as those which include herbicide tolerance or which produce insecticidal substances. Such plants would be classified as category 2 irrespective of whether such traits could occur naturally or via conventional breeding techniques.

When applying to register NGT1 plants, applicants would need to submit a patent declaration listing all granted patents and pending patent applications concerning the NGT plant of interest (including those owned by third parties), or declare that no such patents exist. Such declarations should be made “to the best of their knowledge” and this patent information will be available in a public database managed by the EU Commission in the hope to increase transparency for breeders and farmers. Importantly, patents allow you to prevent third parties from using your invention, but no not necessarily allow you to launch your product without infringing.

Category 2 (“NGT2”) – Subject to full GMO rules

All other NGT plants with more complex or “non‑natural‑equivalent” genomic modifications remain subject to existing GMO legislation, including mandatory authorisation, full traceability, and labelling requirements, with the possibility of adding a factual statement on the intended purpose of the genetic modification.

Consequences of the vote

If the regulation passes

If passed, the regulation could apply from 29 March 2028, leading to a major shift in EU agricultural policy towards faster adoption of climate-resilient, gene-edited crops. The impacts of this provisional regulation include:

• • Greater transparency requirements for patent disclosures in the NGT1 category. This will:
    
    • Increase the importance of early-stage patent landscaping
    • Heighten the need for freedom-to-operate (FTO) assessments
    • Affect licensing negotiations and royalty considerations
      
      
  • Clearer regulatory pathways when planning R&D portfolios and IP strategies, and reduced regulatory burden for plant breeders – particularly for SMEs – who struggle under the current one‑size‑fits‑all GMO regime.
  • Greater innovation and shorter time-to-market for NGT1 plants due to streamlined verification schemes and fewer regulatory hurdles, enabling climate‑resilient, drought‑tolerant, and reduced‑input crops to reach the market more quickly, with lower regulatory hurdles. Patent filing strategies should take this accelerated timeline into consideration.
  • More competitive positioning of Europe relative to global markets who have more permissive regulatory environments for gene-edited plants.

However, those developing NGT2 plants must still comply with the highly demanding GMO framework, including labelling and authorisation. However, it is hoped that once the more flexible NGT1 framework is adopted, this may pave the way for Europe to re-review its NGT2 regulations.

If the regulation fails

• All NGT plants remain regulated as GMOs, preserving the current restrictive regime for both NGT1 and NGT2 plants
• Breeders may reconsider commercialisation timelines or shift focus to non‑EU markets where regulation is more permissive
• Investment pipelines could be delayed or redirected due to regulatory difficulties.

How we can help - IP Strategy & Patent Landscape Analysis

Regardless of the vote outcome, we can help to make sure that your intellectual property assets are aligned with your commercial requirements. The team here at Mewburn can:

• Draft robust patents aligned with the two‑tier system – faster R&D cycles for NGT1 plants will require well‑timed and strategically drafted patent applications to protect improvements before rapid commercialisation. Applications will need to be thoughtfully drafted to comply with the various different IP regimes associated with gene edited plants and to ensure that the technical effects and supporting data aligns with NGT1/NGT2 plant requirements.
• Assist with patent landscaping and freedom‑to‑operate (FTO) analysis – prior to applying for NGT1 plant status, in-depth FTO analyses may be necessary to identify all relevant patents (including those of third parties) to ensure that all patent declaration requirements are met. We have substantial expertise in performing FTO analyses, so please do discuss your upcoming product launches with us to find out how we can help you navigate the IP landscape.
• Adapt patent portfolios ahead of market entry and advise on filing strategies, geographical scope and jurisdictional requirements.
• Advise on additional forms of Intellectual Property (IP) which may offer useful ancillary protection for your products.