EU trilogue opens regulatory pathway for plants developed using new genomic techniques (NGTs) to the benefit of agritech and foodtech innovators

While formal adoption is still pending, the agreement marks a decisive shift from policy debate to regulatory reality.

For biotech companies and plant breeders, the agreement promises greater clarity on how gene-edited plants will be regulated in the EU.

Why are the EU introducing new regulations for NGTs?

Despite the widespread adoption of genetically modified and gene-edited crops in many non-EU jurisdictions, the EU has, at least until now, applied a largely uniform regulatory approach to all plants developed using genetic engineering technologies.

Under the existing framework, plants obtained using new genomic techniques, such as CRISPR-based gene editing, are regulated as GMOs in the same way as plants produced using traditional transgenic methods. However, approval under this regime is challenging, time-consuming and costly. Moreover, market acceptance of GMOs in the EU has historically been limited.

In contrast, plants obtained through long-established, non-specific mutagenesis techniques - for example chemical or radiation-induced mutagenesis - are not regulated as GMOs and are subject to less onerous regulatory requirements. These conventional plants are, however, generally excluded from patent protection across the EU, whereas GMO and NGT plants are patentable at the European Patent Office and most national patent offices, despite being subject to the significantly more stringent regulatory requirements.

It was against this backdrop that the Commission’s proposal sought to introduce a more proportionate framework for certain NGT plants. The initial proposal introduced a two-tier regulatory system distinguishing between:

1. Plants that could also be obtained by conventional breeding, now commonly referred to as NGT-1
2. More complex gene-edited plants, referred to as NGT-2, which would remain subject to full GMO requirements

While the Commission’s proposal was initially welcomed as a step towards regulatory differentiation for gene-edited plants, it quickly became clear that it raised significant concerns for biotech companies and plant breeders.  

In particular, the proposal sparked intense debate around intellectual property, following the introduction of measures aimed at addressing perceived patenting issues in the NGT space, including calls during the legislative process for restrictions or outright bans on patent protection for NGT plants.

What has been agreed and how will it impact innovators using NGTs?

In December 2025, the European Parliament and the Council reached a provisional trilogue agreement on the regulation. Although the final legal text must still be formally adopted, the core structure of the regime is now largely settled.

In line with the Commission’s proposal, plants qualifying as NGT-1 will be treated as equivalent to conventionally bred plants for the purposes of EU GMO legislation and will not require full GMO authorisation or consumer-facing GMO labelling.

However, the agreement makes clear that to obtain NGT-1 status developers must submit information to national authorities to verify that the plant meets the NGT-1 criteria. In addition, certain categories of plants are explicitly excluded from NGT-1 eligibility, regardless of the technique used. These include, for example, plants engineered for herbicide tolerance or for the production of insecticidal substances which will fall within the more heavily regulated NGT-2 category.

NGT-2 plants remain subject to existing GMO rules on risk assessment, authorisation, traceability and labelling requirements. Member States also retain the ability to restrict or prohibit cultivation of NGT-2 plants at national level.

The agreement further confirms that seeds and plant reproductive material derived from NGT-1 plants must be labelled, enabling traceability at the upstream level, and that NGT plants remain excluded from organic production under EU organic rules.

Using patents and IP transparency effectively to support the EU's new NGT regulations

One of the most sensitive aspects of the legislative process concerned patents. Early debates included proposals aimed at limiting or even prohibiting patent protection for NGT-1 plants.

Innovators can, however, breathe a sigh of relief.

As the December 2025 agreement stops short of any patent ban. This will avoid further legal uncertainty around patent protection that underpins investment and commercialisation in plant biotechnology. Instead, it introduces patent transparency obligations for NGT-1 plants. It will be a requirement for developers to disclose relevant patents and patent applications. These will be published in a dedicated database.

In parallel, one year after the regulation enters into force the Commission has committed to publishing a study examining the impact of patenting on innovation, the availability of seeds to farmers and the competitiveness of the EU plant breeding sector, focusing specifically on breeders’ access to patented NGT plants.

Depending on the outcome of this study, the Commission is expected to indicate whether follow-up measures are required or to bring forward legislative proposals to address any issues identified.

This forthcoming assessment builds on work already commissioned by the Commission in the context of the original NGT proposal [here] examining the role of intellectual property protection in supporting innovation in the bioeconomy.

This research highlights the importance of a balanced and coherent IP framework for the plant breeding and plant biotechnology sectors. In particular, it recognises the role of patents in rewarding research investment and attracting private funding for R&D-intensive innovation. It also emphasises the complementary function of plant variety rights in safeguarding access to plant material and maintaining diversity within breeding programmes.

While the approach taken in the agreement avoids direct interference with patentability, it introduces a new regulatory interface with IP strategy. Developers may need to consider how disclosure obligations interact with licensing, collaboration and investment decisions, particularly in politically sensitive markets.

What do the EU's new regulations mean for developers and breeders?

The provisional agreement brings welcome clarity, but it does not amount to wholesale deregulation. NGT-1 offers a more accessible regulatory route, provided products are designed with eligibility criteria in mind while more complex gene-edited plants remain subject to the full weight of EU GMO legislation.

As the EU moves towards formal adoption and implementation, developers should begin aligning regulatory, IP and commercial strategies accordingly. If you would like our help to review and refine your current IP strategy, please contact our biotech specialists today.