A new regulatory framework has commenced for new genomic techniques and is set to transform plant innovation in Europe. Beyond the opportunities to develop more competitive and sustainable varieties, the sector must prepare for significant implications regarding intellectual property, licensing, and market access.
Regulation (EU) 2026/1388 now has a date: it entered into force on July 16, 2026, and will apply on July 17, 2028 (although the provisions regarding intellectual property guidance, the code of conduct, and the expert group have been in effect since July 16, 2026). The countdown has begun for plant breeders, seed companies, R&D centers, and agri-food operators: NGTs open up a more streamlined path for innovation in plant varieties, but they also require a review of patents, licenses, traceability, and protection strategies.
What are NGTs, and why are they so important for the agri-food sector?
New genomic techniques allow precise modifications to be made to a plant’s genome without necessarily incorporating genetic material from non-crossable species. The new European Regulation focuses on certain techniques, in particular targeted mutagenesis and cisgenesis, including intragenesis, as well as on the plants and products derived from them. Plants obtained through transgenesis fall outside its scope and remain subject to EU legislation on genetically modified organisms (GMOs).
Their importance for the agri-food sector is clear: they can accelerate the development of varieties that are more resistant to diseases, drought, extreme temperatures, or pests, and improve agronomic, nutritional, or sustainability characteristics. In a context of climate change and pressure on natural resources, having faster and more precise plant breeding tools —such as CRISPR — can become a decisive competitive advantage.
Until now, these techniques were subject to the European GMO framework, which was designed for technology at an earlier stage. The ruling by the Court of Justice of the EU in Case C-528/16 (Confédération Paysanne, 2018) confirmed that NGTs are subject to the full GMO regime. This regime was conceived primarily for transgenesis, involving lengthy and costly procedures that, in many cases, were ill-suited to modifications that could be equivalent to those obtained from conventional breeding. This left the EU lagging behind other countries that were adopting more flexible frameworks.
The institutional response came with Decision (EU) 2019/1904, in which the Council requested a study from the Commission on the status of NGTs under EU law in light of the ruling. Published in 2021, the study concluded that GMO legislation was not fit for the purpose of regulating plants obtained from certain NGTs and that the authorization and risk assessment procedures could be disproportionate or inadequate. This decade of uncertainty is precisely what the new Regulation (EU) 2026/1388 aims to resolve by establishing itself as lex specialis with regard to the GMO legislation and creating a regime better suited to the current status of plant innovation.
The new system: NGT-1 and NGT-2
The Regulation creates two categories of NGT plants: category 1 (NGT-1) and category 2 (NGT-2). Classification into one category or the other is not simply a technical distinction, being instead the gateway to a completely different legal regime: it determines the applicable administrative procedure, the need for authorization, labeling and traceability obligations, conditions for placing them on the market, and, in practice, the intellectual property strategy that operators will have to implement. Below we explain what each category entails:
- Category 1 NGT plants (NGT-1): plants with modifications that are considered equivalent to those occurring naturally or through conventional breeding, as determined by the technical criteria listed in Annex I to the Regulation.
From a legal standpoint, the consequence is decisive: these plants are no longer subject to most of the obligations set out in GMO legislation and are now governed by the specific regime established in the NGT Regulation. Instead of prior authorization as GMOs, they now require a simplified procedure to verify their NGT-1 status with the competent national authority before conducting field trials in the Union, or with the European Food Safety Authority (EFSA) prior to being placed on the market.
The final product does not carry GMO labeling, although seeds and plant reproductive material must be labeled as NGT-1. Plants with herbicide-tolerant traits or producing known insecticidal substances fall outside this category. According to the European Commission’s impact assessment, it is estimated that approximately 94% would fall into this category.
- Category 2 NGT plants (NGT-2): all NGT plants not meeting the equivalence criteria required for category 1. They remain subject to the GMO regime: they require formal authorization, a comprehensive risk assessment (tailored to the specific case), and are subject to traceability and labeling requirements as GMOs. Moreover, member states may restrict or prohibit their cultivation on their territory, in the same way as with traditional GMOs.
Put concisely, classification as NGT-1 or NGT-2 is not simply a technical distinction: it determines whether a plant is regulated as a conventional crop or as a genetically modified organism, with all that this entails in terms of timelines, costs, administrative burden, and market access.
Patents and plant breeders’ rights: the major friction point
The relationship between NGTs, patents and plant breeders’ rights are one of the Regulation’s most sensitive issues . It needs to be noted that the Regulation does not alter the substantive rules on patentability: the European Parliament’s initial proposal to ban patents on NGT plants was not adopted during the trilogue negotiations. It remains possible therefore to patent NGT plants, except for traits or sequences that occur naturally or are produced by exclusively biological means.
Transparency requirements are being introduced, however. The NGT-1 verification request must be accompanied by information on published patents or applications that claim the biological material of the NGT plant. Although this information is purely declaratory and does not affect the classification, its omission may result in the application being held inadmissible. Furthermore, the applicant may include a voluntary license statement, indicating their willingness to license under fair and reasonable conditions and their participation in licensing platforms. Both statements will be included on a public database.
The Regulation is based on the existence of the breeders’ exemption, already recognized under European patent law. This means that patent rights do not extend to the use of biological material for cultivation or for discovering and developing new plant varieties. Its legal basis is found in article 27(c) of the Agreement on a Unified Patent Court.
The Regulation further provides three additional tools to enhance transparency and facilitate access to protected material. The first is guidance from the Commission relating to plant intellectual property, to be published not later than July 17, 2028. Another is a European code of conduct to enhance transparency, facilitate access to protected material, and promote licensing under fair and reasonable conditions, to be finalized not later than January 17, 2028. And the other is an expert group on the impact of patents on NGT plants, to which both the European Patent Office and the Community Plant Variety Office may each appoint one expert.
The key message is clear: the regulatory classification of a plant as NGT-1 does not, by itself, guarantee freedom to operate (FTO). Before initiating a breeding program or launching a variety on the market, it will continue to be essential to analyze the existence of potentially infringed patent rights and, where relevant, obtain the necessary licenses.
Conclusion: an opportunity requiring preparation
The European NGT Regulation marks a turning point in plant breeding. Rather than absolute liberalization, it brings a framework better aligned with the current status of science and the needs of the European agri-food sector, putting an end to nearly a decade of legal uncertainty.
In addition to mastering the technology, a competitive advantage will lie also in integrating it into a coherent framework of regulations, patents, plant breeders’ rights, contracts, and traceability. For plant breeders, seed companies, research centers, and agri-food operators, the opportunity is clear: if they start now to categorize their projects, audit patents and licenses, and prepare their traceability systems, they will be better placed to lead this new era of plant innovation in Europe.
