April 2025 Update on Regulation of New Genomic Techniques in the EU

On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods that, in the EU, are collectively termed “new genomic techniques” (NGTs). This agreement came after months of political deadlock and allows new formal negotiations with the European Parliament to begin. It marks a pivotal step forward in advancing the legislative proposal adopted by the European Commission on July 5, 2023 (Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625; 2023 Proposal), which aims to create new regulations tailored to plants produced using NGTs (NGT Regulation) in order to adapt the EU regulatory landscape to better fit the technological developments of recent decades in the field of plant breeding. Thus, the March 2025 agreement sets the stage for further negotiations, bringing the EU closer to finalization and implementation of the NGT Regulation.

Specifically, the agreement allows the Council’s president to commence negotiations with the European Parliament to determine the final wording of the NGT Regulation. The NGT Regulations, once finalized, will then only enter into force after they are formally adopted by both the Council and the Parliament. In the meantime, NGT plants in the EU remain regulated under the EU’s regulatory framework for genetically modified organisms (GMOs).

Understanding the EU Legislative Process

Under the EU’s “ordinary legislative procedure,” a legislative proposal must be approved jointly by two bodies: the European Parliament (representing the EU’s citizens) and the Council of the EU (representing the governments of the 27 EU Member States). Proposals originate from the European Commission, the EU’s executive body.

Once a proposal is published by the Commission, both the Parliament and the Council review it separately. If they adopt different versions, they enter so-called “trilogue” negotiations—informal talks between representatives of the Commission, the Parliament, and the Council to find a compromise. The Parliament and the Council must agree on the final wording in order for a regulation to become law across the EU.

The Proposal of the European Commission

According to the 2023 Proposal, an “NGT plant” is “a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant.” The 2023 Proposal then divides such NGT plants into two categories: Category 1 NGT plants and Category 2 NGT plants, with different regulatory burdens between the two categories.

Category 1 NGT plants are NGT plants that could also occur naturally or be generated through conventional breeding techniques, as well as progeny obtained by conventional breeding of such NGT plants. The 2023 Proposal considers an NGT plant “equivalent” to a conventional plant, and thus to be a Category 1 plant, “when it differs from the recipient/parent plant by no more than 20 genetic modifications” of any of the following types:

(a) “substitution or insertion of no more than 20 nucleotides”;

(b) “deletion of any number of nucleotides”;

(c) “targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool” (i.e., found in the genome of conventional plants of the same species, or any species capable of being cross-bred with that species, including via advanced breeding techniques), so long as the insertion “does not interrupt an endogenous gene”;

(d) “targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool”, so long as the substitution “does not interrupt an endogenous gene”;

(e) “targeted inversion of a sequence of any number of nucleotides”; and

(f) “any other targeted modification of any size, on the condition that the resulting DNA sequences already occur . . . in a species from the breeders’ gene pool,” with the possibility of further including substitutions or insertions of no more than 20 nucleotides and/or deletion of any number of nucleotides. 

Furthermore, all such modifications must occur “in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools,” though the exact required similarity threshold remains undefined.

Category 1 NGT plants would be exempted from current EU GMO regulations and (with the exception of plant reproductive material such as seeds) would not require labeling.

Category 2 NGT plants, on the other hand, are all other NGT plants (i.e., NGT plants that are not Category 1 plants). These plants would continue to fall under the current GMO legislation, which means they would be subject to risk assessment and approval before being placed on the market and would require appropriate labeling.

For more details on the 2023 Proposal, please read our previous blog post on the European Commission’s proposal (Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU | MoFo Life Sciences).

The European Parliament and the Proposed Patent Ban: Recap and Update

This 2023 Proposal did not include any provisions directly regulating the patentability of NGT plants, which are governed by complex layers of existing EU and international intellectual property laws, intergovernmental organizations, and treaties. However, in its first reading of the 2023 Proposal of the European Commission in February of 2024, the European Parliament—while generally agreeing on the concept of Category 1 plants and Category 2 plants—called, to the surprise of many, for a full ban on patents for all NGT plants to be introduced into the regulation. (Please read our previous blog post for more details: February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU | MoFo Life Sciences).

This position sparked continued debate among the Member States. Proponents of the ban argued that it would be essential to prevent legal uncertainty, rising costs, and growing dependencies for farmers and plant breeders. Opponents cautioned that a ban could prevent technological progress, given that patents serve as a key incentive for investment in costly and high-risk biotechnological research. In addition, opponents warned that such a total ban could violate international legal law.

Because Parliament and Council must both agree on the law’s final text, the Council had to adopt a common position before negotiations with Parliament could start. However, Parliament’s proposed patent ban proved highly controversial among Member States.

The Council needs a “qualified majority” (roughly 55% of Member States representing at least 65% of the EU’s population) to adopt a negotiating mandate. In this case, disagreement over patents made that impossible. Without such a mandate, the legislative process stalled.

Despite efforts by the Spanish and Belgian presidencies to build consensus, six Member States formally opposed the mandate as of December 2024—which left the legislative proposal in limbo for months.

However, as already expressed in the 2023 Proposal, the Commission acknowledges the importance of striking a balance between safeguarding access to patented techniques and promoting seed diversity, while also preserving incentives for innovations in plant breeding.

Resolution of the Deadlock

When Poland assumed the rotating Council presidency in January 2025, it circulated a revised compromise proposal. This version did not adopt the Parliament’s call for a full patent ban but instead proposed targeted changes to the Commission’s initial proposal to improve transparency in the use of patents.

On March 14, 2025, the revised text received majority support in the Council, reviving the legislative process and allowing trilogue negotiations with Parliament and Commission to begin.

In its accompanying communication, the Commission emphasized that it would assess, as part of a broader market analysis, the impact of patenting practices on plant breeding innovations, breeders’ access to genetic materials and technologies, the availability and affordability of seeds for farmers, and the overall competitiveness of the EU biotech industry. This analysis is to be completed and reported by 2026 and is intended to identify potential challenges and guide any future policy actions in the field of intellectual property and NGTs.

To assist discussions, a comparison of the Commission, Parliament, and Council’s proposals has been published.

Key Changes Introduced by the Council

While the Council supports large parts of the elements of the European Commission’s proposals, it also suggests a number of significant amendments, most notably regarding the patentability of NGT plants. These proposal changes include the following:

Patentability: Transparency Instead of a Ban

The Council has moved away from the European Parliament’s proposed patent ban. Instead, it suggests a different, transparency-based approach, under which patent protection would remain possible for both Category 1 and Category 2 NGT plants.

Further, Category 1 NGT plants would have new transparency requirements: Applicants would be required to disclose any existing or pending patents when registering a Category 1 NGT plant, and this patent information would be required to be listed in the publicly available database maintained by the European Commission. Whether a plant is patented or not would have no influence on whether it is recognized as a Category 1 NGT plant, as this decision would be based solely on the scientific equivalence criteria summarized above. Voluntary declarations about the patent holder’s willingness to license the patents under equitable conditions would also be able to be submitted.

Category 2 NGT plants, by contrast, would remain under the scope of conventional GMO legislation, with no additional patent-related provisions in this mandate.

Addressing Stakeholder Concerns – Maintenance of Breeder’s Exemption

Stakeholders, especially breeders and farmers, have expressed concerns that patents on NGT plants could limit access to plant material and breeding tools. The Council addresses this by affirming the continued applicability of Article 27(c) of the Agreement on a Unified Patent Court, which explicitly ensures: “The rights conferred by a patent shall not extend to any of the following: the use of biological material for the purpose of breeding, or discovering and developing other plant varieties.” The so-called “breeders’ exemption” therefore remains intact, even under the new regulation.

Expert Group and Patent Impact Study

In order to ensure appropriate action in case of adverse impacts of patented NGT plants, the negotiating mandate requires the Commission to (1) conduct a study (to be published one year after the entry into force) on the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding, on breeders’ access to plant genetic materials and techniques, and on the availability of plant reproductive materials to farmers as well as the overall competitiveness of the EU plant breeding industry, and (2) establish an expert group on the effects of the patenting of NGT plants. A second study is anticipated four to six years later, if no measures are proposed after the first.

Additional Key Elements in the Council’s New Proposal

• Opt-out from cultivation: Member States shall be allowed to prohibit the cultivation of Category 2 NGT plants in their territory.
• Co-existence measures: Member States may take measures to prevent the unintentional presence of Category 2 NGT plants in other products, as well as the unintended presence of Category 1 NGT plants in organic farming.
• Labeling: When the label of Category 2 NGT plants refers to trait(s) conveyed by the genetic modification, the label shall mention all traits conveyed by the modification and shall not just refer to some.
• Trait of tolerance to herbicides: NGT plants that include tolerance to herbicides among the intended traits conveyed by the genetic modification should be subject to the provisions for Category 2 NGT plants.

What Happens Next?

Now that the Council has adopted its position, trilogue negotiations will begin with the European Parliament and Commission. These closed-door talks are aimed at agreeing on a final version of the law that can be formally adopted by both the Council and the Parliament.

The timeline for these negotiations remains uncertain and depends on the pace of political compromise. We are closely monitoring developments in this area and will continue to share updates.

Research assistant Marie Mihanovic substantially contributed to this article.