Trilogue negotiations – state of play

News

If everything goes according to the Danish Presidency's plans, the negotiations on new legislation for New GMOs (or New Genomic Techniques, NGTs) will be finalized on 3 December during the fourth trilogue. At the third trilogue on 13 November, Denmark will seek agreement on patents and sustainability. 

The Presidency is apparently trying to offer Parliament a few concessions on sustainability in return for it abandoning any demands for a total ban on patents for all NGTs (via an amendment to the EU’s Directive 98/44/EC on Bio-Patents), the major sticking point.

On the other hand, labelling and traceability of New GMOs, crucial for consumers and business operators, play only a minor role within negotiations between the EU Parliament, Council and EU Commission, if any. Although Parliament was the only one of the three institutions to vote in favour of labelling and traceability, only the Greens, the Left and S&D are pushing for it in negotiations.

Agreement on Annex I of the legislative proposal

In October 2025, all three lawmaking institutions reached a compromise on Annex I. This means that NGT plants of category 1 (which are considered equivalent to conventionally bred plants if the number of genetic modifications remains under 20) should receive accelerated market access. For them, risk assessment and post-marketing monitoring will be no longer required; whether labelling, traceability and detection methods will apply is extremely questionable. According to the German Federal Agency for Nature Protection, 94% of all plants in companies' pipelines will fall under category 1. 

Negotiations on sustainability criteria for a NGT1 classification

The Parliament wants to link an NGT-1 classification to at least one sustainability criterion, as defined in Annex III, including a two-step process which shows that the respective plants meet the criteria (first a sustainability declaration during the verification process whether an NGT falls under category 1, in a second step a data-based confirmation that the plant meets the declared sustainability criterion). The Council, on the other hand, had only demanded that herbicide-tolerant plants should not be classified as NGT1, the EU Commission’s legislative proposal doesn’t foresee any link between an NGT1 classification and sustainability.

The second trilogue on 14 October 2025 concluded that three possible compromise options should be examined:
1) Positive trait-list: An NGT-1 status should be linked to compliance with (at least one) of the sustainability criteria on a comprehensive, dynamic and non-exhaustive positive list.
2) Negative trait-list: An NGT-1 status should be linked to the absence of all exclusion criteria on a negative list. 
3) Incentives: An NGT-1 status should not be linked to compliance with sustainability criteria; however, (positive) criteria/characteristics shall serve as triggers for incentives.

At the moment, it seems as though several Member States could agree on option 2.

Negotiations on patents

In the trilogue process, the Parliament indicated its readiness to drop the full patent ban (for NGTs of category 1 and 2) it voted for if safeguards protect breeders and farmers. The Parliament requested:
-    Legal clarity on patent-protected traits;
-    No patents on naturally occurring or conventionally obtainable traits;
-    Anti-market-concentration safeguards;
-    Farmers' rights to save seeds;
-    Fair, reasonable and non-discriminatory licensing;
-    A guaranteed EU-wide breeders' research exemption (breeders can use a variety protected by a patent or patents as source material for the development of a new variety).

The Danish Presidency flagged that existing tools already address several concerns and proposed strengthened transparency, including monitoring of licensing platforms through a code-of-conduct-like mechanism. The final outcome is still uncertain. The Greens, S&D, Left, Renew, PfE and ECR originally rejected patents on NGTs completely.

What happens next?

If it goes according to the Danish Presidency’s plans, the trilogue will end with a final meeting on 3 December where the whole legislative text needs to be agreed at political level. Then the text has to be cleaned by the lawyer-linguists (this can take a couple of weeks). The clean text will be sent back to the Parliament and the Council for adoption. In Parliament the lead committee - ENVI (environment) - will vote, if a simple majority approves the results of negotiations, the new legislation will move to the plenary. In Parliament’s plenary, a demand to open a deadline for amendments can be made. If no amendments are tabled, the text is deemed adopted. If amendments obtain a simple majority, the trilogue on these points will start again. In the Council, first COREPER (the Member states’ permanent representatives), then the AGRIFISH Council will vote on it. For a qualified majority, 55% of all member states that represent 65% of the EU’s population have to vote in favour. Following the passing of the law, the law must be implemented two years after its adoption.