Preparation of the new EU regulation on genetically modified organisms, focusing in particular on plants obtained by certain new genomic techniques (NGTs), is advancing in Europe. The legislative proposal presented by the European Commission (COM(2023) 411 final) has been discussed during early 2026 in the European Parliament, the Council of the European Union, and earlier within the Permanent Representatives Committee. The legislative process can be followed openly online. Recent developments show that consensus among Member States has not yet been fully achieved.
The European legislative procedure is transparent and publicly accessible, and this text reviews the most recent and key stages in the preparation of the GMO/NGT regulation. The Commission’s original proposal has been amended during negotiations, and the revised objectives of the reform are set out in the Council’s draft statement of reasons adopted on 8 April 2026.
EU Law Tracer https://law-tracker.europa.eu/procedure/2023_226?lang=en
The Council supports a regulatory framework that reflects scientific progress since the adoption of the EU’s GMO legislation in 2001. The proposed regulation aims to promote innovation and sustainability in line with the European Green Deal, while maintaining a high level of protection for human health and the environment.
The Council supports a regulatory approach that distinguishes between two categories of NGT plants:
- Category 1 NGT plants are considered equivalent to conventionally bred plants, as their genetic changes could occur naturally or through traditional breeding. After a verification procedure, these plants are exempt from GMO legislation, with no general labelling requirement (except for reproductive material).
- Category 2 NGT plants involve more complex genetic modifications without foreign DNA and remain largely subject to GMO rules, although with more flexible, risk-adapted assessment and monitoring requirements.
The Council’s position introduces additional sustainability safeguards, including a list of excluded traits that would prevent certain plants from qualifying as Category 1. Regulatory incentives are provided for Category 2 plants that contribute positively to sustainability.
The Regulation also includes measures addressing patenting concerns, such as enhanced transparency, monitoring of licensing practices, support for small and medium-sized breeders, and the creation of a voluntary Code of Conduct under Commission oversight.
NGT plants and products are excluded from organic production, while Member States retain the right to opt out of cultivating Category 2 NGT plants and to apply coexistence measures. Monitoring and reporting obligations are strengthened, particularly regarding sustainability, patent impacts, and effects on the organic sector.
Overall, the Council considers its position a balanced compromise reflecting negotiations with the European Parliament and the Commission, expected to promote innovation and sustainability in EU agriculture while safeguarding health, the environment and consumer interests.
Draft Statement of the Council Reasons https://data.consilium.europa.eu/doc/document/ST-17037-2025-ADD-1/en/pdf
Despite this compromise, several Member States expressed strong opposition in their statements on 10 April 2026. Croatia, Hungary, Austria, Slovenia and Slovakia acknowledged the potential benefits of innovation and new genomic techniques, but argued that the regulation does not adequately apply the precautionary principle. They raised concerns about the absence of mandatory risk assessments, insufficient labelling and traceability requirements, environmental risks including contamination and lack of liability mechanisms, limitations on Member State autonomy, scientific and legal uncertainties regarding equivalence criteria, and the potential negative impact of patenting on small and medium-sized breeding companies. As these concerns were not sufficiently addressed, these countries stated that they could not support the adoption of the regulation.
Statements https://data.consilium.europa.eu/doc/document/ST-7616-2026-ADD-1/en/pdf
Overall, while the legislative process is moving forward, the debate over the regulation highlights enduring tensions between innovation, consumer protection, environmental safeguards and national regulatory autonomy within the EU.
This text is prepared in ASAP project https://sites.uwasa.fi/asap/
The grammar is polished with Copilot.
Kristian Siikavirta
