Current EU GMO legislation was adopted in 2001, before the emergence of new genomic techniques (NGTs).
As scientific advances outpaced the existing framework, in 2023 the European Commission proposed updated rules to maintain high safety standards while better supporting innovation, sustainability and competitiveness in plant breeding.
On 17 June 2026, the European Parliament and the Council adopted these new rules applicable to plants obtained by targeted mutagenesis and cisgenesis and their food and feed.
The new rules entered into force on 16 July 2026 and will apply from 17 July 2028.
In the meantime, plants and food and feed products obtained by targeted mutagenesis and cisgenesis remain subject to the existing rules on GMOs.
- Regulation (EU) 2026/1388 of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625.
- Press release
- Factsheet: New genomic techniques in a nutshell
- Factsheet: EU rules on New Genomic Techniques
- Q&As: New EU rules on plants obtained by new genomic techniques
Implementation Strategy
The Commission has prepared an implementation strategy of Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques and their products to support coordinated implementation by the Commission, Union bodies and agencies and Member States, and to inform stakeholders and the public of planned actions. The implementation strategy outlines the planned activities and indicative milestones at EU and Member State level leading up to the application of the new rules.
Commission proposal
5 July 2023
Proposal for a new Regulation on plants produced by certain new genomic techniques
On 5 July 2023, the European Commission adopted a proposal for a new Regulation on plants produced by certain NGTs. The proposal was part of a package of legislative proposals to support the EU's Farm to Fork and Biodiversity strategies. It also supported the objective of the Vision for Agriculture and Food to boost the resilience and competitiveness of the agri-food sector.
Main documents:
Impact assessment and supporting studies
The impact assessment analysed the possible impacts of available policy options, guiding the preparation of the proposal.
Supported by consultation activities, the impact assessment took into account an external study, JRC case studies on several applications of NGTs and the relevant scientific work of EFSA.
- Executive summary of the impact assessment report (SWD (2023) 413)
- Impact assessment report (SWD (2023) 412)
- Subsidiarity grid (SWD(2023) 411)
- Opinion of the Regulatory Scrutiny Board (SEC(2023) 411)
- External study supporting the impact assessment, executive summary and annexes
- Case study on disease resistant potatoes and apples developed with cisgenesis
- Case study on the socioeconomic impact of low-gluten celiac-safe wheat developed by gene editing
- EFSA - New advances in biotechnology
- European Union Reference Laboratory for GM Food and Feed (EURL GMFF) 2019 and 2023 reports on the detection of food and feed plant products obtained by new mutagenesis techniques
Consultation activities
The roadmap (inception impact assessment) for the initiative, setting out the initial analysis of the problem, policy objectives and outlines of different options to achieve the objectives as well as some of their likely impacts, was published on 24 September 2021. A summary of the feedback received can be found in Annex 2a of the impact assessment.
In the context of the impact assessment, the Commission carried out extensive consultation activities.
A public consultation for the initiative was open for 12 weeks from 29 April until 22 July 2022. An overview of contributions is provided in the factual summary of the public consultation. The public consultation was complemented by targeted consultations.
More details about all consultation activities are provided in the consultation strategy (Annex 4 of the impact assessment report) and the dedicated Q&A page.
The proposal was subject to public feedback from 7 July to 5 November 2023. An overview of the feedback received is provided in the summary of the feedback.
Why and how was the proposal developed?
In July 2018, the Court of Justice of the European Union (CJEU) ruled that organisms from new mutagenesis techniques fall within the scope of the EU GMO legislation.
In November 2019, the European Council requested the Commission to provide a study on new genomic techniques. The study was published on 29 April 2021. Detailed information and materials related to the study are available.
The Council also asked the Commission to "submit a proposal, if appropriate in view of the outcomes of the study ", ensuring that any proposal is accompanied by an impact assessment. Based on the outcome of the study, the Commission initiated the policy action on plants produced by targeted mutagenesis and cisgenesis.
The Commission engaged in a wide-ranging communication effort to share and discuss the outcome of the study and the preparation of the proposal with the EU institutions and stakeholders in dedicated meetings:
- Joint Working Group meeting - 9 February 2023
- Joint Working Group meeting - 24 October 2022
- Joint Working Group meeting - 25 May 2022
- Agriculture and Fisheries Council - 26 May 2021
- EP ENVI Committee Public Hearing on new genomic techniques in the food sector - 10 May 2021
- EP AGRI Committee "New genomic techniques: study presented by the EC DG SANTE" - 22 June 2021.
- Ad hoc meeting of Member States' Competent authorities - "Joint Working Group meeting" - 7 May 2021
- Ad hoc meeting of the Advisory Group on the Food Chain and Animal and Plant Health on Article 241 studies - 19 May 2021
- Informative session on New Genomic Techniques (NGTs) to Third Countries - 30 June 2021
- High-level online event "New genomic techniques - the way forward for safe and sustainable innovation in the agri-food sector" – 29 November 2021