EU publishes plan to deploy NGT framework by July 2028

17 Jul, 2026

The EU Commission has prepared an implementation strategy of Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques and their products to ensure the EU NGT framework becomes fully functional on 17 July 2028.

The plan shares the coordinated implementation by the Commission, European Union bodies and agencies and member states. It shares the implementation strategy activities and milestones at leading up to the application of the new rules.

The deployment involves the European Commission's Directorate-General for Health and Food Safety, Biotechnology unit (DG SANTE), European Food Safety Authority (EFSA), the EU Reference Laboratory for GM Food and Feed (EURL GMFF), the European Network of GMO Laboratories, European Patent Office (EPO), member states and public.

Brief overview

The implementation strategy produced by the Commission's DG SANTE for the recently approved NGT Regulation (Regulation 2026/1388). The NGT Regulation entered into force on 16 July 2026 and becomes applicable on 17 July 2028, giving two years to make the framework operational. The strategy is a roadmap of intent rather than a set of legally binding commitments.

The main introduction of the NTGT Regulation is a two-tier categorisation of plants produced by new genomic techniques:

• Category 1 NGT plants: Treated as equivalent to conventionally bred or naturally occurring plants. Subject to a verification procedure and exempted from the GMO legislation entirely.
• Category 2 NGT plants: Products that contain more complex modifications and remain within the GMO regime, but with the possibility of a tailored risk assessment, waiving of post-market environmental monitoring, an adapted analytical-method requirements, and indefinite authorisation validity after first renewal.

Eight strategy implementation areas

The strategy organises the work into eight implementation areas, their milestones and named actors. These areas include:

1. Delegated and implementing acts: A delegated act (Article 25) specifying what information demonstrates NGT-plant status and how the category 1 verification procedure works, and an implementing act (Article 27) covering category 2 notifications, applications, the adapted risk assessment, and analytical-method arrangements.
2. Guidance: technical guidance from EFSA (on category 1 verification requests and category 2 notifications/applications, plus the adapted risk assessment) and from the EURL GMFF, assisted by the ENGL (on analytical detection methods for category 2 plants), together with information on support for NGT research and development.
3. Member States' regulatory and administrative preparations: national-level work: running the category 1 verification procedure (Article 6), adapting national GMO legislation where needed, and preparing for controls and enforcement (Article 34).
4. EU administrative preparations: the Commission and EFSA establish an EU-level verification procedure (Article 7), EFSA's enhanced pre-submission advice for category 2 plants (Article 23), and internal procedural and capacity adaptations.
5. Patents Commission guidance on plant intellectual property (Article 29(3)), a voluntary stakeholder-driven Code of Conduct (Article 30), and an expert group on the effects of NGT-plant patenting (Article 31).
6. IT systems: adapting the E-Submission Food Chain platform (Article 8), building the public database of category 1 status decisions (Article 9), and updating variety catalogues and forest reproductive material information systems (Article 10).
7. Monitoring programme: an indicator-based programme (Articles 32 and 33) to gather environmental, economic, and social data, including the sustainability indicators.
8. Communication and outreach: the Q4 2026 Brussels conference, public awareness-raising at EU and national level, and international outreach through the WTO and the Biosafety Clearing House.

How the framework is planned to be deployed

The framework will be deployed over three stages of foundational development, drafting and feedback and adoption.

The foundational work will take place over the remainder of 2026. EFSA will be mandated for scientific support; calls for evidence launched and expert groups established; IT will be scoped; patent guidance drafting begins and the Code of Conduct process opens with an inaugural stakeholder meeting; the flagship NGT conference will be held in Brusselsand international notifications begun via WTO/Biosafety Clearing House.

Drafting and feedback on the guidance and approach will take place over 2027. This includes: a four-week public feedback on the draft delegated act; expert-group feedback and the draft monitoring programme; the Code of Conduct finalised and signed, plus Member State consultation on patent guidance.

The guidelines are planned to go live by the 17 July 2028 application date. This includes: the adapted E-Submission Food Chain (ESFC) platform; the public database of category 1 decisions; EFSA and EURL guidance; functioning verification procedures at both national and EU level, and; an indicator-based monitoring programme.

Patents

In response to concerns about the potential impacts of NGT plant patenting on breeders and farmers the strategy provides more information with regard to how patents are being considered, created and promoted. The purpose is to increase transparency, facilitate access to patented NGT biological material, improve legal certainty, and establish a monitoring-and-reporting framework.

The strategy describes four instruments regarding patents:

1. Patent information in the verification procedure: As part of applying for category 1 status, requesters must submit information on patents and, where relevant, patent-licensing declarations.
2. Commission guidance on plant intellectual property: Designed to raise operators' awareness of the IP framework and of bodies that support breeders and SMEs. Drafting for this work begins Q3/Q4 2026, followed by consultation with member states and publication targetted for Q1 2028.
3. A voluntary Code of Conduct on patents This aims to enhance transparency about patents on NGT material, facilitate breeders' access under fair and reasonable conditions, and improve legal certainty for breeders and farmers on patent enforcement. This code is planned to be finalised within 18 months of entry into force (target Q4 2027). The Commission will oversee this process as a means to safeguard a fair balance among the different interests at stake, paying particular attention to SMEs.
4. Establishment of an expert group on the effects of NGT-plant patenting: This will include member state experts and the European Patent Office and Community Plant Variety Office. It supports the Commission's formal assessment of patenting impacts which are due one year after the first NGT products reach the market and then every four-to-six years.

More details on the plan can be found here

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