IN Brief:
- Regulation (EU) 2026/1388 will apply from 17 July 2028, introducing separate regulatory routes for category 1 and category 2 NGT plants.
- Delegated and implementing acts will define information and procedural requirements for verification, deliberate release, and market applications.
- Stakeholders have until 28 September 2026 to submit evidence before the Commission develops the secondary legislation.
The European Commission has opened a call for evidence on the secondary legislation needed to make the European Union’s new rules for plants produced by new genomic techniques operational. The consultation, launched on 31 August, covers a delegated act and an implementing act under Regulation (EU) 2026/1388 and remains open until 28 September 2026.
The measures will set procedural and information requirements covering verification, notification for deliberate release, and applications to place new genomic technique, or NGT, plants on the market. They will also apply to food and feed containing, consisting of, or produced from NGT plants, turning the regulation’s broad framework into procedures that breeders, ingredient suppliers, manufacturers, and authorities can use.
Regulation (EU) 2026/1388 was adopted on 17 June 2026, entered into force on 16 July, and will apply from 17 July 2028. Until then, plants and products obtained through targeted mutagenesis and cisgenesis remain subject to the EU’s existing GMO rules. The Commission intends to have the delegated and implementing measures in place when the new regime starts applying.
The framework separates NGT plants into two categories. Category 1 covers plants meeting criteria intended to establish equivalence with conventionally bred plants, although herbicide tolerance and production of a known insecticidal substance specifically exclude a plant from category 1 status. Once category 1 status has been established under the regulation, those plants and their products are treated outside the EU GMO framework specified by the new legislation.
Category 2 covers NGT plants that do not qualify for the first route. They remain subject to consent or authorisation requirements, including case-by-case risk assessment for category 2 plants and related food and feed. The implementing detail will consequently determine what evidence applicants need to assemble, how authorities verify submissions, and how consistently those procedures can be applied across Member States.
Practical compliance questions extend well beyond the breeding stage. Ingredient specifications, supplier declarations, product-development records, and traceability arrangements will need to provide enough information for manufacturers to understand the regulatory status of inputs derived from NGT plants. Category 2 materials will carry a materially different regulatory burden from products derived from plants that have secured category 1 status.
The evidence call gives seed developers, ingredient suppliers, laboratories, food businesses, regulators, and other stakeholders an opportunity to address those procedures before the secondary legislation is drafted. The main regulation already establishes the category structure; the next layer will determine the information burden attached to verification and market applications, including how evidence is presented to competent authorities.
Food manufacturers will also need to consider how the new status information is incorporated into supplier approval and change-control procedures. A raw material derived from an NGT plant may pass through several processors before reaching a finished-food factory, so regulatory status will need to remain clear across specifications, technical documentation, and purchasing systems. That makes implementation detail relevant not only to plant developers but also to quality, regulatory, procurement, and product-development teams further downstream.
Product-development cycles add urgency despite the July 2028 application date. Plant breeding, crop multiplication, ingredient qualification, reformulation, customer approval, and packaging or labelling changes can span several seasons, particularly where a finished product is sold across multiple EU markets. Companies evaluating NGT-derived ingredients will need sufficient regulatory clarity before commercial quantities enter routine procurement.
The techniques covered include targeted mutagenesis and cisgenesis, which allow genetic changes to be made in more targeted ways than many established breeding approaches. Cisgenesis uses genetic material from within the conventional breeding gene pool, while targeted mutagenesis changes genetic material at selected locations. The new framework reflects an EU decision to regulate qualifying plants differently according to their characteristics rather than treating every product produced through these techniques identically.
That distinction places considerable weight on the verification system now being designed. A workable procedure needs to establish category status reliably without adding unnecessary uncertainty to breeding, ingredient sourcing, and subsequent food production, while category 2 applications still need to support the health and environmental assessments required by the regulation.
The Commission plans to complete the necessary secondary legislation by 17 July 2028. Evidence submitted before 28 September 2026 will feed into that preparatory work, leaving the next two years for the detailed rules to be drafted, adopted, and put in place before the new NGT framework becomes operational.
