Key data
| Regulation | Regulation (EU) 2026/1388 of the European Parliament and of the Council, of 17 June 2026 |
|---|---|
| Publication | 26 June 2026 |
| Entry into force | Not specified in the published text |
| Affected parties | Seed companies, farmers, food industry, distributors and importers in the EU and EEA |
| Category | Agriculture and Fisheries |
| Amended regulation | Regulation (EU) 2017/625 on official controls |
| Territorial scope | The entire European Economic Area, including imports from third countries |
European agri-food companies face a major regulatory framework change. Regulation (EU) 2026/1388, published on 26 June 2026 in the Official Journal of the EU, establishes for the first time specific rules for plants obtained through new genomic techniques (NGT), separating them from the general GMO regime and creating a dual authorization pathway based on the degree of genetic modification. Anyone who buys seeds, sells food or imports plant products in the EEA needs to understand which category applies to each product and what specific obligations it entails.
What does this regulation establish?
The regulation introduces a fundamental distinction between two types of NGT plants, with very different operational consequences:
| Category | Definition | Authorization regime | Risk assessment |
|---|---|---|---|
| NGT1 | Plants equivalent to conventional varieties obtained by traditional methods | Simplified procedures | Does not require complete risk assessment |
| NGT2 | Plants with a higher degree of genomic modification | Complete assessment, similar to current GMO regime | Mandatory complete risk assessment |
In addition to the dual authorization pathway, the regulation establishes two additional operational pillars that affect the entire value chain:
- Mandatory traceability: operators must be able to identify and document the NGT origin of plants and their derived products at all stages of the chain.
- Mandatory labeling: specific information is required for consumers and operators to identify whether a product comes from NGT1 or NGT2 plants.
Finally, the regulation amends Regulation (EU) 2017/625 on official controls, integrating the new NGT categories into existing inspection systems. This means that the competent authorities of each Member State will incorporate NGT compliance verification into their routine inspections, without the need to create a separate inspection body.
Economic and operational impact
The regulation does not set specific financial penalties in the published text, but its operational consequences are immediate and affect several cost areas:
- Purchasing and procurement processes: seed companies and agricultural raw material buyers will need to request documentation certifying the NGT category (or absence of NGT) of each variety. This involves reviewing supplier contracts and updating purchasing specifications.
- Labeling and packaging: the food industry and distributors will need to review the labeling of products that contain or may contain ingredients of NGT origin, with the associated redesign and reprinting costs.
- Documentation and traceability: food chain operators will need systems capable of recording and transmitting information about the NGT status of products, which may require software investment or ERP adaptation.
- Authorization for NGT2: companies wishing to market NGT2 varieties will need to bear the cost of a complete risk assessment, equivalent to the current process for GMOs, which is significantly longer and more costly than the simplified NGT1 procedure.
- Imports: importers from third countries will need to verify that imported plant products comply with the categories and requirements of the regulation, under the modified official controls system.
Who does it affect?
- Seed companies: must classify their varieties as NGT1 or NGT2 and obtain the corresponding authorization before marketing them in the EEA.
- Farmers: when buying seeds, they must know the NGT category of the varieties they purchase and keep supporting documentation.
- Food industry: required to adapt labeling and traceability systems for products incorporating ingredients of NGT origin.
- Distributors: must ensure that the products they market comply with NGT labeling requirements before placing them on the market.
- EU importers: plant products from third countries are subject to the same controls, so they must verify the NGT status of their international suppliers.
- Control authorities: official inspections regulated by Regulation (EU) 2017/625 will incorporate NGT compliance verification as a new control area.
Practical example
A Spanish vegetable seed company develops a new tomato variety using genome editing techniques. Before marketing it, it must determine whether the variety is NGT1 (equivalent to a conventional variety, simplified procedure) or NGT2 (greater modification, complete risk assessment similar to GMO).
If the variety is classified as NGT1, it can access the market with an agile procedure, similar to any conventional variety, and the labeling must indicate its NGT1 status to inform farmers and chain operators.
If, on the other hand, the variety is NGT2, the company will need to initiate a complete risk assessment—equivalent to the current process for GMOs—before being able to sell it in any EEA country. A farmer buying that seed will need to keep traceability documentation, and the canned food manufacturer using those tomatoes will need to reflect it on the final product label. If that manufacturer also imports tomatoes from outside the EU, it will need to verify that its international suppliers can prove the NGT status of their products to the control authorities.
What should companies do now?
- Audit the catalog of varieties or ingredients: identify which own or supplier products may be obtained through NGT techniques and determine whether they correspond to the NGT1 or NGT2 category.
- Review contracts with seed and raw material suppliers: include clauses that require suppliers to declare the NGT status of their products and provide the corresponding authorization documentation.
- Update traceability systems: ensure that the ERP or management system can record and transmit NGT status throughout the entire supply chain.
- Review product labeling: identify which references need updating to comply with NGT information requirements for consumers and operators.
- Verify international suppliers: importers must check that their third-country suppliers can prove compliance with the regulation's categories and requirements to the EEA control authorities.
- Monitor entry into force: the exact date of application has not yet been published. It is essential to monitor the Official Journal of the EU to know the adaptation deadlines and avoid non-compliance.
Frequently asked questions
What is the difference between NGT1 and NGT2 plants?
NGT1 plants are those considered equivalent to conventional varieties obtained by traditional methods: they access the market through simplified procedures and without complete risk assessment. NGT2 plants have a higher degree of genomic modification and are subject to a complete risk assessment, similar to the current process for GMOs, before they can be marketed in the EEA.
When does Regulation (EU) 2026/1388 enter into force?
The exact date of entry into force has not been specified in the text published on 26 June 2026. It is necessary to monitor the Official Journal of the European Union to know the specific application and adaptation deadlines.
What labeling obligations does the regulation impose on the food industry?
The regulation establishes mandatory labeling to inform both consumers and operators about whether a product comes from NGT1 or NGT2 plants. The food industry and distributors will need to review and update the labeling of all products that contain or may contain ingredients of NGT origin.
Does this regulation affect imports from outside the EU?
Yes. The regulation applies throughout the European Economic Area and also affects imports from third countries. Importers will need to verify that plant products they bring into the EEA comply with the NGT categories and requirements established, and will be subject to official controls modified by Regulation (EU) 2017/625.
What regulation does this regulation amend and what does the change consist of?
Regulation (EU) 2026/1388 amends Regulation (EU) 2017/625 on official controls. The change consists of integrating the new NGT1 and NGT2 categories into existing inspection systems, so that the competent authorities of each Member State incorporate NGT compliance verification into their routine inspections.
Official source
Consult complete regulation in official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601388