This Regulation (EU) 2026/1388 establishes a new, specialized legal framework for plants obtained through specific “New Genomic Techniques” (NGTs), such as targeted mutagenesis and cisgenesis. It aims to modernize the EU’s approach to biotechnology by distinguishing between plants that could occur naturally or through conventional breeding and those with more complex modifications. By creating a tiered regulatory system, the act seeks to foster innovation, support the European Green Deal’s sustainability goals, and ensure a high level of safety for human health and the environment. ****: This regulation has direct implications for agricultural trade, food security, and the competitiveness of the agri-food sector in Ukraine, which is a major partner of the EU in these areas.
### Structure and Main Provisions
The Regulation functions as *lex specialis* (specialized law) to the existing EU GMO legislation. Its structure is divided into four main chapters:
1. **General Provisions:** Defines the scope and key terminology, distinguishing between NGT plants and traditional GMOs.
2. **Category 1 NGT Plants:** These are plants deemed equivalent to those produced by conventional breeding. They are exempt from the strict authorization and labeling requirements of the 2001 GMO Directive, provided they meet specific scientific criteria (Annex I) and do not possess excluded traits (Annex II, such as herbicide tolerance).
3. **Category 2 NGT Plants:** These plants remain subject to the existing, albeit adapted, EU GMO legislation. They require a risk assessment and authorization, though the Regulation provides for more flexible data requirements and potential incentives for sustainable traits.
4. **Final Provisions:** Covers transparency, intellectual property (IP) considerations, monitoring, and the establishment of expert groups.
Compared to previous versions of EU GMO law, this act introduces a **verification procedure** to determine the “category” of a plant before it enters the market, replacing the “one-size-fits-all” authorization process with a risk-proportionate approach.
### Key Provisions for Practical Use
* **Equivalence Criteria (Annex I):** This is the most critical technical component. It sets specific limits on the number and type of genetic modifications (e.g., max 20 modifications per monoploid genome) that allow a plant to be classified as “Category 1.”
* **Exclusion of Certain Traits (Annex II):** Even if a plant is scientifically equivalent to a conventional one, it cannot be “Category 1” if it is engineered for herbicide tolerance or the production of insecticidal substances. These must follow the stricter “Category 2” path.
* **Transparency and Labeling:** Category 1 NGT plant reproductive material must be labeled as “NGT-1” and listed in a public database. This ensures traceability for organic producers and consumers who wish to avoid NGT products.
* **Incentives for Sustainability:** Developers of Category 2 NGT plants that offer sustainability benefits (e.g., climate resilience, improved nutrient efficiency) can benefit from accelerated risk assessment procedures and fee waivers for SMEs.
* **Intellectual Property (IP) and Code of Conduct:** The Regulation mandates the creation of a code of conduct to ensure fair access to patented biological material for breeders and farmers, addressing concerns about market concentration and the ability of smaller entities to innovate.
* **Monitoring and Evaluation:** The Commission is required to report on the implementation of the Regulation between three and seven years after the first products reach the market, ensuring the framework remains aligned with scientific progress.
