Commission Delegated Regulation (EU) 2026/1195 establishes a formal, standardized procedure for identifying and listing “high-risk” plants and plant products that pose a potential phytosanitary threat to the European Union. It mandates that any proposal to restrict such imports must be supported by a comprehensive technical dossier containing scientific evidence of pest risks. By creating a dedicated preliminary assessment group, the regulation ensures that decisions to prohibit or regulate the entry of specific botanical goods are based on transparent, evidence-based, and uniform criteria across all Member States.
### Structure and Main Provisions
The regulation is structured to govern the lifecycle of a “high-risk” classification request, from initial submission to final decision. It functions as a procedural supplement to the broader Regulation (EU) 2016/2031.
* **Submission of Evidence (Articles 2 & 3):** It defines the requirements for a technical dossier, which must include data on import volumes, pest interception history, domestic production, and specific pest-host information. This applies both to requests initiated by Member States and those initiated by the Commission itself.
* **Verification and Assessment (Articles 4 & 5):** The Commission is tasked with checking the completeness of dossiers before passing them to a newly established “preliminary assessment group.” This group, composed of experts from Member States, the European Food Safety Authority (EFSA), and the Commission, conducts the actual risk evaluation.
* **Confidentiality (Article 6):** The regulation introduces specific protections for sensitive commercial information, such as production methods, business strategies, and supply chain details, ensuring that the transparency of the process does not compromise the competitive position of the entities involved.
Compared to previous frameworks, this regulation formalizes the “preliminary assessment” phase, which was previously less structured, thereby providing greater legal certainty for both regulators and economic operators.
### Key Provisions for Practical Application
For those navigating this legislation, the following elements are critical:
1. **The Technical Dossier Requirements:** Any entity or Member State seeking to trigger a high-risk listing must provide robust data. Specifically, Article 2(3)(e) requires proof that the risk is not already sufficiently mitigated by existing EU measures (specifically those in Implementing Regulation (EU) 2019/2072).
2. **The Role of the Preliminary Assessment Group:** This is the central decision-making body. Its ability to request additional information or clarifications means that the process is iterative rather than a one-time submission.
3. **Confidentiality Safeguards:** Article 6 is essential for businesses. It allows stakeholders to request that specific industrial or commercial data be kept confidential, provided they demonstrate a “legitimate interest.” This balances the public interest in phytosanitary safety with the protection of private intellectual property.
4. **Direct Applicability:** As a delegated regulation, it is binding in its entirety and directly applicable in all Member States, meaning it does not require national transposition and creates immediate, uniform obligations across the EU.
**:** This regulation directly impacts the trade of agricultural and botanical products between the European Union and third countries, including Ukraine. As Ukraine is a significant exporter of agricultural goods to the EU, any new “high-risk” listing triggered under this procedure could lead to immediate import prohibitions or stricter phytosanitary requirements for Ukrainian producers, necessitating careful monitoring of the Commission’s assessment dossiers.
