This Commission Delegated Regulation supplements Regulation (EU) 2023/988 on general product safety by establishing detailed rules for the Safety Gate Rapid Alert System – the EU’s system for rapid exchange of information about dangerous non-food products. The regulation sets requirements for notifications about dangerous products, criteria for risk assessment, and rules for system operation.The regulation consists of 3 articles and 2 detailed annexes. Annex I provides comprehensive rules on different types of notifications, required information, validation procedures, and system operation. Annex II establishes criteria and methodology for assessing product risks, including a 4-level classification of harm severity and probability assessment.Key provisions include:
- Five types of notifications: serious risk, other risk, information notifications, follow-up notifications, and Commission alerts
- Detailed requirements for information that must be included in notifications (product details, risk description, traceability info, etc.)
- Specific criteria for assessing health/safety risks and other public interest risks
- Four-level classification system for harm severity (from minor to life-threatening)
- Methodology for calculating risk probability and determining overall risk level
- Cases where serious risk can be presumed without individual assessment
The regulation aims to ensure consistent and effective operation of the Safety Gate system across EU member states through standardized notification procedures and risk assessment criteria. It applies from December 13, 2024.
