This Commission Delegated Regulation supplements Regulation (EU) 2023/988 on general product safety by establishing detailed rules for the operation of the Safety Gate Rapid Alert System. It sets requirements for notifications about dangerous products, criteria for risk assessment, and rules for information exchange between Member States through this system.The regulation consists of 3 main articles and 2 detailed annexes. Annex I provides comprehensive rules on different types of notifications, required information, and procedures for submitting and managing notifications through the Safety Gate system. Annex II establishes criteria and methodology for assessing product risks, including a four-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 identification, risk description, traceability information, etc.)
- Specific criteria for assessing health and safety risks as well as other public interest risks
- A structured methodology for determining risk levels (serious, high, medium, low) based on harm severity and probability
- Cases where serious risk can be presumed without individual assessment
The regulation introduces significant changes by establishing a more structured and detailed framework for product safety notifications compared to previous systems, with clear criteria for risk assessment and information requirements. It aims to ensure consistent and effective operation of the EU’s rapid alert system for dangerous products.
