Commission Delegated Regulation (EU) 2024/3173 of 27 August 2024 supplementing Re... (32024R3173)
Commission Delegated Regulation (EU) 2024/3173 of 27 August 2024 supplementing Regulation (EU) 2023/988 supplementing Regulation (EU) 2023/988 of the European Parliament and of the Council with regard to rules on access to and operation of the Safety Gate Rapid Alert System, information to be entered in that System, notification requirements and the criteria for assessment of the level of risk
- COMMISSION DELEGATED REGULATION (EU) 2024/3173
- of 27 August 2024
- supplementing Regulation (EU) 2023/988 supplementing Regulation (EU) 2023/988 of the European Parliament and of the Council with regard to rules on access to and operation of the Safety Gate Rapid Alert System, information to be entered in that System, notification requirements and the criteria for assessment of the level of risk
- (Text with EEA relevance)
- Article 1
- Article 2
- Article 3
- ANNEX I
- RULES ON ACCESS TO AND OPERATION OF THE SAFETY GATE RAPID ALERT SYSTEM, INFORMATION TO BE ENTERED IN THAT SYSTEM AND NOTIFICATION REQUIREMENTS
- 1. TYPES OF NOTIFICATIONS THROUGH THE SAFETY GATE RAPID ALERT SYSTEM
- 1.1.
- Serious risk notification
- 1.2.
- Other risk notification
- 1.3.
- Notification for information
- 1.4.
- Follow-up notifications
- 1.5.
- Alerts sent by the Commission
- 2. INFORMATION TO BE INCLUDED IN NOTIFICATIONS SUBMITTED BY NATIONAL AUTHORITIES THROUGH THE SAFETY GATE RAPID ALERT SYSTEM
- 3. CHECK OF NOTIFICATIONS BY THE COMMISSION AND PUBLICATION
- 4. UPDATE OF NOTIFICATIONS
- 5. SPECIFIC RULES CONCERNING FOLLOW-UP NOTIFICATIONS
- 6. REMOVAL OF NOTIFICATIONS FROM THE SAFETY GATE RAPID ALERT SYSTEM AND THE SAFETY GATE PORTAL
- ANNEX II
- CRITERIA FOR ASSESSMENT OF THE LEVEL OF RISK
- 1. DEFINITIONS
- 2. RISKS
- 2.2.1.
- Risks to health and safety
- 2.2.2.
- Risks to public interests other than those referred to in point 2.2.1 as regards products covered by Regulation (EU) 2019/1020
- 3. SEQUENCE WHEN ASSESSING THE LEVEL OF THE RISK
- 3.1.
- Assessment of the anticipated harm scenario
- 3.2.
- Harm scenario: steps leading to harm(s)
- 3.3.
- Severity of the injury or harm
- 3.4.
- Probability of harm
- 3.5.
- Expressing the probability of the materialisation of the harm
- 3.6.
- Determining the level of risk
- 3.7.
- Determination of the level of the risk for different harm scenarios
- 3.8.
- Documentation of the assessment of the level of the risk
- 4. PRESUMPTION OF SERIOUS RISK
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