
COMMISSION REGULATION (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed) 

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Purpose
Article 1 
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Scope
Article 2 
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Definitions
Article 3 
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Significant changes
Article 4 
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Risk management process
Article 5 
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Independent assessment
Article 6 
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Safety assessment reports
Article 7 
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Risk control management/internal and external audits
Article 8 
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Feedback and technical progress
Article 9 
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Entry into force
Article 10 
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ANNEX I
1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS 
 1.1. General principles and obligations 
 1.1.1. The risk management process covered by this Regulation shall start from a definition of the system under assessment and comprise the following activities: 

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 1.1.2. This iterative risk management process: 

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 1.1.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.1.4. The actors who already have in place methods or tools for risk assessment may continue to apply them as far as they are compatible with the provisions of this Regulation and subject to the following conditions: 

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 1.1.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.1.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.1.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2. Interfaces management 
 1.2.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 1.2.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS 
 2.1. General description 
 2.1.1. The risk assessment process is the overall iterative process that comprises: 

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 2.1.2. The system definition should address at least the following issues: 

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 2.1.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.1.4. The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles: 

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 2.1.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.1.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.1.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2. Hazard identification 
 2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a competent team, all reasonably foreseeable hazards for the whole system under assessment, its functions where appropriate and its interfaces. 

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 2.2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.2.6. Whenever a code of practices or a reference system is used to control the risk, the hazard identification can be limited to: 

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 2.3. Use of codes of practice and risk evaluation 
 2.3.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3.2. The codes of practice shall satisfy at least the following requirements: 

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 2.3.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3.5. If one or more hazards are controlled by codes of practice fulfilling the requirements of point 2.3.2, then the risks associated with these hazards shall be considered as acceptable. This means that: 

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 2.3.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3.7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.3.8. When all hazards are controlled by codes of practice, the risk management process may be limited to: 

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 2.4. Use of reference system and risk evaluation 
 2.4.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.4.2. A reference system shall satisfy at least the following requirements: 

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 2.4.3. If a reference system fulfils the requirements listed in point 2.4.2, then for the system under assessment: 

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 2.4.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.4.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5. Explicit risk estimation and evaluation 
 2.5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5.2. The acceptability of the estimated risks shall be evaluated using risk acceptance criteria either derived from or based on legal requirements stated in Community legislation or in notified national rules. Depending on the risk acceptance criteria, the acceptability of the risk may be evaluated either individually for each associated hazard or globally for the combination of all hazards considered in the explicit risk estimation. 

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 2.5.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5.4. Where hazards arise from failures of technical systems not covered by codes of practice or the use of a reference system, the following risk acceptance criterion shall apply for the design of the technical system: 

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 2.5.5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2.5.6. If a technical system is developed by applying the 10-9 criterion defined in point 2.5.4, the principle of mutual recognition is applicable in accordance with Article 7(4) of this Regulation. 

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 2.5.7. The explicit risk estimation and evaluation shall satisfy at least the following requirements: 

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3. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS 
 3.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. HAZARD MANAGEMENT 
 4.1. Hazard management process 
 4.1.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.1.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4.2. Exchange of information 

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5. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS 
 5.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Appendix
Risk management process and independent assessment
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ANNEX II
CRITERIA WHICH MUST BE FULFILLED BY THE ASSESSMENT BODIES
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. The staff responsible for the assessments must possess: 

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5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
