Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the commo... (32013R0402)
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Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 Text with EEA relevance
- COMMISSION IMPLEMENTING REGULATION (EU) No 402/2013
- of 30 April 2013
- on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009
- (Text with EEA relevance)
- Article 1
- Subject matter
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- Significant changes
- Article 5
- Risk management process
- Article 6
- Independent assessment
- Article 7
- Accreditation/recognition of the assessment body
- Article 8
- Acceptance of accreditation/recognition
- Article 9
- Types of recognition of the assessment body
- Article 10
- Validity of recognition
- Article 11
- Surveillance by recognition body
- Article 12
- Relaxed criteria where a significant change is not to be mutually recognised
- Article 13
- Provision of information to the Agency
- Article 14
- Support from the Agency to accreditation or recognition of the assessment body
- Article 15
- Safety assessment reports
- Article 16
- Declaration by the proposer
- Article 17
- Risk control management and audits
- Article 18
- Feedback and technical progress
- Article 19
- Repeal
- Article 20
- Entry into force and application
- ANNEX I
- 1.
- GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS
- 1.1.
- General principles and obligations
- 1.2.
- Interfaces management
- 2.
- DESCRIPTION OF THE RISK ASSESSMENT PROCESS
- 2.1.
- General description
- 2.2.
- Hazard identification
- 2.3.
- Use of codes of practice and risk evaluation
- 2.4.
- Use of reference system and risk evaluation
- 2.5.
- Explicit risk estimation and evaluation
- 3.
- DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS
- 4.
- HAZARD MANAGEMENT
- 4.1.
- Hazard management process
- 4.2.
- Exchange of information
- 5.
- EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS
- Appendix
- Risk management process and independent assessment
- ANNEX II
- CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY
- ANNEX III
- SAFETY ASSESSMENT REPORT OF THE ASSESSMENT BODY
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