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to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (Text with EEA relevance) (repealed)

EU Regulation No 352/2009 · Adopted 24 April 2009 · Extends to United Kingdom

Contents

1. 1Purpose Repealed
2. 2Scope Repealed
3. 3Definitions Repealed
4. 4Significant changes Repealed
5. 5Risk management process Repealed
6. 6Independent assessment Repealed
7. 7Safety assessment reports Repealed
8. 8Risk control management/internal and external audits Repealed
9. 9Feedback and technical progress Repealed
10. 10Entry into force Repealed
11. Signature
12. Annex I Repealed
13. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS Repealed
14. General principles and obligations Repealed
15. 1.1.1The risk management process covered by this Regulation shall start from a definition of the system under assessment and comprise the following activities: Repealed
16. 1.1.2This iterative risk management process: Repealed
17. 1.1.3Division 1.1.3 Repealed
18. 1.1.4The 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them as far as they are compatible with the provisions of this Regulation and subject to the following conditions: Repealed
19. 1.1.5Division 1.1.5 Repealed
20. 1.1.6Division 1.1.6 Repealed
21. 1.1.7Division 1.1.7 Repealed
22. Interfaces management Repealed
23. 1.2.1Division 1.2.1 Repealed
24. 1.2.2Division 1.2.2 Repealed
25. 1.2.3Division 1.2.3 Repealed
26. 1.2.4Division 1.2.4 Repealed
27. 1.2.5Division 1.2.5 Repealed
28. 1.2.6Division 1.2.6 Repealed
29. 1.2.7Division 1.2.7 Repealed
30. DESCRIPTION OF THE RISK ASSESSMENT PROCESS Repealed
31. General description Repealed
32. 2.1.1The risk assessment process is the overall iterative process that comprises: Repealed
33. 2.1.2The system definition should address at least the following issues: Repealed
34. 2.1.3Division 2.1.3 Repealed
35. 2.1.4The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles: Repealed
36. 2.1.5Division 2.1.5 Repealed
37. 2.1.6Division 2.1.6 Repealed
38. 2.1.7Division 2.1.7 Repealed
39. Hazard identification Repealed
40. 2.2.1The 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. Repealed
41. 2.2.2Division 2.2.2 Repealed
42. 2.2.3Division 2.2.3 Repealed
43. 2.2.4Division 2.2.4 Repealed
44. 2.2.5Division 2.2.5 Repealed
45. 2.2.6Whenever a code of practices or a reference system is used to control the risk, the hazard identification can be limited to: Repealed
46. Use of codes of practice and risk evaluation Repealed
47. 2.3.1Division 2.3.1 Repealed
48. 2.3.2The codes of practice shall satisfy at least the following requirements: Repealed
49. 2.3.3Division 2.3.3 Repealed
50. 2.3.4Division 2.3.4 Repealed
51. 2.3.5If 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: Repealed
52. 2.3.6Division 2.3.6 Repealed
53. 2.3.7Division 2.3.7 Repealed
54. 2.3.8When all hazards are controlled by codes of practice, the risk management process may be limited to: Repealed
55. Use of reference system and risk evaluation Repealed
56. 2.4.1Division 2.4.1 Repealed
57. 2.4.2A reference system shall satisfy at least the following requirements: Repealed
58. 2.4.3If a reference system fulfils the requirements listed in point 2.4.2, then for the system under assessment: Repealed
59. 2.4.4Division 2.4.4 Repealed
60. 2.4.5Division 2.4.5 Repealed
61. Explicit risk estimation and evaluation Repealed
62. 2.5.1Division 2.5.1 Repealed
63. 2.5.2The 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. Repealed
64. 2.5.3Division 2.5.3 Repealed
65. 2.5.4Where 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: Repealed
66. 2.5.5Division 2.5.5 Repealed
67. 2.5.6If 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. Repealed
68. 2.5.7The explicit risk estimation and evaluation shall satisfy at least the following requirements: Repealed
69. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS Repealed
70. 3.1Division 3.1 Repealed
71. 3.2Division 3.2 Repealed
72. 3.3Division 3.3 Repealed
73. 3.4Division 3.4 Repealed
74. HAZARD MANAGEMENT Repealed
75. Hazard management process Repealed
76. 4.1.1Division 4.1.1 Repealed
77. 4.1.2Division 4.1.2 Repealed
78. 4.2Exchange of information Repealed
79. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS Repealed
80. 5.1Division 5.1 Repealed
81. 5.2Division 5.2 Repealed
82. Risk management process and independent assessment Repealed
83. Annex II: CRITERIA WHICH MUST BE FULFILLED BY THE ASSESSMENT BODIES Repealed
84. 1Division 1 Repealed
85. 2Division 2 Repealed
86. 3Division 3 Repealed
87. 4The staff responsible for the assessments must possess: Repealed
88. 5Division 5 Repealed
89. 6Division 6 Repealed
90. 7Division 7 Repealed