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Commission Regulation (EU) No 1169/2010 of 10 December 2010 on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation (Text with EEA relevance)

EU Regulation No 1169/2010 · Adopted 10 December 2010 · Extends to United Kingdom

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Commission Regulation (EU) No 1169/2010

of 10 December 2010

on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive)f1, and in particular Article 6(1) thereof,

Having regard to Recommendation ERA/REC/SAF/09-2009 from the European Railway Agency, delivered to the Commission on 18 September 2009, on a common safety method (CSM) for conformity assessment,

Whereas:

(1)

The purpose of the common safety method (CSM) to be established is to provide a framework for national safety authorities to harmonise their decision-making criteria across the Union, in accordance with Article 17(4) of Directive 2004/49/EC. It should enable national safety authorities to assess conformity with requirements in a uniform manner.

(2)

The CSM should include all the harmonised requirements and assessment methods to enable national safety authorities to issue an infrastructure manager with a safety authorisation covering the adequacy of the safety management system in general and any network-specific authorisation. Furthermore, it is likely that the infrastructure manager will apply for the network-specific part of the authorisation at the same time as it applies for a general authorisation based on its safety management system.

(3)

National safety authorities assess the ability of an infrastructure manager to comply with all the requirements required to operate in general and on the specific network for which it is seeking an authorisation by assessing its safety management system at global level.

(4)

Each national safety authority needs to put in place arrangements to examine whether the results outlined in the application for a safety authorisation are being delivered in operation after the award of the authorisation and whether all the necessary requirements are complied with on a continuous basis, as required by Article 16(2)(f) and Article 17(2) of Directive 2004/49/EC. This therefore requires the development of a post-award supervision regime based on key fundamental principles in order to ensure a harmonised approach by national safety authorities in each Member State.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 27(1) of Directive 2004/49/EC,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 164, 30.4.2004, p. 44.

Contents

  1. 1Subject-matter Repealed
  2. 2Definitions
  3. 3Procedures for assessing applications
  4. 4Supervision
  5. 5Entry into force
  6. Signature
  7. Annex I: Procedure for assessing conformity with requirements for obtaining safety authorisations to be issued in accordance with regulations 10, 11 and 12 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 27 to 38 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013regulations 8, 9 and 10 of the Railways (Safety Management) Regulations (Northern Ireland) 2006
  8. 1Division 1
  9. (a)Setting up and reviewing the assessment process
  10. (b)Quality of the assessment process
  11. (c)Scope of the assessment
  12. (d)Timing of the assessment
  13. (e)Decision making during the assessment
  14. 2Division 2
  15. 3Division 3
  16. 4Division 4
  17. Annex II: Criteria for assessing conformity with the requirements for obtaining safety authorisations to be issued in accordance with regulations 10, 11 and 12 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 27 to 38 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 regulations 8, 9 and 10 of the Railways (Safety Management) Regulations (Northern Ireland) 2006
  18. RISK CONTROL MEASURES FOR ALL RISKS ASSOCIATED WITH THE ACTIVITY OF THE INFRASTRUCTURE MANAGER
  19. A.1Division A.1
  20. A.2Division A.2
  21. A.3Division A.3
  22. A.4Division A.4
  23. A.5Division A.5
  24. A.6Division A.6
  25. RISK CONTROL RELATED TO THE SUPPLY OF MAINTENANCE AND MATERIAL
  26. B.1Division B.1
  27. B.2Division B.2
  28. B.3Division B.3
  29. B.4Division B.4
  30. B.5Division B.5
  31. B.6Division B.6
  32. RISK CONTROL RELATED TO THE USE OF CONTRACTORS AND CONTROL OF SUPPLIERS
  33. C.1Division C.1
  34. C.2Division C.2
  35. C.3Division C.3
  36. C.4Division C.4
  37. C.5Division C.5
  38. RISKS ARISING FROM THE ACTIVITIES OF OTHER PARTIES EXTERNAL TO THE RAILWAY SYSTEM
  39. D.1Division D.1
  40. D.2Division D.2
  41. D.3Division D.3
  42. DOCUMENTATION OF THE SAFETY MANAGEMENT SYSTEM
  43. E.1Division E.1
  44. E.2Division E.2
  45. E.3Division E.3
  46. E.4Division E.4
  47. DISTRIBUTION OF RESPONSIBILITIES
  48. F.1Division F.1
  49. F.2Division F.2
  50. F.3Division F.3
  51. F.4Division F.4
  52. SECURING CONTROL BY THE MANAGEMENT ON DIFFERENT LEVELS
  53. G.1Division G.1
  54. G.2Division G.2
  55. G.3Division G.3
  56. G.4Division G.4
  57. G.5Division G.5
  58. INVOLVING STAFF AND THEIR REPRESENTATIVES ON ALL LEVELS
  59. H.1Division H.1
  60. H.2Division H.2
  61. IENSURING CONTINUOUS IMPROVEMENT
  62. JSAFETY POLICY APPROVED BY THE ORGANISATION’S CHIEF EXECUTIVE AND COMMUNICATED TO ALL STAFF
  63. QUALITATIVE AND QUANTATIVE TARGETS OF THE ORGANISATION FOR MAINTAINING AND ENHANCING SAFETY, AND PLANS AND PROCEDURES FOR REACHING THESE TARGETS
  64. K.1Division K.1
  65. K.2Division K.2
  66. K.3Division K.3
  67. K.4There are procedures in place to regularly monitor and review operational arrangements by:
  68. K.5Division K.5
  69. PROCEDURES TO MEET EXISTING, NEW AND ALTERED TECHNICAL AND OPERATIONAL STANDARDS OR OTHER PRESCRIPTIVE CONDITIONS
  70. L.1For safety-related requirements relevant to the type and extent of operations, there are procedures for:
  71. L.2Division L.2
  72. L.3Division L.3
  73. PROCEDURES AND METHODS FOR CARRYING OUT RISK EVALUATION AND IMPLEMENTING RISK CONTROL MEASURES WHENEVER A CHANGE OF THE OPERATING CONDITIONS OR NEW MATERIAL IMPOSES NEW RISKS ON THE INFRASTRUCTURE OR ON OPERATION
  74. M.1Division M.1
  75. M.2Division M.2
  76. M.3Division M.3
  77. PROVISION OF STAFF TRAINING PROGRAMMES AND SYSTEMS TO ENSURE THAT STAFF COMPETENCE IS MAINTAINED AND TASKS CARRIED OUT ACCORDINGLY
  78. N.1There is a competence management system that includes at least:
  79. N.2There are procedures within the competence management system providing for:
  80. ARRANGEMENTS FOR THE PROVISION OF SUFFICIENT INFORMATION WITHIN THE ORGANISATION AND, WHERE APPROPRIATE, BETWEEN ORGANISATIONS OPERATING ON THE SAME INFRASTRUCTURE
  81. O.1There are procedures to ensure that:
  82. O.2There are procedures to ensure that:
  83. O.3Division O.3
  84. PROCEDURES AND FORMATS FOR DOCUMENTING SAFETY INFORMATION, AND DESIGNATION OF A PROCEDURE FOR CONFIGURATION CONTROL OF VITAL SAFETY INFORMATION
  85. P.1Division P.1
  86. P.2There are procedures to:
  87. P.3Division P.3
  88. PROCEDURES TO ENSURE THAT ACCIDENTS, INCIDENTS, NEAR MISSES AND OTHER DANGEROUS OCCURRENCES ARE REPORTED, INVESTIGATED AND ANALYSED AND THAT NECESSARY PREVENTIVE MEASURES ARE TAKEN
  89. Q.1There are procedures to ensure that accidents, incidents, near misses and other dangerous occurrences:
  90. Q.2There are procedures to ensure that:
  91. Q.3Division Q.3
  92. PROVISION OF PLANS FOR ACTION AND ALERTS AND INFORMATION IN CASE OF EMERGENCY, AGREED UPON WITH THE APPROPRIATE PUBLIC AUTHORITIES
  93. R.1Division R.1
  94. R.2There are procedures in place to ensure that, for each identified type of emergency:
  95. R.3Division R.3
  96. R.4Plans for action, alerts and information exist and include:
  97. R.5Division R.5
  98. R.6Division R.6
  99. R.7Division R.7
  100. R.8Division R.8
  101. R.9Division R.9
  102. PROVISIONS FOR RECURRENT INTERNAL AUDITING OF THE SAFETY MANAGEMENT SYSTEM
  103. S.1Division S.1
  104. S.2Division S.2
  105. S.3Division S.3
  106. S.4Procedures are in place to:
  107. S.5Division S.5
  108. S.6Division S.6
  109. SAFE DESIGN OF THE RAILWAY INFRASTRUCTURE
  110. T.1Division T.1
  111. T.2Division T.2
  112. T.3Division T.3
  113. SAFE OPERATION OF THE INFRASTRUCTURE
  114. U.1Division U.1
  115. U.2Division U.2
  116. U.3Division U.3
  117. U.4Division U.4
  118. PROVISION OF MAINTENANCE & MATERIAL
  119. V.1Division V.1
  120. V.2Division V.2
  121. V.3Division V.3
  122. MAINTENANCE AND OPERATION OF THE TRAFFIC CONTROL AND SIGNALLING SYSTEM
  123. W.1Division W.1
  124. W.2Division W.2
  125. W.3Division W.3
  126. W.4Division W.4
  127. Annex III: Principles for supervision after the award of an authorisation
  128. 1Division 1
  129. 2Division 2
  130. 3Division 3
  131. 4Division 4
  132. 5Division 5
  133. 6Division 6
  134. 7Division 7
  135. 8Division 8