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Commission Regulation (EU) No 1158/2010 of 9 December 2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety certificates (Text with EEA relevance)

EU Regulation No 1158/2010 · Adopted 9 December 2010 · Extends to United Kingdom

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Commission Regulation (EU) No 1158/2010

of 9 December 2010

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

(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 for conformity assessment.

Whereas:

(1)

Directive 2004/49/EC provides a framework for equal conditions for all railway undertakings, through the application of the same safety certification requirements across the Union. The purpose of the common safety method (CSM) 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.

(2)

It is necessary to provide for a method for national safety authorities to assess the adequacy of processes developed by railway undertakings to meet the harmonised requirements for obtaining Part A safety certificates issued in accordance with Article 10(2)(a) and Part B safety certificates issued in accordance with Article 10(2)(b) of Directive 2004/49/EC. The criteria by which assessment by national safety authorities shall be carried out should be defined and the procedures to be followed should be established.

(3)

Regarding conformity with the safety requirement according to which responsibility for railway vehicle maintenance should be clearly defined, a railway undertaking which is not the entity in charge of maintenance for all vehicles used in its operation, should through appropriate contractual arrangements, such as the General Contract of Use (GCU), ensure that every vehicle has an entity in charge of maintenance to take responsibility for vehicle maintenance in accordance with Article 14a of Directive 2004/49/EC. The contract between the parties should specify the exchange of information between both undertakings needed to guarantee the safe operation of vehicles.

(4)

In assessing conformity with safety requirements of products or services provided by contractors or suppliers of railway undertakings, such as provision of services by training centres recognised in accordance with Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification of train drivers operating locomotives and trains on the railway system in the Communityf2, authorisations or certificates granted in accordance with relevant Union law to contractors or suppliers may be considered valid evidence. Certification of entities in charge of maintenance in accordance with Article 14a of Directive 2004/49/EC may also be regarded valid evidence. Until the European certification system enters into force, certificates delivered on the basis of the Memorandum of Understanding establishing the basic principles of a common system of certification of entities in charge of maintenance for freight wagonsf3 signed on 14 May 2009 may be considered valid evidence when assessing conformity with relevant safety requirements.

(5)

National safety authorities assess a railway undertaking’s ability to comply with all the requirements required to operate in general and on the specific network for which it is seeking a certificate by assessing its safety management system at global level.

(6)

Each national safety authority should put in place arrangements to examine whether the results outlined in the application for a safety certificate are being delivered in operation after the award of the certificate 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.

(7)

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.

f2

OJ L 315, 3.12.2007, p. 51.

f3

http://ec.europa.eu/transport/rail/interoperability/doc/signed_mou_on_ecm.pdf

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 certificates to be issued in accordance with regulations 7, 8 and 9 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or by the Intergovernmental Commission regulations 5, 6 and 7 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. 5Division 5
  18. 6Division 6
  19. 7Division 7
  20. 8Division 8
  21. 9Division 9
  22. 10Division 10
  23. Annex II: Criteria for assessing conformity with the requirements for obtaining Part A safety certificates
  24. RISK CONTROL MEASURES FOR ALL RISKS ASSOCIATED WITH THE ACTIVITY OF THE RAILWAY UNDERTAKING
  25. A.1Division A.1
  26. A.2Division A.2
  27. A.3Division A.3
  28. A.4Division A.4
  29. A.5Division A.5
  30. A.6Division A.6
  31. RISK CONTROL RELATED TO THE SUPPLY OF MAINTENANCE AND MATERIAL
  32. B.1Division B.1
  33. B.2Division B.2
  34. B.3Division B.3
  35. B.4Division B.4
  36. B.5Division B.5
  37. B.6Division B.6
  38. RISK CONTROL RELATED TO THE USE OF CONTRACTORS AND CONTROL OF SUPPLIERS
  39. C.1Division C.1
  40. C.2Division C.2
  41. C.3Division C.3
  42. C.4Division C.4
  43. C.5Division C.5
  44. RISKS ARISING FROM THE ACTIVITIES OF OTHER PARTIES EXTERNAL TO THE RAILWAY SYSTEM
  45. D.1Division D.1
  46. D.2Division D.2
  47. D.3Division D.3
  48. DOCUMENTATION OF THE SAFETY MANAGEMENT SYSTEM
  49. E.1Division E.1
  50. E.2Division E.2
  51. E.3Division E.3
  52. E.4Division E.4
  53. DISTRIBUTION OF RESPONSIBILITIES
  54. F.1Division F.1
  55. F.2Division F.2
  56. F.3Division F.3
  57. F.4Division F.4
  58. SECURING CONTROL BY THE MANAGEMENT ON DIFFERENT LEVELS
  59. G.1Division G.1
  60. G.2Division G.2
  61. G.3Division G.3
  62. G.4Division G.4
  63. G.5Division G.5
  64. INVOLVING STAFF AND THEIR REPRESENTATIVES ON ALL LEVELS
  65. H.1Division H.1
  66. H.2Division H.2
  67. IENSURING CONTINUOUS IMPROVEMENT
  68. JSAFETY POLICY APPROVED BY THE ORGANISATION’S CHIEF EXECUTIVE AND COMMUNICATED TO ALL STAFF
  69. QUALITATIVE AND QUANTATIVE TARGETS OF THE ORGANISATION FOR MAINTAINING AND ENHANCING SAFETY, AND PLANS AND PROCEDURES FOR REACHING THESE TARGETS
  70. K.1Division K.1
  71. K.2Division K.2
  72. K.3Division K.3
  73. K.4There are procedures in place to regularly monitor and review operational arrangements by:
  74. K.5Division K.5
  75. PROCEDURES TO MEET EXISTING, NEW AND ALTERED TECHNICAL AND OPERATIONAL STANDARDS OR OTHER PRESCRIPTIVE CONDITIONS
  76. L.1For safety related requirements relevant to the type and extent of operations, there are procedures for:
  77. L.2Division L.2
  78. L.3Division L.3
  79. 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
  80. M.1Division M.1
  81. M.2Division M.2
  82. M.3Division M.3
  83. PROVISION OF STAFF TRAINING PROGRAMMES AND SYSTEMS TO ENSURE THAT THE STAFF COMPETENCE IS MAINTAINED AND TASKS CARRIED OUT ACCORDINGLY
  84. N.1There is a competence management system that includes at least:
  85. N.2There are procedures within the competence management system providing for:
  86. ARRANGEMENTS FOR THE PROVISION OF SUFFICIENT INFORMATION WITHIN THE ORGANISATION AND, WHERE APPROPRIATE, BETWEEN ORGANISATIONS OPERATING ON THE SAME INFRASTRUCTURE
  87. O.1There are procedures to ensure that:
  88. O.2There are procedures to ensure that:
  89. O.3Division O.3
  90. PROCEDURES AND FORMATS FOR DOCUMENTING SAFETY INFORMATION, AND DESIGNATION OF A PROCEDURE FOR CONFIGURATION CONTROL OF VITAL SAFETY INFORMATION
  91. P.1Division P.1
  92. P.2There are procedures to:
  93. P.3Division P.3
  94. PROCEDURES TO ENSURE THAT ACCIDENTS, INCIDENTS, NEAR MISSES AND OTHER DANGEROUS OCCURRENCES ARE REPORTED, INVESTIGATED AND ANALYSED AND THAT NECESSARY PREVENTIVE MEASURES ARE TAKEN
  95. Q.1There are procedures to ensure that accidents, incidents, near misses and other dangerous occurrences:
  96. Q.2There are procedures to ensure that:
  97. Q.3Division Q.3
  98. PROVISION OF PLANS FOR ACTION AND ALERTS AND INFORMATION IN CASE OF EMERGENCY, AGREED UPON WITH THE APPROPRIATE PUBLIC AUTHORITIES
  99. R.1Division R.1
  100. R.2There are procedures in place to ensure that, for each identified type of emergency:
  101. R.3Division R.3
  102. R.4Plans for action, alerts and information exist and include:
  103. R.5Division R.5
  104. R.6Division R.6
  105. R.7Division R.7
  106. R.8Division R.8
  107. R.9Division R.9
  108. PROVISIONS FOR RECURRENT INTERNAL AUDITING OF THE SAFETY MANAGEMENT SYSTEM
  109. S.1Division S.1
  110. S.2Division S.2
  111. S.3Division S.3
  112. S.4Procedures are in place to:
  113. S.5Division S.5
  114. S.6Division S.6
  115. Annex III: Criteria for assessing conformity with the requirements for obtaining Part B safety certificates
  116. GENERAL
  117. COMPLIANCE WITH NETWORK-SPECIFIC RULES
  118. A.1Division A.1
  119. A.2Division A.2
  120. A.3Division A.3
  121. A.4Division A.4
  122. A.5Division A.5
  123. COMPLIANCE WITH NETWORK-SPECIFIC REQUIREMENTS FOR STAFF COMPETENCE
  124. B.1The documentation demonstrates that the applicant’s safety management system contains a competence management system to:
  125. B.2Division B.2
  126. B.3Division B.3
  127. COMPLIANCE WITH NETWORK-SPECIFIC REQUIREMENTS FOR MANAGEMENT OF ROLLING STOCK
  128. C.1Division C.1
  129. C.2Division C.2
  130. C.3Division C.3
  131. C.4Division C.4
  132. Annex IV: Principles for supervision after the award of a Part A safety certificate or Part B safety certificate certificate
  133. 1Division 1
  134. 2Division 2
  135. 3Division 3
  136. 4Division 4
  137. 5Division 5
  138. 6Division 6
  139. 7Division 7
  140. 8Division 8