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Commission Delegated Regulation (EU) 2018/762 of 8 March 2018 establishing common safety methods on safety management system requirements pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulations (EU) No 1158/2010 and (EU) No 1169/2010 (Text with EEA relevance)

EU Regulation 2018/762 · Adopted 8 March 2018 · Extends to United Kingdom

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Commission Delegated Regulation (EU) 2018/762

of 8 March 2018

establishing common safety methods on safety management system requirements pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulations (EU) No 1158/2010 and (EU) No 1169/2010

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safetyf1, and in particular Article 6(6) thereof,

Having regard to Recommendation ERA-REC-115-REC from the European Union Agency for Railways delivered to the Commission on 9 March 2017, on the revision of the common safety methods for conformity assessment and the common safety methods for supervision,

Whereas:

(1)

The common safety methods (CSMs) describe how the safety levels and the achievement of safety targets and compliance with other safety requirements are assessed.

(2)

In accordance with Article 6(5) of Directive (EU) 2016/798, the CSMs are to be revised at regular intervals, taking into account the experience gained from their application and the global development of railway safety and with the objective of generally maintaining and, where reasonably practicable, continuously improving safety.

(3)

By its Implementing Decision of 1 September 2016f2, the Commission issued a mandate to the European Union Agency for Railways (the ‘Agency’) in accordance with Article 6(2) of Directive (EU) 2016/798 to revise Commission Regulations (EU) No 1158/2010f3, (EU) No 1169/2010f4 and (EU) No 1077/2012f5. On 9 March 2017, the Agency issued its recommendation, enclosing a report on the results of the consultation of national safety authorities, social partners and users and a report assessing the impact of the amended CSMs to be adopted, to address the mandate of the Commission. The Commission examined the recommendation issued by the Agency to verify that the mandate was fulfilled as referred to in Article 6(4) of Directive (EU) 2016/798.

(4)

The purpose of the safety management system is to ensure that the railway undertakings and infrastructure managers achieve their business objectives in a safe manner. The safety management system is often integrated with other management systems to increase the overall performance of the organisation and reduce costs while mutualising the efforts at all levels of the organisation. To this end, the common framework of the ISO High Level Structuref6 is used to functionally cluster the requirements of the safety management system, as referred to in Article 9 of Directive (EU) 2016/798. This framework also facilitates the understanding and application of a process approach by the railway undertakings and infrastructure managers when developing, implementing, maintaining and continually improving their safety management system.

(5)

Once issued with a single safety certificate or with a safety authorisation, the applicant should continue to use its safety management system as referred to in Article 9 of Directive (EU) 2016/798.

(6)

The human behaviour plays a central role in the safe and efficient operation of the railway. Where that behaviour is considered to have contributed to an accident or incident, it may be that organisational factors, such as workload or job design, had an influence on that behaviour, and thus led to a lesser performance and aggravation of the consequences of that accident or incident. Therefore, it is essential that the railway undertakings and infrastructure managers take a systematic approach to supporting human performance and managing human and organisational factors within the safety management system.

(7)

The way safety is perceived, valued and prioritised in an organisation reflects the real commitment to safety at all levels in the organisation. Therefore, it is also important for railway undertakings and infrastructure managers to identify the actions and behaviours that can shape a positive safety culture and to promote through their safety management system this culture of mutual trust, confidence and learning in which staff are encouraged to contribute to the development of safety by reporting dangerous occurrences and providing safety-related information.

(8)

The safety management system should take into account the fact that Council Directive 89/391/EECf7 and its relevant individual directives are fully applicable to the protection of the health and safety of workers engaged in railway construction, operation and maintenance. It does not create any additional responsibilities or tasks for the issuing authority other than to check if health and safety risks have been taken into account by the applicant for a single safety certificate or for a safety authorisation. Responsibility for checking the compliance with Directive 89/391/EEC may still be allocated on other competent authorities appointed by the Member States.

(9)

The safety management system should where relevant take into consideration the potential additional risks generated by transporting dangerous goods by rail and thereby, should also take account of Directive 2008/68/EC of the European Parliament and of the Councilf8.

(10)

Regulations (EU) No 1158/2010 and (EU) No 1169/2010 will become obsolete and should therefore be replaced by this Regulation.

(11)

As regards safety certificates, it follows from Article 10(15) of Directive (EU) 2016/798 that the national safety authority may require that the safety certificates be revised following substantial changes to the safety regulatory framework. The changes brought about by Article 9 of Directive (EU) 2016/798 and by this Regulation, even though relevant and important, are not substantial. Therefore, Regulation (EU) No 1158/2010 should apply to safety certificates issued in accordance with Directive 2004/49/EC of the European Parliament and of the Councilf9, until their expiry date. For the same reason, it is also necessary to postpone the repeal of Regulation (EU) No 1158/2010 until the end of the last day of the period during which it may still be applied by national safety authorities for the purposes of supervision. Moreover, in accordance with Directive (EU) 2016/798, existing safety certificates continue to be subject to Directive 2004/49/EC, on which Regulation (EU) No 1158/2010 was based.

(12)

As regards safety authorisations, it follows from Article 12(2), second subparagraph of Directive (EU) 2016/798 that the national safety authority may require that the safety authorisations be revised following substantial changes to the safety regulatory framework. The changes brought about by Article 9 of Directive 2016/798/EC and by this Regulation, even though relevant and important, are not substantial. Therefore, Regulation (EU) No 1169/2010 should apply to safety authorisations issued in accordance with Directive 2004/49/EC, until their expiry date. For the same reason, it is also necessary to postpone the repeal of Regulation (EU) No 1169/2010 until the end of the last day of the period during which it may still be applied by national safety authorities for the purposes of supervision,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 138, 26.5.2016, p. 102.

f2

Commission Implementing Decision of 1 September 2016 on a mandate to the European Union Agency for Railways for the revision of the common safety methods for conformity assessment and the common safety method for supervision and repealing Implementing Decision C(2014) 1649 final (C(2016) 5504 final).

f3

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 (OJ L 326, 10.12.2010, p. 11).

f4

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 (OJ L 327, 11.12.2010, p. 13).

f5

Commission Regulation (EU) No 1077/2012 of 16 November 2012 on a common safety method for supervision by national safety authorities after issuing a safety certificate or safety authorisation (OJ L 320, 17.11.2012, p. 3).

f6

ISO/IEC Directives, Part 1, consolidated supplement 2016, Annex SL Appendix 2.

f7

Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

f8

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

f9

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) (OJ L 164, 30.4.2004, p. 44).

Contents

  1. 1Subject matter and scope
  2. 2Definition
  3. 3Safety management system requirements related to railway undertakings
  4. 4Safety management system requirements related to infrastructure managers
  5. 5Repeal
  6. 6Entry into force and application
  7. Signature
  8. Annex I: Safety management system requirements related to railway undertakings
  9. CONTEXT OF THE ORGANISATION
  10. 1.1Division 1.1
  11. LEADERSHIP
  12. Leadership and commitment
  13. 2.1.1Division 2.1.1
  14. Safety policy
  15. 2.2.1Division 2.2.1
  16. 2.2.2Division 2.2.2
  17. Organisational roles, responsibilities, accountabilities and authorities
  18. 2.3.1Division 2.3.1
  19. 2.3.2Division 2.3.2
  20. 2.3.3Division 2.3.3
  21. 2.3.4Division 2.3.4
  22. Consultation of staff and other parties
  23. 2.4.1Division 2.4.1
  24. 2.4.2Division 2.4.2
  25. PLANNING
  26. Actions to address risks
  27. Risk assessment
  28. 3.1.1.1Division 3.1.1.1
  29. 3.1.1.2Division 3.1.1.2
  30. Planning for change
  31. 3.1.2.1Division 3.1.2.1
  32. Safety objectives and planning
  33. 3.2.1Division 3.2.1
  34. 3.2.2Division 3.2.2
  35. 3.2.3Division 3.2.3
  36. 3.2.4Division 3.2.4
  37. SUPPORT
  38. Resources
  39. 4.1.1Division 4.1.1
  40. Competence
  41. 4.2.1Division 4.2.1
  42. 4.2.2Division 4.2.2
  43. 4.2.3Division 4.2.3
  44. Awareness
  45. 4.3.1Division 4.3.1
  46. Information and communication
  47. 4.4.1Division 4.4.1
  48. 4.4.2Division 4.4.2
  49. 4.4.3Division 4.4.3
  50. Documented information
  51. Safety management system documentation
  52. 4.5.1.1Division 4.5.1.1
  53. 4.5.1.2Division 4.5.1.2
  54. Creating and updating
  55. 4.5.2.1Division 4.5.2.1
  56. Control of documented information
  57. 4.5.3.1Division 4.5.3.1
  58. Integration of human and organisational factors
  59. 4.6.1Division 4.6.1
  60. OPERATION
  61. Operational planning and control
  62. 5.1.1Division 5.1.1
  63. 5.1.2Division 5.1.2
  64. 5.1.3Division 5.1.3
  65. 5.1.4Division 5.1.4
  66. 5.1.5Division 5.1.5
  67. 5.1.6Division 5.1.6
  68. Asset management
  69. 5.2.1Division 5.2.1
  70. 5.2.2Division 5.2.2
  71. 5.2.3Division 5.2.3
  72. 5.2.4Division 5.2.4
  73. 5.2.5Division 5.2.5
  74. Contractors, partners and suppliers
  75. 5.3.1Division 5.3.1
  76. 5.3.2Division 5.3.2
  77. 5.3.3Division 5.3.3
  78. Management of change
  79. 5.4.1Division 5.4.1
  80. Emergency management
  81. 5.5.1Division 5.5.1
  82. 5.5.2Division 5.5.2
  83. 5.5.3Division 5.5.3
  84. 5.5.4Division 5.5.4
  85. 5.5.5Division 5.5.5
  86. 5.5.6Division 5.5.6
  87. 5.5.7Division 5.5.7
  88. 5.5.8Division 5.5.8
  89. PERFORMANCE EVALUATION
  90. Monitoring
  91. 6.1.1Division 6.1.1
  92. 6.1.2Division 6.1.2
  93. Internal auditing
  94. 6.2.1Division 6.2.1
  95. Management review
  96. 6.3.1Division 6.3.1
  97. 6.3.2Division 6.3.2
  98. IMPROVEMENT
  99. Learning from accidents and incidents
  100. 7.1.1Division 7.1.1
  101. 7.1.2Division 7.1.2
  102. 7.1.3Division 7.1.3
  103. Continual improvement
  104. 7.2.1Division 7.2.1
  105. 7.2.2Division 7.2.2
  106. 7.2.3Division 7.2.3
  107. Annex II: Safety management system requirements related to infrastructure managers
  108. CONTEXT OF THE ORGANISATION
  109. 1.1Division 1.1
  110. 1.2Division 1.2
  111. LEADERSHIP
  112. Leadership and commitment
  113. 2.1.1Division 2.1.1
  114. Safety policy
  115. 2.2.1Division 2.2.1
  116. 2.2.2Division 2.2.2
  117. Organisational roles, responsibilities, accountabilities and authorities
  118. 2.3.1Division 2.3.1
  119. 2.3.2Division 2.3.2
  120. 2.3.3Division 2.3.3
  121. 2.3.4Division 2.3.4
  122. Consultation of staff and other parties
  123. 2.4.1Division 2.4.1
  124. 2.4.2Division 2.4.2
  125. PLANNING
  126. Actions to address risks
  127. Risk assessment
  128. 3.1.1.1Division 3.1.1.1
  129. 3.1.1.2Division 3.1.1.2
  130. Planning for change
  131. 3.1.2.1Division 3.1.2.1
  132. Safety objectives and planning
  133. 3.2.1Division 3.2.1
  134. 3.2.2Division 3.2.2
  135. 3.2.3Division 3.2.3
  136. 3.2.4Division 3.2.4
  137. SUPPORT
  138. Resources
  139. 4.1.1Division 4.1.1
  140. Competence
  141. 4.2.1Division 4.2.1
  142. 4.2.2Division 4.2.2
  143. 4.2.3Division 4.2.3
  144. Awareness
  145. 4.3.1Division 4.3.1
  146. Information and communication
  147. 4.4.1Division 4.4.1
  148. 4.4.2Division 4.4.2
  149. 4.4.3Division 4.4.3
  150. Documented information
  151. Safety management system documentation
  152. 4.5.1.1Division 4.5.1.1
  153. 4.5.1.2Division 4.5.1.2
  154. Creating and updating
  155. 4.5.2.1Division 4.5.2.1
  156. Control of documented information
  157. 4.5.3.1Division 4.5.3.1
  158. Integration of human and organisational factors
  159. 4.6.1Division 4.6.1
  160. OPERATION
  161. Operational planning and control
  162. 5.1.1Division 5.1.1
  163. 5.1.2Division 5.1.2
  164. 5.1.3Division 5.1.3
  165. 5.1.4Division 5.1.4
  166. 5.1.5Division 5.1.5
  167. 5.1.6Division 5.1.6
  168. Asset management
  169. 5.2.1Division 5.2.1
  170. 5.2.2Division 5.2.2
  171. 5.2.3Division 5.2.3
  172. 5.2.4Division 5.2.4
  173. 5.2.5Division 5.2.5
  174. Contractors, partners and suppliers
  175. 5.3.1Division 5.3.1
  176. 5.3.2Division 5.3.2
  177. 5.3.3Division 5.3.3
  178. Management of change
  179. 5.4.1Division 5.4.1
  180. Emergency management
  181. 5.5.1Division 5.5.1
  182. 5.5.2Division 5.5.2
  183. 5.5.3Division 5.5.3
  184. 5.5.4Division 5.5.4
  185. 5.5.5Division 5.5.5
  186. 5.5.6Division 5.5.6
  187. 5.5.7Division 5.5.7
  188. 5.5.8Division 5.5.8
  189. 5.5.9Division 5.5.9
  190. PERFORMANCE EVALUATION
  191. Monitoring
  192. 6.1.1Division 6.1.1
  193. 6.1.2Division 6.1.2
  194. Internal auditing
  195. 6.2.1Division 6.2.1
  196. Management review
  197. 6.3.1Division 6.3.1
  198. 6.3.2Division 6.3.2
  199. IMPROVEMENT
  200. Learning from accidents and incidents
  201. 7.1.1Division 7.1.1
  202. 7.1.2Division 7.1.2
  203. 7.1.3Division 7.1.3
  204. Continual improvement
  205. 7.2.1Division 7.2.1
  206. 7.2.2Division 7.2.2
  207. 7.2.3Division 7.2.3