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) (1), 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 Community (2), 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 wagons (3) 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:
Article 1
Subject-matter
This Regulation establishes a common safety method (CSM) for assessing conformity with requirements for obtaining safety certificates as referred to in Article 6(3)(b) of Directive 2004/49/EC.
The CSM includes:
(a)
a procedure and criteria for assessing applications by railway undertakings for safety certificates as referred to in Article 10(2) of Directive 2004/49/EC, as set out in Annexes I, II and III to this Regulation;
(b)
principles for supervising compliance with the requirements of Directive 2004/49/EC after the national safety authority has granted the certificate, as set out in Annex IV to this Regulation.
Article 2
Definitions
For the purposes of this Regulation, the following definition shall apply: ‘supervision’ means the arrangements put in place by the national safety authority to oversee safety performance after it has granted a safety certificate.
Article 3
Procedures for assessing applications
1. When examining applications for both Part A and Part B safety certificates submitted after the entry into force of this Regulation, national safety authorities shall apply the procedure set out in Annex I to this Regulation for assessing their conformity with requirements in Directive 2004/49/EC. National safety authorities shall use the assessment criteria set out in Annex II to this Regulation for safety certificates issued in accordance with Article 10(3) of Directive 2004/49/EC and those contained in Annex III to this Regulation for safety certificates issued in accordance with Article 10(4) of Directive 2004/49/EC. These criteria shall also be used in case of renewal of safety certificates in accordance with Article 10(5) of Directive 2004/49/EC.
2. During assessment, national safety authorities may accept commitments by applicants that they will manage risks through the use of contracts with third parties. The contracts shall also specify the exchange of information needed to ensure the safe operation of vehicles, especially in the areas relating to managing maintenance.
3. Products or services provided by contractors or suppliers to railway undertakings shall be presumed to conform to safety requirements if the contractors, suppliers or products are certified in accordance with relevant certification schemes established under Union legislation, for the provision of such products and services.
Article 4
Supervision
After granting a safety certificate, national safety authorities shall, for both Part A and Part B safety certificates, supervise railway undertakings’ continued application of their safety management system and shall apply the principles for supervision set out in Annex IV.
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 December 2010.