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) (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 (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:
Article 1
Subject-matter
This Regulation establishes a common safety method (CSM) for assessing conformity with requirements for obtaining safety authorisation 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 infrastructure managers for safety authorisations as referred to in Article 11(1)(a) and (b) of Directive 2004/49/EC, as set out in Annex I and II to this Regulation;
(b)
principles for supervising compliance with the requirements of Directive 2004/49/EC after the national safety authority has granted the authorisation, as set out in Annex III to this Regulation.
Article 2
Definition
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 authorisation.
Article 3
Procedures for assessing applications
1. When examining applications for safety authorisations 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. The national safety authorities shall also use the assessment criteria set out in Annex II to this Regulation.
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 areas relating to managing maintenance.
3. Products or services provided by contractors or suppliers to infrastructure managers 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 authorisation, national safety authorities shall supervise infrastructure managers’ continued application of their safety management system and shall apply the principles for supervision set out in Annex III.
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, 10 December 2010.