Commission Regulation (EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance  Text with EEA relevance

17.11.2012 EN Official Journal of the European Union L 320/8
COMMISSION REGULATION (EU) No 1078/2012
of 16 November 2012
on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance
(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 thereof,
Whereas:
(1) The Commission should adopt the second series of common safety methods (CSM) covering at least the methods provided for in Article 6(3)(c) of Directive 2004/49/EC, on the basis of a recommendation of the European Railway Agency (the ‘Agency’).
(2) On 5 October 2009 the Commission issued a mandate to the Agency in accordance with Directive 2004/49/EC to draw up a draft CSM for checking conformity of operation and maintenance of structural subsystems with relevant essential requirements. This CSM should specify the methods to be used both to check that the structural sub-systems (including traffic operation and management) are operated and maintained in accordance with all essential requirements related to safety and to monitor that the sub-systems and their integration in the systems continue to fulfil their safety requirements when operated and maintained. The Agency submitted its recommendation on the CSM to the Commission, supported by an impact assessment report to address the mandate of the Commission. This Regulation is based on the recommendation by the Agency.
(3) To enable the safe integration, operation and maintenance of structural sub-systems within the railway system, and to ensure that essential requirements are met in operation, safety management systems of railway undertakings and infrastructure managers, and systems of maintenance of entities in charge of maintenance should include all necessary arrangements, including processes, procedures, technical, operational and organisational risk control measures. Consequently, monitoring the correct application and effectiveness of safety management systems of railway undertakings and infrastructure managers, as well as of systems of maintenance of entities in charge of maintenance, should cover the requirements for structural sub-systems within their operational context.
(4) This Regulation should enable the effective management of safety of the railway system during its operation and maintenance activities and, where necessary and reasonably practicable, should improve the management system.
(5) This Regulation should also enable to identify as early as possible non-compliance in applying a management system in ways that may result in accidents, incidents, near-misses or other dangerous occurrences. To manage these forms of non-compliance during operation and maintenance activities a harmonised process for monitoring activities should be used. In particular that harmonised process should be used to check the achievement of the expected outcome of the safety management systems of railway undertakings and infrastructure managers, and check the achievement of the expected outcome of the system of maintenance of the entities in charge of maintenance.
(6) The railway undertakings and infrastructure managers should monitor the correct application and the outcomes of the arrangements they have developed through their safety management system so as to operate safely, including on specific networks.
(7) This Regulation should facilitate access to the market for rail transport services through harmonisation of the monitoring process to ensure the continuous achievement of the safety performance of the railway system. In addition, this Regulation should help to create mutual trust and transparency between Member States, through a harmonised exchange of safety-related information between different actors involved within the railway sector in order to manage safety across the different interfaces of this sector and harmonised evidence from the application of the monitoring process.
(8) To report to the Commission on the effectiveness and application of this Regulation, and where applicable to make recommendations to improve it, the Agency should be able to gather relevant information from the various involved actors, including from the national safety authorities, from the certification bodies of entities in charge of maintenance of freight wagons and from other entities in charge of maintenance that do not fall under the scope of Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons (2).
(9) 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,