L 121/8 Official Journal of the European Union 3.5.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (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 infra- structure and safety certification (Railway Safety Directive) (1), and in particular Article 6(4) thereof, Whereas: (1) (") ¢ O] 0] In accordance with Directive 2004/49/EC, common safety methods (CSMs) should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved. On 12 October 2010 the Commission issued a mandate to the European Railway Agency (the ‘Agency) in accordance with Directive 2004/49/EC to revise Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (3. The revision should cover the results of the analysis by the Agency under Article 9(4) of the Regulation of the overall effectiveness of the CSM for risk evaluation and assessment and experience with its application as well as further devel- opments in the roles and the responsibilities of the assessment body referred to in Article 6 of that Regu- lation. The revision should also include the qualification requirements (by developing a recognition/accreditation scheme) for the assessment body according to its role in the CSM, with a view to improving clarity in order to avoid differences in application across the Member States, taking into account the interfaces with existing Union authorisation/certification ~procedures in the railway sector. If feasible, the revision of Regulation (EC) No 352/2009 should also cover further devel- opments in risk acceptance criteria that could be used to assess the acceptability of a risk during explicit risk estimation and evaluation. The Agency submitted its recommendation on the revision of the CSM to the L 164, 30.4.2004, p. 44. L 108, 29.4.2009, p. 4. O] 0] Commission, supported by an impact assessment report to address the mandate of the Commission. This Regu- lation is based on that Agency recommendation. In accordance with Directive 2004/49/EC the basic elements for the safety management system should include procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change in operating conditions or new material imposes new risks on the infrastructure or on operations. That basic element of the safety management system is covered by this Regulation. Article 14a(3) of Directive 2004/49/EC requires entities in charge of maintenance to establish a system of main- tenance in order to ensure that the vehicles for which they are in charge of maintenance are in a safe state of running. To manage changes in equipment, procedures, organisation, staffing or interfaces, the entities in charge of maintenance should have in place risk assessment procedures. That requirement for the system of main- tenance is also covered by this Regulation. As a consequence of the application of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (}) and of Article 9(2) of Directive 2004/49/EC, particular attention should be paid to risk management at the interfaces between the actors which are involved in the application of this Regulation. Article 15 of Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Commu- nity () requires Member States to take all appropriate steps to ensure that the structural subsystems consti- tuting the rail system may be placed in service only if they are designed, constructed and installed in such a way as to meet the essential requirements concerning them when integrated into the rail system. In particular, the Member States must check the technical compatibility of these subsystems with the railway system into which they are being integrated and the safe integration of these subsystems in accordance with the scope of this Regu- lation. The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system among the Member L 237, 24.8.1991, p. 25. L 191, 18.7.2008, p. 1.