Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment (Text with EEA relevance)
Commission Implementing Regulation (EU) 2015/1136of 13 July 2015amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment(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)OJ L 164, 30.4.2004, p. 44., and in particular Article 6(4) thereof,Whereas:(1)Pursuant to Directive 2004/49/EC, common safety methods should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved.(2)On 12 October 2010 the Commission issued a mandate to the European Railway Agency (the "Agency") in accordance with Directive 2004/49/EC to amend Commission Regulation (EC) No 352/2009Commission 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 (OJ L 108, 29.4.2009, p. 4).. A revision of this Regulation was necessary to take into account further changes to the roles and responsibilities of the assessment body referred to in Article 6 of that Regulation and additional harmonised risk acceptance criteria that could be used to assess the acceptability of risks arising from failures of technical systems in cases where the proposer chooses to use the explicit risk estimation principle. It was necessary to check that, in including the additional harmonised risk acceptance criteria referred to above, the current level of railway safety would be at least maintained in the Union, as required by Article 4(1) of Directive 2004/49/EC. This required significantly more time than expected, and the Commission therefore adopted the Implementing Regulation (EU) No 402/2013Commission 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 (OJ L 121, 3.5.2013, p. 8). which maintained the one criterion already contained in Regulation (EC) No 352/2009 for risk acceptance.(3)The impact assessment carried out in respect of the changes introduced by Implementing Regulation (EU) No 402/2013 included the analysis of harmonised risk acceptance criteria for technical systems. The report highlighted the importance of including in the common safety method additional risk acceptance criteria not provided for under the current Regulation. Such criteria should facilitate mutual recognition between Member States of structural sub-systems and vehicles compliant with Union legislation in the field of railway interoperability.(4)In order to distinguish the acceptance of risks associated with technical systems from the acceptance of operational risks and of the overall risk at the level of the railway system, the term "risk acceptance criteria" with respect to technical systems should be changed into "harmonised design targets" for such technical systems. The harmonised design targets proposed in this Regulation may be used to demonstrate the acceptability of risks arising from failures of functions of a technical system, in cases where the proposer chooses to use the explicit risk estimation principle. Some definitions should be amended to reflect recent changes in terminology, and new definitions should be added.(5)The Agency submitted to the Commission its recommendation on the amendment to Implementing Regulation (EU) No 402/2013 designed to address the remaining objective of the mandate of the Commission with respect to the harmonised design targets. This Regulation is based on the Agency's recommendation.(6)Implementing Regulation (EU) No 402/2013 should therefore be amended accordingly.(7)The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 27(1) of Directive 2004/49/EC,HAS ADOPTED THIS REGULATION: