L_2009108EN.01000401.xml
| 29.4.2009 | EN | Official Journal of the European Union | L 108/4 |
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
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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,
Whereas:
| (1) | Pursuant to Article 6(1) of Directive 2004/49/EC, the Commission should adopt the first set of common safety methods (hereinafter CSMs) covering at least the risk evaluation and assessment methods mentioned in Article 6(3)(a) of that Directive, on the basis of a recommendation of the European Railway Agency. |
| (2) | The European Railway Agency made a recommendation on the first set of common safety methods (ERA-REC-02-2007-SAF) on 6 December 2007. |
| (3) | In accordance with Directive 2004/49/EC, CSMs should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved. |
| (4) | Article 9(1) of Directive 2004/49/EC requires railway undertakings and infrastructure managers to establish their safety management systems in order to ensure that the railway system can achieve at least the common safety targets (CSTs). According to point (2)(d) of Annex III to Directive 2004/49/EC, the safety management system must include procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change of the 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. |
| (5) | As a consequence of the application of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (2) 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. |
| (6) | 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 Community (3) requires Member States to take all appropriate steps to ensure that the structural subsystems constituting 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 this Regulation. |
| (7) | The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system proved to be one of the obstacles to liberalisation of the railway market. Therefore, in the past, the Member States performed their own assessments in order to accept a system, or parts of it, which had already been developed and proven safe in other Member States. |
| (8) | To facilitate mutual recognition between Member States, the methods used for identifying and managing risks should be harmonised among the actors involved in the development and operation of the railway system as well as the methods for demonstrating that the railway system in the territory of the Community conform to safety requirements. As a first step, it is necessary to harmonise the procedures and methods for carrying out risk evaluation and implementing control measures whenever a change of the operating conditions or new material imposes new risks on the infrastructure or on operations, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC. |
| (9) | If there is no notified national rule for defining whether or not a change is significant in a Member State, the person in charge of implementing the change (hereinafter referred to as the proposer) should initially consider the potential impact of the change in question on the safety of the railway system. If the proposed change has an impact on safety, the proposer should assess, by expert judgement, the significance of the change based on a set of criteria that should be set out in this Regulation. This assessment should lead to one of three conclusions. In the first situation the change is not considered to be significant and the proposer should implement the change by applying its own safety method. In the second situation the change is considered to be significant and the proposer should implement the change by applying this Regulation, without the need for a specific intervention of the safety authority. In the third situation the change is considered to be significant but there are Community provisions which require a specific intervention of the relevant safety authority, such as a new authorisation for placing in service of a vehicle or a revision/update of the safety certificate of a railway undertaking or a revision/update of the safety authorisation of an infrastructure manager. |
| (10) | Whenever the railway system already in use is subject to a change, the significance of the change should also be assessed taking into account all safety-related changes affecting the same part of the system since the entry into force of this Regulation or since the last application of the risk management process described in this Regulation, whichever is the latest. The purpose is to assess whether or not the totality of such changes amounts to a significant change requiring the full application of the CSM on risk evaluation and assessment. |
| (11) | The risk acceptability of a significant change should be evaluated by using one or more of the following risk acceptance principles: the application of codes of practice, a comparison with similar parts of the railway system, an explicit risk estimation. All principles have been used successfully in a number of railway applications, as well as in other transport modes and other industries. The ‘explicit risk estimation’ principle is frequently used for complex or innovative changes. The proposer should be responsible for the choice of the principle to apply. |
| (12) | In accordance with the principle of proportionality as set out in Article 5 of the Treaty, this Regulation should not go beyond what is necessary to achieve its objective which is to establish a CSM on risk evaluation and assessment. When a widely recognised code of practice is applied, it should therefore be possible to reduce the impact of applying the CSM. In the same way, where there are Community provisions which require the specific intervention of the safety authority, the latter should be allowed to act as the independent assessment body in order to reduce double checking, undue costs to the industry and time to market. |
| (13) | Article 6(5) of Directive 2004/49/EC requires the Member States to make any necessary amendments to their national safety rules to comply with the CSMs. |
| (14) | In view of the different approaches currently in use for assessing safety, a transitional period is necessary, in order to give sufficient time to the actors concerned, where needed, to learn and apply the new common approach as well as to gain experience from it. |
| (15) | As a formalised risk-based approach is relatively new in some Member States, the CSM on risk evaluation and assessment should remain voluntary with respect to operational or organisational changes until 1 July 2012. This should allow the European Railway Agency to assist such applications, where possible, and to propose improvements, if appropriate, to that CSM before 1 July 2012. |
| (16) | 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:
Article 1
Purpose
1. This Regulation establishes a common safety method on risk evaluation and assessment (CSM) as referred to in Article 6(3)(a) of Directive 2004/49/EC.
2. The purpose of the CSM on risk evaluation and assessment is to maintain or to improve the level of safety on the Community’s railways, when and where necessary and reasonably practicable. The CSM shall facilitate the access to the market for rail transport services through harmonisation of:
| (a) | the risk management processes used to assess the safety levels and the compliance with safety requirements; |
| (b) | the exchange of safety-relevant information between different actors within the rail sector in order to manage safety across the different interfaces which may exist within this sector; |
| (c) | the evidence resulting from the application of a risk management process. |
Article 2
Scope
1. The CSM on risk evaluation and assessment shall apply to any change of the railway system in a Member State, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC, which is considered to be significant within the meaning of Article 4 of this Regulation. Those changes may be of a technical, operational or organisational nature. As regards...
