A new safety regulatory framework for the European Union is taking shape

1. A new safety regulatory framework for the European Union is taking shape Anders Lundström Head of Unit, the European Railway Agency Anders.lundstrom@era.europa.eu International Railway Safety Conference 2008, Denver

2. Content of the presentation • EU railway policy and legislation • The safety directive • The European Railway Agency • Common Safety Methods (CSM) • Safety certification and safety management systems • Moving forward International Railway Safety Conference 2008, Denver

3. EU railway legislation • Creation of a single market for rail transport services • First directive published in 1991 • Completed for freight transport in 2007 • Continues with passenger transport from 2010 • Technical standardisation and harmonisation • Interoperability of trans-European networks • Gradually developed since 1996 • Applicable to new and upgraded subsystems • Long-term implementation International Railway Safety Conference 2008, Denver

4. The safety directive • Complements market opening and technical legislation • Deals with the existing railway system: • Harmonises the regulatory structure in member states • Defines responsibilities between actors • Sets a framework for developing common safety targets and common safety methods • Requires the establishment of a safety authority and an investigation body in each member state • Defines principles for management, regulation and supervision of safety International Railway Safety Conference 2008, Denver

5. A framework for further development • Some of the provisions of the directive are to be developed in detailed decisions: • Common safety targets and methods • Assessment of safety management systems • Safety certification provisions • Annexes of the directive to be updated with technical progress • In particular common safety indicators (Annex I) The European Railway Agency has been mandated to carry out the technical work International Railway Safety Conference 2008, Denver

6. The European Railway Agency • A regulatory agency to develop proposals for secondary technical legislation • Final adoption is the task of the European Commission • The main activity areas are safety and interoperability • Brings together all the relevant actors of the European railway sector • Representatives of European associations are nominated for each working party of the Agency • Consultation of social partners and customers International Railway Safety Conference 2008, Denver

7. Decision Commission Agency Working party … NSA Network … Social Partners Internal reconcilement … Passengers / customers The process to decisions No decision power for the Agency, the Agency gives recommendations to the Commissionand technical opinions upon specific request! Comitology (Article 21 Committee) NSA = National Safety Authority International Railway Safety Conference 2008, Denver

8. Safety as a barrier for market opening • Historically rail safety in Europe has been driven by national developments • Requirements and rules have often been derived from lessons learnt from accidents • Resulted in fragmentation of the market for rail products and services NOW: • Gradual technical harmonisation through the interoperability directives • The safety directive sets out to harmonise processes and procedures (methods) International Railway Safety Conference 2008, Denver

9. Common Safety Methods • Recommendation developed by the Agency based on existing methods: • Application of codes of practice • Comparison with reference system • Explicit risk estimation • To be applied only to significant changes • Technical, operational and organisational • The objective is to achieve a higher degree of mutual recognition and thus facilitate market opening and cross-border traffic International Railway Safety Conference 2008, Denver

10. Risk management process • Risk Management is an iterative process that comprises: • The decision on the significance of the change • Risk Assessment Process that shall identify: • the hazards; • the associated safety measures; • the resulting safety requirements; • Demonstration of compliance with the safety requirements; • Management of all identified hazards and associated safety measures; • Risk management shall be assessed independently by an assessment body Harmonised process facilitating the mutual recognition 7-10-2008 N° 10

11. Decision on the significance of the change • CSM shall be applied only to assess predicatively the safety of significant changes. • When notified national rules do not define what is significant change, the significance of the change shall be evaluated based on expert's judgement and defined criteria. • Decision shall be documented to allow NSA monitoring Focus effort s and costs on significant changes 7-10-2008 N° 11

12. The way forward • The recommendation of the Agency has been transformed into a draft Commission Regulation • Submitted to the Committee of member states for opinion (November 2008?) • Applicable to vehicles from July 2010 and for all changes from 2012 • Still widely debated in certain member states not fully acquainted with a risk based approach • The opposition indicates that adoption will lead to real harmonisation • The Agency is preparing dissemination and promotion activities from next year International Railway Safety Conference 2008, Denver

13. Safety certification • All railway undertakings required to hold a safety certificate, granted in two parts: • Part A for the safety management system, mutually recognised across Europe • Part B related to requirements for the specific network • The Agency works on several aspects to facilitate safety certification and to harmonise requirements and assessment criteria: • Common safety method for conformity assessment • Harmonised Part B requirements • Common formats for application guidance documents International Railway Safety Conference 2008, Denver

14. Safety management systems • European Legislation (Railway Safety Directive 2004/49/EC): • Responsibility for the safe operation of the railway system and the control of risks associated with it is laid upon the infrastructure managers and railway undertakings – through risk control measures, application of national safety rules and standards, establishment of a safety management system (SMS). • General aim of the SMS: • Railway undertakings and Infrastructure Managers shall be in the position to fulfil their roles and responsibilities as given in the Railway Safety Directive by establishing an SMS – built according to harmonised principles. • Introducing the SMS helps to maintain the high level of safety within the railway sector by ensuring safe interfaces between the players in a newly organised open market. N° 14 7-10-2008 International Railway Safety Conference 2008, Denver

15. Content and structure • European Legislation (Railway Safety Directive 2004/49/EC): • Infrastructure managers and railway undertakings shall establish a safety management system. • It shall ensure the control of all risks associated with the respective activity (including supply of maintenance and material, use of contractors). • Where appropriate and reasonable, the risks arising as a result of activities by other parties shall be taken into account. • Structure of the SMS: • The safety management system for the railway sector follows the risk-based process-oriented approach of well-established management systems in general. • Preparation is under way to develop a European standard to facilitate the implementation of the SMs and to allow for 3rd party assessment. N° 15 7-10-2008 International Railway Safety Conference 2008, Denver

16. Assessment of the SMS • European Legislation (Railway Safety Directive 2004/49/EC): • National Safety Authorities need to confirm their acceptance with the provisions of the railway undertakings and infrastructure managers. • From 2010 on, the NSA certification will be carried out according to a harmonised Common Safety Method (CSM for Conformity Assessment). • The National Safety Authority’s Certificate is split into two parts: • Part A – Confirmation of acceptance with the general SMS • Part B – Confirmation of acceptance with the network-related adaptation • Not to be forgotten: • Part A of the safety certificate is – once obtained in one Member State – valid all over the European Union without re-assessment, which is to facilitate market entrance! N° 16 7-10-2008 International Railway Safety Conference 2008, Denver

17. Working with the safety authorities • Safety certificates are granted by national safety authorities • Part A for safety management systems are valid across Europe • Thus, it is important to create confidence among authorities that processes and applied criteria are comparable and to avoid re-assessments • Therefore the authorities have agreed to carry out peer reviews to learn from best practices • The Agency is participating as observer and is overlooking the process International Railway Safety Conference 2008, Denver

18. Moving towards a common approach • The Agency has given new impetus to the development of European-wide standards • More important, the Agency represents a centre of competence bringing together the sector for: • Exchange of experience and demonstration of good examples • Leading discussions based on facts • Understanding of differences in safety culture • Collecting and publishing information • More on the website: www.era.europa.eu International Railway Safety Conference 2008, Denver