Railway Safety Directive 2004/49/EC

Railway Safety Directive 2004/49/EC Dragan JOVICIC Safety Assessment Sector Slide n 1

Content 1. Existing railway context & 1 st steps for establishing a EU railway area 2. Objectives of the European Union 3. Purpose and scope of the safety directive (SD) 4. Scope of safety directive 5. Most important definitions 6. Development and management of safety 7. IM/RU safety management system (SMS) 8. Safety certification of RU and safety authorisation of IM 9. Further development 10. Common safety methods (CSM) 11. Common safety targets (CST) 12. Common safety indicators (CSI) 13. National safety rules (NSR) 14. Other requirements in safety directive Slide n 2

1 Existing Railway Context & 1 st steps for establishing a EU railway area without frontiers MS developed until beginning 2000 their safety rules and standards based on national technical and operational concepts Differences in principles, approach and culture created technical barriers to establish international transport operations Very close links between national industries and railways over years to detriment of opening of railway transport market 1 st EU provisions (91/440/EEC 2001/12/EC, 95/18/EC 2001/13/EC and 2001/14/EC) laid foundation stone towards regulation of EU railway transport market by opening market for international rail freight Although laying down basis, provisions on interoperability of whole network and on safety insufficient (differences in safety requirements): Interoperability Directives (96/48/EC and 2001/16/EC) 2008/57/EC sets conditions to achieve interoperability in EU rail system vs. provisions SD Safety Directive 2004/49/EC 2008/110/EC complements technical legislation (ID) and establishes common regulatory framework for railway safety Slide n 3

2 The objectives of the European Union are... to open the market for rail transport services and railway supply! to make railways business oriented and competitive! to prevent the sector from using safety as a barrier to market access or an excuse to resist change! Some cornerstones in new EU law in relation to safety: Moving the railways from self-regulation to regulation by public authorities; Introducing a framework for entry into the market for railway undertakings (licensing and safety certification); Creating a basis for mutual trust through the development of common approaches to safety; Transparency of safety data, CSI, CST, CSM, etc. Slide n 4

3 Purpose of safety directive 2004/49/EC (SD) Amended by Directive 2008/110/EC of 16 December 2008 Safety Directive 2004/49/EC put in place to support creation of an integrated European railway area Complementary to market opening and restructuring directives of 1 st railway package (Directives 2001/12/EC, 2001/13/EC and 2001/14/EC) With its full implementation, SD will contribute to improvement of safety: by moving railways from deterministic to risk based approach by defining principles for management, regulation and supervision of safety by requiring establishment of safety management systems by setting framework for developing CST and CSM by putting in place system for independent accident investigation by harmonising regulatory structure (NSA) in each Member State by defining the responsibilities between actors With harmonised approach to safety, SD supports mutual trust and thus mutual recognition (or cross acceptance) between Member States (MS); Slide n 5

4 Scope of safety directive (Art. 2(1) of SD) Safety Directive 2004/49/EC applies to railway system in MS, broken down into subsystems for structural and operational areas (Annex II of Interoperability Directive 2008/57/EC) It covers safety requirements of system as a whole, including safe management of infrastructure and of traffic operation and interaction between RU and IM Out of scope of SD: MS may exclude in implementing safety directive metros, trams and other light rail systems; networks functionally separate from railway system and intended only for operation of local, urban or suburban passenger services; privately owned railway infrastructure used by infrastructure owner for own freight operations; heritage vehicles running on national networks provided they comply with NSR and regulations in order to ensure safe circulation of such vehicles; heritage, museum and tourist railways operating on own network, including workshops, vehicles and staff. Slide n 6

5 Most important definitions (Art. 3 of SD) For purpose of SD, definitions for following terms are provided: railway system infrastructure manager railway undertaking safety authority national safety rules investigator-in-charge accident serious accident incident investigation causes safety management systems common safety targets (CSTs) common safety methods (CSMs) common safety indicators (CSIs) Agency (European Railway Agency) technical specification for interoperability (TSI) notified bodies interoperability constituents 'safety management system means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations Slide n 7

6 Development and Management of Safety (Art. 4 in SD) SD acknowledges safety levels in EU rail system generally high: important safety at least maintained during restructuring phase separating functions of previously integrated railway companies and moving railway sector further from self-regulation to public regulation when reasonably practicable, safety improved vs. EU legislation, technical and scientific progress considering competitiveness of rail transport mode safety processes to harmonise based on existing methods in EU MS shall ensure priority given to prevention of serious accidents MS ensure safety rules laid-down, applied and enforced in open and non-discriminatory manner supporting development of single EU rail transport system MS ensure measures to develop and improve railway safety take account need of system based approach as TSIs define minimum safety levels and requirements of sub-systems Slide n 8

6 Development and Management of Safety (Art. 4 in SD) SD sets up responsibility for safe operation of railway system and control of risks associated with upon those operating railway system (IM & RU), each for its part of system IM/RU have to identify and implement risk control measures, where appropriate in cooperation with each other, to apply national safety rules and standards and to establish Safety Management System (SMS) in compliance SD Other actors (manufacturers, maintenance suppliers, wagon keepers, service providers and procurement entities) bear responsibility for their products or services NSA does not have any immediate responsibility for safety. It provides national regulatory framework + supervision of operator's performance Slide n 9

7 IM/RU Safety Management System (SMS) (Art. 9 in SD) SMS backbone process enabling IM/RU : to ensure safe management of railway operation and control of all risks associated linked to IM/RU activity, including supply of maintenance and material and use of contractors to deliver general requirements in Art. 4 of SD, where general concept of continuous improvement of railway safety, a system-based approach and allocation of responsibilities within IM/RU organisation are introduced SMS process-orientated management system, built around harmonised principles. Shall contain for IM/RU description of safety related processes and procedures, all of which shall be capable of internal audits SMS principles in Art. 9 & detailed requirements in Annex III of SD IM/RU SMS submitted to safety certification/authorisation by safety authority (NSA) according to Art. 10 & 11 of SD Slide n 10

7 IM/RU Safety Management System (SMS) Key Elements Key elements of cyclical/ iterative SMS process: planning of preventative/ corrective actions implementation on an adequate scale assessment/monitoring/ verification of effectiveness enforcement, review and revision IM/RU submit NSA Annual Safety Report achievement safety targets development national safety indicators and CSI (Ax I SD) results internal safety audits found deficiencies Audit Policy Organising Planning & Implementing Measuring Performance Reviewing Performance Slide n 11

8 Safety Certification of RU (Art. 10 in SD) Safety Authorisation of IM (Art. 11 in SD) Grant access to infrastructure RU Safety Certificate from NSA: Part A : NSA acceptance of RU SMS vs. Art. 9 & Annex III SD Standard & valid throughout whole Community (X-Acceptance) Part B: additional requirements specific to network NSA of other MS Renewed at intervals not exceeding 5 years or updated wholly/partially type or extent of operation substantially altered Revoked by NSA if conditions for certification no longer satisfied Manage and operate infrastructure IM Safety Authorisation from NSA Part A : NSA acceptance of IMSMS vs. Art. 9 & Annex III SD Part B: provisions for specific requirements (design, mainten., oper. infra) Renewed at intervals not exceeding 5 years or updated wholly/partially whenever substantial changes to infrastructure Revoked by NSA if IM no longer satisfies conditions for safety authorisation NSA keep ERA informed issued, renewed, amended, revoked SC/SA Slide n 12

9 Further Development Ensure high level of safety maintained in Community rail system and, when and where necessary and reasonably practicable, improved in non-discriminatory way important to: harmonise methods describing how assess safety levels and compliance with safety requirements (Common Safety Methods CSM) harmonise methods for defining safety targets and describing how assess achievement of safety targets (Common Safety Targets CST) harmonise safety indicators used for monitoring railway safety performance in MS (Common Safety Indicators CSI) harmonise safety rules and use common standards requires during transition period collection and analysis of national safety rules for identifying differences between MS (National Safety Rule) European Railway Agency (ERA) set up to provide recommendations on CSM/CST/CSI, further harmonisation measures towards "a common approach to railway safety" and to monitor railway safety development in Community (Regulation (EC) N 881/2004) Slide n 13

10 Common Safety Methods (CSM) (Art. 6 in SD) What kinds of CSMs in Directive 2004/49/EC? Article 6(3): "The CSMs shall describe how the safety level, and the achievement of safety targets and compliance with other safety requirements, are assessed by elaborating and defining:" a) risk evaluation and assessment methods b) methods for assessing conformity with requirements in Safety Certificates and Safety Authorisations issued in accordance with Art. 10 and 11, and c) as far as they are not yet covered by TSIs, methods to check that the structural subsystems of the railway system are operated and maintained in accordance with the relevant essential requirements Art. 6(3)(a) addresses requirement in Annex III(2)(d): IM/RU SMS has "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" CSM based on examination of existing methods in MS. Revised at regular intervals, taking into account experience gained from their application and global development of railway safety and obligations on MS as laid down in Art. 4(1) (i.e. maintain safety + improve where reasonably practicable) Slide n 14

10 Common Safety Methods (CSM) (Art. 6 in SD) CSM on Risk Assessment (Art. 6(3)(a) in SD) Preliminar y System Definition Significant Change? CSM Regulation adopted RISK ASSESSMENT Basically 3 steps: 1. Hazard identification 2. Risk analysis based on exiting principles 3. Demonstration of compliance with requirements Additional requirements 1. Hazard Management 2. Independent Assessment (Assessment Body) INDEPENDENT ASSESSMENT Codes of Practice SYSTEM DEFINITION² RISK ANALYSIS HAZARD IDENTIFICATION AND CLASSIFICATION Similar Reference Systems Explicit Risk Estimation RISK EVALUATION (vs. Risk Acceptance Criteria) Safety Requirements (i.e. safety measures to be implemented) HAZARD MANAGEMENT [Ax III(2)(g) of SD] Demonstration of Compliance with Safety Requirements Slide n 15

11 Common Safety Targets (CST) (Art. 7 in SD) CSTs define safety levels at least be reached by different parts of railway system and system as whole in each MS, expressed in RAC for: (a) (b) individual risks relating to passengers, staff, level crossing users and others, and, without prejudice to existing national and international liability rules, individual risks relating to unauthorised persons on railway premises; societal risks. Two steps approach: 1 st set CSTs: examine existing targets and safety performance in MS. Ensure current safety performance of rail system not reduced in any MS 2 nd set CSTs: based on experience gained from 1 st set CSTs and their implementation, reflect any priority areas where safety needs to be further improved (what risk and which MS) Definition of CST based on economic evaluation of estimated cost and benefits (for operators and societal acceptance of risk) CST revised at regular intervals, taking into account global development of railway safety and obligations MS amend national safety rules to achieve at least CST and revised CST Slide n 16

12 Common Safety Indicators (CSI) (Art. 5 in SD) Information on safety of railway system rare and not generally publicly available necessary to establish CSIs: to assess harmonised way achievement of CST by railway system coordination between CSI and CST developments, and to facilitate monitoring of railway safety performance (transparency) National definitions related to CSIs may apply during transitional period List of CSI + associated units given in Annex I of SD, e.g. number of train collisions number of train derailments number of accidents at level crossings etc. European Railway Agency proposing harmonised definitions of safety indicators between MS. Some economic indicator definitions added vs. Annex I MS collect information about CSI and included in NSA Annual Report Slide n 17

13 National Safety Rules (NSR) (Art. 8 in SD) Current situation where national safety rules continue to play a role regarded as transitional stage leading ultimately to situation in which European harmonised rules will apply To harmonise those rules (market opening & X-acceptance), MS establish binding NSR & ensure published & made available to all IM, RU and applicants for SC/SA (clear language & understandable) Applicable NSR notified to EC vs. Annex II of SD ERA centralises (data base) and analyses NSR, looking at: establishment of binding NSR? publication of rules? availability of rules? rules in clear language can be understood? body or organisation responsible for publication Appropriate recom-mendations to EC to make relevant information more easily accessible Slide n 18

13 National Safety Rules (NSR) Notification of new NSR (Art. 8 in SD) To keep at minimum new specific national rules, not based on common standards, to prevent further barriers being created and to harmonise gradually safety rules, EC monitor introduction of new rules by MS New rules shall be in line with Community legislation and facilitate migration towards a common approach to railway safety. All interested parties shall be consulted before a MS adopts a NSR requiring a higher safety level than CSTs New draft rule, with justification of reasons for its introduction, shall be submitted to Commission for examination If it appears draft safety rule not in conformity with Community legislation or constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operation between MS. Concerned MS suspend adoption, entry into force or implementation of rule until decision adopted (Committee procedure) Slide n 19

14 Other Requirements in Safety Directive Each MS shall establish an independent safety authority (NSA) NSA to exchange views and experience to harmonise their decision-making criteria across EU and to get mutual-trust (Chapter IV - Art.16,17 & 18) Each MS shall establish an independent accident and incident investigation body (NIB) NIB conduct active exchange of views and experience to develop common investigation methods and draw up common principles for follow up of recommendations (Chapter V) Slide n 20

Thank you for your attention! Thank you for your attention! Slide n 21