Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Introduction

1.1. The EU regulatory framework

Since the first steps towards a single market for rail transport services were taken with Directive 91/440/EEC it has been evident that differences in railway safety regulation and different national safety requirements are principal reasons behind the fact that international rail transport still is mainly managed in the old way, by national operators handing over trains and responsibilities at the borders. Railway safety must be tackled more thoroughly on the European level.

Through the directives on interoperability, 96/48/EC (on the high-speed rail system) and 2001/16/EC (on the conventional rail system), essential requirements for safety on subsystem level have been defined and further specified by technical specifications for interoperability (TSI). Notified bodies will be used to assess conformity or suitability for use of the interoperability constituents and for appraising the procedure for verification of the subsystems.

The TSIs are, however, not applicable to the existing railway equipment and do not cover overall requirements on safety and the managerial and regulatory aspects. The assessment and verification procedures have been carried out in a variety of ways for existing subsystems, making it difficult to achieve mutual acceptance for existing subsystems between Member States and their rail networks.

Directives 95/18/EC, on licensing, and 95/19/EC, which among other issues deal with safety certification of railway undertakings, made very little to improve the situation. They provide for that an EU licence should be issued and that it could be combined with national safety certificates covering the different territories of operation by a railway undertaking. However, there are few examples of a railway undertaking carrying out international services under the provisions of the directives.

The infrastructure package, Directives 2001/12/EC, 2001/13/EC and 2001/14/EC, introduced only minor adjustments to the safety regulatory framework by obliging the Member States to take responsibility for laying down and enforcing safety rules and standards and for ensuring that accidents would be investigated.

1.2. The Commission's study

In the Commission's White Paper in 1996 [1], with a strategy for revitalising the Community's railways, safety was noted as one of the subjects that the Commission needed to investigate further. It stated that the Community should work towards the development of common safety appraisal techniques and a probability based safety regime.

[1] COM(96) 421 final

When agreement was reached by the Council on the infrastructure package in December 1999 the Commission consequently announced its intention to complete the legislative framework with a directive on railway safety. Preparatory work had already started in March 1999 with a study [2] on railway safety regulations and standards, which was completed in February 2000.

[2] National Economic Research Associates (NERA): Safety Regulations and Standards for European Railways; Final Report, Volumes I-V; February 2000.

The key recommendation of the study was that EU policy should be designed to steer European rail safety regulation progressively towards due process within which procedures:

- are documented;

- make relevant information available to all parties; and provide for all affected parties to be heard;

- are applied consistently, with specified substantive (as well as procedural) decision rules;

- give reasons for decisions;

- are subject to independent appeal; and

- are preferably subject to staged timetables.

Other recommendations aimed at: providing information on safety performance and accident data; steering railway safety regulation towards stronger analysis of costs and benefits; provision of due process and separation of powers in Member States; strengthening and coordination of the European level bodies and the creation of a European Railway Agency.

The study showed that there are currently different national approaches to railway safety, different targets and different methods applied. Technical standards as well as requirements on staff and management organisation differ from Member State to Member State and the process to approve rolling stock or certify staff or railway undertakings has not been adapted to the needs of an integrated European rail system. Even though there are many safety requirements that emanates from technical and operational differences of the networks there is also in the sector a lack of understanding of the different national approaches and sometimes mutual suspicion that have its origins in lack of knowledge and absence of transparency.

The restructuring of European railways has led to the separation of functions between infrastructure managers and railway undertakings, a process that is still evolving. Many regulatory functions have been transferred from the railway actors themselves to public authorities, bringing rapid change also to the way safety is regulated and managed in the sector. During this transition it is essential that the roles of the different actors be clearly defined and that responsibilities for managing, regulating and enforcing safety are redistributed in a similar and harmonised way in Europe. The opening of the market may not be carried out at the expense of safety, neither should safety be used as an excuse for maintaining status quo.

1.3. The safety level of the European rail system

Safety performance of the rail transport mode in Europe is generally very good, in particular in comparison with its main competitor, road transport. Introduction of centralised traffic control, automatic train protection systems, more crashworthy vehicles and modern safety management has reduced fatality rates substantially during the last 30 years. The number of passengers killed in accidents average on around 100 a year in the EU Member States and total fatalities (mainly trespassers and car occupants on level crossings) are about 800-900, while on the other hand more than 40.000 people are killed on the roads each year.

Railway accidents happen however and whenever they occur they reveal weaknesses in safety and illustrate further risk reduction potentials. The high impact on public opinion of multiple-fatality rail crashes is evident and pictures from the accident scenes of Eschede (Germany 1998) and Ladbroke Grove (Paddington Station, United Kingdom 1999) remind us of the possible catastrophic consequences of human errors or technical failures in rail transport. In a society where such accidents are less and less tolerated efforts should be made to further reduce risks without endangering the competitiveness of the rail mode. With the emerging single market for rail transport services and supply of railway equipment such efforts need to be co-ordinated and harmonised on the European level.

1.4. The safety directive

The proposed directive on the regulation of safety and investigation of accidents and incidents on the Community's railways addresses four main problem areas related to the development of safe railways in Europe: harmonisation of the safety regulatory structure and the content of safety rules; remaining obstacles to further market opening; the provision of transparency and information on safety; and investigation of serious accidents and incidents.

The directive aims at completing the regulatory structure for a single European rail system and is linked to other proposals in this same package, in particular the proposal to amend the directives on interoperability and the proposal to create a European Rail Agency. It applies a gradual approach to harmonisation and the development of common principles, taking into account the great differences that exist between the Member States.

The migration from national rail networks to a single European rail system will require time and a significant amount of effort from all those involved and interested in the development. With synchronous progress of market and safety performance the rail transport mode will be strengthened and given the possibility to exploit its inherent advantages on the transport market.

2. The safety regulatory structure

2.1. Responsibilities of the actors

The first and most important task in the evolving restructuring of European railways is to modernise and harmonise the safety regulatory structure and the content of safety rules in the Member States and on the European level. This is to ensure that responsibilities are defined and distributed in a common manner and that safety is ensured through the restructuring process.

The main concern raised by the safety professionals of the sector is that the separation of infrastructure management from rail traffic operations will bring obscurity and confusion into safety management of the railway system, bearing in mind its integrated character. A single entity or company will no longer have full and undivided responsibility for safety in the restructured railway sector. It is therefore of the utmost importance to make a clear distinction between the operative responsibilities of the infrastructure managers and the railway undertakings on one side and the regulatory and supervisory responsibility of the Member State safety authorities on the other. The safety regulator may not play an operative role and thus deprive the actors of their responsibilities.

Experience from Member States applying full institutional separation between infrastructure management and transport operations has shown that it is possible to distribute these operational responsibilities between the parties without endangering the overall safety of the system. In this respect the railway system must also draw on the experiences by other transport modes that operate under rigorous safety requirements, such as aviation. No particular airport or national carrier has the overall responsibility for aviation safety in a Member State, but all actors must fulfil the safety requirements and cooperate within the given regulatory framework. It is the safety authority that grants access to the system.

Infrastructure managers must provide a safe infrastructure and, where applicable, control the movements of train through the signalling and control command system, implementing a safety management system to control risks and applying rules and regulations laid down by the relevant authorities. Railway undertakings must operate on the network under the signalling and control command system operated by the infrastructure manager who also in other aspects should coordinate their activities. They shall implement the safety management system to control risks and apply rules and regulations.

The directive states that infrastructure managers and railway undertakings have the full responsibility for the safe operation of their respective part of the system and for the control of risks that they create, with regards to users, customers and third parties. This includes also the supply of material or services provided for by manufacturers, contractors or assessment bodies. The safety management system of any infrastructure manager or railway undertaking must provide for the control of risks created by contractors or the introduction of new material. Suppliers and assessment bodies bear responsibility for their products or service under normal liability rules vis-à-vis the infrastructure manager or the railway undertaking, as regulated under national law or in contracts.

2.2. The national safety authorities

The directive provides for the creation of authorities in the Member States with responsibility to regulate and supervise safety and for their coordination on the European level. A common minimum set of tasks for these authorities is outlined.

The directives currently in force allow for a variety of bodies dealing with safety regulation. In many Member States these functions or some of them have been attributed to the infrastructure manager, for example the granting of safety certificates. The infrastructure manager should, however, according to the main ideas established by Directive 2001/14/EC, be set up with responsibility for offering and allocating capacity on the network and maintaining and developing the infrastructure. This is not in the long run compatible with the execution of regulatory authority for safety. Fair and transparent regulation requires equal treatment of all actors in the sector under a public authority to avoid that safety costs and risk control responsibilities are levied on railway undertakings in an undue way.

In order to facilitate the coordination of safety regulation on the European level it is necessary to establish harmonised structures in all Member States. Currently the interoperability directives define it as a Member State responsibility to authorise the placing into service of the subsystems of the trans-European rail networks and the supervision of their compliance with the essential requirements. They shall also supervise that interoperability constituents meet the essential requirements.

This directive goes one step further in attributing these tasks to the safety authorities, although the tasks do involve other essential requirements on the subsystems and interoperability constituents than those related to safety. For the same reason it is important to concentrate all crucial safety regulatory functions, such as adoption of legally binding safety rules, to one body. There is nothing in the directive preventing the Member States from combining the safety regulatory tasks with the market regulation as provided for in Directive 2001/14/EC, Article 30 or with other authorities involved in railway regulation.

It should be noted that the proposed directive does not regulate how safety regulatory provisions are developed. Even if the safety authority shall be responsible for the formal decisions, the development of safety rules, for example, should well involve the different actors of the sector and their professional organisations. Infrastructure managers could play a role for the preparation of safety certification, in particular concerning route acceptance checks for rolling stock.

The authorities established, and other bodies currently carrying out the safety regulatory tasks, apply a variety of methods for inspecting and assessing conformity with safety requirements. They range from detailed technical inspections by field inspectors to system inspections and audits, in many cases by the use of external auditors. When introducing a European approach to railway safety it will be increasingly important to reach a common understanding of how inspections should be carried out, and to what extent, to facilitate trust and mutual recognition of results between the safety authorities.

By applying the gradual approach the directive defines procedures for the development of common inspection and assessment methods, common safety methods (CSM).

2.3. Harmonisation of national safety rules

Safety rules and standards - such as operating rules, signalling rules, staff requirements, technical requirements on rolling stock and fixed installations - have developed mainly from national sources. Based on technical differences - but sometimes also on different traditions in rolling stock design, safety philosophy or worker protection regulations - the national rules impose barriers on the road to a single European rail system. Through the provisions of the directives on interoperability a harmonisation process have been initiated. These directives do however not apply to the full scope of national safety rules and the transition period to complete interoperability will in many cases cover decades.

Freight wagons and passenger carriages have been designed to operate cross-border traffic according to rules laid down by the International Union of Railways (UIC) and the corresponding RIV and RIC regulations. In other fields the UIC has issued non-binding standards through its system of normative leaflets. The main body of the safety regulation has however remained a matter for the Member State or the state owned monopoly railway company, given that the normal mode of cooperation between these railway companies was to hand over wagons and carriages at the border-crossing, but letting locomotives and train crews operate only on the home country network.

It is thus necessary to overcome these differences in national rules and, complementary to the interoperability directives, provide for harmonisation during the transition period before all relevant TSI have been adopted and implemented. In any case the development of new national rules, or amendment of old ones, should be carried out in a process that takes into account the need for harmonisation on Community level.

The directive establishes a mechanism for migration towards common safety rules by a notification procedure, which requires European acceptance of new or amended national safety rules.

3. Removing obstacles to a functioning single market

3.1. Safety certification

The second problem addressed by the directive is the removal of barriers to further market opening and the creation of a single European rail transport market. The safety certificate, granted to the railway undertaking for operation on a specific network, is still recognised as the means to achieve access to infrastructure. Experience from the implementation of the earlier EU directives show, however, that it is a difficult and time-consuming procedure to obtain a safety certificate for operation on a foreign network. The difficulties are often seen as insurmountable, shown by the fact that most international operations are still pursued under the old cooperative mode, even by newcomers on the market.

The safety certificate as outlined in the current directives consists of different parts: certification of the railway undertakings internal organisation; its commitment to adhere to national rules for the operation; the certification of its rolling stock; and the certification of the staff used in the operation.

In this directive the concept is further developed by introducing common requirements for and common elements of a safety management system that must be implemented by all railway undertakings. The safety management system must also be established by the infrastructure managers in line with the general concept of the directive. The directive provides for that once the safety management system of a railway undertaking is established and certified in one Member State it shall not be subject to renewed certification in other Member States. It will have Community validity for the type of operation it covers. The European Rail Agency will keep a public record of all such safety certificates.

In addition the railway undertaking would still need to declare its intention to adhere to national rules and be granted an acceptance of the rolling stock and staff used for each of the networks it intends to operate on. These parts are still mainly subject to national rules, but the safety authorities are obliged to cooperate when they issue safety certificates for railway undertakings using international train paths.

The directive obliges the Member States to ensure that training facilities and certification of staff are available to undertakings planning to take up rail transport services. It defines a procedure for mutual acceptance and certification of rolling stock that has been certified in at least one Member State.

The concept of different national safety certificates is, however, still and impediment to the development of a single European rail system. Ultimately there should be one single Community certificate subject to recognition by all Member States. The directive imposes on the Agency to develop a migration strategy to reach this goal.

3.2. Common safety targets, common safety methods

One concern raised during the work of the Member State Committee on the TSI for interoperability is that there is no common understanding of the safety levels that should be attained by the European rail system. This can give rise to suspicion and might be used as an argument for not accepting railway undertakings or railway equipment coming from another Member State. Some of the TSI may define a level of safety that must be contained by the relevant subsystem, for example the signalling and control command system, but the interoperability process do not define safety levels for the system as a whole. The Committee has however come to the agreement that the present safety level, although not quantified and known in detail, is sufficient.

For the creation of the single European rail transport market it is therefore important to increase confidence between actors on the market and between Member States. For that purpose the directive introduces a mechanism to adopt common minimum safety targets (CST) expressed in risk acceptance criteria for individuals and the society. Different targets could be valid for different parts of the system, such as the high-speed system, the conventional rail system or lines dedicated for freight traffic.

The common safety methods (CSM) will also be developed to assess if the targets are met.

4. Application of due process in railway regulation

4.1. Availability of information on regulation and processes

The third problem area addressed by the directive concerns transparency, information and the application of due process in national railway regulation.

The world of the old state owned monopoly railways was from many aspects a closed world. It was mainly self-regulatory and there was no real need to give information to the public on safety and to apply transparent decision rules. Development of operating rules, acceptance of new material and certification of staff were mainly in-house processes. With an open market and regulation by public authorities the requirements on the rail sector will increase. It must develop in the same direction as other modes of transport.

The directive introduces common principles for decisions by the railway authorities and harmonises them on the European level. It requires public availability of rules, regulations and standards, stages timetables and makes mandatory provisions for actors to be allowed to appeal against all decisions. It stipulates that the safety authority must be independent in its organisation and decision-making from infrastructure managers and railway undertakings.

4.2. Common safety indicators

Information on the safety performance of railways is scarce. It is not normally published in the annual reports of the railway companies and only some Member States publish detailed statistics on accidents. The UIC collects accident data among its member railway companies and publishes part of them. However, given the voluntary character and that the statistics only cover UIC members, these accident statistics have grown less reliable, as have all other European railway statistics based on UIC figures.

In February 2001 the Commission submitted a proposal for a regulation of the European Parliament and the Council on rail transport statistics [3]. The regulation provides for the submission of accident data by the Member States, which will render it possible to have an overall estimation of the development of safety on the railways and to allow modal comparisons. Indicators on accidents, required by this directive, have been outlined to coincide with data required by the proposed regulation. They will be collected according to the procedures laid down in the proposed regulation.

[3] COM(2000) 798 final

Accident data are anyway blunt instruments when safety on the railways shall be assessed and when proactive measures are considered. Serious accidents on the railways are rare, but have a huge impact on the perception of safety. If possible, risks should be acted upon by proactive measures - assessing precursors as more useful safety indicators. The directive lists some indicators that are known to be used in Member States for assessment of safety performance, such as signals passed at danger, broken rails and broken wheels. They relate to the activities of both infrastructure managers and railway undertakings. Other indicators that can be used for the follow-up and monitoring of rail safety are indicators related to the standard of the network, to the functioning of the safety management system and to costs.

Common safety indicators (CSI) as described above are laid down by the directive but need to be further developed through the committee procedure. To make them globally useful they must be based on common definitions, including where possible standard statistical definitions, and common calculation methods. The indicators will render it possible to monitor the development of railway safety in the Member States and on Community level and facilitate the assessment of the safety level according to the common safety targets.

4.3. Annual reports

Railway undertakings and infrastructure managers will be obliged to submit annual reports on the development of safety to their national safety authority which in its turn must publish a report each year and make it available to the European Rail Agency. The European rail Agency will make information available on the European level.

This transparency will further open up the closed structures and enable all actors to share experience and gain confidence.

5. Investigation of accidents and incidents

5.1. The current state of the art

The fourth area addressed by the directive is investigation of accidents and incidents.

It has shown that there is a great variety in Member State legislation on accident investigations. In many cases accidents are still investigated by the national state railway, or by the judicial authorities such as police or prosecutors, whereas in some Member States independent accident investigation bodies have been set up.

Influenced by legislation for accident investigation in aviation, provided for on Community level by Directive 94/56/EC, many Member States move towards independent accident investigation also for other transport modes and, in some cases, towards the creation of multi-modal investigation boards, modelled after National Transportation Safety Board (NTSB) in the USA.

Serious rail accidents have a huge impact on public opinion and it requires in increasing degree information from independent sources. The creation of a single market for rail transport and railway equipment renders it in addition more important to share information and learn lessons from accidents and incidents Europe-wide. Technical failures and operational and managerial deficiencies could be more easily detected and avoided if information would be available and spread within the sector.

5.2. Two types of investigation

The safety investigation aims at establishing root causes to avoid future occurrences, whereas the police investigation (judicial inquiry) aims at finding the person responsible for a criminal offence, if there is one. If no one is prosecuted the police report will normally not be made public. The two types of investigation deal with different aspects of the accident, apply different methodologies and require different skills by their investigators. If they are not kept apart the appropriate lessons for safety will never be learned. To achieve this Member States must provide for that the police investigation will not hamper or delay the safety investigation and that all necessary information is shared.

The involved parties and persons must be encouraged to submit information and evidence to the safety investigation without having to fear that their testimony will be used against them. For that reason the sole purpose of the investigation should be to find the causes of the accident or incident in order to prevent future occurrences. Recommendations resulting from such an investigation should not presume blame or liability. Openness and transparency should be guiding principles during the investigation and the results must be published.

5.3. An independent investigating body

A permanent body should carry out investigation of accidents above a certain level of seriousness. This is to ensure consistency in investigations and to facilitate harmonisation and cooperation on Community level. The permanent body must also be responsible for the follow-up of safety recommendations that have been issued after such investigations.

For the sake of public trust in a safety investigation, as well as the confidence of involved parties, an independent body must carry it out. Since underlying causes of an accident often can be traced back to the regulatory framework for safety and the certification of railway undertakings, staff and rolling stock, the investigation body should be independent also of the safety regulator. In fact the safety authority is normally the main addressee of recommendations and responsible for implementation and enforcement of safety improvements after investigations.

5.4. Defining the mandatory domain

Serious train accidents, such as derailments and collisions with fatal consequences, occur rarely, but when they do they attract public interest and the interest of the safety professionals all over Europe. It is therefore justified to define a minimum level where serious collisions and derailments should be mandatory investigated by the independent body. Other serious accidents, such as level crossing accidents, fires or discharge of dangerous goods should also be investigated if it is justified or of importance from a safety point of view. In this case the investigation body should have a possibility to decide whether an investigation is necessary or not.

A proactive approach should be applied to the development of railway safety. Therefore the investigation of serious incidents and near misses is often more important than investigation of accidents, although there is rarely any public request for such investigations. The opening of investigations on incidents and near-misses should be left to the discretion of the investigating body, taking into account some principles laid down by the directive.

Besides the serious accidents and incidents that need to be investigated by an independent body there are numerous of other occurrences that need some kind of investigation. The safety management systems of infrastructure managers and railway undertakings require all accidents and incidents to be investigated and acted upon within their relevant organisation. The safety authority may also carry out certain investigations as a part of its supervisory tasks.

6. Links with other proposals

6.1. Interoperability and safety

The safety directive should not be seen as an isolated piece of legislation. It is complementary on system level what the interoperability directives introduced on sub-system level and it relies on the same committee (Article 21 Committee, established by Directive 96/48) as is used for the development of the TSI. Thus it ensures that interoperability and safety will be developed in a consistent and coherent way.

Furthermore it builds on the proposal to amend the interoperability directives, included in this package. In particular its starting point is that the scope of these directives should no longer be restricted to the trans-European Networks, but be extended to cover the whole European rail system.

The gradual approach is similar to that introduced by Directive 2001/16/EC on the interoperability of the conventional rail system and will heavily depend on support by the actors of the sector and by the European Rail Agency, proposed in this same package.

6.2. The European Rail Agency

The Agency will develop draft proposals for the common safety targets and common safety methods and prepare amendments to the common safety indicators. It will elaborate harmonised definitions and calculation methods linked to the indicators and bear responsibility for coordination of the national safety authorities and investigation bodies. The Agency will scrutinise new national safety rules, keep records and registers of safety indicators, investigation reports and safety certificates and monitor the development of railway safety. It will be indispensable for the implementation of this directive.

Safety regulation for railways could not be developed without the close involvement of the actors of the sector. As for interoperability this means that the railway operators and infrastructure managers and the manufacturing industry through their relevant organisations must play a decisive role when the proposals are prepared by the Agency. When it comes to the development of safety targets, methods and indicators and harmonisation of safety certificates the relevant safety authorities in the Member States should also be involved in the process.

Involvement of the sector in the process is covered in detail by the regulation establishing the Agency and is not provided for in this directive.

6.3. Consequential changes in existing directives

Since the regulation of safety certification for railway undertakings will be provided by this directive the current Article 32 of Directive 2001/14/EC will be redundant and the directive could be amended. This is done through this directive together with consequential changes in Article 30 (appeal functions for safety regulation) including also a change of the title. The content of Article 7 (2) of Directive 91/440/EEC will also be covered by the provisions of the safety directive and the abrogation of this Article is provided for by the proposed directive to amend Directive 91/440/EEC in this package.

Directive 95/18/EC on licensing of railway undertakings duplicates to a certain degree requirements on the safety management system provided for in the safety directive. This directive therefore amends part of Article 8 and section II of the Annex to Directive 95/18/EC.

7. Justification of the proposal

What are the aims of the intended activities as compared with the Community's obligations and what is the Community dimension of the problem (for example how many Member States are involved and what solution has been applied so far)*

The Treaty foresees the implementation of a common transport policy which among others allow the Community to lay down common rules applicable to international transport to and from the territory of a Member State and measures to improve transport safety. A Community regulatory framework for railway safety concerns all Member States and is necessary to accomplish the common transport policy and a single market for rail transport services.

Do the intended activities fall within the exclusive competence of the Community or within a competence that is shared with the Member States*

The activities in question are a matter of shared competence in accordance with Article 71 of the EC Treaty.

Comparatively speaking is the Community or the Member States approach more efficient*

The Member States are not in a position to harmonise the regulatory framework for safety and to lay down common principles for railway safety and create common safety targets and common safety methods. This could only be achieved by Community action.

What practical added value do the intended Community activities provide and what would be the cost of inaction*

This directive will, together with other proposals in this package, complete the regulatory framework for an open market for rail transport services, in particular for freight transport. This is necessary to halt the decline of the rail transport mode, experienced during the last 30 years. A revitalisation of the railways is an integrated part of the common transport policy and a precondition for a more sustainable transport system in Europe.

Any absence of action is deemed to be detrimental to the development of rail transport, its competitiveness and its efficiency. In the long run this would affect the whole European transport system and increase its costs for congestion, pollution and accidents.

What forms of action is the Community able to take*

The only suitable form of action is a directive addressed to the Member States. Many of the provisions of the proposal need to be implemented in Member State legislation and integrated in their existing legal provisions for railway safety.

Is a uniform body of regulations needed or would a directive laying down general aims and transferring implementation to the Member States be sufficient*

As mentioned above the directive is the most suitable action. This directive gives however a framework for further Community decision-making by leaving open the development of common safety targets and common safety methods and the further development of common safety indicators and adaptation of technical annexes. Decisions on these issues will be adopted by the Commission according to a Committee procedure where the Member States participate.

8. Comments on the articles

8.1. Chapter I

8.1.1. Article 2

The scope of the directive coincides mainly with the scope of the directives on interoperability as proposed in this package. Compared with the directives of the infrastructure package, Directives 2001/12/EC, 2001/13/EC and 2001/14/EC, the scope has been widened to cover all relevant railway undertakings operating on the European rail system irrespective of their geographical coverage or whether they carry out domestic or international transport activities.

Member States may exclude isolated networks and private sidings as long as the railway undertakings operating on these lines are not involved in operations on the main network.

8.1.2. Article 3

The definitions of the directive are harmonised with those of other directives, except for the definition of 'railway undertaking' which in this directive includes all such undertakings, not only those holding a licence. The consequence will be that infrastructure managers might be considered as railway undertakings to the extent that they carry out transport operations, for example for maintenance work or supply of material.

It should be noted that definitions related to the safety indicators will eventually be established by the Committee procedure adapting Annex I.

8.2. Chapter II

8.2.1. Article 4

The current railway safety level in the Member States is generally considered as sufficient and should be globally maintained, which means that risk assessment should be used to verify that new activities or new equipment does not harmfully endanger the overall level. Improvements of safety should take into account the costs and other effects on the efficiency and competitiveness of the rail system. Member States should apply a European perspective to the development of the regulatory framework.

Infrastructure managers and railway undertakings bear the full responsibility for safe operations, as further described in Article 9.

8.2.2. Article 5

The common safety targets (CST) and common safety methods (CSM) shall be developed by the Agency, based on an examination of existing targets and methods in the Member States. It is necessary to issue a mandate for the development where priorities and timetables could be laid down. The adoption process involves the Member States through the committee procedure.

The resulting safety targets will describe the minimum safety level, meaning that Member States could apply more demanding targets, for example for infrastructure, as long as they do not impose requirements above the CST on railway undertakings.

The CSM could harmonise the use of independent safety assessors for checking compliance with essential requirements or for assessing conformity with requirements of safety certificates.

8.2.3. Article 6

Currently there are very few examples of safety indicators in use. Even if accident statistics are published the definitions are not harmonised. The Annex provides a first list of indicators and the procedure described in the article allows for their further development and for harmonisation of definitions and calculation methods.

8.2.4. Articles 7 and 8

I must be noted that the article only deals with the formal adoption or approval of national rules. The process leading to final adoption might very well involve other bodies than the safety authority, for example sector organisations.

The current situation where national safety rules still are dominating is seen by the directive as a transition period towards a situation where European rules normally apply. To avoid that further obstacles are raised and to steer the process towards harmonisation the articles define a procedure where new and amended national rules are scrutinised and subject to Community approval. This is in line with the general approach of gradual harmonisation applied by the directive.

8.2.5. Article 9

The directives currently in force have not explicitly required a safety management system, although references to the internal organisation of the railway undertaking imply the establishment of such a system. Building on experiences in the Member States a set of common requirements and definition of the main elements of the safety management system have been developed in this article and in Annex III. The requirements apply equally to railway undertakings and infrastructure managers, whereas only the safety management system of the railway undertaking is subject to certification according to the provisions of Article 10. Member States are, however, allowed to introduce national certificates or licences for their infrastructure managers.

Through the provisions of the proposed regulation establishing the Agency a European standard for a safety management system could be developed, based on the principles laid down in this article and in Annex III. With such a standard independent conformity assessment of the safety management system with a Community validity will be facilitated.

8.3. Chapter III

8.3.1. Article 10

Through this article the safety certificate is divided into two parts: one with European validity, covering the safety management system, and one with network wide validity, covering the safety rules, the rolling stock and the staff necessary for safe operations. The final aim is to have a single Community safety certificate.

8.3.2. Article 11

Experience has shown that it is necessary to regulate the supply of information to railway undertakings and the obligation of the safety authorities to give guidance to applicants. The application procedure must be subject to staged timetables.

8.3.3. Article 12

A critical aspect of safety certification concerns the training and certification of staff, in particular train drivers. If a railway undertaking applying for a safety certificate can not recruit trained and certified staff in the Member State where it plans to operate, it has to rely on that training and certification of their existing staff is available. Since training involves operating rules, the signalling and control command system, route knowledge and emergency procedures it will in the foreseeable future only be provided on a national network basis.

It must be the responsibility of the Member States and their safety authorities to ensure that training facilities and certification are available to all railway undertakings applying for a safety certificate. If in some cases a monopoly operator still provides these facilities the market should be opened on equal and non-discriminatory conditions.

8.3.4. Article 13

A railway undertaking operating in one Member State and applying for a safety certificate in another Member State usually wants to be granted certification also for its existing rolling stock, for example locomotives. Provided that the rolling stock meet the safety requirements of the network where it was originally certified it should be subject to mutual recognition in additional Member States as long as it complies with the restrictive parameters of the infrastructure. This is in line with the assumption that the safety level in the Member States generally is considered as sufficient, although the more detailed prescriptions may vary for cultural or historical reasons.

Experience has shown that such in-use rolling stock normally are subject to rules and procedures valid for new rolling stock in additional Member States, although it could be justified that they instead be compared with existing, in-use, rolling stock. Minor derogations from national prescriptions should be granted if they do not endanger safety. The burden of proof in such cases should be laid upon the applicant.

8.3.5. Article 14

In line with the concept of gradual harmonisation this article provides for harmonisation of certification requirements and application guidance documents.

8.4. Chapter IV

8.4.1. Articles 15 and 16

It is necessary to harmonise the structure for safety regulation in the Member States to facilitate the exchange of information and experience and coordination on Community level. Regulatory powers should be attributed to public bodies that have sufficient resources at their disposal. A minimum set of regulatory and supervisory tasks is outlined and some common decision-making principles described. Nothing prevents Member States from attributing these tasks to the regulatory bodies established by Article 30 of Directive 2001/14/EC.

8.5. Chapter V

8.5.1. Article 18

The article deals only with investigations from a safety point of view and its objectives. In parallel Member States may require that a judicial inquiry be carried out. The safety authority may as well be assigned to carry out other investigations within its remit of supervising safety.

The definition of the occurrences that mandatory must be investigated according to this chapter is based on what should reasonably be of European interest. Member States are free to require that also occurrences below the thresholds defined in this article be investigated in the same way.

8.5.2. Article 19

It is necessary for Member States to ensure that the judicial inquiry and the safety investigation are carried out separately, but in cooperation with each other. Both types of investigations need access to the accident site and its evidence and to witnesses. If nothing else is specifically legislated the judicial inquiry will in most Member States take precedence over the safety inquiry. This article is to ensure that the safety investigation will have access to all necessary evidence without involving itself in conflicts with the relevant authorities.

8.5.3. Article 20

The independence criteria of the investigating body are tightly defined to ensure that it will not be incorporated in any of the actors of sector. The tasks may however be assigned to other existing bodies, for example investigating bodies for other modes of transport, universities, technical institutes or other suitable and independent organisations.

The independence of the investigators contracted in each case for an investigation should be guaranteed by the independence of the body and its internal rules established by the Member State. The permanent character of the body is guaranteed by the requirement to comprise at least one investigator-in-charge. This is also a minimum criterion if the body shall be able to respond to accident reports immediately.

It can be expected that accidents will have an increasing impact on the European level with the emerging single market. For that purpose the ERA should be required to put expertise at the disposal of national investigation bodies.

8.5.4. Articles 21 and 22

The purpose of safety investigations is to provide information to prevent accidents. Thus it is important to allow for all parties to be heard and supply information to the investigation. A public investigation will not gain public confidence unless it is open and transparent, allowing for all involved to have a word before the final report is published. Reports must be made available to all interested parties and to the professionals of the sector.

8.5.5. Article 22

One of the main reasons behind the requirement to let a permanent body be responsible for safety investigations is that it ensures consistency and coherence of safety recommendations. The investigating body must also be responsible for follow-up of recommendations and the article requires the addressees to respond to recommendations.

8.6. Chapters VI and VII

8.6.1. Articles 25-26

In line with the gradual approach to harmonisation this directive will mainly provide a framework for the further development of Community railway safety. Requirements laid down in annexes to the directive can be adapted to technical and scientific progress through the committee procedure. The Agency will play a crucial role in the further development of the annexes as well as in the formulation of CST and CSM.

The close links between the interoperability directives and this directive has led to the use of a common Member State Committee. It will ensure the consistency between TSI and the provisions of the safety directive.

8.7. Chapter VII

8.7.1. Articles 27-28

The provisions of parts of Article 8 and part of the Annex of Directive 95/18/EC will merely duplicate what will now be regulated in more detail in this directive through Article 9. Also the provisions for safety certification laid down in Directive 2001/14/EC will be superseded by this directive and should thus be abrogated.

9. Financial impact

This proposal does not include a financial statement. The costs incurred by the proposal (technical support for development of a common approach to railway safety and harmonisation of safety regulation) will be borne by the European Railway Agency and are accounted for in the financial statement of the proposed regulation establishing this agency. In addition an existing Committee (Directive 96/48/EC Article 21) will be used for the decision making procedures established by this proposal. A possible increase in the number of necessary meetings will be accounted for under the budget line of this Committee.

2002/0022(COD)

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 71 (1) thereof,

Having regard to the proposal from the Commission [4],

[4] OJ C [...], [...], p. [...].

Having regard to the opinion of the Economic and Social Committee [5],

[5] OJ C [...], [...], p. [...].

Having regard to the opinion of the Committee of the Regions [6],

[6] OJ C [...], [...], p. [...].

Acting in accordance with the procedure laid down in Article 251 of the Treaty [7],

[7] OJ C [...], [...], p. [...].

Whereas:

(1) In order to pursue efforts to establish a single market for rail transport services, initiated by Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways [8], it is necessary to establish a common regulatory framework for railway safety. Member States have until now developed their safety rules and standards mainly on national lines, based on national technical and operational concepts. Simultaneously differences in principles, approach and culture have made it difficult to break through the technical barriers and establish international transport operations.

[8] OJ L 237, 24.8.1991, p. 25. Directive as amended by Directive 2001/12/EC (OJ L 75, 15.3.2001, p. 1).

(2) Directive 91/440/EEC, Council Directive 95/18/EC of 19 June 1995 on the licensing of railway undertakings [9] and Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification [10] provide the first steps towards regulation of the European rail transport market by opening the market for international rail freight services,. However, the provisions on safety have proved to be insufficient and different safety requirements still present major barriers to seamless rail transport in the Community. It is of particular importance to harmonise the regulatory structure in the Member States, the content of safety rules, safety certification of railway undertakings, the tasks and roles of the safety authorities and the investigation of accidents.

[9] OJ L 143, 27.6.1995, p. 70. Directive as amended by Directive 2001/13/EC of the European Parliament and of the Council (OJ L 75, 15.3.2001, p. 26).

[10] OJ L 75, 15.3.2001, p. 29.

(3) Metros, trams and other light rail systems are in many Member States subject to local or regional safety rules and are often supervised by local or regional authorities and not covered by the requirements on Community interoperability or licensing. Trams are furthermore often subject to road safety legislation and could therefore not be fully covered by railway safety rules. For these reasons and according to the principle of subsidiarity as set out in Article 5 of the Treaty, Member States should be allowed to exclude such local rail systems from the scope of this Directive.

(4) Safety levels in the Community rail system are generally high, in particular compared to road transport. It is important that safety is maintained during the current restructuring phase, which will separate functions of previously integrated railway companies and move the railway sector further from self-regulation to public regulation. In line with technical and scientific progress safety should be further improved, when reasonably practical and taking into account the competitiveness of the rail transport mode.

(5) All those operating the railway system, infrastructure managers and railway undertakings, should bear the full responsibility for the safety of the system, each for his part. Member States should make a clear distinction between this immediate responsibility for safety and the safety authorities' task of providing a national regulatory framework and supervising the performance of the operators.

(6) Requirements on safety of the subsystems of the trans-European rail networks are laid down in Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system [11] and Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system. [12] However, those Directives do not define common requirements at system level and do not deal in detail with regulation, management and supervision of safety. When minimum safety levels of the subsystems are defined by technical specifications for interoperability (TSI) it will be increasingly important to establish safety targets at system level as well.

[11] OJ L 262, 16.10.1996, p. 18 (Directive as amended by Directive .../.../EC of the European Parliament and of the Council amending Council Directive 96/48/EC and Directive 2001/16/EC (OJ L....)(

[12] OJ L 110, 20.4.2001, p. 1. (Directive as amended by Directive .../.../EC of the European Parliament and of the Council amending Council Directive 96/48/EC and Directive 2001/16/EC (OJ L....)(

(7) Common safety targets (CST) and common safety methods (CSM) should be gradually introduced to ensure that a high level of safety is maintained and to provide tools for assessment of the safety level and the performance of the operators on the European level as well as in the Member States.

(8) Information on safety of the railway system is scarce and not generally publicly available. It is thus necessary to establish common safety indicators (CSI) in order to assess that the system complies with the CST and to facilitate the monitoring of railway safety performance.

(9) National safety rules, which are often based on national technical standards, should gradually be replaced by rules based on common standards, established by TSI. New national rules should be in line with Community legislation and facilitate the migration towards a common approach to railway safety. They should therefore be subject to a Community approval process.

(10) The development of CST, CSM and CSI as well as the need to facilitate the process towards a common approach to railway safety requires technical support on Community level. The European Railway Agency instituted by Regulation (EC) No --/-- of the European Parliament and of the Council [13] is set up to deliver recommendations concerning CST, CSM and CSI and further harmonisation measures and to monitor the development of railway safety in the Community.

[13] OJ L ( (

(11) In carrying out their duties and fulfilling their responsibilities, infrastructure managers and railway undertakings should implement a safety management system, fulfilling Community requirements and containing common elements. Information on safety and the implementation of the safety management system should be submitted to the safety authority in the Member State.

(12) The safety management system should take into account that the provisions of Council Directive 89/391/EC of 12 June 1989 [14] on the introduction of measures to encourage improvements in the safety and health of workers at work and its relevant individual directives are fully applicable to the protection of the health and safety of workers engaged in railway transport.

[14] OJ L 183, 29.06.1989, p. 1.

(13) To ensure a high level of safety on the railways and equal conditions for all railway undertakings, they should be subject to the same safety requirements. The safety certificate should give evidence that the railway undertaking has established its safety management system and is able to comply with the relevant safety standards and rules. For international transport services it should be enough to approve the safety management system in one Member State and give the approval Community validity. Adherence to national rules on the other hand should be subject to additional certification in each Member State. The final aim should be to establish a common safety certificate with Community validity.

(14) Member States should make efforts to assist applicants wanting to enter the market as railway undertakings. In particular they should provide information and act promptly on requests for safety certification. For railway undertakings operating international transport services, it is important that the procedures are similar in different Member States. Although the safety certificate will contain national parts for the foreseeable future, it should nevertheless be possible to harmonise the common parts of it and facilitate the creation of a common template.

(15) Certification of train staff and in-use rolling stock for the different national networks are often insurmountable barriers to new entrants. Member States should be responsible for providing training and certification of train staff and mutual acceptance of basic requirements of train staff should be guaranteed. A common procedure should be established for mutual acceptance of in-use rolling stock.

(16) As part of the new common regulatory framework for safety, national authorities should be set up in all Member States to regulate and supervise railway safety. To facilitate cooperation between them at Community level, they should be given the same minimum tasks and responsibilities. The safety authorities should be granted a high degree of independence. They should carry out their tasks in an open and non-discriminatory way to help to create a single Community rail system and cooperate to coordinate their decision-making criteria, in particular concerning safety certification of railway undertakings carrying out international rail transport.

(17) Serious accidents on the railways are rare. However, they can have disastrous consequences and raise concern among the public about the safety performance of the railway system. All accidents should, therefore, be investigated from a safety perspective to avoid recurrence and the results of the investigations should be made public. Near misses and other incidents are significant precursors to serious accidents and should also, be subject to safety investigations.

(18) A safety investigation should be kept separate from the judicial inquiry into the same incident and be granted access to evidence and witnesses. It should be carried out by a permanent body, independent of the actors including the safety authority, under as much openness as possible. For each occurrence the investigation body should establish the relevant investigation group with necessary expertise to find the immediate causes and underlying causes of the incident.

(19) The reports on investigations and any findings and recommendations provide crucial information for the further improvement of rail safety and should be made publicly available at Community level. Safety recommendations should be acted upon by the addressees and actions reported back to the investigating body.

(20) Since the objectives of the proposed action, namely to coordinate activities in the Member States to regulate and supervise safety and to investigate accidents and to establish at Community level common safety targets, common safety methods, common safety indicators and common requirements of safety certificates, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

(21) Since most of the measures necessary for the implementation of this Directive are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission [15], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision. In accordance with Article 2 of Decision 1999/468/EC, some measures for the implementation of this Directive should be adopted by use of the advisory procedure provided for in Article 3 of that Decision.

[15] OJ L 184, 17.7.1999, p. 23.

(22) Since some provisions of Directive 95/18/EC and Directive 2001/14/EC are superseded by this Directive, those Directives should be amended.

(23) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.

HAVE ADOPTED THIS DIRECTIVE:

Chapter I

INTRODUCTORY PROVISIONS

Article 1

Subject-matter

The purpose of this Directive is to ensure the development and improvement of safety on the Community's railways by:

(a) harmonising the regulatory structure in the Member States,

(b) defining responsibilities between the actors,

(c) developing common safety targets and common safety methods,

(d) requiring the establishment, in every Member State, of national safety authorities and independent national bodies for accident investigation,

(e) defining common principles for the management, regulation and supervision of railway safety.

Article 2

Scope

1. This Directive applies to the railway system in the Member States, which may be broken down into subsystems for structural and operational areas. It covers safety requirements on the system as a whole, including the safe management of infrastructure and of traffic operation and the interaction between railway undertakings and infrastructure managers.

2. Member States may exclude from the measures they adopt in implementation of this Directive:

(a) metros, trams and other light rail systems;

(b) networks that are technically separated from any part of the trans-European conventional and high-speed rail systems and intended only for the operation of local, urban or suburban passenger services and railway undertakings operating solely on these networks;

(c) privately owned railway infrastructure that exists solely for use by the infrastructure owner for its own freight operations.

Article 3

Definitions

For the purpose of this Directive, the following definitions shall apply:

(a) 'railway system' means the totality of the subsystems for structural and operational areas, such as infrastructure, energy, control and command and signalling, rolling stock, traffic operation and management, maintenance, telematics applications for passenger and freight services, environment and users, as defined in Directives 96/48/EC and 2001/16/EC, as well as the management and operation of the system as a whole;

(b) 'infrastructure manager' means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings;

(c) 'railway undertaking' means any public or private undertaking, the activity of which is to provide transport of goods and/or passengers by rail with a requirement that the undertaking must ensure traction; this also includes undertakings which provide traction only;

(d) 'technical specification for interoperability (TSI)' means the specifications by which each subsystem or part of a subsystem is covered in order to meet the essential requirements and ensure the interoperability of the trans-European high-speed and conventional rail systems as defined in Directive 96/48/EC and Directive 01/16/EC;

(e) 'common safety targets (CST)' means the minimum safety levels that must be reached by different parts of the rail system (the conventional rail system, the high speed rail system or lines solely used for freight transport) and by the system as a whole, expressed in risk acceptance criteria;

(f) 'common safety methods (CSM)' means the methods that shall be developed to describe how the CST are reached and how compliance is assessed;

(g) 'safety authority' means the national body entrusted with the task to regulate and supervise railway safety according to the provisions of this Directive;

(h) 'national safety rules' means all rules containing railway safety requirements imposed at Member State level and applicable to more than one railway undertaking, irrespective of the body issuing them;

(i) '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;

(j) 'investigator-in-charge' means a person responsible for the organisation, conduct and control of an investigation;

(k) 'serious accident' means:

a) accidents caused by collision or derailment of trains, resulting in at least one killed person or five or more seriously injured persons,

b) other railway accidents causing the loss of human lives, multiple serious injuries or extensive damage to rolling stock, the infrastructure or the environment and with an obvious impact on railway safety regulation or the management of safety;

(l) 'incident' means any occurrence, other than serious accidents, associated with the operation of trains and affecting the safety of operation;

(m) 'investigation' means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations;

(n) 'causes' means actions, omissions, events or conditions, or a combination thereof, which led to the accident or incident;

(o) 'Agency' means the European Railway Agency, the Community agency for railway safety and interoperability, established by Regulation (EC) No ---/--/ of the European Parliament and of the Council [16];

[16] OJ L ( (.

(p) 'notified bodies' means the bodies which are responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the EC procedure for verification of the subsystems, as defined in Directive 96/48/EC and Directive 2001/16/EC;

(q) 'interoperability constituents' means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem upon which the high-speed or conventional rail system depends directly or indirectly, as defined in Directives 96/48/EC and 2001/16/EC. The concept of a 'constituent' covers both tangible objects and intangible objects such as software.

Chapter II

DEVELOPMENT AND MANAGEMENT OF SAFETY

Article 4

Development and improvement of railway safety

1. Member States shall ensure that railway safety is generally maintained and, where reasonably practicable, continuously improved, taking into consideration the development of Community legislation and the technical and scientific progress and giving priority to the prevention of serious accidents.

Member States shall ensure that safety rules are laid down, applied and enforced in an open and non-discriminatory manner, fostering the development of a single European rail transport system.

2. member States shall ensure that the responsibility for the safe operation of the railway system and the control of risks created on it shall be laid upon the infrastructure managers and railway undertakings, obliging them to implement necessary risk control measures, to apply national safety rules and standards, and to establish safety management systems according to the provisions of this Directive.

Each infrastructure manager and railway undertaking shall be made responsible for its part of the system and its safe operation, including supply of material and contracting of services, vis-à-vis users, customers and third parties.

Article 5

Common safety targets, common safety methods

1. The CST and CSM shall be adopted by the Commission, by (date( [17] at the latest, in accordance with the procedure referred to in Article 26(2). They shall be published in the Official Journal of the European Communities.

[17] Five years after entry into force of the Directive

Prior to the adoption of CST and CSM, non-binding guidelines on CST and CSM may be adopted in accordance with the procedure referred to in Article 26(3). They shall be published in the Official Journal of the European Communities.

2. Draft CST and CSM and draft non-binding guidelines shall be drawn up by the Agency under a mandate which shall be adopted in accordance with the procedure referred to in Article 26(2).

The draft CST and CSM shall be based on an examination of existing targets and methods in the Member States and take account of the estimated costs and benefits. They shall analyse the possible impact on TSI for the subsystems and contain, where appropriate, consequential proposals for amendments to the TSI.

3. The CST shall define in particular the minimum safety levels that must be reached by different parts of the railway system and by the system as a whole expressed in risk acceptance criteria for:

a) individual risks related to passengers, staff including the staff of contractors, level crossing users and unauthorised persons on railway premises,

b) societal risks.

4. The CSM shall describe how compliance with the CST is assessed by elaborating and defining:

a) risk evaluation and assessment methods,

b) methods for assessing conformity with requirements in safety certificates issued in accordance with Article 10, and

c) methods to check that the structural subsystems of the trans-European high-speed and conventional rail systems are operated and maintained in accordance with the relevant essential requirements.

5. The CST and CSM shall be revised at regular intervals, in accordance with the procedure referred to in Article 26(2), taking into account the global development of railway safety and technical and scientific progress.

Article 6

Common safety indicators

1. In order to facilitate the assessment of conformity with the CST and to provide for the monitoring of the general development of railway safety Member States shall collect information on common safety indicators (CSI) through the annual reports of the safety authorities as referred to in Article 17.

The first reference year for the CSI will be -- [18] to be reported with the annual report the year after.

[18] Two years after the year of entry into force of this Directive

The CSI are established as set out in Annex I.

2. By (date( [19] at the latest Annex I shall be revised in accordance with the procedure referred to in Article 26(2), in particular to include common definitions of the CSI and common methods to calculate accident costs.

[19] Five years after entry into force of the Directive.

Article 7

National safety rules

1. Member States shall ensure that the national safety rules are published and made available to all infrastructure managers, railway undertakings and applicants for a safety certificate.

2. Member States shall ensure that the safety authorities are made responsible for adoption of national safety rules.

3. By (date( [20] at the latest Member States shall notify the Commission of all the relevant national safety rules in force, as set out in Annex II, and indicate their area of application.

[20] Twelve months after entry into force of the Directive

The notification shall further provide information on the principal content of the rules with references to the legal texts, on the form of legislation and on which body or organisation is responsible for its publication.

Article 8

Adoption of new national safety rules

1. When a Member State intends to introduce new national safety rules or amendments to existing rules as referred to in Annex II, it shall send the draft rule to the Commission, unless the rules are wholly related to the implementation of TSI.

If the draft rule is not in conformity with Community legislation a Decision, addressed to the Member State concerned, shall be adopted in accordance with the procedure referred to in Article 26(2);

If no Decision is adopted within six months after the submission of the draft, the Member State shall be free to adopt the rule.

2. Paragraph 1 shall not apply in those cases where adoption of a new rule is urgent for safety reasons. The Member State shall in such a case inform the Commission of its intention to adopt the rule without following the procedure referred to in paragraph 1 and give the reasons which warrant the urgency of the measures taken. The Commission shall give its views on the information as soon as possible.

Article 9

Safety management systems

1. Infrastructure managers and railway undertakings shall establish their safety management systems to ensure that the railway system is in conformity with CST and with safety requirements laid down in TSI and that the relevant parts of CSM are applied.

In the absence of TSI, CST and CSM, the safety management system shall meet requirements laid down in national safety rules as described in Article 7 and Annex II.

2. The safety management system shall meet the requirements and contain the elements laid down in Annex III, adapted to the character, size and other conditions of the activity pursued. It shall ensure the control of all risks created by the activity of the infrastructure manager or railway undertaking, including the supply of maintenance and material and the use of contractors, and, where appropriate, the risks arising as a result of operations by other parties.

3. The safety management system of any infrastructure manager shall take into account the effects of operations by different railway undertakings on the network and make provisions to allow all railway undertakings to operate in accordance with TSI and national safety rules and with conditions laid down in their safety certificate. It shall furthermore be developed with the aim of coordinating the emergency procedures of the infrastructure manager with all railway undertakings that operate on its infrastructure.

4. Each year all infrastructure managers and railway undertakings shall submit to the safety authority by 30 June at the latest an annual safety report concerning the preceding year. The safety report shall contain:

(a) information on how the organisation's corporate safety targets are met and the results of safety plans;

(b) the development of national safety indicators and of the CSI laid down in Annex I, as far as it is relevant to the reporting organisation;

(c) the results of internal safety auditing;

(d) observations on deficiencies and malfunctions of railway operations and infrastructure management that might be relevant for the safety authority.

Chapter III

SAFETY CERTIFICATION

Article 10

Safety certificates

1. In order to be granted access to the railway infrastructure a railway undertaking must hold a safety certificate according to the provisions of this Chapter. The safety certificate may cover the whole railway network of a Member State or only a defined part thereof.

The purpose of the safety certificate is to give evidence that the railway undertaking has established its safety management system and can meet requirements laid down in TSI and other relevant Community legislation and in national safety rules in order to control risks and operate safely on the network.

2. The safety certificate shall comprise:

(a) certification confirming acceptance of the railway undertaking's safety management system as described in Article 9 and Annex III, and

(b) certification confirming acceptance of the provisions made by the railway undertaking to meet specific requirements necessary for the safe operation on the relevant network concerning the application of TSI and national safety rules and the certification of staff and rolling stock, based on documentation submitted by the railway undertaking as described in Annex IV.

3. The safety authority in the Member State where the railway undertaking first establishes its operation shall grant the certification according to paragraph 2 (a) and (b).

The certification according to paragraph 2 (a) must specify the type and extension of the railway operations covered. It shall be valid throughout the Community for equivalent rail transport operations.

4. The safety authority in the Member State in which the railway undertaking is planning to operate additional rail transport services shall grant the additional national certification necessary according to paragraph 2 (b).

5. The safety certificate shall be renewed every fifth year. It shall be wholly or partly updated whenever the type or extension of the operation is substantially altered.

The holder of the safety certificate shall without delay inform the competent safety authority of all major changes in the conditions of the safety certificate. It shall furthermore notify the competent safety authority whenever new categories of staff or new types of rolling stock are introduced.

The safety authority may require that the safety certificate be revised following substantial changes in the safety regulatory framework.

If the safety authority finds that a holder no longer satisfies the conditions for a safety certificate, it shall revoke the certificate immediately giving reasons for its decision.

6. The safety authority shall inform the Agency on the safety certificates referred to in paragraph 2 (a) that have been issued, renewed, amended or revoked. The information shall state the name and address of the railway undertaking, the issuing date, scope and validity of the safety certificate and, in case of revocation, the reasons for the decision.

7. By (date( [21] at the latest the Agency shall evaluate the development of safety certification and submit a report to the Commission with recommendations on a migration strategy towards a single Community safety certificate. The Commission shall take appropriate action following the recommendation.

[21] Five years after the entry into force of the Directive.

Article 11

Application requirements

1. The safety authority shall take a decision on an application for safety certification without delay, but not more than four months after all information required and any supplementary information requested by the safety authority has been submitted. If the applicant is requested to submit supplementary information, such requests shall be communicated promptly.

2. In order to facilitate the establishment of new railway undertakings and the submission of applications from railway undertakings from other Member States, the safety authority shall give detailed guidance on how to obtain the safety certificate. It shall list all requirements that have been laid down for the purpose of Article 10(2) and make all relevant documents available to the applicant.

Special guidance shall be given to railway undertakings that apply for a safety certificate concerning services on a defined limited part of an infrastructure, specifically identifying the rules that are valid for the part in question.

3. An application guidance document describing and explaining the requirements and listing the documents that must be submitted shall be made available to the applicants free of charge.

Article 12

Training and certification of train staff

1. Train drivers and staff accompanying the trains of a railway undertaking that have been certified according to Article 10(2) (b) in one Member State to meet basic requirements concerning minimum or maximum age, basic abilities, fitness and health status shall be mutually accepted by other Member States.

2. Member States shall ensure that railway undertakings applying for a safety certificate have fair and non-discriminatory access to training facilities for train drivers and staff accompanying the trains, whenever such training is necessary for the fulfilment of requirements to obtain the safety certificate.

The services offered must include necessary route knowledge, operating rules, the signalling and control command system and emergency procedures applied on the routes operated.

If the training services do not include examination and certification, Member States shall ensure that railway undertakings have access to such certification if it is a requirement of the safety certificate.

The safety authority shall ensure that the provision of training services or, where appropriate, certification meets the safety requirements laid down in TSI or national safety rules described in Article 7 and Annex II.

3. If the training facilities are available only through the services of one single railway undertaking or the infrastructure manager, Member States shall ensure that they are made available to other railway undertakings at a reasonable and non-discriminatory price.

Article 13

Certification of in-use rolling stock

1. Railway undertakings operating rolling stock that are certified in one Member State according to Article 10(2) (b) and not, fully in compliance with a TSI shall be certified in additional Member States.

2. The railway undertaking applying for certification in additional Member States shall submit a technical file concerning the rolling stock or type of rolling stock to the relevant safety authority, indicating its intended use on the network. The file shall contain the following information:

(a) evidence that the rolling stock has been certified by a safety authority in another Member State and records that show its history of operation, maintenance and, where applicable, technical modifications undertaken after certification;

(b) relevant technical data and operational characteristics requested by the safety authority and needed for its complementary certification;

(c) evidence on technical and operational characteristics that show that the rolling stock is in compliance with the energy supply system, the signalling and control command system, the track gauge and infrastructure gauges, the maximum allowed axle load and other constraints of the network;

(d) information on exemptions from national safety rules that are needed to grant certification and evidence, based on risk assessment, showing that the acceptance of the rolling stock does not import undue risks on the network.

3. The safety authority may request that test runs on the network be undertaken to verify compliance with the restrictive parameters referred to in paragraph 2 (c) and shall in that case prescribe their range and content.

4. The safety authority shall adopt its decision on an application according to this Article without delay and not later than four months after the complete technical file, including documentation of the test runs, has been submitted. The certificate may contain conditions for use and other restrictions.

Article 14

Harmonisation of safety certificates

1. By (date( [22] at the latest, decisions on common harmonised requirements according to Article 10(2) (b) and Annex IV and a common format for application guidance documents shall be adopted in accordance with the procedure referred to in Article 26(2).

[22] Five years after entry into force of the Directive

2. Prior to the adoption of harmonised requirements and a common format for application guidance documents non-binding guidelines may be adopted in accordance with the procedure referred to in Article 26(3).

3. The Agency shall recommend harmonised requirements and a common format for application guidance documents under a mandate which shall be adopted in accordance with the procedure referred to in Article 26(2).

Chapter IV

SAFETY AUTHORITY

Article 15

Tasks of the safety authority

1. Each Member State shall establish a safety authority to supervise and regulate railway safety. It shall be independent in its organisation, legal structure and decision making from any railway undertaking, infrastructure manager and applicant.

2. The safety authority shall be entrusted with at least the following regulatory tasks:

(a) authorising the bringing into service of the structural subsystems constituting the trans-European high-speed rail system according to Article 14 of Directive 96/48/EC;

(b) authorising the bringing into service of the structural subsystems constituting the trans-European conventional rail system, according to Article 14 of Directive 2001/16/EEC;

(c) authorising the bringing into service of new and substantially altered rolling stock that are not yet covered by a TSI;

(d) the issue, renewal, amendments and revocation of relevant parts of safety certificates according to Article 10;

(e) the adoption of legally binding national safety rules as described in Article 7 and Annex II, unless the rules are issued by the national Parliament or the Government.

3. The safety authority shall be entrusted with the following supervisory tasks:

(a) checking that the structural subsystems of the trans-European high-speed rail system are operated and maintained in accordance with the relevant essential requirements;

(b) checking that the structural subsystems of the trans-European conventional rail system are operated and maintained in accordance with the relevant essential requirements;

(c) carrying out the Member State responsibility concerning the supervision of the interoperability constituents and their compliance with the essential requirements;

(d) checking that infrastructure managers and railway undertakings are operating under the requirements laid down in rules under Community or national law and that conditions and requirements laid down in safety certificates are met;

(e) supervising that rolling stock are duly registered and that safety related information in the national register, established in accordance with Article (...( of Directive 96/48/EC and Article (...( of Directive 2001/16/EC is accurate and kept up-to-date.

4. The tasks referred to in paragraphs 2 and 3 may not be transferred or contracted to any infrastructure manager or railway undertaking.

Article 16

Decision-making principles of the safety authority

1. The safety authority shall carry out its tasks in an open, non-discriminatory and transparent way. In particular shall it allow all parties to be heard and give reasons for decisions.

It shall promptly respond to requests and applications and communicate its requests for information and its decisions without undue delay.

In the process of developing the national regulatory framework the safety authority shall consult all involved and interested parties, including infrastructure managers, railway undertakings, manufacturers and maintenance providers, users and staff representatives.

2. The safety authority shall be free to carry out all inspections and investigations that are needed for accomplishment of its supervisory task and it shall be granted access to all relevant documents and to premises, installations and equipment of infrastructure managers and railway undertakings.

3. Member States shall take the measures necessary to ensure that decisions taken by the safety authority are subject to judicial review.

4. The safety authorities shall conduct an active exchange of views and experience for the purpose of harmonising their decision-making criteria across the Community. The cooperation shall in particular aim at facilitating and coordinating the safety certification of railway undertakings which have been granted international train paths according to the procedure laid down in Article 15 of Directive 2001/14.

The Agency shall support them in these tasks.

Article 17

Annual report

Each year the safety authority shall publish an annual report concerning its activities in the preceding year and send it to the Agency by 30 September at the latest. The report shall contain information on:

(a) the development of railway safety, including an aggregation on Member State level of the CSI laid down in Annex I;

(b) important changes in legislation and regulation concerning railway safety;

(c) the development of safety certification;

(d) results of and experiences from the supervision of infrastructure managers and railway undertakings.

Chapter V

ACCIDENT AND INCIDENT INVESTIGATION

Article 18

Occurrences that shall be investigated

1. Member States shall ensure that an investigation is carried out after serious accidents and incidents on the railway system, the objective of which is possible improvement of railway safety and the prevention of future accidents and incidents.

2. Occurrences that shall be investigated include:

(a) serious accidents;

(b) incidents that under slightly altered conditions might have led to serious accidents, including technical failures to the structural subsystems or to interoperability constituents of the trans-European high-speed or conventional rail systems.

3. The extent of investigations and the procedure to be followed in carrying out such investigations shall be determined by the investigating body referred to in Article 20, taking into account the principles and the objectives of Articles 19 and 21 and depending on the lessons it expects to draw from the accident or incident for the improvement of safety.

It is at the discretion of the investigating body to decide whether an investigation of an occurrence referred to in paragraph 2 (b) shall be established or not. In its decision it shall take into account:

(a) the seriousness of the incident,

(b) whether it forms part of a series of incidents with relevance on system level,

(c) its impact on railway safety in a Community perspective, and

(d) requests from infrastructure managers, railway undertakings or the safety authority.

4. The investigation shall in no case be concerned with apportioning blame or liability.

Article 19

Status of investigation

1. Member States shall define, in the framework of their respective internal legal systems, a legal status of the investigation that will enable the investigators-in-charge to carry out their task in the most efficient way and within the shortest time.

2. In accordance with the legislation in force in the Member States and, where appropriate, in cooperation with the authorities responsible for the judicial inquiry, the investigators shall, as soon as possible, be given:

(a) access to the site of the accident or incident as well as to the rolling stock involved, the related infrastructure and traffic control and signalling installations;

(b) the right to an immediate listing of evidence and controlled removal of wreckage, infrastructure installations or components for examination or analysis purposes;

(c) access to and use of the contents of on-board recorders and equipment for recording of verbal messages and registration of the operation of the signalling and control system;

(d) access to the results of examination of the bodies of victims;

(e) access to the results of examinations of the train staff and other railway staff involved in the accident or incident;

(f) the opportunity to examine involved railway staff and other witnesses;

(g) access to any relevant information or records held by the infrastructure manager, the railway undertakings involved and the safety authority.

3. The investigation shall be accomplished independent of any judicial inquiry and the progress of work may in no case be delayed or restrained by the judicial proceedings.

Article 20

Investigating body

1. Each Member State shall ensure that investigations of accidents and incidents referred to in Article 18(2) are conducted by a permanent body. This body shall be independent in its organisation, legal structure and decision-making from any infrastructure manager, railway undertaking, charging body, allocation body, and notified body. It shall furthermore be independent of the safety authority, of any regulator of railways and of any party whose interests could conflict with the tasks entrusted to the investigating body.

2. The investigating body shall be given the means required to carry out its responsibilities independent of the organisations referred to in paragraph 1 and shall be able to obtain sufficient resources to do so. Its investigators shall be afforded status giving them the necessary guarantees of independence. It shall comprise at least one investigator able to perform the function of investigator-in-charge in the event of an accident or incident.

3. Member States shall make provisions that railway undertakings, infrastructure managers and, where appropriate, the safety authority, are obliged to immediately report accidents and incidents referred to in Article 18(2) to the investigating body. The investigating body shall be able to respond to such reports and make necessary arrangements to establish the investigation without delay.

4. The investigating body may combine its tasks under this Directive with the tasks to investigate other occurrences than railway accidents and incidents as long as such investigations do not endanger the independence of the body.

5. If necessary the body may request the assistance of investigating bodies from other Member States or from the Agency to supply expertise or to carry out technical inspections, analyses or evaluations.

6. Member States may entrust the investigating body with the task to carry out investigations of other rail accidents and incidents than those referred to in Article 18(2).

7. The investigating bodies shall conduct an active exchange of views and experience for the purpose of developing common investigation methods, elaborating common principles for follow-up of safety recommendations and adapt to the development of technical and scientific progress.

The Agency shall support them in this task.

Article 21

Accomplishment of investigations

1. An accident or incident referred to in Article 18(2) shall be investigated by the investigation body of the Member State in which it occurred. If it is not possible to establish in which Member State it occurred or if it occurred on the border between two Member States the relevant bodies shall agree which one of them that will carry out the investigation or agree to carry it out in cooperation. The other body shall in the first case be allowed to participate in the investigation and fully share its results.

2. For each accident or incident the body responsible for the investigation shall arrange for the appropriate means, comprising the necessary operational and technical expertise to carry out the task.

3. The investigation shall be accomplished under as much openness as possible, allowing for all parties to be heard and sharing the results. The relevant infrastructure manager and railway undertakings, the safety authority, victims and their relatives, owners of damaged property, manufacturers, the emergency services involved and representatives of staff and users shall be informed of the investigation and its results and be given, as far as practicable, the opportunity to take part in the proceedings.

Article 22

Reports

1. An investigation of an accident or incident referred to in Article 18(2) shall be the subject of reports in a form appropriate to the type and seriousness of the accident or incident and the relevance of the findings. The reports shall state the objectives of the investigations as referred to in Article 18(1) and contain, where appropriate, safety recommendations.

2. The investigating body shall make public the final report in the shortest possible time and normally not later than 12 months after the date of the occurrence. The report shall, as close as possible, follow the reporting structure laid down in Annex V. The report, including the safety recommendations shall be communicated to the relevant parties referred to in Article 21(3) and to bodies and parties concerned in other Member States.

3. Each year the investigating body shall publish by 30 September at the latest an annual report accounting for the investigations carried out in the preceding year, the safety recommendations that were issued and actions taken according to recommendations issued previously.

Article 23

Information to be sent to the Agency

1. Within one week after the decision to open an investigation the investigating body shall inform the Agency thereof. The information shall indicate the date, time and place of the occurrence, as well as its type and its consequences as regards loss of lives, injuries and damage.

2. The investigating body shall send the Agency a copy of the final reports referred to in Article 22(2) and of the annual report ref