Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance)

REGULATION (EU) 2016/796 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(1) The progressive establishment of a single European railway area requires Union action in the field of the rules applicable to railways with regard to technical safety and interoperability aspects, the two being inextricably linked and both requiring a higher level of harmonisation at Union level. Relevant railway legislation has been adopted in the last two decades, in particular three railway packages of which Directive 2004/49/EC of the European Parliament and of the Council (4) and Directive 2008/57/EC of the European Parliament and of the Council (5) are the most relevant in this regard.

(2) The simultaneous pursuit of the goals of railway safety and interoperability requires substantial technical work led by a specialised body. That is why it was necessary, as part of the Second Railway Package in 2004, to create within the existing institutional framework, and with respect for the balance of power in the Union, a European agency dealing with railway safety and interoperability.

(3) Regulation (EC) No 881/2004 of the European Parliament and of the Council (6) establishes a European railway agency (‘the Agency’) in order to promote the establishment of a European railway area without borders and to help revitalise the railway sector while reinforcing its essential advantages in terms of safety. The Fourth Railway Package contains important changes designed to improve the functioning of the single European railway area through amendments by way of recast to Directive 2004/49/EC and Directive 2008/57/EC, both of which are directly linked to the tasks of the Agency. Those Directives provide in particular for the performance of tasks relating to the issuing of vehicle authorisations and safety certificates at Union level. It involves a greater role for the Agency. Due to the substantial number of changes that it introduces to the tasks and internal organisation of the Agency, Regulation (EC) No 881/2004 should be repealed and replaced by a new legal act.

(4) The Agency should contribute to the development of a genuine European railway culture providing an essential tool for dialogue, consultation and the exchange of views between all the actors in the railway sector, having due regard to their respective functions, as well as the technical characteristics of the railway sector. When performing its tasks, and particularly when drafting recommendations and opinions, the Agency should take utmost account of external railway expertise, in particular that of professionals from the railway sector and from the relevant national authorities. The Agency should therefore set up competent and representative working parties and groups composed predominantly of those professionals.

(5) In order to provide insight into the economic effects on the railway sector and its impact on society, to allow others, in particular the Commission, the Management Board of the Agency (‘the Management Board’) and the Executive Director of the Agency (‘the Executive Director’) to make informed decisions, and to manage the work priorities and resource allocation within the Agency more effectively, the Agency should further develop its engagement in impact-assessment activity.

(6) The Agency should provide independent and objective technical support predominantly to the Commission. Directive (EU) 2016/797 of the European Parliament and of the Council (7) provides for the drafting and revision of technical specifications for interoperability (‘TSIs’), while Directive (EU) 2016/798 of the European Parliament and of the Council (8) provides for the drafting and revision of common safety methods (‘CSMs’), common safety targets (‘CSTs’) and common safety indicators (‘CSIs’). The continuity of the work and of the development of TSIs, CSMs, CSTs and CSIs requires a permanent technical framework and a specialised body with a dedicated staff possessing a high level of expertise. To that end, the Agency should be responsible for providing the Commission with recommendations and opinions in relation to the drafting and revision of TSIs, CSMs, CSTs and CSIs. The Agency should also provide an independent technical opinion, upon request from the national safety authorities and regulatory bodies.

(7) In order to make the issuing of single safety certificates to railway undertakings more efficient and impartial, it is essential that the Agency be assigned a central role. Where the area of operation is limited to one Member State, the railway undertaking concerned should have the possibility of choosing whether to submit its application for a single safety certificate to the Agency or to the national safety authority. Directive (EU) 2016/798 is to provide for this.

(8) Currently, Directive 2008/57/EC provides, in the case of rail vehicles, for the granting of authorisation for the placing in service of such vehicles in each Member State, except in certain specific cases. The task force on vehicle authorisation set up by the Commission in 2011 discussed several cases where manufacturers and railway undertakings have suffered as a result of the excessive duration and cost of the authorisation process and proposed a number of improvements. As some problems are due to the complexity of the current vehicle authorisation process, it should be simplified and, where possible, unified under a single procedure. Each rail vehicle should only receive one authorisation. Where the area of use is limited to a network or networks within one Member State only, the applicant should have the possibility of choosing whether to submit its application for vehicle authorisation, through the one-stop shop referred to in this Regulation, to the Agency or to the national safety authority. This would bring tangible benefits for the sector by reducing the cost and duration of the procedure, and would diminish the risk of potential discrimination, especially against new companies wishing to enter a railway market. Directive (EU) 2016/797 is to provide for this.

(9) It is essential that Directive (EU) 2016/797 and Directive (EU) 2016/798 should not lead to a reduced level of safety in the Union rail system. In that respect, the Agency should take full responsibility for the vehicle authorisations and single safety certificates it issues, assuming, inter alia, both contractual and non-contractual liability in respect thereof.

(10) With regard to liability of the staff of the Agency when carrying out the tasks assigned to the Agency, Protocol No 7 on the privileges and immunities of the European Union should apply. The application of that Protocol should not lead to undue delays or the imposition of unjustified restrictions on the conduct of national judicial proceedings. In the event of judicial proceedings involving the staff of the Agency, in which a member of the staff is requested to appear before a national court, the Management Board should decide without undue delay to waive that member of the staff's immunity, provided that such waiver will not compromise the interests of the Union. Such a decision should be duly justified and should be amenable to judicial review before the Court of Justice of the European Union.

(11) The Agency should cooperate loyally with the national judicial authorities, in particular in cases in which the participation of the Agency is necessary by reason of the Agency having exercised its powers in relation to vehicle authorisations, single safety certificates issued by it and decisions for the approval of European Rail Traffic Management System (ERTMS) trackside equipment projects. Where the Agency or a member of its staff is requested to provide information in the context of relevant national proceedings, the Agency should ensure that such request for information or, if necessary, participation in proceedings, is handled with due diligence and within a reasonable period of time. To that end, the Management Board should adopt appropriate procedures to be used in such cases.

(12) In order to further pursue the development of the single European railway area, in particular in relation to providing appropriate information to freight customers and passengers, and to avoid fragmented development of telematics applications, it is necessary to give the Agency a strengthened role in the field of such applications. The Agency, as a competent body at Union level, should be given a prominent role so as to ensure consistency in the development and deployment of all telematics applications. To that end, the Agency should be empowered to act as the system authority for telematics applications, and should, in that capacity, maintain, monitor and manage all corresponding subsystems requirements at Union level.

(13) Given the importance of the ERTMS for the smooth development of the single European railway area and its safety, and in order to avoid fragmented development of the ERTMS, it is necessary to strengthen overall coordination at Union level. Therefore, the Agency, as the Union body with the greatest expertise in the field, should be given a more prominent role in this field so as to ensure consistency in the development of the ERTMS, to contribute to ensuring that ERTMS equipment complies with the specifications in force and to ensure that ERTMS-related European research programmes are coordinated with the development of ERTMS technical specifications. In particular, the Agency should prevent additional national requirements in relation to the ERTMS from jeopardising its interoperability. However, incompatible national requirements should be applied only on a voluntary basis or repealed.

(14) In order to make the procedures for issuing authorisations for the placing in service of trackside control-command and signalling subsystems more efficient and to harmonise those procedures at Union level, it is essential that, before any call for tenders relating to ERTMS trackside equipment, the Agency check that the technical solutions envisaged are fully compliant with the relevant TSIs and are therefore fully interoperable. Directive (EU) 2016/797 is to provide for this. The Agency should establish a group composed of notified conformity assessment bodies active in the field of the ERTMS. The participation of such bodies in the group should be encouraged as much as possible.

(15) In order to facilitate cooperation and guarantee a clear distribution of tasks and responsibilities between the Agency and national safety authorities, a communication protocol between them should be developed. In addition, a common information and communication platform with a virtual one-stop-shop functionality should be developed, if appropriate on the basis of the existing applications and registers, by extending their functionality with the aim of keeping the Agency and national safety authorities informed about all applications for authorisations and safety certifications, the stages of these procedures and their outcome. An important objective of this platform is to identify at an early stage the need to coordinate decisions to be taken by national safety authorities and the Agency in the case of different applications requesting similar authorisations and safety certificates. Such cases should be identified in a summarised way by automatic notifications.

(16) Competent national authorities have, thus far, been charging for issuing vehicle authorisations and single safety certificates. With the transfer of competences to the Union, the Agency should be entitled to charge applicants for issuing the certificates and authorisations mentioned in the preceding recitals. It is important to establish certain principles applicable to fees and charges payable to the Agency. The level of those fees and charges should be estimated in such a way as to cover the full cost of the service delivered, including as appropriate the relevant costs resulting from the tasks assigned to the national safety authorities. Those fees and charges should be equal to or lower than the current average for the relevant services and should be set in a transparent, fair and uniform manner in cooperation with Member States. They should not jeopardise the competitiveness of the European railway sector and should be established on a basis which takes due account of the ability of undertakings to pay and should not result in the imposition of an unnecessary financial burden on companies. They should also take into account, as appropriate, the specific needs of small and medium-sized enterprises.

(17) It is a general objective that the new allocation of functions and tasks between national safety authorities and the Agency should be done efficiently, without diminishing the current high levels of safety. To that end, cooperation agreements, including cost elements, should be concluded between the Agency and the national safety authorities. The Agency should have sufficient resources to enable it to carry out its new tasks, and the timing of the allocation of those resources should be based on clearly defined needs.

(18) When drafting recommendations, the Agency should take into account the cases of networks which are isolated from the rest of the Union rail system and which require specific expertise for geographical or historical reasons. In addition, where operation is limited to such networks, it should be possible for applicants for single safety certificates and vehicle authorisations to fulfil the necessary formalities locally through the relevant national safety authorities. To that end, and with a view to reducing administrative burdens and costs, it should be possible for cooperation agreements concluded between the Agency and the relevant national safety authorities to provide for the appropriate allocation of tasks, without prejudice to the assumption by the Agency of final responsibility for issuing the authorisation or the single safety certificate.

(19) Taking into account the knowledge of national authorities, in particular the national safety authorities, the Agency should be allowed to make appropriate use of that expertise when granting the relevant authorisations and single safety certificates. To that end, secondment of national experts to the Agency should be encouraged.

(20) Directive (EU) 2016/798 and Directive (EU) 2016/797 are to provide for examination of national measures from the point of view of railway safety and interoperability, and compatibility with competition rules. They are also to limit the possibility for Member States to adopt new national rules. The current system in which numerous national rules continue to exist may lead to possible conflicts with Union rules and give rise to insufficient transparency and possible discrimination against operators, including smaller and new ones. In order to migrate towards a system of truly transparent and impartial railway rules at Union level, a gradual reduction of national rules, including operating rules, needs to be reinforced. An opinion based on independent and neutral expertise is essential at Union level. To that end, the role of the Agency needs to be strengthened.

(21) Performance, organisation and decision-making procedures in the field of railway safety and interoperability vary substantially among the national safety authorities and notified conformity assessment bodies, with a detrimental effect on the smooth operation of the single European railway area. In particular, small and medium-sized enterprises wishing to enter the railway market in another Member State can be negatively affected. Therefore, strengthened coordination with a view to greater harmonisation at Union level is essential. To that end, the Agency should monitor the performance and decision-making of the national safety authorities and the notified conformity assessment bodies through audits and inspections, where appropriate in cooperation with national accreditation bodies.

(22) In the field of safety, it is important to ensure the greatest possible transparency and an effective flow of information. An analysis of performance, based on CSIs and linking all parties in the sector, is important and should be carried out. As regards statistics, close collaboration with Eurostat is necessary.

(23) The Agency should be responsible for publishing a report every 2 years in order to monitor progress in achieving railway safety and interoperability. Given its technical expertise and impartiality, the Agency should also assist the Commission in the performance by the latter of its task of monitoring the implementation of Union railway safety and interoperability legislation.

(24) The interoperability of the trans-European transport network should be enhanced and the new investment projects chosen for support by the Union should be in line with the objective of interoperability set out in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (9). The Agency is the appropriate body to contribute to the attainment of those objectives and should cooperate closely with competent Union bodies in relation to projects concerning the trans-European transport network. With regard to ERTMS deployment and ERTMS projects, the Agency's role should include helping applicants to implement projects which are compliant with the TSI on control-command and signalling.

(25) The maintenance of rolling stock is an important part of the safety system. There has been no genuine European market for the maintenance of rail equipment owing to the lack of a system for certification of maintenance workshops. This situation has led to increased costs for the sector and results in journeys without loads. Common conditions for the certification of maintenance workshops and of entities in charge of the maintenance of vehicles other than freight wagons should therefore be gradually developed and updated, with the Agency being the most appropriate body to propose adequate solutions to the Commission.

(26) The vocational qualifications required of train drivers are a major factor in both railway safety and interoperability within the Union. Vocational qualifications are also a precondition for the free movement of workers in the railway sector. This issue should be addressed within the existing framework for social dialogue. The Agency should provide the technical support necessary in order to take account of this aspect at Union level.

(27) The Agency should facilitate cooperation between the national safety authorities, the national investigating bodies and representative bodies from the railway sector acting at Union level in order to promote good practice, the exchange of relevant information and the collection of railway-related data, and to monitor the overall safety performance of the Union rail system.

(28) In order to ensure the greatest possible levels of transparency and equal access for all parties to relevant information, the registers, where relevant, and the documents envisaged for the railway safety and interoperability processes should be accessible to the public. The same applies to licences, single safety certificates and other relevant railway documents. The Agency should provide efficient, user-friendly and easily accessible means of exchanging and publishing that information, in particular through appropriate IT solutions, with a view to improving the cost-effectiveness of the railway system and supporting the operational needs of the sector.

(29) The promotion of innovation and research in the railway field is important and should be encouraged by the Agency. Any financial assistance provided within the framework of the Agency's activities in this respect should not lead to any distortion in the relevant market.

(30) In order to increase the efficiency of Union financial support, its quality and its compatibility with relevant technical regulations, the Agency should play an active role in the assessment of rail projects.

(31) Proper and uniform understanding of legislation on railway safety and interoperability, implementation guides and recommendations of the Agency are preconditions for effective implementation of the railway acquis and the functioning of the railway market. Therefore, the Agency should actively engage in training and explanatory activities in that regard.

(32) Taking into account the new functions of the Agency in relation to the issuing of vehicle authorisations and single safety certificates, there will be an important need for training and publication activities in those areas. The national safety authorities should be invited to participate in training activities free of charge, whenever possible, in particular when they have been involved in their preparation.

(33) In order to perform its tasks properly, the Agency should have legal personality and an autonomous budget funded mainly through a contribution by the Union and through fees and charges paid by applicants. The Agency's independence and impartiality should not be compromised by any financial contribution that it receives from Member States, third countries or other entities. In order to ensure independence in its daily management and in the opinions, recommendations and decisions which it issues, the Agency's organisation should be transparent and the Executive Director should have full responsibility. The Agency's staff should be independent and should be employed on both short-term and long-term contracts in order to maintain its organisational knowledge and business continuity, while keeping a necessary and ongoing exchange of expertise with the railway sector. The expenditure of the Agency should include staff, administrative, infrastructure and operational expenses, and, inter alia, the amount paid to the national safety authorities for their work in the vehicle authorisation and the single safety certification process, in accordance with the relevant cooperation agreements and with the provisions of the implementing act concerning the determination of fees and charges.

(34) With regard to the prevention and management of conflicts of interest, it is essential that the Agency act impartially, demonstrate integrity and establish high professional standards. There should never be any legitimate reason to suspect that decisions might be influenced by interests conflicting with the role of the Agency as a body serving the Union as a whole or by private interests or affiliations of any member of the Agency staff, any seconded national expert, or any member of the Management Board or Boards of Appeal which would create, or have the potential to create, a conflict with the proper performance of the official duties of the person concerned. The Management Board should therefore adopt comprehensive rules on conflicts of interests that cover the entire Agency. Those rules should take account of recommendations issued by the Court of Auditors in its Special Report No 15 of 2012.

(35) In order to streamline the decision-making process in the Agency and to contribute to enhancing efficiency and effectiveness, a two-level governance structure should be introduced. To that end, the Member States and the Commission should be represented on a Management Board vested with the necessary powers, including the power to establish the budget and approve the programming document. The Management Board should give general orientations for the Agency's activities and be more closely involved in the monitoring of the Agency's activities, with a view to reinforcing supervision on administrative and budgetary matters. A smaller Executive Board should be set up with the task of preparing the meetings of the Management Board in an appropriate manner and supporting its decision-making process. The powers of the Executive Board should be defined in a mandate to be adopted by the Management Board and should, where appropriate, include opinions and provisional decisions subject to final endorsement by the Management Board.

(36) In order to guarantee the transparency of the Management Board's decisions, representatives of the sectors concerned should attend its meetings, but without the right to vote. The representatives of the various stakeholders should be appointed by the Commission on the basis of their representativeness at Union level of railway undertakings, infrastructure managers, the railway industry, trade-union organisations, passengers and freight customers.

(37) It is necessary to ensure that parties affected by decisions made by the Agency have the right to seek the necessary remedies, which should be granted in an independent and impartial manner. An appropriate appeal mechanism should be set up in order for decisions of the Executive Director to be subject to appeal before a specialised Board of Appeal.

(38) In cases of disagreement between the Agency and national safety authorities on the issuing of single safety certificates or vehicle authorisations, an arbitration procedure should be established so that decisions are taken in a concerted and cooperative manner.

(39) A broader strategic perspective in relation to the activities of the Agency would facilitate the planning and management of its resources in a more effective manner and would contribute to a higher quality of its outputs. This is confirmed and reinforced by the Commission Delegated Regulation (EU) No 1271/2013 (10). Therefore, a single programming document containing the annual and multi-annual work programmes should be adopted and updated periodically by the Management Board, following proper consultation of the relevant stakeholders.

(40) When a new task is assigned to the Agency in relation to the safety and interoperability of the Union rail system after the adoption of the programming document, the Management Board should, if necessary, amend the programming document to include that new task following an analysis of the impact, in human and budgetary terms, on resources.

(41) The activity of the Agency should be transparent. Effective control by the European Parliament should be ensured and, to that end, the European Parliament should be consulted on the draft multiannual part of the programming document of the Agency and have the possibility of hearing the Executive Director of the Agency and receiving the annual report on the Agency's activities. The Agency should also apply the relevant Union legislation concerning public access to documents.

(42) Over the past years, as more decentralised agencies have been created, transparency and control over the management of Union funding allocated to them has improved, in particular as regards the budgetisation of fees, financial control, power of discharge, pension scheme contributions and the internal budgetary procedure (code of conduct). Similarly, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (11) should apply without restriction to the Agency, which should accede to the Inter-institutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (12).

(43) The Agency should actively promote the Union approach to railway safety and interoperability in its relations with international organisations and third countries. That should also include, within the limits of the Agency's competence, facilitating reciprocal access for Union railway undertakings to the rail markets of third countries and access for Union rolling stock to the networks of third countries.

(44) In order to ensure uniform conditions for the implementation of this Regulation with regard to the examination of draft national rules and existing national rules, the monitoring of national safety authorities and notified conformity assessment bodies, the establishment of the rules of procedure of the Boards of Appeal and the determination of fees and charges which the Agency is entitled to levy, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (13).

(45) Since the objective of this Regulation, namely to establish a specialised body to formulate common solutions on matters concerning railway safety and interoperability, cannot be sufficiently achieved by the Member States but can rather, by reason of the joint nature of the work to be done, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(46) It is necessary for the proper functioning of the Agency to implement certain principles regarding the governance of the Agency in order to comply with the Joint Statement and Common Approach agreed by the Inter-Institutional Working Group on EU decentralised agencies in July 2012, the purpose of which is to streamline the activities of agencies and increase their performance.

(47) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,

HAVE ADOPTED THIS REGULATION:

CHAPTER 1

PRINCIPLES

Article 1

Subject-matter and scope

(a) the establishment and tasks of the Agency;

(b) the tasks of the Member States in the context of this Regulation.

(a) interoperability within the Union rail system provided for in Directive (EU) 2016/797;

(b) safety of the Union rail system provided for in Directive (EU) 2016/798;

(c) the certification of train drivers provided for in Directive 2007/59/EC of the European Parliament and of the Council (14).

Article 2

Objectives of the Agency

The objective of the Agency shall be to contribute to the further development and effective functioning of a single European railway area without frontiers, by guaranteeing a high level of railway safety and interoperability, while improving the competitive position of the railway sector. In particular, the Agency shall contribute, on technical matters, to the implementation of Union legislation by developing a common approach to safety on the Union rail system and by enhancing the level of interoperability on the Union rail system.

Further objectives of the Agency shall be to follow the development of national railway rules in order to support the performance of national authorities acting in the fields of railway safety and interoperability and to promote the optimisation of procedures.

Where provided for by Directive (EU) 2016/797 and Directive (EU) 2016/798, the Agency shall perform the role of Union authority responsible for issuing authorisations for the placing on the market of railway vehicles and vehicle types and for issuing single safety certificates for railway undertakings.

In pursuing those objectives, the Agency shall take full account of the process of enlargement of the Union and of the specific constraints relating to rail links with third countries.

Article 3

Legal status

Article 4

Type of acts of the Agency

The Agency may:

(a) address recommendations to the Commission concerning the application of Articles 13, 15, 17, 19, 35, 36 and 37;

(b) address recommendations to Member States concerning the application of Article 34;

(c) issue opinions to the Commission pursuant to Article 10(2) and Article 42, and to the authorities concerned in the Member States pursuant to Articles 10, 25 and 26;

(d) address recommendations to national safety authorities pursuant to Article 33(4);

(e) issue decisions pursuant to Articles 14, 20, 21 and 22;

(f) issue opinions constituting acceptable means of compliance pursuant to Article 19;

(g) issue technical documents pursuant to Article 19;

(h) issue audit reports pursuant to Articles 33 and 34;

(i) issue guidelines and other non-binding documents facilitating application of railway safety and interoperability legislation pursuant to Articles 13, 19, 28, 32, 33 and 37.

CHAPTER 2

WORKING METHODS

Article 5

Creation and composition of the working parties and groups

The Agency may set up working parties in other duly justified cases at the request of the Commission or the Committee referred to in Article 81 (‘the committee’) or on its own initiative, after consulting the Commission.

The working parties shall be chaired by a representative of the Agency.

— representatives nominated by the competent national authorities to participate in the working parties,

— professionals from the railway sector selected by the Agency from the list referred to in paragraph 3. The Agency shall ensure adequate representation of those sectors of the industry and of those users which could be affected by measures the Commission may propose on the basis of the recommendations addressed to it by the Agency. The Agency shall strive, where possible, for a balanced geographical representation.

The Agency may, if necessary, appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned. Members of the staff of the Agency may not be appointed to the working parties, except for the chair of the working parties, who shall be a representative of the Agency.

Article 6

Consultation of the social partners

Whenever the tasks provided for in Articles 13, 15, 19, and 36 have a direct impact on the social environment or working conditions of workers in the industry, the Agency shall consult the social partners within the framework of the sectoral dialogue committee set up pursuant to Commission Decision 98/500/EC (15). In such cases, the social partners may react to those consultations, provided that they do so within 3 months.

Those consultations shall be held before the Agency addresses its recommendations to the Commission. The Agency shall take due account of those consultations, and shall, at all times, be available to expound on its recommendations. The opinions expressed by the sectoral dialogue committee shall be forwarded by the Agency, together with the recommendation by the Agency, to the Commission and by the Commission to the committee.

Article 7

Consultation of rail freight customers and passengers

Whenever the tasks provided for in Articles 13 and 19 have a direct impact on rail freight customers and passengers, the Agency shall consult the organisations representing them, including representatives of persons with disabilities and persons with reduced mobility. In such cases, those organisations may react to those consultations, provided that they do so within 3 months.

The list of organisations to be consulted shall be drawn up by the Commission with the assistance of the committee.

Those consultations shall be held before the Agency addresses its recommendations to the Commission. The Agency shall take due account of those consultations, and shall, at all times, be available to expound on its recommendations. The opinions expressed by the organisations concerned shall be forwarded by the Agency, together with the recommendation by the Agency, to the Commission and by the Commission to the committee.

Article 8

Impact assessment

(a) the issue to be solved and the possible solutions;

(b) the extent to which a specific action, including addressing a recommendation or issuing an opinion of the Agency, would be required;

(c) the expected Agency contribution to the solution of the problem.

Before any activities or projects are included in the programming document, they shall be made subject to an efficiency analysis individually and in conjunction with each other, in order to make best use of the budget and resources of the Agency.

At the request of the Agency, the representative bodies shall provide the Agency with non-confidential data necessary for the impact assessment.

Article 9

Studies

Where required for the implementation of its tasks, the Agency shall order studies, involving, where appropriate, the working parties and groups referred to in Article 5, and shall finance those studies from its budget.

Article 10

Opinions

Article 11

Visits to Member States

Article 12

One-stop shop

(a) a single entry point through which the applicant shall submit its application files for type authorisation, vehicle authorisations for placing on the market and single safety certificates. Where the area of use or operation is limited to a network or networks within one Member State only, the single entry point shall be developed so as to ensure that the applicant selects the authority it wishes to process the application for issuing authorisations or single safety certificates for the whole procedure;

(b) a common information-exchange platform, providing the Agency and national safety authorities with information about all applications for authorisations and single safety certificates, the stages of these procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal;

(c) a common information-exchange platform, providing the Agency and national safety authorities with information about requests for approvals by the Agency in accordance with Article 19 of Directive (EU) 2016/797 and applications for authorisations of trackside control-command and signalling subsystems involving European Train Control System (ETCS) and/or Global System for Mobile Communications – Railway (GSM-R) equipment, the stages of these procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal;

(d) an early-warning system able to identify at an early stage the needs for coordination between decisions to be taken by national safety authorities and the Agency in the case of different applications requesting similar authorisations or single safety certificates.

(a) informing applicant(s) that there is another or similar request for authorisation or certification;

(b) coordinating with the relevant national safety authority in order to ensure consistency of decisions to be taken by national safety authorities and the Agency. If no mutually acceptable solution can be found within 1 month of the beginning of the coordination process, the matter shall be referred for arbitration to the Board of Appeal referred to in Articles 55, 61 and 62.

CHAPTER 3

TASKS OF THE AGENCY RELATING TO RAILWAY SAFETY

Article 13

Technical support – recommendations on railway safety

Article 14

Single safety certificates

The Agency shall issue, renew, suspend and amend single safety certificates and cooperate with national safety authorities in that respect in accordance with Articles 10, 11 and 18 of Directive (EU) 2016/798.

The Agency shall restrict or revoke single safety certificates and cooperate with national safety authorities in that respect in accordance with Article 17 of Directive (EU) 2016/798.

Article 15

Maintenance of vehicles

Article 16

Cooperation with national investigating bodies

The Agency shall cooperate with national investigating bodies in accordance with Article 20(3), Article 22(1), (2), (5) and (7) and Article 26 of Directive (EU) 2016/798.

Article 17

Transport of dangerous goods by rail

The Agency shall follow developments in the legislation dealing with the transport of dangerous goods by rail within the meaning of Directive 2008/68/EC of the European Parliament and of the Council (17) and shall, together with the Commission, ensure that such developments are consistent with the legislation dealing with rail safety and interoperability, in particular the essential requirements. To that end, the Agency shall assist the Commission and may issue recommendations at the Commission's request or on its own initiative.

Article 18

Exchange of information on safety-related accidents

The Agency shall encourage, the exchange of information on safety-related accidents, incidents and near misses, taking into account the experience of the railway actors referred to in Article 4 of Directive (EU) 2016/798. That exchange of information shall lead to the development of good practices at Member State level.

CHAPTER 4

TASKS OF THE AGENCY RELATING TO INTEROPERABILITY

Article 19

Technical support in the field of railway interoperability

(a) address recommendations to the Commission on the TSIs and their revision, in accordance with Article 5 of Directive (EU) 2016/797;

(b) address recommendations to the Commission on the templates for the ‘EC’ declaration of verification and for documents of the technical file that has to accompany it for the purposes of Article 15(9) of Directive (EU) 2016/797;

(c) address recommendations to the Commission on specifications for registers and their revision for the purposes of Articles 47, 48 and 49 of Directive (EU) 2016/797;

(d) issue opinions which constitute acceptable means of compliance concerning deficiencies in TSIs, in accordance with Article 6(4) of Directive (EU) 2016/797, and provide those opinions to the Commission;

(e) at the request of the Commission, issue opinions to it regarding requests by Member States for non-application of TSIs, in accordance with Article 7 of Directive (EU) 2016/797;

(f) issue technical documents, in accordance with Article 4(8) of Directive (EU) 2016/797;

(g) issue a decision for approval before any call for tenders relating to ERTMS trackside equipment in order to ensure harmonised implementation of the ERTMS in the Union pursuant to Article 19 of Directive (EU) 2016/797;

(h) issue recommendations to the Commission regarding the training and certification of on-board staff with safety-critical tasks;

(i) issue detailed guidance concerning standards for the relevant European standardisation bodies to complement the mandate given to them by the Commission;

(j) address recommendations to the Commission relating to the working conditions of all staff carrying out safety-critical tasks;

(k) address recommendations to the Commission in relation to harmonised standards to be developed by European standardisation bodies and standards relating to interchangeable spare parts which may improve the level of safety and interoperability of the Union rail system;

(l) address, where appropriate, recommendations to the Commission in relation to safety-critical components.

(a) ensure that the TSIs and the specifications for registers are adapted to technical progress, market trends and social requirements;

(b) ensure that the development and updating of the TSIs and the development of any European standards which prove necessary for interoperability are coordinated, and maintain relevant contacts with European standardisation bodies;

(c) participate, where appropriate, as an observer in the relevant working groups established by recognised standardisation bodies.

Article 20

Authorisations for the placing on the market of vehicles

The Agency shall issue authorisations for the placing on the market of railway vehicles, and shall be empowered to renew, amend, suspend and revoke authorisations issued by it. For that purpose, the Agency shall cooperate with national safety authorities in accordance with Article 21 of Directive (EU) 2016/797.

Article 21

Authorisations for the placing on the market of vehicle types

The Agency shall issue authorisations for the placing on the market of vehicle types, and shall be empowered to renew, amend, suspend and revoke authorisations issued by it, in accordance with Article 24 of Directive (EU) 2016/797.

Article 22

Placing in service of trackside control-command and signalling subsystems

The Agency shall, before any call for tenders relating to ERTMS trackside equipment, check that the technical solutions are fully compliant with the relevant TSIs and are therefore fully interoperable, and take a decision for approval in accordance with Article 19 of Directive (EU) 2016/797.

Article 23

Telematics applications

Article 24

Support for notified conformity assessment bodies

CHAPTER 5

TASKS OF THE AGENCY RELATING TO NATIONAL RULES

Article 25

Examination of draft national rules

Within that period, the Agency shall exchange relevant information with the Member State concerned, consult the relevant stakeholders where appropriate, and subsequently inform the Member State of the outcome of the examination.

(a) issue an opinion addressed to the Member State concerned, stating the reasons why the national rule or rules in question should not enter into force and/or be applied; and

(b) inform the Commission of its negative assessment, stating the reasons why the national rule or rules in question should not enter into force and/or be applied.

This shall not prejudice the right of a Member State to adopt a new national rule in accordance with point (c) of Article 8(3) of Directive (EU) 2016/798 or with point (b) of Article 14(4) of Directive (EU) 2016/797.

Where the reasons provided are deemed not to be sufficient, or in the absence of such information, and the Member State adopts the national rule in question without paying sufficient heed to the opinion referred to in paragraph 3, the Commission may adopt, by way of implementing acts, a decision addressed to the Member State concerned, requesting it to modify or repeal that rule. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 81(2).

Article 26

Examination of existing national rules

Within that period, the Agency shall exchange relevant information with the Member State concerned and subsequently inform it of the outcome of the examination.

(a) issue an opinion addressed to the Member State concerned, stating that the national rule or rules in question has or have been the subject of a negative assessment and the reasons why the rule or rules in question should be modified or repealed; and

(b) inform the Commission of its negative assessment, stating the reasons why the national rule or rules in question should be modified or repealed.

In the case of a positive assessment by the Agency and if the national rule in question has an impact on more than one Member State, the Commission, working in cooperation with the Agency and Member States, shall take the appropriate measures, including the revision of CSMs and TSIs where necessary.

Article 27

IT system to be used for notification purposes and classification of national rules

CHAPTER 6

TASKS OF THE AGENCY RELATING TO THE EUROPEAN RAIL TRAFFIC MANAGEMENT SYSTEM (ERTMS)

Article 28

System authority for the ERTMS

Article 29

ERTMS group of notified conformity assessment bodies

The group shall check the consistency of application of the procedure for assessing the conformity or suitability for use of an interoperability constituent as referred to in Article 9 of Directive (EU) 2016/797 and of the ‘EC’ procedures for verification referred to in Article 10 of Directive (EU) 2016/797 and carried out by notified conformity assessment bodies.

Article 30

Compatibility between ERTMS on-board and trackside subsystems

(a) without prejudice to Article 21(5) of Directive (EU) 2016/797, and before issuing an authorisation for the placing on the market of a vehicle equipped with an ERTMS on-board subsystem, advise applicants at their request, on the technical compatibility between ERTMS on-board and trackside subsystems;

(b) without prejudice to Article 17 of Directive (EU) 2016/798, and after issuing an authorisation for the placing on the market of a vehicle equipped with an ERTMS on-board subsystem, advise railway undertakings at their request, before they use a vehicle equipped with an ERTMS on-board subsystem, on the operational compatibility between ERTMS on-board and trackside subsystems.

For the purposes of this paragraph, the Agency shall cooperate with the relevant national safety authorities.

Article 31

Supporting ERTMS deployment and ERTMS projects

Article 32

Accreditation of laboratories

CHAPTER 7

TASKS OF THE AGENCY RELATING TO MONITORING THE SINGLE EUROPEAN RAILWAY AREA

Article 33

Monitoring of the performance and decision-making of national safety authorities

(a) the capacity of national safety authorities to execute tasks relating to railway safety and interoperability; and

(b) the effectiveness of the monitoring by national safety authorities of safety management systems of actors as referred to in Article 17 of Directive (EU) 2016/798.

The Management Board shall adopt the policy, working methods, procedures and practical arrangements for the application of this paragraph, including, where appropriate, arrangements regarding consultation with Member States before the publication of information.

The Agency shall promote the inclusion in the audit team of qualified auditors from national safety authorities that are not subject to the actual audit. For that purpose, the Agency shall establish a list of qualified auditors and provide them with training when needed.

The policy, working methods and procedure for performing the inspections shall be adopted by the Management Board.

Article 34

Monitoring of notified conformity assessment bodies

Article 35

Monitoring progress of railway safety and interoperability

CHAPTER 8

OTHER TASKS OF THE AGENCY

Article 36

Railway staff

Article 37

Registers and their accessibility

(a) the European Vehicle Register in accordance with Article 47 of Directive (EU) 2016/797;

(b) the European register of authorised vehicle types in accordance with Article 48 of Directive (EU) 2016/797.

(a) developing and maintaining specifications of the registers;

(b) coordinating developments in the Member States in relation to the registers;

(c) providing guidance on the registers to relevant stakeholders;

(d) addressing recommendations to the Commission regarding improvements to the specifications of existing registers, where necessary including simplification and deletion of redundant information, and any need to set up new ones, subject to a cost-benefit analysis.

(a) the ‘EC’ declarations of verification of subsystems;

(b) the ‘EC’ declarations of conformity of interoperability constituents and ‘EC’ declarations of suitability of use of interoperability constituents;

(c) the licences issued in accordance with Article 24(8) of Directive 2012/34/EU of the European Parliament and of the Council (21);

(d) the single safety certificates issued in accordance with Article 10 of Directive (EU) 2016/798;

(e) the investigation reports sent to the Agency in accordance with Article 24 of Directive (EU) 2016/798;

(f) the national rules notified to the Commission in accordance with Article 8 of Directive (EU) 2016/798 and Article 14 of Directive (EU) 2016/797;

(g) the vehicle registers referred to in Article 47 of Directive (EU) 2016/797, including via the links to relevant national registers;

(h) the infrastructure registers, including via the links to relevant national registers;