EN Official Journal of the European Union L 138/1

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

1. This Regulation establishes a European Union Agency for Railways (‘the Agency’).

2. This Regulation provides for:

(a) the establishment and tasks of the Agency;

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

3. This Regulation supports the establishment of the single European railway area, and in particular the objectives relating to:

(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

1. The Agency shall be a body of the Union with legal personality.

2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.

3. The Agency shall be represented by its Executive Director.

4. The Agency shall have sole responsibility for the functions and powers assigned to it.

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

1. The Agency shall set up a limited number of working parties for the purpose of drawing up recommendations and, where relevant, guidelines, in particular relating to technical specifications for interoperability (‘TSIs’), common safety targets (‘CSTs’), common safety methods (‘CSMs’) and the use of common safety indicators (‘CSIs’).

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.

2. The working parties shall be composed of:

— 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.

3. Each representative body referred to in Article 38(4) shall forward to the Agency a list of the most qualified experts mandated to represent it in each working party and shall update that list whenever changes occur.

4. Whenever the work of such working parties has a direct impact on the working conditions, health and safety of workers in the industry, representatives designated by the trade-union organisations acting at European level shall participate in the relevant working parties as full members.

5. Travel and subsistence expenses of the members of the working parties, based on rules and scales adopted by the Management Board, shall be met by the Agency.

6. The Agency shall take due account of the outcome of the work done by the working parties when drawing up the recommendations and guidelines referred to in paragraph 1.

7. The Agency shall set up groups for the purposes of Articles 24, 29 and Article 38(1).

8. The Agency may set up groups in accordance with Article 38(4) and in duly justified cases at the request of the Commission or of the committee, or on its own initiative.

9. The work of the working parties and of the groups shall be transparent. The Management Board shall adopt the rules of procedure of the working parties and of the groups, including transparency rules.

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

1. The Agency shall conduct an impact assessment of its recommendations and opinions. The Management Board shall adopt an impact-assessment methodology based on the methodology of the Commission. The Agency shall liaise with the Commission to ensure that relevant work at the Commission is duly taken into account. The Agency shall clearly identify the assumptions used as the basis for the impact assessment and the data sources used in the report accompanying each recommendation.

2. Before including an activity in the programming document adopted by the Management Board, in accordance with Article 51(1), the Agency shall conduct an early impact assessment in relation to which it shall state:

(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.

3. The Agency may conduct an ex post assessment of the legislation based on its recommendations.

4. Member States shall provide the Agency with the data necessary for an impact assessment, where available.

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

1. The Agency shall issue opinions at the request of one or more national regulatory bodies referred to in Article 55 of Directive 2012/34/EU of the European Parliament and of the Council (16), in particular concerning safety-related and interoperability-related aspects of matters drawn to their attention.

2. The Agency shall issue opinions at the request of the Commission on amendments to any act adopted on the basis of Directive (EU) 2016/797 or Directive (EU) 2016/798, especially where any alleged deficiency is signalled.

3. All opinions of the Agency, and in particular those referred to in paragraph 2, shall be issued by the Agency as soon as possible and at the latest within 2 months of receipt of the request therefor, unless otherwise agreed with the requesting party. Those opinions shall be made public by the Agency within 1 month after they are issued, in a version from which all commercially confidential material has been removed.

Article 11

Visits to Member States

1. In order to perform the tasks entrusted to it, in particular those referred to in Articles 14, 20, 21, 25, 26, 31, 32, 33, 34, 35 and 42, and to assist the Commission in fulfilling its duties under the Treaty on the Functioning of European Union (TFEU), including, in particular the assessment of the effective implementation of relevant Union legislation, the Agency may carry out visits to the Member States, in accordance with the policy, working methods and procedures adopted by the Management Board.

2. Following consultation with the Member State concerned, the Agency shall inform the latter in good time of the planned visit, the names of the Agency officials delegated to carry out the visit, the date on which the visit is to start and its expected duration. The Agency officials delegated to carry out such visits shall do so on presentation of a decision in writing by the Executive Director specifying the purpose and the aims of their visit.

3. The national authorities of the Member States concerned shall facilitate the work of the Agency's staff.

4. The Agency shall draw up a report on each visit referred to in paragraph 1 and send it to the Commission and to the Member State concerned.

5. This Article is without prejudice to the inspections referred to in Articles 33(7) and 34(6).

6. Travel, accommodation, subsistence and other expenses incurred by the Agency's staff shall be met by the Agency.

Article 12

One-stop shop

1. The Agency shall establish and manage an information and communications system with at least the following one-stop-shop functions:

(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.

2. The technical and functional specifications of the one-stop shop referred to in paragraph 1 shall be developed in cooperation with the network of national safety authorities referred to in Article 38 on the basis of a draft prepared by the Agency taking into account the results of a cost-benefit analysis. On this basis, the Management Board shall adopt the technical and functional specifications and a plan to establish the one-stop shop. The one-stop shop shall be developed without prejudice to the intellectual property rights and the required confidentiality level, and taking into consideration, if appropriate, the IT applications and registers already set up by the Agency, such as those referred to in Article 37.

3. The one-stop shop shall be operational by 16 June 2019.

4. The Agency shall monitor the applications submitted through the one-stop shop, in particular by using the early-warning system referred to in point (d) of paragraph 1. If different applications requesting similar authorisations or single safety certificates are detected, the Agency shall ensure appropriate follow-up, such as:

(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

1. The Agency shall address recommendations to the Commission on the CSIs, CSMs and CSTs provided for in Articles 5, 6 and 7 of Directive (EU) 2016/798. The Agency shall also address recommendations on periodic revision of CSIs, CSMs and CSTs to the Commission.

2. The Agency shall address recommendations to the Commission, at the request of the Commission or on its own initiative, on other measures in the field of safety, taking into account the experience gained.

3. The Agency shall issue guidelines in order to assist national safety authorities with regard to supervision of railway undertakings, infrastructure managers and other actors, in accordance with Article 17 of Directive (EU) 2016/798.

4. The Agency may address recommendations to the Commission on the CSMs covering any elements of the safety management system which need to be harmonised at Union level, in accordance with Article 9(7) of Directive (EU) 2016/798.

5. The Agency may issue guidelines and other non-binding documents to facilitate the implementation of railway safety legislation, including the provision of assistance to Member States in identifying national rules that can be repealed further to the adoption and/or revision of CSMs and guidelines for the adoption of new national rules or the amendment of existing national rules. The Agency may also issue guidelines on railway safety and safety certification, including lists of examples of good practice, in particular for cross-border transport and infrastructure.

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

1. The Agency shall assist the Commission with regard to the system of certification of entities in charge of maintenance in accordance with Article 14(7) of Directive (EU) 2016/798.

2. The Agency shall address recommendations to the Commission for the purposes of Article 14(8) of Directive (EU) 2016/798.

3. The Agency shall analyse any alternative measures decided in accordance with Article 15 of Directive (EU) 2016/798 and shall include the outcome of its analysis in the report referred to in Article 35(4) of this Regulation.

4. The Agency shall support and, upon request, coordinate the national safety authorities in the supervision of entities in charge of maintenance as referred to in point (c) of Article 17(1) of Directive (EU) 2016/798.

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

1. The Agency shall:

(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.

2. In drafting recommendations as referred to in points (a), (b), (c), (h), (k) and (l) of paragraph 1, the Agency shall:

(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.

3. The Agency may issue guidelines and other non-binding documents to facilitate the implementation of railway interoperability legislation, including assistance to Member States in identifying national rules that can be repealed further to the adoption or revision of TSIs.

4. In cases of non-compliance of interoperability constituents with essential requirements, the Agency shall assist the Commission in accordance with Article 11 of Directive (EU) 2016/797.

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

1. The Agency shall act as the system authority to ensure the coordinated development of telematics applications in the Union, in accordance with relevant TSIs. To that end, the Agency shall maintain, monitor and manage the corresponding subsystems requirements.

2. The Agency shall define, publish and apply the procedure for managing requests for changes to specifications for telematics applications. To that end, the Agency shall set up, maintain and update a register of requests for changes to such specifications and their status, accompanied by the relevant justifications.

3. The Agency shall develop and maintain the technical tools for managing the different versions of specifications for telematics applications and endeavour to ensure backward compatibility.

4. The Agency shall assist the Commission in the monitoring of deployment of specifications for telematics applications in accordance with relevant TSIs.

Article 24

Support for notified conformity assessment bodies

1. The Agency shall support the activities of notified conformity assessment bodies as referred to in Article 30 of Directive (EU) 2016/797. That support shall include, in particular, the issue of drafting guidelines 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 guidelines for the ‘EC’ verification procedure referred to in Articles 10 and 15 of Directive (EU) 2016/797.

2. The Agency may facilitate cooperation between notified conformity assessment bodies, in accordance with Article 44 of Directive (EU) 2016/797, and may, in particular, act as the technical secretariat for their coordination group.

CHAPTER 5

TASKS OF THE AGENCY RELATING TO NATIONAL RULES

Article 25

Examination of draft national rules

1. The Agency shall, within 2 months of receipt thereof, examine the draft national rules submitted to it in accordance with Article 8(4) of Directive (EU) 2016/798 and Article 14(5) of Directive (EU) 2016/797. If translation is necessary or the draft national rule is long or complex the Agency may extend this time period by up to 3 additional months, subject to the consent of the Member State. However, in exceptional circumstances, the Agency and the Member State concerned may mutually agree to further extend that period.

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.

2. Where, after the examination referred to in paragraph 1, the Agency considers that the draft national rules enable the essential requirements for railway interoperability to be fulfilled, the CSMs and TSIs in force to be respected and the CSTs to be achieved, and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operations between Member States, the Agency shall inform the Commission and the Member State concerned of its positive assessment. In that case, the Commission may validate the rules in the IT system referred to in Article 27. Where the Agency within 2 months of receipt of the draft national rule or within the extended time period agreed in accordance with paragraph 1 does not inform the Commission and the Member State concerned of its assessment, the Member State may proceed with the introduction of the rule without prejudice to Article 26.

3. Where the examination referred to in paragraph 1 leads to a negative assessment, the Agency shall inform the Member State concerned and ask it to state its position regarding that assessment. If, following that exchange of views with the Member State concerned, the Agency maintains its negative assessment, the Agency shall within a maximum period of 1 month:

(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.

4. The Member State concerned shall inform the Commission of its position on the opinion referred to in paragraph 3 within 2 months, including its reasons in the event of disagreement.

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

1. The Agency shall, within 2 months of receipt thereof, examine the national rules notified in accordance with Article 14(6) of Directive (EU) 2016/798 and Article 8(6) of Directive (EU) 2016/797. If translation is necessary or the national rule is long or complex the Agency may extend this time period by up to 3 additional months, subject to the consent of the Member State. However, in exceptional circumstances, the Agency and the Member State concerned may mutually agree to further extend that time period.

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

2. Where, after the examination referred to in paragraph 1, the Agency considers that the national rules enable the essential requirements for railway interoperability to be fulfilled, the CSMs and TSIs in force to be respected and the CSTs to be achieved, and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operations between Member States, the Agency shall inform the Commission and the Member State concerned of its positive assessment. In that case, the Commission may validate the rules in the IT system referred to in Article 27. Where the Agency does not inform the Commission and the Member State concerned within 2 months of receipt of the national rules, or within the extended time period agreed in accordance with paragraph 1, the rule shall remain valid.

3. Where the examination referred to in paragraph 1 leads to a negative assessment, the Agency shall inform the Member State concerned and ask it to state its position regarding that assessment. If, following that exchange of views with the Member State concerned, the Agency maintains its negative assessment, the Agency shall within a maximum period of 1 month:

(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.

4. The Member State concerned shall inform the Commission of its position on the opinion referred to in paragraph 3 within 2 months, including its reasons in the event of disagreement. Where the reasons provided are deemed not to be sufficient, or in the absence of such information, the Commission may adopt, by way of implementing acts, a decision addressed to the Member State concerned, requesting it to modify or repeal the national rule in question. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 81(2).

5. By way of derogation from paragraphs 3 and 4, in the case of urgent preventive measures, where the examination referred to in paragraph 1 leads to a negative assessment and if the Member State concerned has not amended or repealed the national rule in question within 2 months of receipt of the opinion of the Agency, the Commission may adopt a decision, by way of implementing acts, requesting the Member State to amend or repeal that rule. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 81(2).

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.

6. The procedure referred to in paragraphs 2, 3 and 4 shall apply, mutatis mutandis, in cases where the Agency becomes aware of any national rule, whether or not notified, that is redundant, in conflict with the CSMs, CSTs, TSIs or any other Union legislation in the railway field or creates an unjustified barrier to the single railway market.

Article 27

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

1. The Agency shall manage a dedicated IT system containing national rules as referred to in Articles 25 and 26 and acceptable national means of compliance referred to in point 34 of Article 2 of Directive (EU) 2016/797. The Agency shall make them accessible to stakeholders for the purposes of consultation, where appropriate.

2. Member States shall notify national rules as referred to in Articles 25(1) and 26(1) to the Agency and to the Commission through the IT system referred to in paragraph 1 of this Article. The Agency shall publish those rules in that IT system, including the status of their examination and, when completed, the positive or negative outcome of the assessment, and use that IT system for the purposes of informing the Commission in accordance with Articles 25 and 26.

3. The Agency shall carry out a technical examination of the existing national rules referred to in the available national legislation, which, as of 15 June 2016 are listed in its reference document database. The Agency shall classify notified national rules in accordance with Article 14(10) of Directive (EU) 2016/797. To that end, it shall use the system referred to in paragraph 1 of this Article.

4. The Agency shall classify notified national rules in accordance with Article 8 of, and Annex I to, Directive (EU) 2016/798, taking into account the development of Union legislation. To that end, the Agency shall develop a rule management tool to be used by Member States for simplifying their systems of national rules. The Agency shall use the system referred to in paragraph 1 of this Article to publish the rule management tool.

CHAPTER 6

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

Article 28

System authority for the ERTMS

1. The Agency shall act as the system authority to ensure the coordinated development of the ERTMS within the Union, in accordance with relevant TSIs. To that end, the Agency shall maintain, monitor and manage the corresponding subsystem requirements, including the technical specifications for ETCS and GSM-R.

2. The Agency shall define, publish and apply the procedure for managing requests for changes to the ERTMS specifications. To that end, the Agency shall set up, maintain and update a register of requests for changes to ERTMS specifications and their status, accompanied by the relevant justifications.

3. The development of new versions of ERTMS technical specifications shall not be detrimental to the rate of deployment of the ERTMS, the stability of the specifications which is needed to optimise the production of ERTMS equipment, the return on investment for railway undertakings, infrastructure managers and keepers, and efficient planning of the deployment of the ERTMS.

4. The Agency shall develop and maintain the technical tools for managing the different versions of the ERTMS, with the aim of ensuring technical and operational compatibility between networks and vehicles fitted with different versions and of providing incentives for the swift and coordinated implementation of the versions in force.

5. In accordance with Article 5(10) of Directive (EU) 2016/797, the Agency shall ensure that successive versions of ERTMS equipment are technically compatible with earlier versions.

6. The Agency shall draw up and disseminate relevant application guidelines for stakeholders and explanatory documentation relating to the technical specifications for the ERTMS.

Article 29

ERTMS group of notified conformity assessment bodies

1. The Agency shall set up and chair an ERTMS group of notified conformity assessment bodies as referred to in Article 30(7) of Directive (EU) 2016/797.

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.

2. The Agency shall report every year to the Commission on the activities of the group referred to in paragraph 1, including by means of statistics on attendance of notified conformity assessment bodies' representatives in the group.

3. The Agency shall evaluate the application of the procedure for conformity assessment of interoperability constituents and of the ‘EC’ verification procedure for ERTMS equipment, and shall submit to the Commission, every 2 years, a report including, where appropriate, recommendations for any improvements.

Article 30

Compatibility between ERTMS on-board and trackside subsystems

1. The Agency shall decide to:

(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.

2. Where, before an authorisation is issued by the national safety authority, the Agency becomes aware or is informed by the applicant through the one-stop shop in accordance with Article 19(6) of Directive (EU) 2016/797 that a project design or specification was changed after the Agency had issued an approval in accordance with Article 19 of Directive (EU) 2016/797 and that there is a risk of a lack of technical and operational compatibility between the ERTMS trackside subsystem and vehicles fitted with ERTMS, it shall cooperate with the parties involved, including the applicant and the relevant national safety authority, in order to find a mutually acceptable solution. If no mutually acceptable solution can be found within 1 month of the beginning of the coordination process, the matter shall be referred to the Board of Appeal for arbitration.

3. Where the Agency finds after an authorisation is issued by the national safety authority that there is a risk of a lack of technical or operational compatibility between the relevant networks and vehicles fitted with ERTMS equipment, the national safety authority and the Agency shall cooperate with all parties involved in order to find, without delay, a mutually acceptable solution. The Agency shall inform the Commission about such cases.

Article 31

Supporting ERTMS deployment and ERTMS projects

1. The Agency shall assist the Commission in monitoring the deployment of the ERTMS in accordance with the European deployment plan in force. At the Commission's request, it shall facilitate the coordination of ERTMS deployment along the Trans-European Transport Corridors and Rail Freight Corridors as provided for in Regulation (EU) No 913/2010 of the European Parliament and of the Council (18).

2. The Agency shall ensure technical follow-up of Union-funded projects for the deployment of the ERTMS, including, where applicable and without causing undue delay to the process, analysis of tendering documents at the time of the call for tenders. The Agency shall also, if necessary, assist the beneficiaries of those Union funds to ensure that the technical solutions implemented within projects are fully compliant with the TSIs relating to control-command and signalling and are therefore fully interoperable.

Article 32

Accreditation of laboratories

1. The Agency shall support, in particular by giving appropriate guidelines to the accreditation bodies, harmonised accreditation of ERTMS laboratories in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (19).

2. The Agency shall inform Member States and the Commission in cases of non-conformity with the requirements of Regulation (EC) No 765/2008 in relation to the accreditation of ERTMS laboratories.

3. The Agency may participate as an observer in the peer evaluations required by Regulation (EC) No 765/2008.

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

1. In order to perform the tasks entrusted to it and to assist the Commission in fulfilling its duties under the TFEU, the Agency shall monitor the performance and decision-making of national safety authorities through audit and inspections, on behalf of the Commission.

2. The Agency shall be entitled to audit:

(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.

3. The Agency shall issue audit reports and send them to the national safety authority concerned, to the Member State concerned and to the Commission. Each audit report shall include, in particular, a list of any deficiencies identified by the Agency as well as recommendations for improvement.

4. If the Agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability, the Agency shall recommend to the national safety authority that it take appropriate steps within a mutually agreed time limit, taking into account the seriousness of the deficiency. The Member State concerned shall be kept informed by the Agency about such a recommendation.

5. Where a national safety authority disagrees with the Agency's recommendations referred to in paragraph 4, or does not take the appropriate steps referred to in paragraph 4, or where no answer is given by a national safety authority in response to the Agency's recommendations within 3 months of receipt thereof, the Agency shall inform the Commission.

6. The Commission shall inform the Member State concerned of the issue and ask it to state its position regarding the recommendation referred to in paragraph 4. Where the answers provided are deemed not to be sufficient or, where no answer is given by the Member State within 3 months of the Commission's request, the Commission may within 6 months take appropriate action concerning the steps to be taken as a result of the audit, where relevant.

7. The Agency shall be entitled to conduct pre-announced inspections of national safety authorities, to verify specific areas of their activities and operation, and in particular to review documents, processes and records relating to their tasks as referred to in Directive (EU) 2016/798. The inspections may be conducted on an ad hoc basis or in accordance with a plan developed by the Agency. The duration of an inspection shall not exceed 2 days. The national authorities of the Member States shall facilitate the work of the Agency's staff. The Agency shall provide the Commission, the Member State concerned and the national safety authority concerned with a report on each inspection.

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

1. For the purposes of Article 41 of Directive (EU) 2016/797, the Agency shall support the Commission in monitoring the notified conformity assessment bodies through the provision of assistance to accreditation bodies and to the relevant national authorities, and through audits and inspections, as provided for in paragraphs 2 to 6.

2. The Agency shall support harmonised accreditation of notified conformity assessment bodies, in particular by giving the accreditation bodies appropriate guidance on evaluation criteria and procedures to assess whether notified bodies meet the requirements referred to in Chapter VI of Directive (EU) 2016/797, via the European accreditation infrastructure recognised pursuant to Article 14 of Regulation (EC) No 765/2008.

3. In the case of notified conformity assessment bodies which are not accredited in accordance with Article 27 of Directive (EU) 2016/797, the Agency may audit their capacity to meet the requirements laid down in Article 30 of Directive (EU) 2016/797. The procedure for performing audits shall be adopted by the Management Board.

4. The Agency shall issue audit reports covering the activities referred to in paragraph 3 and send them to the notified conformity assessment body concerned, to the Member State concerned and to the Commission. Each audit report shall include, in particular, a list of any deficiencies identified by the Agency as well as recommendations for improvement. If the Agency considers that those deficiencies prevent the notified conformity assessment body concerned from effectively performing its tasks in relation to railway interoperability, the Agency shall adopt a recommendation requesting the Member State in which that notified body is established to take appropriate steps, within a mutually agreed time limit, taking into account the seriousness of the deficiency.

5. Where a Member State disagrees with the recommendation referred to in paragraph 4 or does not take the appropriate steps referred to in paragraph 4, or where no answer is given by a notified body in response to the Agency's recommendation within 3 months of receipt thereof, the Agency shall inform the Commission. The Commission shall inform the Member State concerned about the issue and ask it to state its position regarding the recommendation. Where the answers provided are deemed not to be sufficient or where no answer is given by the Member State within 3 months of receipt of the Commission's request, the Commission may adopt a decision within a period of 6 months.

6. The Agency shall be entitled to conduct pre-announced or unannounced inspections of notified conformity assessment bodies, to verify specific areas of their activities and operation, and in particular to review documents, certificates and records relating to their tasks as referred to in Article 41 of Directive (EU) 2016/797. In the case of accredited bodies, the Agency shall cooperate with the relevant national accreditation bodies. In the case of conformity assessment bodies which are not accredited, the Agency shall cooperate with the relevant national authorities that recognised the notified bodies concerned. The inspections may be conducted on an ad hoc basis or in accordance with the policy, working methods and procedures developed by the Agency. The duration of an inspection shall not exceed 2 days. The notified conformity assessment bodies shall facilitate the work of the Agency's staff. The Agency shall provide the Commission and the Member State concerned with a report on each inspection.

Article 35

Monitoring progress of railway safety and interoperability

1. The Agency, together with the national investigation bodies, shall collect relevant data on accidents and incidents, taking into account the contribution of the national investigation bodies to the safety of the Union rail system.

2. The Agency shall monitor the overall safety performance of the Union rail system. The Agency may in particular seek the assistance of the bodies referred to in Article 38, including assistance in the form of the collection of data and access to the results of the peer review in accordance with Article 22(7) of Directive (EU) 2016/798. The Agency shall also draw on the data collected by Eurostat and shall cooperate with Eurostat to prevent any duplication of work and to ensure methodological consistency between the CSIs and the indicators used in other modes of transport.

3. At the Commission's request, the Agency shall issue recommendations on how to improve the interoperability of the Union rail system, in particular by facilitating coordination between railway undertakings and infrastructure managers, or between infrastructure managers.

4. The Agency shall monitor progress on the safety and interoperability of the Union rail system. Every 2 years it shall present to the Commission, and publish, a report on progress on safety and interoperability in the single European railway area.

5. The Agency shall, at the Commission's request, provide reports on the state of implementation and application of Union legislation on railway safety and interoperability in a given Member State.

6. The Agency shall, at the request of a Member State or the Commission, provide an overview of the safety and interoperability level of the Union rail system and establish a dedicated tool for that purpose, in accordance with Article 53(2) of Directive (EU) 2016/797.

CHAPTER 8

OTHER TASKS OF THE AGENCY

Article 36

Railway staff

1. The Agency shall perform the appropriate tasks relating to railway staff set out in Articles 4, 22, 23, 25, 28, 33, 34, 35 and 37 of Directive 2007/59/EC of the European Parliament and of the Council (20).

2. The Commission may request the Agency to perform other tasks relating to railway staff in accordance with Directive 2007/59/EC and to issue recommendations relating to railway staff entrusted with safety tasks not covered by Directive 2007/59/EC.

3. The Agency shall consult the national authorities competent with regard to railway staff issues concerning the tasks referred to in paragraphs 1 and 2. The Agency may promote cooperation between those authorities, including by organising appropriate meetings with their representatives.

Article 37

Registers and their accessibility

1. The Agency shall set up and maintain, where relevant in cooperation with the competent national actors:

(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.

2. The Agency shall act as the system authority for all registers and databases referred to in Directive (EU) 2016/797, Directive (EU) 2016/798 and Directive 2007/59/EC. Its actions in that capacity shall include, in particular:

(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.

3. The Agency shall make the following documents and registers provided for in Directive (EU) 2016/797 and Directive (EU) 2016/798 publicly available:

(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;

(i) the registers relating to entities in charge of maintenance and their certification bodies;

(j) the European register of authorised types of vehicles in accordance with Article 48 of Directive (EU) 2016/797;

(k) the register of requests for changes and planned changes to the ERTMS specifications, in accordance with Article 28(2) of this Regulation;

(l) the register of requests for changes and planned changes to the TSIs for telematics applications for passengers (‘TAPs’) and telematics applications for freight (‘TAFs’), in accordance with Article 23(2) of this Regulation;

(m) the register of vehicle keeper markings kept by the Agency in accordance with the TSI on operation and traffic management;

(n) the quality reports issued in accordance with Article 28(2) of Regulation (EC) No 1371/2007 of the European Parliament and of the Council (22).

4. The practical arrangements for sending the documents referred to in paragraph 3 shall be discussed and agreed by the Commission and the Member States on the basis of a draft prepared by the Agency.

5. When the documents referred to in paragraph 3 are being sent, the bodies concerned may indicate which documents are not to be disclosed to the public for reasons of security.

6. The national authorities responsible for issuing the licences referred to in point (c) of paragraph 3 of this Article shall notify the Agency of each individual decision to issue, renew, amend or revoke those licenses, in accordance with Directive 2012/34/EU.

The national safety authorities responsible for issuing the single safety certificates referred to in point (d) of paragraph 3 of this Article shall notify the Agency, in accordance with Article 10(16) of Directive (EU) 2016/798, of each individual decision to issue, renew, amend, restrict or revoke those certificates.

7. The Agency may include any public document or link relevant to the objectives of this Regulation in the public database, taking into account applicable Union legislation on data protection.

Article 38

Cooperation among national safety authorities, investigating bodies and representative bodies

1. The Agency shall establish a network of the national safety authorities referred to in Article 16 of Directive (EU) 2016/798. The Agency shall provide the network with a secretariat.

2. The Agency shall support the investigating bodies in accordance with Article 22(7) of Directive (EU) 2016/798. To facilitate cooperation among the investigating bodies, the Agency shall provide a secretariat which shall be organised separately from the functions within the Agency relating to safety certification of railway undertakings and authorisations to place vehicles on the market.

3. The objectives of the cooperation between the bodies referred to in paragraph 1 and 2 shall be, in particular:

(a) exchange of information relating to railway safety and interoperability;

(b) promotion of good practices and dissemination of relevant knowledge;

(c) provision to the Agency of data on railway safety, in particular data relating to CSIs.

The Agency shall facilitate cooperation between the national safety authorities and national investigating bodies, in particular by holding joint meetings.

4. The Agency may establish a network of representative bodies from the railway sector acting at Union level. The list of those bodies shall be defined by the Commission. The Agency may provide the network with a secretariat. The tasks of the network shall be, in particular:

(a) exchange of information relating to railway safety and interoperability;

(b) promotion of good practices and dissemination of relevant knowledge;

(c) provision to the Agency of data on railway safety and interoperability.

5. The networks and bodies referred to in paragraphs 1, 2 and 4 of this Article may comment on the draft opinions referred to in Article 10(2).

6. The Agency may establish other networks with bodies or authorities having responsibility for a part of the Union rail system.

7. The Commission may participate in the meetings of networks referred to in this Article.

Article 39

Communication and dissemination

The Agency shall communicate and disseminate to relevant stakeholders information relating to the Union framework of railway law and the development of standards and guidance in accordance with relevant communication and dissemination plans adopted by the Management Board on the basis of a draft prepared by the Agency. Those plans, based on an analysis of needs, shall be regularly updated by the Management Board.

Article 40

Research and promotion of innovation

1. The Agency shall contribute, at the Commission's request or on its own initiative subject to the procedure referred to in Article 52(4), to railway research activities at Union level, including by providing support to relevant Commission services and representative bodies. Such contributions shall be without prejudice to other research activities at Union level.

2. The Commission may entrust the Agency with the task of promoting innovation aimed at improving railway safety and interoperability, particularly the use of new information technologies, timetable information and tracking and tracing systems.

Article 41

Assistance to the Commission

The Agency shall, at the Commission's request, assist the Commission with the implementation of Union legislation aimed at enhancing the level of interoperability of railway systems and at developing a common approach to safety on the Union rail system.

Such assistance may include providing technical advice in matters requiring specific knowledge and collecting information through the networks referred to in Article 38.

Article 42

Assistance with the assessment of rail projects

Without prejudice to the derogations provided for by Article 7 of Directive (EU) 2016/797, the Agency shall, at the Commission's request, examine, from the point of view of railway safety and interoperability, any project involving the design, construction, renewal or upgrading of any subsystem in respect of which an application for Union financial support has been submitted.

Within a period to be agreed with the Commission, which may not exceed 2 months, taking into account the importance of the project and the resources available, the Agency shall give an opinion on whether the project complies with the relevant railway safety and interoperability legislation.

Article 43

Assistance to Member States, candidate countries and stakeholders

1. At the request of the Commission, Member States, candidate countries or the networks referred to in Article 38, the Agency shall engage in training and other appropriate activities concerning the application and explanation of railway safety and interoperability legislation and related products of the Agency such as registers, implementation guides and recommendations.

2. The nature and extent of the activities referred to in paragraph 1, including the possible impact on resources, shall be decided by the Management Board and included in the Agency's programming document. The costs of such assistance shall be borne by the requesting parties unless otherwise agreed.

Article 44

International relations

1. In so far as is necessary in order to achieve the objectives set out in this Regulation, and without prejudice to the respective competences of the Member States, the institutions of the Union and the European External Action Service, the Agency may strengthen coordination with international organisations on the basis of concluded agreements and develop contacts and enter into administrative arrangements with supervisory authorities, international organisations and the administrations of third countries competent in matters covered by Agency activities in order to keep up with scientific and technical developments and to ensure promotion of the Union railways legislation and standards.

2. The arrangements referred to in paragraph 1 shall not create legal obligations incumbent on the Union and its Member States, nor shall they prevent Member States and their competent authorities from concluding bilateral or multilateral arrangements with the supervisory authorities, international organisations and the administrations of third countries referred to in paragraph 1. Such bilateral or multilateral arrangements and cooperation shall be subject to prior discussion with the Commission and periodical reporting to it. The Management Board shall be duly informed of those bilateral or multilateral arrangements.

3. The Management Board shall adopt a strategy for relations with third countries or international organisations concerning matters for which the Agency is competent. That strategy shall be included in the programming document of the Agency, with a specification of associated resources.

Article 45

Coordination regarding spare parts

The Agency shall contribute to the identification of potential interchangeable spare parts to be standardised, including main interfaces to such spare parts. To that end, the Agency may establish a working party to coordinate the activities of relevant stakeholders and may establish contacts with the European standardisation bodies. The Agency shall present to the Commission appropriate recommendations.

CHAPTER 9

ORGANISATION OF THE AGENCY

Article 46

Administrative and management structure

The Agency's administrative and management structure shall comprise:

(a) a Management Board, which shall exercise the functions set out in Article 51;

(b) an Executive Board, which shall exercise the functions set out in Article 53;

(c) an Executive Director, who shall exercise the duties set out in Article 54;

(d) one or more Boards of Appeal, which shall exercise the functions set out in Articles 58 to 62.

Article 47

Composition of the Management Board

1. The Management Board shall be composed of one representative from each Member State and two representatives of the Commission, all with a right to vote.

The Management Board shall also include six representatives, without a right to vote, representing, at European level, the following stakeholders:

(a) railway undertakings;

(b) infrastructure managers;

(c) the railway industry;

(d) trade-union organisations;

(e) passengers;

(f) freight customers.

For each of those stakeholders, the Commission shall appoint a representative and an alternate from a shortlist of four names submitted by their respective European organisations.

2. Board members and their alternates shall be appointed in light of their knowledge of the Agency's core business, taking into account relevant managerial, administrative and budgetary skills. All parties shall make efforts to limit turnover of their representatives on the Management Board, in order to ensure continuity of the Management Board's work. All parties shall aim to achieve a balanced gender representation on the Management Board.

3. Member States and the Commission shall appoint members of the Management Board and their respective alternates who shall replace the members in their absence.

4. The term of office of the members shall be 4 years and may be renewed.

5. Where appropriate, the participation of representatives of third countries and the conditions of such participation shall be established in the arrangements referred to in Article 75.

Article 48

Chairperson of the Management Board

1. The Management Board shall elect, by a two-thirds majority of its members entitled to vote, a chairperson from among the representatives of the Member States and a deputy chairperson from among its members.

The deputy chairperson shall replace the chairperson in the event of the chairperson being unable to attend to his or her duties.

2. The term of office of the chairperson and deputy chairperson shall be 4 years and may be renewed once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically also expire on that date.

Article 49

Meetings

1. Meetings of the Management Board shall be conducted in accordance with its rules of procedure and convened by its chairperson. The Executive Director of the Agency shall participate in the meetings, except when his or her participation may lead to a conflict of interests, as decided by the chairperson, or when the Management Board is to take a decision relating to Article 70, in accordance with point (i) of Article 51(1).

The Management Board may invite any person whose opinion may be of interest to attend specific agenda items of its meetings as an observer.

2. The Management Board shall meet at least twice a year. It shall also meet on the initiative of the chairperson or at the request of the Commission, of a majority of its members, or of one-third of the Member States' representatives on the Board.

3. When a matter of confidentiality or a conflict of interest arises, the Management Board may decide to examine specific items on its agenda without the members concerned being present. This does not affect the right of the Member States and of the Commission to be represented by an alternate or by any other person. Detailed rules for the application of this provision shall be laid down in the Management Board's rules of procedure.

Article 50

Voting

Unless stated otherwise in this Regulation, the Management Board shall take its decisions by an absolute majority of its members entitled to vote. Each member entitled to vote shall have one vote.

Article 51

Functions of the Management Board

1. In order to ensure that the Agency carries out its tasks, the Management Board shall:

(a) adopt the annual report on the Agency's activities for the previous year, send it by 1 July to the European Parliament, the Council, the Commission and the Court of Auditors, and make it public;

(b) adopt each year, by a two-thirds majority of its members entitled to vote, after having received the opinion of the Commission and in accordance with Article 52, the programming document of the Agency;

(c) adopt, by a two-thirds majority of its members entitled to vote, the annual budget of the Agency and exercise other functions in relation to the Agency's budget, in accordance with Chapter 10;

(d) establish procedures for decision-making by the Executive Director;

(e) adopt a policy, working methods and procedures in relation to visits, audits and inspections pursuant to Articles 11, 33 and 34;

(f) establish its rules of procedure;

(g) adopt and update the communication and dissemination plans referred to in Article 39;

(h) subject to paragraph 2, exercise, with respect to the staff of the Agency, the powers conferred by the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union (‘Staff Regulations’ and the ‘Conditions of Employment of Other Servants’) laid down in Regulation (EEC, Euratom, ECSC) No 259/68 (23) on the appointing authority and on the authority empowered to conclude contracts of employment;

(i) take duly reasoned decisions in relation to waiver of immunity in accordance with Article 17 of Protocol No 7 on the privileges and immunities of the European Union;

(j) submit to the Commission, for it