EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

1.1. Recent EU policy developments in the railway field

In its White Paper ‘Roadmap to a Single European Transport Area — Towards a competitive and resource efficient transport system’, adopted on 28 March 2011 (‘the 2011 White Paper’), the Commission set out its vision of a Single European Railway Area, i.e. an internal railway market in which European railway undertakings could provide services without unnecessary technical and administrative barriers.

The European Council conclusions of January 2012 also highlight the importance of releasing the growth-creating potential of a fully integrated Single Market, for network industries as well as others[1]. Furthermore, the Commission Communication on Action for Stability, Growth and Jobs adopted on 30 May 2012[2] stresses the importance of reducing further the regulatory burden and barriers to entry in the rail sector, making country-specific recommendations for this purpose. And on 6 June 2012, the Commission adopted the Communication on strengthening the governance of the single market, which likewise stresses the importance of the transport sector[3].

In the last decade, the EU railway market has seen massive changes, gradually introduced by three legislative ‘railway packages’ (and some accompanying acts) intended to open up the national markets and make railways more competitive and interoperable at EU level, while maintaining a high level of safety. However, despite the considerable development of EU laws and other measures (the ‘EU acquis’) establishing an internal market for rail transport services, the railways’ share of intra-EU transport has remained modest. The Commission has therefore come forward with a Fourth Railway Package to enhance the quality and efficiency of rail services by removing the remaining market obstacles.

The present Regulation is a component of the Fourth Railway Package focusing on the removal of remaining administrative and technical barriers, in particular by establishing a common approach to safety and interoperability rules to increase economies of scale for railway undertakings active across the EU, decreasing administrative costs and accelerating administrative procedures, as well as avoiding disguised discrimination, through a European Union Agency for Railways. It is intended to replace the original founding Regulation, and add new important tasks to the Agency making it a truly European Railway Authority in the field of interoperability and safety.

1.2. Why to replace existing Regulation 881/2004 (as amended) with a new act?

Since 2004, when the original founding Regulation was drafted, a number of developments have taken place in relation to the European railways and the Agency. There has been mounting evidence on the functioning of the EU railway internal market, also in relation to its interoperability and safety aspects. New legislation emerged which resulted in amending the Agency Regulation (2008) or which developed the existing tasks of ERA without changing its Regulation (e.g. Decision 2011/155/EU).

The impact assessment report accompanying this proposal has identified a number of measures which would give new powers to the Agency and streamline existing processes.

Moreover, a number of changes have to be introduced to improve the functioning of the Agency in result of the evaluation of ERA founding Regulation and of the Agency (2009-2010) as well as the recommendations of the Joint Statement of the Commission, the European Parliament and the Council on decentralised agencies (2012), and the Position paper of the Administrative Board on the future of the Agency (2012). This concerns particularly improvements to internal structure, governance and decision-making of the Agency, and its relations with stakeholders.

A new Regulation will also help to clarify the structure of the legal act (e.g. by removing and renumbering the Articles) and make it more logical (e.g. by moving some Articles to more relevant Chapters, creating new Chapters and deleting the obsolete ones). Finally, the Interoperability and Safety Directives are also being amended within this legislative package and they are closely related to the tasks of ERA, therefore this Regulation has to properly take this into account.

On the basis above, and taking into account the advice of the Legal Service, the Commission intends to propose a new ERA Regulation replacing original Regulation 881/2004. There is a number of changes in relation to Regulation 881/2004, which can be grouped in three different categories:

· New provisions: new tasks of the Agency (issuing vehicle authorisations for placing on the market, authorisations for placing in service of trackside control-command and signalling sub-systems and safety certificates), reinforced control over national authorities, more powers in relation to national rules, new source of ERA’s budget (fees and charges), the Board of Appeal; some new provisions – especially in the internal organisation part – result from the Common Approach on the EU agencies.

· Clarification/simplification of existing provisions: especially in relation to working methods, the ERTMS, railway staff, registers, other tasks.

· Updates due to the evolution of the legislative and political framework: provisions concerning internal structure and operation, as well as references to comitology procedures and delegated acts.

· Editorial changes in relation to the original Regulation.

1.3. Links between this Regulation and the Interoperability and Safety Directives

Directive 2008/57/EC (Railway Interoperability Directive) and Directive 2004/49/EC (Railway Safety Directive) are closely linked with original Regulation 881/2004. In the 4th railway package, these Directives are proposed to be recast; they will, nevertheless, remain closely linked with the present Regulation. This predominantly stems from the fact that the Agency acts in the fields of railway interoperability and safety for which those directives provide the legal basis.

In the present Regulation, the links concern in particular:

– technical specifications for interoperability (TSIs; Interoperability Directive), common safety targets (CSTs; Safety Directive) and common safety methods (CSMs; Safety Directive): the Agency is responsible for drawing up recommendations for them to be adopted by the Commission, and for issuing opinions to the Commission regarding non-application of TSIs;

– safety certificates: the Agency is responsible for issuing them, while the full procedure is provided in the Safety Directive;

– registers: the Agency is responsible for issuing recommendations to the Commission regarding specification for registers (referred to in the Interoperability Directive) and their revision, and ensuring there are accessible to the public;

– authorisations for placing on the market for railway vehicles and types of vehicles and authorisation for placing in service of trackside control-command and signalling sub-systems: the Agency is responsible for issuing them, while the full procedure for applying for them is provided in the Interoperability Directive;

– telematics applications and European Rail Traffic Management System (ERTMS): these are specific areas governed by relevant TSIs adopted under the Interoperability Directive where the Agency has an important role to play being a system authority;

– notified conformity assessment bodies: the Agency is responsible for supporting and monitoring their activities while they are created and given tasks by the Interoperability Directive;

– national safety authorities: the Agency is responsible for supporting and monitoring their activities while they are created and given tasks by the Safety Directive;

– national railway rules: the Agency is responsible for their examination with a view to their reduction while the procedure for their notification is provided for in the Safety and Interoperability Directives.

2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

The Commission services have discussed the developments of the Single European Railway Area with sector representatives on an on-going basis. In 2010-2011 it conducted an ex post evaluation of Regulation 881/2004 and the functioning of the European Union Agency for Railways[4]. This evaluation, together with the general evaluation of the EU Agencies in 2009, showed the added value provided by the Agency and in general a positive opinion of stakeholders in relation to ERA and its outputs. The results of the evaluation have been used as an important input and preparatory work to the subsequent process of impact assessment linked with the revision of the Regulation.

The European Commission carried out a thorough impact assessment to support legislative proposals on improving the efficiency and competitiveness of the Single European Railway Area in the field of interoperability and safety. An Impact Assessment Steering Group (IASG) was created in June 2011 to which all DGs were invited by DG MOVE to participate.

An external consultant drafted an impact assessment support study and conducted a targeted consultation of stakeholders. The targeted consultation started on 18 November 2011 with an internet survey that finished on 30 December 2011. It was followed by interviews with the most significant stakeholders and a stakeholder workshop at the end of February 2012.

Since then, DG MOVE has engaged in bilateral meetings with the sector to gauge their views on what should be done in the Fourth Package in the area of interoperability and safety.

Given the technical nature of the initiative, no public consultation was carried out. However, the Commission took care that all interested parties were consulted in due time and discussions covered all the key elements of the initiative.

Impact Assessment Board:

On 5 September 2012 the Impact Assessment Board met and subsequently gave a positive opinion. The Board’s main recommendations were incorporated in the impact assessment report:

– more statistics and information on stakeholders’ consultation were added;

– expected synergies with other elements of the Fourth Railway Package were added and indirect impacts clarified;

– the core measures common to options 2-5 were described in more detail and clarified regarding their differentiation;

– the methods used to assess impact were clarified and better explained; the logic was brought out by better cross-referencing;

– administrative costs for economic actors (railway operators) and the cost to public administrations (national authorities, ERA and the Commission) were distinguished more clearly.

Options identified:

Based on the screening of individual measures, the Commission has identified five policy options (options 2-6), besides the baseline scenario. By construction, options 2-5 concern primarily the level of interaction between the European Union Agency for Railways (ERA or the Agency) and national authorities and are all capable of tackling the three operational objectives. Option 6 is a set of horizontal measures which are mostly independent of the interactions between ERA and national authorities and can be applied on top of any of the option 2-5, with expected reinforcement of the overall final impact.

Option 1: Baseline scenario (do nothing) — continuing on the path that is currently set out for the sector

Option 2: Greater coordination role for the Agency in ensuring a consistent approach to certification of railway undertakings and vehicle authorisation

Option 3: ERA as a one-stop-shop, where the final decision on certification and authorisation remains with the NSAs but ERA performs entry and exit checks of applications and of the decisions

Option 4: ERA and NSAs share competencies, where the final decision on certification and authorisation is taken by the Agency

Option 5: ERA takes over activities of NSAs in relation to certification of railway undertakings and vehicle authorisation

Option 6: Horizontal measures, includes other legislative and soft measures (beyond sharing the responsibilities between national authorities and ERA) that could be implemented to improve the competitiveness of the rail sector, like enhancing the role of ERA in the dissemination of railway-related information and training or migrating from national technical and safety rules to a system of EU rules (through the identification of unnecessary rules by ERA and NSAs and then the requirement for national authorities to remove those rules, as well as limiting the possibility of adopting new rules).

Impacts of the options: The environmental impact of all the options was assessed as positive, though low. The social impact of all the options was assessed as low/marginal.

The table below presents the economic benefits (efficiency) and number of objectives met (effectiveness) for combined options:

Option || Efficiency (Total Net Benefit € m) || Effectiveness (number of operational objectives met)

Option 2+6: Further ERA ‘Coordination’ + horizontal measures || 411 || 1

Option 3+6: ERA as One-Stop-Shop+ horizontal measures || 461 || 2

Option 4+6: ERA and NSAs share competencies + horizontal measures || 497 || 3

Option 5+6: ERA takes over activities of NSAs regarding authorisation & certification+ horizontal measures || 476 || 3

It was concluded that Option 4 (combined with option 6) was the preferred option as it provides the best balance of outcomes in relation to:

– the industry, in terms of reduced costs and timescales for safety certification and vehicle and other sub-system authorisation;

– cost implications for the EU budget;

– the cost impacts on national institutions;

– accordance with the subsidiarity and proportionality principles;

– addressing the problems identified, and

– meeting the objectives.

More information on the impact assessment and the results of the stakeholder consultation is provided in the Commission staff working document accompanying legislative proposals to eliminate remaining administrative and technical barriers in the field of interoperability and safety on the EU railway market. It will be published on the website of the Secretariat-General of the Commission following the adoption of this legal act.

3. LEGAL ELEMENTS OF THE PROPOSAL

This section comments on and explains the main provisions of the new ERA Regulation, when necessary in relation to amendments to the original text of Regulation 881/2004.

CHAPTER 1 PRINCIPLES:

Article 1: the objectives have been revised to reflect new tasks of the Agency and moved to the recitals; instead, a "subject matter and scope" is given, for clarity.

Article 2: legal status moved here as more appropriate (previously original Article 22).

Article 3: amended to properly reflect new types of acts of the Agency.

CHAPTER 2 WORKING METHODS:

New chapter added to cover issues which were originally in other chapters but which in fact relate to the methods by which ERA attains its objectives.

Article 4: "working parties" article rewritten for legal clarity, in particular: the reference to AEIF is obsolete now and can be deleted; original Article 24(4) was moved here instead of the article on ERA staff; rules of procedure to be adopted by the Board.

Article 7: "impact assessment"; the original text limited cost-benefit analysis to safety only (Article 6(4)); this task should not be part of any particular Agency activity, hence the need to move the paragraphs into a general section, make it generally applicable and provide clear tasks; this is in accordance with the Position paper of the Board on the future of ERA and the principles of activity-based budgeting and management.

Article 8: "studies"; previously Article 20 — moved as studies are means of achieving the objectives and not tasks as such.

Article 9: "opinions"; formerly Article 10 on Technical Opinions; the word ‘technical’ is deleted, in line with the directives; paragraph 2a(b) removed as obsolete; paragraph 3 (original paragraph 2b) amended to broaden its scope (previously limited to TSIs only, without a clear rationale).

Article 10: "visits to Member States"; previously Article 33 — moved to this section as the visits are means of achieving the Agency’s objectives.

CHAPTER 3 TASKS RELATING TO RAILWAY SAFETY:

Article 11: "technical support – safety"; minor changes clarifying the Agency’s tasks.

Article 12: "safety certificates"; new role of ERA (issuing of safety certificates), as proposed in the IA report, in line with the revised Safety Directive.

Article 13: "maintenance of vehicles"; new article — left over from original Chapter 3a, simplified and moved to the safety part as being the most relevant.

Article 14: "transport of dangerous goods by rail"; new article, formalising what ERA is actually doing already in the field of transport of dangerous goods by rail.

CHAPTER 4 TASKS RELATING TO INTEROPERABILITY:

Article 15: "technical support – interoperability"; amended slightly to reflect changes in the Interoperability Directive (points b and c) and to clarify the existing tasks of ERA.

Article 16: "vehicle authorisations"; new article — covering ERA’s new role in issuing vehicle authorisations for placing on the market, as proposed in the IA report, in line with the amended Interoperability Directive.

Article 17: "authorisations for type of vehicles"; new article — covering ERA’s new role in issuing authorisations for placing on the market for types of vehicles, in line with the amended Interoperability Directive.

Article 18: "authorisation for placing in service of trackside control-command and signalling sub-systems"; new article — covering ERA’s new role regarding authorisation of track-side control-command and signalling equipment; linked with ERA’s role as the system authority and the consequences of the new task of issuing of vehicle authorisations for placing on the market for the ERTMS (in order to ensure that the authorisations for placing on the market issued for vehicles with ERTMS equipment on board are consistent with track-side systems).

Article 19: "telematics applications"; new article added to formalise the existing role ERA plays already, according to TAP/TAF TSI, and in line with the IA report.

Article 20: "support for the notified conformity assessment bodies"; amended — provisions on Commission monitoring of notified bodies have been moved to the new section on monitoring; the remainder is support for notified bodies (the Commission assigned tasks relating to the Technical Secretariat of the NB Rail to the Agency as of 20 April 2011 and this activity is already on-going; this needs to be properly reflected in the legislation).

CHAPTER 5 TASKS RELATING TO NATIONAL RULES (moved after the chapter on interoperability):

Articles 21, 22 and 23: "national rules"; new articles which incorporate original Articles 9a and 9b, amended to align procedures with the Interoperability and Safety Directives and take into account the extended powers of ERA in relation to national rules resulting from the IA report and draft report of the Task Force on National Safety Rules; management of the IT database given clearly to ERA, in order to clarify previous mixed responsibilities (Commission and ERA) and to overcome current technical, coordination and ownership problems.

CHAPTER 6 TASKS RELATING TO ERTMS: the ERTMS section deserves a separate new chapter.

Articles 24-28: "ERTMS tasks" these incorporate the original Article 21a, amended to clarify the responsibilities of the Agency and other actors in relation to the ERTMS, to improve ERTMS deployment, and to reflect what ERA is already currently doing in this field; Article 13e amended in line with preliminary Commission evaluation of four years of technical follow-up.

CHAPTER 7 TASKS RELATING TO MONITORING SINGLE EUROPEAN RAILWAY AREA: new chapter — various tasks related to monitoring are now combined together in one chapter for better visibility and clarity.

Article 29: "monitoring of national safety authorities"; new article — new ERA task: control over NSAs, as proposed in the IA report (and in the evaluation of the ERA Regulation).

Article 30: "monitoring of notified bodies"; new article — new ERA task: control over notified bodies, as proposed in the IA report.

Article 31: "monitoring progress of interoperability and safety"; partly based on original Article 9 (new paragraphs 1 and 2, with ERA’s tasks in relation to safety monitoring now clarified), on original Article 14 (new paragraphs 3 and 4, with two separate reports on interoperability and safety now merged into one); paragraph 5 — based on Article 21b (2a), in accordance with the IA report and the evaluation of the ERA Regulation.

CHAPTER 8 OTHER TASKS – new chapter combining previous chapters on registers, railway staff and other tasks:

Article 32: "railway staff"; combines original Articles 16b, 16c and 17 to simplify: some tasks are obsolete, others are described in Directive 2007/59; amended to avoid legal ambiguity and repetition.

Article 33: "registers"; this article combines original Articles 18 and 19, updated and aligned with legislation.

Article 34: "networks of national safety authorities, investigating bodies and representative bodies"; previously partly in original Article 6(5) and Article 9; the network of representative bodies has been added (paragraph 2) to improve and structure coordination of stakeholders at Agency level; paragraph 3 has been added to improve and structure consultation of all stakeholders, and ultimately to obtain higher quality outputs from the Agency (in line with the evaluation of ERA Regulation and Position paper on the future of ERA).

Article 35: "communication and dissemination"; new article, formalising partly the existing activities of ERA and stemming from IA report, the evaluation of the ERA Regulation and the Position paper on the future of the Agency.

Article 36: "research and promotion of innovation"; original article with research added, formalising what ERA is already doing to a large extent; in line with the Position paper of the Board on the Future of ERA.

Article 37: "assistance to the Commission"; amended slightly.

Article 38: "assistance with the assessment of rail projects"; originally Article 15, scope was extended to cover safety.

Article 39: "assistance to MS and stakeholders"; new article, following the IA report (measure from Option 6) and the results of the evaluation of the ERA Regulation.

Article 40: "international relations"; new article formalising what ERA is already doing to a large extent; in line with the IA report and the Position paper of the Board on the Future of ERA.

Article 41: "spare parts"; new article — new task in line with the IA report.

CHAPTER 9 ORGANISATION OF THE AGENCY: drafted largely to follow the Joint Statement of the Commission, the European Parliament and the Council on decentralised agencies and the Common Approach (2012), in particular in relation to: extended competences of the Management Board (previously Administrative); creation of Executive Board; multi-annual work programme; other standard provisions regarding HR and budgetary issues.

Other important changes:

Article 48: "annual and multi-annual work programmes"; new, separate article on work programmes deemed useful for clarity; in accordance with the Joint Statement and recommendations of the CoA, EP, the evaluation of the ERA Regulation and the Position paper of the ERA Board on the Future of the Agency (multi-annual perspective, ABB and ABM, relations with stakeholders).

Articles 51-57: "Board of Appeal"; new articles — Board of Appeal necessary following extension of ERA competences (issuing of vehicle authorisations for placing on the market and safety certificates); IA report provides for the creation of an independent Appeal Body outside the Agency, however, it seems that the solution already in place at the EASA is more appropriate; based on the relevant provisions of the EASA Regulation.

CHAPTER 10 FINANCIAL PROVISIONS:

Article 58(2): new point (c) — new sources of ERA income added (external fees and charges for issuing vehicle authorisations for placing on the market and safety certificates (new tasks)); new point (e) — to bring it into line with the EASA regulation

CHAPTER 11 STAFF: new chapter, following largely standard provisions resulting from the Common Approach on agencies (Articles 62 and 63).

Article 61: "staff – general provisions"; originally Article 24, amended in accordance with the Joint Statement on agencies, the evaluation of the ERA Regulation and the Position paper of the ERA Board on the Future of the Agency; previous limitations of maximum contract deleted.

CHAPTER 12 GENERAL PROVISIONS:

Articles 64, 66-68, 70-72: moved from other parts of the original Regulation, amended if necessary following Joint Statement on agencies.

Article 65: "headquarters agreement and operating conditions"; new article, following the Joint Statement on decentralised agencies (2012).

Article 69: "cooperation with national authorities and bodies"; new articles resulting from new powers of ERA to issue certificates and authorisations; cooperation with national bodies and authorities in some cases deemed necessary due to their expertise; possibility of (sub)contract part of ERA's tasks.

CHAPTER 13 FINAL PROVISIONS: new chapter

Article 73 and 74: "delegated acts"; new articles — following ERA’s new powers (to issue safety certificates and vehicle authorisations for placing on the market, own resources) there is a need to adopt delegated measures; this is similar to the case of EASA.

Article 75: "committee procedure"; new article, made in order not to refer to other acts (Interoperability Directive).

Article 76: "evaluation and review"; original article amended in accordance with the Joint Statement on agencies.

ARTICLES WHICH STAYED THE SAME AS IN REGULATION 881/2004: 5, 6, 58, 59, 60.

4. BUDGETARY IMPLICATION

This new Regulation provides a legislative basis for budgetary and staff commitments in relation to the European Union Agency for Railways. The detailed calculations are provided in the Annex, in the Legislative Financial Statement.

It is important to point out that, as far as ERA staffing is concerned, the present act incorporates:

1. resources calculations from two previous Financial Legislative Statements attached to the original Regulation 881/2004 and the 2008 amendment to it (Regulation 1335/2008), which provided for 104 temporary staff for ERA;

2. budgetary procedures for 2005-2013 by which the Budgetary Authority granted ERA an extra 39 posts to cover additional tasks not reflected in the founding Regulation, resulting in total 143 temporary staff posts in 2013;

3. the estimated resources implications of the new tasks and enhanced powers of ERA envisaged in the current new Regulation, set at 43 persons.

Regarding point 2, note that the number of posts has gradually increased since ERA was set up in 2005. This change has been subject to detailed annual scrutiny and has been adopted by the budgetary authority every year in accordance with the number of posts proposed by the Commission. The main explanation for the difference between point 1 and 2 is that a number of functions and activities such as legal affairs, Data Protection Officer, Secretariat for the Administrative Board, internal audit, quality and business planning, economic evaluation (impact assessment), procurement, facilities management, and a Head of Administration were not provided for in the founding Regulation — or at least not planned to be carried out by dedicated staff. For some areas of activity, including HR, IT and Finance, resource needs were considerably underestimated.

Concerning economic evaluation, this activity follows from the fact that ERA was set up to contribute to an integrated and competitive railway area. It has been an integral part of the Agency’s activities from the beginning — even if no dedicated staff were provided for in the financial statement. The need for this activity is unquestionable and has recently grown in line with the Activity-Based Budgeting approach; this is reflected in the fact that a new Article is proposed for inclusion in the new Agency Regulation.

In addition to these developments, various Commission acts have given the Agency additional tasks with resource implications, without being properly reflected in the financial statement. For example, Commission Decision 2011/155/EU on the publication and management of the reference document referred to in Article 27(4) of Directive 2008/57/EC put additional tasks on the Agency in relation to making transparent and simplifying the processes and rules used for authorising railway vehicles and subsystems. More specifically, ERA’s role concerns documentation of authorisation processes in Member States, documentation of national rules applied to the authorisation of railway vehicles and checking of data consistencies, support to National Safety Authorities and management and maintenance of data.

Regarding point 3, the budgetary and staff implications of new and extended tasks stem principally from the impact assessment calculations, implementation of the recommendations in the Joint Statement by the Commission, the European Parliament and the Council on decentralised agencies, Court of Auditors and Internal Audit Service recommendations, and the evaluation of the ERA Regulation. All the changes in legislation are substantially explained in part 3 of this Memorandum. The total of 70 persons is estimated to be needed to deal with these new and extended tasks, with 43 additional staff in relation to the current level of staffing of the Agency. These 43 new persons will be dealing with issuing authorisations and certificates and will be covered by external fees and charges while the remaining needs of 27 persons will be covered by internal redeployment of existing staff of the Agency. Therefore, there will be no additional impact on the EU budget (except for years 2015 and 2016, when external fees and charges will not be available yet).

The planned additional personnel of 43 would cover the following categories:

· Technical experts (41 persons), to deal with issuing of authorisations for placing on the market of vehicles and vehicles types (30), authorisations for placing in service of trackside control-command and signalling sub-systems (6) and safety certificates (5);

· Linked administrative staff (2), including an accountant to deal with management of a planned system of external fees and charges, including cooperation with national authorities.

The external fees and charges would also cover linked overhead costs, mainly:

· Translation of decisions issued by ERA into national languages;

· IT system needed for accountancy purposes (external fees and charges).

The remaining 27 persons, to be covered by internal redeployment of existing staff of the Agency, would deal with:

· Monitoring of national safety authorities and notified bodies, and implementation of national safety and interoperability legislation ;

· Reduction of number of national rules ;

· Advice and support to Member States and stakeholders, dissemination of railway-related information and training and coordination of potential spare parts to be standardised .

The overall budgetary implication of ERA for the EU budget in 2015-2020 is estimated at € 157.113 M. The cost to the EU budget of new tasks amounts to € 0.4113 M as from 2017 onwards they will be covered by fees and charges paid by the industry.

There is also impact on Commission resources (in the DG MOVE). With regard to this, the present Regulation incorporates:

1. resources calculations from two previous Legislative Financial Statements attached to the original Regulation 881/2004 and the 2008 amendment to it (Regulation 1335/2008), which provided for two officials/temporary staff for the Commission;

2. changes for 2005-2013, with three extra Commission staff dealing with ERA-related issues, to cover additional tasks not reflected in the founding Regulation;

The overall total for the Commission linked to the current initiative will be 5 persons, with no new staff requested.

2013/0014 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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[5],

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

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) The progressive establishment of a European railway area without frontiers requires Union action in the field of the technical regulations applicable to railways with regard to the technical aspects (interoperability) and the safety aspects, the two being inextricably linked and both requiring higher level of harmonisation at the Union level. Relevant railway legislation, in particular three railway packages, was adopted in the last two decades, with Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community being the most relevant.

(2) Simultaneous pursuit of the goals of railway safety and interoperability requires substantial technical work which must be 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 responsible for railway safety and interoperability (hereinafter referred to as the Agency).

(3) The European Railway Agency was originally established by Regulation (EC) 881/2004 of the European Parliament and of the Council of 29 April 2004[7] , 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. Regulation 881/2004 has to be replaced by a new act due to substantial amount of changes to the tasks of the Agency and its internal organisation.

(4) The Fourth Railway Package proposes important changes 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 directly linked to the tasks of the Agency. Those Directives, together with this Regulation, provide in particular for performing tasks related to issuing vehicle authorisations and safety certificates at the Union level. It implies a greater role of the Agency.

(5) The Agency should contribute to the creation and effective functioning of a Single European railway area without frontiers and guaranteeing a high level of safety while improving the competitive position of the railway sector. That should be attained by contributing, on technical matters, to the implementation of European Union legislation by enhancing the level of interoperability of railway systems and to developing a common approach to safety on the European railway system. The Agency should also perform the role of European authority responsible for issuing authorisations for placing on the market for railway vehicles and for types of vehicles, safety certificates for railway undertakings and authorisations for placing in service of trackside control-command and signalling sub-systems. Moreover, it should monitor national railway rules and the performance of national authorities acting in the railway interoperability and safety fields.

(6) In pursuing its objectives, the Agency should take full account of the process of enlargement of the Union and of the specific constraints relating to rail links with third countries. The Agency should have sole responsibility for the functions and powers assigned to it.

(7) The Agency, while performing its tasks, and particularly in relation to drafting recommendations, should take upmost account of external railway expertise. This expertise should predominantly consist of professionals from the railway sector and the relevant national authorities. They should form competent and representative working parties of the Agency.

(8) In order to provide insight into the economic effects on the railway sector and its impact on society, to allow others to make informed decisions, and to manage the work priorities and resource allocation more effectively within the Agency, the Agency should further develop its engagement in the impact assessment activity.

(9) The Agency should provide independent and objective technical support, predominantly to the Commission. Directive …. [Railway Interoperability] provides the basis for drafting and revising Technical Specifications for Interoperability (TSIs) while Directive … [Railway Safety] provides the basis for drafting and revising Common Safety Methods (CSMs) and Common Safety Targets (CSTs). The continuity of the work and the development of the TSIs, CSMs and CSTs over time require a permanent technical framework and a dedicated staff of a specialised body. To this end, the Agency should be responsible for providing the Commission with recommendations in relation to drafting and revising the TSIs, CSMs and CSTs. The national safety organisations and regulatory bodies should be equally able to request an independent technical opinion from the Agency.

(10) Railway undertakings have been faced with various problems when applying for safety certificates to competent national authorities, ranging from protracting procedures and excessive costs to unfair treatment, especially of new entrants. The certificates issued in one Member State have not been unconditionally recognised in other Member States, with a detriment to the Single European rail area. In order to make the procedures for issuing safety certificates to railway undertakings more efficient and impartial, it is essential to migrate towards a single safety certificate valid throughout the Union and issued by the Agency. The revised Directive … [Railway Safety Directive] provides a basis for this.

(11) Currently Directive 2008/57/EC provides, in the case of rail vehicles, an authorisation of placing in service in each Member State, except in 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 from 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. Each rail vehicle should only receive one authorisation and this authorisation for placing on the market for vehicles and for types of vehicles should be issued by the Agency. This would bring tangible benefits for the sector by reducing the costs and time of the procedure, and would diminish the risk of potential discrimination, especially of new companies wishing to enter a railway market. The revised Directive … [Railway Interoperability] provides a basis for this.

(12) In order to further pursue the development of Single European rail area, in particular with relation to providing appropriate information to freight customers and passengers, and taking into account current involvement of the Agency, it is necessary to give it a strengthened role in the field of telematics applications. This would ensure their consistent development and swift deployment.

(13) Given the importance of the European Rail Traffic Management System (ERTMS) for the smooth development of the Single European railway area and its safety, and taking into account its fragmented development to date, it is necessary to strengthen its s overall coordination at the Union level. Therefore the Agency, as the most competent Union body, should be given a more prominent role in this field to ensure consistent 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. Moreover, in order to make the procedures for issuing authorisations for placing in service of trackside control-command and signalling sub-systems more efficient and impartial, it is essential to migrate towards a single authorisation valid in the Union and issued by the Agency. The revised Directive … [Railway Interoperability Directive] provides a basis for this.

(14) Competent national authorities have been normally charging for issuing vehicle authorisations and safety certificates. With the transfer competence to the Union level, the Agency should be entitled to charge the applicants for issuing the certificates and authorisations mentioned in the preceding recitals. The level of those charges should be equal to or lower than the current average in the Union and should be determined in a delegated act to be adopted by the Commission.

(15) It is a general objective that the transfer of functions and tasks from the Member States to the Agency should be done efficiently, without any reduction in the current high levels of safety. The Agency should have sufficient resources for its new tasks, and the timing of the allocation of these resources should be based on clearly defined needs. Taking into account the know-how 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 certificates. To this end, secondment of national experts to the Agency should be encouraged.

(16) Directive … [Railway Safety] and Directive … [Railway Interoperability] provide for examination of national measures from the point of view of safety and interoperability, and compatibility with competition rules. They also limit the possibility for Member States to adopt new national rules. The current system in which a large number of national rules continue to exist leads to possible conflicts with Union rules and creates a risk of insufficient transparency and disguised discrimination of foreign operators, especially the smaller and new ones. In order to migrate towards a system of truly, transparent and impartial railway rules at Union level, gradual reduction of national rules needs to be reinforced. An opinion based on independent and neutral expertise is essential at Union level. To this end, the role of the Agency needs to be strengthened.

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

(18) 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 common indicators and linking all parties in the sector, is important and should be carried out. As regards statistics, close collaboration with Eurostat is necessary.

(19) In order to monitor progress with the railway interoperability and safety, the Agency should be responsible for publishing a relevant report every two years. Given its technical expertise and impartiality, the Agency should also assist the Commission with monitoring the implementation of Union railway safety and interoperability legislation.

(20) The interoperability of the Trans-European 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 in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the Trans-European transport network[8]. The Agency is the right institution to contribute to these objectives.

(21) Rolling stock maintenance 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 been adding to the costs for the sector and results in journeys without loads. A European certification system for maintenance workshops should therefore gradually be developed and updated, with the Agency being the most appropriate body to propose adequate solutions to the Commission.

(22) The vocational qualifications required for train drivers are a major factor in both safety and interoperability in the Union. They are also a precondition for the free movement of workers in the railway industry. This question should be tackled with respect to 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.

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

(24) In order to ensure the greatest possible transparency and equal access for all parties to relevant information, the documents envisaged for the railway interoperability and safety processes should be accessible to the public. The same applies to licences, safety certificates and other relevant railway documents. The Agency should provide an efficient means of exchanging and publishing this information.

(25) Promotion of innovation and research in the railway field is an important task which the Agency should encourage, given its reputation and position. 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.

(26) In order to increase the efficiency of the Union financial support, its quality and compatibility with relevant technical regulations, the Agency, as the only Union body with reputable competence in the railway field, should play an active role in the assessment of rail projects.

(27) Railway interoperability and safety legislation, implementation guides or recommendations of the Agency may sometimes pose interpretation and other problems to the stakeholders. Proper and uniform understanding of those acts is a precondition 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.

(28) 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. 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, the Executive Director should have full responsibility. The Agency’s staff should be independent and should represent an appropriate balance of short-term and long-term contracts, in order to maintain its organisational knowledge and business continuity while keeping necessary and on-going exchange of expertise with the railway sector.

(29) In order to ensure effectively the accomplishment of the functions of the Agency, the Member States and the Commission should be represented on a Management Board vested with the necessary powers, including to establish the budget and approve the annual and multi-annual work programmes.

(30) 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, that right being reserved for the representatives of public authorities who are accountable to the democratic control authorities. The representatives of the sector should be appointed by the Commission on the basis of their representativeness at Union level of railway undertakings, infrastructure managers, railway industry, workers unions, passengers and freight customers.

(31) In order to properly prepare the meetings of the Management Board and to advice it in relation to the decisions to be taken, an advisory Executive Board should be created.

(32) It is necessary to ensure that parties affected by decisions made by the Agency enjoy the necessary remedies in an independent and impartial manner. An appropriate appeal mechanism should be set up so that decisions of the Executive Director can be subject to appeal to a specialised Board of Appeal, whose decisions are, in turn, open to action before the Court of Justice.

(33) A broader strategic perspective in relation to the activities of the Agency would help to plan and manage its resources more effectively and would contribute to higher quality of its outputs. Therefore, a multi-annual work programme should be adopted and updated regularly by the Management Board, after proper consultation of the relevant stakeholders.

(34) The Agency’s work should be transparent. Effective control by the European Parliament should be ensured and, to this end, the European Parliament should have the possibility of hearing the Executive Director of the Agency and being consulted on the multi-annual work programme. The Agency should also apply the relevant Union legislation concerning public access to documents.

(35) Over the past years, as more decentralised agencies have been created, the budgetary authority has looked to improve transparency and control over the management of the Union funding allocated to them, in particular concerning the budgetisation of fees, financial control, power of discharge, pension scheme contributions and the internal budgetary procedure (code of conduct). In a similar way, Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF)[9] 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[10].

(36) Since the objectives of the action proposed, 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 by reason of the joint nature of the work to be done, and can therefore 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. 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 those objectives,

(37) In order to properly determine the level of fees and charges which the Agency is entitled to levy, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of articles dealing with issuing and renewal of authorisations for placing in service of trackside control-command and signalling subsystems, authorisations for placing on the market for vehicles and for types of vehicles, and safety certificates. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(38) In order to ensure the implementation of Articles 21 and 22 of this Regulation concerning examination of draft national rules and rules in force, implementing powers should be conferred on the Commission.

(39) In order to ensure uniform conditions for the implementation of Articles 29, 30, 31, and 51 of this Regulation, 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 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers.

(40) It is necessary 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.

(41) 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.

3. This Regulation shall apply to:

(a) interoperability within the Union rail system provided for in Directive ../../.EU [Interoperability Directive];

(b) safety of the rail system within the Union provided for in Directive ../../.EU [Railway safety Directive];

(c) certification of train drivers provided for in Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification of train drivers operating locomotives and trains on the railway system in the Community [Train Drivers Directive].

Article 2

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 Director.

Article 3

Types of acts of the Agency

The Agency may:

(a) address recommendations to the Commission concerning the application of Articles 11, 13, 14, 15, 23, 24, 26, 30, 32, 31, 33 and 41;

(b) address recommendations to Member States concerning the application of Articles 21, 22 and 30;

(c) issue opinions to the Commission pursuant to Articles 9, 21, 22 and 38, and to the authorities concerned in the Member States pursuant to Article 9;

(d) issue decisions pursuant to Article 12, 16, 17, 18;

(e) issue opinions constituting acceptable means of compliance pursuant to Article 15;

(f) issue technical documents pursuant to Article 15;

(g) issue audit reports pursuant to Articles 29 and 30;

(h) issue guidelines and other non-binding documents facilitating application of railway interoperability and safety legislation pursuant to Articles 11, 15 and 24.

CHAPTER 2

WORKING METHODS

Article 4

Creation and composition of the working parties

1. The Agency shall set up a limited number of working parties for drawing up recommendations, in particular related to technical specifications for interoperability (TSIs), common safety targets (CSTs) and common safety methods (CSMs).

The Agency may set up working parties in other duly justified cases at the request of the Commission or on its own initiative, after having consulted the Commission.

2. The Agency shall appoint experts to the working parties.

The Agency shall appoint to the working parties representatives nominated by the competent national authorities for the working parties in which they wish to participate.

The Agency shall appoint to the working parties professionals from the railway sector from the list referred to in paragraph 3. It 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 may, if necessary, appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned. Staff of the Agency may not be appointed to the working parties.

3. Each representative body referred to in Article 34 shall forward to the Agency a list of the most qualified experts mandated to represent them in each working party.

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 from the workers’ organisations 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 working parties shall be chaired by a representative of the Agency.

7. The work of the working parties shall be transparent. The Management Board shall lay down rules of procedure of the working parties.

Article 5

Consultation of the social partners

Whenever the work provided for in Articles 11, 12, 15, and 32 has 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 Decision 98/500/EC[11].

These consultations shall be held before the Agency submits its recommendations to the Commission. The Agency shall take due account of these 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 to the Commission and by the Commission to the committee referred to in Article 75.

Article 6

Consultation of rail freight customers and passengers

Whenever the work provided for in Articles 11 and 15 has a direct impact on rail freight customers and passengers, the Agency shall consult the organisations representing them. The list of organisations to be consulted shall be drawn up by the Commission with the assistance of the committee referred to in Article 75.

These consultations shall be held before the Agency submits its proposals to the Commission. The Agency shall take due account of these consultations, and shall, at all times, be available to expound on its proposals. The opinions expressed by the organisations concerned shall be forwarded by the Agency to the Commission and by the Commission to the committee referred to in Article 75.

Article 7

Impact assessment

1. The Agency shall conduct an impact assessment of its recommendations and opinions. The Management Board shall adopt 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.

2. Before launching an activity included in the work programme, the Agency shall conduct an early impact assessment in relation to it which shall state:

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

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

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

Moreover, each activity and project in the work programme shall be subject to an efficiency analysis individually and in conjunction with each other, to make best use of the budget and resources of the Agency.

3. The Agency may conduct an ex post assessment of the legislation resulting from its recommendations.

4. Member States shall provide the Agency with the data necessary for the impact assessment.

Article 8

Studies

Where required for the implementation of its tasks, the Agency shall order studies and finance them from its budget.

Article 9

Opinions

1. The Agency shall issue opinions at request of the national regulatory bodies referred to in Article 55 of Directive 2012/34/EU [Directive establishing a Single European Rail Area (recast)] concerning safety-related and interoperability-related aspects of matters drawn to their attention.

2. The Agency shall issue opinions at request of the Commission on amendments to any act adopted on the basis of Directive … [Interoperability Directive] or … [Railway Safety Directives], especially where any alleged deficiency is signalled.

3. With regard to opinions referred to in previous paragraphs and in other articles of this Regulation, the Agency shall give its opinions within two months, unless otherwise agreed. The opinions shall be made public by the Agency within two months in a version from which all commercially confidential material has been removed.

Article 10

Visits to Member States

1. The Agency may carry out visits to the Member States in order to perform its tasks, in particular those referred to in Articles 12, 21, 22, 16, 17, 27, 29, 30, 31 and 38, in accordance with the policy defined by the Management Board.

2. The Agency shall inform the Member State concerned of the planned visit, the names of the delegated Agency officials, and the date on which the visit is to start. The Agency officials delegated to carry out such visits shall do so on presentation of a decision by the Executive Director specifying the purpose and the aims of their visit.

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

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

5. The preceding paragraphs are without prejudice to inspections referred to in Articles 29 (6) and 30 (6) which shall be pursued in accordance with the procedure described therein.

CHAPTER 3

TASKS RELATING TO RAILWAY SAFETY

Article 11

Technical support - recommendations on railway safety

1. The Agency shall issue recommendations to the Commission on the Common Safety Methods (CSMs) and the Common Safety Targets (CSTs) provided for in Articles 6 and 7 of Directive … [the Railway Safety Directive]. The Agency shall also issue recommendations on periodic revision of CSMs and CSTs to the Commission.

2. The Agency shall issue recommendations to the Commission, at the request of the Commission or on its own initiative, on other measures in the field of safety

3. The Agency may issue guidelines and other non-binding documents to facilitate the implementation of railway safety legislation.

Article 12

Safety certificates

The Agency shall issue single safety certificates in accordance with Articles 10 and 11 of Directive … [the Safety Directive].

Article 13

Maintenance of vehicles

1. The Agency shall assist the Commission with regard to the system of certification of the entities in charge of maintenance in accordance with Article 14 (6) of Directive … [Railway Safety Directive].

2. The Agency shall issue recommendation to the Commission with a view of Article 14 (7) of Directive … [Railway Safety Directive].

3. The Agency shall analyse any alternative measures decided in accordance with Article 15 of Directive… [Railway Safety Directive] in the report referred to in Article 30 (2) of this Regulation.

Article 14

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[12] and compare them with the legislation dealing with rail interoperability and safety, in particular the essential requirements. To this end the Agency shall assist the Commission and may issue recommendations at the Commission’s request or on its own initiative.

CHAPTER 4

TASKS RELATING TO INTEROPERABILITY

Article 15

Technical support in the field of railway interoperability

1. The Agency shall:

(a) issue recommendations to the Commission on the TSIs, and their revision, in accordance with Article 5 of Directive … [Interoperability Directive];

(b) issue recommendations to the Commission on the templates for the 'EU' declaration of verification and for documents of the technical file that has to accompany it, in accordance with Article 15 of Directive … [Interoperability Directive];

(c) issue recommendations to the Commission on specifications for registers, and their revision, in accordance with Articles 43, 44 and 45 of Directive … [Interoperability Directive];

(d) issue opinions which constitute acceptable means of compliance concerning TSI deficiencies, in accordance with Article 6(2) of Directive … [ Interoperability Directive], and provide it to the Commission;

(e) issue opinions to the Commission regarding requests for non-application of TSIs by Member States, in accordance with Article 7 of Directive … [Interoperability Directive];

(f) issue technical documents in accordance with Article 4(9) of Directive … [Interoperability Directive];

(g) issue recommendations to the Commission relating to the working conditions of all staff carrying out safety-critical tasks.

2. For drafting recommendations referred to in paragraph 1, points (a) and (b), the Agency shall:

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

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

3. The Agency may issue guidelines and other non-binding documents to facilitate the implementation of railway interoperability legislation.

Article 16

Authorisations for placing on the market for vehicles

The Agency shall issue authorisations for placing on the market for railway vehicles in accordance with Article 20 of Directive … [the Interoperability Directive].

Article 17

Authorisations for placing on the market for types of vehicles

The Agency shall issue authorisations for placing on the market for types of vehicles in accordance with Article 22 of Directive … [the Interoperability Directive].

Article 18

Authorisations for placing in service of trackside control-command and signalling sub-systems

The Agency shall issue authorisations for placing in service of the trackside control-command and signalling subsystems located or operated in the entire Union in accordance with Article 18 of Directive … [the Interoperability Directive].

Article 19

Telematics applications

1. The Agency shall act as the system authority, being responsible for maintaining the technical specifications for the telematics applications, in accordance with relevant TSIs.

2. The Agency shall define, publish and apply the procedure for managing requests for changes to those specifications. To this end, the Agency shall set up and maintain a register of requests for changes to telematics applications specifications and their status.

3. The Agency shall develop and maintain the technical tools for managing the different versions of the telematics applications' specifications.

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

Article 20

Support for the notified conformity assessment bodies

1. The Agency shall support the activities of notified conformity assessment bodies referred to in Article 27 of Directive … [Interoperability Directive]. That support shall in particular include drafting guidelines for assessing the conformity or suitability for use of an interoperability constituent referred to in Article 9 of Directive … [Interoperability Directive] and guidelines for the EC verification procedure referred to in Article 10 of Directive … [Interoperability Directive].

2. The Agency shall facilitate cooperation of notified conformity assessment bodies, in particular act as the technical secretariat for their coordination group.

CHAPTER 5

TASKS RELATING TO NATIONAL RULES

Article 21

Examination of draft national rules

1. The Agency shall, within two months of their reception, examine the draft national rules submitted to it in accordance with:

(a) Article 8(2) of Directive … [Railway Safety Directive],

(b) Article 14 of Directive … [Interoperability Directive].

2. Where after the examination referred to paragraph 1 the Agency considers that national rules enable the essential requirements for interoperability to be fulfilled, CSMs 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 operation between Member States, the Agency shall inform the Commission and the Member State concerned about its positive assessment. The Commission may validate the rule in the IT system referred to in Article 23.

3. Where the examination referred to in paragraph 1 leads to a negative assessment, the Agency shall:

(a) issue a recommendation addressed to the Member State concerned stating the reasons why the rule in question should not entry into force and/or be applied;

(b) inform the Commission about its negative assessment.

4. Where no action was taken by the Member State within 2 months after receiving the recommendation of the Agency referred to in point (a) of paragraph 3, the Commission, after receiving information referred to in point (b) of paragraph 3 and after having heard the reasons of the Member State concerned, may adopt a decision addressed to the Member State concerned requesting it to modify the draft rule in question, suspend its adoption, entry into force or implementation.

Article 22

Examination of national rules in force

1. The Agency shall, within two months of their reception, examine national rules submitted to it in accordance with Article 14(3) of Directive … [Interoperability Directive].

2. Where after examination referred to in paragraph 1 the Agency considers that national rules enable the essential requirements for interoperability to be fulfilled, CSMs 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 operation between Member States, the Agency shall inform the Commission and the Member State concerned about its positive assessment. The Commission may validate the rule in the IT system referred to in Article 23.

3. Where the examination referred to in paragraph 1 leads to a negative assessment, the Agency shall:

(a) issue a recommendation addressed to the Member State concerned stating the reasons why the rule in question should be modified or repealed;

(b) inform the Commission about its negative assessment.

4. Where no action was taken by the Member State within 2 months after receiving the recommendation of the Agency referred to in point (a) of paragraph 3, the Commission, after receiving information referred to in point (b) of paragraph 3 and after having heard the reasons of the Member State concerned, may adopt a decision addressed to the Member State concerned requesting it to modify or repeal the rule in question.

5. The procedure described in paragraphs 2 and 3 shall apply, mutatis mutandis, in cases where the Agency becomes aware of any national rule, notified or not, being redundant or in conflict with the CSMs, CSTs, TSIs or any other Union legislation in the railway field.

Article 23

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

1. The Agency shall set up and manage a dedicated IT system containing national rules referred to in Articles 21(1) and 22(1) and make it accessible to stakeholders and the public.

2. Member States shall notify national rules referred to in Articles 21(1) and 22(1) to the Agency and to the Commission through the IT system referred to in paragraph 1. The Agency shall publish the rules in this system and use it for informing the Commission in accordance with Articles 21 and 22.

3. The Agency shall classify notified national rules in accordance with Article 14(8) of Directive …. [Interoperability Directive]. To this end, it shall use the system referred to in the first paragraph of this Article.

4. The Agency shall classify national rules notified in accordance with Article 8(2) of Directive … [Railway Safety Directive], taking into account development of EU legislation. To this 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 the first paragraph of this Article to publish the Rule Management Tool.

CHAPTER 6

Tasks Relating To European Rail Traffic Management System (ERTMS)

Article 24

System authority for the ERTMS

1. The Agency shall act as the system authority, being responsible for maintaining the technical specifications for the ERTMS.

2. The Agency shall define, publish and apply the procedure for managing requests for changes to those specifications. To this end, the Agency shall set up and maintain a register of requests for changes to ERTMS specifications and their status.

3. The Agency shall recommend the adoption of a new version of ERTMS Technical specifications. However, it shall only do so when the previous version has been deployed at a sufficient rate. The development of new versions 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 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 a view to ensuring technical and operational compatibility between networks and vehicles fitted with different versions and to providing incentives for the swift implementation of the versions in force.

5. In accordance with Article 5(10) of Directive … [Railway Interoperability Directive], the Agency shall ensure that successive versions of ERTMS equipment are technically compatible with earlier versions.

6. The Agency shall prepare and disseminate relevant application guidelines for stakeholders and explanatory documentation related to the technical specifications for the ERTMS.

Article 25

ERTMS Ad hoc working group of notified conformity assessment bodies

1. The Agency shall set up and chair an ERTMS ad hoc working group of notified conformity assessment bodies referred to in Article 27 of Directive … [Interoperability Directive].

The working group shall check the consistency of application of the procedure for assessing the conformity or suitability for use of an interoperability constituent referred to in Article 9 of Directive … [Interoperability Directive] and of the 'EC' procedures for verification referred to in Article 10 of Directive … [Interoperability Directive] and carried out by notified conformity assessment bodies.

2. The Agency shall report every two years to the Commission on the activities of the working group referred to in paragraph 1, including statistics on attendance of notified conformity assessment bodies’ representatives in the working 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 every two years shall submit a report proposing to the Commission, where appropriate, improvements to be made.

Article 26

Supporting technical and operational compatibility between ERTMS on-board and trackside subsystems

1. The Agency may assist the railway undertakings, at their request, in checking the technical and operational compatibility between ERTMS on-board and trackside subsystems before placing a vehicle in service.

2. Where the Agency finds that there is a risk of a lack of technical and operational compatibility between networks and vehicles fitted with ERTMS equipment in the context of specific ERTMS projects, it may request the appropriate actors, in particular manufacturers, notified conformity assessment bodies, railway undertakings, infrastructure managers and national safety authorities, to provide any information relevant to the procedures applied for 'EC' verification and placing in service, and to operational conditions. The Agency shall inform the Commission about such a risk and, if necessary, recommend appropriate measures to the Commission.

Article 27

Supporting ERTMS deployment and ERTMS projects

1. The Agency shall monitor the deployment of the ERTMS in accordance with the deployment plan set out in Decision 2012/88/EU[13] and shall monitor coordination of ERTMS installation along the Trans-European Transport Corridors and Rail Freight Corridors as provided for in Regulation (EU) No 913/2010[14].

2. The Agency shall ensure technical follow up of Union-funded projects for the deployment of the ERTMS, including, where applicable, analysis of tendering documents at the time of the call for tenders. The Agency shall also assist, if necessary, the beneficiaries of the 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 28

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[15].

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

CHAPTER 7

TASKS RELATING TO MONITORING THE SINGLE EUROPEAN RAILWAY AREA

Article 29

Monitoring of national safety authorities

1. The Agency shall monitor the performance and decision-making of national safety authorities through audit and inspections.

2. The Agency shall be entitled to audit:

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

(b) the effectiveness of national safety authorities' monitoring of safety management systems of actors as referred to in Article 16 in Directive […] [Railway Safety Directive].

The procedure for performing the audits shall be adopted by the Management Board.

3. The Agency shall issue audit reports and send them to the national safety authority 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 to take appropriate steps within a time limit to be defined taking into account the importance of the deficiency.

5. Where a national safety authority disagrees with the Agency's recommendation referred to in paragraph 4, or where no action is taken by a national safety authority as a result of the Agency's recommendation within 3 months from its reception, the Commission may take a decision within six months in accordance with the advisory procedure referred to in Article 75.

6. The Agency shall be also entitled to conduct announced or unannounced inspections in national safety authorities, to verify specific areas of their activities and operation, in particular review documents, processes and records related to their tasks referred to in Article 16 of Directive … [Railway Safety Directive]. 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 two days. The national authorities of the Member States shall facilitate the work of the Agency’s staff. The Agency shall provide the Commission with a report on each inspection.

Article 30

Monitoring of notified conformity assessment bodies

1. The Agency shall monitor the notified conformity assessment bodies through assistance to accreditation bodies, audit and inspections, as provided for in paragraphs 2-5.

2. The Agency shall support harmonised accreditation of notified conformity assessment bodies, in particular by giving appropriate guidance on evaluation criteria and procedures to assess whether notified bodies meet the requirements referred to in Art. 27 of Directive … [Interoperability Directive] to the accreditation bodies, via the European Accreditation infrastructure recognised by Art. 14 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93

3. In case of notified conformity assessment bodies which are not accredited according to Article 24 of Directive… [Interoperability Directive], the Agency may audit their capacities to meet the requirements referred to in Article 27 of that Directive. 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 and to the Commission. Each audit report shall include, in particular, any deficiencies identified by the Agency and recommendations for improvement. If the Agency considers that these deficiencies prevent the notified body concerned from effectively performing its tasks in relation to railway safety and interoperability, the Agency shall adopt a recommendation requesting the Member State in which that notified body is established to take appropriate steps within a time limit.

5. Where a Member State disagrees with the recommendation referred to in paragraph 4, or where no action is taken by a notified body as a result of the Agency's recommendation within 3 months from its reception, the Commission may adopt an opinion within a period of six months in accordance with advisory procedure referred to in Article 75.

6. The Agency may, including in cooperation with the relevant national accreditation bodies, conduct announced or unannounced inspections of notified conformity assessment bodies to verify specific areas of their activities and operation, in particular review documents, certificates and records related to their tasks referred to in Article 27 of Directive […] [Interoperability Directive]. 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 two days. The notified conformity assessment bodies shall facilitate the work of the Agency’s staff. The Agency shall provide the Commission with a report on each inspection.

Article 31

Monitoring progress of interoperability and safety

1. The Agency, together with the network of national investigation bodies, shall collect relevant data on accidents and incidents and monitor the contribution of the national investigation bodies to the safety of the railway system as a whole.

2. The Agency shall monitor the overall safety performance of the railway system. The Agency may in particular seek the assistance of the networks referred to in Article 34, including collection of data. 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 common safety indicators 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 railway systems, in particular by facilitating coordination between railway undertakings and infrastructure managers, or between infrastructure managers.

4. The Agency shall monitor progress on the interoperability and safety of the railway systems. Every two years it shall present to the Commission and publish a report on progress on interoperability and safety 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 the Union legislation on safety and interoperability in a given Member State.

CHAPTER 8

OTHER TASKS

Article 32

Railway staff

1. The Agency shall perform the appropriate tasks relating to railway staff set out in Articles 4, 20, 22, 23, 25, 28, 33, 34, 35 and 37 of Directive 2007/59/EC of the European Parliament and of the Council[16] .

2. The Agency may be requested by the Commission to perform other tasks relating to railway staff in accordance with Directive 2007/59/EC.

3. The Agency shall consult the authorities competent on railway staff issues on 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 33

Registers and their accessibility

1. The Agency shall set up and keep European registers provided for in Article 43, 44 and 45 of Directive … [Interoperability Directive]. The Agency shall act as the system authority for all registers and databases referred to in the Safety, Interoperability and Train Drivers Directives. This shall include, in particular:

(a) developing and maintaining specifications of the registers;

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

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

(d) making recommendations to the Commission regarding improvements to the specification of existing registers and any need to set up new ones.

2. The Agency shall make the following documents and registers provided for by Directive … [Interoperability Directive] and Directive … [Railway Safety Directive] 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 Directive … [Directive on the establishment of the Single European Rail Area (recast)];

(d) the safety certificates issued in accordance with Article 10 of Directive … [Railway Safety Directive];

(e) the investigation reports sent to the Agency in accordance with Article 24 of Directive … [Railway Safety Directive];

(f) the national rules notified to the Commission in accordance with Article 8 of Directive … [Railway Safety Directive] and Articles 14 of Directive … [Interoperability Directive];

(g) the vehicle registers, including via links to relevant national registers;

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

(i) the European register of authorised types of vehicles;

(j) the register of requests for changes and planned changes to the ERTMS specifications;

(k) the register of requests for changes and planned changes to the Telematics Applications for Passengers (TAP) TSI/Telematics Applications for Freight (TAF) TSI specifications;

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

(m) quality reports issued in accordance with Article 28(2) of Regulation (EC) No 1371/2007.

3. The practical arrangements for sending the documents referred to in paragraph 2 shall be discussed and agreed by the Commission and the Member States on the basis of a draft prepared by the Agency.

4. When sending the documents referred to in paragraph 2, the bodies concerned may indicate which documents are not to be disclosed to the public for reasons of security.

5. The national authorities responsible for issuing the licences and certificates referred to in points (c) and (d) of paragraph 2 shall notify the Agency within one month of each individual decision to issue, renew, amend or revoke those licenses and certificates.

6. 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 34

Networks of national safety authorities, investigating bodies and representative bodies

1. The Agency shall establish a network of the national safety authorities and a network of the investigating bodies referred to in Article 21 of Directive…/… [Railway Safety Directive]. The Agency shall provide them with a secretariat. The tasks of the networks shall, in particular, be:

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

(b) promotion of good practices;

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

The Agency shall facilitate cooperation between those networks, in particular it may decide to hold joint meetings of both networks.

2. The Agency shall establish a network of representative bodies from the railway sector acting at the Union level. The list of these bodies shall be defined in an implementing act adopted by the Commission, in accordance with advisory procedure referred to in Article 75. The Agency shall provide the network with a secretariat. The tasks of the network shall, in particular, be:

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

(b) promotion of good practices;

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

3. The networks referred to in paragraphs 1 and 2 may issue non-binding opinions on draft recommendations referred to in Article 9(2).

4. The Agency may establish other networks with bodies or authorities with responsibility for a part of the railway system.

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

Article 35

Communication and dissemination

The Agency shall communicate and disseminate to relevant stakeholders the European framework of railway legislation, standards and guidance, in accordance with relevant communication and dissemination plans adopted by the Management Board. Those plans, based on an analysis of needs, shall be regularly updated by the Management Board.

Article 36

Research and promotion of innovation

1. The Agency shall contribute, upon request of the Commission, to railway research activities at Union level, including through support to relevant Commission services and representative bodies. This contribution shall be without prejudice to other research activities at the Union level.

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

Article 37

Assistance to the Commission

1. 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 European railway system.

2. This assistance may include:

(a) providing technical advice in matters requiring specific know-how;

(b) collecting information through the networks referred to in Article 34.

Article 38

Assistance with the assessment of rail projects

Without prejudice to the derogations provided for by Article 9 of Directive […] [Railway Interoperability Directive], the Agency shall, at the Commission’s request, examine, from the point of view of interoperability and safety, any project involving the design, construction, renewal or upgrading of the subsystem for which an application for Union financial support has been submitted.

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

Article 39

Assistance to Member States, candidate countries and stakeholders

1. On its own initiative or at the request of the Commission, Member States, candidate countries or the networks referred to in Article 34, the Agency shall engage in training and other appropriate activities concerning the application and explanation of railway interoperability and safety legislation and related Agency’s products such as registers, implementation guides or recommendations.

2. The nature and extent of the activities referred to in paragraph 1 shall be decided by the Board and included in the work programme.

Article 40

International relations

1. In so far as is necessary to achieve the objectives set out in this Regulation and without prejudice to the respective competences of the Member States and the Union institutions, including the European External Action Service, the Agency may 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 European Union railways legislation and standards.

2. Those arrangements shall not create legal obligations in respect of the Union and its Member States nor shall they prevent Member States and their competent authorities from concluding bilateral or multilateral arrangements with those supervisory authorities, international organisations and the administrations of third countries. Those arrangements and cooperation shall be subject to prior discussion with the Commission and regular reporting to it.

3. The Management Board shall adopt a strategy for relations with third countries or international organisations concerning matters for which the Agency is competent. This strategy shall be included in the annual and multi-annual work programme of the Agency, with a specification of associated resources.

Article 41

Coordination regarding spare parts

The Agency shall contribute to identifying potential railway spare parts to be standardised. To this end, the Agency may establish a working party in order to coordinate the stakeholders’ activities and may establish contacts with the European standardisation bodies. The Agency shall present the Commission with appropriate recommendations.

CHAPTER 9

ORGANISATION OF THE AGENCY

Article 42

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 47;

(b) An Executive Board which shall exercise the functions set out in Article 49;

(c) An Executive Director who shall exercise the responsibilities set out in Article 50;

(d) A Board of Appeal who shall exercise the responsibilities set out in Articles 54 to 56.

Article 43

Composition of the Management Board

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

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

(a) railway undertakings;

(b) infrastructure managers;

(c) the railway industry;

(d) trade unions;

(e) passengers;

(f) freight customers.

For each of these groups, 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 in the Board, in order to ensure continuity of the Board's work. All parties shall aim to achieve a balanced representation between men and women on the Management Board.

3. Member States and the Commission shall appoint their members of the Management Board and an alternate who will represent the member in his/her absence.

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

5. When appropriate, the participation of representatives of third countries and the conditions thereof shall be established in the arrangements referred to in Article 68.

Article 44

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/her duties.

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

Article 45

Meetings

1. Meetings of the Management Board shall be convened by its Chairperson. The Executive Director of the Agency shall participate in the meetings.

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

Article 46

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 47

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