CELEX: 
Language: en
Date: 2015-11-26
Title: Position of the Council at first reading with a view to the adoption of a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the interoperability of the rail system within the European Union (recast)

Council of the
                 European Union
                                                            Brussels, 26 November 2015
                                                            (OR. en)
                                                            10579/15
       Interinstitutional File:
          2013/0015 (COD)
                                                            TRANS 230
                                                            CODEC 987
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:            Position of the Council at first reading with a view to the adoption of a
                    DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
                    on the interoperability of the rail system within the European Union (recast)
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                                               DGE 2                                          EN
 ---pagebreak---                                        DIRECTIVE (EU).…/….
                OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
                                                    of
               on the interoperability of the rail system within the European Union
                                                 (Recast)
                                      (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
Articles 91(1), 170 and 171 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee 1,
Having regard to the opinion of the Committee of the Regions 2,
Acting in accordance with the ordinary legislative procedure 3,
1
        OJ C 327, 12.11.2013, p. 122.
2
        OJ C 356, 5.12.2013, p. 92.
3
        Position of the European Parliament of 26 February 2014 [(OJ...)] [(not yet published in the
        Official Journal)] and position of the Council at first reading of... [(OJ...)] [(not yet
        published in the Official Journal)]. Position of the European Parliament of... [(OJ...)] [(not
        yet published in the Official Journal)] [and decision of the Council of... ].
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                                                  DGE 2                                             EN
 ---pagebreak--- Whereas:
(1)     Directive 2008/57/EC of the European Parliament and of the Council 1 has been
        substantially amended several times. Since further amendments are to be made, that
        Directive should be recast in the interests of clarity.
(2)     In order to enable citizens of the Union, economic operators and competent authorities to
        benefit to the full from the advantages deriving from the establishment of a single
        European railway area, it is appropriate, in particular, to improve the interlinkage and
        interoperability of the national rail networks as well as access to those networks and to
        implement any measures that may be necessary in the field of technical standardisation as
        provided for in Article 171 of the Treaty on the Functioning of the European Union
        (TFEU).
(3)     The pursuit of interoperability within the Union rail system should lead to the definition of
        an optimal level of technical harmonisation and make it possible to facilitate, improve and
        develop international rail transport services within the Union and with third countries, and
        contribute to the progressive creation of the internal market in equipment and services for
        the construction, renewal, upgrading and operation of the Union rail system.
(4)     In order to contribute to the completion of the single European railway area, reduce the
        costs and duration of authorisation procedures and improve railway safety it is appropriate
        to streamline and harmonise authorisation procedures at Union level.
1
      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 (OJ L 191, 18.7.2008, p. 1).
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                                                 DGE 2                                           EN
 ---pagebreak--- (5)     Metros, trams and other light rail systems are subject in many Member States to local
        technical requirements. Such local public transport systems are usually not subject to
        licensing within the Union. Trams and light rail systems are furthermore often subject to
        road legislation because of shared infrastructure. For those reasons, such local systems do
        not need to be interoperable and should therefore be excluded from the scope of this
        Directive. This does not prevent Member States from applying the provisions of this
        Directive to local rail systems on a voluntary basis if they deem this appropriate.
(6)     A tram-train is a public-transport concept which allows for a combined operation on both
        light-rail infrastructure and heavy-rail infrastructure. Member States should be permitted to
        exclude from the scope of the measures implementing this Directive those vehicles
        primarily used on light-rail infrastructure but equipped with some heavy-rail components
        necessary to enable transit to be effected on a confined and limited section of heavy-rail
        infrastructure for connectivity purposes only. When tram-trains use railway infrastructure,
        compliance with all essential requirements should be ensured, as well as compliance with
        the expected safety level on the relevant lines. For cross-border cases, competent
        authorities should cooperate.
(7)     The commercial operation of trains throughout the rail network requires, in particular,
        excellent compatibility between the characteristics of the infrastructure and those of the
        vehicles, as well as efficient interconnection of the information and communication
        systems of the different infrastructure managers and railway undertakings. Performance
        levels, safety, quality of service and cost depend upon such compatibility and
        interconnection, as does, in particular, the interoperability of the Union rail system.
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                                                 DGE 2                                           EN
 ---pagebreak--- (8)     The railway regulatory framework at Union and Member State level should set clear roles
        and responsibilities for ensuring compliance with the safety, health and consumer
        protection rules applying to the railway networks. This Directive should not lead to a
        reduced level of safety or increase costs in the Union rail system. To that end, the
        European Union Agency for Railways ('the Agency') established by Regulation
        (EU) …./… of the European Parliament and of the Council 1+ and the national safety
        authorities should take full responsibility for the authorisations they issue.
(9)     Major differences exist between national regulations, internal rules and technical
        specifications applicable to rail systems, subsystems and components, since they
        incorporate techniques that are specific to the national industries and lay down specific
        dimensions and devices as well as special characteristics. That situation may prevent trains
        from running without hindrance throughout the Union.
(10)    In order to enhance their competitiveness at world level, the Union railway industries
        require an open and competitive market.
(11)    It is therefore appropriate to define essential requirements relating to rail interoperability
        for the whole of the Union which should apply to its rail system.
1
      Regulation (EU) …/... of the European Parliament and of the Council of … on the European
      Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ…).
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD) and
      complete footnote.
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                                                 DGE 2                                             EN
 ---pagebreak--- (12)    The development of technical specifications for interoperability ('TSIs') has shown the
        need to clarify the relationship between the essential requirements and TSIs on the one
        hand, and the European standards and other documents of a normative nature on the other.
        In particular, a clear distinction should be drawn between the standards or parts of
        standards which should be made mandatory in order to achieve the objectives of this
        Directive, and the 'harmonised standards' that have been developed in accordance with
        Regulation (EU) No 1025/2012 of the European Parliament and of the Council 1. Where
        strictly necessary, the TSIs may make an explicit reference to European standards or
        specifications, which become mandatory from the moment the TSI is applicable.
(13)    In order to genuinely increase the competitiveness of the Union railway sector without
        distorting competition between key actors of the Union rail system, the TSIs and the
        recommendations of the Agency related to these TSIs should be drafted by respecting the
        principles of openness, consensus and transparency as defined in Annex II to Regulation
        (EU) No 1025/2012.
(14)    The quality of rail services in the Union depends, inter alia, on excellent compatibility
        between the characteristics of the network (in the broadest sense, i.e. the fixed parts of all
        the subsystems concerned) and those of the vehicles (including the on-board components
        of all the subsystems concerned). Performance levels, safety, quality of service and cost
        depend upon that compatibility.
1
      Regulation (EU) No 1025/2012 of the European Parliament and of the Council
      of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC
      and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
      2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of
      the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of
      the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
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                                                 DGE 2                                            EN
 ---pagebreak--- (15)    TSIs have a direct or potential impact on the staff involved in the operation and
        maintenance of subsystems. When preparing TSIs, therefore, the Agency should consult
        social partners, where appropriate.
(16)    A TSI should set out all the conditions with which an interoperability constituent is to
        conform, and the procedure to be followed in assessing conformity. In addition, it is
        necessary to specify that every constituent should undergo the procedure for assessing
        conformity and suitability for the use indicated in the TSIs and should have the
        corresponding certificate, comprising either the assessment of the conformity of an
        interoperability constituent, considered in isolation, to the technical specifications to be
        met, or the assessment of the suitability for use of an interoperability constituent,
        considered within its railway environment, in relation to the technical specifications.
(17)    In the development of new TSIs, the aim should always be to ensure compatibility with the
        existing subsystems. This will help to promote the competitiveness of rail transport and
        prevent unnecessary additional costs through the requirement of upgrading or renewal of
        existing subsystems to ensure backward compatibility. In those exceptional cases where it
        will not be possible to ensure compatibility, it should be possible for TSIs to establish the
        framework necessary to decide whether the existing subsystem needs a new decision or
        authorisation for placing in service or placing on the market, and the
        corresponding deadlines.
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                                                DGE 2                                              EN
 ---pagebreak--- (18)    If certain technical aspects corresponding to the essential requirements cannot be explicitly
        covered in a TSI, those aspects which still need to be addressed should be identified in an
        annex to that TSI as open points. For those open points, as well as for specific cases, and
        with the aim of compliance with the existing systems, national rules that may be adopted in
        a Member State by any competent national, regional or local authority should apply. To
        avoid redundant verifications and unnecessary administrative burdens, national rules
        should be classified to establish the equivalence between national rules of different
        Member States covering the same topics.
(19)    The procedure to be followed in the case of essential requirements applicable to a
        subsystem which have not yet been covered in the corresponding TSI should be specified.
        In such a case, the bodies responsible for the conformity assessment and verification
        procedures should be the designated bodies referred to in this Directive.
(20)    This Directive should apply to the entire Union rail system and the scope of the TSIs
        should be extended to cover the vehicles and networks not included in the trans-European
        rail system. Therefore, Annex I to Directive 2008/57/EC should be simplified.
(21)    The functional and technical specifications to be met by subsystems and their interfaces
        may vary according to the use of the subsystems concerned, for example according to the
        categories of lines and vehicles, in particular for ensuring coherence between high-speed
        and conventional rail systems.
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                                                DGE 2                                            EN
 ---pagebreak--- (22)    In order to ensure the progressive implementation of rail interoperability within the whole
        of the Union and to gradually reduce the diversity of legacy systems, the TSIs should
        specify the provisions to be applied in the event of renewal or upgrading of existing
        subsystems and may include proposals for the staged completion of the target system.
        However, in order to keep the railway sector competitive and to prevent undue costs, the
        entry into force of new or amended TSIs should not lead to an immediate adaptation of
        vehicles and infrastructure to the new specifications.
(23)    TSIs should indicate when the upgrade and renewal of infrastructure and vehicles requires
        a new authorisation. In all cases for the upgrade and renewal of infrastructure, the applicant
        should submit, through the one-stop shop referred to in Regulation (EU) …./… +, a file to
        the national safety authority so that it can decide whether a new authorisation is needed on
        the basis of the criteria set out in this Directive. In the case of the upgrade and renewal of
        vehicles which have an authorisation to place on the market, the applicant should be able to
        decide whether it needs to seek a new authorisation from the national safety authority or
        the Agency on the basis of the criteria set out in this Directive.
(24)    In view of the gradual approach to eliminating obstacles to the interoperability of the
        Union rail system and of the time consequently required for the adoption of TSIs, steps
        should be taken to avoid a situation where Member States adopt new national rules or
        undertake projects that increase the diversity of the present system.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
10579/15                                                                    IV/NT/ra                   8
                                                  DGE 2                                            EN
 ---pagebreak--- (25)    In order to eliminate the obstacles to interoperability, and as a consequence of extending
        the scope of the TSIs to the whole of the Union rail system, the volume of national rules
        should progressively be reduced. National rules strictly relating to existing systems should
        be differentiated from those needed to cover open points in TSIs. Rules of the latter type
        should be progressively removed as a result of closure of open points in the TSIs.
(26)    National rules should be drafted and published in such a way that any potential user of a
        national network can understand them. Such rules often refer to other documents such as
        national standards, European standards, international standards or other technical
        specifications which might be partly or fully protected by intellectual property rights.
        Therefore, the obligation of publication should not apply to documents referred to directly
        or indirectly in the national rule.
(27)    The adoption of a gradual approach satisfies the objective of interoperability of the Union
        rail system, which is characterised by old national infrastructure and vehicles requiring
        heavy investment for adaptation or renewal, and particular care should be taken to maintain
        the competitiveness of rail vis-à-vis other modes of transport.
10579/15                                                                 IV/NT/ra                   9
                                                DGE 2                                            EN
 ---pagebreak--- (28)    In view of the extent and complexity of the Union rail system, it has proved necessary, for
        practical reasons, to break it down into the following subsystems: infrastructure, trackside
        control-command and signalling, on-board control-command and signalling, energy,
        rolling stock, operation and traffic management, maintenance and telematics applications
        for passenger and freight services. For each of those subsystems, the essential requirements
        need to be specified and the technical specifications determined, particularly in respect of
        constituents and interfaces, in order to meet those essential requirements. The same system
        is broken down into fixed and mobile elements comprising, on the one hand, the network,
        which is composed of the lines, stations, terminals, and all kinds of fixed equipment
        needed to ensure safe and continuous operation of the system and, on the other hand, all
        vehicles travelling on that network. Therefore, for the purposes of this Directive, a vehicle
        is composed of one subsystem (rolling stock) and where applicable other subsystems
        (mainly the on-board control-command and signalling subsystem). Although the system is
        divided into several elements, the Agency should retain an overview of the system, in order
        to promote interoperability and safety.
(29)    The United Nations Convention on the Rights of Persons with Disabilities, to which the
        Union is a party, establishes accessibility as one of its general principles and requires
        States Parties to take appropriate measures in order to ensure access for persons with
        disabilities on an equal basis with others, including by developing, promulgating and
        monitoring the implementation of minimum standards and guidelines for accessibility.
        Accessibility for persons with disabilities and persons with reduced mobility is therefore an
        essential requirement for the interoperability of the Union rail system.
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                                                DGE 2                                             EN
 ---pagebreak--- (30)  No person is to be discriminated against, either directly or indirectly, on the basis of a
      disability. In order to ensure that all Union citizens can enjoy the benefits resulting from the
      establishment of single European railway area, Member States should promote a railway
      system accessible to all.
(31)    Implementation of the provisions on the interoperability of the Union rail system should
        not give rise to unjustified costs nor undermine the preservation of the interoperability of
        existing rail networks.
(32)    TSIs also have an impact on the conditions of use of rail transport by users, and it is
        therefore necessary to consult those users on aspects concerning them, including
        organisations of persons with disabilities, where appropriate.
(33)    Each Member State concerned should be allowed not to apply certain TSIs in a limited
        number of duly substantiated situations. Those situations and the procedures to be followed
        in cases of non-application of a given TSI should be clearly defined.
(34)    The drawing-up of TSIs and their application to the Union rail system should not impede
        technological innovation, which should be directed towards improving
        economic performance.
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                                                DGE 2                                             EN
 ---pagebreak--- (35)    In order to comply with the appropriate provisions on procurement procedures in the rail
        sector and, in particular, those laid down in Directive 2014/25/EU of the
        European Parliament and of the Council 1, contracting entities are to include technical
        specifications in the general documents or in the terms and conditions for each contract. To
        that end, it is necessary to draw up a set of rules to serve as references for those
        technical specifications.
(36)    An international system of standardisation capable of generating standards which are
        actually used by those involved in international trade and which meet the requirements of
        Union policy would be in the Union's interest. The European standardisation organisations
        should therefore continue their cooperation with international standardisation bodies.
(37)    The contracting entity ordering the design, construction, renewal or upgrading of a
        subsystem could be a railway undertaking, an infrastructure manager, an entity in charge of
        maintenance, a keeper, or a concession-holder responsible for carrying out a project.
        Contracting entities should define the requirements needed to complete European
        specifications or other standards. Those specifications should meet the essential
        requirements that have been harmonised at Union level and which the Union rail system is
        to satisfy.
1
      Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014
      on procurement by entities operating in the water, energy, transport and postal services
      sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).
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                                                DGE 2                                           EN
 ---pagebreak--- (38)    The procedures governing the assessment of conformity or of suitability of use of
        constituents should be based on the use of the modules for the procedures for assessment
        of conformity, suitability for use and 'EC' verification to be used in the technical
        specifications for interoperability adopted under this Directive. As far as possible, and in
        order to promote industrial development, it is appropriate to draw up the procedures
        involving a system of quality assurance.
(39)    Conformity of constituents is linked mainly to their area of use in order to guarantee the
        interoperability of the system and not only their free movement in the Union market. The
        suitability for use of the most critical constituents as regards safety, availability or system
        economy should be assessed. It is therefore not necessary for a manufacturer to affix the
        'CE' marking to constituents that are subject to this Directive. On the basis of the
        assessment of conformity and/or suitability for use, the manufacturer's declaration of
        conformity should be sufficient.
(40)    Manufacturers are nonetheless obliged to affix the 'CE' marking to certain components in
        order to certify their compliance with other Union law relating to them.
(41)    When a TSI enters into force, a number of interoperability constituents are already on the
        market. A transitional period should be provided for, so that those constituents can be
        integrated into a subsystem, even if they do not strictly conform to that TSI.
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                                                  DGE 2                                              EN
 ---pagebreak--- (42)    The subsystems constituting the Union rail system should be subject to a verification
        procedure. That verification should enable the entities responsible for their placing in
        service or placing on the market to be certain that, at the design, construction and placing
        into service stages, the result is in line with the regulations and technical and operational
        provisions in force. It should also result in manufacturers being able to count upon equality
        of treatment in all Member States.
(43)    After a subsystem is placed in service or on the market, care should be taken to ensure that
        it is operated and maintained in accordance with the essential requirements relating to it. In
        accordance with Directive (EU) …/…. of the European Parliament and of the Council 1+,
        responsibility for meeting those requirements lies, for their respective subsystems, with the
        infrastructure manager, the railway undertaking or the entity in charge of maintenance,
        each for their own part.
1
      Directive (EU) …/…. of the European Parliament and of the Council of … on railway safety
      (OJ...).
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD) and
      complete footnote.
10579/15                                                                   IV/NT/ra                   14
                                                  DGE 2                                            EN
 ---pagebreak--- (44)    When during operation it appears that a vehicle or a vehicle type does not meet one of the
        applicable essential requirements, the necessary corrective measures should be taken by the
        railway undertakings concerned in order to bring the vehicle(s) into conformity. In
        addition, if that non-conformity leads to a serious safety risk, it should be possible for the
        national safety authorities responsible for the supervision of the circulation of the vehicle
        to take the necessary temporary safety measures, including immediately restricting or
        suspending the relevant operation. If the corrective measures are insufficient and the
        serious safety risk generated by the non-conformity remains, national safety authorities or
        the Agency should be allowed to revoke or amend the authorisation. A serious safety risk
        in this context should be understood as being serious non-compliance with legal
        obligations or safety requirements, that may in itself or in a series of consequential events
        cause an accident or a serious accident. The process of revocation should be supported by
        an appropriate exchange of information between the Agency and the national safety
        authorities, including the use of registers.
(45)    The respective roles and responsibilities of all actors involved should be clarified in
        relation to the procedures for the placing on the market and use of vehicles, and for the
        placing in service of fixed installations.
(46)    The Agency and national safety authorities should cooperate and share competencies as
        appropriate for the issuing of authorisations with due regard to safety. To that end,
        cooperation agreements between the Agency and the national safety authorities should be
        established.
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                                                DGE 2                                              EN
 ---pagebreak--- (47)    In order to ensure that European Rail Traffic Management System (ERTMS) equipment
        complies with the relevant specifications in force and to prevent additional requirements in
        relation to the ERTMS from undermining its interoperability, the Agency should act as the
        ERTMS system authority. To that end, the Agency should be in charge of assessing the
        technical solutions envisaged before any call for tenders relating to ERTMS trackside
        equipment is launched or published, in order to check whether those technical solutions are
        compliant with the relevant TSIs and are fully interoperable.
        Any overlap between this assessment by the Agency and the tasks of the notified bodies in
        the verification procedure should be avoided. The applicant should therefore inform the
        Agency if the verification procedure carried out by the notified body has already started or
        if any conformity certificate is already available. The applicant should be able to choose to
        request such an assessment from the Agency either for each individual ERTMS project or
        for a combination of projects, a line, a group of lines or a network.
(48)    The entry into force of this Directive should not delay the deployment of ERTMS projects
        for which the tendering or contracting process has been completed.
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                                                DGE 2                                           EN
 ---pagebreak--- (49)    In order to facilitate the placing on the market of vehicles and to reduce administrative
        burdens, the notion of a vehicle authorisation for placing on the market that is valid
        throughout the Union should be introduced. While authorisations for placing on the market
        allow for commercial transactions of vehicles anywhere on the Union market, a vehicle
        may only be used within the area of use covered by its authorisation. In that context, any
        extension of the area of use should be subject to an updated authorisation for the vehicle. It
        is necessary that vehicles already authorised under earlier Directives also receive an
        authorisation for placing on the market if they are intended to be used on networks not
        covered by their authorisation.
(50)    When the area of use is limited to a network or networks within one Member State, the
        applicant should be able to choose whether it submits its application for vehicle
        authorisation, through the one-stop shop referred to in Regulation (EU) …./... +, to the
        national safety authority of that Member State or to the Agency. The choice made by the
        applicant should be binding until the application is completed or terminated.
(51)    An appropriate procedure should be available to enable the applicant to appeal against a
        decision of, or a failure to act by, the Agency or the national safety authorities. In addition,
        clear procedural and dispute resolution provisions should be established to address
        situations where the Agency and the national safety authorities disagree on assessments
        made in relation to the issuing of vehicle authorisations.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                             EN
 ---pagebreak--- (52)    Specific measures, including cooperation agreements, should take account of the specific
        geographical and historical situation of certain Member States, while ensuring the proper
        functioning of the internal market.
(53)    Where operation is limited to networks requiring specific expertise for geographical or
        historical reasons, and where such networks are isolated from the rest of the Union rail
        system, it should be possible for the applicant to fulfil the necessary formalities locally by
        interacting with the relevant national safety authorities. To that end, for the purpose of
        reducing administrative burdens and costs, it should be possible for the cooperation
        agreements that are to be concluded between the Agency and the relevant national safety
        authorities to provide for the appropriate allocation of tasks, without prejudice to the
        assumption by the Agency of final responsibility for issuing the authorisation.
(54)    The railway networks located in the Baltic States (Estonia, Latvia and Lithuania) have
        1520 mm track gauge, which is the same as in neighbouring third countries, but is different
        from that of the main rail network within the Union. These Baltic networks have inherited
        common technical and operational requirements, which provide de facto interoperability
        between them, and, in this respect, the vehicle authorisation issued in one of these Member
        States might be valid for the rest of these networks. To facilitate the efficient and
        proportionate allocation of resources for vehicle authorisation for placing on the market or
        a type authorisation of vehicles, and to reduce the financial and administrative burden for
        the applicant in such cases, the specific cooperation arrangements between the Agency and
        relevant national safety authorities should include, where necessary, the possibility of
        contracting tasks to these national safety authorities.
10579/15                                                                 IV/NT/ra                    18
                                                DGE 2                                              EN
 ---pagebreak--- (55)    Member States with an important share of rail traffic with third countries having the same
        railway gauge which is different from that of the main rail network within the Union
        should be able to maintain different vehicle authorisation procedures for freight wagons
        and passenger coaches which are in shared use with those third countries.
(56)    For traceability and safety reasons, Member States' competent authorities should assign a
        European vehicle number to a vehicle when requested to do so by the vehicle's keeper. The
        vehicle information should then be entered in a vehicle register. The vehicle registers
        should be open to consultation by all Member States and by certain economic players
        within the Union. The vehicle registers should be consistent as regards the data format.
        They should therefore be covered by common operational and technical specifications. In
        order to reduce administrative burdens and undue costs, the Commission should adopt a
        specification for a European Vehicle Register that would incorporate national vehicle
        registers, with a view to creating a common tool, while, at the same time, allowing for the
        maintenance of additional functions relevant to Member States' specific needs.
(57)    To ensure traceability of vehicles and their history, the references of the vehicle
        authorisations for placing on the market should be recorded together with other
        vehicle data.
(58)    Procedures should be established for checking the compatibility between vehicles and the
        routes on which they are to be deployed after delivery of the vehicle authorisation for
        placing on the market and before the use by a railway undertaking of a vehicle in its area of
        use as specified in the vehicle authorisation for placing on the market.
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                                                DGE 2                                           EN
 ---pagebreak--- (59)    The notified bodies responsible for examining the procedures for assessment of conformity
        and suitability for use of constituents, together with the procedure for the assessment of
        subsystems, should, in particular in the absence of any European specification, coordinate
        their decisions as closely as possible.
(60)    Transparent accreditation, as provided for in Regulation (EC) No 765/2008 of the
        European Parliament and of the Council 1, ensuring the necessary level of confidence in
        conformity certificates, should be considered by the national public authorities throughout
        the Union to be the preferred means of demonstrating the technical competence of notified
        bodies and, mutatis mutandis, of the bodies designated to check compliance with national
        rules. However, national authorities should be able to consider that they possess the
        appropriate means of carrying out this evaluation themselves. In such cases, in order to
        ensure the appropriate level of credibility of evaluations carried out by other national
        authorities, they should provide the Commission and the other Member States with the
        necessary documentary evidence demonstrating the compliance of the conformity
        assessment bodies evaluated with the relevant regulatory requirements.
(61)    This Directive should be limited to establishing the interoperability requirements for
        interoperability constituents and subsystems. In order to facilitate compliance with those
        requirements, it is necessary to provide for a presumption of conformity for
        interoperability constituents and subsystems which are in conformity with harmonised
        standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the
        purpose of expressing detailed technical specifications relating to those requirements.
1
      Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
      setting out the requirements for accreditation and market surveillance relating to the
      marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
      p. 30).
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 ---pagebreak--- (62)    Measures adopted pursuant to this Directive should be complemented by initiatives aimed
        at providing financial support to innovative and interoperable technologies in the Union
        rail sector.
(63)    In order to supplement non-essential elements of this Directive, the power to adopt acts in
        accordance with Article 290 TFEU should be delegated to the Commission in respect of
        the specific objectives of each TSI. 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 to the Council.
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 ---pagebreak--- (64)    In order to ensure uniform conditions for the implementation of this Directive,
        implementing powers should be conferred on the Commission relating to: TSIs and
        amendments to TSIs, including those amendments needed to remedy deficiencies in TSIs;
        the template of the 'EC' declaration of conformity or suitability for use of interoperability
        constituents and the accompanying documents; the information to be included in the file
        which should accompany the request for non-application of one or more TSIs or parts of
        them, the format and the transmission methods of that file and, where appropriate, the
        decision on non-application of TSIs; the classification of the notified national rules in
        different groups with the aim of facilitating the compatibility checks between fixed and
        mobile equipment; the details of the 'EC' verification procedure and the verification
        procedure in the case of national rules and the templates for the 'EC' declaration of
        verification and the templates for documents of the technical file that should accompany
        the declaration of verification as well as the templates for certificates of verification; the
        practical arrangements for the purposes of vehicle authorisation; the model of the
        declaration of conformity to type and, where appropriate, ad hoc modules for conformity
        assessment; the national vehicle registers, the European Vehicle register and the register of
        authorisation to place types on the market; and the common specifications relating to
        content, data format, functional and technical architecture, operating mode and rules for
        data input and consultation for the register of infrastructure. Those powers should be
        exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament
        and of the Council 1.
1
      Regulation (EU) No 182/2011 of the European Parliament and of the Council
      of 16 February 2011 laying down the rules and general principles concerning mechanisms
      for control by Member States of the Commission's exercise of implementing powers
      (OJ L 55, 28.2.2011, p.13).
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                                                DGE 2                                               EN
 ---pagebreak--- (65)    The TSIs should be revised at regular intervals. When deficiencies are discovered in the
        TSIs, the Agency should be asked to issue an opinion which, under certain conditions,
        might be published and used by all stakeholders (including industry and notified bodies) as
        an acceptable means of compliance pending the revision of the TSIs concerned.
(66)    Implementing acts establishing new TSIs or amending TSIs should reflect the specific
        objectives set out by the Commission by way of delegated acts.
(67)    Certain organisational steps are necessary in order to prepare the Agency for its enhanced
        role under this Directive. Accordingly, an appropriate transitional period should be
        provided for. During that period, the Commission should review the progress made by the
        Agency in preparing for its enhanced role. Thereafter, the Commission should report
        periodically on the progress made in implementing this Directive. In particular, the report
        should evaluate the vehicle authorisation process, the cases where the TSIs are not applied
        and the use of registers. The Commission should also report on actions taken regarding the
        identification and traceability of safety-critical components.
(68)    It is necessary to allow Member States, national safety authorities and stakeholders
        sufficient time in which to prepare to implement this Directive.
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                                                 DGE 2                                          EN
 ---pagebreak--- (69)    Since the objective of this Directive, namely interoperability within the rail system on a
        Union-wide scale, cannot be sufficiently achieved by the Member States but can rather, by
        reason of its scale and effects, be better achieved at Union level, the Union may adopt
        measures, in accordance with the principle of subsidiarity as set out in Article 5 of the
        Treaty on European Union. In accordance with the principle of proportionality, as set out
        in that Article, this Directive does not go beyond what is necessary in order to achieve
        that objective.
(70)    The obligation to transpose this Directive into national law should be confined to those
        provisions which represent a substantive amendment as compared to
        Directive 2008/57/EC. The obligation to transpose the provisions which are unchanged
        arises under Directive 2008/57/EC.
(71)    This Directive should be without prejudice to the obligations of the Member States relating
        to the time-limits for transposition into national law of the Directives set out in Part B of
        Annex V,
HAVE ADOPTED THIS DIRECTIVE:
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                                                 DGE 2                                             EN
 ---pagebreak---                                           CHAPTER I
                                GENERAL PROVISIONS
                                              Article 1
                                      Subject matter and scope
1.      This Directive establishes the conditions to be met to achieve interoperability within the
        Union rail system in a manner compatible with Directive (EU)…/… +. in order to define an
        optimal level of technical harmonisation, to make it possible to facilitate, improve and
        develop rail transport services within the Union and with third countries and to contribute
        to the completion of the single European railway area and the progressive achievement of
        the internal market. Those conditions concern the design, construction, placing in service,
        upgrading, renewal, operation and maintenance of the parts of that system as well as the
        professional qualifications of, and health and safety conditions applying to, the staff who
        contribute to its operation and maintenance.
2.      This Directive lays down the provisions relating to, for each subsystem, the interoperability
        constituents, the interfaces and procedures, and the conditions of overall compatibility of
        the Union rail system required in order to achieve its interoperability.
3.      This Directive shall not apply to:
        (a)   metros;
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                DGE 2                                            EN
 ---pagebreak---         (b) trams and light rail vehicles, and infrastructure used exclusively by those vehicles;
        (c) networks that are functionally separate from the rest of the Union rail system and
            intended only for the operation of local, urban or suburban passenger services, as
            well as undertakings operating solely on those networks.
4.      Member States may exclude from the scope of the measures implementing this Directive:
        (a) privately owned railway infrastructure, including sidings, used by its owner or by an
            operator for the purpose of their respective freight activities or for the transport of
            persons for non-commercial purposes, and vehicles used exclusively on such
            infrastructure;
        (b) infrastructure and vehicles reserved for a strictly local, historical or touristic use;
        (c) light rail infrastructure occasionally used by heavy rail vehicles under the operational
            conditions of the light rail system, where it is necessary for the purposes of
            connectivity of those vehicles only; and
        (d) vehicles primarily used on light rail infrastructure but equipped with some heavy rail
            components necessary to enable transit to be effected on a confined and limited
            section of heavy rail infrastructure for connectivity purposes only.
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                                              DGE 2                                                EN
 ---pagebreak--- 5.       In the case of tram-trains operating in the Union rail system, where there are no TSIs that
         apply to those tram-trains, the following shall apply:
         (a)   Member States concerned shall ensure that national rules or other relevant accessible
               measures are adopted in order to ensure that such tram-trains meet the relevant
               essential requirements;
         (b)   Member States may adopt national rules in order to specify the authorisation
               procedure applicable to such tram-trains. The authority issuing the vehicle
               authorisation shall consult the relevant national safety authority in order to ensure
               that mixed operation of tram-trains and heavy rail trains meet all essential
               requirements as well as relevant common safety targets ('CSTs');
         (c)   By way of derogation from Article 21, in the case of cross-border operation, the
               relevant competent authorities shall cooperate with a view to issuing the vehicle
               authorisations.
         This paragraph does not apply to vehicles excluded from the scope of this Directive in
         accordance with paragraphs 3 and 4.
                                                Article 2
                                              Definitions
For the purposes of this Directive:
(1)      'Union rail system' means the elements listed in Annex I;
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 ---pagebreak--- (2)     'interoperability' means the ability of a rail system to allow the safe and uninterrupted
        movement of trains which accomplish the required levels of performance;
(3)     'vehicle' means a railway vehicle suitable for circulation on wheels on railway lines, with
        or without traction. A vehicle is composed of one or more structural and functional
        subsystems;
(4)     'network' means the lines, stations, terminals, and all kinds of fixed equipment needed to
        ensure safe and continuous operation of the Union rail system;
(5)     'subsystems' means the structural or functional parts of the Union rail system, as set out in
        Annex II;
(6)     'mobile subsystem' means the rolling stock subsystem and the on-board control-command
        and signalling subsystem;
(7)     'interoperability constituents' means any elementary component, group of components,
        subassembly or complete assembly of equipment incorporated or intended to be
        incorporated into a subsystem, upon which the interoperability of the rail system depends
        directly or indirectly, including both tangible objects and intangible objects;
(8)     'product' means a product obtained through a manufacturing process, including
        interoperability constituents and subsystems;
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                                                 DGE 2                                            EN
 ---pagebreak--- (9)     'essential requirements' means all the conditions set out in Annex III which must be met by
        the Union rail system, the subsystems, and the interoperability constituents, including
        interfaces;
(10)    'European specification' means a specification which falls into one of the following
        categories:
        –      a common technical specification as defined in Annex VIII of Directive 2014/25/EU;
        –      a European technical approval as referred to in Article 60 of Directive 2014/25/EU;
               or
        –      a European standard as defined in point (b) of Article 2(1) of Regulation (EU)
               No 1025/2012;
(11)    'technical specification for interoperability' (TSI) means a specification adopted in
        accordance with this Directive by which each subsystem or part of a subsystem is covered
        in order to meet the essential requirements and ensure the interoperability of the Union
        rail system;
(12)    'basic parameter' means any regulatory, technical or operational condition which is critical
        to interoperability and is specified in the relevant TSIs;
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                                                 DGE 2                                          EN
 ---pagebreak--- (13)    'specific case' means any part of the rail system which needs special provisions in the TSIs,
        either temporary or permanent, because of geographical, topographical or urban
        environment constraints or those affecting compatibility with the existing system, in
        particular railway lines and networks isolated from the rest of the Union, the loading
        gauge, the track gauge or space between the tracks and vehicles strictly intended for local,
        regional or historical use, as well as vehicles originating from or destined for
        third countries;
(14)    'upgrading' means any major modification work on a subsystem or part of it which results
        in a change in the technical file accompanying the 'EC' declaration of verification, if that
        technical file exists, and which improves the overall performance of the subsystem;
(15)    'renewal' means any major substitution work on a subsystem or part of it which does not
        change the overall performance of the subsystem;
(16)    'existing rail system' means the infrastructure composed of lines and fixed installations of
        the existing rail network as well as the vehicles of all categories and origins travelling on
        that infrastructure;
(17)    'substitution in the framework of maintenance' means any replacement of components by
        parts of identical function and performance in the framework of preventive or
        corrective maintenance;
(18)    'tram-train' means a vehicle designed for combined use on both a light-rail infrastructure
        and a heavy-rail infrastructure;
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                                                 DGE 2                                             EN
 ---pagebreak--- (19)    'placing in service' means all the operations by which a subsystem is put into its
        operational service;
(20)    'contracting entity' means a public or private entity which orders the design and/or
        construction or the renewal or upgrading of a subsystem;
(21)    'keeper' means the natural or legal person that, being the owner of a vehicle or having the
        right to use it, exploits the vehicle as a means of transport and is registered as such in a
        vehicle register referred to in Article 47;
(22)    'applicant' means a natural or legal person requesting an authorisation, be it a railway
        undertaking, an infrastructure manager or any other person or legal entity, such as a
        manufacturer, an owner or a keeper; for the purpose of Article 15, the 'applicant' means a
        contracting entity or a manufacturer, or its authorised representatives; for the purpose of
        Article 19, the 'applicant' means a natural or legal person requesting the Agency's decision
        for the approval of the technical solutions envisaged for the ERTMS track-side equipment
        projects;
(23)    'project at an advanced stage of development' means any project the planning or
        construction stage of which has reached a point where a change in the technical
        specifications may compromise the viability of the project as planned;
(24)    'harmonised standard' means a European standard as defined in point (c) of Article 2(1) of
        Regulation (EU) No 1025/2012;
(25)    'national safety authority' means a safety authority as defined in point (7) of Article 3 of
        Directive (EU) …/… +;
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                  DGE 2                                             EN
 ---pagebreak--- (26)    'type' means a vehicle type defining the basic design characteristics of the vehicle as
        covered by a type or design examination certificate described in the relevant
        verification module;
(27)    'series' means a number of identical vehicles of a design type;
(28)    'entity in charge of maintenance' ('ECM') means an entity in charge of maintenance as
        defined in point (20) of Article 3 of Directive (EU)…/… +;
(29)    'light rail' means an urban and/or suburban rail transport system with a crashworthiness of
        C-III or C-IV (in accordance with EN 15227:2011) and a maximum strength of vehicle of
        800 kN (longitudinal compressive force in coupling area); light rail systems may have their
        own right of way or share it with road traffic and usually do not exchange vehicles with
        long-distance passenger or freight traffic;
(30)    'national rules' means all binding rules adopted in a Member State, irrespective of the body
        issuing them, which contain railway safety or technical requirements, other than those laid
        down by Union or international rules which are applicable within that Member State to
        railway undertakings, infrastructure managers or third parties;
(31)    'design operating state' means the normal operating mode and the foreseeable degraded
        conditions (including wear) within the range and the conditions of use specified in the
        technical and maintenance files;
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
10579/15                                                                IV/NT/ra                   32
                                                DGE 2                                           EN
 ---pagebreak--- (32)    'area of use of a vehicle' means a network or networks within a Member State or a group of
        Member States in which a vehicle is intended to be used;
(33)    'acceptable means of compliance' means non-binding opinions issued by the Agency to
        define ways of establishing compliance with the essential requirements;
(34)    'acceptable national means of compliance' means non-binding opinions issued by
        Member States to define ways of establishing compliance with national rules;
(35)    'placing on the market' means the first making available on the Union's market of an
        interoperability constituent, subsystem or vehicle ready to function in its design
        operating state;
(36)    'manufacturer' means any natural or legal person who manufactures a product in the form
        of interoperability constituents, subsystems or vehicles, or has it designed or manufactured,
        and markets it under his name or trademark;
(37)    'authorised representative' means any natural or legal person established within the Union
        who has received a written mandate from a manufacturer or a contracting entity to act on
        behalf of that manufacturer or contracting entity in relation to specified tasks;
(38)    'technical specification' means a document that prescribes technical requirements to be
        fulfilled by a product, subsystem, process or service;
(39)    'accreditation' means accreditation as defined in point (10) of Article 2 of Regulation (EC)
        No 765/2008;
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                                                DGE 2                                            EN
 ---pagebreak--- (40)    'national accreditation body' means a national accreditation body as defined in point (11) of
        Article 2 of Regulation (EC) No 765/2008;
(41)    'conformity assessment' means the process demonstrating whether specified requirements
        relating to a product, process, service, subsystem, person or body have been fulfilled;
(42)    'conformity assessment body' means a body that has been notified or designated to be
        responsible for conformity assessment activities, including calibration, testing, certification
        and inspection. A conformity assessment body is classified as a 'notified body' following
        notification by a Member State. A conformity assessment body is classified as a
        'designated body' following designation by a Member State;
(43)    person with disabilities and person with reduced mobility' shall include any person who
        has a permanent or temporary physical, mental, intellectual or sensory impairment which,
        in interaction with various barriers, may hinder the full and effective use by that person of
        transport on an equal basis with other passengers or whose mobility when using transport
        is reduced due to age;
(44)    'infrastructure manager' means an infrastructure manager as defined in point (2) of
        Article 3 of Directive 2012/34/EU of the European Parliament and of the Council 1;
(45)    'railway undertaking' means a railway undertaking as defined in point (1) of Article 3 of
        Directive 2012/34/EU, and any other public or private undertaking, the activity of which is
        to provide transport of goods and/or passengers by rail on the basis that the undertaking is
        to ensure traction; this also includes undertakings which provide traction only.
1
      Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012
      establishing a single European railway area (OJ L 343, 14.12.2012, p. 32).
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                                                 DGE 2                                            EN
 ---pagebreak---                                               Article 3
                                       Essential requirements
1.      The Union rail system, subsystems and interoperability constituents including interfaces
        shall meet the relevant essential requirements.
2.      The technical specifications referred to in Article 60 of Directive 2014/25/EU, which are
        necessary to complete European specifications or other standards in use within the
        Union, shall not conflict with the essential requirements.
                                         CHAPTER II
   TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY
                                              Article 4
                                           Content of TSIs
1.      Each of the subsystems defined in Annex II shall be covered by one TSI. Where necessary,
        a subsystem may be covered by several TSIs and one TSI may cover several subsystems.
2.      Fixed subsystems shall comply with the TSIs and national rules in force at the time of the
        request for authorisation of placing in service in accordance with this Directive and
        without prejudice to point (f) of paragraph 3.
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                                                DGE 2                                          EN
 ---pagebreak---         Vehicles shall comply with TSIs and national rules in force at the time of the request for
        authorisation of placing on the market in accordance with this Directive and without
        prejudice to point (f) of paragraph 3.
        The conformity and compliance of fixed subsystems and vehicles shall be permanently
        maintained while they are in use.
3.      To the extent necessary to achieve the objectives of this Directive referred to in Article 1,
        each TSI shall:
        (a)   indicate its intended scope (part of network or vehicles referred to in Annex I;
              subsystem or part of subsystem referred to in Annex II);
        (b)   lay down essential requirements for each subsystem concerned and its interfaces in
              relation to other subsystems;
        (c)   establish the functional and technical specifications to be met by the subsystem and
              its interfaces in relation to other subsystems. If necessary, these specifications may
              vary according to the use of the subsystem, for example according to the categories
              of line, hub and/or vehicles provided for in Annex I;
        (d)   determine the interoperability constituents and interfaces which must be covered by
              European specifications, including European standards, which are necessary to
              achieve interoperability within the Union rail system;
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                                                  DGE 2                                           EN
 ---pagebreak---         (e)   state, in each case under consideration, which procedures are to be used in order to
              assess the conformity or the suitability for use of the interoperability constituents, on
              the one hand, or the 'EC' verification of the subsystems, on the other. Those
              procedures shall be based on the modules defined in Commission
              Decision 2010/713/EU 1;
        (f)   indicate the strategy for the application of the TSI. In particular, it is necessary to
              specify the stages to be completed, taking into account the estimated costs and
              benefits and the expected repercussions for the stakeholders affected in order to
              make a gradual transition from the existing situation to the final situation in which
              compliance with the TSI shall be the norm. Where coordinated implementation of the
              TSI is necessary, such as along a corridor or between infrastructure managers and
              railway undertakings, the strategy may include proposals for staged completion;
        (g)   indicate, for the staff concerned, the professional qualifications and health and safety
              conditions at work required for the operation and maintenance of the above
              subsystem, as well as for the application of the TSIs;
        (h)   indicate the provisions applicable to the existing subsystems and vehicles, in
              particular in the event of upgrading and renewal and, in such cases, the modification
              work which requires an application for a new authorisation;
1
      Commission Decision 2010/713/EU of 9 November 2010 on modules for the procedures for
      assessment of conformity, suitability for use and 'EC' verification to be used in the technical
      specifications for interoperability adopted under Directive 2008/57/EC of the
      European Parliament and of the Council (OJ L 319, 4.12.2010, p. 1).
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                                                DGE 2                                               EN
 ---pagebreak---         (i)    indicate the parameters of the vehicles and fixed subsystems to be checked by the
               railway undertaking and the procedures to be applied to check those parameters after
               the delivery of the vehicle authorisation for placing on the market and before the first
               use of the vehicle to ensure compatibility between vehicles and the routes on which
               they are to be operated.
4.      Each TSI shall be drawn up on the basis of an examination of an existing subsystem and
        indicate a target subsystem that may be obtained gradually within a reasonable timescale.
        Accordingly, the adoption of the TSIs and compliance with them shall gradually facilitate
        achievement of the interoperability of the Union rail system.
5.      TSIs shall retain, in an appropriate manner, the compatibility of the existing rail system of
        each Member State. For that purpose, specific cases for each TSI may be provided for,
        with regard to both network and vehicles, and in particular for the loading gauge, the track
        gauge or space between the tracks and vehicles originating from or destined for
        third countries. For each specific case, the TSIs shall stipulate the implementing rules of
        the elements of the TSIs provided for in points (c) to (g) of paragraph 3.
6.      If certain technical aspects corresponding to the essential requirements cannot be explicitly
        covered in a TSI, they shall be clearly identified in an annex to the TSI as open points.
7.      TSIs shall not prevent the Member States from deciding on the use of infrastructures for
        the movement of vehicles not covered by the TSIs.
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                                                DGE 2                                            EN
 ---pagebreak--- 8.      TSIs may make an explicit, clearly identified reference to European or international
        standards or specifications or technical documents published by the Agency where this is
        strictly necessary in order to achieve the objectives of this Directive. In such a case, these
        standards or specifications (or their relevant parts) or technical documents shall be
        regarded as annexes to the TSI concerned and shall become mandatory from the moment
        the TSI is applicable. In the absence of such standards or specifications or technical
        documents, and pending their development, reference may be made to other clearly
        identified normative documents that are easily accessible and in the public domain.
                                                 Article 5
                                 Drafting, adoption and review of TSIs
1.      In order to set out the specific objectives of each TSI, the Commission shall be empowered
        to adopt delegated acts in accordance with Article 50 concerning, in particular and where
        appropriate:
        (a)    the geographical and technical scope of the TSIs;
        (b)    the applicable essential requirements;
        (c)    the list of regulatory, technical and operational conditions to be harmonised at the
               level of subsystems and at the level of the interfaces between subsystems and their
               expected level of harmonisation;
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                                                  DGE 2                                            EN
 ---pagebreak---         (d)   the railway-specific procedures for assessment of conformity and suitability for use
              of the interoperability constituents;
        (e)   the railway-specific procedures to assess the 'EC' verification of the subsystems;
        (f)   the categories of staff involved in the operation and maintenance of the subsystems
              concerned and the general objectives for setting the minimum requirements for
              professional qualifications and health and safety conditions for the staff concerned;
        (g)   any other necessary element to be taken into account to ensure interoperability
              pursuant to Article 1(1) and (2) within the Union rail system, such as alignment of
              TSI with European and international standards or specifications.
        When adopting those delegated acts, the Commission shall justify the need for a new or
        substantially amended TSI, including its impact on existing rules and technical
        specifications.
2.      In order to ensure uniform implementation of the delegated acts referred to in paragraph 1,
        the Commission shall request that the Agency draft TSIs and amendments thereto and
        make the relevant recommendations to the Commission.
        Each draft TSI shall be drawn up in the following stages:
        (a)   the Agency shall identify the basic parameters for the TSI as well as the interfaces
              with the other subsystems and any other specific cases that may be necessary;
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                                                DGE 2                                            EN
 ---pagebreak---         (b)   the Agency shall draw up the draft TSI on the basis of the basic parameters referred
              to in point (a). Where appropriate, the Agency shall take account of technical
              progress, of standardisation work already carried out, of working parties already in
              place and of acknowledged research work.
3.      When drafting or reviewing each TSI, including the basic parameters, the Agency shall
        take account of the estimated costs and benefits of all the technical solutions considered,
        together with the interfaces between them, so as to establish and implement the most viable
        solutions. That assessment shall indicate the likely impact on all the operators and
        economic actors involved and shall take due account of the requirements of Directive
        (EU).../... +. Member States shall participate in this assessment by providing, where
        appropriate, the requisite data.
4.      The Agency shall draft the TSIs and amendments thereto in accordance with Articles 5
        and 19 of Regulation (EU) …/... ++ while fulfilling the criteria of openness, consensus and
        transparency as defined in Annex II to Regulation (EU) No 1025/2012.
5.      The committee referred to in Article 51 ('the committee') shall be kept periodically
        informed of the preparatory work on the TSIs. During that work, to comply with the
        delegated acts referred to in paragraph 1 of this Article, the Commission may formulate
        any terms of reference or useful recommendations concerning the design of the TSIs and a
        cost-benefit analysis. In particular, the Commission may require that alternative solutions
        be examined and that the assessment of the cost and benefits of those alternative solutions
        be set out in the report annexed to the draft TSI.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
++
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                           EN
 ---pagebreak--- 6.      Where different subsystems have to be placed in service simultaneously for reasons of
        technical compatibility, the dates of application of the relevant TSIs shall be the same.
7.      When drafting, adopting or reviewing the TSIs, the Agency shall take account of the
        opinion of users as regards the characteristics which have a direct impact on the conditions
        in which they use the subsystems. To that end, the Agency shall consult associations and
        bodies representing users during the drafting and review phases of the TSIs. It shall
        enclose with the draft TSI a report on the results of that consultation.
8.      In accordance with Article 7 of Regulation (EU) …/… +, the Commission, with the
        assistance of the committee, shall draw up and periodically update the list of passengers'
        associations and bodies to be consulted. That list may be re-examined and updated at the
        request of a Member State or upon the initiative of the Commission.
9.      When drafting or reviewing the TSIs, the Agency shall take account of the opinion of the
        social partners as regards the professional qualifications and health and safety conditions at
        work referred to in point (g) of Article 4(3). To that end, the Agency shall consult the
        social partners before submitting to the Commission recommendations on TSIs and their
        amendments. The social partners shall be consulted within the Sectoral Dialogue
        Committee set up in accordance with Commission Decision 98/500/EC 1. The social
        partners shall issue their opinion within three months of the consultation.
10.     When the revision of a TSI leads to a change of requirements, the new TSI version shall
        ensure compatibility with subsystems placed in service in accordance with former TSI
        versions.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
1
      Commission Decision 98/500/EC of 20 May 1998 on the establishment of Sectoral Dialogue
      Committees promoting the Dialogue between the social partners at European level
      (OJ L 225, 12.8.1998, p. 27).
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                                                DGE 2                                             EN
 ---pagebreak--- 11.     The Commission shall establish, by means of implementing acts, TSIs to implement the
        specific objectives set out in the delegated acts referred to in paragraph 1. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 51(3). They shall include all the elements listed in Article 4(3) and meet all
        the requirements set out in Article 4(4) to 4(6) and (8).
                                                 Article 6
                                           Deficiencies in TSIs
1.      If, after its adoption, it appears that a TSI has a deficiency, that TSI shall be amended in
        accordance with Article 5(11). If appropriate, the Commission shall apply this procedure
        without delay. Such deficiencies shall include cases which could result in unsafe
        operations within a Member State.
2.      Pending the review of a TSI, the Commission may request an opinion from the Agency.
        The Commission shall analyse the Agency's opinion and inform the committee of its
        conclusions.
3.      At the request of the Commission, the Agency's opinion referred to in paragraph 2 shall
        constitute acceptable means of compliance and may therefore be used for the assessment of
        projects, pending the adoption of a revised TSI.
4.      Any member of the network of representative bodies referred to in Article 38(4) of
        Regulation (EU) …/... + may make the Commission aware of possible TSI deficiencies.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                   DGE 2                                           EN
 ---pagebreak---                                                Article 7
                                       Non-application of TSIs
1.      Member States may allow the applicant not to apply one or more TSIs or parts of them in
        the following cases:
        (a)   for a proposed new subsystem or part of it, for the renewal or upgrading of an
              existing subsystem or part of it, or for any element referred to in Article 1(1) which is
              at an advanced stage of development or which is the subject of a contract in the
              course of performance on the date of application of the TSI(s) concerned;
        (b)   where, following an accident or a natural disaster, the conditions for the rapid
              restoration of the network do not economically or technically allow for partial or
              total application of the relevant TSIs, in which case the non-application of the TSIs
              shall be limited to the period before the restoration of the network;
        (c)   for any proposed renewal, extension or upgrading of an existing subsystem or part of
              it, when the application of the TSI(s) concerned would compromise the economic
              viability of the project and/or the compatibility of the rail system in the
              Member State concerned, for example in relation to the loading gauge, track gauge,
              space between tracks or electrification voltage;
        (d)   for vehicles arriving from or going to third countries the track gauge of which is
              different from that of the main rail network within the Union;
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                                                DGE 2                                            EN
 ---pagebreak---         (e)    for a proposed new subsystem or for the proposed renewal or upgrading of an
               existing subsystem in the territory of the Member State concerned when its rail
               network is separated or isolated by the sea or separated as a result of special
               geographical conditions from the rail network of the rest of the Union.
2.      In the case referred to in point (a) of paragraph 1, the Member State concerned shall
        communicate to the Commission, within one year of entry into force of each TSI, a list of
        projects that are taking place within its territory and which, in the view of the
        Member State concerned, are at an advanced stage of development.
3.      In the cases referred to in points (a) and (b) of paragraph 1, the Member State concerned
        shall communicate to the Commission its decision not to apply one or more TSIs or parts
        of them.
4.      In the cases referred to in points (a), (c), (d) and (e) of paragraph 1 of this Article, the
        Member State concerned shall submit to the Commission the request for non-application of
        the TSIs or parts of them, accompanied by a file containing the justification for the request,
        and specifying the alternative provisions that that Member State intends to apply instead of
        the TSIs. In the case referred to in point (e) of paragraph 1 of this Article, the Commission
        shall analyse the request and decide whether or not to accept it on the basis of the
        completeness and coherence of the information contained in the file. In the cases referred
        to in points (c) and (d) of paragraph 1 of this Article, the Commission shall adopt its
        decision by means of implementing acts on the basis of such analysis. Those implementing
        acts shall be adopted in accordance with the examination procedure referred to in
        Article 51(3).
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                                                  DGE 2                                              EN
 ---pagebreak---         In the cases referred to in the third subparagraph of Article 21(6), the applicant shall
        submit the file to the Agency. The Agency shall consult the relevant safety authorities and
        give its final opinion to the Commission.
5.      The Commission shall, by means of an implementing act, establish the information to be
        included in the file referred to in paragraph 4, the required format of that file and the
        method to be used for its transmission. That implementing act shall be adopted in
        accordance with the examination procedure referred to in Article 51(3).
6.      Pending the decision of the Commission, the Member State may apply the alternative
        provisions referred to in paragraph 4 without delay.
7.      The Commission shall give its decision within four months of submission of the request
        supported by the complete file. In the absence of such a decision, the request shall be
        deemed to have been accepted.
8.      Member States shall be informed of the results of the analyses and of the outcome of the
        procedure set out in paragraph 4.
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                                                 DGE 2                                            EN
 ---pagebreak---                                          CHAPTER III
                     INTEROPERABILITY CONSTITUENTS
                                                Article 8
              Conditions for the placing on the market of interoperability constituents
1.      Member States shall take all necessary steps to ensure that interoperability constituents are:
        (a)    placed on the market only if they enable interoperability to be achieved within the
               Union rail system while at the same time meeting the essential requirements;
        (b)    used in their area of use as intended and suitably installed and maintained.
        This paragraph shall not prevent the placing on the market of those constituents for
        other applications.
2.      Member States shall not, in their territory and on the basis of this Directive, prohibit,
        restrict or hinder the placing on the market of interoperability constituents for use in the
        Union rail system where these constituents comply with this Directive. In particular, they
        shall not require checks which have already been carried out as part of the procedure for
        'EC' declaration of conformity or suitability for use as provided for in Article 10.
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                                                 DGE 2                                             EN
 ---pagebreak---                                                 Article 9
                                   Conformity or suitability for use
1.      Member States and the Agency shall consider that an interoperability constituent meets the
        essential requirements if it complies with the conditions laid down in the corresponding
        TSI or the corresponding European specifications developed to comply with those
        conditions. The 'EC' declaration of conformity or suitability for use shall attest that the
        interoperability constituents have been subject to the procedures laid down in the
        corresponding TSI for assessing conformity or suitability for use.
2.      Where the TSI so requires, the 'EC' declaration shall be accompanied by:
        (a)   a certificate, issued by a notified body or bodies, of the intrinsic conformity of an
              interoperability constituent considered in isolation, to the technical specifications to
              be met;
        (b)   a certificate, issued by a notified body or bodies, of the suitability for use of an
              interoperability constituent considered within its railway environment, particularly in
              the case of functional requirements concerned.
3.      The 'EC' declaration shall be dated and signed by the manufacturer or its authorised
        representative.
4.      The Commission shall establish, by means of implementing acts, the template of the 'EC'
        declaration of conformity or suitability for use of interoperability constituents and the list
        of accompanying documents. Those implementing acts shall be adopted in accordance with
        the examination procedure referred to in Article 51(3).
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                                                 DGE 2                                             EN
 ---pagebreak--- 5.      Spare parts for subsystems that are already placed in service when the corresponding TSI
        enters into force may be installed in those subsystems without being subject to
        paragraph 1.
6.      TSIs may provide for a period of transition for rail products identified by those TSIs as
        interoperability constituents which have already been placed on the market when the TSIs
        enter into force. Such constituents shall comply with Article 8(1).
                                              Article 10
                 Procedure for 'EC' declaration of conformity or suitability for use
1.      In order to establish the 'EC' declaration of conformity or suitability for use of an
        interoperability constituent, the manufacturer or his authorised representative shall apply
        the provisions laid down by the relevant TSIs.
2.      Where the corresponding TSI so requires, assessment of the conformity or suitability for
        use of an interoperability constituent shall be carried out by the notified body with which
        the manufacturer or his authorised representative has lodged the application.
3.      Where interoperability constituents are the subject of other legal acts of the Union covering
        other matters, the 'EC' declaration of conformity or suitability for use shall state that the
        interoperability constituents also meet the requirements of those other legal acts.
10579/15                                                                 IV/NT/ra                     49
                                                 DGE 2                                              EN
 ---pagebreak--- 4.      Where neither the manufacturer nor his authorised representative has met the obligations
        laid down in paragraphs 1 and 3, those obligations shall be incumbent on any person who
        places interoperability constituents on the market. For the purposes of this Directive, the
        same obligations shall apply to any person who assembles interoperability constituents, or
        parts of interoperability constituents having diverse origins, or manufactures
        interoperability constituents for his own use.
5.      If a Member State finds that the 'EC' declaration has been drawn up improperly, it shall
        ensure that the interoperability constituent is not placed on the market. In such a case, the
        manufacturer or his authorised representative shall be required to restore the
        interoperability constituent to a state of conformity under the conditions laid down by that
        Member State.
                                                Article 11
            Non-compliance of interoperability constituents with essential requirements
1.      Where a Member State finds that an interoperability constituent covered by the 'EC'
        declaration of conformity or suitability for use and placed on the market is, when used as
        intended, unlikely to meet the essential requirements, that Member State shall take all
        necessary steps to restrict its field of application, prohibit its use, withdraw it from the
        market or recall it. The Member State shall forthwith inform the Commission, the Agency
        and the other Member States of the measures taken and give reasons for its decision,
        stating in particular whether the failure to conform is due to:
        (a)   failure to meet the essential requirements;
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                                                  DGE 2                                              EN
 ---pagebreak---         (b)   incorrect application of European specifications where application of such
              specifications is relied upon;
        (c)   inadequacy of European specifications.
2.      The Agency, on a mandate from the Commission, shall start the consultation process with
        the parties concerned without delay and in any case within 20 days of the date of receipt of
        that mandate. Where, following that consultation, the Agency establishes that the measure
        is unjustified, it shall forthwith inform the Commission, the Member State that has taken
        the initiative as well as other Member States, and the manufacturer or his authorised
        representative. Where the Agency establishes that the measure is justified, it shall forthwith
        inform the Member States.
3.      Where the decision referred to in paragraph 1 results from an inadequacy of European
        specifications, the Member States, the Commission or the Agency, as appropriate, shall
        apply one or more of the following measures:
        (a)   partial or total withdrawal of the specification concerned from the publications
              containing them;
        (b)   if the relevant specification is a harmonised standard, restriction or withdrawal of
              that standard in accordance with Article 11 of Regulation (EU) No 1025/2012;
        (c)   review of the TSI in accordance with Article 6.
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                                                 DGE 2                                           EN
 ---pagebreak--- 4.       Where an interoperability constituent bearing the 'EC' declaration of conformity fails to
         comply with the essential requirements, the competent Member State shall take appropriate
         measures against any entity which has drawn up the declaration and shall inform the
         Commission and the other Member States thereof.
                                         CHAPTER IV
                                         SUBSYSTEMS
                                                Article 12
                                     Free movement of subsystems
Without prejudice to the provisions of Chapter V, Member States shall not, in their territory and on
grounds relating to this Directive, prohibit, restrict or hinder the construction, placing in service and
operation of structural subsystems constituting the rail system which meet the essential
requirements. In particular, they shall not require checks which have already been carried out:
(a)      as part of the procedure leading to the 'EC' declaration of verification; or
(b)      in other Member States, before or after the entry into force of this Directive, with a view to
         verifying compliance with identical requirements under identical operational conditions.
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                                                  DGE 2                                              EN
 ---pagebreak---                                               Article 13
                              Conformity with TSIs and national rules
1.      The Agency and the national safety authorities shall consider as meeting the essential
        requirements, those structural subsystems constituting the rail system which are covered,
        as appropriate, by the 'EC' declaration of verification established by reference to TSIs, in
        accordance with Article 15, or the declaration of verification established by reference to
        national rules in accordance with Article 15(8), or both.
2.      National rules for implementing the essential requirements and, where relevant, acceptable
        national means of compliance, shall apply in the following cases:
        (a)   where the TSIs do not cover, or do not fully cover, certain aspects corresponding to
              the essential requirements, including open points as referred to in Article 4(6);
        (b)   where non-application of one or more TSIs or parts of them has been notified under
              Article 7;
        (c)   where a specific case requires the application of technical rules not included in the
              relevant TSI;
        (d)   national rules used to specify existing systems, limited to the aim of assessing
              technical compatibility of the vehicle with the network;
        (e)   networks and vehicles not covered by TSIs;
        (f)   as an urgent temporary preventive measure, in particular following an accident.
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                                               DGE 2                                             EN
 ---pagebreak---                                                Article 14
                                     Notification of national rules
1.      Member States shall notify to the Commission and to the Agency the existing national
        rules referred to in Article 13(2) in the following cases:
        (a)    where the national rule(s) has/have not been notified by... *. In that case, they shall be
               notified by... **;
        (b)    each time the rules are changed;
        (c)    when a new request has been submitted in accordance with Article 7 for
               non-application of the TSI;
        (d)    where national rules become redundant after publication or revision of the
               TSI concerned.
2.      Member States shall notify the full text of national rules referred to in paragraph 1 through
        the appropriate IT system in accordance with Article 27 of Regulation (EU) …/… +.
3.      Member States shall ensure that national rules referred to in paragraph 1, including those
        covering the interfaces between vehicles and networks, are easily accessible, in the public
        domain and formulated in terminology that all interested parties can understand. Member
        States may be requested to provide additional information on those national rules.
*
      OJ: Please insert the date of entry into force of this Directive.
**
      OJ: Please insert the date: six months after the entry into force of this Directive.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                              EN
 ---pagebreak--- 4.      Member States may lay down new national rules only in the following cases:
        (a)    when a TSI does not fully meet the essential requirements;
        (b)    as an urgent preventive measure, in particular following an accident.
5.      Member States shall submit, through the appropriate IT system in accordance with
        Article 27 of Regulation (EU) …/... +, the drafts of new national rules to the Agency and
        the Commission for consideration before the expected introduction of the proposed new
        rule into the national legal system, in due time and within the deadlines referred to in
        Article 25(1) of Regulation (EU) …/...+ and provide justification for the introduction of
        that new national rule. Member States shall ensure that the draft is sufficiently developed
        to allow the Agency to carry out its examination in accordance with Article 25(2) of
        Regulation (EU) …/...+.
6.      When they adopt a new national rule, Member States shall notify it to the Agency and the
        Commission through the appropriate IT system in accordance with Article 27 of
        Regulation (EU) …./…+.
7.      In the case of urgent preventive measures, Member States may adopt and apply a new
        national rule immediately. That rule shall be notified in accordance with Article 27(2) of
        Regulation (EU).../...+ and subject to the assessment of the Agency in accordance with
        Article 26(1), (2) and (5) of that Regulation.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                           EN
 ---pagebreak--- 8.      When notifying a national rule referred to in paragraph 1 or a new national rule, Member
        States shall provide justification of the need for that rule in order to fulfil an essential
        requirement not already covered by the relevant TSI.
9.      Draft national rules and national rules referred to in paragraph 1 shall be examined by the
        Agency in accordance with the procedures laid down in Articles 25 and 26 of Regulation
        (EU) …/… +.
10.     The Commission shall establish, by means of implementing acts, the classification of the
        notified national rules in different groups with the aim of facilitating cross-acceptance in
        different Member States and the placing on the market of vehicles¸ including compatibility
        between fixed and mobile equipment. Those implementing acts shall build on the progress
        achieved by the Agency in the field of cross-acceptance and shall be adopted in accordance
        with the examination procedure referred to in Article 51(3).
        The Agency shall classify, in accordance with the implementing acts referred to in the
        first subparagraph, the national rules which are notified in accordance with this Article.
11.     Member States may decide not to notify rules and restrictions of a strictly local nature. In
        such cases, Member States shall mention those rules and restrictions in the registers of
        infrastructure referred to in Article 49.
12.     National rules notified under this Article are not subject to the notification procedure set
        out in Directive (EU) 2015/1535 of the European Parliament and of the Council 1.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
1
      Directive (EU) 2015/1535 of the European Parliament and of the Council of
      9 September 2015 laying down a procedure for the provision of information in the field of
      technical regulations and rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
10579/15                                                                  IV/NT/ra                    56
                                                 DGE 2                                               EN
 ---pagebreak--- 13.     National rules not notified in accordance with this Article shall not apply for the purposes
        of this Directive.
                                              Article 15
                   Procedure for establishing the 'EC' declaration of verification
1.      In order to establish the 'EC' declaration of verification necessary for placing on the market
        and placing in service referred to in Chapter V, the applicant shall request the conformity
        assessment body or bodies that it has selected for that purpose to apply the 'EC' verification
        procedure set out in Annex IV.
2.      The applicant shall establish the 'EC' declaration of verification of a subsystem. The
        applicant shall declare on his sole responsibility that the subsystem concerned has been
        subject to the relevant verification procedures and that it satisfies the requirements of
        relevant Union law and any relevant national rule. The 'EC' declaration of verification and
        the accompanying documents shall be dated and signed by the applicant.
3.      The task of the notified body responsible for the 'EC' verification of a subsystem shall
        begin at the design stage and cover the entire manufacturing period through to the
        acceptance stage before the subsystem is placed on the market or in service. It shall, in
        accordance with the relevant TSI, also cover verification of the interfaces of the subsystem
        in question with the system into which it is incorporated.
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                                                 DGE 2                                            EN
 ---pagebreak--- 4.      The applicant shall be responsible for compiling the technical file that is to accompany the
        'EC' declaration of verification. That technical file shall contain all the necessary
        documents relating to the characteristics of the subsystem and, where appropriate, all the
        documents certifying conformity of the interoperability constituents. It shall also contain
        all the elements relating to the conditions and limits of use and to the instructions
        concerning servicing, constant or routine monitoring, adjustment and maintenance.
5.      In the event of the renewal or upgrading of a subsystem resulting in an amendment to the
        technical file and affecting the validity of the verification procedures already carried out,
        the applicant shall assess the need for a new 'EC' declaration of verification.
6.      The notified body may issue intermediate statement verifications to cover certain stages of
        the verification procedure or certain parts of the subsystem.
7.      If the relevant TSIs allow, the notified body may issue certificates of verification for one or
        more subsystems or certain parts of those subsystems.
8.      Member States shall designate the bodies responsible for carrying out the verification
        procedure in respect of national rules. In that regard, designated bodies shall be responsible
        for the tasks involved. Without prejudice to Article 30, a Member State may appoint a
        notified body as a designated body, in which case the entire process may be carried out by
        a single conformity assessment body.
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                                                 DGE 2                                            EN
 ---pagebreak--- 9.      The Commission may specify, by means of implementing acts:
        (a)   the details of the 'EC' verification procedures for subsystems, including the
              verification procedure in the case of national rules and the documents to be submitted
              by the applicant for the purposes of that procedure;
        (b)   the templates for the 'EC' declaration of verification, including in the case of a
              modification of the subsystem or in the case of additional verifications, the
              intermediate statement of verification, and templates for documents of the technical
              file that is to accompany those declarations as well as templates for the certificate of
              verification.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to Article 51(3).
                                               Article 16
                     Non-compliance of subsystems with essential requirements
1.      Where a Member State finds that a structural subsystem covered by the 'EC' declaration of
        verification accompanied by the technical file does not fully comply with this Directive
        and, in particular, does not meet the essential requirements, it may request that additional
        checks be carried out.
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                                                 DGE 2                                            EN
 ---pagebreak--- 2.       The Member State making the request shall forthwith inform the Commission of any
         additional checks requested and set out the reasons therefor. The Commission shall consult
         the interested parties.
3.       The Member State making the request shall state whether the failure to fully comply with
         this Directive is due to:
         (a)    non-compliance with the essential requirements or with a TSI, or incorrect
                application of a TSI, in which case the Commission shall forthwith inform the
                Member State where the person who drew up the 'EC' declaration of verification in
                error resides and shall request that Member State to take the appropriate measures;
         (b)    inadequacy of a TSI, in which case the procedure for amending the TSI as referred to
                in Article 6 shall apply.
                                                Article 17
                                       Presumption of conformity
Interoperability constituents and subsystems which are in conformity with harmonised standards or
parts thereof, the references of which have been published in the Official Journal of the
European Union, shall be presumed to be in conformity with the essential requirements covered by
those standards or parts thereof.
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                                                  DGE 2                                          EN
 ---pagebreak---                                           CHAPTER V
    PLACING ON THE MARKET AND PLACING IN SERVICE
                                               Article 18
                    Authorisation for the placing in service of fixed installations
1.      The trackside control-command and signalling, energy and infrastructure subsystems shall
        be placed in service only if they are designed, constructed and installed in such a way as to
        meet the essential requirements, and the relevant authorisation is received in accordance
        with paragraphs 3 and 4.
2.      Each national safety authority shall authorise the placing in service of the energy,
        infrastructure and trackside control-command and signalling subsystems which are located
        or operated in the territory of its Member State.
3.      National safety authorities shall provide detailed guidance on how to obtain the
        authorisations referred to in this Article. An application guidance document describing and
        explaining the requirements for those authorisations and listing the documents required
        shall be made available to applicants free of charge. The Agency and the national safety
        authorities shall cooperate in disseminating such information.
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                                                 DGE 2                                          EN
 ---pagebreak--- 4.      The applicant shall submit a request for authorisation of the placing in service of fixed
        installations to the national safety authority. The application shall be accompanied by a file
        which includes documentary evidence of:
        (a)    the declarations of verification referred to in Article 15;
        (b)    the technical compatibility of the subsystems with the system into which they are
               being integrated, established on the basis of the relevant TSIs, national rules
               and registers;
        (c)    the safe integration of the subsystems, established on the basis of the relevant TSIs,
               national rules, and the common safety methods ('CSMs') set out in Article 6 of
               Directive (EU) …/… +;
        (d)    in the case of trackside control-command and signalling subsystems involving
               European Train Control System (ETCS) and/or Global System for Mobile
               Communications – Railway (GSM-R) equipment, the positive decision of the
               Agency issued in accordance with Article 19 of this Directive; and, in the case of a
               change to the draft tender specifications or to the description of the envisaged
               technical solutions that occurred after the positive decision, the compliance with the
               result of the procedure referred to in Article 30(2) of Regulation (EU).../… ++.
5.      Within one month of receipt of the applicant's request, the national safety authority shall
        inform the applicant that the file is complete or ask for relevant supplementary
        information, setting a reasonable deadline for the provision thereof.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
++
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                            EN
 ---pagebreak---         The national safety authority shall verify the completeness, relevance and consistency of
        the file, and, in the case of trackside ERTMS equipment, compliance with the positive
        decision of the Agency issued in accordance with Article 19 of this Directive and, where
        appropriate, compliance with the result of the procedure referred to in Article 30(2) of
        Regulation (EU) …/... +. Following such verification, the national safety authority shall
        issue the authorisation for placing in service of fixed installations, or inform the applicant
        of its negative decision, within a pre-determined, reasonable time, and, in any case, within
        four months of receipt of all relevant information.
6.      In the event of renewal or upgrading of existing subsystems, the applicant shall send a file
        describing the project to the national safety authority. Within one month of receipt of the
        applicant's request, the national safety authority shall inform the applicant that the file is
        complete or ask for relevant supplementary information, setting a reasonable deadline for
        the provision thereof. The national safety authority, in close cooperation with the Agency
        in the case of trackside ERTMS projects, shall examine the file and shall decide whether a
        new authorisation for placing in service is needed, on the basis of the following criteria:
        (a)    the overall safety level of the subsystem concerned may be adversely affected by the
               works envisaged;
        (b)    it is required by the relevant TSIs;
        (c)    it is required by the national implementation plans established by the Member States;
               or
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                              EN
 ---pagebreak---         (d)    changes are made to the values of the parameters on the basis of which the
               authorisation was already granted.
        The national safety authority shall take its decision within a predetermined, reasonable
        time, and, in any case, within four months of receipt of all relevant information.
7.      A decision refusing a request for an authorisation for the placing in service of fixed
        installations shall be duly substantiated by the national safety authority. The applicant may,
        within one month of receipt of the negative decision, submit a request that the national
        safety authority review its decision. The request shall be accompanied by a justification.
        The national safety authority shall have two months from the date of receipt of the request
        for review in which to confirm or reverse its decision. If the negative decision of a national
        safety authority is confirmed, the applicant may bring an appeal before the appeal body
        designated by the relevant Member State under Article 18(3) of Directive (EU) …/… +.
                                              Article 19
                        Harmonised implementation of ERTMS in the Union
1.      In the case of trackside control-command and signalling subsystems involving ETCS
        and/or GSM-R equipment, the Agency shall ensure the harmonised implementation of
        ERTMS in the Union.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                DGE 2                                             EN
 ---pagebreak--- 2.      In order to ensure the harmonised implementation of ERTMS and interoperability at Union
        level, before any call for tenders relating to ERTMS track-side equipment, the Agency
        shall check that the technical solutions envisaged are fully compliant with the relevant
        TSIs and are therefore fully interoperable.
3.      The applicant shall submit a request for the Agency's approval. The application relating to
        individual ERTMS projects or for a combination of projects, a line, a group of lines or a
        network, shall be accompanied by a file which includes:
        (a)    the draft tender specifications or the description of the envisaged technical solutions;
        (b)    documentary evidence of the conditions necessary for technical and operational
               compatibility of the subsystem with the vehicles intended to operate on the relevant
               network;
        (c)    documentary evidence of the compliance of technical solutions envisaged with the
               relevant TSIs;
        (d)    any other relevant documents, such as national safety authority opinions, declarations
               of verification or conformity certificates.
        That application and information about all applications, the stages of the relevant
        procedures and their outcome, and, where applicable, the requests and decisions of the
        Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of
        Regulation (EU) …/... +.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                             EN
 ---pagebreak---         The national safety authorities may issue an opinion on the request for approval either to
        the applicant before the submission of the request or to the Agency after such a
        submission.
4.      Within one month of receipt of the applicant's request, the Agency shall inform the
        applicant that the file is complete or ask for relevant supplementary information, setting a
        reasonable deadline for the provision thereof.
        The Agency shall issue a positive decision, or inform the applicant of possible deficiencies,
        within a predetermined, reasonable time period, and in any case, within two months of
        receipt of all relevant information. The Agency shall base its opinion on the file of the
        applicant and on possible opinions from the national safety authorities.
        If the applicant agrees with the deficiencies identified by the Agency, the applicant shall
        rectify the project design and introduce a new request for approval to the Agency.
        If the applicant does not agree with the deficiencies identified by the Agency, the
        procedure referred to in paragraph 5 shall apply.
        In the case referred to in point (a) of Article 7(1), the applicant shall not request a new
        assessment.
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                                                 DGE 2                                              EN
 ---pagebreak--- 5.      If the decision of the Agency is not positive, it shall be duly substantiated by the Agency.
        The applicant may, within one month of receipt of such a decision, submit a reasoned
        request that the Agency review its decision. The Agency shall confirm or reverse its
        decision within two months of the date of receipt of the request. If the Agency confirms its
        initial decision, the applicant is entitled to bring an appeal before the Board of Appeal
        established under Article 55 of Regulation (EU) …/…. +.
6.      In the case of a change to the draft tender specifications or to the description of the
        envisaged technical solutions that occurred after the positive decision, the applicant shall
        inform, without undue delay, the Agency and the national safety authority through the one-
        stop shop referred to in Article 12 of Regulation (EU) …/...+. In that case, point (a) of
        Article 30(2) of that Regulation shall apply.
                                                Article 20
                             Placing on the market of mobile subsystems
1.      Mobile subsystems shall be placed on the market by the applicant only if they are
        designed, constructed and installed in such a way as to meet the essential requirements.
2.      In particular, the applicant shall ensure that the relevant declaration of verification has
        been provided.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                  DGE 2                                             EN
 ---pagebreak---                                                Article 21
                            Vehicle authorisation for placing on the market
1.      The applicant shall place a vehicle on the market only after having received the vehicle
        authorisation for placing on the market issued by the Agency in accordance with
        paragraphs 5 to 7 or by the national safety authority in accordance with paragraph 8.
2.      In its application for a vehicle authorisation for placing on the market, the applicant shall
        specify the area of use of the vehicle. The application shall include evidence that the
        technical compatibility between the vehicle and the network of the area of use has
        been checked.
3.      The application for a vehicle authorisation for placing on the market shall be accompanied
        by a file concerning the vehicle or vehicle type and including documentary evidence of:
        (a)    the placing on the market of the mobile subsystems of which the vehicle is composed
               in accordance with Article 20, on the basis of the 'EC' declaration of verification;
        (b)    the technical compatibility of the subsystems referred to in point (a) within the
               vehicle, established on the basis of the relevant TSIs, and where applicable,
               national rules;
        (c)    the safe integration of the subsystems referred to in point (a) within the vehicle,
               established on the basis of the relevant TSIs, and where applicable, national rules,
               and the CSM's referred to in Article 6 of Directive (EU) …/… +;
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                 DGE 2                                             EN
 ---pagebreak---         (d)   the technical compatibility of the vehicle with the network in the area of use referred
              to in paragraph 2, established on the basis of the relevant TSIs and, where applicable,
              national rules, registers of infrastructure and the CSM on risk assessment referred to
              in Article 6 of Directive (EU) …/… +.
        That application and information about all applications, the stages of the relevant
        procedures and their outcome, and, where applicable, the requests and decisions of the
        Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of
        Regulation (EU) …/... ++.
        Whenever tests are necessary in order to obtain documentary evidence of the technical
        compatibility referred to in points (b) and (d) of the first subparagraph, the national safety
        authorities involved may issue temporary authorisations to the applicant to use the vehicle
        for practical verifications on the network. The infrastructure manager, in consultation with
        the applicant, shall make every effort to ensure that any tests take place within three
        months of receipt of the applicant's request. Where appropriate, the national safety
        authority shall take measures to ensure that the tests take place.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
++
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                             EN
 ---pagebreak--- 4.      The Agency or, in the case of paragraph 8, the national safety authority shall issue vehicle
        authorisations for placing on the market or inform the applicant of its negative decision
        within a predetermined, reasonable time, and in any case within four months of receipt of
        all relevant information from the applicant. The Agency, or, in the cases provided for in
        paragraph 8, the national safety authority, shall apply the practical arrangements on the
        authorisation procedure to be established in an implementing act, as referred to in
        paragraph 9. Those authorisations shall allow vehicles to be placed on the Union market.
5.      The Agency shall issue vehicle authorisations for placing on the market in respect of
        vehicles having an area of use in one or more Member States. In order to issue such
        authorisations, the Agency shall:
        (a)    assess the elements of the file specified in points (b), (c) and (d) of the first
               subparagraph of paragraph 3 in order to verify the completeness, relevance and
               consistency of the file in relation to the relevant TSIs; and
        (b)    refer the applicant's file to the national safety authorities concerned by the intended
               area of use for assessment of the file in order to verify its completeness, relevance
               and consistency in relation to point (d) of the first subparagraph of paragraph 3 and
               to the elements specified in points (a), (b) and (c) of the first subparagraph of
               paragraph 3 in relation to the relevant national rules.
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                                                   DGE 2                                            EN
 ---pagebreak---         As part of the assessments pursuant to points (a) and (b) and in the case of justified doubts,
        the Agency or the national safety authorities may request that tests be conducted on the
        network. In order to facilitate those tests, the national safety authorities involved may issue
        temporary authorisations to the applicant to use the vehicle for tests on the network. The
        infrastructure manager shall make every effort to ensure that any such test takes place
        within three months of the request of the Agency or the national safety authority.
6.      Within one month of receipt of the applicant's request, the Agency shall inform the
        applicant that the file is complete or ask for relevant supplementary information, setting a
        reasonable deadline for the provision thereof. With regard to the completeness, relevance
        and consistency of the file, the Agency may also assess the elements specified in point (d)
        of paragraph 3.
        The Agency shall take full account of the assessments under paragraph 5 before taking its
        decision on the issuance of the vehicle authorisation for placing on the market. The
        Agency shall issue the authorisation for placing on the market, or inform the applicant of
        its negative decision, within a predetermined, reasonable time, and in any case within four
        months of receipt of all relevant information.
        In the event of non-application of one or more TSIs or parts of them as referred to in
        Article 7, the Agency shall issue the vehicle authorisation only after application of the
        procedure laid down in that Article.
        The Agency shall take full responsibility for the authorisations it issues.
10579/15                                                                  IV/NT/ra                   71
                                                 DGE 2                                            EN
 ---pagebreak--- 7.      When the Agency disagrees with a negative assessment carried out by one or more national
        safety authorities pursuant to point (b) of paragraph 5, it shall inform the authority or
        authorities in question, giving reasons for its disagreement. The Agency and the national
        safety authority or authorities shall cooperate with a view to reaching a mutually
        acceptable assessment. Where necessary, as decided by the Agency and the national safety
        authority or authorities, this process shall also involve the applicant. If no mutually
        acceptable assessment can be agreed on within one month after the Agency has informed
        the national safety authority or authorities of its disagreement, the Agency shall take its
        final decision unless the national safety authority or authorities have referred the matter for
        arbitration to the Board of Appeal established under Article 55 of Regulation (EU) …/… +.
        The Board of Appeal shall decide whether to confirm the Agency's draft decision within
        one month of the request of the national safety authority or authorities.
        Where the Board of Appeal agrees with the Agency, the Agency shall take a decision
        without delay.
        Where the Board of Appeal agrees with the negative assessment of the national safety
        authority, the Agency shall issue an authorisation with an area of use excluding the parts of
        the network which received a negative assessment.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
10579/15                                                                  IV/NT/ra                   72
                                                 DGE 2                                            EN
 ---pagebreak---         Where the Agency disagrees with a positive assessment of one or more national safety
        authorities pursuant to point (b) of paragraph 5, it shall inform the authority or authorities
        in question, giving reasons for its disagreement. The Agency and the national safety
        authority or authorities shall cooperate with a view to agreeing on a mutually acceptable
        assessment. Where necessary, as decided by the Agency and the national safety authority
        or authorities, this process shall also involve the applicant. If no mutually acceptable
        assessment can be agreed on within one month after the Agency has informed the national
        safety authority and authorities of its disagreement, the Agency shall take its final decision.
8.      Where the area of use is limited to a network or networks within one Member State only,
        the national safety authority of that Member State may, under its own responsibility and
        when the applicant so requests, issue the vehicle authorisation for placing on the market. In
        order to issue such authorisations, the national safety authority shall assess the file in
        relation to the elements specified in paragraph 3 and in accordance with the procedures to
        be established in the implementing act adopted pursuant to paragraph 9. Within one month
        of receipt of the request of the applicant, the national safety authority shall inform the
        applicant that the file is complete or ask for relevant supplementary information. The
        authorisation shall also be valid without extension of the area of use for vehicles travelling
        to stations in neighbouring Member States with similar network characteristics, when those
        stations are close to the border, following consultation of the competent national safety
        authorities. This consultation may be carried out on a case-by-case basis or set out in a
        cross-border agreement between national safety authorities.
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                                                  DGE 2                                            EN
 ---pagebreak---         If the area of use is limited to the territory of one Member State and in the event of
        non-application of one or more TSIs or parts of them as referred to in Article 7, the
        national safety authority shall issue the vehicle authorisation only after application of the
        procedure laid down in that Article.
        The national safety authority shall take full responsibility for the authorisations it issues.
9.      By… ∗, the Commission shall adopt by means of implementing acts practical arrangements
        specifying :
        (a)    how the requirements for the vehicle authorisation for placing on the market and for
               vehicle type authorisation laid down in this Article shall be fulfilled by the applicant
               and listing the documents required;
        (b)    the details of the authorisation process, such as procedural stages and timeframes for
               each stage of the process;
        (c)    how the requirements laid down in this Article shall be complied with by the Agency
               and the national safety authority through the different stages of the application and
               authorisation process including in the assessment of applicants' files.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 51(3). They shall take into account the experience gained during the
        preparation of the cooperation agreements referred to in paragraph 14 of this Article.
∗
      OJ: Please insert date: two years after the entry into force of this Directive.
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                                                   DGE 2                                            EN
 ---pagebreak--- 10.     Vehicle authorisations for placing on the market shall state:
        (a)    the area(s) of use;
        (b)    the values of the parameters set out in the TSIs and, where applicable, in the national
               rules, for checking the technical compatibility between the vehicle and the area
               of use;
        (c)    the vehicle's compliance with the relevant TSIs and sets of national rules, relating to
               the parameters referred to in point (b);
        (d)    the conditions for use of the vehicle and other restrictions.
11.     Any decision refusing the vehicle authorisation for placing on the market or excluding part
        of the network in accordance with a negative assessment as referred to in paragraph 7 shall
        be duly substantiated. The applicant may, within a period of one month from receipt of the
        negative decision, request that the Agency or the national safety authority, as appropriate,
        review the decision. The Agency or the national safety authority shall have two months
        from the date of receipt of the request for review in which to confirm or reverse its
        decision.
        If the negative decision of the Agency is confirmed, the applicant may bring an appeal
        before the Board of Appeal designated under Article 55 of Regulation (EU) …/… +.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                            EN
 ---pagebreak---         If the negative decision of a national safety authority is confirmed, the applicant may bring
        an appeal before an appeal body in accordance with the national law. Member States may
        designate the regulatory body referred to in Article 55 of Directive 2012/34/EU for the
        purpose of this appeal procedure. In that case, Article 18(3) of Directive (EU) …./… ++
        shall apply.
12.     In the event of renewal or upgrading of existing vehicles which already have a vehicle
        authorisation for placing on the market, a new vehicle authorisation for placing on the
        market shall be required if:
        (a)    changes are made to the values of the parameters referred to in point (b) of
               paragraph 10 which are outside the range of acceptable parameters as defined in the
               TSIs;
        (b)    the overall safety level of the vehicle concerned may be adversely affected by the
               works envisaged; or
        (c)    it is required by the relevant TSIs.
13.     Where the applicant wishes to extend the area of use of a vehicle which has already been
        authorised, it shall supplement the file with the relevant documents referred to in
        paragraph 3 concerning the additional area of use. The applicant shall submit the file to the
        Agency, which shall, after following the procedures laid down in paragraphs 4 to 7, issue
        an updated authorisation covering the extended area of use.
++
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                 DGE 2                                           EN
 ---pagebreak---         If the applicant has received a vehicle authorisation in accordance with paragraph 8 and
        wishes to extend the area of use within that Member State, it shall supplement the file with
        the relevant documents referred to in paragraph 3 concerning the additional area of use. It
        shall submit the file to the national safety authority which shall, after following the
        procedures laid down in paragraph 8, issue an updated authorisation covering the extended
        area of use.
14.     For the purposes of paragraphs 5 and 6 of this Article, the Agency shall conclude
        cooperation agreements with national safety authorities in accordance with Article 76 of
        Regulation (EU) …./… +. Those agreements may be specific or framework agreements, and
        may involve one or more national safety authorities. They shall contain a detailed
        description of tasks and conditions for deliverables, the time-limits applying to their
        delivery, and an apportionment of the fees payable by the applicant. They may also include
        specific cooperation arrangements in the case of networks requiring specific expertise for
        geographical or historical reasons, with a view to reducing administrative burdens and
        costs to the applicant. Where such networks are isolated from the rest of the Union rail
        system, such specific cooperation arrangements may include the possibility of contracting
        tasks to the relevant national safety authorities when this is necessary in order to ensure the
        efficient and proportionate allocation of resources for authorisation. Those agreements
        shall be in place before the Agency shall undertake the authorisation tasks in accordance
        with Article 54(4) of this Directive.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                 DGE 2                                            EN
 ---pagebreak--- 15      In the case of those Member States whose rail networks have a track gauge that is different
        from that of the main rail network within the Union and share identical technical and
        operational requirements with neighbouring third countries, in addition to the cooperation
        agreements referred to in paragraph 14, all national safety authorities concerned in those
        Member States shall conclude with the Agency a multilateral agreement with a view to
        defining the conditions under which a vehicle authorisation issued in one of those Member
        States is also valid for the other Member States concerned.
16.     This Article shall not apply to freight wagons or passenger coaches which are in shared use
        with third countries, the track gauge of which is different from that of the main rail
        network within the Union and authorised in accordance with a different vehicle
        authorisation procedure. The rules governing the procedure for authorisation of such
        vehicles shall be published and notified to the Commission. The conformity of those
        vehicles with the essential requirements of this Directive shall be ensured by the railway
        undertaking concerned in the context of its safety management system. The Commission,
        on the basis of the report by the Agency may give an opinion on whether such rules are
        compliant with the objectives of this Directive. If such rules are not compliant, the Member
        States concerned and the Commission may cooperate in order to lay down appropriate
        actions to be taken, involving relevant international bodies, if necessary.
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                                                DGE 2                                           EN
 ---pagebreak--- 17.     A Member State may decide not to apply this Article to locomotives or self-propelling
        trains arriving from third countries and intended to run until a station that is situated close
        to the border in its territory and designated for cross-border operations. The conformity of
        such vehicles with the essential requirements of this Directive shall be ensured by the
        railway undertaking concerned in the context of its safety management system and, where
        relevant, in accordance with Article 10(9) of Directive (EU)…./… +.
                                               Article 22
                    Registration of vehicles authorised to be placed on the market
1.      Before a vehicle is used for the first time, and after the authorisation to be placed on the
        market in accordance with Article 21 is granted, it shall be registered in a vehicle register
        as referred to in Article 47 at the request of the keeper.
2.      When the area of use of the vehicle is restricted to the territory of one Member State,
        it shall be registered in that Member State.
3.      When the area of use of the vehicle covers the territory of more than one Member State, it
        shall be registered in one of the Member States concerned.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                 DGE 2                                              EN
 ---pagebreak---                                               Article 23
                            Checks before the use of authorised vehicles
1.      Before a railway undertaking uses a vehicle in the area of use specified in its authorisation
        for placing on the market, it shall check:
        (a)   that the vehicle has been authorised for placing on the market in accordance with
              Article 21 and is duly registered;
        (b)   that the vehicle is compatible with the route on the basis of the infrastructure register,
              the relevant TSIs or any relevant information to be provided by the infrastructure
              manager free of charge and within a reasonable period of time, where such a register
              does not exist or is incomplete; and
        (c)   that the vehicle is properly integrated in the composition of the train where it is
              intended to operate, taking into account the safety management system set out in
              Article 9 of Directive (EU) …./… + and the TSI on operation and traffic management.
2.      For the purposes of paragraph 1, the railway undertaking may carry out tests in cooperation
        with the infrastructure manager.
        The infrastructure manager, in consultation with the applicant, shall make every effort to
        ensure that any tests take place within three months of receipt of the applicant's request.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                DGE 2                                             EN
 ---pagebreak---                                               Article 24
                                    Type authorisation of vehicles
1.      The Agency or a national safety authority may, where appropriate, in accordance with the
        procedure laid down in Article 21, grant vehicle type authorisations. The application for a
        vehicle type authorisation and information about all applications, the stages of the relevant
        procedures and their outcome, and, where applicable, the requests and decisions of the
        Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of
        Regulation (EU) …/... +.
2.      If the Agency or a national safety authority issues a vehicle authorisation for placing on the
        market, it shall at the same time as the applicant's request issue the vehicle type
        authorisation, which is related to the same area of use of the vehicle.
3.      In the event of changes to any relevant provisions in TSIs or national rules, on the basis of
        which an authorisation of a vehicle type has been issued, the TSI or national rule shall
        determine whether the vehicle type authorisation already granted remains valid or needs to
        be renewed. If that authorisation needs to be renewed, the checks performed by the Agency
        or by a national safety authority may only concern the changed rules.
4.      The Commission shall establish, by means of implementing acts, the model of declaration
        of conformity to type. Those implementing acts shall be adopted in accordance with the
        examination procedure referred to in Article 51(3).
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                DGE 2                                            EN
 ---pagebreak--- 5.      The declaration of conformity to type shall be established in accordance with:
        (a)    the verification procedures of the relevant TSIs; or
        (b)    where TSIs do not apply, the conformity assessment procedures as defined in
               modules B+D, B+F and H1 of Decision 768/2008/EC of the European Parliament
               and of the Council 1.
6.      Where appropriate, the Commission may adopt implementing acts establishing ad hoc
        modules for conformity assessment. Those implementing acts shall be adopted in
        accordance with the examination procedure referred to in Article 51(3).
7.      The authorisation of vehicle types shall be registered in the European register of authorised
        vehicle types referred to in Article 48.
                                              Article 25
                        Conformity of vehicles with an authorised vehicle type
1.      A vehicle or a series of vehicles which is in conformity with an authorised vehicle type
        shall, without further checks, receive a vehicle authorisation in accordance with Article 21
        on the basis of a declaration of conformity to that vehicle type submitted by the applicant.
2.      The renewal of the authorisation of a vehicle type as referred to in Article 24(3) shall not
        affect vehicle authorisations for placing on the market already issued on the basis of the
        previous authorisation to place that vehicle type on the market.
1
      Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
      a common framework for the marketing of products, and repealing Council
      Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
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                                                 DGE 2                                            EN
 ---pagebreak---                                               Article 26
             Non-compliance of vehicles or vehicle types with essential requirements
1.      When a railway undertaking finds, during operation, that a vehicle it is using does not meet
        one of the applicable essential requirements, it shall take the necessary corrective measures
        in order to bring the vehicle into conformity. Furthermore, it may inform the Agency and
        any national safety authorities concerned of the measures taken. If the railway undertaking
        has evidence that the non-compliance existed already at the time when the authorisation for
        placing on the market was issued, it shall inform the Agency and any other national safety
        authorities concerned.
2.      When a national safety authority becomes aware, for instance within the process of
        supervision provided for in Article 17 of Directive (EU)…/… +, that a vehicle or a vehicle
        type to which an authorisation for placing on the market was granted either by the Agency,
        in accordance with Article 21(5) or Article 24, or by the national safety authority, in
        accordance with Article 21(8) or Article 24, when used as intended, does not meet one of
        the applicable essential requirements, it shall inform the railway undertaking using the
        vehicle or the vehicle type and ask it to take the necessary corrective measures in order to
        bring the vehicle(s) into conformity. The national safety authority shall inform the Agency
        and any other national safety authorities concerned, including those in a territory where
        application for authorisation for placing on the market for a vehicle of the same type
        is ongoing.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                DGE 2                                           EN
 ---pagebreak--- 3.      When, in the cases set out in paragraphs 1 or 2 of this Article, the corrective measures
        applied by the railway undertaking do not ensure conformity with the applicable essential
        requirements and that non-conformity leads to a serious safety risk, the national safety
        authority concerned may apply temporary safety measures under its supervision tasks, in
        accordance with Article 17(6) of Directive (EU)…/… +. Temporary safety measures in the
        form of a suspension of type authorisation of a vehicle may be applied in parallel by the
        national safety authority or by the Agency and shall be subject to judicial review and the
        arbitration procedure laid down in Article 21(7).
4.      In the cases referred to in paragraph 3, the Agency or the national safety authority which
        issued the authorisation, following a review of the effectiveness of any measures taken to
        address the serious safety risk, may decide to revoke or amend the authorisation when it is
        proven that an essential requirement was not met at the time of authorisation. To that end,
        they shall notify their decision to the holder of the authorisation for placing on the market
        or of the vehicle type authorisation, giving the reasons for their decisions. The holder may,
        within a period of one month from receipt of the decision of the Agency or the national
        safety authority, request them to review the decision. In that case, the decision to revoke
        shall be temporarily suspended. The Agency or the national safety authority shall have one
        month from the date of receipt of the request for review in which to confirm or reverse
        their decision.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                 DGE 2                                            EN
 ---pagebreak---         Where relevant, in the event of disagreement between the Agency and the national safety
        authority concerning the need to restrict or revoke the authorisation, the arbitration
        procedure provided for in Article 21(7) shall be followed. If the result of that procedure is
        that the vehicle authorisation is neither to be restricted nor revoked, the temporary safety
        measures referred to in paragraph 3 of this Article shall be suspended.
5.      If the decision of the Agency is confirmed, the holder of the vehicle authorisation may
        bring an appeal before the Board of Appeal designated under Article 55 of Regulation
        (EU) …/… + within the time-limit referred to in Article 59 of that Regulation. If the
        decision of a national safety authority is confirmed, the holder of the vehicle authorisation
        may bring an appeal, within two months of the notification of that decision, under the
        national judicial review referred to in Article 18(3) of Directive (EU) …./… ++. Member
        States may designate the regulatory body set out in Article 56 of Directive 2012/34/EU for
        the purpose of this appeal procedure.
6.      When the Agency decides to revoke or amend an authorisation for placing on the market
        which it has granted, it shall directly inform all national safety authorities, giving the
        reasons for its decision.
        When a national safety authority decides to revoke an authorisation for placing on the
        market which it has granted, it shall forthwith inform the Agency thereof and give the
        reasons for its decision. The Agency shall then inform the other national safety authorities.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
++
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                 DGE 2                                             EN
 ---pagebreak--- 7.      The decision of the Agency or the national safety authority to revoke the authorisation
        shall be reflected in the appropriate vehicle register, in accordance with Article 22 or, in
        the case of an authorisation of a vehicle type, in the European register of authorised vehicle
        types in accordance with Article 24(7). The Agency and the national safety authorities
        shall ensure that railway undertakings using vehicles of the same type as the vehicle or
        type subject to the revocation are properly informed. Such railway undertakings shall first
        check whether the same problem of non-compliance applies. In that event, the procedure
        provided for in this Article shall apply.
8.      When an authorisation for placing on the market is revoked, the vehicle concerned shall no
        longer be used and its area of use shall not be extended. When a vehicle type authorisation
        is revoked, vehicles built on the basis of it shall not be placed on the market or, if they had
        already been placed on the market, they shall be withdrawn. A new authorisation may be
        requested on the basis of the procedure provided for in Article 21 in the case of individual
        vehicles or Article 24 in the case of a vehicle type.
9.      When, in the cases provided for in paragraphs 1 or 2, the non-compliance with the essential
        requirements is limited to part of the area of use of the vehicle concerned and such
        non-compliance already existed at the time when the authorisation for placing on the
        market was issued, the latter shall be amended to exclude the parts of the area of
        use concerned.
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                                                DGE 2                                              EN
 ---pagebreak---                                         CHAPTER VI
                    CONFORMITY ASSESSMENT BODIES
                                              Article 27
                                        Notifying authorities
1.      Member States shall appoint notifying authorities that shall be responsible for setting up
        and carrying out the necessary procedures for the assessment, notification and monitoring
        of conformity assessment bodies, including compliance with Article 34.
2.      Member States shall ensure that those authorities notify the Commission and other
        Member States' bodies authorised to carry out third-party conformity assessment tasks as
        provided for in Articles 10(2) and 15(1). They shall also ensure that they inform the
        Commission and the other Member States of the designated bodies referred to in
        Article 15(8).
3.      Member States may decide that the assessment and monitoring referred to in paragraph 1
        are to be carried out by a national accreditation body within the meaning of, and in
        accordance with, Regulation (EC) No 765/2008.
4.      Where the notifying authority delegates or otherwise entrusts the assessment, notification
        or monitoring referred to in paragraph 1 of this Article to a body which is not a
        governmental entity, that body shall be a legal person and shall comply with the
        requirements laid down in Article 28. It shall put in place arrangements to cover liabilities
        arising out of its activities.
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 ---pagebreak--- 5.       The notifying authority shall take full responsibility for the tasks performed by the body
         referred to in paragraph 3.
                                               Article 28
                            Requirements relating to notifying authorities
A notifying authority shall:
(a)      be established in such a way as to avoid any conflict of interest with conformity
         assessment bodies;
(b)      be organised and operated in such a way as to safeguard the objectivity and impartiality of
         its activities;
(c)      be organised in such a way that each decision relating to notification of a conformity
         assessment body is taken by competent persons different from those who carried out the
         assessment;
(d)      not offer or provide any activities that are performed by conformity assessment bodies or
         consultancy services on a commercial or competitive basis;
(e)      safeguard the confidentiality of the information it obtains;
(f)      have at its disposal a sufficient number of competent personnel for the proper performance
         of its tasks.
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 ---pagebreak---                                                Article 29
                     Obligation of notifying authorities to provide information
Member States shall inform the Commission of their procedures for the assessment, notification and
monitoring of conformity assessment bodies, and of any changes to those procedures.
The Commission shall make that information publicly available.
                                               Article 30
                                    Conformity assessment bodies
1.      For the purposes of notification, a conformity assessment body shall meet the requirements
        laid down in paragraphs 2 to 7 of this Article and in Articles 31 and 32.
2.      A conformity assessment body shall be established under national law and shall have
        legal personality.
3.      A conformity assessment body shall be capable of carrying out all the conformity
        assessment tasks assigned to it by the relevant TSI and in relation to which it has been
        notified, whether those tasks are carried out by the conformity assessment body itself or on
        its behalf and under its responsibility.
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 ---pagebreak---         At all times and for each conformity assessment procedure and each kind or category of
        product in relation to which it has been notified, a conformity assessment body shall have
        at its disposal:
        (a)    the necessary personnel with technical knowledge and sufficient and appropriate
               experience to perform the conformity assessment tasks;
        (b)    the relevant descriptions of procedures in accordance with which conformity
               assessment is to be carried out, ensuring the transparency and the ability to apply
               those procedures. It shall have in place appropriate policies and procedures that
               distinguish between the tasks it carries out as a notified conformity assessment body
               and other activities;
        (c)    the proper procedures for the performance of activities which take due account of the
               size of an undertaking, the sector in which it operates, its structure, the degree of
               complexity of the product technology in question and the mass or serial nature of the
               production process.
        It shall have the means necessary to perform in an appropriate manner the technical and
        administrative tasks connected with the conformity assessment activities and shall have
        access to all necessary equipment or facilities.
4.      Conformity assessment bodies shall take out liability insurance unless liability is assumed
        by the State in accordance with national law, or unless the Member State itself is directly
        responsible for the conformity assessment.
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 ---pagebreak--- 5.      The personnel of a conformity assessment body shall observe professional secrecy with
        regard to all information obtained in carrying out their tasks under the relevant TSI or any
        provision of national law giving effect to it, except in relation to the competent authorities
        of the Member State in which its activities are carried out. Proprietary rights shall
        be protected.
6.      Conformity assessment bodies shall participate in, or ensure that their assessment
        personnel are informed of, the relevant standardisation activities and the activities of the
        notified conformity assessment bodies coordination group established under the relevant
        Union law, and shall apply as general guidance the administrative decisions and documents
        produced as a result of the work of that group.
7.      Conformity assessment bodies that are notified for trackside and/or on-board
        control-command and signalling subsystems shall participate in, or shall ensure that their
        assessment personnel are informed of, the activities of the ERTMS group referred to in
        Article 29 of Regulation (EU) …/… +. They shall follow the guidelines produced as a result
        of the work of that group. In the event that they consider it inappropriate or impossible to
        apply them, the conformity assessment bodies concerned shall submit their observations
        for discussion to the ERTMS group for the continuous improvement of the guidelines.
+
      OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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 ---pagebreak---                                                Article 31
                             Impartiality of conformity assessment bodies
1.      A conformity assessment body shall be a third-party body independent of the organisation
        or of the manufacturer of the product it assesses.
        A body belonging to a business association or professional federation representing
        undertakings involved in the design, manufacturing, provision, assembly, use or
        maintenance of products which it assesses may, on condition that its independence and the
        absence of any conflict of interest are demonstrated, be considered to be such a body.
2.      The impartiality of the conformity assessment bodies, of their top-level management and
        of the assessment personnel shall be guaranteed.
3.      A conformity assessment body, its top-level management and the personnel responsible for
        carrying out the conformity assessment tasks shall not be the designer, manufacturer,
        supplier, installer, purchaser, owner, user or maintainer of the products which they assess,
        or the authorised representative of any of those parties. This shall not preclude the use of
        assessed products that are necessary for the operations of the conformity assessment body
        or the use of such products for personal purposes.
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 ---pagebreak--- 4.      A conformity assessment body, its top-level management and the personnel responsible for
        carrying out the conformity assessment tasks shall not be directly involved in the design,
        manufacture or construction, marketing, installation, use or maintenance of those products,
        or represent the parties engaged in those activities. They shall not engage in any activity
        that may conflict with their independence of judgement or integrity in relation to
        conformity assessment activities for which they are notified. This prohibition shall apply,
        in particular, to consultancy services.
5.      Conformity assessment bodies shall ensure that the activities of their subsidiaries or
        subcontractors do not affect the confidentiality, objectivity or impartiality of their
        conformity assessment activities.
6.      Conformity assessment bodies and their personnel shall carry out the conformity
        assessment activities with the highest degree of professional integrity and the requisite
        technical competence in the specific field and shall be free from all pressures and
        inducements, particularly financial, which might influence their judgement or the results of
        their conformity assessment activities, especially as regards persons or groups of persons
        with an interest in the results of those activities.
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 ---pagebreak---                                                Article 32
                              Personnel of conformity assessment bodies
1.      The personnel responsible for carrying out conformity assessment activities shall have the
        following skills:
        (a)   sound technical and vocational training covering all the conformity assessment
              activities in relation to which the conformity assessment body has been notified;
        (b)   satisfactory knowledge of the requirements of the assessments they carry out and
              adequate authority to carry out those assessments;
        (c)   appropriate knowledge and understanding of the essential requirements, of the
              applicable harmonised standards and of the relevant provisions of Union law;
        (d)   the ability to draw up certificates, records and reports demonstrating that assessments
              have been carried out.
2.      The remuneration of the top-level management and assessment personnel of a conformity
        assessment body shall not depend on the number of assessments carried out or on the
        results of those assessments.
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 ---pagebreak---                                                  Article 33
                      Presumption of conformity of a conformity assessment body
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the
relevant harmonised standards or parts thereof, the references of which have been published in the
Official Journal of the European Union, it shall be presumed to comply with the requirements set
out in Articles 30 to 32, in so far as the applicable harmonised standards cover those requirements.
                                                 Article 34
                         Subsidiaries of, and subcontracting by, notified bodies
1.        Where a notified body subcontracts specific tasks connected with conformity assessment
          or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets
          the requirements set out in Articles 30 to 32 and shall inform the notifying
          authority accordingly.
2.        Notified bodies shall take full responsibility for the tasks performed by subcontractors or
          subsidiaries wherever these are established.
3.        Activities of notified bodies may be subcontracted or carried out by a subsidiary only with
          the agreement of the client.
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 ---pagebreak--- 4.      Notified bodies shall keep at the disposal of the notifying authority the relevant documents
        concerning the assessment of the qualifications of the subcontractor or the subsidiary and
        the work carried out by them under the relevant TSI.
                                               Article 35
                                       Accredited in-house bodies
1.      Applicants may use an accredited in-house body to carry out conformity assessment
        activities for the purpose of implementing the procedures set out in modules A1, A2, C1
        or C2 laid down in Annex II to Decision 768/2008/EC and modules CA1 and CA2 laid
        down in Annex I to Decision 2010/713/EU. That body shall constitute a separate and
        distinct part of the applicant concerned and shall not participate in the design, production,
        supply, installation, use or maintenance of the products it assesses.
2.      An accredited in-house body shall meet the following requirements:
        (a)    it shall be accredited in accordance with Regulation (EC) No 765/2008;
        (b)    the body and its personnel shall, within the undertaking of which they form a part, be
               organisationally identifiable and have reporting methods which ensure their
               impartiality, and shall demonstrate it to the competent national accreditation body;
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 ---pagebreak---         (c)    neither the body nor its personnel shall be responsible for the design, manufacture,
               supply, installation, operation or maintenance of the products they assess, nor shall
               they engage in any activity that might conflict with their independence of judgement
               or integrity in relation to their assessment activities;
        (d)    the body shall supply its services exclusively to the undertaking of which it forms
               a part.
3.      An accredited in-house body shall not be notified to the Member States or the
        Commission, but information concerning its accreditation shall be given by the
        undertaking of which it forms a part or by the national accreditation body to the notifying
        authority at the request of that authority.
                                                 Article 36
                                       Application for notification
1.      A conformity assessment body shall submit an application for notification to the notifying
        authority of the Member State in which it is established.
2.      That application shall be accompanied by a description of the conformity assessment
        activities, the conformity assessment module or modules and the product or products for
        which that body claims to be competent, as well as by an accreditation certificate, where
        one exists, issued by a national accreditation body attesting that the conformity assessment
        body fulfils the requirements laid down in Articles 30 to 32.
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 ---pagebreak--- 3.      Where the conformity assessment body concerned cannot provide an accreditation
        certificate, it shall provide the notifying authority with all the documentary evidence
        necessary for the verification, recognition and regular monitoring of its compliance with
        the requirements laid down in Articles 30 to 32.
                                                Article 37
                                         Notification procedure
1.      Notifying authorities shall only notify conformity assessment bodies which comply with
        the requirements laid down in Articles 30 to 32.
2.      Notifying authorities shall notify the bodies referred to in paragraph 1 to the Commission
        and the other Member States using the electronic notification tool developed and managed
        by the Commission.
3.      The notification shall include full details of the conformity assessment activities, the
        conformity assessment module or modules and the product or products concerned, and the
        relevant accreditation certificate or other attestation of competence provided for in
        paragraph 4.
4.      Where a notification is not based on an accreditation certificate as referred to in Article
        36(2), the notifying authority shall provide the Commission and the other Member States
        with documentary evidence which attests to the conformity assessment body's competence
        and the arrangements in place to ensure that that body will be monitored periodically and
        will continue to satisfy the requirements laid down in Articles 30 to 32.
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 ---pagebreak--- 5.      The body concerned may perform the activities of a notified body only where no
        objections are raised by the Commission or the other Member States within two weeks of a
        notification where an accreditation certificate is used or within two months of a
        notification where accreditation is not used.
6.      The Commission and the other Member States shall be notified of any subsequent relevant
        changes to the notification.
                                              Article 38
                         Identification numbers and lists of notified bodies
1.      The Commission shall assign an identification number to a notified body.
        A notified body shall be assigned a single identification number even where it is notified
        under several legal acts of the Union.
2.      The Commission shall make publicly available the list of the bodies notified under this
        Directive, including the identification numbers that have been allocated to them and the
        activities for which they have been notified.
        The Commission shall ensure that that list is kept up to date.
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                                                DGE 2                                           EN
 ---pagebreak---                                                Article 39
                                        Changes to notifications
1.      Where a notifying authority has ascertained or has been informed that a notified body no
        longer meets the requirements laid down in Articles 30 to 32, or that it is failing to fulfil its
        obligations, the notifying authority shall restrict, suspend or withdraw notification as
        appropriate, depending on the seriousness of the failure to meet those requirements or fulfil
        those obligations. It shall immediately inform the Commission and the other Member
        States accordingly.
2.      In the event of restriction, suspension or withdrawal of notification, or where the notified
        body has ceased its activity, the notifying Member State shall take appropriate steps to
        ensure that the files of that body are either processed by another notified body or kept
        available for the responsible notifying and market surveillance authorities at their request.
                                               Article 40
                           Challenges to the competence of notified bodies
1.      The Commission shall investigate all cases where it has any doubt, or where a doubt is
        brought to its attention, regarding the competence of a notified body or the continued
        fulfilment by a notified body of the requirements and responsibilities to which it is subject.
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 ---pagebreak--- 2.      The notifying Member State shall provide the Commission, on request, with all
        information relating to the basis for the notification or the maintenance of the competence
        of the body concerned.
3.      The Commission shall ensure that all sensitive information obtained in the course of its
        investigations is treated confidentially.
4.      Where the Commission ascertains that a notified body does not meet, or no longer meets,
        the requirements for its notification, it shall inform the notifying Member State accordingly
        and request it to take the necessary corrective measures, including withdrawal of
        notification if necessary.
                                               Article 41
                               Operational obligations of notified bodies
1.      Notified bodies shall carry out conformity assessments in accordance with the conformity
        assessment procedures provided for in the relevant TSI.
2.      Conformity assessments shall be carried out in a proportionate manner, avoiding
        unnecessary burdens for economic operators. Notified bodies, when performing their
        activities, shall take due account of the size of an undertaking, the sector in which it
        operates, its structure, the degree of complexity of the product technology in question and
        the mass or serial nature of the production process.
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 ---pagebreak---         In so doing, they shall nevertheless operate with the aim of assessing the compliance of the
        product with this Directive.
3.      Where a notified body finds that requirements laid down in the relevant TSI or
        corresponding harmonised standards or technical specifications have not been met by a
        manufacturer, it shall require that manufacturer to take appropriate corrective measures and
        shall not issue a conformity certificate.
4.      Where, in the course of the monitoring of conformity following the issue of a certificate, a
        notified body finds that a product no longer complies with the relevant TSI or
        corresponding harmonised standards or technical specifications, it shall require the
        manufacturer to take appropriate corrective measures and shall suspend or withdraw the
        certificate if necessary.
5.      Where corrective measures are not taken or do not have the required effect, the notified
        body shall restrict, suspend or withdraw any certificates, as appropriate.
                                               Article 42
                         Obligation of notified bodies to provide information
1.      Notified bodies shall inform the notifying authority of the following:
        (a)    any refusal, restriction, suspension or withdrawal of a certificate;
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 ---pagebreak---         (b)    any circumstances affecting the scope of, and conditions for, notification;
        (c)    any request for information which they have received from market surveillance
               authorities regarding conformity assessment activities;
        (d)    on request, conformity assessment activities performed within the scope of their
               notification and any other activity performed, including cross-border activities
               and subcontracting.
        The competent national safety authorities shall also be informed of any refusal, restriction,
        suspension or withdrawal of a certificate under point (a).
2.      Notified bodies shall provide the other bodies notified under this Directive carrying out
        similar conformity assessment activities covering the same products with relevant
        information on issues relating to negative and, on request, positive conformity
        assessment results.
3.      Notified bodies shall provide the Agency with 'EC' certificates of verification of
        subsystems, 'EC' certificates of conformity of interoperability constituents and 'EC'
        certificates of suitability of use of interoperability constituents.
                                                Article 43
                                       Exchanges of best practice
The Commission shall provide for the organisation of exchanges of best practices between the
Member States' national authorities responsible for notification policy.
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 ---pagebreak---                                                 Article 44
                                      Coordination of notified bodies
The Commission shall ensure appropriate coordination and cooperation between bodies notified
under this Directive through the establishment of a sectoral group of notified bodies. The Agency
shall support the activities of notified bodies in accordance with Article 24 of Regulation (EU)
…/... +.
Member States shall ensure that the bodies notified by them participate in the work of that group,
directly or by means of designated representatives.
                                                Article 45
                                            Designated bodies
1.        The requirements relating to conformity assessment bodies set out in Articles 30 to 34 shall
          also apply to bodies designated under Article 15(8), except:
          (a)   in the case of skills required by its personnel under point (c) of Article 32(1), where
                the designated body shall have appropriate knowledge and understanding of
                national law;
          (b)   in the case of documents to be kept at the disposal of the notifying authority under
                Article 34(4), where the designated body shall include documents relating to work
                carried out by subsidiaries or subcontractors under the relevant national rules.
+
         OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                                   DGE 2                                            EN
 ---pagebreak--- 2.      The operational obligations laid down in Article 41 shall also apply to bodies designated
        under Article 15(8), except that those obligations refer to national rules instead of TSIs.
3.      The information obligation laid down in Article 42(1) shall also apply to designated
        bodies, which shall inform Member States accordingly.
                                       CHAPTER VII
                                         REGISTERS
                                             Article 46
                                     Vehicle numbering system
1.      Upon registration in accordance with Article 22, each vehicle shall be assigned a European
        vehicle number (EVN) by the competent authority in the Member State of registration.
        Each vehicle shall be marked with an assigned EVN.
2.      The specifications of the EVN shall be set out in the measures referred to in Article 47(2),
        in accordance with the relevant TSI.
3.      Each vehicle shall be assigned an EVN only once, unless otherwise specified in the
        measures referred to in Article 47(2), in accordance with the relevant TSI.
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 ---pagebreak--- 4.      Notwithstanding paragraph 1, in the case of vehicles operated or meant to be operated from
        or to third countries the track gauge of which is different from that of the main rail network
        within the Union, Member States may accept vehicles clearly identified in accordance with
        a different coding system.
                                                Article 47
                                              Vehicle registers
1.      Until the European Vehicle Register referred to in paragraph 5 is operational, each
        Member State shall keep a national vehicle register. That register shall:
        (a)    comply with the common specifications referred to in paragraph 2;
        (b)    be kept updated by a body independent of any railway undertaking;
        (c)    be accessible to the national safety authorities and investigating bodies designated in
               Articles 16 and 22 of Directive (EU) …/… +; it shall also be made accessible, in
               response to any legitimate request, to the regulatory bodies referred to in Article 55
               of Directive 2012/34/EU, and to the Agency, the railway undertakings and the
               infrastructure managers, as well as those persons or organisations registering vehicles
               or identified in the register.
+
      OJ: Please insert the number of the Directive in document 2013/0016 (COD).
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                                                  DGE 2                                           EN
 ---pagebreak--- 2.      The Commission shall adopt common specifications for the national vehicle registers as
        regards their content, data format, functional and technical architecture, operating mode,
        including arrangements for the exchange of data, and rules for data input and consultation,
        by means of implementing acts.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 51(3).
3.      The national vehicle register shall contain at least the following elements:
        (a)   the EVN;
        (b)   references to the 'EC' declaration of verification and the issuing body;
        (c)   references to the European register of authorised vehicle types referred to in
              Article 48;
        (d)   identification of the owner of the vehicle and the keeper;
        (e)   restrictions on how the vehicle may be used;
        (f)   the entity in charge of maintenance.
4.      As long as Member States' national vehicle registers are not linked in accordance with the
        specification referred to in paragraph 2, each Member State shall update its register, as
        regards the data with which it is concerned, with the modifications made by another
        Member State in its own register.
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 ---pagebreak--- 5.      With a view to reducing administrative burdens and undue costs for Member States and
        stakeholders, by… ∗, the Commission, taking into account the result of a cost-benefit
        analysis, shall adopt by means of implementing acts the technical and functional
        specifications for the European Vehicle Register, which would incorporate the national
        vehicle registers with a view to providing a harmonised interface to all users for the
        registration of vehicles and data management. Points (b) and (c) of paragraph 1 and
        paragraph 3 shall apply. Such a specification shall include content, data format, functional
        and technical architecture, operating mode, including arrangements for the exchange of
        data, and rules for data input, and consultation, as well as migration steps.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 51(3) and on the basis of a recommendation of the Agency.
        The European Vehicle Register shall be developed taking into consideration the IT
        applications and registers already set up by the Agency and the Member States, such as the
        European Centralised Virtual Vehicle Register connected to the national vehicle registers.
        The European Vehicle Register shall be operational by… ∗∗.
6.      The keeper shall immediately declare any modification to the data entered in the vehicle
        registers, the destruction of a vehicle or its decision to no longer register a vehicle, to the
        Member State where the vehicle has been registered.
∗
      OJ: please insert date: two years after the entry into force of this Directive.
∗∗
      OJ: please insert date: five years after the entry into force of this Directive.
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 ---pagebreak--- 7.      In the case of vehicles authorised for the first time in a third country and subsequently used
        in a Member State, that Member State shall ensure that the vehicle data, including at least
        data relating to the keeper of the vehicle concerned, the entity in charge of its maintenance
        and the restrictions on how the vehicle may be used, can be retrieved through a vehicle
        register or are otherwise made available without delay in an easily readable format and in
        accordance with the same non-discriminatory principles that apply to similar data from a
        vehicle register.
                                              Article 48
                            European register of authorised vehicle types
1.      The Agency shall set up and keep a register of authorisations to place vehicle types on the
        market issued in accordance with Article 24. That register shall:
        (a)   be public and electronically accessible;
        (b)   comply with the common specifications referred to in paragraph 2;
        (c)   be linked with relevant vehicle registers.
2.      The Commission shall adopt common specifications for the register of authorised vehicle
        types relating to content, data format, functional and technical architecture, operating mode
        and rules for data input and consultation, by means of implementing acts. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 51(3).
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 ---pagebreak--- 3.      The register shall include at least the following elements for each type of vehicle:
        (a)   technical characteristics, including those related to accessibility for persons with
              disabilities and persons with reduced mobility, of the type of vehicle as defined in the
              relevant TSIs;
        (b)   the manufacturer's name;
        (c)   the data of the authorisations related to the area of use for a vehicle type, including
              any restrictions or withdrawals.
                                               Article 49
                                      Register of infrastructure
1.      Each Member State shall ensure that a register of infrastructure, stating the values of the
        network parameters of each subsystem or part subsystem concerned, as set out in the
        relevant TSI, is published.
2.      The values of the parameters recorded in the register of infrastructure shall be used in
        combination with the values of the parameters recorded in the vehicle authorisation for
        placing on the market to check the technical compatibility between vehicle and network.
3.      The register of infrastructure may stipulate conditions for the use of fixed installations and
        other restrictions.
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 ---pagebreak--- 4.      Each Member State shall ensure that the register of infrastructure is updated in accordance
        with paragraph 5.
5.      The Commission shall adopt common specifications for the register of infrastructure
        relating to content, data format, functional and technical architecture, operating mode and
        rules for data input and consultation, by means of implementing acts. Those implementing
        acts shall be adopted in accordance with the examination procedure referred to in
        Article 51(3).
                                       CHAPTER VIII
                 TRANSITIONAL AND FINAL PROVISIONS
                                              Article 50
                                        Exercise of delegation
1.      The power to adopt delegated acts is conferred on the Commission subject to the
        conditions laid down in this Article.
2.      The power to adopt delegated acts referred to in Article 5(1) shall be conferred on the
        Commission for a period of five years from …*. The Commission shall draw up a report in
        respect of the delegation of power not later than nine months before the end of the
        five-year period. The delegation of power shall be tacitly extended for periods of an
        identical duration, unless the European Parliament or the Council opposes such extension
        not later than three months before the end of each period.
*
      OJ: Please, insert the date of entry into force of this Directive.
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 ---pagebreak--- 3.      It is of particular importance that the Commission follow its usual practice and carry out
        consultations with experts, including Member States' experts, before adopting those
        delegated acts.
4.      The delegation of power referred to in Article 5(1) may be revoked at any time by the
        European Parliament or by the Council. A decision of revocation shall put an end to the
        delegation of the power specified in that decision. It shall take effect the day following the
        publication of the decision in the Official Journal of the European Union or at a later date
        specified therein. It shall not affect the validity of any delegated acts already in force.
5.      As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the
        European Parliament and to the Council.
6.      A delegated act adopted pursuant to Article 5(1) shall enter into force only if no objection
        has been expressed either by the European Parliament or the Council within a period of
        two months of notification of that act to the European Parliament and the Council or if,
        before the expiry of that period, the European Parliament and the Council have both
        informed the Commission that they will not object. That period shall be extended by two
        months at the initiative of the European Parliament or of the Council.
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 ---pagebreak---                                                 Article 51
                                           Committee procedure
1.       The Commission shall be assisted by the committee established by Article 21 of Council
         Directive 96/48/EC 1. That committee shall be a committee within the meaning of
         Regulation (EU) No 182/2011.
2.       Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011
         shall apply.
3.       Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall
         apply. Where the committee delivers no opinion, the Commission shall not adopt the draft
         implementing act and the third subparagraph of Article 5(4) of Regulation (EU)
         No 182/2011 shall apply.
                                                Article 52
                                                Motivation
Any decision taken pursuant to this Directive concerning the assessment of conformity or suitability
for use of interoperability constituents or the checking of subsystems constituting the Union rail
system or any decision taken pursuant to Articles 7, 12 and 17 shall set out in detail the reasons on
which it is based. It shall be notified as soon as possible to the party concerned, together with an
indication of the remedies available under the law in force in the Member State concerned and of
the time-limits allowed for the exercise of such remedies.
1
        Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European
        high-speed rail system, OJ L 235, 17.9.1996, p. 6.
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                                                  DGE 2                                            EN
 ---pagebreak---                                                 Article 53
                                        Reports and information
1.      By…, ∗ the Commission shall report on the progress made in preparing for the Agency's
        enhanced role under this Directive. Additionally, every three years and for the first time
        three years after the end of the transitional period provided for by Article 54, the
        Commission shall report to the European Parliament and to the Council on the progress
        made towards achieving interoperability of the Union rail system and the functioning of
        the Agency in this context. That report shall also include an evaluation of the
        implementation and use of the registers under Chapter VII and an analysis of the cases set
        out in Article 7 and of the application of Chapter V, assessing in particular the functioning
        of the cooperation agreements concluded between the Agency and national safety
        authorities. For the purposes of the first report, after the end of the transitional period the
        Commission shall carry out extensive consultations with the relevant stakeholders and
        shall establish a programme to allow for the assessment of progress. The Commission
        shall, if appropriate in the light of the above analysis, propose legislative measures
        including measures for the future role of the Agency in enhancing interoperability.
2.      The Agency shall develop and periodically update a tool capable of providing, at the
        request of a Member State, the European Parliament or of the Commission, an overview of
        the interoperability level of the Union rail system. That tool shall use the information
        included in the registers provided for in Chapter VII.
∗
      OJ: please insert date: two years after the entry into force of this Directive.
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                                                  DGE 2                                              EN
 ---pagebreak---                                               Article 54
                               Transitional regime for using vehicles
1.      Without prejudice to paragraph 4 of this Article, vehicles which need to be authorised
        between ∗ … and... ∗∗ shall be subject to the provisions set out in Chapter V of
        Directive 2008/57/EC.
2.      Authorisations for the placing in service of vehicles which have been granted pursuant to
        paragraph 1 and all other authorisations granted prior to…∗, including authorisations
        delivered under international agreements, in particular RIC (Regolamento Internazionale
        Carrozze) and RIV (Regolamento Internazionale Veicoli), shall remain valid in accordance
        with the conditions under which the authorisations have been granted.
3.      Vehicles authorised for placing in service pursuant to paragraphs 1 and 2 shall receive a
        new vehicle authorisation for placing on the market in order to operate on one or more
        networks which are not yet covered by their authorisation. The placing on the market on
        those additional networks shall be subject to Article 21.
∗
      OJ: please insert date of entry into force of this Directive.
∗∗
      OJ: please insert date: three years after the entry into force of this Directive.
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                                                 DGE 2                                         EN
 ---pagebreak--- 4.      By... ∗ the Agency shall carry out the authorisation tasks pursuant to Articles 21 and 24 and
        the tasks referred to in Article 19 in respect of areas of use in the Member States that have
        not notified the Agency and the Commission in accordance with Article 57(2). By way of
        derogation from Articles 21 and 24, national safety authorities of Member States which
        have notified the Agency and Commission pursuant to Article 57(2) may continue to issue
        authorisations in accordance with Directive 2008/57/EC until … ∗∗.
                                               Article 55
                                     Other transitional provisions
1.      Annexes IV, V, VII and IX to Directive 2008/57/EC shall apply until the date of
        application of the corresponding implementing acts referred to in Article7(5), Article 9(4),
        Article 14(10) and Article 15(9) of this Directive.
2.      Directive 2008/57/EC shall continue to apply in relation to ERTMS trackside projects
        which are to be placed in service between … *** and …*.
3.      Projects which have completed the tendering or contracting phase prior to...* are not
        subject to the pre-authorisation by the Agency referred to in Article 19.
4.      Until... ∗∗∗∗ options included in contracts which were signed before …***. shall not be
        subject to the pre-authorisation by the Agency referred to in Article 19, even if they are
        exercised after …***.
∗
      OJ: please insert date: three years after the entry into force of this Directive.
∗∗
      OJ: please insert date: four years after the entry into force of this Directive.
***
      OJ: please insert the date of the entry into force of this Directive.
∗∗∗∗
      OJ: please insert date: 15 years after the entry into force of this Directive.
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                                                 DGE 2                                            EN
 ---pagebreak--- 5.      Before authorising the placing in service of any ERTMS track-side equipment which was
        not subject to the pre-authorisation by the Agency referred to in Article 19, national safety
        authorities shall cooperate with the Agency in order to ensure that the technical solutions
        are fully interoperable, in accordance with Articles 30(3) and 31(2) of Regulation
        (EU) …/... +.
                                              Article 56
                            Recommendations and opinions of the Agency
The Agency shall provide recommendations and opinions in accordance with Article 19 of
Regulation (EU) …/…+ for the purpose of application of this Directive. Where relevant, those
recommendations and opinions shall be taken into account when implementing acts are being drawn
up pursuant to this Directive.
+
       OJ: Please insert the number of the Regulation in document 2013/0014 (COD).
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                                               DGE 2                                             EN
 ---pagebreak---                                                Article 57
                                             Transposition
1.      Member States shall bring into force the laws, regulations and administrative provisions
        necessary to comply with Articles 1 and 2, Article 7(1) to (4) and (6), Article 8,
        Article 9(1), Article 10(5), Article 11(1), (3) and (4), Articles 12, 13 and 14, Article 15(1)
        to (8), Article 16, Article 18, Article 19(3), Articles 21 to 39, Article 40(2), Articles 41, 42,
        44, 45 and 46, Article 47(1), (3), (4) and (7), Article 49(1) to (4), Article 54 and Annexes I,
        II, III and IV by… ∗. They shall immediately communicate the text of those measures to the
        Commission.
2.      Member States may extend the transposition period referred to in paragraph 1 by one year.
        For that purpose, by… ∗∗, Member States which do not bring into force the laws,
        regulations and administrative provisions within the transposition period referred to in
        paragraph 1 shall notify the Agency and the Commission thereof and present the reasons
        for such extension.
3.      When Member States adopt those measures, they shall contain a reference to this Directive
        or be accompanied by such a reference on the occasion of their official publication. They
        shall also include a statement that references in existing laws, regulations and
        administrative provisions to the Directives repealed by this Directive shall be construed as
        references to this Directive. Member States shall determine how such reference is to be
        made and how that statement is to be formulated.
∗
      OJ: Please insert date: three years after the entry into force of this Directive.
∗∗
      OJ: Please insert date: 30 months after the date of entry into force of this Directive.
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                                                 DGE 2                                              EN
 ---pagebreak--- 4.        Member States shall communicate to the Commission the text of the main provisions of
          national law which they adopt in the field covered by this Directive.
5.        The obligation to transpose and implement Article 13, Article 14(1) to (8), (11) and (12),
          Article 15(1) to (9), Article 16(1), Articles 19 to 26, Articles 45, 46 and 47, Article 49(1) to
          (4) and Article 54 of this Directive shall not apply to Cyprus and Malta for as long as no
          rail system is established within their territories.
          However, as soon as a public or private entity submits an official application to build a
          railway line with a view to its operation by one or more railway undertakings, the
          Member States concerned shall put in place measures to implement the Articles referred to
          in the first subparagraph within two years of receipt of the application.
                                                Article 58
                                                  Repeal
Directive 2008/57/EC, as amended by the Directives listed in Annex V, Part A, is repealed with
effect from... ∗, without prejudice to the obligations of the Member States relating to the time-limits
for the transposition into national law of the Directives set out in Annex V, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be
read in accordance with the correlation table in Annex VI.
∗
        OJ: please insert date: four years after the entry into force of this Directive.
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 ---pagebreak---                                                Article 59
                                            Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
                                               Article 60
                                              Addressees
This Directive is addressed to the Member States.
Done at...,
For the European Parliament                                  For the Council
The President                                                The President
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 ---pagebreak---                                              ANNEX I
                          ELEMENTS OF THE UNION RAIL SYSTEM
1.      Network
        For the purposes of this Directive, the Union's network shall include the following
        elements:
        (a)   specially built high-speed lines equipped for speeds generally equal to or greater than
              250 km/h,
        (b)   specially upgraded high-speed lines equipped for speeds of the order of 200 km/h,
        (c)   specially upgraded high-speed lines which have special features as a result of
              topographical, relief or town-planning constraints, to which the speed must be
              adapted in each case. This category includes interconnecting lines between
              high-speed and conventional networks, lines through stations, accesses to terminals,
              depots, etc. travelled at conventional speed by 'high-speed' rolling stock,
        (d)   conventional lines intended for passenger services,
        (e)   conventional lines intended for mixed traffic (passengers and freight),
        (f)   conventional lines intended for freight services,
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ANNEX I                                         DGE 2                                           EN
 ---pagebreak---         (g)    passenger hubs,
        (h)    freight hubs, including intermodal terminals,
        (i)    lines connecting the abovementioned elements.
        This network includes traffic management, tracking and navigation systems, technical
        installations for data processing and telecommunications intended for long-distance
        passenger services and freight services on the network in order to guarantee the safe and
        harmonious operation of the network and efficient traffic management.
2.      Vehicles
        For the purposes of this Directive, Union vehicles shall comprise all vehicles likely to
        travel on all or part of the Union's network:
        –      locomotives and passenger rolling stock, including thermal or electric traction units,
               self-propelling thermal or electric passenger trains, and passenger coaches;
        –      freight wagons, including low-deck vehicles designed for the entire network and
               vehicles designed to carry lorries;
        –      special vehicles, such as on-track machines.
        This list of vehicles shall include those which are specially designed to operate on the
        different types of high-speed lines described in point 1.
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ANNEX I                                          DGE 2                                           EN
 ---pagebreak---                                              ANNEX II
                                          SUBSYSTEMS
1.      List of subsystems
        For the purposes of this Directive, the system constituting the Union rail system may be
        broken down into the following subsystems, either:
        (a)   structural areas:
              –     infrastructure,
              –     energy,
              –     trackside control-command and signalling,
              –     on-board control-command and signalling,
              –     rolling stock; or
        (b)   functional areas:
              –     operation and traffic management,
              –     maintenance,
              –     telematics applications for passenger and freight services.
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ANNEX II                                        DGE 2                                          EN
 ---pagebreak--- 2.      Description of the subsystems
        For each subsystem or part of a subsystem, the list of constituents and aspects relating to
        interoperability is proposed by the Agency at the time of drawing up the relevant draft TSI.
        Without prejudging the choice of aspects and constituents relating to interoperability or the
        order in which they will be made subject to TSIs, the subsystems include the following:
2.1.    Infrastructure
        The track, points, level crossings, engineering structures (bridges, tunnels, etc.), rail-related
        elements of stations (including entrances, platforms, zones of access, service venues,
        toilets and information systems, as well as their accessibility features for persons with
        disabilities and persons with reduced mobility), safety and protective equipment.
2.2.    Energy
        The electrification system, including overhead lines and the trackside electricity
        consumption measuring and charging system.
2.3.    Trackside control-command and signalling
        All the trackside equipment required to ensure safety and to command and control
        movements of trains authorised to travel on the network.
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ANNEX II                                        DGE 2                                               EN
 ---pagebreak--- 2.4.    On-board control-command and signalling
        All the on-board equipment required to ensure safety and to command and control
        movements of trains authorised to travel on the network.
2.5.    Operation and traffic management
        The procedures and related equipment permitting coherent operation of the various
        structural subsystems, during both normal and degraded operation, including in particular
        train composition and train driving, traffic planning and management.
        The professional qualifications which may be required for carrying out any type of
        railway service.
2.6.    Telematics applications
        In accordance with Annex I, this subsystem comprises two elements:
        (a)    applications for passenger services, including systems which provide passengers with
               information before and during the journey, reservation and payment systems,
               luggage management and management of connections between trains and with other
               modes of transport;
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ANNEX II                                        DGE 2                                         EN
 ---pagebreak---         (b)    applications for freight services, including information systems (real-time monitoring
               of freight and trains), marshalling and allocation systems, reservation, payment and
               invoicing systems, management of connections with other modes of transport and
               production of electronic accompanying documents.
2.7.    Rolling stock
        Structural body, command and control system for all train equipment, electric current
        collection devices, traction and energy conversion units, on-board equipment for electricity
        consumption measuring and charging, braking, coupling and running gear (bogies, axles,
        etc.) and suspension, doors, man/machine interfaces (driver, on-board staff and passengers,
        including accessibility features for persons with disabilities and persons with reduced
        mobility), passive or active safety devices and requisites for the health of passengers and
        on-board staff.
2.8.    Maintenance
        The procedures, associated equipment, logistics centres for maintenance work and reserves
        providing the mandatory corrective and preventive maintenance to ensure the
        interoperability of the Union rail system and guarantee the performance required.
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ANNEX II                                         DGE 2                                           EN
 ---pagebreak---                                             ANNEX III
                                 ESSENTIAL REQUIREMENTS
1.      General requirements
1.1.    Safety
1.1.1.  The design, construction or assembly, maintenance and monitoring of safety-critical
        components, and more particularly of the components involved in train movements, must
        be such as to guarantee safety at the level corresponding to the aims laid down for the
        network, including those for specific degraded situations.
1.1.2.  The parameters involved in the wheel/rail contact must meet the stability requirements
        needed in order to guarantee safe movement at the maximum authorised speed. The
        parameters of brake equipment must guarantee that it is possible to stop within a given
        brake distance at the maximum authorised speed.
1.1.3.  The components used must withstand any normal or exceptional stresses that have been
        specified during their period in service. The safety repercussions of any accidental failures
        must be limited by appropriate means.
1.1.4.  The design of fixed installations and rolling stock and the choice of the materials used
        must be aimed at limiting the generation, propagation and effects of fire and smoke in the
        event of a fire.
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ANNEX III                                       DGE 2                                            EN
 ---pagebreak--- 1.1.5.  Any devices intended to be handled by users must be designed in such a way as not to
        impair the safe operation of the devices or the health and safety of users if used in a
        foreseeable manner, albeit not in accordance with the posted instructions.
1.2.    Reliability and availability
        The monitoring and maintenance of fixed or movable components that are involved in train
        movements must be organised, carried out and quantified in such a manner as to maintain
        their operation under the intended conditions.
1.3.    Health
1.3.1.  Materials likely, by virtue of the way they are used, to constitute a health hazard to those
        having access to them must not be used in trains and railway infrastructures.
1.3.2.  Those materials must be selected, deployed and used in such a way as to restrict the
        emission of harmful and dangerous fumes or gases, particularly in the event of fire.
1.4.    Environmental protection
1.4.1.  The environmental impact of establishment and operation of the rail system must be
        assessed and taken into account at the design stage of the system in accordance with
        Union law.
1.4.2.  The materials used in the trains and infrastructures must prevent the emission of fumes or
        gases which are harmful and dangerous to the environment, particularly in the event of fire.
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ANNEX III                                       DGE 2                                             EN
 ---pagebreak--- 1.4.3.  The rolling stock and energy-supply systems must be designed and manufactured in such a
        way as to be electromagnetically compatible with the installations, equipment and public
        or private networks with which they might interfere.
1.4.4.  The design and operation of the rail system must not lead to an inadmissible level of noise
        generated by it:
        –     in areas close to railway infrastructure, as defined in point (3) of Article 3 of
              Directive 2012/34/EU, and
        –     in the driver's cab.
1.4.5.  Operation of the rail system must not give rise to an inadmissible level of ground
        vibrations for the activities and areas close to the infrastructure and in a normal state of
        maintenance.
1.5.    Technical compatibility
        The technical characteristics of the infrastructure and fixed installations must be
        compatible with each other and with those of the trains to be used on the rail system. This
        requirement includes the safe integration of the vehicle's subsystem with the infrastructure.
        If compliance with these characteristics proves difficult on certain sections of the network,
        temporary solutions, which ensure compatibility in the future, may be implemented.
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ANNEX III                                        DGE 2                                             EN
 ---pagebreak--- 1.6.    Accessibility
1.6.1.  The "infrastructure" and "rolling stock" subsystems must be accessible to persons with
        disabilities and persons with reduced mobility in order to ensure access on an equal basis
        with others by way of the prevention or removal of barriers, and by way of other
        appropriate measures. This shall include the design, construction, renewal, upgrade,
        maintenance and operation of the relevant parts of the subsystems to which the public
        has access.
1.6.2.  The "operations" and "telematics applications for passengers" subsystems must provide for
        the necessary functionality required to facilitate access for persons with disabilities and
        persons with reduced mobility on an equal basis with others by way of the prevention or
        removal of barriers, and by way of other appropriate measures.
2.      Requirements specific to each subsystem
2.1.    Infrastructure
2.1.1.  Safety
        Appropriate steps must be taken to prevent access to, or undesirable intrusions into,
        installations.
        Steps must be taken to limit the dangers to which persons are exposed, particularly when
        trains pass through stations.
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ANNEX III                                      DGE 2                                              EN
 ---pagebreak---         Infrastructure to which the public has access must be designed and made in such a way as
        to limit any human safety hazards (stability, fire, access, evacuation, platforms, etc.).
        Appropriate provisions must be laid down to take account of the particular safety
        conditions in very long tunnels and viaducts.
2.1.2.  Accessibility
        Infrastructure subsystems to which the public has access must be accessible for persons
        with disabilities and persons with reduced mobility in accordance with point 1.6.
2.2.    Energy
2.2.1.  Safety
        Operation of the energy-supply systems must not impair the safety either of trains or of
        persons (users, operating staff, trackside dwellers and third parties).
2.2.2.  Environmental protection
        The functioning of the electrical or thermal energy-supply systems must not interfere with
        the environment beyond the specified limits.
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ANNEX III                                       DGE 2                                             EN
 ---pagebreak--- 2.2.3.  Technical compatibility
        The electricity/thermal energy-supply systems used must:
        –      enable trains to achieve the specified performance levels,
        –      in the case of electricity energy-supply systems, be compatible with the collection
               devices fitted to the trains.
2.3.    Control-command and signalling
2.3.1.  Safety
        The control-command and signalling installations and procedures used must enable trains
        to travel with a level of safety which corresponds to the objectives set for the network. The
        control-command and signalling systems must continue to provide for safe passage of
        trains permitted to run under degraded conditions.
2.3.2.  Technical compatibility
        All new infrastructure and all new rolling stock manufactured or developed after adoption
        of compatible control-command and signalling systems must be tailored to the use of those
        systems.
        The control-command and signalling equipment installed in the train drivers' cabs must
        permit normal operation, under the specified conditions, throughout the rail system.
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ANNEX III                                        DGE 2                                           EN
 ---pagebreak--- 2.4.    Rolling stock
2.4.1.  Safety
        The rolling-stock structures and those of the links between vehicles must be designed in
        such a way as to protect the passenger and driving compartments in the event of collision
        or derailment.
        The electrical equipment must not impair the safety and functioning of the control-
        command and signalling installations.
        The braking techniques and the stresses exerted must be compatible with the design of the
        tracks, engineering structures and signalling systems.
        Steps must be taken to prevent access to electrically-live constituents in order not to
        endanger the safety of persons.
        In the event of danger, devices must enable passengers to inform the driver and
        accompanying staff to contact them.
        The safety of passengers boarding and alighting from trains must be ensured. The access
        doors must incorporate an opening and closing system which guarantees passenger safety.
        Emergency exits must be provided and indicated.
        Appropriate provisions must be laid down to take account of the particular safety
        conditions in very long tunnels.
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ANNEX III                                      DGE 2                                            EN
 ---pagebreak---         An emergency lighting system having a sufficient intensity and duration is an absolute
        requirement on board trains.
        Trains must be equipped with a public address system which provides a means of
        communication to the public from on-board staff.
        Passengers must be given easily understandable and comprehensive information about
        rules applicable to them both in railway stations and in trains.
2.4.2.  Reliability and availability
        The design of the vital equipment and the running, traction and braking equipment as well
        as the control-command system must, in a specific degraded situation, be such as to enable
        the train to continue without adverse consequences for the equipment remaining in service.
2.4.3.  Technical compatibility
        The electrical equipment must be compatible with the operation of the control-command
        and signalling installations.
        In the case of electric traction, the characteristics of the current-collection devices must be
        such as to enable trains to travel under the energy-supply systems for the rail system.
        The characteristics of the rolling stock must be such as to allow it to travel on any line on
        which it is expected to operate, taking account of relevant climatic conditions.
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ANNEX III                                        DGE 2                                             EN
 ---pagebreak--- 2.4.4.  Controls
        Trains must be equipped with a recording device. The data collected by that device and the
        processing of the information must be harmonised.
2.4.5.  Accessibility
        Rolling-stock subsystems to which the public has access must be accessible for persons
        with disabilities and persons with reduced mobility in accordance with point 1.6.
2.5.    Maintenance
2.5.1.  Health and safety
        The technical installations and the procedures used in the centres must ensure the safe
        operation of the subsystem and not constitute a danger to health and safety.
2.5.2.  Environmental protection
        The technical installations and the procedures used in the maintenance centres must not
        exceed the permissible levels of nuisance with regard to the surrounding environment.
2.5.3.  Technical compatibility
        The maintenance installations for rolling stock must be such as to enable safety, health and
        comfort operations to be carried out on all stock for which they have been designed.
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ANNEX III                                      DGE 2                                            EN
 ---pagebreak--- 2.6.    Operation and traffic management
2.6.1.  Safety
        Alignment of the network operating rules and the qualifications of drivers and on-board
        staff and of the staff in the control centres must be such as to ensure safe operation, bearing
        in mind the different requirements of cross-border and domestic services.
        The maintenance operations and intervals, the training and qualifications of the
        maintenance and control centre staff and the quality assurance system set up by the
        operators concerned in the control and maintenance centres must be such as to ensure a
        high level of safety.
2.6.2.  Reliability and availability
        The maintenance operations and periods, the training and qualifications of the maintenance
        and control centre staff and the quality assurance system set up by the operators concerned
        in the control and maintenance centres must be such as to ensure a high level of system
        reliability and availability.
2.6.3.  Technical compatibility
        Alignment of the network operating rules and the qualifications of drivers, on-board staff
        and traffic managers must be such as to ensure operating efficiency on the rail system,
        bearing in mind the different requirements of cross-border and domestic services.
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ANNEX III                                        DGE 2                                            EN
 ---pagebreak--- 2.6.4.  Accessibility
        Appropriate steps must be taken to ensure that operating rules provide for the necessary
        functionality required to ensure accessibility for persons with disabilities and persons with
        reduced mobility.
2.7.    Telematics applications for freight and passengers
2.7.1.  Technical compatibility
        The essential requirements for telematics applications guarantee a minimum quality of
        service for passengers and carriers of goods, particularly in terms of technical
        compatibility.
        Steps must be taken to ensure:
        –     that the databases, software and data communication protocols are developed in a
              manner allowing maximum data interchange between different applications and
              operators, excluding confidential commercial data,
        –     easy access to the information for users.
2.7.2.  Reliability and availability
        The methods of use, management, updating and maintenance of these databases, software
        and data communication protocols must guarantee the efficiency of these systems and the
        quality of the service.
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ANNEX III                                      DGE 2                                             EN
 ---pagebreak--- 2.7.3.  Health
        The interfaces between these systems and users must comply with the minimum rules on
        ergonomics and health protection.
2.7.4.  Safety
        Suitable levels of integrity and dependability must be provided for the storage or
        transmission of safety-related information.
2.7.5.  Accessibility
        Appropriate steps must be taken to ensure that telematics applications for passenger
        subsystems provide for the necessary functionality required to ensure accessibility for
        persons with disabilities and persons with reduced mobility.
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ANNEX III                                      DGE 2                                            EN
 ---pagebreak---                                              ANNEX IV
                    'EC' VERIFICATION PROCEDURE FOR SUBSYSTEMS
1.      GENERAL PRINCIPLES
        "'EC' verification" means a procedure carried out by the applicant within the meaning of
        Article15 to demonstrate that the requirements of the relevant Union law and any relevant
        national rules relating to a subsystem have been fulfilled and the subsystem may be
        authorised to be placed in service.
2.      CERTIFICATE OF VERIFICATION ISSUED BY A NOTIFIED BODY
2.1.    Introduction
        For the purpose of this Directive, the verification by reference to TSIs is the procedure
        whereby a notified body checks and certifies that the subsystem complies with the relevant
        technical specifications for interoperability (TSI).
        This is without prejudice to the obligations of the applicant to comply with the other
        applicable legal acts of the Union and any verifications by the assessment bodies required
        by the other rules.
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ANNEX IV                                        DGE 2                                            EN
 ---pagebreak--- 2.2.    Intermediate statement of verification (ISV)
2.2.1   Principles
        At the request of the applicant the verifications may be done for parts of a subsystem or
        may be limited to certain stages of the verification procedure. In these cases, the results of
        verification may be documented in an "intermediate statement of verification" (ISV) issued
        by the notified body chosen by the applicant. The ISV must provide reference to the TSIs
        with which the conformity has been assessed.
2.2.2   Parts of the subsystem
        The applicant may apply for an ISV for any part into which he decides to split the
        subsystem. Each part shall be checked at each stage as set out in point 2.2.3.
2.2.3   Stages of the verification procedure
        The subsystem, or certain parts of the subsystem, shall be checked at each of the following
        stages:
        (a)   overall design,
        (b)   production: construction, including, in particular, civil-engineering activities,
              manufacturing, constituent assembly and overall adjustment,
        (c)   final testing.
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 ---pagebreak---         The applicant may apply for an ISV for the design stage (including the type tests) and for
        the production stage for the whole subsystem or for any part into which the applicant
        decided to split it (see point 2.2.2).
2.3.    Certificate of verification
2.3.1.  The notified bodies responsible for the verification assess the design, production and final
        testing of the subsystem and draw up the certificate of verification intended for the
        applicant who in turn draws up the 'EC' declaration of verification. The certificate of
        verification must provide reference to the TSIs with which the conformity has been
        assessed.
        Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in
        the case of a derogation, partial application of TSIs for upgrade or renewal, transitional
        period in a TSI or specific case), the certificate of verification shall give the precise
        reference to the TSI(s) or their parts whose conformity has not been examined by the
        notified body during the verification procedure.
2.3.2.  Where ISV have been issued, the notified body responsible for the verification of the
        subsystem takes these ISV into account, and, before issuing its certificate of verification:
        (a)   verifies that the ISV cover correctly the relevant requirements of the TSI(s),
        (b)   checks all aspects that are not covered by the ISV, and
        (c)   checks the final testing of the subsystem as a whole.
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 ---pagebreak--- 2.3.3.  In the case of a modification to a subsystem already covered by a certificate of verification,
        the notified body shall perform only those examinations and tests that are relevant and
        necessary, i.e. assessment shall relate only to the parts of the subsystem that are changed
        and their interfaces to the unchanged parts of the subsystem.
2.3.4   Each notified body involved in the verification of a subsystem shall draw up a file in
        accordance with Article 15(4) covering the scope of its activities.
2.4.    Technical file accompanying the 'EC' declaration of verification.
        The technical file accompanying the 'EC' declaration of verification shall be assembled by
        the applicant and must contain the following:
        (a)   technical characteristics linked to the design including general and detailed drawings
              with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams,
              description of data-processing and automatic systems to the level of detail sufficient
              for documenting the verification of conformity carried out, documentation on
              operation and maintenance, etc., relevant for the subsystem concerned,
        (b)   a list of interoperability constituents, referred to in point (d) of Article 4(3),
              incorporated into the subsystem,
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 ---pagebreak---         (c) the files referred to in Article 15(4), compiled by each of the notified bodies involved
            in the verification of the subsystem, which shall include:
            –      copies of the 'EC' declarations of verification and, where applicable, 'EC'
                   declarations of suitability for use established for interoperability constituents
                   referred to in point (d) of Article 4(3) and accompanied, where appropriate, by
                   the corresponding calculation notes and a copy of the records of the tests and
                   examinations carried out by the notified bodies on the basis of the common
                   technical specifications,
            –      where available, the ISV that accompany the certificate of verification,
                   including the result of verification by the notified body of the ISV validity,
            –      the certificate of verification, accompanied by corresponding calculation notes
                   and signed by the notified body responsible for the verification, stating that the
                   subsystem complies with the requirements of the relevant TSI(s) and
                   mentioning any reservations recorded during performance of the activities and
                   not withdrawn; the certificate of verification should also be accompanied by
                   the inspection and audit reports drawn up by the same body in connection with
                   its task, as specified in points 2.5.2 and 2.5.3,
        (d) certificates of verification issued in accordance with other legal acts of the Union,
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 ---pagebreak---         (e)    when verification of safe integration is required pursuant to in point (c) of
               Article 18(4) and in point (c) of Article 21(3), the relevant technical file shall include
               the assessors' report(s) on the CSM's on risk assessment referred to in Article 6(3) of
               Directive 2004/49/EC.
2.5.    Surveillance by notified bodies.
2.5.1.  The notified body responsible for checking production must have permanent access to
        building sites, production workshops, storage areas and, where appropriate, prefabrication
        or testing facilities and, more generally, to all premises which it considers necessary for its
        task. The notified body must receive from the applicant all the documents needed for that
        purpose and, in particular, the implementation plans and technical documentation
        concerning the subsystem.
2.5.2.  The notified body responsible for checking implementation must periodically carry out
        audits in order to confirm compliance with the relevant TSI(s). It must provide those
        responsible for implementation with an audit report. Its presence may be required at certain
        stages of the building operations.
2.5.3.  In addition, the notified body may pay unexpected visits to the worksite or to the
        production workshops. At the time of such visits the notified body may conduct complete
        or partial audits. It must provide those responsible for implementation with an inspection
        report and, if appropriate, an audit report.
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 ---pagebreak--- 2.5.4.  The notified body shall be able to monitor a subsystem on which an interoperability
        constituent is mounted in order to assess, where required by the corresponding TSI, its
        suitability for use in its intended railway environment.
2.6.    Submission
        A copy of the technical file accompanying the 'EC' declaration of verification must be kept
        by the applicant) throughout the service life of the subsystem. It must be sent to any
        Member State or the Agency, upon request.
        The documentation submitted for an application for an authorisation for placing in service
        shall be submitted to the authority where the authorisation is sought. The national safety
        authority or the Agency may request that part(s) of the documents submitted together with
        the authorisation is/are translated into its own language.
2.7.    Publication
        Each notified body must periodically publish relevant information concerning:
        (a)   requests for verification and ISV received,
        (b)   request for assessment of conformity and suitability for use of ICs,
        (c)   ISV issued or refused,
        (d)   certificates of verification and 'EC' certificates for suitability for use issued or
              refused,
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 ---pagebreak---         (e)    certificates of verification issued or refused.
2.8.    Language
        The files and correspondence relating to the 'EC' verification procedure must be written in
        a Union official language of the Member State in which the applicant is established or in a
        Union official language accepted by the applicant
3.      CERTIFICATE OF VERIFICATION ISSUED BY A DESIGNATED BODY
3.1.    Introduction
        In the case where national rules apply, the verification shall include a procedure whereby
        the body designated pursuant to Article 15(8), (the designated body) checks and certifies
        that the subsystem complies with the national rules notified in accordance with Article14
        for each Member State in which the subsystem is intended to be authorised to be placed in
        service.
3.2.    Certificate of verification
        The designated body draws up the certificate of verification intended for the applicant.
        The certificate shall contain a precise reference to the national rule(s) whose conformity
        has been examined by the designated body in the verification process.
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 ---pagebreak---         In the case of national rules related to the subsystems composing a vehicle, the designated
        body shall divide the certificate into two parts, one part including the references to those
        national rules strictly related to the technical compatibility between the vehicle and the
        network concerned, and the other part for all other national rules.
3.3.    File
        The file compiled by the designated body and accompanying the certificate of verification
        in the case of national rules must be included in the technical file accompanying the 'EC'
        declaration of verification referred to in point 2.4 and shall contain the technical data
        relevant for the assessment of the conformity of the subsystem with those national rules.
3.4.    Language
        The files and correspondence relating to the 'EC' verification procedure must be written in
        a Union official language of the Member State in which the applicant) is established or in a
        Union official language accepted by the applicant.
4.      VERIFICATION OF PARTS OF SUBSYSTEMS IN ACCORDANCE WITH
        ARTICLE 15(7)
        If a certificate of verification is to be issued for certain parts of a subsystem, provisions for
        this Annex shall apply mutatis mutandis for those parts.
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 ---pagebreak---                                      ANNEX V
                                      PART A
                                Repealed Directives
                 with list of the successive amendments thereto
                             (referred to in Article 58)
         Directive 2008/57/EC                (OJ L 191, 18.7.2008, p. 1.)
         Directive 2009/131/EC               (OJ L 273, 17.10.2009, p. 12.)
         Directive 2011/18/EU                (OJ L 57, 2.3.2011, p. 21.)
                                      PART B
                 Time-limits for transposition into national law
                             (referred to in Article 57)
                   Directive                   Deadline for transposition
         2008/57/EC                         19 July 2010
         2009/131/EC                        19 July 2010
         2011/18/EU                         31 December 2011
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 ---pagebreak---                                       ANNEX VI
                                    Correlation table
               Directive 2008/57/EC                             This Directive
Article 1                                     Article 1
Article 2(a) to (z)                           Article 2(1) to (5), (7) to (17) and (19) to (28)
-                                             Article 2(6), (18) and (29) to (45)
Article 3                                     -
Article 4                                     Article 3
Article 5(1) to (3)(g)                        Article 4(1) to (3)(g)
-                                             Article 4(3)(h) and (i)
Article 5(4) to (8)                           Article 4(4) to (8)
Article 6                                     Article 5
Article 7                                     Article 6
Article 8                                     -
Article 9                                     Article 7
Article 10                                    Article 8
Article 11                                    Article 9
Article 12                                    -
Article 13                                    Article 10
Article 14                                    Article 11
Article 15(1)                                 Articles 18(2)
Article 15(2) and (3)                         -
Article 16                                    Article 12
Article 17                                    Articles 13 and 14
Article 18                                    Article 15
Article 19                                    Article 16
-                                             Article 17
-                                             Article 18 (except 18(3))
-                                             Articles 19, 20, 21, 22 and 23
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 ---pagebreak---                Directive 2008/57/EC                      This Directive
Article 20                              -
Article 21                              -
Articles 22 to 25                       -
Article 26                              Article 24
Article 27                              Article 14(10)
-                                       Article 26
Article 28 and Annex VIII               Articles 27 to 44
-                                       Article 45
Article 29                              Article 51
Articles 30 and 31                      -
Article 32                              Article 46
Article 33                              Article 47(3), (4), (6) and (7)
-                                       Article 47(1), (2) and (5)
Article 34                              Article 48
Article 35                              Article 49
Article 36                              -
-                                       Article 50-
Article 37                              Article 52
Article 38                              Article 57
Article 39                              Article 53
-                                       Articles 54 and 55
-                                       Article 56
Article 40                              Article 58
Article 41                              Article 59
Article 42                              Article 60
Annex I to III                          Annex I to III
Annex IV                                Article 9(2)
Annex V                                 Article 15(9)
Annex VI                                Annex IV
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 ---pagebreak---            Directive 2008/57/EC                      This Directive
Annex VII                           Article 14(10)
Annex VIII                          Articles 30, 31 and 32
Annex IX                            Article 7(5)
Annex X                             Annex V
Annex XI                            Annex VI
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