(Ordinary legislative procedure – recast)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2013)0030),

–  having regard to Article 294(2) and Articles 91(1), 170 and 171 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0027/2013),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Seimas of the Republic of Lithuania and the Swedish Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–  having regard to the opinion of the European Economic and Social Committee of 11 July 2013(1),

–  having regard to the opinion of the Committee of the Regions of 7 October 2013(2),

–  having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(3),

–  having regard to the letter of 16 December 2013 from the Committee on Legal Affairs to the Committee on Transport and Tourism in accordance with Rule 87(3) of its Rules of Procedure,

–  having regard to Rules 87 and 55 of its Rules of Procedure,

–  having regard to the report of the Committee on Transport and Tourism and the opinion of the Committee on Regional Development (A7-0033/2014),

A.  whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1.  Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) OJ C 327, 12.11.2013, p. 122. (2) OJ C 356, 5.12.2013, p. 92. (3) OJ C 77, 28.3.2002, p. 1.

(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),

Whereas:

(1)  Directive 2008/57/EC of the European Parliament and of the Council(4) 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 regional and local authorities to benefit to the full from the advantages deriving from the establishing of an area without internal frontiers and to attain the objective of territorial cohesion, it is appropriate, in particular, to improve the interlinking and interoperability of the national rail networks as well as access thereto, including for passengers with disabilities, implementing any measures that may prove necessary in the field of technical standardisation. [Am. 1]

(3)  The pursuit of interoperability within the Union's 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 rail system within the Union. [Am. 2]

(4)  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 and ticketing 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 rail system. [Am. 3]

(5)  The railway regulatory framework should set clear responsibilities for ensuring compliance with the safety, health, social and consumer protection rules applying to the railway networks. [Am. 4]

(6)  There are major differences 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 prescribe specific dimensions and devices and special characteristics. This situation prevents trains from being able to run without hindrance throughout the Union and from reaping the benefits of standardisation and economies of scale in the single market. [Am. 5]

(7)  Over the years, this situation has created very close links between the national railway industries and the national railways, to the detriment of a genuine opening-up of markets allowing new entrants to emerge. In order to enhance their competitiveness at world level, these industries require an open, competitive European market.

(8)  It is therefore appropriate to define essential requirements related to rail interoperability for the whole of the Union which should apply to its rail system.

(9)  The development of technical specifications for interoperability (TSIs) has shown the need to clarify the relationship between the essential requirements and the 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(5). 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.

(10)  In order to genuinely increase the competitiveness of the Union railway sector without distorting competition between key actors of the rail system, the TSIs, should be drafted by respecting the principles of openness, consensus and transparency as defined in Annex II to Regulation (EU) No 1025/2012.

(11)  The quality of rail services in the Union depends, inter alia, on excellent compatibility between the characteristics of the network in the broadest sense, including the fixed parts of all the subsystems concerned and those of the vehicles including the onboard components of all the subsystems concerned. Performance levels, safety, quality of service and cost depend upon that compatibility.

(12)  A TSI sets all the conditions with which an interoperability constituent should 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 have the corresponding certificate.

(13)  When developing new TSIs the aim should always be to ensure compatibility with the existing system. 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, TSIs may establish the framework necessary to decide whether the existing subsystem needs a new decision or authorisation for placing in service, and the corresponding deadlines.

(14)  It is necessary for safety reasons to assign an identification code to each vehicle placed in service. The vehicle should then be entered in a national vehicle register. The registers should be open to consultation by all Member States and by certain economic players within the Union. The national vehicle registers should be consistent as regards the data format. They should therefore be covered by common operational and technical specifications.

(15)  If certain technical aspects corresponding to the essential requirements cannot be explicitly covered in a TSI, such aspects which need still to be addressed are identified in an annex to the TSI as open points. For these open points, pending the completion of the TSI, national rules apply.

(16)  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 case, the bodies responsible for the conformity assessment and verification procedures should be the notified bodies referred to in Article 17 of Directive 2008/57/EC.

(17)  Directive 2008/57/EC applies to the entire rail system within the Union and the scope of the TSIs is being extended to cover also the vehicles and networks not included in the trans-European rail system. Therefore, Annex I should be simplified by removing specific references to the trans-European rail system.

(18)  The functional and technical specifications to be met by the subsystems and their interfaces may vary according to the use of subsystems, for example according to the categories of lines and vehicles.

(19)  In order to ensure the progressive implementation of rail interoperability within the whole Union and 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 specify deadlines for achieving the target system.

(20)  In view of the gradual approach to eliminating obstacles to the interoperability of the 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.

(21)  In order to eliminate the obstacles to interoperability, and as a consequence of extending the scope of the TSIs to the whole Union's rail system, the amount of national rules should progressively be reduced. National rules should be differentiated between rules strictly related to local requirements and rules needed to cover open points in TSIs. The second type of rules should progressively be removed as a result of closure of open points in the TSIs.

(22)  The adoption of a gradual approach satisfies the special needs of the objective of the interoperability of the rail system, which is characterised by old national infrastructure and vehicles requiring heavy investment for adaptation or renewal, and particular care should be taken not to penalise rail economically vis-à-vis other modes of transport.

(23)  In view of the extent and complexity of the 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 these subsystems the essential requirements must be specified and the technical specifications determined, particularly in respect of constituents and interfaces, in order to meet these essential requirements. The same system is broken down into fixed and mobile elements comprising, on the one hand, the network, 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 this 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 European Union Agency for Railways ('the Agency') should retain an overview of the system, in order to guarantee safety and interoperability. [Am. 6]

(24)  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 to ensure to persons with disabilities access 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 important requirement for the interoperability of the rail system, in line with Union legislation on passengers with reduced mobility. [Am. 7]

(25)  Implementation of the provisions on the interoperability of the rail system should not create unjustified barriers in cost-benefit terms to the preservation of the existing rail network of each Member State, but should endeavour to retain the objective of interoperability.

(26)  TSIs also have an impact on the conditions of use of rail transport by users, and it is therefore necessary to consult these users on aspects concerning them, including organisations of persons with disabilities. [Am. 8]

(27)  Each Member State concerned should be allowed not to apply certain TSIs in a limited number of duly substantiated situations. These situations and the procedures to be followed in case of non-application of the TSI should be clearly defined.

(28)  The drawing up of TSIs and their application to the rail system should not impede technological innovation, which should be directed towards improving economic performance.

(29)  To comply with the appropriate provisions on procurement procedures in the rail sector and in particular Directive 2004/17/EC of the European Parliament and of the Council(6), the contracting entities should include technical specifications in the general documents or in the terms and conditions for each contract. To this end it is necessary to build up a set of rules in order to serve as references for these technical specifications.

(30)  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 the Union policy would be in the Union’s interest. The European standardisation organisations should therefore continue their cooperation with the international standardisation bodies.

(31)  The contracting entities are to define the further requirements needed to complete European specifications or other standards. These specifications should meet the essential requirements that have been harmonised at Union level and which the rail system must satisfy.

(32)  The procedures governing the assessment of conformity or of suitability of use of constituents should be based on the use of the modules covered by Commission Decision 2010/713/EU(7). 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.

(33)  Conformity of constituents is mainly linked to their area of use in order to guarantee the interoperability of the system and not only their free movement on 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 the provisions of this Directive. On the basis of the assessment of conformity and/or suitability for use, the manufacturer’s declaration of conformity should be sufficient.

(34)  Manufacturers are nonetheless obliged to affix the CE marking to certain components in order to certify their compliance with other Union provisions relating to them.

(35)  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 these constituents can be integrated into a subsystem, even if they do not strictly conform to that TSI.

(36)  The subsystems constituting the rail system should be subject to a verification procedure. This verification should enable the entities responsible for their placing in service to be certain that, at the design, construction and putting into service stages, the result is in line with the regulations and technical and operational provisions in force. It should also enable manufacturers to be able to count upon equality of treatment whatever the Member State.

(37)  After a subsystem is placed in service, care should be taken to ensure that it is operated and maintained in accordance with the essential requirements relating to it. Under Directive …/…/EU of the European Parliament and of the Council [Railway Safety Directive](8), responsibility for meeting these requirements lies, for their respective subsystems, with the infrastructure manager or the railway undertaking.

(38)  The procedure for placing in service of vehicles and fixed installations should be clarified taking into account the responsibilities of infrastructure managers and railway undertakings.

(39)  In order to facilitate the placing in service of vehicles and reduce administrative burdens, the notion of a vehicle authorisation for placing on the market valid throughout the Union should be introduced as a precondition to enable railway undertakings to place in service a vehicle. In addition, this notion is more in line with Decision No 768/2008/EC of the European Parliament and of the Council(9).

(39a)  In order to create the single European railway area, reduce the costs and duration of authorisation procedures and improve railway safety, authorisation procedures need to be streamlined and harmonised at Union level. This requires a clear distribution of tasks and responsibilities between the Agency and the national safety authorities during the transitional period.

The Agency should use the valuable expertise, local knowledge and experience of national safety authorities. It should delegate specific tasks and responsibilities to national safety authorities on the basis of contractual agreements as referred to in Article 22a but should take the final decision in all authorisation procedures. [Am. 9]

(40)  To ensure traceability of the vehicles and their history, the references of the vehicle authorisations for placing on the market should be recorded together with the other vehicle data. [Am. 10]

(41)  The TSIs should specify the procedures for checking the compatibility between vehicles and network after the delivery of the vehicle authorisation for placing on the market and before the decision to place into service start of a new operation. [Am. 11]

(42)  To help railway undertakings decide on the placing into service of a vehicle and to avoid redundant verifications and unnecessary administrative burden, national rules should also be classified to establish the equivalence between national rules of different Member States covering the same topics.

(43)  The notified bodies responsible for examining the procedures for conformity assessment and suitability for the 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.

(44)  Transparent accreditation as provided for in Regulation (EC) No 765/2008 of the European Parliament and of the Council(10), ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Union the preferred means of demonstrating the technical competence of notified and, mutatis mutandis, the bodies designated to check the compliance with national rules. However, national authorities may 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.

(45)  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 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 of those requirements.

(46)  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.

(46a)  Regulatory measures should be complemented by initiatives aimed at providing financial support to innovative and interoperable technologies in the rail sector, such as the 'Shift2Rail' project. [Am. 12]

(47)  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 acting alone, since no individual Member State is in a position to take the action needed in order to achieve such interoperability and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty 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.

(48)  In order to amend non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adaptation to technical progress of Annex II regarding the breakdown of the rail system into subsystems and to the description of these subsystems, the content of the TSIs and the amendments to TSIs, including those amendments needed to remedy TSIs deficiencies, the scope and the content of the 'EC' declaration of conformity and suitability for use of interoperability constituents, the verification procedures for subsystems, including the general principles, the content, procedure and documents related to the 'EC' verification procedure, and to the verification procedure in the case of national rules. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. [Am. 13]

(49)  In order to address the deficiencies discovered in TSIs, the Commission should adopt delegated acts amending those TSIs under the urgency procedure.

(50)  In order to ensure the implementation of Article 6(1) of this Directive concerning the mandate to the Agency to draft TSIs and their amendments and to make the relevant recommendations to the Commission, implementing powers should be conferred on the Commission.

(51)  In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission relating to: the content of the file which shall accompany the request of non-application of one or more TSIs or parts of them, the details, the format and the transmission modalities of that file; the scope and the content of the format and the details of the information included in the EC declaration of conformity and suitability for use of interoperability constituents, its format and the details of the information included in it; the classification of the notified national rules in different groups with the aim of facilitating the compatibility checks between fixed and mobile equipment; the verification procedures for subsystems, including the general principles, the content, procedure and documents related to the ‘EC’ verification procedure, and to the verification procedure in the case of national rules; the templates for the 'EC' declaration of verification and for the declaration of verification in the case of national rules and templates for documents of the technical file that has to accompany the declaration of verification; 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(11). [Am. 14]

(52)  In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

(53)  The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.

(54)  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 Annex IV, part B,

HAVE ADOPTED THIS DIRECTIVE:

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’s rail system in a manner compatible with the provisions of Directive …/…/EU [Railway Safety Directive]. These conditions concern the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of this system as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance. The pursuit of that objective necessarily entails the determination of an optimum level of technical harmonisation, making it possible to contribute to the progressive creation of the internal market in equipment and services for the construction, renewal, upgrading and operation of the rail system in the Union. [Am. 15]

2.  This Directive lays down the provisions relating to, for each subsystem, the interoperability constituents, the interfaces and procedures as well as the conditions of overall compatibility of the rail system required to achieve its interoperability.

3.  The following systems are excluded Member States may exclude from the scope of the measures implementing this Directive: [Am. 16]

(a)  metros, trams, tram-trains and light rail systems; [Am. 17]

(b)  networks that are functionally separate from the rest of the rail system and intended only for the operation of local, urban or suburban passenger services, as well as railway undertakings operating solely on these networks;

(ba)  privately owned railway infrastructure and vehicles exclusively used on such infrastructure where this exists solely for use by the owner for its own freight operations; [Am. 19]

(bb)  infrastructure and vehicles reserved for a strictly local, historical or touristic use. [Am. 20]

4.  Member States may exclude from the scope of the measures implementing this Directive: 

(a)  privately owned railway infrastructure and vehicles exclusively used on such infrastructure where this exists solely for use by the owner for its own freight operations;

(b)  infrastructure and vehicles reserved for a strictly local, historical or touristic use. [Am. 21]

Article 2

Definitions

For the purposes of this Directive:

(1)  ‘Union rail system’ means the elements of the conventional and high-speed rail systems listed in points 1 and 2 of Annex I; [Am. 22]

(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 for these lines. This ability depends on all regulatory, technical and operational conditions that need to be applied in order to meet essential requirements; [Am. 23]

(3)  ‘vehicle’ means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction, in a fixed or variable composition. A vehicle is composed of one or more structural and functional subsystems; [Am. 24]

(4)  ‘network’ means the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the rail system;

(5)  ‘subsystems’ means the structural or functional parts of the rail system, as set out in Annex II;

(5a)  ‘mobile subsystem’ means the rolling stock subsystem, the on-board control-command and signalling subsystem and the vehicle, when it is composed of one subsystem; [Am. 25]

(6)  ‘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;

(7)  ‘essential requirements’ means all the conditions set out in Annex III which must be met by the rail system, the subsystems, and the interoperability constituents, including interfaces;

(8)  ‘European specification’ means a common technical specification, a European technical approval as defined in Annex XXI to Directive 2004/17/EC or a European standard as defined in Article 2(1)(b) of Regulation (EU) No 1025/2012;

(9)  ‘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 rail system;

(9a)  ‘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 of its existence by a Member State. A conformity assessment body is classified as a 'designated body' following its designation by a Member State; [Am. 27]

(10)  ‘basic parameter’ means any regulatory, technical or operational condition which is critical to interoperability and is specified in the relevant TSIs;

(11)  ‘specific case’ means any part of the rail system which needs special provisions in the TSIs, either temporary or definitive, 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;

(12)  ‘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 this technical file exists, and which improves the overall performance of the subsystem. Where modification work is to be carried out in respect of a subsystem or vehicle, the relevant TSI shall specify whether or not the work in question is to be classified as major and, if it is, the reasons for such classification; [Am. 28]

(13)  ‘renewal’ means any major substitution work on a subsystem or part of it which does not change the overall performance of the subsystem. Where substitution work is to be carried out in respect of a subsystem or vehicle, the relevant TSI shall specify whether or not the work in question is to be classified as major and, if it is, the reasons for such classification; [Am. 29]

(14)  ‘existing rail system’ means the structure composed of lines and fixed installations of the existing rail system as well as the vehicles of all categories and origin travelling on that infrastructure;

(15)  ‘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;

(16)  ‘placing in service’ means all the operations by which a subsystem or a vehicle is put into its operational service;

(17)  ‘contracting entity’ means public or private entity which orders the design and/or construction or the renewal or upgrading of a subsystem. This entity may be a railway undertaking, an infrastructure manager or a keeper, an entity in charge of maintenance or a concession holder responsible for carrying out a project; [Am. 30]

(18)  ‘keeper’ means the person or entity that, being the owner of a vehicle or having the right to use it, the vehicle, exploits the vehicle it as a means of transport and is registered as such in the national vehicle register registers referred to in Article 43 Articles 43 and 43a; [Am. 31]

(18a)  ‘owner’ means the person or entity that is the owner of a vehicle and is registered as such in the vehicle registers referred to in Articles 43 and 43a; [Am. 32]

(19)  ‘project at an advanced stage of development’ means any project whose planning/construction stage has reached a point where a change in the technical specifications may compromise the viability of the project as planned;

(20)  ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;

(21)  ‘national safety authority’ means a safety authority as defined in Article 3 of Directive …/…/EU [Railway Safety Directive];

(22)  ‘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;

(23)  ‘series’ means a number of identical vehicles of a design type;

(24)  ‘entity in charge of maintenance’ means an entity in charge of maintenance as defined in Article 3 of Directive …/…/EU [Railway Safety Directive];

(25)  ‘light rail’ means an urban and/or sub-urban rail transport system with lower capacity and lower speeds than heavy rail and metro systems, but higher capacity and higher speeds than tram systems. 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;

(26)  ‘national rules’ means all binding rules notified by a Member State containing railway safety or technical requirements imposed at Member State level and applicable to railway undertakings actors, irrespective of the body issuing them; [Am. 33]

(27)  ‘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;

(27a)  ‘area of use’ means a network or networks in the Union, whether within a Member State or a group of Member States, on which a vehicle is technically compatible according to its technical file; [Am. 34]

(27b)  ‘isolated rail network’ means the rail network of a Member State, or a part thereof, with a track gauge of 1 520 mm, which is geographically or technically detached from the European network with standard nominal track gauge (1 435mm – hereafter 'standard gauge') and well integrated in the rail network of 1 520 mm track gauge together with third countries, but isolated from the Union's standard network; [Am. 35]

(28)  ‘acceptable means of compliance’ means non-binding opinions issued by the Agency to define ways of establishing compliance with the essential requirements, so as to offset temporarily shortcomings in a TSI until such time as that TSI has been amended; [Am. 36]

(28a)  ‘acceptable national means of compliance’ means other means of compliance laid down in a Member State which give rise to a presumption of compliance with the relevant section of the national rules. Those acceptable national means of compliance shall be notified to the Agency; [Am. 37]

(29)  ‘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;

(30)  ‘manufacturer’ means any natural or legal person who manufactures an interoperability constituent or subsystem or has it designed or manufactured, and markets it under his name or trademark;

(31)  ‘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 his or its behalf in relation to specified tasks; [Am. 38]

(32)  ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, subsystem, process or service; [Am. 39]

(33)  ‘accreditation’ has the meaning assigned to it by Regulation (EC) No 765/2008;

(34)  ‘national accreditation body’ has the meaning assigned to it by Regulation (EC) No 765/2008;

(35)  ‘conformity assessment’ means the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

(36)  ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(37)  ‘disabled 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 their full and effective use of transport on an equal basis with other passengers or whose mobility when using transport is reduced due to age and who thus requires special services; [Am. 40]

(38)  ‘infrastructure manager’ means infrastructure manager as defined in Article 3 of Directive …/…/EU of the European Parliament and of the Council(12) [establishing a single European railway area];

(39)  ‘railway undertaking’ means railway undertaking as defined in Article 3 of Directive …/…/EU [establishing a single European railway area], 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 must ensure traction; this also includes undertakings which provide traction only.

Article 3

Essential requirements

1.  The rail system, subsystems and interoperability constituents including interfaces shall meet the relevant essential requirements.

2.  The technical specifications referred to in Article 34 of Directive 2004/17/EC which are necessary to complete European specifications or other standards in use within the Union shall not conflict with the essential requirements.

2a.  No person shall 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 an area without internal borders, Member States shall ensure that the railway system is barrier-free. [Am. 41]

CHAPTER II

TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY

Article 4

Content of Technical Specifications for Interoperability

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.  The Commission shall be empowered to adopt delegated acts in accordance with Article 46 concerning adaptation to technical progress of Annex II regarding the breakdown of the rail system into subsystems and to the description of these subsystems.

3.  Fixed subsystems shall comply with the TSIs in force at the time of their placing in service, upgrading or renewal, in accordance with this Directive; this first appointment of a notified body and at the latest at the time of the granting of building permits. Vehicles shall be in conformity with the TSIs and shall comply with national rules in force at the time of the first appointment of a notified body. Such conformity and compliance shall be permanently maintained while each subsystem is in use. [Am. 42]

4.  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 need be, these specifications may vary according to the use of the subsystem;

(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 rail system. This shall include the identification of the rail spare parts to be standardised in accordance with Article 41 of Regulation (EU) No .../… of the European Parliament and of the Council(13). The list of spare parts to be standardised, including existing parts, shall be included in each TSI; [Am. 43]

(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 hand. These procedures shall be based on the modules defined in Decision 2010/713/EU;

(f)  indicate the strategy for the application of the TSIs. In particular, it is necessary to specify the stages to be completed in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSIs shall be the norm including setting deadlines for completion of those stages where necessary. The timetable fixing the stages shall be linked to an assessment analysing the estimated costs and benefits of its implementation and the expected repercussions on the operators and economic agents affected; [Am. 44]

(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 types of vehicles, in particular in the event of upgrading and renewal, with and without a new authorisation or decision for placing in service;

(i)  indicate the parameters 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 decision for placing in service to ensure the compatibility between vehicles and routes on which they are intended to be operated; [Am. 45]

(ia)  indicate the specific parameters to be verified and provide descriptions for the renewal, improvement or replacement of spare parts or interoperability constituents to be dealt with in conjunction with Article 21(3). [Am. 46]

5.  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 time-scale. Accordingly, the gradual adoption of the TSIs and compliance with them shall facilitate gradually within that time-scale to achieve the interoperability of the rail system.

6.  TSIs shall retain, in an appropriate manner, the compatibility of the existing rail system of each Member State. With this objective, provision may be made for specific cases for each TSI, 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 paragraph 4(c) to (g).

7.  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.

8.  TSIs shall not prevent the Member States from deciding on the use of infrastructures for the movement of vehicles not covered by the TSIs.

9.  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 objective of this Directive. In such 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.  The Commission shall issue a mandate to the Agency to draft TSIs and their amendments and to make the relevant recommendations to the Commission.

1a.  The drafting, adoption and review of each TSI, including the basic parameters, 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. [Am. 47]

2.  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. The most viable alternative solutions accompanied by technical and economic justification shall be put forward for each of these parameters and interfaces;

(b)  the Agency shall draw up the draft TSI on the basis of these basic parameters. 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.

An overall assessment of the estimated costs and benefits of the implementation of the TSIs shall be attached to the draft TSI. This assessment shall indicate the likely impact for all the operators and economic agents involved, and shall take due account of the requirements of Directive .../.../EU [Railway Safety Directive]. The Member States shall participate in that assessment by providing, where appropriate, the requisite data. [Am. 48]

3.  The Agency, in order to take account of developments in technology or social requirements, shall draft the TSIs and their amendments under the mandate referred to in paragraph 1, in accordance with Articles 4 and 15 of Regulation (EU) No …/… [Agency Regulation] and by respecting the principles of openness, consensus and transparency as defined in Annex II to Regulation (EU) No 1025/2012.

4.  During The committee referred to in Article 48 shall be kept regularly informed of the preparatory work on the TSIs. During that work, the Commission may, at the request of the committee, formulate any terms of reference or useful recommendations concerning the design of the TSIs and the cost-benefit analysis. In particular, the Commission may, at the request of a Member State, require that alternative solutions be examined and that the assessment of the cost and benefits of these alternative solutions be set out in the report annexed to the draft TSI. [Am. 49]

5.  Where different subsystems have to be placed in service simultaneously for reasons of technical compatibility, the dates of entry into force of the corresponding TSIs shall be the same.

6.  The drafting, adoption and review of the TSIs 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 this consultation.

7.  In accordance with Article 6 of Regulation (EU) No …/… [Agency Regulation], the Agency shall draw up and regularly update the list of users' associations and bodies to be consulted. This list shall necessarily include representative associations and bodies from all the Member States and may be re-examined and updated at the request of a Member State or upon the initiative of the Commission. [Am. 50]

8.  The drafting, adoption and review of the TSIs shall take account of the opinion of the representative social partners in all the Member States as regards the conditions referred to in Article 4(4)(g), and in any other TSI that directly or indirectly affects the staff involved. To this 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 in the context of the Sectoral Dialogue Committee set up in accordance with Commission Decision 98/500/EC(14). The social partners shall issue their opinion within three months. [Am. 51]

9.  When 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.

10.  The Commission shall be empowered to adopt delegated acts in accordance with Article 46 concerning the TSIs and their amendments.

Where, in the case of deficiencies discovered in TSIs in accordance with Article 6, imperative grounds of urgency so require, the procedure provided for in Article 47 shall apply to delegated acts adopted pursuant to this Article.

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(3).

2.  Pending the review of the TSI, the Commission may request an opinion from the Agency. The Commission shall analyse the Agency opinion and inform the Member States of its conclusions.

3.  At the request of the Commission, the Agency opinions referred to in paragraph 2 shall constitute acceptable means of compliance to meet the essential requirements and may therefore be used for the assessment of projects.

3a.  A member of the network of representative bodies can act as applicant to request opinions about deficiencies in TSIs via the Commission. The applicant shall be informed of the decision taken. The Commission shall duly provide a statement of reasons for any refusal. [Am. 52]

Article 7

Non-application of the TSIs

1.  Member States are allowed 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) at an advanced stage of development or the subject of a contract in the course of performance at the date of application of these TSIs;

(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 this case, the non-application of the TSIs shall be limited in time;

(c)  for any proposed renewal, extension or upgrading of an existing subsystem or part of it, when the application of these TSIs would seriously compromise the economic viability of the project. [Am. 53]

2.  In the case referred to in paragraph 1, point (a), each Member State 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 are at an advanced stage of development.

3.  In all cases referred to in paragraph 1, the Member State concerned shall submit to the Commission the request for non-application of the TSI, also specifying the alternative provisions that the Member State intends to apply instead of the TSIs. The Commission shall by means of implementing acts establish the content of the file which shall accompany the request of non-application of one or more TSIs or parts of them, the details, the format and the transmission modalities of that file. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). The Commission shall check that file, analyse the alternative provisions that the Member State intends to apply instead of the TSIs, decide whether to accept or not the request of non-application of the TSI and inform the Member State of this decision.

4.  Pending the decision of the Commission, the Member State may apply the alternative provisions as referred to in paragraph 3 without delay.

5.  The Commission shall give its decision within four months of the 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.

6.  All Member States shall be informed of the results of the analyses and of the outcome of the procedure set out in paragraph 3.

CHAPTER III

INTEROPERABILITY CONSTITUENTS

Article 8

Placing on the market of interoperability constituents

1.  Member States shall take all necessary steps to ensure that interoperability constituents:

(a)  are placed on the market only if they enable interoperability to be achieved within the rail system while at the same time meeting the essential requirements;

(b)  are used in their area of use as intended in accordance with the area of use as defined in point (27a) of Article 2 and are suitably installed and maintained. [Am. 54]

These provisions shall not obstruct the placing on the market of these constituents for other applications.

2.  Member States may 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 rail system where they comply with this Directive. In particular, they may not require checks which have already been carried out as part of the procedure of 'EC' declaration of conformity or suitability for use.

A Member State may not prohibit, restrict or hinder the placing in service of interoperability constituents that have been recognised for an area for which they are intended, if that area is situated within its territory. [Am. 55]

The Commission shall establish, by means of implementing acts, be empowered to adopt delegated acts in accordance with Article 46 concerning the scope and the content of the EC declaration of conformity and suitability for use of interoperability constituents, its format and the details of the information included in it. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). [Am. 56]

2a.  The Commission shall establish, by means of implementing acts, the format and the details of the information included in the EC declaration of conformity and suitability for use of interoperability constituents. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). [Am. 57]

Article 9

Conformity or suitability for use

1.  Member States and the Agency shall consider as being interoperable and meeting the essential requirements, those interoperability constituents which are covered by the 'EC' declaration of conformity or suitability for use.

2.  All interoperability constituents shall be subject to the procedure for assessing conformity and suitability for the use indicated in the relevant TSI and shall be accompanied by the corresponding certificate.

3.  Member States and the Agency shall consider that an interoperability constituent meets the essential requirements if it complies with the conditions laid down by the corresponding TSI or the corresponding European specifications developed to comply with these conditions.

4.  Spare parts for subsystems that are already placed in service when the corresponding TSI enters into force may be installed in these subsystems without being subject to the procedure referred to in paragraph 2.

5.  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 satisfy the requirements of 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 established in the Union 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 conformity assessment body with which the manufacturer or his authorised representative established in the Union has lodged the application.

3.  Where interoperability constituents are the subject of other Union directives covering other aspects, the 'EC' declaration of conformity or suitability for use shall, in such cases, state that the interoperability constituents also meet the requirements of those other directives.

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. 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, for the purposes of this Directive.

5.  In order to avoid that interoperability constituents non complying with essential requirements are being placed on the market, and without prejudice to the provisions of Article 11:

(a)  in each instance where the Member State finds that the 'EC' declaration of conformity has been drawn up improperly, the manufacturer or his authorised representative established in the Union shall be required, if necessary, to restore the interoperability constituent to a state of conformity and to terminate the infringement under the conditions laid down by that Member State;

(b)  where non-conformity persists, the Member State shall take all appropriate steps to restrict or prohibit the placing on the market of the interoperability constituent in question, or to ensure that it is withdrawn from the market in accordance with the procedures provided for in Article 11.

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 unlikely, when used as intended, to meet the essential requirements, it 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 and the other Member States of the measures taken and give the reasons for its decision, stating in particular whether failure to conform is due to:

(a)  failure to meet the essential requirements;

(b)  incorrect application of European specifications where application of such specifications is relied upon;

(c)  inadequacy of European specifications.

2.  The Commission shall consult the parties concerned as quickly as possible. Where, following that consultation, the Commission establishes that the measure is justified it shall forthwith inform the Member State that has taken the initiative thereof. Where, after 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. Following that consultation, the Commission establishes that Agency shall establish whether the measure is unjustified it justified. The Agency shall forthwith inform the Commission, the Member State that has taken the initiative in that regard and the manufacturer or his authorised representative established within the Union thereof. [Am. 58]

3.  Where an interoperability constituent bearing the 'EC' declaration of conformity fails to comply, the competent Member State shall take appropriate measures against any person who has drawn up the declaration and shall inform the Commission and the other Member States thereof.

4.  The Commission shall ensure that the Member States are kept informed of the course and results of that procedure. [Am. 59]

CHAPTER IV

SUBSYSTEMS

Article 12

Free movement of subsystems

Without prejudice to the provisions of Chapter V, Member States may 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 may not require checks which have already been carried out:

(a)  either as part of the procedure leading to the 'EC' declaration of verification,

(b)  or 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.

Article 13

Conformity with TSIs and national rules

1.  Member States and the Agency shall consider as being interoperable, and 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 by the declaration of verification established by reference to notified national rules in accordance with Article 15a, or both. [Am. 60]

2.  Verification of the interoperability, in accordance with the essential requirements, of a structural subsystem constituting the rail system shall be established by reference to TSIs, and national rules notified in accordance with paragraph 3. [Am. 61]

2a.  Decisions on granting authorisation shall be based on TSIs and on notified national rules applicable when the application was made. [Am. 62]

3.  Member States shall draw up, for each subsystem, a list of the national rules in use for implementing the essential requirements and/or acceptable national means of compliance in the following cases: [Am. 63]

(a)  when the TSIs do not fully cover certain aspects corresponding to the essential requirements (open points);

(b)  when a non-application of one or more TSIs or parts of them has been notified under Article 7;

(c)  when specific case requires the application of technical rules not included in the relevant TSI;

(d)  in case of national rules used to describe existing systems;

(da)  in the case of networks and vehicles not covered by TSIs; [Am. 64]

(db)  for safety reasons specific to one or more Member States, provided that they have been substantiated and without prejudice to the prerogatives of the Agency. [Am. 65]

4.  Member States shall designate the bodies responsible for establishing, in the case of these technical regulations, the EC declaration of verification referred to in Article 15.

Article 14

National rules

1.  Member States shall notify to the Commission and to the Agency the list of national rules in use, as referred to in Article 13(3) either, in the following cases: [Am. 66]

(a)  each time the list of rules is changed, or [Am. 67]

(b)  after when a request for non-application of the TSI has been submitted in accordance with Article 7, or [Am. 68]

(c)  after publication of the TSI concerned or its revision, in view of the removal of national rules made redundant by the closure of open points in the TSIs,

(ca)  where the national rule(s) has/have not yet been notified by the date of entry into force of this Directive. [Am. 69]

1a.  Within one month after the entry into force of this Directive, Member States shall notify to the Commission any existing national rule which has not been notified by that date. [Am. 70]

2.  Member States shall notify the full text of existing national rules to the Agency and the Commission through the appropriate IT system in accordance with Article 23 of Regulation (EU) No …/… [Agency Regulation]. [Am. 71]

3.  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.

4.  If a Member State intends to introduce a new national rule, it shall notify submit the draft to the Agency and the Commission for consideration at least three months before the scheduled entry into force of the proposed new rule, giving the reason for its introduction, in accordance with Article 21 of Regulation (EU) No .../... [Agency Regulation], through the appropriate IT system in accordance with Article 23 of that Regulation. [Am. 72]

4a.  When notifying an existing or new national rule, Member States shall provide proof of the need for that rule in order to fulfil an essential requirement not already covered by the relevant TSI. Member States shall not be permitted to notify any national rule without substantiating that need.

The Agency shall have two months in which to consider the draft rule and to make a recommendation to the Commission. The Commission shall approve or reject the draft rule. Only in the case of emergency preventive measures, Member States may adopt and apply a new rule immediately and that rule shall be valid for two months. If such a rule affects several Member States, the Commission, working in cooperation with the Agency and the national safety authorities, shall harmonise the rule at Union level. [Am. 73]

5.  Member States shall ensure that national rules, including those covering the interfaces between vehicles and network, are made available free of charge and in a language that can be understood by all parties concerned.

6.  Member States may decide not to notify rules and restrictions of a strictly local nature. In such cases, Member States shall mention these rules and restrictions in the infrastructure registers referred to in Article 45.

7.  National rules notified under this Article are not subject to the notification procedure set out in Directive 98/34/EC of the European Parliament and of the Council(15).

8.  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 compatibility checks between fixed and mobile equipment. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). The Agency shall classify, in accordance with those implementing acts, the national rules notified pursuant to this Article, and shall publish the corresponding register. That register shall also list any acceptable national means of compliance. [Am. 74]

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.

9.  Draft national rules and national rules in force shall be examined by the Agency in accordance with the procedures laid down in Articles 21 and 22 of Regulation (EU) No …/… [Agency Regulation].

Article 15

Procedure for establishing the 'EC' declaration of verification

1.  In order to establish the 'EC' declaration of verification, the applicant shall ask the notified conformity assessment body that it has selected for that purpose to apply the 'EC' verification procedure. The applicant may be the contracting entity or the manufacturer, or their authorised representative within the Union.

2.  The task of the notified conformity assessment 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 in service. It may shall also cover verification of the interfaces of the subsystem in question with the system into which it is incorporated, based on the information available in the relevant TSI and in the registers provided for in Articles 44 and 45. [Am. 75]

3.  The notified conformity assessment body shall be responsible for compiling the technical file that has to accompany the 'EC' declaration of verification. This 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.

4.  Any amendment of the technical file referred to in paragraph 3 that has an impact on the verifications carried out implies upgrading shall entail the need to establish a new 'EC' declaration of verification. [Am. 76]

5.  The notified conformity assessment body may issue intermediate statement verifications to cover certain stages of the verification procedure or certain parts of the subsystem. In such a case, the verification procedures established in accordance with paragraph 7(a) shall apply.

6.  If the relevant TSIs allow, the notified conformity assessment body may issue certificates of conformity for a series of subsystems or certain parts of those subsystems.

7.  The Commission shall establish, by means of implementing acts:

(a)  the verification procedures for subsystems, including the general principles, the content, procedure and documents related to the 'EC' verification procedure, and to the verification procedure in the case of national rules.

(b)  the templates for the 'EC' declaration of verification and for the declaration of verification in the case of national rules and templates for documents of the technical file that has to accompany the declaration of verification.

Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 48(3). [Am. 78]

7a.  The Commission shall be empowered to adopt delegated acts in accordance with Article 46 in order to establish the verification procedures for subsystems, including the general principles, the content, procedure and documents related to the 'EC' verification procedure, and the verification procedure in the case of national rules. [Am. 79]

7b.  The Commission shall establish, by means of implementing acts, the templates for the 'EC' declaration of verification and for the declaration of verification in the case of national rules and templates for documents to be contained in the technical file that has to accompany the declaration of verification.

Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 48(3). [Am. 80]

Article 15a

Procedure for establishing the declaration of verification in the case of national rules

The procedures for establishing the 'EC' declaration of verification referred to in Article 15 shall also apply, where appropriate, for the establishment of the declaration of verification in respect of national rules.

Member States shall designate the bodies responsible for carrying out the verification procedure in respect of national rules in accordance with Chapter VI. [Am. 77]

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.

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 that 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 that 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 set out in Annex III.

CHAPTER V

PLACING ON THE MARKET AND PLACING IN SERVICE

Article 18

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 as set out in Annex III, and the relevant authorisation is received in accordance with paragraph 2.

2.  Each national safety authority shall authorise the placing in service of the energy and infrastructure subsystems and the trackside control-command and signalling which are is not ERTMS located or operated in the territory of its Member State. National safety authorities shall take into account the opinion of the Agency when TEN-T corridors or cross borders sections are involved.

The Agency shall authorise cross-border infrastructures with one single infrastructure manager. [Am. 81]

The Agency shall grant decisions authorising the placing in service of the trackside control-command and signalling subsystems located or operated throughout authorise the ERTMS in close cooperation with the national safety authorities. Before the Agency authorises the ERTMS, the national safety authority shall be competent for verifying the operational compatibility with the national networks. The Agency shall ensure the uniform application of the ERTMS in the Union. [Am. 82]

In the case of the ERTMS, the Agency shall consult the national safety authority concerned within one month of receipt of the complete application in order to ensure a coherent development of the ERTMS within the Union. The national safety authority shall issue an opinion to the Agency regarding the technical and operational compatibility of the subsystem with the vehicles intended to operate on the relevant part of the network within two months. The Agency shall, to the extent possible, take that opinion into account before issuing the authorisation and, in the event of disagreement, shall inform the national safety authority, stating the reasons therefor. This Article is without prejudice to the Agency's obligations as a system authority under Chapter 6 of Regulation (EU) No .../... [Agency Regulation].

When the Agency disagrees with a negative assessment carried out by a national safety authority, it shall inform the authority in question to that effect, giving reasons for the disagreement. The Agency and the national safety authority shall cooperate with a view to reaching a mutually acceptable assessment. Where necessary, as decided by the Agency and the national safety authority, this process shall also involve the applicant. If no mutually acceptable assessment can be found within one month after the Agency has informed the national safety authority of its disagreement, the Agency shall take its final decision unless the national safety authority has referred the matter for arbitration to the Board of Appeal established under Article 51 of Regulation (EU) No .../... [Agency Regulation]. 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.

Any decision refusing the request for an authorisation for placing in service of fixed installations shall be duly substantiated by the Agency. The applicant may, within one month of receipt of the negative decision, submit a request that the Agency review its decision. That request shall be accompanied by a statement of grounds. The Agency 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 established under Article 51 of Regulation (EU) No .../... [Agency Regulation]. [Am. 83]

The Agency and the national safety authorities shall provide detailed guidance on how to obtain the authorisations referred to in the first and second subparagraph. An application guidance document describing and explaining the requirements for those authorisations and listing the required documents shall be made available to applicants free of charge. The Agency and the national safety authorities shall cooperate in disseminating such information.

3.  In order to authorise the placing in service of the subsystems referred to in paragraph 1, the national safety authority or the Agency, depending on which is the competent authority as set out in paragraph 2, shall obtain proof of:

(a)  the EC declaration of verification;

(b)  the technical compatibility of these 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 these subsystems, established on the basis of the relevant TSIs, national rules, registers, and the common safety methods set out in Article 6 of Directive…/…/EU [Railway Safety Directive];

(ca)  the declaration of verification in the case of national rules. [Am. 84]

Within one month of receipt of the request of the applicant, the Agency or the national safety authority, depending on which is the competent authority, shall inform the applicant that the file is complete or ask for relevant supplementary information, setting a reasonable deadline for the provision of that information. [Am. 85]

4.  In the event of renewal or upgrading of existing subsystems, the applicant shall send a file describing the project to the national safety authority (for energy and infrastructure subsystems and for trackside control-command and signalling subsystems which are not ERTMS) or the Agency (for trackside control-command and signalling subsystems ERTMS and for cross-border infrastructures with one single infrastructure manager), a file describing the project. The national safety authority or the Agency shall examine this file and shall decide, on the basis of the criteria set out in paragraph 5, whether a new authorisation for placing in service is needed. The national safety authority and the Agency shall take their decisions within a pre-determined, reasonable time, and, in any case, within four three months from receipt of all relevant information. [Am. 86]

5.  In the event of renewal or upgrading of existing subsystems, a new 'EC' declaration of verification shall be needed as set out in Article 15(4). In addition, a new authorisation for placing in service shall be required when:

(a)  the overall safety level of the subsystem concerned may be adversely affected by the works envisaged; or

(b)  it is required by the relevant TSIs; or

(c)  it is required by the national implementation plans established by the Member States.

Article 19

Placing on the market of mobile subsystems

1.  The rolling stock subsystem and the on-board control-command and signalling subsystem 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 as set out in Annex III. [Am. 87]

2.  In particular, the applicant shall ensure that the EC declaration of verification has been provided.

3.  In the event of renewal or upgrading of existing subsystems, a new 'EC' declaration of verification shall be needed as set out in Article 15(4).

Article 20

Vehicle authorisation for placing on the market

1.  A vehicle shall be placed on the market only after having received the a vehicle authorisation for placing on the market issued by the Agency in accordance with paragraph 5 this Article. [Am. 88]

The vehicle authorisation shall state:

(a)  the area of use;

(b)  the values of the parameters set out in the TSIs and, where applicable, in the national rules, as relevant 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, in relation to the parameters referred to in point (b);

(d)  the conditions for the use of the vehicle and any other restrictions. [Am. 89]

2.  The Agency shall issue decisions granting vehicle authorisations for placing on the market. Those authorisations attest the values of the parameters relevant for checking the technical compatibility between the vehicle and the fixed installations as set out in the TSIs. The vehicle authorisation for placing on the market shall also provide information about the vehicle’s compliance with the relevant TSIs and sets of national rules, related to these parameters. The vehicle authorisation shall be issued on the basis of a file in respect of the vehicle or type of vehicle produced by the applicant and including documentary evidence of the following:

–  in relation to the mobile subsystems composing the vehicle:

(a)  the appropriate declaration of verification in accordance with Article 19;

(b)  the technical compatibility within the vehicle;

(c)  the safe integration within the vehicle;

–  in relation to the vehicle:

the technical compatibility of the vehicle with the networks in the area of use. [Am. 90]

The technical compatibility shall be established on the basis of the relevant TSIs and, where applicable, national rules and registers. Whenever tests are necessary in order to obtain documentary evidence of the technical compatibility, 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 one month of receipt of the applicant's request. Where appropriate, the national safety authority shall take measures to ensure that tests take place.

The safe integration of the subsystems within the vehicle shall be established on the basis of the relevant TSIs, the common safety methods set out in Article 6 of Directive .../.../EU [Railway Safety Directive] and, where applicable, national rules. [Am. 91]

3.  The Agency shall grant a vehicle authorisation for placing on the market may stipulate conditions for the use of the vehicle and other restrictions after having assessed the elements of the file referred to in paragraph 2 within a pre-determined, reasonable time, and, in any case, within four months from receipt of all relevant information from the applicant. Within one month, the Agency shall indicate to the applicant whether or not the file is complete. Any negative decision made in relation to an application shall be duly substantiated.

Authorisations shall be recognised in all Member States.

The Agency shall assume full responsibility for the authorisations it issues. [Am. 92]

3a.  During the transitional period referred to in Article 50a, the applicant may choose to submit its application for vehicle authorisation to the Agency or to the relevant national safety authority. [Am. 94]

4.  The vehicle authorisation for placing on the market shall be issued on the basis of a file of the vehicle or type of vehicle produced by the applicant and including the documentary evidence of:

(a)  the placing on the market of the mobile subsystems composing the vehicle according to Article 19;

(b)  the technical compatibility of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, national rules and registers;

(c)  the safe integration of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, national rules, and the common safety methods set out in Article 6 of Directive …/… [on the safety of the rail system within the Union]. [Am. 93]

5.  The Agency Any decision refusing the authorisation of a vehicle shall take the decisions referred to in paragraph 2 within a pre-determined, reasonable time, and, in any case, within four 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 all relevant information. These authorisations shall be valid in all Member States. the request for review in which to confirm or reverse its decision. [Am. 95]

If a negative decision is confirmed by the Agency, the applicant may bring an appeal before the Board of Appeal designated under Article 51 of Regulation (EU) No .../... [Agency Regulation]. [Am. 96]

If the negative decision of a national safety authority is confirmed, the applicant may bring an appeal before the appeal body designated by the competent Member State under Article 17(3) of Directive .../... [Railway Safety Directive]. Member States may designate the regulatory body set out in Article 56 of Directive 2012/34/EU of the European Parliament and of the Council(16) for the purposes of that appeal procedure. [Am. 97]

The Agency shall provide detailed guidance on how to obtain the vehicle authorisation for placing on the market. An application guidance document describing and explaining the requirements for the vehicle authorisation for placing on the market and listing the required documents shall be made available to applicants free of charge. The national safety authorities shall cooperate with the Agency in disseminating such information.

6.  The Agency may issue amend or revoke a vehicle authorisation for placing on the market for a series of vehicles. Those authorisations shall be valid in all Member States if it no longer satisfies the conditions according to which it was issued, giving reasons for its decision in that regard. The Agency shall immediately update the European vehicle register defined in Article 43a.

If a national safety authority finds that an authorised vehicle does not comply with essential requirements, it shall immediately inform the Agency and all other relevant national safety authorities. The Agency shall decide on the necessary measures within one month. In cases necessitating urgent preventive measures, the Agency may immediately restrict or suspend the authorisation before taking its decision. [Am. 98]

7.  The applicant may bring an appeal before the Board of Appeal designated under Article 51 of Regulation (EU) No …/… [establishing a European railway agency] against decisions of the Agency or its failure to act within the time limits referred to in paragraph 5. The Commission shall be empowered to adopt, not later than six months after the adoption of this Directive, delegated acts in accordance with Article 46, concerning detailed rules on the authorisation procedure, including:

(a)   detailed guidance describing and explaining the requirements for the vehicle authorisation and the documents required;

(b)  procedural arrangements for the authorisation process, such as content and timeframes for each stage of the process;

(c)  criteria for assessment of the applicants' files. [Am. 99]

8.  In the event of renewal or upgrading of existing vehicles which already have a vehicle authorisation for placing on the market:

(a)  a new 'EC' declaration of verification shall be needed as set out in Article 15(4), and

(b)  a new vehicle authorisation for placing on the market shall be required if any major changes are made to the values of the parameters included in the vehicle authorisation already granted. [Am. 100]

9.  At the request of the applicant, the vehicle authorisation for placing on the market may include a clear indication of the networks or lines or groups of networks or lines where the railway undertaking may place such a vehicle in service without further verifications, checks or tests concerning the technical compatibility between the vehicle and these networks or lines. In that case, the applicant shall include in its request the proof of the technical compatibility of the vehicle with the networks or lines concerned.

This indication may be also added, at the request of the original or another applicant, after the relevant authorisation for placing on the market has been issued. [Am. 101]

9a.  Authorisation for vehicles operated or intended to be operated on railway infrastructure of isolated rail networks may also be granted by national safety authorities of the Member States in which the network in question is located. In such cases, the applicant may choose between applying to the Agency or to the national safety authorities of those Member States.

Within the transitional period referred to in Article 50a, the national safety authorities of the Member States in which an isolated rail network is located shall establish common vehicle authorisation procedures and ensure mutual recognition of vehicle authorisations issued by them. In the case of conflicting decisions of the national safety authorities and in the absence of any mutually acceptable decision, the Agency shall take a decision in accordance with Article 16 of Regulation (EU) No .../... [Agency Regulation] accordingly.

If by the end of the transitional period referred to in Article 50a, those national safety authorities have not established arrangements for common authorisation procedures and mutual recognition of vehicle authorisations, the authorisations referred to in this Article shall be granted only by the Agency.

If the arrangements for common authorisation procedures and mutual recognition of vehicle authorisations are established, the national safety authorities of the Member States having isolated rail networks may continue to issue vehicle authorisations and the applicant may choose to apply for vehicle authorisation to the Agency or to the relevant national safety authorities after the end of the transitional period referred in Article 50a.

Ten years after the entry into force of this Directive, the Commission shall present to the European Parliament and the Council a report on the progress achieved towards interoperability on the isolated rail network and shall, if necessary, submit the appropriate legislative proposal. [Am. 102]

Article 20a

Registration of authorised vehicles

Before a vehicle is used for the first time, after authorisation in respect of it has been granted in accordance with Article 20, it shall be registered at the request of the keeper.

When the authorisation has been granted by the Agency, the vehicle shall be registered in the European Register in accordance with Article 43a.

When the area of use of the vehicle is restricted to the territory of one Member State and the authorisation has been granted by a national safety authority, it shall be registered in the national vehicle register of that Member State in accordance with Article 43. [Am. 103]

Article 21

Placing in service Use of vehicles [Am. 104]

1.  Railway undertakings shall place in service Before a railway undertaking uses a vehicle only after having checked, , in consultation with the infrastructure manager, the technical compatibility between the vehicle and the route and the safe integration of the vehicle into the system in which it is intended to operate, established on the basis of the relevant TSIs, national rules, registers, and the common in the area of use specified in the vehicle authorisation, it shall ensure, using its safety methods set out in Article 6 of Directive. management system: [Am. 105]

To this aim, vehicles shall first receive

(a)  that the vehicle authorisation for placing on the market has been authorised in accordance with Article 20 and is duly registered; [Am. 106]

(aa)  the technical compatibility between the vehicle and the route on the basis of the infrastructure register, the relevant TSIs and any other information to be provided by the infrastructure manager free of charge and within a reasonable period of time, where the infrastructure register does not exist or is incomplete; and [Am. 107]

(ab)  the integration of the vehicle into the composition of the train in which it is intended to operate, on the basis of safety management systems as set out in Article 9 of the Safety directive and the TSI on operation and management. [Am. 108]

1a.   In order to help the railway undertakings to check the technical compatibility and safe integration as between the vehicle and the route(s), the infrastructure manager shall, upon request, provide the railway undertakings with additional information relating to the characteristics of the route(s). [Am. 109]

2.  The railway undertaking shall communicate its decisions with respect to the placing in service operation of vehicles to the Agency, the infrastructure manager and the national safety authority concerned. These decisions shall be recorded in the national vehicle registers register referred to in Article 43 and in the European Register referred to in Article 43a. [Am. 110]

3.  In the event of renewal or upgrading of existing vehicles, a new 'EC' declaration of verification shall be needed as set out in Article 15(4). In addition, a new decision taken by the railway undertaking for placing in service of these vehicles shall be required when:

(a)  the overall safety level of the subsystem concerned may be adversely affected by the works envisaged, or

(b)  it is required by the relevant TSIs. [Am. 111]

Article 22

Authorisation to place vehicle types on the market Vehicle type authorisation [Am. 112]

1.  The Agency shall grant authorisations to place, or the national safety authorities during the transitional period referred to in Article 50a, shall grant vehicle types on the market type authorisations. [Am. 113]

The Agency and the national safety authorities shall provide detailed guidance on how to obtain the authorisation to place vehicle types on the market type authorisation. An application guidance document describing and explaining the requirements for the authorisation to place vehicle types on the market and listing the required documents shall be made available to applicants free of charge. The national safety authorities shall cooperate with the Agency in disseminating such information. [Am. 114]

2.  However, if a vehicle authorisation is issued by the Agency issues a or by the national safety authorities, the vehicle type authorisation for placing on the market, it shall shall be issued at the same time issue the authorisation to place the corresponding vehicle type on the market. [Am. 115]

3.  A vehicle which is in conformity with a vehicle type for which an authorisation to place the corresponding vehicle type on the market has been already issued shall, without further checks, receive a vehicle authorisation for placing on the market on the basis of a declaration of conformity to this type submitted by the applicant. [Am. 116]

4.  In the event of changes to any relevant provisions in TSIs or national rules, on the basis of which an a vehicle type authorisation to place a vehicle type on the market has been issued, the TSI or national rule shall determine whether the vehicle type authorisation to place that vehicle type on the market already granted remains valid or needs to be renewed. If that authorisation needs to be renewed, the checks performed by the Agency may only concern the changed rules. The renewal of the vehicle type authorisation to place a vehicle type on the market does not affect the vehicle authorisations for placing on the market already issued on the basis of the previous vehicle type authorisation to place that vehicle type on the market. [Am. 117]

5.  The declaration of conformity to type shall be established in accordance with Decision 2010/713/EU.

6.  The declaration of conformity to type shall be established in accordance with:

(a)  for TSI-conform vehicles, the verification procedures of the relevant TSIs;

(b)  for non-TSI-conform vehicles, the conformity assessment procedures as defined in modules B+D and B+F of Decision 768/2008/EC. 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 48(3).

7.  The authorisation to place vehicle types on the market shall be registered in the European register of authorisations to place a vehicle types on the market referred to in Article 44.

Article 22a

Cooperation between the Agency and the national safety authorities

For the purposes of Articles 18, 20 and 22, the Agency may conclude cooperation agreements with national safety authorities in accordance with Article 69 of Regulation (EU) No .../... [Agency Regulation].

Such 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 and shall specify the time-limits applying to their delivery, as well as details of the apportionment of the fees paid by the applicant.

They may also include specific cooperation arrangements in the case of networks requiring specific expertise due to geographical, advanced ERTMS deployment or a different gauge, or for historical reasons, with a view to reducing the administrative burden and the costs to be borne by the applicant. Such agreements shall be in place before the Agency is entitled to receive applications in accordance with this Directive, and in any case by six months following the date of entry into force of this Directive.

The Commission shall be empowered to adopt delegated acts in accordance with Article 46 concerning such cooperation agreements. Those delegated acts shall be adopted at the latest six months following the date of entry into force of this Directive.

Five years after the conclusion of the first cooperation agreement, and every three years thereafter, the Commission shall present to the European Parliament and to the Council a report assessing the cooperation agreements concluded by the Agency. [Am. 118]

CHAPTER VI

NOTIFICATION OF CONFORMITY ASSESMENT BODIES

Article 23

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.

Article 24

Notifying authorities

1.  Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified conformity assessment bodies, including compliance with the provisions of Articles 27 to 29.

2.  Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3.  Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply with the requirements laid down in Article 25. It shall put in place arrangements to cover liabilities arising out of its activities.

4.  The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 25

Requirements relating to notifying authorities

1.  A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2.  A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3.  A notifying authority shall 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.

4.  A notifying authority shall not offer or provide any activities that are performed by conformity assessment bodies or consultancy services on a commercial or competitive basis.

5.  A notifying authority shall safeguard the confidentiality of the information it obtains.

6.  A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 26

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 27

Requirements relating to conformity assessment bodies

1.  For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 7 and in Articles 28 and 29. These requirements are also applicable to bodies designated by Member States pursuant to Article 13(4).

2.  A conformity assessment body shall be established under national law and 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.

At all times and for each conformity assessment procedure and each kind or category of products 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 carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between 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 the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner 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 the Member State itself is directly responsible for the conformity assessment.

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's legislation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

7.  Conformity assessment bodies shall participate in, or shall ensure that their assessment personnel are informed of, the activities of the ERTMS ad hoc working group set out in Article 25 of Regulation (EU) No …/… [Agency Regulation]. They shall follow the guidelines produced as a result of the work of that group. In case they consider it inappropriate or impossible to apply them, the conformity assessment bodies concerned shall submit their observations for discussion to the ERTMS ad hoc working group for the continuous improvement of the guidelines.

Article 28

Impartiality of conformity assessment bodies

1.  A conformity assessment body shall be a third-party body independent from the organisation or from 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 such a body.

2.  The impartiality of the conformity assessment bodies, 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, nor 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.

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, the 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 shall in particular apply 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.

Article 29

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, as well as training concerning accessibility issues; [Am. 119]

(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's legislation and of its implementing regulations;

(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.

Article 30

Presumption of conformity of a conformity assesment 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 27 to 29, in so far as the applicable harmonised standards cover those requirements.

Article 31

Subsidiaries of and subcontracting by conformity asssessment bodies

1.  Where a notified conformity assessment 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 27 to 29 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.

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 32

Accredited in-house bodies

1.  The applicant undertaking 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 defined in Annex II to Decision 768/2008/EC and modules CA1 and CA2 defined in Annex I to Decision 2010/713/EC. That body shall constitute a separate and distinct part of the applicant undertaking 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 be organisationally identifiable and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;

(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 judgment 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 33

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 27 to 29.

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 27 to 29.

Article 34

Notification procedure

1.  Notifying authorities may notify only conformity assessment bodies which comply with the requirements laid down in Articles 27 to 29.

2.  They shall notify 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 product or products concerned and the relevant attestation of competence.

4.  Where a notification is not based on an accreditation certificate as referred to in Article 33(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 regularly and will continue to satisfy the requirements laid down in Articles 27 to 29.

5.  The body concerned may perform the activities of a notified conformity assessment 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 35

Identification numbers and lists of notified conformity assessment bodies

1.  The Commission shall assign an identification number to a notified conformity assessment body.

A notified conformity assessment body shall be assigned a single identification number even where it is notified under several Union acts.

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.

Article 36

Changes to notifications

1.  Where a notifying authority has ascertained or has been informed that a notified conformity assessment body no longer meets the requirements laid down in Articles 27 to 29, 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 conformity assessment 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 conformity assessment body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 37

Challenge of the competence of notified bodies

1.  The Commission shall investigate all cases where it doubts, or doubt is brought to its attention, regarding the competence of a notified conformity assessment body or the continued fulfilment by a notified conformity assessment body of the requirements and responsibilities to which it is subject.

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 conformity assessment 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 38

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. Conformity assessment bodies shall perform their activities taking 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.

In so doing they shall nevertheless operate with the aim of assessing the compliance of the product with the provisions of this Directive.

3.  Where a notified conformity assessment 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 conformity assessment 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 conformity assessment body shall restrict, suspend or withdraw any certificates, as appropriate.

Article 39

Information obligation on notified bodies

1.  Notified bodies shall inform the notifying authority of the following:

(a)  any refusal, restriction, suspension or withdrawal of a certificate;

(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.

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 to the Agency the EC certificates of verification of subsystems, the EC certificates of conformity of interoperability constituents and the EC certificates of suitability of use of interoperability constituents.

Article 40

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States’ national authorities responsible for notification policy.

Article 41

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies. The Agency shall support the activities of notified bodies in accordance with Article 20 of Regulation (EU) No …/… [Agency Regulation].

Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

CHAPTER VII

REGISTERS

Article 42

Vehicle numbering system

1.  Any vehicle placed in service in the Union's rail system shall carry a European vehicle number (EVN) assigned by the national safety authority competent for the relevant territory before the first placing in service Agency at the time of issuing the vehicle authorisation. [Am. 120]

2.  The railway undertaking operating a vehicle shall ensure the vehicle is marked with the assigned EVN and shall be responsible for ensuring that the vehicle is properly registered. [Am. 121]

3.  The EVN is specified in Commission Decision 2007/756/EC(17).

4.  A vehicle shall be assigned an EVN only once, unless otherwise specified in Decision 2007/756/EC.

5.  Notwithstanding paragraph 1, in the case of vehicles operated or intended 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 according to a different coding system.

Article 43

National vehicle registers

1.  Each Member State shall keep a register of the vehicles placed in service in its territory. This register shall meet the following criteria:

(a)  it shall comply with the common specifications referred to in paragraph 2;

(b)  it shall be kept updated by a body independent of any railway undertaking;

(c)  it shall be accessible to the national safety authorities and investigating bodies designated in Articles 16 and 21 of Directive […/… on the safety of the rail system within the Union]; it shall also be made accessible, in response to any legitimate request, to the regulatory bodies designated in Articles 55 and 56 of Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area(18) 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 public. [Am. 122]

2.  The Commission shall adopt common specifications on content, data format, functional and technical architecture, operating mode, including arrangements for the exchange of data, and rules for data input and consultation for the national vehicle registers by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

2a.  For each vehicle, the register shall contain at least the following information:

(a)  the EVN;

(b)  references to the declaration of verification and the issuing body;

(c)  identification of the keeper and the owner of the vehicle;

(d)  restrictions on how the vehicle may be used;

(e)  the entity in charge of maintenance. [Am. 123]

3.  The registration holder shall immediately declare any modification to the data entered in the national vehicle register, the destruction of a vehicle or its decision to no longer register a vehicle, to the national safety authority of any Member State where the vehicle has been placed in service used. [Am. 124]

4.  As long as Member States’ national vehicle registers are not linked, Each Member State shall update its register with the modifications made by another Member State in its own register, as regards the data with which it is concerned. [Am. 125]

5.  In the case of vehicles placed in service for the first time in a third country and subsequently placed in service used in a Member State, that Member State shall ensure that the vehicle data can be retrieved through the national vehicle register or through provisions of an international agreement. [Am. 126]

5a.  The national vehicle registers shall be incorporated in the European vehicle register after the end of the transitional period referred to in Article 50a, except in cases referred to in Article 20(9a) under the conditions laid down in that Article. The Commission shall establish, by means of implementing acts, the format type document. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3). [Am. 127]

Article 43a

European vehicle register

1.  The Agency shall keep a register of the vehicles placed in service in the Union. That register shall meet the following criteria:

(a)  it shall comply with the common specifications referred to in paragraph 2.

(b)  it shall be kept updated by the Agency;

(c)  it shall be public.

2.  The Commission shall adopt common specifications on content, data format, functional and technical architecture, operating mode, including arrangements for the exchange of data, and rules for data input and consultation for the European vehicle registers by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

3.  The registration holder shall immediately declare to the Agency any modification to the data entered in the European vehicle register, the destruction of a vehicle or its decision to no longer register a vehicle.

4.  For each vehicle, the register shall contain at least the following information:

(a)  the EVN;

(b)  references to the 'EC' declaration of verification and the issuing body;

(c)  references to the European register of authorised types of vehicles referred to in Article 44;

(d)  identification of the keeper and the owner of the vehicle;

(e)  restrictions on how the vehicle may be used;

(f)  the entity in charge of maintenance.

Whenever the Agency issues, renews, amends, suspends or revokes a vehicle authorisation, it shall update the register without delay.

5.  In the case of vehicles used 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, as a minimum, data relating to the vehicle keeper, the entity in charge of maintenance and the restrictions on how the vehicle may be used, can be retrieved through the European vehicle register or through provisions of an international agreement. [Am. 128]

Article 44

European register of authorisation to place vehicle types on the market

1.  The Agency shall set up and keep a register of authorisations to place vehicle types on the market issued in accordance with Article 22. This register shall meet the following criteria:

(a)  it shall be public and electronically accessible;

(b)  it shall comply with the common specifications referred to in paragraph 3.

(c)  it shall be linked with all national vehicle registers. [Am. 129]

2.  The Commission shall adopt common specifications relating to content, data format, functional and technical architecture, operating mode and rules for data input and consultation for the register of authorisations to place vehicle types on the market by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

2a.  That register shall include at least the following details for each type of vehicle:

(a)  the technical characteristics of the type of vehicle, as defined in the relevant TSI;

(b)  the manufacturer's name;

(c)  the dates and references of the successive authorisations for that type of vehicle, including any restrictions or withdrawals;

(d)  design features intended for persons with reduced mobility and persons with disabilities;

(e)  identification of the owner and the keeper of the vehicle;

When the Agency issues, renews, amends, suspends or revokes an authorisation to place vehicle types in service, it shall update the register without delay. [Am. 130]

Article 45

Register of infrastructure

1.  Each Member State shall publish ensure that a register of infrastructure is published stating the values of the network parameters of each subsystem or part of subsystem concerned. [Am. 131]

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, including temporary restrictions which are to apply for longer than six months. [Am. 132]

4.  Each Member State shall update ensure that the register of infrastructure is updated in accordance with Commission Implementing Decision 2011/633/EU(19). [Am. 133]

5.  Other registers, such as a register on accessibility, may for persons with disabilities and persons with reduced mobility, shall also be associated to the register of infrastructure. [Am. 134]

6.  The Commissionshall adopt 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 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3)

CHAPTER VIII

TRANSITIONAL AND FINAL PROVISIONS

Article 46

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 Articles 4(2), 5(10), 8(2), 15(7a), 20(7) and 22a(4) shall be conferred on the Commission for an indeterminate a period of time five years from the date of entry into force of this Directive.

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. [Am. 135]

3.  The delegation of power referred to in Articles 4(2), 5(10), 8(2), 15(7a), 20(7) and 22a(4) 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.

4.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.  A delegated act adopted pursuant to Articles 4(2), 5(10), 8(2), 15(7a), 20(7) and 22a(4) 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.

Article 47

Urgency procedure

1.  Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

2.  Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 46(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council.

Article 48

Committee procedure

1.  The Commission shall be assisted by the committee established by Article 21 of Council Directive 96/48/EC(20). 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.

4.  Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 shall apply.

Article 49

Motivation

Any decision taken pursuant to this Directive concerning the assessment of conformity or suitability for use of interoperability constituents, the checking of subsystems constituting the rail system or any decision taken pursuant to Articles 6, 11 and 16 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.

Article 49a

Penalties

The Commission shall be empowered to adopt delegated acts in accordance with Article 46 in order to establish rules on penalties for failure to comply with the deadlines set in this Regulation for the adoption of decisions by the Agency. It shall also establish a compensation scheme for cases in which the Board of Appeal provided for in Regulation (EU) No …/… [Agency Regulation] finds in favour of the addressee of an Agency decision. The penalties and the compensation scheme must be effective, proportionate, non-discriminatory and dissuasive. [Am. 136]

Article 50

Reports and information

1.  Every three years and for the first time three two years after the publication of this Directive, the Commission shall report to the European Parliament and the Council on the progress made towards achieving interoperability of the rail system. That report shall also include an analysis of the cases set out in Article 7 and of the application of Chapter V. On the basis of the findings of the report, the Commission shall propose improvements and measures to strengthen the Agency’s role in implementing interoperability. [Am. 137]

1a.  Two years after the publication of this Directive and after consultation with the various agents involved, the Commission shall submit to the European Parliament and the Council a report on the functioning of the Agency and the progress made by it in carrying out its new responsibilities. [Am. 138]

2.  The Agency shall develop and regularly update a tool capable of providing, at the request of a Member State, the European Parliament or the Commission, an overview of the interoperability level of the rail system. That tool shall use the information included in the registers provided for in Chapter VII. [Am. 139]

Article 50a

Transitional regime

Without prejudice to Article 20(9a), as from four years after the entry into force of this Directive, the vehicle authorisations referred to in Articles 20 and 22 shall be granted by the Agency. During that transitional period, a vehicle authorisation may be granted by the Agency or by the national safety authority, at the option of the applicant.

The Agency shall have the necessary organisational capacity and expertise to perform all of its functions pursuant to Articles 18, 20 and 22 at the latest four years after the entry into force of this Directive.

In order to fulfil its obligations, the Agency may conclude cooperation agreements with national safety authorities in accordance with Article 22a. [Am. 140]

Article 51

Transitional regime for placing in service of vehicles

1.  Member States may continue to apply the provisions set out in Chapter V of Directive 2008/57/EC until [two years one year after the date of entry into force] [Am. 141]

2.  Authorisations for placing in service of vehicles which have been granted pursuant to paragraph 1, 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, have to receive a vehicle authorisation for placing on the market in order to operate on one or more networks not covered by their authorisation. The placing in service on these additional networks is subject to the provisions of Article 21.

Article 52

Other transitional provisions

Annexes IV, V, VI, VII and IX to Directive 2008/57/EC shall apply until the date of application of the corresponding delegated acts referred to in Articles 8(2) and 15(7a), and of the implementing acts referred to in Articles 8(2), 14(8), 15(7) and 7(3), of this Directive. [Am. 142]

Article 53

Recommendations and opinions and of the Agency

The Agency shall provide recommendations and opinions in accordance with Article 15 of Regulation (EU) No …/… [Agency Regulation] for the purpose of application of this Directive. These recommendations and opinions will serve as basis for any Union measure adopted pursuant this Directive.

Article 54

Transposition

1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1, Article 2, Article 7(1) to (4), Article 11(1), Article 13, Article 14(1) to (7), Article 15(1) to (6), Articles 17 to 21, Article 22(3) to (7), Articles 23 to 36, Article 37(2), Article 38, Article 39, Articles 41 to 43, Article 45(1) to (5), Article 51, and Annexes I to III by [two years one year after the date of entry into force] at the latest. They shall forthwith communicate to the Commission the text of those measures and a correlation table between those measures and this Directive. The correlation tables are needed to enable all actors concerned to clearly identify the relevant provisions applicable at national level for the implementation of this Directive. [Am. 143]

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference at the time 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.

2.  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.

3.  The obligation to transpose and implement Article 13, Article 14(1) to (7), Article 15(1) to (6), Articles 17 to 21, Article 42, Article 43, Article 45(1) to (5) and Article 51 of this Directive shall not apply to the Republic of Cyprus and the Republic of Malta for as long as no rail system is established within their territory.

However, as soon as a public or private entity submits an official application to build a railway line in view of its operation by one or more railway undertakings, the Member States concerned shall put in place legislation to implement the Articles referred to in the first subparagraph within one year from the receipt of the application.

Article 55

Repeal

Directive 2008/57/EC, as amended by the Directives listed in Annex IV, Part A, is repealed with effect from [two years one year after the date of entry into force], 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 IV, Part B. [Am. 144]

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 V.

Article 56

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.

Articles 3 to 10, Article 11(2), (3) and (4), Article 12, Article 16, shall apply from [two years after the date of entry into force].

Article 57

Addressees

This Directive is addressed to the Member States.

Done at ...

For the European Parliament For the Council

The President The President

ANNEX I

Elements of Union rail system

1.  Network

For the purposes of this Directive, the Union's Union network shall include the following elements of the high-speed network as defined in points (a), (b) and (c) and the conventional network as defined in points (d) to (i):

(a)   specially built high-speed lines equipped for speeds generally equal to or greater than 250 km/h, while enabling speeds of over 300 km/h to be reached in appropriate circumstances,

(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,

(g)   passenger hubs,

(h)   freight hubs, including intermodal terminals,

(i)   lines connecting the abovementioned elements. [Am. 145]

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, including:

–  locomotives and passenger rolling stock, including thermal or electric traction units, self-propelling thermal or electric passenger trains, passenger coaches;

–  vehicles designed to travel at speeds of at least 250 km/h on lines specially built for high speeds, while enabling speeds exceeding 300 km/h to be reached in appropriate circumstances;

–  vehicles designed to travel at speeds of the order of 200 km/h on high-speed lines or on lines specially built or specially upgraded for high speeds, where they are compatible with the possibilities offered by those lines.

In addition, vehicles designed to operate with a maximum speed lower than 200 km/h which are likely to travel on all or part of the trans-European high-speed network, where compatible with the performance levels of that network, shall fulfil the requirements ensuring safe operation on that network. To that end, the TSIs for conventional vehicles shall also specify requirements for safe operation of conventional vehicles on high-speed networks. [Am. 146]

–  freight wagons, including low-deck vehicles designed for the entire network and vehicles designed to carry lorries; [Am. 147]

–  special vehicles, such as on track machines.

Each of the above categories may be subdivided into:

–  vehicles for international use;

–  vehicles for national use.

The TSIs shall specify the requirements to ensure the safe operation of these vehicles on different categories of line.

ANNEX II

SUBSYSTEMS

1.  List of subsystems

For the purposes of this Directive, the system constituting the 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;

(b)  functional areas:

–  operation and traffic management,

–  maintenance,

–  telematics applications for passenger and freight services.

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, engineering structures (bridges, tunnels, etc.), rail-related station components (including entrances, platforms, zones of access, service venues, toilets and information systems, as well as their accessibility features for persons with reduced mobility and persons with disabilities), safety and protective equipment.

2.2.  Energy

The electrification system, including overhead lines and the trackside of the electricity consumption measuring 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.

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 enabling 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;

(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

Structure, command and control system for all train equipment, electric current collection devices, traction and energy conversion units, on-board equipment for electricity consumption measuring, 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 reduced mobility and persons with disabilities ), 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 rail system and guarantee the performance required.

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.

1.1.5.  Any devices intended to be handled by users must be so designed 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 the Union provisions in force.

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.

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.  Operation of the rail system must respect existing regulations on noise pollution.

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.

If compliance with these characteristics proves difficult on certain sections of the network, temporary solutions, which ensure compatibility in the future, may be implemented.

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.

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.

2.2.  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.

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 should 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.

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/or conductor and to request accompanying staff to contact him or them. [Am. 148]

It must be possible to board and alight from trains safely. The access doors must incorporate an opening and closing system which guarantees mechanisms for the doors, the platform gap width and the arrangements for making trains ready for departure must guarantee passenger safety. Trains must be designed in such a way that passengers cannot be trapped. [Am. 149]

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.

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 and/or drivers. [Am. 150]

Passengers must be given easily understandable, comprehensive information about rules applicable both in railway stations and in trains (no-entry points, entrances and exits, instructions concerning conduct, access for persons with reduced mobility, what markings mean, hazard areas, etc.). [Am. 151]

2.4.2.  Reliability and availability

The design of the vital equipment and the running, traction and braking equipment and also the control and 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 and topography. [Am. 152]

2.4.4.  Controls

Trains must be equipped with a recording device. The data collected by this device and the processing of the information must be harmonised.

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.

2.6.  Operation and traffic management

2.6.1.  Safety

Alignment of the network operating rules and the qualifications of drivers, rolling-stock inspectors, movement controllers 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. Efforts must be made to ensure, across the Union, a high level of training with advanced qualifications. [Am. 153]

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.

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.

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.

ANNEX IV

PART A

Repealed Directives

with list of the successive amendments thereto

(referred to in Article 55)

PART B

Time limits for transposition into national law

(referred to in Article 55)

ANNEX V

CORRELATION TABLE

(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. (4) 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). (5) 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). (6) Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (OJ L 134, 30.4.2004, p. 1). (7) 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). (8) Directive …/…/EU of the European Parliament and of the Council of … (OJ L ...). (9) 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). (10) 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). (11) 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). (12) Directive …/…/EU of the European Parliament and of the Council of … [establishing a single European railway area] (OJ L …). (13) Regulation (EU) No .../… of the European Parliament and of the Council of ... on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L ...). (14) 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). (15) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37). (16) 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). (17) Commission Decision 2007/756/EC of 9 November 2007 adopting a common specification of the national vehicle register provided for under Articles 14(4) and (5) of Directives 96/48/EC and 2001/16/EC (OJ L 305, 23.11.2007, p. 30). (18) OJ L 343, 14.12.2012, p. 32. (19) Commission Implementing Decision 2011/633/EU of 15 September 2011 on the common specifications of the register of railway infrastructure (OJ L 256, 1.10.2011, p. 1). (20) 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).