EUROPEAN COMMISSION Brussels, 30.1.2013 COM(2013) 30 final 2013/0015(COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the interoperability of the rail system within the European Union (Recast) (Text with EEA relevance) {SWD(2013) 8}

{SWD(2013) 9}



EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL 1.1.Recent EU policy developments in the railway field In its White Paper ‘Roadmap to a Single European Transport Area — Towards a competitive and resource efficient transport system’, adopted on 28 March 2011 (‘2011 White Paper’), the Commission announced its vision for the establishment of a Single European Railway Area, clarifying that this objective implies creating an internal railway market where European railway undertakings can provide services free from unnecessary technical and administrative barriers. Moreover, the European Council conclusions of January 2012 highlight the importance of releasing the growth-creating potential of a fully integrated Single Market, including as regards network industries. Furthermore, the Commission Communication on Action for Stability, Growth and Jobs adopted on 30 May 2012 stresses the importance of a further reduction in the regulatory burden and barriers to entry in the rail sector, making country-specific recommendations in that direction. In the same vein, on 6 June 2012 the Commission adopted the Communication on strengthening the governance of the single market, which likewise stresses the importance of the transport sector. In the last decade, the EU railway market has seen massive changes, gradually introduced by three legislative ‘railway packages’ (with some accompanying acts) intended to open up national markets and make railways more competitive and interoperable at the EU level, while maintaining high levels of safety. However, despite the considerable development of the ‘EU acquis’ establishing an internal market for rail transport services, the modal share of rail in intra-EU transport remains modest. Thus, the Commission has planned to come forward with the fourth railway package in order to enhance the quality and efficiency of rail services by removing the remaining market obstacles. This Directive is a component of the fourth railway package, focusing on the removal of remaining administrative and technical barriers, in particular by: establishing a common approach to safety and interoperability rules to increase economies of scale for railway undertakings active across the EU; decreasing administrative costs and accelerating administrative procedures; and by avoiding disguised discrimination. 1.2.Legal framework for interoperability Under the Treaty on the Functioning of the European Union (Articles 170 and 171), the Union must contribute to the establishment and development of trans-European networks in the areas of transport. In order to achieve these objectives, the Union must take any measures necessary to ensure the interoperability of the networks, particularly in the field of technical standardisation. The initial measures taken in the rail sector were Directive 96/48/EC on the interoperability of the trans-European high-speed rail system and Directive 2001/16/EC on the interoperability of the trans-European conventional rail system, amended by Directive 2004/50/EC. These Directives were recast by Directive 2008/57/EC on the interoperability of the rail system within the Community, which is currently in force as amended by Directive 2009/131/EC and Directive 2011/18/EU. 1.3.Why recast interoperability Directive 2008/57/EC as amended? Several lessons have been learned based on the work done on developing TSIs, the application of the interoperability Directives to specific projects, the work of the Committee set up under Article 29 of Directive 2008/57/EC and feedback from stakeholders. Furthermore, the legislative context for the marketing of products has evolved in recent years, with the result that the interoperability legislation needs to be updated. On this basis, the Commission intends to propose a number of changes to Directive 2008/57/EC, which can be grouped into three different categories: new provisions: a number of new definitions, the concept of a vehicle authorisation for placing on the market, and some provisions on registers; clarification of existing provisions: scope of the Directive, application of TSI to existing systems, TSI derogations, TSI deficiencies and applicability of national rules; updates due to the evolution of the legislative framework: provisions concerning conformity assessment and conformity assessment bodies, as well as references to comitology procedures and delegated acts; editorial changes: consolidation of previous amendments to the text of the Directive, renumbering of articles and annexes, references to other components of the fourth railway package, targeted rewording of a few sentences to avoid translation ambiguities. 2.RESULTS OF CONSULTATIONS WITH INTERESTED PARTIES AND IMPACT ASSESSMENTS The European Commission carried out a thorough impact assessment to support legislative proposals for improving the efficiency and competitiveness of the Single European Railway Area in the field of interoperability and safety. An Impact Assessment Steering Group (IASG) was created in June 2011. While all DGs were invited by DG MOVE to participate, the DGs most concerned were ENTR, EMPL, SG, SJ, HR, RTD, BUDG, REGIO, ENER and ELARG.

The Commission departments have discussed developments in the Single European Railway Area with sector representatives on an ongoing basis. In 2010-2011 they also conducted an ex-post evaluation of Regulation 881/2004 establishing the European Railway Agency. To support the Commission in the impact assessment process, an external consultant was tasked to prepare an impact assessment support study and to undertake a targeted consultation of stakeholders. The targeted consultation of interested parties started on 18 November 2011 with an internet survey which finished on 30 December 2011. It was followed by interviews with major stakeholders and a stakeholder workshop at the end of February 2012. Since then, DG MOVE has taken part in bilateral meetings with the sector to gauge their views on what should be done in the fourth railway package with respect to interoperability and safety. Given the technical nature of the initiative, there was no public consultation. However, the Commission made sure that all interested parties were consulted at the appropriate time and that the discussions covered all the key elements of the initiative. More information on the impact assessment and the results of the stakeholder consultation is provided in the Commission staff working document accompanying legislative proposals to eliminate remaining administrative and technical barriers in the field of interoperability and safety on the EU railway market. 3.LEGAL ELEMENTS OF THE PROPOSAL This section provides comments and explanations relating to significant changes in the text of the Directive. It does not provide detailed comments on minor changes introduced as a consequence of the Lisbon Treaty, editorial modifications and other obvious amendments. The numbering corresponds to the renumbered articles and annexes, unless preceded by ‘ex’, in which case it refers to the numbering as it is in Directive 2008/57/EC. CHAPTER I Article 1 The Commission services, together with the committee referred to in Article 29 of Directive 2008/57/EC, had already addressed in February 2009 the clarification of the scope of the Directive as far as lines and vehicles used for local, urban and suburban services were concerned. The conclusion of this analysis was a three-fold approach: i) exclusion of urban rail and clarification of the scope; ii) development of a dedicated urban rail European voluntary standardisation framework; and iii) development of essential requirements for urban transport. The first action was initiated in October 2009, when the Commission services invited Member States to exclude from the scope of the measures transposing Directive 2008/57/EC cases (a) and (b) as defined in its Article 1(3). This was to avoid a situation in which a Member State might apply the Directive to de facto cases not covered by the TSIs. Such a situation would in fact imply that Member States notify all national rules in use for metro, tram and light rail systems in the absence of TSIs and follow for these systems all the procedures set out by the Directive for heavy rail, which would amount to a disproportionate administrative, technical and legal burden. To avoid this situation, the proposed amendment formalises in paragraph 3 the indication already given by the Commission services in October 2009, thus completing the first action. The second action was formally initiated in February 2011, when the Commission issued a mandate addressed to the European standardisation bodies to develop voluntary standards in urban rail. To contribute to the abovementioned third action, in October 2011 the associations representing the urban rail sector issued a set of ‘fundamental requirements’, which are being used as basic references for the execution of the urban rail standardisation programme proposed by CEN/CENELEC and ETSI in October 2011. On this basis, interoperability for local, urban and suburban systems is considered to be adequately addressed in the voluntary field and does not need to be covered by this Directive. Article 2 For the sake of clarity, and to take account of the evolution of the legal framework, some definitions have been reworded or added. Ex Article 3 It has been deleted because redundant with Article 1.

Article 3 No substantial change. CHAPTER II Article 4 Further provisions are to be specified in the TSIs to cover existing subsystems and to enable railway undertakings to check compatibility between vehicles and routes on which these vehicles are intended to be operated. Article 5 No substantial change, apart from those required by the Lisbon Treaty. Article 6 This clarifies the use of Agency opinions pending the amendment of TSIs as a result of deficiencies discovered. Ex Article 7 This article has been deleted because it has become obsolete. In fact, the TSIs will have been extended by the time this Directive enters into force. Article 7 The cases of possible non-application of TSIs have been reduced because case 1(b) of Article 9 of the current Directive is unclear, has never been used and could be covered, as in cases 1(c) and 1(f), by specific cases in TSIs. Articles 8, 9 and 10 No substantial change, apart from those required by the Lisbon Treaty. Ex Article 12 Deleted because covered by Directive 1025/2012/EU. Article 11 No substantial change. CHAPTER IV

Ex Article 15 Its provisions are transferred to articles in Chapter V. Article 12 No substantial change. Articles 13 and 14 These articles have been reworded for consistency with the revised text of this Directive and for consistency with the Agency Regulation and the Safety Directive. They clarify the role of national rules, the cases in which national rules may be introduced, and the procedures for their withdrawal and their publication. The Agency retains its tasks concerning the classification of national rules (ex Article 27); in addition, the Agency shall examine notified national rules and invite Member States to repeal them in case of redundancy or incompatibility with the EU legislation. Article 15 It clarifies the circumstances which trigger a new EC declaration of verification. Article 16 No substantial change. Article 17 It recalls the general principle of presumption of conformity set out in Directive 1025/2012/EU. Ex Article 20 Some of the content has been clarified and transferred to Chapter V. The remaining content is already covered by Article 7 (non-application of TSIs). CHAPTER V Ex Articles 21 to 25 have been deleted and replaced with new articles 18 to 20. Article 18 For fixed installations the procedure is practically identical to that of Directive 2008/57, except for trackside control-command and signalling subsystems, which will be authorised by the Agency for consistency with the corresponding on-board subsystems. Article 19

It addresses the placing on the market of mobile subsystems, which can be done by both railway undertakings and manufacturers. In practice, mobile subsystems are not placed in service individually; their placing in service is done when they are integrated in a vehicle, and the placing in service of a vehicle is addressed in Article 21. Article 20 It introduces the notion of vehicle authorisation for placing on the market, which is partially replacing the concept of vehicle authorisation for placing in service issued by the national safety authority as set out in Directive 2008/57/EC. The vehicle authorisation for placing on the market is issued by the Agency and contains all information needed later by the railway undertaking to place a vehicle in commercial service. The applicant (railway undertaking, manufacturer, etc.) may ask the Agency to complement the vehicle authorisation for placing on the market with a statement concerning the technical compatibility of the vehicle with a particular set of lines or networks defined by the applicant on the basis of commercial and/or technical considerations. This complementary statement will facilitate the railway undertaking in its task of placing the vehicle in service. Article 21 It clarifies the role of railway undertakings and infrastructure managers in checking the technical compatibility of the vehicle with the route and the safe integration of the vehicle in the system in which it is intended to operate. Article 22 It concerns the authorisation for placing on the market for types of vehicles and has been amended to reflect the provisions of Articles 18 to 21. ex Article 27 It has been deleted because some of its provisions have been transferred to the Agency Regulation. CHAPTER VI Articles 23 to 41 concerning conformity assessment bodies replace and complement ex Article 28 and ex Annex VIII to include the provisions of the new legislative framework for the marketing of products as defined in Decision 768/2008/EC. Ex Article 31 This article has been deleted because it is obsolete. CHAPTER VII Articles 42 to 45 on EVN and registers have been updated to reflect the provisions of Chapter V. Ex Article 36 This article has been deleted because it is obsolete. CHAPTER VIII Articles 46 and 47

These articles concern the delegation of powers to the Commission under the Lisbon Treaty. Article 48 It has been modified to take into account the new comitology procedures. Ex Article 30 This article has been deleted because it is obsolete. Articles 49 and 50 These articles have been updated for consistency with the text of this Directive. Article 51 It includes the new provisions with respect to the transitional regime for placing in service of vehicles. This will enable the parallel application of both regimes (Directive 2008/57/EC and this Directive) for a limited period. Article 52 As a consequence of the Lisbon Treaty, a number of Annexes to Directive 2008/57/EC are transformed into implementing acts to be adopted by the Commission. This article sets out the provisions to be applied until the date of application of those implementing acts. Articles 53 It provides for correspondence tables to be communicated by Member States when transposing this Directive into national legislation. These tables are needed because of the substantial changes introduced by this Directive in Chapters V and VI and are considered necessary to enable all actors to easily identify the national legislation applicable. Article 54 New article concerning the role of Agency opinions and recommendations. Articles 55 to 57 They have been updated for consistency with the text of this Directive. Annex I There is no longer any mention of the trans-European rail system because the TSIs will have been extended de facto by the time this Directive enters into force. The separation between high-speed (HS) and conventional rail (CR) has also been removed in view of the merging of a number of HS and CR TSIs.

Taking account of the above, the classification of vehicles has been simplified. Annexes II and III No substantial change. Ex Annex IV It is transformed into an implementing act, see Article 8(2). Ex Annexes V and VI They are transformed into implementing acts, see Article 15(7). Ex Annex VII It is transformed into an implementing act, see Article 14(8). Ex Annex VIII This article has been deleted because it is included in Articles 27, 28 and 29. Ex Annex IX It is transformed into an implementing act, see Article 7(3). Annexes IV and V They have been updated for consistency with the text of this Directive. ê 2008/57/EC (adapted) 2013/0015 (COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the interoperability of the rail system within the European Union (Recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union establishing the European Community, and in particular Articles 71 and 156 Ö 91(1), 170 and 171 Õ 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, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, Whereas: ê 2008/57/EC recital 1 (adapted) Council Directive 96/48/EC of 23 July 1996on the interoperability of the trans-European high-speed rail system and Directive 2001/16/EC of the European Parliament and of the Council of 19 March 2001 on the interoperability of the trans-European conventional rail system were substantially amended by Directive 2004/50/EC of the European Parliament and of the Council . As new amendments are now being introduced, it is appropriate to recast the Directives for the sake of clarity and merge their provisions together into a single instrument with a view to simplification. ò new (1)Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community has been substantially amended several times. Since further amendments are to be made, that Directive should be recast in the interests of clarity. ê 2008/57/EC recital 2 (adapted) (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, it is appropriate, in particular, to improve the interlinking and interoperability of the national rail networks as well as access thereto, implementing any measures that may prove necessary in the field of technical standardisation, as provided for in Article 155 of the Treaty.

ò new (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. ê 2008/57/EC recital 3 (adapted) By signing the Protocol adopted in Kyoto on 12 December 1997 the European Union has undertaken to reduce its greenhouse gas emissions. These objectives require an adjustment to the balance between the various modes of transport, and consequently an increase in the competitiveness of rail transport. ê 2008/57/EC recital 43 (adapted) The Community strategy for the integration of environmental and sustainable development concerns into its transport policy highlights the need to act to reduce the environmental impact of transport. ê 2008/57/EC recital 5 (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 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. ê 2008/57/EC recital 6 (adapted) ð new (5)Member States are responsible ð The railway regulatory framework should set clear responsibilities ï for ensuring compliance with the safety, health and consumer protection rules applying to the railway networks in general during the design, construction, putting into service and operation of those railways. ê 2008/57/EC recital 7 (adapted) (6)There are major differences between the national regulations, and between internal rules and technical specifications which the railways apply Ö applicable to rail systems, subsystems and components Õ , 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 Community Ö Union Õ network.

ê 2008/57/EC recital 8 (adapted) ð new (7)Over the years, this situation has created very close links between the national railway industries and the national railways, to the detriment of the Ö a Õ genuine opening-up of markets ð allowing new entrants to emerge ï. In order to enhance their competitiveness at world level, these industries require an open, competitive European market. ê 2008/57/EC recital 9 (adapted) ð new (8)It is therefore appropriate to define basic essential requirements ð related to rail interoperability ï for the whole of the Community Ö Union Õ which will Ö should Õ apply to its rail system. ê 2008/57/EC recital 10 To achieve these objectives an initial measure was taken by the Council on 23 July 1996 with the adoption of Directive 96/48/EC. The European Parliament and the Council subsequently adopted Directive 2001/16/EC. ê 2008/57/EC recital 11 The entry into force of Directives 2001/12/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC on the development of the Community's railways , 2001/13/EC of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC on the licensing of railway undertakings and 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification has had an impact on the implementation of interoperability. As in the case of other transport modes, the extension of access rights must be accompanied by the requisite harmonisation measures. It is therefore necessary to implement interoperability on the whole network by extending progressively the geographical scope of Directive 2001/16/EC. It is also necessary to extend the legal basis of Directive 2001/16/EC to Article 71 of the Treaty, on which Directive 2001/12/EC is founded. ê 2008/57/EC recital 12 (adapted) ð new (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 must Ö should Õ be made mandatory in order to achieve the objectives of this Directive, and the "harmonised standards" that have been developed ð in accordance with 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 ï in the spirit of the new approach to technical harmonisation and standardisation. ð 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. ï ò new (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. ê 2008/57/EC recital 13 As a rule, European specifications are developed in the spirit of the new approach to technical harmonisation and standardisation. They enable a presumption to be made of conformity with certain essential requirements of this Directive, particularly in the case of interoperability constituents and interfaces. These European specifications, or the applicable parts thereof, are not mandatory and no explicit reference to these specifications may be made in the TSIs. References to these European specifications are published in the Official Journal of the European Union, and Member States publish the references to the national standards transposing the European standards. ê 2008/57/EC recital 14 TSIs may in certain cases make an explicit reference to European standards or specifications where this is strictly necessary in order to achieve the objectives of this Directive. Such explicit reference has consequences which must be made clear; in particular, these European standards or specifications become mandatory from the moment the TSI is applicable. ê 2008/57/EC recital 15 (adapted) (12)A TSI sets all the conditions with which an interoperability constituent must Ö should Õ conform, and the procedure to be followed in assessing conformity. In addition, it is necessary to specify that every constituent must Ö should Õ undergo the procedure for assessing conformity and suitability for the use indicated in the TSIs, and have the corresponding certificate. ê 2008/57/EC recital 16 (adapted) (13)When developing new TSIs the aim should always be to ensure compatibility with the existing authorised 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 authorised 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 may need to be re-authorised Ö needs a new decision or authorisation for placing in service Õ , and the corresponding deadlines. ê 2008/57/EC recital 17 (adapted) (14)It is necessary for safety reasons to require Member States to assign an identification code to each vehicle placed in service. The vehicle should then be entered in a national vehicle register. The registers Ö should Õ must be open to consultation by all Member States and by certain Community economic players Ö within the Union Õ. The Ö national vehicle Õ registers should be consistent as regards the data format. They should therefore be covered by common operational and technical specifications. ò new (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.

ê 2008/57/EC recital 18 (adapted) (16)The procedure to be followed in the case of essential requirements applicable to a subsystem which have not yet been covered by detailed specifications 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 20 of Directives 2008/57/EC 96/48/EC and 2001/16/EC. ò new (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. ê 2008/57/EC recital 19 The distinction between a high-speed rail system and a conventional rail system does not warrant two separate directives. The procedures for developing TSIs are the same for both systems, as are those for the certification of the interoperability constituents and the subsystems. The essential requirements are practically identical, as is the subdivision of the system into subsystems for which technical specifications have to be prepared. Moreover, since trains have to be able to move freely from the high-speed network to the conventional network, the technical specifications for the two systems overlap to a large extent. Work on developing the TSIs has shown that, for certain subsystems, a single TSI can serve both systems. It is therefore appropriate to combine Directives 96/48/EC and 2001/16/EC. ò new (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. ê 2008/57/EC recital 20 Directive 2004/50/EC provided for the progressive extension of the scope of Directive 2001/16/EC as new TSIs were adopted or existing ones revised. When this Directive enters into force, its scope will cover conventional and high-speed European networks as defined in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the trans-European transport network , and the vehicles likely to travel on those networks. The scope will be progressively extended to the whole network and all vehicles, provided that an impact assessment shows the economic benefit of so doing. ê 2008/57/EC recital 21 (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. ò new

(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. ê 2008/57/EC recital 22 (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. ê 2008/57/EC recital 23 In its Legislative Resolutions of 10 March 1999 on the railway package, the European Parliament asked that the progressive opening up of the rail sector go hand-in-hand with the fastest and most effective technical harmonisation measures possible. ê 2008/57/EC recital 24 The Council, at its meeting on 6 October 1999, asked the Commission to propose a strategy on improving the interoperability of rail transport and reducing bottlenecks with a view to eliminating technical, administrative and economic obstacles to the interoperability of networks without delay while guaranteeing a high level of safety and training and qualifications of the staff concerned. ê 2008/57/EC recital 26 Pursuant to Council Directive 91/440/EEC of 29 July 1991 on the development of the Community's railways , railway companies must have increased access to Member States' rail networks, which in turn requires the interoperability of infrastructure, equipment, rolling stock and systems of management and operation, including those staff qualifications and hygiene and safety conditions at work required for the operation and maintenance of the subsystems in question and for the implementation of each TSI. However, it is not the aim of this Directive, directly or indirectly, to harmonise working conditions in the rail sector. ê 2008/57/EC recital 26 (adapted) (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, Ö trackside Õ control-command and signalling, Ö on-board control-command and signalling, Õ 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 for the whole of the Community, 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 one or more parts of other subsystems (mainly the on-board part of the control-command and signalling subsystemand the onboard part of the energy subsystem). ò new (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 is therefore an important requirement for the interoperability of the rail system.

ê 2008/57/EC recital 27 (adapted) (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 must Ö should Õ endeavour to retain the objective of interoperability. ê 2008/57/EC recital 28 (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. ê 2008/57/EC recital 29 ð new (27)Each Member State concerned should be allowed not to apply certain TSIs in ð 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 ï special cases, provided that there are procedures to ensure that these derogations are justified.Article 155 of the Treaty requires Community activities in the field of interoperability to take account of the potential economic viability of projects. ê 2008/57/EC recital 30 (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. ê 2008/57/EC recital 31 Advantage should be taken of the interoperability of the rail system, particularly in the case of freight, to bring about the conditions for greater interoperability between modes of transport. ê 2008/57/EC recital 32 (adapted) (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 of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services, 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 Ö set of rules Õ body of European specifications in order to serve as references for these technical specifications. ê 2008/57/EC recital 33 (adapted)

(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 Community Ö the Union Õ policy would be in the Community’s Ö Union’s Õ interest. The European standardisation Ö organisations Õ bodies Ö should Õ must therefore continue their cooperation with the international standardisation bodies. ê 2008/57/EC recital 34 (adapted) (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 Community Ö Union Õ level and which the rail system must satisfy. ê 2008/57/EC recital 35 (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 Council Decision 93/465/EEC 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 . 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. ê 2008/57/EC recital 36 (adapted) (33)Conformity of constituents is mainly linked to their area of use in order to guarantee the interoperability of the system and not only to their free movement on the Community Ö Union Õ 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. ê 2008/57/EC recital 37 (adapted) (34)Manufacturers are nonetheless obliged to affix the CE marking to certain components in order to certify their compliance with other Community Ö Union Õ provisions relating to them. ê 2008/57/EC recital 38 (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. ê 2008/57/EC recital 39 (adapted) (36)The subsystems constituting the rail system should be subjected to a verification procedure. This verification must Ö should Õ enable the authorities Ö entities Õ responsible for authorising 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 must Ö should Õ also enable manufacturers to be able to count upon equality of treatment whatever the country Ö Member State Õ . It is therefore necessary to lay down one or more modules defining the principles and conditions applying to 'EC' verification of subsystems.

ê 2008/57/EC recital 40 ð new (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 […/…] 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community railways [Railway Safety Directive] , responsibility for meeting these requirements lies, for their respective subsystems, with the infrastructure manager or the railway undertaking. Member States can check compliance with these requirements when granting safety certificates and safety approvals pursuant to Articles 10 and 11 of the Railway Safety Directive. ê 2008/57/EC recital 41 (adapted) ð new (38)As far as vehicles are concerned, The procedure for placing in service ð of vehicles and fixed installations ï should be clarified taking into account the ð responsibilities of infrastructure managers and railway undertakings ï definition of vehicle which is composed of one or more subsystems. In addition, as Directives 96/48/EC and 2001/16/EC deal with new and upgraded subsystems and Directive 2004/49/EC deals with in-use vehicles, all provisions regarding authorisations for placing in service of vehicles should be integrated in this Directive. Furthermore, a procedure for authorisation of vehicle types should be added. In order to facilitate this procedure and help identify vehicle types, a European register of authorised types of vehicles should be set up and maintained by the European Railway Agency (hereinafter referred to as the Agency). (39)Ö In order Õ with a view to Ö facilitate Õ facilitating the placing in service of vehicles and reduce administrative burdens, ð 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 of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC ï . ò new (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. (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. ê 2008/57/EC recital 42 Experience has shown that the implementation of such a procedure at national level is often complicated and subject to different national requirements that lack transparency, or even duplicate each other. Consequently, this procedure poses a major obstacle to the creation of new railway undertakings, particularly in the freight sector. Steps should therefore be taken to clarify and simplify the procedures for authorising vehicles. Firstly, the general principle that one authorisation is sufficient for the whole Community rail network should be established. Secondly, the procedure for authorising vehicles which are TSI conform should be simpler and quicker than in the case of non-TSI conform. Thirdly, the principle of mutual recognition should be applied as far as possible: when a vehicle has already been placed in service in one Member States, other Member States should not invoke national rules to impose unnecessary requirements and redundant verifications, unless these are strictly necessary for verifying the technical compatibility of the vehicle with the relevant network. To this end national rules should be classified and compared according to a check-list in order to determine to which extent national rules can be declared as equivalent in terms of requirements, performances and safety. Fourthly, the principle of legal certainty as regards the outcome of the procedure should be pursued. To this end, in the absence of a decision of a national safety authority within the prescribed time limits an applicant should be authorised to place in service a vehicle. Such an authorisation would only be possible if the vehicle has already been authorised in another Member State. In addition, it would only be possible for a railway undertaking or an infrastructure manager duly certified in accordance with Directive 2004/49/EC to use such a vehicle under their full responsibility. ò new (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. ê 2008/57/EC recital 43

The authorisation procedures for TSI conform and non-TSI conform vehicles are different. There may be cases where the choice of the procedure is not straightforward. Vehicles which come within the scope of TSI conform vehicles should be those vehicles where all the relevant TSIs have entered into force, including at least the TSI on rolling stock. This would mean that a significant part of the essential requirements has been laid down. For example, until such time that the conventional TSI on locomotives has entered into force, locomotives fall within scope of non-TSI conform vehicles, even though they might comply with other relevant TSIs in force at the time of their placing in service. ê 2008/57/EC recital 44 If certain technical aspects corresponding to the essential requirements cannot be explicitly covered in a TSI, they are identified in an annex to the TSI as open points. When a TSI conform vehicle has already been authorised in one Member State, additional authorisations should only consider those open points that relate to technical compatibility between the vehicle and the network. ê 2008/57/EC recital 45 The list of parameters to be checked in conjunction with the placing in service of non-TSI conform vehicles is a key element for the achievement of interoperability of railway systems, in particular with regard to existing vehicles. This list takes into account experience across a limited number of networks. Therefore it is necessary that the Agency review the parameters in Annex VII and make the recommendations it considers appropriate to the Commission. ê 2008/57/EC recital 46 (adapted) (43)The 'EC' verification procedure should be based on TSIs. These TSIs are subject to the provisions of Article 18 34 of Directive 93/38/EEC. 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 must Ö should Õ , in particular in the absence of any European specification, coordinate their decisions as closely as possible. ê 2008/57/EC recital 47 The notified bodies should be structured in such a way as to meet the criteria which must apply to this type of body in all sectors of the new approach to technical harmonisation and conformity verification, especially criteria relating to independence and competence. ò new (44)Transparent accreditation as provided for in 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, 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. ê 2008/57/EC recital 48 (adapted) ð new

(46)Ö The Õ TSIs will Ö should Õ be revised at regular intervals. When errors Ö deficiencies Õ are discovered ð in the TSIs, the European Union Agency for Railways (hereinafter referred to as 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. ï an ad hoc rapid procedure should be set up in such a way that a provisional corrigendum is first agreed in the context of a committee and then published by the Agency. This will allow an earlier use of this corrigendum by all stakeholders, including industry, notified bodies and authorities, pending a formal revision of the TSI by the Commission. In order to avoid confusion with official corrigenda of the Commission, the term technical opinion will be used. This procedure is in line with the mandate adopted by the Commission in Decision of 13 July 2007 concerning a framework mandate to the European Railway Agency for the performance of certain activities under Directives 96/48/EC and 2001/16/EC. However, if the TSI needs to be amended because of an important or critical error, a revision procedure should be applied. ê 2008/57/EC recital 49 The definition of the keeper should be as close as possible to the definition used in the 1999 Convention concerning International Carriage by Rail (COTIF). Many entities can be identified as a keeper of a vehicle, such as the owner, a company carrying on a business with a fleet of wagons, a company leasing vehicles to a railway undertaking, a railway undertaking or an infrastructure manager using vehicles for maintaining its infrastructure. These entities have control over the vehicle with a view to its use as a means of transport by the railway undertakings and the infrastructure managers. In order to avoid any doubt, the keeper should be clearly identified in the national vehicle registers. ê 2008/57/EC recital 50 The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission . ê 2008/57/EC recital 51 In particular, the Commission should be empowered to adopt and update the TSIs. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. ê 2008/57/EC recital 52 When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of measures designed to amend non-essential elements of this Directive by supplementing it with TSIs or amendments thereto. ê 2008/57/EC recital 53 (adapted) (47)Since the objective of this Directive, namely interoperability within the rail system in Ö on a Õ Community Ö Union Õ -wide scale, cannot be sufficiently achieved by the Member States Ö acting alone Õ , 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 Community Ö Union Õ level, the Community Ö Union Õ may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty Ö on European Union Õ . 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. ê 2008/57/EC recital 54 In accordance with point 34 of the Interinstitutional Agreement on better law-making , Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

ò new (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. 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. (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 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 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. (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. ê 2008/57/EC recital 55 (adapted) (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 Directives. The obligation to transpose the provisions which are unchanged arises under the earlier Directives. ò new (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. ê 2008/57/EC recital 56 Article 14 of Directive 2004/49/EC and Directives 96/48/EC and 2001/16/EC should therefore be repealed. ê 2008/57/EC (adapted) HAVE ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS

Article 1 Purpose Ö Subject matter Õ and scope 1. This Directive sets out to establish Ö establishes Õ the conditions to be met to achieve interoperability within the Community Ö Union’s Õ rail system in a manner compatible with the provisions of Directive […/…on the safety of the rail system within the Union] 2004/49/EC. 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. Ö 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. Õ ê 2008/57/EC ð new 2. The pursuit of this objective must lead to the definition of an optimal level of technical harmonisation and make it possible to: (a) facilitate, improve and develop international rail transport services within the European Union and with third countries; (b) 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 Community; (c) contribute to the interoperability of the rail system within the Community. 3. Member States may exclude from the measures they adopt in implementation ð The following systems are excluded from the scope ï of this Directive: ê 2008/57/EC (adapted) (a) metros, trams and other light rail systems; (b) networks that are functionally separate from the rest of the railway system and intended only for the operation of local, urban or suburban passenger services, as well as railway undertakings operating solely on these networks. Ö 4. Member States may exclude from the scope of the measures implementing this Directive: Õ ê 2008/57/EC (adapted) (ac) privately owned railway infrastructure and vehicles exclusively used on such infrastructure Ö where this exists Õ that exist solely for use by the owner for its own freight operations;

(bd) infrastructure and vehicles reserved for a strictly local, historical or touristic use. 4. The scope of the TSIs shall be progressively extended in accordance with Article 8 to the whole rail system, including track access to terminals and main port facilities serving or potentially serving more than one user, without prejudice to the derogations to the application of TSIs as listed in Article 9. Article 2 Definitions For the purposes of this Directive: ê 2008/57/EC (adapted) ð new (1)‘trans- ð Union ï rail system’ means the trans-European conventional and high-speed rail systems Öelements listed Õ as set out in Annex I, points 1 and 2, respectively; ê 2008/57/EC (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 the regulatory, technical and operational conditions which must be met in order to satisfy the essential requirements; ê 2008/57/EC (adapted) ð new (3)‘vehicle’ means a railway vehicle Ö suitable for circulation Õ that runs on its own wheels on railway lines, with or without traction, ð in a fixed or variable composition ï . A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems; ê 2008/57/EC (4)‘network’ means the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the rail system;

ê 2008/57/EC (adapted) (5)‘subsystems’ means the Ö structural or functional parts Õ result of the division of the rail system, as shown Ö set out Õ in Annex II; These subsystems, for which essential requirements must be laid down, may be structural or functional; (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, Ö including Õ . The concept of a ‘constituent’ covers both tangible objects and intangible objects such as software; ê 2008/57/EC (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; ê 2008/57/EC (adapted) ð new (8)‘European specification’ means a common technical specification, a European technical approval Ö as defined in Annex XXI to Directive 2004/17/EC Õ or a national ð European ï standard ð as defined in Article 2(1)(b) of Regulation (EU) No 1025/2012; ï transposing a European standard, as defined in Annex XXI to Directive 2004/17/EC; ê 2008/57/EC (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; ‘notified bodies’ means the bodies which are responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the 'EC' procedure for verification of the subsystems; ê 2008/57/EC (adapted) ð new (10)‘basic parameters’ 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,. This may include in particular railway lines and networks isolated from the rest of the Community Ö Union Õ, 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 subsystem Ö of it Õ which ð results in a change in the technical file accompanying the 'EC' declaration of verification, if this technical file exists, and which ï improves the overall performance of the subsystem;

(13)‘renewal’ means any major substitution work on a subsystem or part subsystem Ö of it Õ which does not change the overall performance of thesubsystem; (14)‘existing rail system’ means the structure composed of lines and fixed installations of the existing rail system plus Ö as well as Õ the vehicles of all categories and origin travelling on that infrastructure; ê 2008/57/EC (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; ê 2008/57/EC (adapted) (16)‘placing in service’ means all the operations by which a subsystem or a vehicle is put into its Ö operational service Õ design operating state; (17)‘contracting entity’ means any Ö public or private Õ entity, whether public or private, 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, or Ö a Õ the concession holder responsible for carrying out a project; ê 2008/57/EC ð new (18)‘keeper’ means the person or entity that, being the owner of a vehicle or having the right to use it, exploits the vehicle as a means of transport and is registered as such in the national vehicle register referred to in Article 4333; (19)‘project at an advanced stage of development’ means any project whose planning/construction stage has reached a point where techncal specifications exist and a change in the technical specifications would ð may compromise the viability of the project as planned; ï be unacceptable to the Member State concerned. Such an impediment may be legal, contractual, economic, financial, social or environmental in nature and must be duly substantiated; ê 2008/57/EC (adapted) ð new (20)‘harmonised standard’ means any Ö a Õ European standard ð as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012 ï adopted by one of the European standardisation bodies listed in Annex I to 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 and of rules on Information Society services in connection with a mandate by the Commission drawn up in accordance with the procedure referred to in Article 6(3) of that Directive, which, by itself or together with other standards, provides a solution as regards compliance with a legal provision; (21)‘national safety authority’ means a safety authority as defined in Article 3(g) of Directive Ö …/… [on the safety of the rail system within the Union] Õ 2004/49/EC; (22)‘type’ means a vehicle type defining the basic design characteristics of the vehicle as covered by a Ö type or design examination certificate described in the relevant verification module Õ single type-examination certificate described in module B of Decision 93/465/EEC;

ê 2008/57/EC (23)‘series’ means a number of identical vehicles of a design type; ‘Agency’ means the European Railway Agency, as established by Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European railway agency (Agency Regulation) ; ê 2008/57/EC (adapted) (24)‘entity in charge of maintenance’ means an entity in charge of maintenance Ö as defined in Article 3 of Directive …/…. [Railway Safety Directive] Õ of a vehicle, and registered as such in the national vehicle register;. ò new (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 containing railway safety or technical requirements imposed at Member State level and applicable to railway undertakings, irrespective of the body issuing them; (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; (28)‘acceptable means of compliance’ means non-binding opinions issued by the Agency to define ways of establishing compliance with the essential requirements; (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 to act on his behalf in relation to specified tasks; (32)‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service; (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 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. (38)‘infrastructure manager’ means infrastructure manager as defined in Article 3 of Directive …/… [establishing a single European railway area]; (39)‘railway undertaking’ means railway undertaking as defined in Article 3 of Directive …/… [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. ê 2008/57/EC Article 3 Overall compatibility 1. This Directive concerns 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. 2. The provisions of this Directive shall apply without prejudice to any other relevant Community provisions. However, in the case of interoperability constituents, including interfaces, Compliance with the essential requirements of this Directive may require the use of individual European specifications drawn up for that purpose. Article 34 Essential requirements 1. The rail system, subsystems and interoperability constituents including interfaces shall meet the relevant essential requirements. ê 2008/57/EC (adapted) 2. The further 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 Community Ö Union shall Õ must not conflict with the essential requirements. ê 2008/57/EC (adapted) ð new CHAPTER II

TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY Article 45 Content of TSIsÖ Technical Specifications for Interoperability Õ 1. Each of the subsystems Ö defined in Annex II Õ shall be covered by one TSI. Where necessary, a subsystem may be covered by several TSIs and one TSI may cover several subsystems. The decision to develop or to revise a TSI and the choice of its technical and geographical scope requires a mandate in accordance with Article 6(1). ò new 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. ê 2008/57/EC 32. 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 compliance shall be permanently maintained while each subsystem is in use. ê 2008/57/EC (adapted) 43. To the extent necessary to achieve the objective referred to in Article 1, eEach TSI shall: ê 2008/57/EC (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); ê 2008/57/EC (adapted) (b) lay down essential requirements for each subsystem concerned and its interfaces vis-à-vis Ö in relation to Õ other subsystems; (c) establish the functional and technical specifications to be met by the subsystem and its interfaces vis-à-vis Ö in relation to Õ other subsystems. If need be, these specifications may vary according to the use of the subsystem, for example according to the categories of line, hub and/or vehicles provided for in Annex I;

ê 2008/57/EC (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; (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 93/465/EEC; ê 2008/57/EC (adapted) ð new (f) indicate the strategy for implementing Ö the application of Õ 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 ð including setting deadlines for completion of those stages where necessary ï ; (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 implementation Ö application Õ of the TSIs. ò new (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; ê 2008/57/EC (adapted) ð new 54. 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 Ö with them shall facilitate Õ therewith will help gradually ð within that time-scale ï to achieve the interoperability of the rail system. 65. 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, ð and in particular for ï ; special attention must be given to 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 indicated Ö provided for Õ in paragraph 43(c) to (g). ê 2008/57/EC

76. 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. Article 17(3) shall apply to these aspects. ê 2008/57/EC (adapted) 87. TSIs shall not Ö prevent Õ be an impediment to decisions by the Member States concerningÖ from deciding on Õ the use of infrastructures for the movement of vehicles not covered by the TSIs. 98. 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; in such case, this shall concern documents that are easily accessible and in the public domain. Article 56 Ö Drafting, adoption and review Õ Adoption, review and publication of TSIs ê 2008/57/EC 1. Draft TSIs and subsequent draft amendments to TSIs shall be drafted by the Agency under a mandate from the Commission in accordance with the regulatory procedure referred to in Article 29(3) of this Directive. They shall be drafted in accordance with Articles 3 and 12 of Regulation (EC) No 881/2004 and in cooperation with the working parties mentioned in those Articles. Measures designed to amend non-essential elements of this Directive by supplementing it with TSIs or amendments thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 29(5). 2. The Agency shall be responsible for preparing the review and updating of TSIs and making any recommendations to the Commission in order to take account of developments in technology or social requirements. The Commission shall inform the committee referred to in Article 29 of such recommendations. ò new 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. ê 2008/57/EC (adapted) 32. Each draft TSI shall be drawn up in two Ö the following Õ stages. (a) Firstly, 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) Secondly, 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.

ê 2008/57/EC ð new 4. 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. The Member States shall participate in this assessment by providing the requisite data. 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. 45. The committee referred to in Article 29 shall be kept regularly informed of the preparatory work on the TSIs. During ð the preparatory work on TSIs ï this 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. 56. On the adoption of each TSI, the date of entry into force of that TSI shall be established in accordance with the regulatory procedure with scrutiny referred to in Article 29(4). 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. 67. 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. ê 2008/57/EC (adapted) ð new 7. ð In accordance with Article 6 of Regulation (EU) No …/… [Agency Regulation], the Agency shall draw up and regularly update ï Tthe list of Ö users' Õ associations and bodies to be consulted shall be drawn up by the Commission, after consulting the committee in accordance with the advisory procedure referred to in Article 29(2), and Ö . This list Õ may be re-examined and updated at the request of a Member State or upon the initiative of the Commission. ê 2008/57/EC (adapted) ð new 8. The drafting, adoption and review of the TSIs shall take account of the opinion of the social partners as regards the conditions referred to in Article 54(4)(g). ð To this end, the Agency shall consult the social partners before submitting to the Commission recommendations on TSIs and their amendments. ï To this end, the social partners shall be consulted before the draft TSI is submitted, for adoption or review, to the committee referred to in Article 29.The social partners shall be consulted in the context of the Sectoral Dialogue Committee set up in accordance with 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. The social partners shall issue their opinion within three months. 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. In case a new authorisation, renewal or upgrading of these subsystems is needed for duly justified safety or interoperability reasons, corresponding deadlines shall be fixed either in the TSI or, as appropriate, by the Member States.

10. The TSIs shall be published by the Commission in the Official Journal of the European Union.Article 67 Deficiencies in TSIs 1. If, after its adoption, it appears that a TSI does not fully meet the essential requirements, the committee referred to in Article 29 may be consulted at the request of a Member State or upon the initiative of the Commission. The Commission may request a technical opinion from the Agency. The Commission, with the involvement of the committee, shall analyse the technical opinion. 2. If the TSI needs to be amended because of a minor error and this does not justify an immediate revision, the Commission may recommend that the technical opinion is used pending the review of the TSI in accordance with Article 6(1). In that case, the Agency shall publish the technical opinion. 3. If the TSI needs to be amended because of an important or critical error, the revision procedure referred to in Article 6(1) shall be applied forthwith. ò new 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. ê 2008/57/EC Article 8 Extension of the scope of TSIs 1. The Commission shall adopt, in accordance with the regulatory procedure referred to in Article 29(3), one or more mandates aiming at the development of new TSIs and/or the review of TSIs already adopted with a view to covering lines and vehicles not yet covered. 2. The first such mandate shall indicate a first group of new TSIs and/or amendments to TSIs to be adopted by January 2012, without prejudice to Article 5(5) as regards the possibility of providing for specific cases and without prejudice to Article 9 allowing for derogations in particular circumstances. This first mandate shall be drawn up on the basis of a recommendation from the Agency with a view to determining new TSIs to be developed and/or existing TSIs to be amended in the light of the expected cost-effectiveness of each proposed measure and on the basis of the principle of proportionality of measures to be taken at Community level. To this end, appropriate consideration shall be given to Annex I, point 4 and the necessary balance between, on the one hand, the objectives of uninterrupted movement of trains and of technical harmonisation, and, on the other hand, the trans-European, national, regional or local level of traffic concerned. 3. Until such time as the extension of the scope of the TSIs to cover the whole of the rail network takes effect: (a) authorisations for the placing in service –of vehicles and on-board control-command and signalling subsystems to be used at least partially on the part of the network that does not yet fall within the scope of the TSIs, in respect of that part of the network,

–of infrastructure, energy and trackside control-command and signalling subsystems on the parts of the network that do not yet fall within the scope of the TSIs, shall be granted in accordance with the national rules referred to in Article 8 of Directive 2004/49/EC, or, where applicable, Article 17(3) of this Directive; (b) authorisations for the placing in service of vehicles to be used occasionally on the part of the network that does not yet fall within the scope of the TSIs, in respect of that part of the network, shall be granted in accordance with Articles 21 to 27 and the national rules referred to in Article 8 of Directive 2004/49/EC, or, where applicable, Article 17(3) of this Directive. 4. A Member State need not apply the new or revised TSIs adopted in accordance with paragraph 2 in the case of projects at an advanced stage of development or subject to a contract in the course of performance when the relevant group of TSIs is published. ê 2008/57/EC (adapted) Article 79 Derogations Ö Non-application of the TSIs Õ ò new 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 compromise the economic viability of the project. 2. In the case referred to in paragraph 1(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. ê 2008/57/EC

1. In the absence of relevant specific cases, a Member State need not apply one or more TSIs in accordance with this Article in the following cases: (a) for a proposed new subsystem, for the renewal or upgrading of an existing subsystem, 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 when these TSIs are published; (b) for any project concerning the renewal or upgrading of an existing subsystem where the loading gauge, track gauge, space between the tracks or electrification voltage in these TSIs is not compatible with those of the existing subsystem; (c) for a proposed new subsystem or for the proposed renewal or upgrading of an existing subsystem in the territory of that Member State when its rail network is separated or isolated by the sea or separated as a result of special geographical conditions from the rail network of the rest of the Community; (d) for any proposed renewal, extension or upgrading of an existing subsystem, when the application of these TSIs would compromise the economic viability of the project and/or the compatibility of the rail system in that Member State; (e) 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; (f) for vehicles coming from or going to third countries the track gauge of which is different from that of the main rail network within the Community. 2. In the cases referred to in paragraph 1, the Member State concerned shall communicate to the Commission a file containing the information set out in Annex IX. The Commission shall analyse the measures proposed by the Member State and shall inform the committee referred to in Article 29. 3. In the case referred to in paragraph 1(a), within one year of entry into force of each TSI each Member State shall communicate to the Commission a list of projects that are taking place within its territory and are at an advanced stage of development. 4. In the cases referred to in paragraph 1(a), (c) and (e), the Commission shall check that the file is in conformity and shall inform the Member State of the results of its analysis. Where necessary, a recommendation shall be drawn up concerning the specifications to be applied. The Member State may apply the alternative provisions referred to in Annex IX without delay. 5. In the cases referred to in paragraph 1(b), (d) and (f), the Commission shall decide, in accordance with the regulatory procedure referred to in Article 29(3), whether to accept a request for a derogation. In the case referred to in paragraph 1(b), the Commission's decision shall not cover the loading gauge and the track gauge. The Commission shall give its decision within six 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. Pending the Commission's decision, in the case referred to in paragraph 1(f), a Member State may apply the alternative provisions referred to in Annex IX. ê 2008/57/EC 6. All Member States shall be informed of the results of the analyses and of the outcome of the procedure set out in paragraphs 3 4 and 5. ê 2008/57/EC CHAPTER III INTEROPERABILITY CONSTITUENTS Article 810 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 and are suitably installed and maintained. 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, the components of which are set out in Annex IV. ò new The Commission shall establish, by means of implementing acts, 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). ê 2008/57/EC (adapted) ð new Article 911 Conformity or suitability for use 1. Member States ð and the Agency ï shall consider Ö as being interoperable and meeting the essential requirements Õ, those interoperability constituents ð which are covered by ï which bear the 'EC' declaration of conformity or suitability for use. as complying with the essential requirements of this Directive. ê 2008/57/EC ð new 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 ð and the Agency ï 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 810(1). Article 12 Non-compliance of European specifications with essential requirements Where it appears to a Member State or the Commission that a TSIs do not comply with the essential requirements European specifications used directly or indirectly to achieve the objectives of this Directive do not meet the essential requirements, the committee referred to in Article 29 shall be informed thereof and the Commission shall adopt the most appropriate measure, being: (a) partial or total withdrawal of the specifications concerned from the publications containing them, or their amendment, after consultation, where European standards are involved, of the Committee set up under Directive 98/34/EC, or (b) review of the TSI in accordance with Article 7. ê 2008/57/EC (adapted) ð new Article 1013 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 Community Ö Union Õ 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 Ö conformity assessment Õ body with which the manufacturer or his authorised representative established in the Community Ö Union Õ has lodged the application. 3. Where interoperability constituents are the subject of other Community Ö Union Õ 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 established in the Community has met the obligations Ö laid down in Õ of 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 Ö any person who Õ whomsoever 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. ð In order to avoid that interoperability constituents non complying with essential requirements are being placed on the market, and without ï Without prejudice to the provisions of Article 1114: (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 Community Ö Union Õ 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; ê 2008/57/EC (b) where no