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Document 02016L0797-20200528
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (recast) (Text with EEA relevance)Text with EEA relevance
Consolidated text: Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (recast) (Text with EEA relevance)Text with EEA relevance
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (recast) (Text with EEA relevance)Text with EEA relevance
02016L0797 — EN — 28.05.2020 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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DIRECTIVE (EU) 2016/797 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2016 on the interoperability of the rail system within the European Union (recast) (OJ L 138 26.5.2016, p. 44) |
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DIRECTIVE (EU) 2020/700 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 May 2020 |
L 165 |
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27.5.2020 |
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DIRECTIVE (EU) 2016/797 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 May 2016
on the interoperability of the rail system within the European Union
(recast)
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
This Directive shall not apply to:
metros;
trams and light rail vehicles, and infrastructure used exclusively by those vehicles;
networks that are functionally separate from the rest of the Union rail system and intended only for the operation of local, urban or suburban passenger services, as well as undertakings operating solely on those networks.
Member States may exclude from the scope of the measures implementing this Directive:
privately owned railway infrastructure, including sidings, used by its owner or by an operator for the purpose of their respective freight activities or for the transport of persons for non-commercial purposes, and vehicles used exclusively on such infrastructure;
infrastructure and vehicles reserved for a strictly local, historical or touristic use;
light rail infrastructure occasionally used by heavy rail vehicles under the operational conditions of the light rail system, where it is necessary for the purposes of connectivity of those vehicles only; and
vehicles primarily used on light rail infrastructure but equipped with some heavy rail components necessary to enable transit to be effected on a confined and limited section of heavy rail infrastructure for connectivity purposes only.
In the case of tram-trains operating in the Union rail system, where there are no TSIs that apply to those tram-trains, the following shall apply:
Member States concerned shall ensure that national rules or other relevant accessible measures are adopted in order to ensure that such tram-trains meet the relevant essential requirements;
Member States may adopt national rules in order to specify the authorisation procedure applicable to such tram-trains. The authority issuing the vehicle authorisation shall consult the relevant national safety authority in order to ensure that mixed operation of tram-trains and heavy rail trains meet all essential requirements as well as relevant common safety targets (‘CSTs’);
by way of derogation from Article 21, in the case of cross-border operation, the relevant competent authorities shall cooperate with a view to issuing the vehicle authorisations.
This paragraph does not apply to vehicles excluded from the scope of this Directive in accordance with paragraphs 3 and 4.
Article 2
Definitions
For the purposes of this Directive:
‘Union rail system’ means the elements listed in Annex I;
‘interoperability’ means the ability of a rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance;
‘vehicle’ means a railway vehicle suitable for circulation on wheels on railway lines, with or without traction; a vehicle is composed of one or more structural and functional subsystems;
‘network’ means the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the Union rail system;
‘subsystems’ means the structural or functional parts of the Union rail system, as set out in Annex II;
‘mobile subsystem’ means the rolling stock subsystem and the on-board control-command and signalling subsystem;
‘interoperability constituents’ means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly, including both tangible objects and intangible objects;
‘product’ means a product obtained through a manufacturing process, including interoperability constituents and subsystems;
‘essential requirements’ means all the conditions set out in Annex III which must be met by the Union rail system, the subsystems, and the interoperability constituents, including interfaces;
‘European specification’ means a specification which falls into one of the following categories:
‘technical specification for interoperability’ (TSI) means a specification adopted in accordance with this Directive by which each subsystem or part of a subsystem is covered in order to meet the essential requirements and ensure the interoperability of the Union rail system;
‘basic parameter’ means any regulatory, technical or operational condition which is critical to interoperability and is specified in the relevant TSIs;
‘specific case’ means any part of the rail system which needs special provisions in the TSIs, either temporary or permanent, because of geographical, topographical or urban environment constraints or those affecting compatibility with the existing system, in particular railway lines and networks isolated from the rest of the Union, the loading gauge, the track gauge or space between the tracks and vehicles strictly intended for local, regional or historical use, as well as vehicles originating from or destined for third countries;
‘upgrading’ means any major modification work on a subsystem or part of it which results in a change in the technical file accompanying the ‘EC’ declaration of verification, if that technical file exists, and which improves the overall performance of the subsystem;
‘renewal’ means any major substitution work on a subsystem or part of it which does not change the overall performance of the subsystem;
‘existing rail system’ means the infrastructure composed of lines and fixed installations of the existing rail network as well as the vehicles of all categories and origins travelling on that infrastructure;
‘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;
‘tram-train’ means a vehicle designed for combined use on both a light-rail infrastructure and a heavy-rail infrastructure;
‘placing in service’ means all the operations by which a subsystem is put into its operational service;
‘contracting entity’ means a public or private entity which orders the design and/or construction or the renewal or upgrading of a subsystem;
‘keeper’ means the natural or legal person that, being the owner of a vehicle or having the right to use it, exploits the vehicle as a means of transport and is registered as such in a vehicle register referred to in Article 47;
‘applicant’ means a natural or legal person requesting an authorisation, be it a railway undertaking, an infrastructure manager or any other person or legal entity, such as a manufacturer, an owner or a keeper; for the purpose of Article 15, the ‘applicant’ means a contracting entity or a manufacturer, or its authorised representatives; for the purpose of Article 19, the ‘applicant’ means a natural or legal person requesting the Agency's decision for the approval of the technical solutions envisaged for the ERTMS track-side equipment projects;
‘project at an advanced stage of development’ means any project the planning or construction stage of which has reached a point where a change in the technical specifications may compromise the viability of the project as planned;
‘harmonised standard’ means a European standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012;
‘national safety authority’ means a safety authority as defined in point (7) of Article 3 of Directive (EU) 2016/798;
‘type’ means a vehicle type defining the basic design characteristics of the vehicle as covered by a type or design examination certificate described in the relevant verification module;
‘series’ means a number of identical vehicles of a design type;
‘entity in charge of maintenance’ (‘ECM’) means an entity in charge of maintenance as defined in point (20) of Article 3 of Directive (EU) 2016/798;
‘light rail’ means an urban and/or suburban rail transport system with a crashworthiness of C-III or C-IV (in accordance with EN 15227:2011) and a maximum strength of vehicle of 800 kN (longitudinal compressive force in coupling area); light rail systems may have their own right of way or share it with road traffic and usually do not exchange vehicles with long-distance passenger or freight traffic;
‘national rules’ means all binding rules adopted in a Member State, irrespective of the body issuing them, which contain railway safety or technical requirements, other than those laid down by Union or international rules which are applicable within that Member State to railway undertakings, infrastructure managers or third parties;
‘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;
‘area of use of a vehicle’ means a network or networks within a Member State or a group of Member States in which a vehicle is intended to be used;
‘acceptable means of compliance’ means non-binding opinions issued by the Agency to define ways of establishing compliance with the essential requirements;
‘acceptable national means of compliance’ means non-binding opinions issued by Member States to define ways of establishing compliance with national rules;
‘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;
‘manufacturer’ means any natural or legal person who manufactures a product in the form of interoperability constituents, subsystems or vehicles, or has it designed or manufactured, and markets it under his name or trademark;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer or a contracting entity to act on behalf of that manufacturer or contracting entity in relation to specified tasks;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, subsystem, process or service;
‘accreditation’ means accreditation as defined in point (10) of Article 2 of Regulation (EC) No 765/2008;
‘national accreditation body’ means a national accreditation body as defined in point (11) of Article 2 of Regulation (EC) No 765/2008;
‘conformity assessment’ means the process demonstrating whether specified requirements relating to a product, process, service, subsystem, person or body have been fulfilled;
‘conformity assessment body’ means a body that has been notified or designated to be responsible for conformity assessment activities, including calibration, testing, certification and inspection; a conformity assessment body is classified as a ‘notified body’ following notification by a Member State; a conformity assessment body is classified as a ‘designated body’ following designation by a Member State;
‘person with disabilities’ and ‘person with reduced mobility’ shall include any person who has a permanent or temporary physical, mental, intellectual or sensory impairment which, in interaction with various barriers, may hinder the full and effective use by that person of transport on an equal basis with other passengers or whose mobility when using transport is reduced due to age;
‘infrastructure manager’ means an infrastructure manager as defined in point (2) of Article 3 of Directive 2012/34/EU of the European Parliament and of the Council ( 1 );
‘railway undertaking’ means a railway undertaking as defined in point (1) of Article 3 of Directive 2012/34/EU, and any other public or private undertaking, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking is to ensure traction; this also includes undertakings which provide traction only.
Article 3
Essential requirements
CHAPTER II
TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY
Article 4
Content of TSIs
Vehicles shall comply with TSIs and national rules in force at the time of the request for authorisation of placing on the market in accordance with this Directive and without prejudice to point (f) of paragraph 3.
The conformity and compliance of fixed subsystems and vehicles shall be permanently maintained while they are in use.
To the extent necessary to achieve the objectives of this Directive referred to in Article 1, each TSI shall:
indicate its intended scope (part of network or vehicles referred to in Annex I; subsystem or part of subsystem referred to in Annex II);
lay down essential requirements for each subsystem concerned and its interfaces in relation to other subsystems;
establish the functional and technical specifications to be met by the subsystem and its interfaces in relation to other subsystems. If necessary, these specifications may vary according to the use of the subsystem, for example according to the categories of line, hub and/or vehicles provided for in Annex I;
determine the interoperability constituents and interfaces which must be covered by European specifications, including European standards, which are necessary to achieve interoperability within the Union rail system;
state, in each case under consideration, which procedures are to be used in order to assess the conformity or the suitability for use of the interoperability constituents, on the one hand, or the ‘EC’ verification of the subsystems, on the other. Those procedures shall be based on the modules defined in Commission Decision 2010/713/EU ( 2 );
indicate the strategy for the application of the TSI. In particular, it is necessary to specify the stages to be completed, taking into account the estimated costs and benefits and the expected repercussions for the stakeholders affected in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSI shall be the norm. Where coordinated implementation of the TSI is necessary, such as along a corridor or between infrastructure managers and railway undertakings, the strategy may include proposals for staged completion;
indicate, for the staff concerned, the professional qualifications and health and safety conditions at work required for the operation and maintenance of the above subsystem, as well as for the application of the TSIs;
indicate the provisions applicable to the existing subsystems and vehicles, in particular in the event of upgrading and renewal and, in such cases, the modification work which requires an application for a new authorisation;
indicate the parameters of the vehicles and fixed subsystems to be checked by the railway undertaking and the procedures to be applied to check those parameters after the delivery of the vehicle authorisation for placing on the market and before the first use of the vehicle to ensure compatibility between vehicles and the routes on which they are to be operated.
Article 5
Drafting, adoption and review of TSIs
In order to set out the specific objectives of each TSI, the Commission shall be empowered to adopt delegated acts in accordance with Article 50 concerning, in particular and where appropriate:
the geographical and technical scope of the TSIs;
the applicable essential requirements;
the list of regulatory, technical and operational conditions to be harmonised at the level of subsystems and at the level of the interfaces between subsystems and their expected level of harmonisation;
the railway-specific procedures for assessment of conformity and suitability for use of the interoperability constituents;
the railway-specific procedures to assess the ‘EC’ verification of the subsystems;
the categories of staff involved in the operation and maintenance of the subsystems concerned and the general objectives for setting the minimum requirements for professional qualifications and health and safety conditions for the staff concerned;
any other necessary element to be taken into account to ensure interoperability pursuant to Article 1(1) and (2) within the Union rail system, such as alignment of TSI with European and international standards or specifications.
When adopting those delegated acts, the Commission shall justify the need for a new or substantially amended TSI, including its impact on existing rules and technical specifications.
Each draft TSI shall be drawn up in the following stages:
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 Agency shall draw up the draft TSI on the basis of the basic parameters referred to in point (a). Where appropriate, the Agency shall take account of technical progress, of standardisation work already carried out, of working parties already in place and of acknowledged research work.
Article 6
Deficiencies in TSIs
Article 7
Non-application of TSIs
Member States may allow the applicant not to apply one or more TSIs or parts of them in the following cases:
for a proposed new subsystem or part of it, for the renewal or upgrading of an existing subsystem or part of it, or for any element referred to in Article 1(1) which is at an advanced stage of development or which is the subject of a contract in the course of performance on the date of application of the TSI(s) concerned;
where, following an accident or a natural disaster, the conditions for the rapid restoration of the network do not economically or technically allow for partial or total application of the relevant TSIs, in which case the non-application of the TSIs shall be limited to the period before the restoration of the network;
for any proposed renewal, extension or upgrading of an existing subsystem or part of it, when the application of the TSI(s) concerned would compromise the economic viability of the project and/or the compatibility of the rail system in the Member State concerned, for example in relation to the loading gauge, track gauge, space between tracks or electrification voltage;
for vehicles arriving from or going to third countries the track gauge of which is different from that of the main rail network within the Union;
for a proposed new subsystem or for the proposed renewal or upgrading of an existing subsystem in the territory of the Member State concerned when its rail network is separated or isolated by the sea or separated as a result of special geographical conditions from the rail network of the rest of the Union.
In the cases referred to in the third subparagraph of Article 21(6), the applicant shall submit the file to the Agency. The Agency shall consult the relevant safety authorities and give its final opinion to the Commission.
CHAPTER III
INTEROPERABILITY CONSTITUENTS
Article 8
Conditions for the placing on the market of interoperability constituents
Member States shall take all necessary steps to ensure that interoperability constituents are:
placed on the market only if they enable interoperability to be achieved within the Union rail system while at the same time meeting the essential requirements;
used in their area of use as intended and suitably installed and maintained.
This paragraph shall not prevent the placing on the market of those constituents for other applications.
Article 9
Conformity or suitability for use
Where the TSI so requires, the ‘EC’ declaration shall be accompanied by:
a certificate, issued by a notified body or bodies, of the intrinsic conformity of an interoperability constituent considered in isolation, to the technical specifications to be met;
a certificate, issued by a notified body or bodies, of the suitability for use of an interoperability constituent considered within its railway environment, particularly in the case of functional requirements concerned.
Article 10
Procedure for ‘EC’ declaration of conformity or suitability for use
Article 11
Non-compliance of interoperability constituents with essential requirements
Where a Member State finds that an interoperability constituent covered by the ‘EC’ declaration of conformity or suitability for use and placed on the market is, when used as intended, unlikely to meet the essential requirements, that Member State shall take all necessary steps to restrict its field of application, prohibit its use, withdraw it from the market or recall it. The Member State shall forthwith inform the Commission, the Agency and the other Member States of the measures taken and give reasons for its decision, stating in particular whether the failure to conform is due to:
failure to meet the essential requirements;
incorrect application of European specifications where application of such specifications is relied upon;
inadequacy of European specifications.
Where the decision referred to in paragraph 1 results from an inadequacy of European specifications, the Member States, the Commission or the Agency, as appropriate, shall apply one or more of the following measures:
partial or total withdrawal of the specification concerned from the publications containing them;
if the relevant specification is a harmonised standard, restriction or withdrawal of that standard in accordance with Article 11 of Regulation (EU) No 1025/2012;
review of the TSI in accordance with Article 6.
CHAPTER IV
SUBSYSTEMS
Article 12
Free movement of subsystems
Without prejudice to the provisions of Chapter V, Member States shall not, in their territory and on grounds relating to this Directive, prohibit, restrict or hinder the construction, placing in service and operation of structural subsystems constituting the rail system which meet the essential requirements. In particular, they shall not require checks which have already been carried out:
as part of the procedure leading to the ‘EC’ declaration of verification; or
in other Member States, before or after the entry into force of this Directive, with a view to verifying compliance with identical requirements under identical operational conditions.
Article 13
Conformity with TSIs and national rules
National rules for implementing the essential requirements and, where relevant, acceptable national means of compliance, shall apply in the following cases:
where the TSIs do not cover, or do not fully cover, certain aspects corresponding to the essential requirements, including open points as referred to in Article 4(6);
where non-application of one or more TSIs or parts of them has been notified under Article 7;
where a specific case requires the application of technical rules not included in the relevant TSI;
national rules used to specify existing systems, limited to the aim of assessing technical compatibility of the vehicle with the network;
networks and vehicles not covered by TSIs;
as an urgent temporary preventive measure, in particular following an accident.
Article 14
Notification of national rules
Member States shall notify to the Commission and to the Agency the existing national rules referred to in Article 13(2) in the following cases:
where the national rule(s) has/have not been notified by 15 June 2016. In that case, they shall be notified by 16 December 2016;
each time the rules are changed;
when a new request has been submitted in accordance with Article 7 for non-application of the TSI;
where national rules become redundant after publication or revision of the TSI concerned.
Member States may lay down new national rules only in the following cases:
when a TSI does not fully meet the essential requirements;
as an urgent preventive measure, in particular following an accident.
The Agency shall classify, in accordance with the implementing acts referred to in the first subparagraph, the national rules which are notified in accordance with this Article.
Article 15
Procedure for establishing the ‘EC’ declaration of verification
The Commission may specify, by means of implementing acts:
the details of the ‘EC’ verification procedures for subsystems, including the verification procedure in the case of national rules and the documents to be submitted by the applicant for the purposes of that procedure;
the templates for the ‘EC’ declaration of verification, including in the case of a modification of the subsystem or in the case of additional verifications, the intermediate statement of verification, and templates for documents of the technical file that is to accompany those declarations as well as templates for the certificate of verification.
Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 51(3).
Article 16
Non-compliance of subsystems with essential requirements
The Member State making the request shall state whether the failure to fully comply with this Directive is due to:
non-compliance with the essential requirements or with a TSI, or incorrect application of a TSI, in which case the Commission shall forthwith inform the Member State where the person who drew up the ‘EC’ declaration of verification in error resides and shall request that Member State to take the appropriate measures;
inadequacy of a TSI, in which case the procedure for amending the TSI as referred to in Article 6 shall apply.
Article 17
Presumption of conformity
Interoperability constituents and subsystems which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements covered by those standards or parts thereof.
CHAPTER V
PLACING ON THE MARKET AND PLACING IN SERVICE
Article 18
Authorisation for the placing in service of fixed installations
The applicant shall submit a request for authorisation of the placing in service of fixed installations to the national safety authority. The application shall be accompanied by a file which includes documentary evidence of:
the declarations of verification referred to in Article 15;
the technical compatibility of the subsystems with the system into which they are being integrated, established on the basis of the relevant TSIs, national rules and registers;
the safe integration of the subsystems, established on the basis of the relevant TSIs, national rules, and the common safety methods (‘CSMs’) set out in Article 6 of Directive (EU) 2016/798;
in the case of trackside control-command and signalling subsystems involving European Train Control System (ETCS) and/or Global System for Mobile Communications — Railway (GSM-R) equipment, the positive decision of the Agency issued in accordance with Article 19 of this Directive; and, in the case of a change to the draft tender specifications or to the description of the envisaged technical solutions that occurred after the positive decision, the compliance with the result of the procedure referred to in Article 30(2) of Regulation (EU) 2016/796.
The national safety authority shall verify the completeness, relevance and consistency of the file, and, in the case of trackside ERTMS equipment, compliance with the positive decision of the Agency issued in accordance with Article 19 of this Directive and, where appropriate, compliance with the result of the procedure referred to in Article 30(2) of Regulation (EU) 2016/796. Following such verification, the national safety authority shall issue the authorisation for placing in service of fixed installations, or inform the applicant of its negative decision, within a pre-determined, reasonable time, and, in any case, within four months of receipt of all relevant information.
In the event of renewal or upgrading of existing subsystems, the applicant shall send a file describing the project to the national safety authority. Within one month of receipt of the applicant's request, the national safety authority shall inform the applicant that the file is complete or ask for relevant supplementary information, setting a reasonable deadline for the provision thereof. The national safety authority, in close cooperation with the Agency in the case of trackside ERTMS projects, shall examine the file and shall decide whether a new authorisation for placing in service is needed, on the basis of the following criteria:
the overall safety level of the subsystem concerned may be adversely affected by the works envisaged;
it is required by the relevant TSIs;
it is required by the national implementation plans established by the Member States; or
changes are made to the values of the parameters on the basis of which the authorisation was already granted.
The national safety authority shall take its decision within a predetermined, reasonable time, and, in any case, within four months of receipt of all relevant information.
Article 19
Harmonised implementation of ERTMS in the Union
The applicant shall submit a request for the Agency's approval. The application relating to individual ERTMS projects or for a combination of projects, a line, a group of lines or a network, shall be accompanied by a file which includes:
the draft tender specifications or the description of the envisaged technical solutions;
documentary evidence of the conditions necessary for technical and operational compatibility of the subsystem with the vehicles intended to operate on the relevant network;
documentary evidence of the compliance of technical solutions envisaged with the relevant TSIs;
any other relevant documents, such as national safety authority opinions, declarations of verification or conformity certificates.
That application and information about all applications, the stages of the relevant procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796.
The national safety authorities may issue an opinion on the request for approval either to the applicant before the submission of the request or to the Agency after such a submission.
The Agency shall issue a positive decision, or inform the applicant of possible deficiencies, within a predetermined, reasonable time period, and in any case, within two months of receipt of all relevant information. The Agency shall base its opinion on the file of the applicant and on possible opinions from the national safety authorities.
If the applicant agrees with the deficiencies identified by the Agency, the applicant shall rectify the project design and introduce a new request for approval to the Agency.
If the applicant does not agree with the deficiencies identified by the Agency, the procedure referred to in paragraph 5 shall apply.
In the case referred to in point (a) of Article 7(1), the applicant shall not request a new assessment.
Article 20
Placing on the market of mobile subsystems
Article 21
Vehicle authorisation for placing on the market
The application for a vehicle authorisation for placing on the market shall be accompanied by a file concerning the vehicle or vehicle type and including documentary evidence of:
the placing on the market of the mobile subsystems of which the vehicle is composed in accordance with Article 20, on the basis of the ‘EC’ declaration of verification;
the technical compatibility of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, and where applicable, national rules;
the safe integration of the subsystems referred to in point (a) within the vehicle, established on the basis of the relevant TSIs, and where applicable, national rules, and the CSMs referred to in Article 6 of Directive (EU) 2016/798;
the technical compatibility of the vehicle with the network in the area of use referred to in paragraph 2, established on the basis of the relevant TSIs and, where applicable, national rules, registers of infrastructure and the CSM on risk assessment referred to in Article 6 of Directive (EU) 2016/798.
That application and information about all applications, the stages of the relevant procedures and their outcome, and, where applicable, the requests and decisions of the Board of Appeal, shall be submitted through the one-stop shop referred to in Article 12 of Regulation (EU) 2016/796.
Whenever tests are necessary in order to obtain documentary evidence of the technical compatibility referred to in points (b) and (d) of the first subparagraph, the national safety authorities involved may issue temporary authorisations to the applicant to use the vehicle for practical verifications on the network. The infrastructure manager, in consultation with the applicant, shall make every effort to ensure that any tests take place within three months of receipt of the applicant's request. Where appropriate, the national safety authority shall take measures to ensure that the tests take place.
The Agency shall issue vehicle authorisations for placing on the market in respect of vehicles having an area of use in one or more Member States. In order to issue such authorisations, the Agency shall:
assess the elements of the file specified in points (b), (c) and (d) of the first subparagraph of paragraph 3 in order to verify the completeness, relevance and consistency of the file in relation to the relevant TSIs; and
refer the applicant's file to the national safety authorities concerned by the intended area of use for assessment of the file in order to verify its completeness, relevance and consistency in relation to point (d) of the first subparagraph of paragraph 3 and to the elements specified in points (a), (b) and (c) of the first subparagraph of paragraph 3 in relation to the relevant national rules.
As part of the assessments pursuant to points (a) and (b) and in the case of justified doubts, the Agency or the national safety authorities may request that tests be conducted on the network. In order to facilitate those tests, the national safety authorities involved may issue temporary authorisations to the applicant to use the vehicle for tests on the network. The infrastructure manager shall make every effort to ensure that any such test takes place within three months of the request of the Agency or the national safety authority.
The Agency shall take full account of the assessments under paragraph 5 before taking its decision on the issuance of the vehicle authorisation for placing on the market. The Agency shall issue the authorisation for placing on the market, or inform the applicant of its negative decision, within a predetermined, reasonable time, and in any case within four months of receipt of all relevant information.
In the event of non-application of one or more TSIs or parts of them as referred to in Article 7, the Agency shall issue the vehicle authorisation only after application of the procedure laid down in that Article.
The Agency shall take full responsibility for the authorisations it issues.
Where the Board of Appeal agrees with the Agency, the Agency shall take a decision without delay.
Where the Board of Appeal agrees with the negative assessment of the national safety authority, the Agency shall issue an authorisation with an area of use excluding the parts of the network which received a negative assessment.
Where the Agency disagrees with a positive assessment of one or more national safety authorities pursuant to point (b) of paragraph 5, it shall inform the authority or authorities in question, giving reasons for its disagreement. The Agency and the national safety authority or authorities shall cooperate with a view to agreeing on a mutually acceptable assessment. Where necessary, as decided by the Agency and the national safety authority or authorities, this process shall also involve the applicant. If no mutually acceptable assessment can be agreed on within one month after the Agency has informed the national safety authority and authorities of its disagreement, the Agency shall take its final decision.
If the area of use is limited to the territory of one Member State and in the event of non-application of one or more TSIs or parts of them as referred to in Article 7, the national safety authority shall issue the vehicle authorisation only after application of the procedure laid down in that Article.
The national safety authority shall take full responsibility for the authorisations it issues.
By 16 June 2018, the Commission shall adopt by means of implementing acts practical arrangements specifying:
how the requirements for the vehicle authorisation for placing on the market and for vehicle type authorisation laid down in this Article shall be fulfilled by the applicant and listing the documents required;
the details of the authorisation process, such as procedural stages and timeframes for each stage of the process;
how the requirements laid down in this Article shall be complied with by the Agency and the national safety authority through the different stages of the application and authorisation process including in the assessment of applicants' files.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(3). They shall take into account the experience gained during the preparation of the cooperation agreements referred to in paragraph 14 of this Article.
Vehicle authorisations for placing on the market shall state:
the area(s) of use;
the values of the parameters set out in the TSIs and, where applicable, in the national rules, for checking the technical compatibility between the vehicle and the area of use;
the vehicle's compliance with the relevant TSIs and sets of national rules, relating to the parameters referred to in point (b);
the conditions for use of the vehicle and other restrictions.
If the negative decision of the Agency is confirmed, the applicant may bring an appeal before the Board of Appeal designated under Article 55 of Regulation (EU) 2016/796.
If the negative decision of a national safety authority is confirmed, the applicant may bring an appeal before an appeal body in accordance with the national law. Member States may designate the regulatory body referred to in Article 55 of Directive 2012/34/EU for the purpose of this appeal procedure. In that case, Article 18(3) of Directive (EU) 2016/798 shall apply.
In the event of renewal or upgrading of existing vehicles which already have a vehicle authorisation for placing on the market, a new vehicle authorisation for placing on the market shall be required if:
changes are made to the values of the parameters referred to in point (b) of paragraph 10 which are outside the range of acceptable parameters as defined in the TSIs;
the overall safety level of the vehicle concerned may be adversely affected by the works envisaged; or
it is required by the relevant TSIs.
If the applicant has received a vehicle authorisation in accordance with paragraph 8 and wishes to extend the area of use within that Member State, it shall supplement the file with the relevant documents referred to in paragraph 3 concerning the additional area of use. It shall submit the file to the national safety authority which shall, after following the procedures laid down in paragraph 8, issue an updated authorisation covering the extended area of use.
Article 22
Registration of vehicles authorised to be placed on the market
Article 23
Checks before the use of authorised vehicles
Before a railway undertaking uses a vehicle in the area of use specified in its authorisation for placing on the market, it shall check:
that the vehicle has been authorised for placing on the market in accordance with Article 21 and is duly registered;
that the vehicle is compatible with the route on the basis of the infrastructure register, the relevant TSIs or any relevant information to be provided by the infrastructure manager free of charge and within a reasonable period of time, where such a register does not exist or is incomplete; and
that the vehicle is properly integrated in the composition of the train where it is intended to operate, taking into account the safety management system set out in Article 9 of Directive (EU) 2016/798 and the TSI on operation and traffic management.
The infrastructure manager, in consultation with the applicant, shall make every effort to ensure that any tests take place within three months of receipt of the applicant's request.
Article 24
Type authorisation of vehicles
The declaration of conformity to type shall be established in accordance with:
the verification procedures of the relevant TSIs; or
where TSIs do not apply, the conformity assessment procedures as defined in modules B+D, B+F and H1 of Decision No 768/2008/EC of the European Parliament and of the Council ( 5 ).
Article 25
Conformity of vehicles with an authorised vehicle type
Article 26
Non-compliance of vehicles or vehicle types with essential requirements
Where relevant, in the event of disagreement between the Agency and the national safety authority concerning the need to restrict or revoke the authorisation, the arbitration procedure provided for in Article 21(7) shall be followed. If the result of that procedure is that the vehicle authorisation is neither to be restricted nor revoked, the temporary safety measures referred to in paragraph 3 of this Article shall be suspended.
When a national safety authority decides to revoke an authorisation for placing on the market which it has granted, it shall forthwith inform the Agency thereof and give the reasons for its decision. The Agency shall then inform the other national safety authorities.
CHAPTER VI
CONFORMITY ASSESSMENT BODIES
Article 27
Notifying authorities
Article 28
Requirements relating to notifying authorities
A notifying authority shall:
be established in such a way as to avoid any conflict of interest with conformity assessment bodies;
be organised and operated in such a way as to safeguard the objectivity and impartiality of its activities;
be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment;
not offer or provide any activities that are performed by conformity assessment bodies or consultancy services on a commercial or competitive basis;
safeguard the confidentiality of the information it obtains;
have at its disposal a sufficient number of competent personnel for the proper performance of its tasks.
Article 29
Obligation of notifying authorities to provide information
Member States shall inform the Commission of their procedures for the assessment, notification and monitoring of conformity assessment bodies, and of any changes to those procedures.
The Commission shall make that information publicly available.
Article 30
Conformity assessment bodies
At all times and for each conformity assessment procedure and each kind or category of product in relation to which it has been notified, a conformity assessment body shall have at its disposal:
the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
the relevant descriptions of procedures in accordance with which conformity assessment is to be carried out, ensuring the transparency and the ability to apply those procedures. It shall have in place appropriate policies and procedures that distinguish between the tasks it carries out as a notified conformity assessment body and other activities;
the proper procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
It shall have the means necessary to perform in an appropriate manner the technical and administrative tasks connected with the conformity assessment activities and shall have access to all necessary equipment or facilities.
Article 31
Impartiality of conformity assessment bodies
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a body.
Article 32
Personnel of conformity assessment bodies
The personnel responsible for carrying out conformity assessment activities shall have the following skills:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Union law;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
Article 33
Presumption of conformity of a conformity assessment body
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Articles 30 to 32, in so far as the applicable harmonised standards cover those requirements.
Article 34
Subsidiaries of, and subcontracting by, notified bodies
Article 35
Accredited in-house bodies
An accredited in-house body shall meet the following requirements:
it shall be accredited in accordance with Regulation (EC) No 765/2008;
the body and its personnel shall, within the undertaking of which they form a part, be organisationally identifiable and have reporting methods which ensure their impartiality, and shall demonstrate it to the competent national accreditation body;
neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the products they assess, nor shall they engage in any activity that might conflict with their independence of judgement or integrity in relation to their assessment activities;
the body shall supply its services exclusively to the undertaking of which it forms a part.
Article 36
Application for notification
Article 37
Notification procedure
Article 38
Identification numbers and lists of notified bodies
A notified body shall be assigned a single identification number even where it is notified under several legal acts of the Union.
The Commission shall ensure that that list is kept up to date.
Article 39
Changes to notifications
Article 40
Challenges to the competence of notified bodies
Article 41
Operational obligations of notified bodies
In so doing, they shall nevertheless operate with the aim of assessing the compliance of the product with this Directive.
Article 42
Obligation of notified bodies to provide information
Notified bodies shall inform the notifying authority of the following:
any refusal, restriction, suspension or withdrawal of a certificate;
any circumstances affecting the scope of, and conditions for, notification;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
The competent national safety authorities shall also be informed of any refusal, restriction, suspension or withdrawal of a certificate under point (a).
Article 43
Exchanges of best practice
The Commission shall provide for the organisation of exchanges of best practices between the Member States' national authorities responsible for notification policy.
Article 44
Coordination of notified bodies
The Commission shall ensure appropriate coordination and cooperation between bodies notified under this Directive through the establishment of a sectoral group of notified bodies. The Agency shall support the activities of notified bodies in accordance with Article 24 of Regulation (EU) 2016/796.
Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.
Article 45
Designated bodies
The requirements relating to conformity assessment bodies set out in Articles 30 to 34 shall also apply to bodies designated under Article 15(8), except:
in the case of skills required by its personnel under point (c) of Article 32(1), where the designated body shall have appropriate knowledge and understanding of national law;
in the case of documents to be kept at the disposal of the notifying authority under Article 34(4), where the designated body shall include documents relating to work carried out by subsidiaries or subcontractors under the relevant national rules.
CHAPTER VII
REGISTERS
Article 46
Vehicle numbering system
Article 47
Vehicle registers
Until the European Vehicle Register referred to in paragraph 5 is operational, each Member State shall keep a national vehicle register. That register shall:
comply with the common specifications referred to in paragraph 2;
be kept updated by a body independent of any railway undertaking;
be accessible to the national safety authorities and investigating bodies designated in Articles 16 and 22 of Directive (EU) 2016/798; it shall also be made accessible, in response to any legitimate request, to the regulatory bodies referred to in Article 55 of Directive 2012/34/EU, and to the Agency, the railway undertakings and the infrastructure managers, as well as those persons or organisations registering vehicles or identified in the register.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(3).
The national vehicle register shall contain at least the following elements:
the EVN;
references to the ‘EC’ declaration of verification and the issuing body;
references to the European register of authorised vehicle types referred to in Article 48;
identification of the owner of the vehicle and the keeper;
restrictions on how the vehicle may be used;
references to the entity in charge of maintenance.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(3) and on the basis of a recommendation of the Agency.
The European Vehicle Register shall be developed taking into consideration the IT applications and registers already set up by the Agency and the Member States, such as the European Centralised Virtual Vehicle Register connected to the national vehicle registers. The European Vehicle Register shall be operational by 16 June 2021.
Article 48
European register of authorised vehicle types
The Agency shall set up and keep a register of authorisations to place vehicle types on the market issued in accordance with Article 24. That register shall:
be public and electronically accessible;
comply with the common specifications referred to in paragraph 2;
be linked with relevant vehicle registers.
The register shall include at least the following elements for each type of vehicle:
technical characteristics, including those related to accessibility for persons with disabilities and persons with reduced mobility, of the type of vehicle as defined in the relevant TSIs;
the manufacturer's name;
the data of the authorisations related to the area of use for a vehicle type, including any restrictions or withdrawals.
Article 49
Register of infrastructure
CHAPTER VIII
TRANSITIONAL AND FINAL PROVISIONS
Article 50
Exercise of delegation
Article 51
Committee procedure
Article 52
Motivation
Any decision taken pursuant to this Directive concerning the assessment of conformity or suitability for use of interoperability constituents or the checking of subsystems constituting the Union rail system or any decision taken pursuant to Articles 7, 12 and 17 shall set out in detail the reasons on which it is based. It shall be notified as soon as possible to the party concerned, together with an indication of the remedies available under the law in force in the Member State concerned and of the time limits allowed for the exercise of such remedies.
Article 53
Reports and information
Article 54
Transitional regime for using vehicles
Article 55
Other transitional provisions
Article 56
Recommendations and opinions of the Agency
The Agency shall provide recommendations and opinions in accordance with Article 19 of Regulation (EU) 2016/796 for the purpose of application of this Directive. Where relevant, those recommendations and opinions shall be taken into account when implementing acts are being drawn up pursuant to this Directive.
Article 57
Transposition
However, as soon as a public or private entity submits an official application to build a railway line with a view to its operation by one or more railway undertakings, the Member States concerned shall put in place measures to implement the Articles referred to in the first subparagraph within two years of receipt of the application.
Article 58
Repeal
Directive 2008/57/EC, as amended by the Directives listed in Annex V, Part A, is repealed with effect from ►M1 31 October 2020 ◄ , without prejudice to the obligations of the Member States relating to the time limits for the transposition into national law of the Directives set out in Annex V, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VI.
Article 59
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 60
Addressees
This Directive is addressed to the Member States.
ANNEX I
ELEMENTS OF THE UNION RAIL SYSTEM
1. Network
For the purposes of this Directive, the Union's network shall include the following elements:
specially built high-speed lines equipped for speeds generally equal to or greater than 250 km/h;
specially upgraded high-speed lines equipped for speeds of the order of 200 km/h;
specially upgraded high-speed lines which have special features as a result of topographical, relief or town-planning constraints, to which the speed must be adapted in each case. This category includes interconnecting lines between high-speed and conventional networks, lines through stations, accesses to terminals, depots, etc. travelled at conventional speed by ‘high-speed’ rolling stock;
conventional lines intended for passenger services;
conventional lines intended for mixed traffic (passengers and freight);
conventional lines intended for freight services;
passenger hubs;
freight hubs, including intermodal terminals;
lines connecting the abovementioned elements.
This network includes traffic management, tracking and navigation systems, technical installations for data processing and telecommunications intended for long-distance passenger services and freight services on the network in order to guarantee the safe and harmonious operation of the network and efficient traffic management.
2. Vehicles
For the purposes of this Directive, Union vehicles shall comprise all vehicles likely to travel on all or part of the Union's network:
This list of vehicles shall include those which are specially designed to operate on the different types of high-speed lines described in point 1.
ANNEX II
SUBSYSTEMS
1. List of subsystems
For the purposes of this Directive, the system constituting the Union rail system may be broken down into the following subsystems, either:
structural areas:
functional areas:
2. Description of the subsystems
For each subsystem or part of a subsystem, the list of constituents and aspects relating to interoperability is proposed by the Agency at the time of drawing up the relevant draft TSI. Without prejudging the choice of aspects and constituents relating to interoperability or the order in which they will be made subject to TSIs, the subsystems include the following:
2.1. Infrastructure
The track, points, level crossings, engineering structures (bridges, tunnels, etc.), rail-related elements of stations (including entrances, platforms, zones of access, service venues, toilets and information systems, as well as their accessibility features for persons with disabilities and persons with reduced mobility), safety and protective equipment.
2.2. Energy
The electrification system, including overhead lines and the trackside electricity consumption measuring and charging system.
2.3. Trackside control-command and signalling
All the trackside equipment required to ensure safety and to command and control movements of trains authorised to travel on the network.
2.4. On-board control-command and signalling
All the on-board equipment required to ensure safety and to command and control movements of trains authorised to travel on the network.
2.5. Operation and traffic management
The procedures and related equipment permitting coherent operation of the various structural subsystems, during both normal and degraded operation, including in particular train composition and train driving, traffic planning and management.
The professional qualifications which may be required for carrying out any type of railway service.
2.6. Telematics applications
In accordance with Annex I, this subsystem comprises two elements:
applications for passenger services, including systems which provide passengers with information before and during the journey, reservation and payment systems, luggage management and management of connections between trains and with other modes of transport;
applications for freight services, including information systems (real-time monitoring of freight and trains), marshalling and allocation systems, reservation, payment and invoicing systems, management of connections with other modes of transport and production of electronic accompanying documents.
2.7. Rolling stock
Structural body, command and control system for all train equipment, electric current collection devices, traction and energy conversion units, on-board equipment for electricity consumption measuring and charging, braking, coupling and running gear (bogies, axles, etc.) and suspension, doors, man/machine interfaces (driver, on-board staff and passengers, including accessibility features for persons with disabilities and persons with reduced mobility), passive or active safety devices and requisites for the health of passengers and on-board staff.
2.8. Maintenance
The procedures, associated equipment, logistics centres for maintenance work and reserves providing the mandatory corrective and preventive maintenance to ensure the interoperability of the Union rail system and guarantee the performance required.
ANNEX III
ESSENTIAL REQUIREMENTS
1. General requirements
1.1. Safety
|
1.1.1. |
The design, construction or assembly, maintenance and monitoring of safety-critical components, and more particularly of the components involved in train movements, must be such as to guarantee safety at the level corresponding to the aims laid down for the network, including those for specific degraded situations. |
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1.1.2. |
The parameters involved in the wheel/rail contact must meet the stability requirements needed in order to guarantee safe movement at the maximum authorised speed. The parameters of brake equipment must guarantee that it is possible to stop within a given brake distance at the maximum authorised speed. |
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1.1.3. |
The components used must withstand any normal or exceptional stresses that have been specified during their period in service. The safety repercussions of any accidental failures must be limited by appropriate means. |
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1.1.4. |
The design of fixed installations and rolling stock and the choice of the materials used must be aimed at limiting the generation, propagation and effects of fire and smoke in the event of a fire. |
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1.1.5. |
Any devices intended to be handled by users must be designed in such a way as not to impair the safe operation of the devices or the health and safety of users if used in a foreseeable manner, albeit not in accordance with the posted instructions. |
1.2. Reliability and availability
The monitoring and maintenance of fixed or movable components that are involved in train movements must be organised, carried out and quantified in such a manner as to maintain their operation under the intended conditions.
1.3. Health
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1.3.1. |
Materials likely, by virtue of the way they are used, to constitute a health hazard to those having access to them must not be used in trains and railway infrastructures. |
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1.3.2. |
Those materials must be selected, deployed and used in such a way as to restrict the emission of harmful and dangerous fumes or gases, particularly in the event of fire. |
1.4. Environmental protection
|
1.4.1. |
The environmental impact of establishment and operation of the rail system must be assessed and taken into account at the design stage of the system in accordance with Union law. |
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1.4.2. |
The materials used in the trains and infrastructures must prevent the emission of fumes or gases which are harmful and dangerous to the environment, particularly in the event of fire. |
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1.4.3. |
The rolling stock and energy-supply systems must be designed and manufactured in such a way as to be electromagnetically compatible with the installations, equipment and public or private networks with which they might interfere. |
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1.4.4. |
The design and operation of the rail system must not lead to an inadmissible level of noise generated by it:
—
in areas close to railway infrastructure, as defined in point (3) of Article 3 of Directive 2012/34/EU, and
—
in the driver's cab.
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|
1.4.5. |
Operation of the rail system must not give rise to an inadmissible level of ground vibrations for the activities and areas close to the infrastructure and in a normal state of maintenance. |
1.5. Technical compatibility
The technical characteristics of the infrastructure and fixed installations must be compatible with each other and with those of the trains to be used on the rail system. This requirement includes the safe integration of the vehicle's subsystem with the infrastructure.
If compliance with these characteristics proves difficult on certain sections of the network, temporary solutions, which ensure compatibility in the future, may be implemented.
1.6. Accessibility
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1.6.1. |
The ‘infrastructure’ and ‘rolling stock’ subsystems must be accessible to persons with disabilities and persons with reduced mobility in order to ensure access on an equal basis with others by way of the prevention or removal of barriers, and by way of other appropriate measures. This shall include the design, construction, renewal, upgrade, maintenance and operation of the relevant parts of the subsystems to which the public has access. |
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1.6.2. |
The ‘operations’ and ‘telematics applications for passengers’ subsystems must provide for the necessary functionality required to facilitate access for persons with disabilities and persons with reduced mobility on an equal basis with others by way of the prevention or removal of barriers, and by way of other appropriate measures. |
2. Requirements specific to each subsystem
2.1. Infrastructure
2.1.1.
Appropriate steps must be taken to prevent access to, or undesirable intrusions into, installations.
Steps must be taken to limit the dangers to which persons are exposed, particularly when trains pass through stations.
Infrastructure to which the public has access must be designed and made in such a way as to limit any human safety hazards (stability, fire, access, evacuation, platforms, etc.).
Appropriate provisions must be laid down to take account of the particular safety conditions in very long tunnels and viaducts.
2.1.2.
Infrastructure subsystems to which the public has access must be accessible for persons with disabilities and persons with reduced mobility in accordance with point 1.6.
2.2. Energy
2.2.1.
Operation of the energy-supply systems must not impair the safety either of trains or of persons (users, operating staff, trackside dwellers and third parties).
2.2.2.
The functioning of the electrical or thermal energy-supply systems must not interfere with the environment beyond the specified limits.
2.2.3.
The electricity/thermal energy-supply systems used must:
2.3. Control-command and signalling
2.3.1.
The control-command and signalling installations and procedures used must enable trains to travel with a level of safety which corresponds to the objectives set for the network. The control-command and signalling systems must continue to provide for safe passage of trains permitted to run under degraded conditions.
2.3.2.
All new infrastructure and all new rolling stock manufactured or developed after adoption of compatible control-command and signalling systems must be tailored to the use of those systems.
The control-command and signalling equipment installed in the train drivers' cabs must permit normal operation, under the specified conditions, throughout the rail system.
2.4. Rolling stock
2.4.1.
The rolling-stock structures and those of the links between vehicles must be designed in such a way as to protect the passenger and driving compartments in the event of collision or derailment.
The electrical equipment must not impair the safety and functioning of the control-command and signalling installations.
The braking techniques and the stresses exerted must be compatible with the design of the tracks, engineering structures and signalling systems.
Steps must be taken to prevent access to electrically-live constituents in order not to endanger the safety of persons.
In the event of danger, devices must enable passengers to inform the driver and accompanying staff to contact them.
The safety of passengers boarding and alighting from trains must be ensured. The access doors must incorporate an opening and closing system which guarantees passenger safety.
Emergency exits must be provided and indicated.
Appropriate provisions must be laid down to take account of the particular safety conditions in very long tunnels.
An emergency lighting system having a sufficient intensity and duration is an absolute requirement on board trains.
Trains must be equipped with a public address system which provides a means of communication to the public from on-board staff.
Passengers must be given easily understandable and comprehensive information about rules applicable to them both in railway stations and in trains.
2.4.2.
The design of the vital equipment and the running, traction and braking equipment as well as the control-command system must, in a specific degraded situation, be such as to enable the train to continue without adverse consequences for the equipment remaining in service.
2.4.3.
The electrical equipment must be compatible with the operation of the control-command and signalling installations.
In the case of electric traction, the characteristics of the current-collection devices must be such as to enable trains to travel under the energy-supply systems for the rail system.
The characteristics of the rolling stock must be such as to allow it to travel on any line on which it is expected to operate, taking account of relevant climatic conditions.
2.4.4.
Trains must be equipped with a recording device. The data collected by that device and the processing of the information must be harmonised.
2.4.5.
Rolling-stock subsystems to which the public has access must be accessible for persons with disabilities and persons with reduced mobility in accordance with point 1.6.
2.5. Maintenance
2.5.1.
The technical installations and the procedures used in the centres must ensure the safe operation of the subsystem and not constitute a danger to health and safety.
2.5.2.
The technical installations and the procedures used in the maintenance centres must not exceed the permissible levels of nuisance with regard to the surrounding environment.
2.5.3.
The maintenance installations for rolling stock must be such as to enable safety, health and comfort operations to be carried out on all stock for which they have been designed.
2.6. Operation and traffic management
2.6.1.
Alignment of the network operating rules and the qualifications of drivers and on-board staff and of the staff in the control centres must be such as to ensure safe operation, bearing in mind the different requirements of cross-border and domestic services.
The maintenance operations and intervals, the training and qualifications of the maintenance and control centre staff and the quality assurance system set up by the operators concerned in the control and maintenance centres must be such as to ensure a high level of safety.
2.6.2.
The maintenance operations and periods, the training and qualifications of the maintenance and control centre staff and the quality assurance system set up by the operators concerned in the control and maintenance centres must be such as to ensure a high level of system reliability and availability.
2.6.3.
Alignment of the network operating rules and the qualifications of drivers, on-board staff and traffic managers must be such as to ensure operating efficiency on the rail system, bearing in mind the different requirements of cross-border and domestic services.
2.6.4.
Appropriate steps must be taken to ensure that operating rules provide for the necessary functionality required to ensure accessibility for persons with disabilities and persons with reduced mobility.
2.7. Telematics applications for freight and passengers
2.7.1.
The essential requirements for telematics applications guarantee a minimum quality of service for passengers and carriers of goods, particularly in terms of technical compatibility.
Steps must be taken to ensure:
2.7.2.
The methods of use, management, updating and maintenance of these databases, software and data communication protocols must guarantee the efficiency of these systems and the quality of the service.
2.7.3.
The interfaces between these systems and users must comply with the minimum rules on ergonomics and health protection.
2.7.4.
Suitable levels of integrity and dependability must be provided for the storage or transmission of safety-related information.
2.7.5.
Appropriate steps must be taken to ensure that telematics applications for passenger subsystems provide for the necessary functionality required to ensure accessibility for persons with disabilities and persons with reduced mobility.
ANNEX IV
‘EC’ VERIFICATION PROCEDURE FOR SUBSYSTEMS
1. GENERAL PRINCIPLES
‘ “EC” verification’ means a procedure carried out by the applicant within the meaning of Article 15 to demonstrate that the requirements of the relevant Union law and any relevant national rules relating to a subsystem have been fulfilled and the subsystem may be authorised to be placed in service.
2. CERTIFICATE OF VERIFICATION ISSUED BY A NOTIFIED BODY
2.1. Introduction
For the purpose of this Directive, the verification by reference to TSIs is the procedure whereby a notified body checks and certifies that the subsystem complies with the relevant technical specifications for interoperability (TSI).
This is without prejudice to the obligations of the applicant to comply with the other applicable legal acts of the Union and any verifications by the assessment bodies required by the other rules.
2.2. Intermediate statement of verification (ISV)
2.2.1 Principles
At the request of the applicant the verifications may be done for parts of a subsystem or may be limited to certain stages of the verification procedure. In these cases, the results of verification may be documented in an ‘intermediate statement of verification’ (ISV) issued by the notified body chosen by the applicant. The ISV must provide reference to the TSIs with which the conformity has been assessed.
2.2.2 Parts of the subsystem
The applicant may apply for an ISV for any part into which he decides to split the subsystem. Each part shall be checked at each stage as set out in point 2.2.3.
2.2.3 Stages of the verification procedure
The subsystem, or certain parts of the subsystem, shall be checked at each of the following stages:
overall design;
production: construction, including, in particular, civil-engineering activities, manufacturing, constituent assembly and overall adjustment;
final testing.
The applicant may apply for an ISV for the design stage (including the type tests) and for the production stage for the whole subsystem or for any part into which the applicant decided to split it (see point 2.2.2).
2.3. Certificate of verification
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2.3.1. |
The notified bodies responsible for the verification assess the design, production and final testing of the subsystem and draw up the certificate of verification intended for the applicant who in turn draws up the ‘EC’ declaration of verification. The certificate of verification must provide reference to the TSIs with which the conformity has been assessed. Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in the case of a derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case), the certificate of verification shall give the precise reference to the TSI(s) or their parts whose conformity has not been examined by the notified body during the verification procedure. |
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2.3.2. |
Where ISV have been issued, the notified body responsible for the verification of the subsystem takes these ISV into account, and, before issuing its certificate of verification:
(a)
verifies that the ISV cover correctly the relevant requirements of the TSI(s);
(b)
checks all aspects that are not covered by the ISV; and
(c)
checks the final testing of the subsystem as a whole. |
|
2.3.3. |
In the case of a modification to a subsystem already covered by a certificate of verification, the notified body shall perform only those examinations and tests that are relevant and necessary, i.e. assessment shall relate only to the parts of the subsystem that are changed and their interfaces to the unchanged parts of the subsystem. |
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2.3.4 |
Each notified body involved in the verification of a subsystem shall draw up a file in accordance with Article 15(4) covering the scope of its activities. |
2.4. Technical file accompanying the ‘EC’ declaration of verification.
The technical file accompanying the ‘EC’ declaration of verification shall be assembled by the applicant and must contain the following:
technical characteristics linked to the design including general and detailed drawings with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems to the level of detail sufficient for documenting the verification of conformity carried out, documentation on operation and maintenance, etc., relevant for the subsystem concerned;
a list of interoperability constituents, referred to in point (d) of Article 4(3), incorporated into the subsystem;
the files referred to in Article 15(4), compiled by each of the notified bodies involved in the verification of the subsystem, which shall include:
certificates of verification issued in accordance with other legal acts of the Union;
when verification of safe integration is required pursuant to in point (c) of Article 18(4) and in point (c) of Article 21(3), the relevant technical file shall include the assessors' report(s) on the CSMs on risk assessment referred to in Article 6(3) of Directive 2004/49/EC ( 7 ).
2.5. Surveillance by notified bodies.
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2.5.1. |
The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The notified body must receive from the applicant all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem. |
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2.5.2. |
The notified body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the relevant TSI(s). It must provide those responsible for implementation with an audit report. Its presence may be required at certain stages of the building operations. |
|
2.5.3. |
In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the notified body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report. |
|
2.5.4. |
The notified body shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where required by the corresponding TSI, its suitability for use in its intended railway environment. |
2.6. Submission
A copy of the technical file accompanying the ‘EC’ declaration of verification must be kept by the applicant) throughout the service life of the subsystem. It must be sent to any Member State or the Agency, upon request.
The documentation submitted for an application for an authorisation for placing in service shall be submitted to the authority where the authorisation is sought. The national safety authority or the Agency may request that part(s) of the documents submitted together with the authorisation is/are translated into its own language.
2.7. Publication
Each notified body must periodically publish relevant information concerning:
requests for verification and ISV received;
request for assessment of conformity and suitability for use of ICs;
ISV issued or refused;
certificates of verification and ‘EC’ certificates for suitability for use issued or refused;
certificates of verification issued or refused.
2.8. Language
The files and correspondence relating to the ‘EC’ verification procedure must be written in a Union official language of the Member State in which the applicant is established or in a Union official language accepted by the applicant
3. CERTIFICATE OF VERIFICATION ISSUED BY A DESIGNATED BODY
3.1. Introduction
In the case where national rules apply, the verification shall include a procedure whereby the body designated pursuant to Article 15(8), (the designated body) checks and certifies that the subsystem complies with the national rules notified in accordance with Article 14 for each Member State in which the subsystem is intended to be authorised to be placed in service.
3.2. Certificate of verification
The designated body draws up the certificate of verification intended for the applicant.
The certificate shall contain a precise reference to the national rule(s) whose conformity has been examined by the designated body in the verification process.
In the case of national rules related to the subsystems composing a vehicle, the designated body shall divide the certificate into two parts, one part including the references to those national rules strictly related to the technical compatibility between the vehicle and the network concerned, and the other part for all other national rules.
3.3. File
The file compiled by the designated body and accompanying the certificate of verification in the case of national rules must be included in the technical file accompanying the ‘EC’ declaration of verification referred to in point 2.4 and shall contain the technical data relevant for the assessment of the conformity of the subsystem with those national rules.
3.4. Language
The files and correspondence relating to the ‘EC’ verification procedure must be written in a Union official language of the Member State in which the applicant is established or in a Union official language accepted by the applicant.
4. VERIFICATION OF PARTS OF SUBSYSTEMS IN ACCORDANCE WITH ARTICLE 15(7)
If a certificate of verification is to be issued for certain parts of a subsystem, provisions for this Annex shall apply mutatis mutandis for those parts.
ANNEX V
PART A
Repealed Directives with list of the successive amendments thereto
(referred to in Article 58)
|
Directive 2008/57/EC |
(OJ L 191, 18.7.2008, p. 1.) |
|
Directive 2009/131/EC |
(OJ L 273, 17.10.2009, p. 12.) |
|
Directive 2011/18/EU |
(OJ L 57, 2.3.2011, p. 21.) |
PART B
Time limits for transposition into national law
(referred to in Article 57)
|
Directive |
Deadline for transposition |
|
2008/57/EC |
19 July 2010 |
|
2009/131/EC |
19 July 2010 |
|
2011/18/EU |
31 December 2011 |
ANNEX VI
Correlation table
|
Directive 2008/57/EC |
This Directive |
|
Article 1 |
Article 1 |
|
Article 2(a) to (z) |
Article 2(1) to (5), (7) to (17) and (19) to (28) |
|
- |
Article 2(6), (18) and (29) to (45) |
|
Article 3 |
- |
|
Article 4 |
Article 3 |
|
Article 5(1) to (3)(g) |
Article 4(1) to (3)(g) |
|
- |
Article 4(3)(h) and (i) |
|
Article 5(4) to (8) |
Article 4(4) to (8) |
|
Article 6 |
Article 5 |
|
Article 7 |
Article 6 |
|
Article 8 |
- |
|
Article 9 |
Article 7 |
|
Article 10 |
Article 8 |
|
Article 11 |
Article 9 |
|
Article 12 |
- |
|
Article 13 |
Article 10 |
|
Article 14 |
Article 11 |
|
Article 15(1) |
Articles 18(2) |
|
Article 15(2) and (3) |
- |
|
Article 16 |
Article 12 |
|
Article 17 |
Articles 13 and 14 |
|
Article 18 |
Article 15 |
|
Article 19 |
Article 16 |
|
- |
Article 17 |
|
- |
Article 18 (except 18(3)) |
|
- |
Articles 19, 20, 21, 22 and 23 |
|
Article 20 |
- |
|
Article 21 |
- |
|
Articles 22 to 25 |
- |
|
Article 26 |
Article 24 |
|
Article 27 |
Article 14(10) |
|
- |
Article 26 |
|
Article 28 and Annex VIII |
Articles 27 to 44 |
|
- |
Article 45 |
|
Article 29 |
Article 51 |
|
Articles 30 and 31 |
- |
|
Article 32 |
Article 46 |
|
Article 33 |
Article 47(3), (4), (6) and (7) |
|
- |
Article 47(1), (2) and (5) |
|
Article 34 |
Article 48 |
|
Article 35 |
Article 49 |
|
Article 36 |
- |
|
- |
Article 50- |
|
Article 37 |
Article 52 |
|
Article 38 |
Article 57 |
|
Article 39 |
Article 53 |
|
- |
Articles 54 and 55 |
|
- |
Article 56 |
|
Article 40 |
Article 58 |
|
Article 41 |
Article 59 |
|
Article 42 |
Article 60 |
|
Annex I to III |
Annex I to III |
|
Annex IV |
Article 9(2) |
|
Annex V |
Article 15(9) |
|
Annex VI |
Annex IV |
|
Annex VII |
Article 14(10) |
|
Annex VIII |
Articles 30, 31 and 32 |
|
Annex IX |
Article 7(5) |
|
Annex X |
Annex V |
|
Annex XI |
Annex VI |
( 1 ) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32).
( 2 ) Commission Decision 2010/713/EU of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and ‘EC’ verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (OJ L 319, 4.12.2010, p. 1).
( 3 ) Commission Decision 98/500/EC of 20 May 1998 on the establishment of Sectoral Dialogue Committees promoting the Dialogue between the social partners at European level (OJ L 225, 12.8.1998, p. 27).
( 4 ) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
( 5 ) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
( 6 ) Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system (OJ L 235, 17.9.1996, p. 6).
( 7 ) Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, p. 44).