RL Interoperabilität 2016 0797 - 2020 05 - EN Konsolidiert
RL Interoperabilität 2016 0797 - 2020 05 - EN Konsolidiert
RL Interoperabilität 2016 0797 - 2020 05 - EN Konsolidiert
001 — 1
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Amended by:
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►M1 Directive (EU) 2020/700 of the European Parliament and of the L 165 27 27.5.2020
Council of 25 May 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
2. This Directive lays down the provisions relating to, for each
subsystem, the interoperability constituents, the interfaces and
procedures, and the conditions of overall compatibility of the Union
rail system required in order to achieve its interoperability.
(a) metros;
(b) trams and light rail vehicles, and infrastructure used exclusively by
those vehicles;
(c) networks that are functionally separate from the rest of the Union
rail system and intended only for the operation of local, urban or
suburban passenger services, as well as undertakings operating
solely on those networks.
4. Member States may exclude from the scope of the measures im
plementing this Directive:
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(c) light rail infrastructure occasionally used by heavy rail vehicles
under the operational conditions of the light rail system, where it
is necessary for the purposes of connectivity of those vehicles only;
and
(d) vehicles primarily used on light rail infrastructure but equipped with
some heavy rail components necessary to enable transit to be
effected on a confined and limited section of heavy rail infra
structure for connectivity purposes only.
(a) Member States concerned shall ensure that national rules or other
relevant accessible measures are adopted in order to ensure that
such tram-trains meet the relevant essential requirements;
(b) Member States may adopt national rules in order to specify the
authorisation procedure applicable to such tram-trains. The
authority issuing the vehicle authorisation shall consult the
relevant national safety authority in order to ensure that mixed
operation of tram-trains and heavy rail trains meet all essential
requirements as well as relevant common safety targets (‘CSTs’);
This paragraph does not apply to vehicles excluded from the scope of
this Directive in accordance with paragraphs 3 and 4.
Article 2
Definitions
(4) ‘network’ means the lines, stations, terminals, and all kinds of
fixed equipment needed to ensure safe and continuous operation
of the Union rail system;
(6) ‘mobile subsystem’ means the rolling stock subsystem and the on-
board control-command and signalling subsystem;
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(7) ‘interoperability constituents’ means any elementary component,
group of components, subassembly or complete assembly of
equipment incorporated or intended to be incorporated into a
subsystem, upon which the interoperability of the rail system
depends directly or indirectly, including both tangible objects
and intangible objects;
(9) ‘essential requirements’ means all the conditions set out in Annex
III which must be met by the Union rail system, the subsystems,
and the interoperability constituents, including interfaces;
(13) ‘specific case’ means any part of the rail system which needs
special provisions in the TSIs, either temporary or permanent,
because of geographical, topographical or urban environment
constraints or those affecting compatibility with the existing
system, in particular railway lines and networks isolated from
the rest of the Union, the loading gauge, the track gauge or
space between the tracks and vehicles strictly intended for local,
regional or historical use, as well as vehicles originating from or
destined for third countries;
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(18) ‘tram-train’ means a vehicle designed for combined use on both a
light-rail infrastructure and a heavy-rail infrastructure;
(21) ‘keeper’ means the natural or legal person that, being the owner of
a vehicle or having the right to use it, exploits the vehicle as a
means of transport and is registered as such in a vehicle register
referred to in Article 47;
(26) ‘type’ means a vehicle type defining the basic design characteris
tics of the vehicle as covered by a type or design examination
certificate described in the relevant verification module;
(29) ‘light rail’ means an urban and/or suburban rail transport system
with a crashworthiness of C-III or C-IV (in accordance with EN
15227:2011) and a maximum strength of vehicle of 800 kN (longi
tudinal compressive force in coupling area); light rail systems may
have their own right of way or share it with road traffic and
usually do not exchange vehicles with long-distance passenger or
freight traffic;
(30) ‘national rules’ means all binding rules adopted in a Member State,
irrespective of the body issuing them, which contain railway safety
or technical requirements, other than those laid down by Union or
international rules which are applicable within that Member State
to railway undertakings, infrastructure managers or third parties;
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(31) ‘design operating state’ means the normal operating mode and the
foreseeable degraded conditions (including wear) within the range
and the conditions of use specified in the technical and main
tenance files;
(35) ‘placing on the market’ means the first making available on the
Union's market of an interoperability constituent, subsystem or
vehicle ready to function in its design operating state;
(42) ‘conformity assessment body’ means a body that has been notified
or designated to be responsible for conformity assessment activ
ities, including calibration, testing, certification and inspection; a
conformity assessment body is classified as a ‘notified body’
following notification by a Member State; a conformity assessment
body is classified as a ‘designated body’ following designation by
a Member State;
(43) ‘person with disabilities’ and ‘person with reduced mobility’ shall
include any person who has a permanent or temporary physical,
mental, intellectual or sensory impairment which, in interaction
with various barriers, may hinder the full and effective use by
that person of transport on an equal basis with other passengers
or whose mobility when using transport is reduced due to age;
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(44) ‘infrastructure manager’ means an infrastructure manager as
defined in point (2) of Article 3 of Directive 2012/34/EU of the
European Parliament and of the Council (1);
Article 3
Essential requirements
CHAPTER II
Article 4
Content of TSIs
2. Fixed subsystems shall comply with the TSIs and national rules in
force at the time of the request for authorisation of placing in service in
accordance with this Directive and without prejudice to point (f) of
paragraph 3.
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.
(b) lay down essential requirements for each subsystem concerned and
its interfaces in relation to other subsystems;
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(c) establish the functional and technical specifications to be met by the
subsystem and its interfaces in relation to other subsystems. If
necessary, these specifications may vary according to the use of
the subsystem, for example according to the categories of line,
hub and/or vehicles provided for in Annex I;
(f) indicate the strategy for the application of the TSI. In particular, it is
necessary to specify the stages to be completed, taking into account
the estimated costs and benefits and the expected repercussions for
the stakeholders affected in order to make a gradual transition from
the existing situation to the final situation in which compliance with
the TSI shall be the norm. Where coordinated implementation of the
TSI is necessary, such as along a corridor or between infrastructure
managers and railway undertakings, the strategy may include
proposals for staged completion;
(g) indicate, for the staff concerned, the professional qualifications and
health and safety conditions at work required for the operation and
maintenance of the above subsystem, as well as for the application
of the TSIs;
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space between the tracks and vehicles originating from or destined for
third countries. For each specific case, the TSIs shall stipulate the im
plementing rules of the elements of the TSIs provided for in points (c)
to (g) of paragraph 3.
7. TSIs shall not prevent the Member States from deciding on the use
of infrastructures for the movement of vehicles not covered by the TSIs.
Article 5
Drafting, adoption and review of TSIs
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.
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Each draft TSI shall be drawn up in the following stages:
(a) the Agency shall identify the basic parameters for the TSI as well as
the interfaces with the other subsystems and any other specific cases
that may be necessary;
(b) the Agency shall draw up the draft TSI on the basis of the basic
parameters referred to in point (a). Where appropriate, the Agency
shall take account of technical progress, of standardisation work
already carried out, of working parties already in place and of
acknowledged research work.
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on TSIs and their amendments. The social partners shall be consulted
within the Sectoral Dialogue Committee set up in accordance with
Commission Decision 98/500/EC (1). The social partners shall issue
their opinion within three months of the consultation.
Article 6
Deficiencies in TSIs
1. If, after its adoption, it appears that a TSI has a deficiency, that
TSI shall be amended in accordance with Article 5(11). If appropriate,
the Commission shall apply this procedure without delay. Such defi
ciencies shall include cases which could result in unsafe operations
within a Member State.
Article 7
Non-application of TSIs
1. Member States may allow the applicant not to apply one or more
TSIs or parts of them in the following cases:
(a) for a proposed new subsystem or part of it, for the renewal or
upgrading of an existing subsystem or part of it, or for any
element referred to in Article 1(1) which is at an advanced stage
of development or which is the subject of a contract in the course of
performance on the date of application of the TSI(s) concerned;
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(b) where, following an accident or a natural disaster, the conditions for
the rapid restoration of the network do not economically or tech
nically 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;
(d) for vehicles arriving from or going to third countries the track gauge
of which is different from that of the main rail network within the
Union;
4. In the cases referred to in points (a), (c), (d) and (e) of paragraph 1
of this Article, the Member State concerned shall submit to the
Commission the request for non-application of the TSIs or parts of
them, accompanied by a file containing the justification for the
request, and specifying the alternative provisions that that Member
State intends to apply instead of the TSIs. In the case referred to in
point (e) of paragraph 1 of this Article, the Commission shall analyse
the request and decide whether or not to accept it on the basis of the
completeness and coherence of the information contained in the file. In
the cases referred to in points (c) and (d) of paragraph 1 of this Article,
the Commission shall adopt its decision by means of implementing acts
on the basis of such analysis. Those implementing acts shall be adopted
in accordance with the examination procedure referred to in
Article 51(3).
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7. The Commission shall give its decision within four months of
submission of the request supported by the complete file. In the
absence of such a decision, the request shall be deemed to have been
accepted.
CHAPTER III
INTEROPERABILITY CONSTITUENTS
Article 8
Conditions for the placing on the market of interoperability
constituents
1. Member States shall take all necessary steps to ensure that inter
operability constituents are:
(b) used in their area of use as intended and suitably installed and
maintained.
This paragraph shall not prevent the placing on the market of those
constituents for other applications.
2. Member States shall not, in their territory and on the basis of this
Directive, prohibit, restrict or hinder the placing on the market of inter
operability constituents for use in the Union rail system where these
constituents comply with this Directive. In particular, they shall not
require checks which have already been carried out as part of the
procedure for ‘EC’ declaration of conformity or suitability for use as
provided for in Article 10.
Article 9
Conformity or suitability for use
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3. The ‘EC’ declaration shall be dated and signed by the manu
facturer or its authorised representative.
5. Spare parts for subsystems that are already placed in service when
the corresponding TSI enters into force may be installed in those
subsystems without being subject to paragraph 1.
Article 10
Procedure for ‘EC’ declaration of conformity or suitability for use
5. If a Member State finds that the ‘EC’ declaration has been drawn
up improperly, it shall ensure that the interoperability constituent is not
placed on the market. In such a case, the manufacturer or his authorised
representative shall be required to restore the interoperability constituent
to a state of conformity under the conditions laid down by that Member
State.
Article 11
Non-compliance of interoperability constituents with essential
requirements
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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:
CHAPTER IV
SUBSYSTEMS
Article 12
Free movement of subsystems
(b) in other Member States, before or after the entry into force of this
Directive, with a view to verifying compliance with identical
requirements under identical operational conditions.
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Article 13
Conformity with TSIs and national rules
(a) where the TSIs do not cover, or do not fully cover, certain aspects
corresponding to the essential requirements, including open points
as referred to in Article 4(6);
(c) where a specific case requires the application of technical rules not
included in the relevant TSI;
(d) national rules used to specify existing systems, limited to the aim of
assessing technical compatibility of the vehicle with the network;
Article 14
Notification of national rules
(a) 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;
2. Member States shall notify the full text of national rules referred
to in paragraph 1 through the appropriate IT system in accordance with
Article 27 of Regulation (EU) 2016/796.
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4. Member States may lay down new national rules only in the
following cases:
(a) when a TSI does not fully meet the essential requirements;
6. When they adopt a new national rule, Member States shall notify
it to the Agency and the Commission through the appropriate IT system
in accordance with Article 27 of Regulation (EU) 2016/796.
11. Member States may decide not to notify rules and restrictions of
a strictly local nature. In such cases, Member States shall mention those
rules and restrictions in the registers of infrastructure referred to in
Article 49.
12. National rules notified under this Article are not subject to the
notification procedure set out in Directive (EU) 2015/1535 of the
European Parliament and of the Council (1).
13. National rules not notified in accordance with this Article shall
not apply for the purposes of this Directive.
(1) Directive (EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of information
in the field of technical regulations and rules on Information Society services
(OJ L 241, 17.9.2015, p. 1).
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Article 15
Procedure for establishing the ‘EC’ declaration of verification
3. The task of the notified body responsible for the ‘EC’ verification
of a subsystem shall begin at the design stage and cover the entire
manufacturing period through to the acceptance stage before the
subsystem is placed on the market or in service. It shall, in accordance
with the relevant TSI, also cover verification of the interfaces of the
subsystem in question with the system into which it is incorporated.
7. If the relevant TSIs allow, the notified body may issue certificates
of verification for one or more subsystems or certain parts of those
subsystems.
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Those implementing acts shall be adopted in accordance with the exa
mination procedure referred to Article 51(3).
Article 16
Non-compliance of subsystems with essential requirements
2. The Member State making the request shall forthwith inform the
Commission of any additional checks requested and set out the reasons
therefor. The Commission shall consult the interested parties.
3. The Member State making the request shall state whether the
failure to fully comply with this Directive is due to:
(b) inadequacy of a TSI, in which case the procedure for amending the
TSI as referred to in Article 6 shall apply.
Article 17
Presumption of conformity
CHAPTER V
Article 18
Authorisation for the placing in service of fixed installations
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4. The applicant shall submit a request for authorisation of the
placing in service of fixed installations to the national safety authority.
The application shall be accompanied by a file which includes docu
mentary evidence of:
(b) the technical compatibility of the subsystems with the system into
which they are being integrated, established on the basis of the
relevant TSIs, national rules and registers;
(d) changes are made to the values of the parameters on the basis of
which the authorisation was already granted.
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The national safety authority shall take its decision within a predeter
mined, reasonable time, and, in any case, within four months of receipt
of all relevant information.
Article 19
Harmonised implementation of ERTMS in the Union
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.
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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 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
1. The applicant shall place a vehicle on the market only after having
received the vehicle authorisation for placing on the market issued by
the Agency in accordance with paragraphs 5 to 7 or by the national
safety authority in accordance with paragraph 8.
(a) the placing on the market of the mobile subsystems of which the
vehicle is composed in accordance with Article 20, on the basis of
the ‘EC’ declaration of verification;
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(b) the technical compatibility of the subsystems referred to in point (a)
within the vehicle, established on the basis of the relevant TSIs, and
where applicable, national rules;
(c) the safe integration of the subsystems referred to in point (a) within
the vehicle, established on the basis of the relevant TSIs, and where
applicable, national rules, and the CSMs referred to in Article 6 of
Directive (EU) 2016/798;
(d) the technical compatibility of the vehicle with the network in the
area of use referred to in paragraph 2, established on the basis of the
relevant TSIs and, where applicable, national rules, registers of
infrastructure and the CSM on risk assessment referred to in
Article 6 of Directive (EU) 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.
(a) assess the elements of the file specified in points (b), (c) and (d) of
the first subparagraph of paragraph 3 in order to verify the
completeness, relevance and consistency of the file in relation to
the relevant TSIs; and
(b) refer the applicant's file to the national safety authorities concerned
by the intended area of use for assessment of the file in order to
verify its completeness, relevance and consistency in relation to
point (d) of the first subparagraph of paragraph 3 and to the
elements specified in points (a), (b) and (c) of the first subparagraph
of paragraph 3 in relation to the relevant national rules.
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
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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.
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.
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8. Where the area of use is limited to a network or networks within
one Member State only, the national safety authority of that Member
State may, under its own responsibility and when the applicant so
requests, issue the vehicle authorisation for placing on the market. In
order to issue such authorisations, the national safety authority shall
assess the file in relation to the elements specified in paragraph 3 and
in accordance with the procedures to be established in the implementing
act adopted pursuant to paragraph 9. Within one month of receipt of the
request of the applicant, the national safety authority shall inform the
applicant that the file is complete or ask for relevant supplementary
information. The authorisation shall also be valid without extension of
the area of use for vehicles travelling to stations in neighbouring
Member States with similar network characteristics, when those
stations are close to the border, following consultation of the
competent national safety authorities. This consultation may be carried
out on a case-by-case basis or set out in a cross-border agreement
between national safety authorities.
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 auth
orisations it issues.
(a) how the requirements for the vehicle authorisation for placing on
the market and for vehicle type authorisation laid down in this
Article shall be fulfilled by the applicant and listing the
documents required;
(c) how the requirements laid down in this Article shall be complied
with by the Agency and the national safety authority through the
different stages of the application and authorisation process
including in the assessment of applicants' files.
(b) the values of the parameters set out in the TSIs and, where
applicable, in the national rules, for checking the technical compati
bility between the vehicle and the area of use;
(c) the vehicle's compliance with the relevant TSIs and sets of national
rules, relating to the parameters referred to in point (b);
(d) the conditions for use of the vehicle and other restrictions.
11. Any decision refusing the vehicle authorisation for placing on the
market or excluding part of the network in accordance with a negative
assessment as referred to in paragraph 7 shall be duly substantiated. The
applicant may, within a period of one month from receipt of the
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negative decision, request that the Agency or the national safety auth
ority, as appropriate, review the decision. The Agency or the national
safety authority shall have two months from the date of receipt of the
request for review in which to confirm or reverse its decision.
(b) the overall safety level of the vehicle concerned may be adversely
affected by the works envisaged; or
13. Where the applicant wishes to extend the area of use of a vehicle
which has already been authorised, it shall supplement the file with the
relevant documents referred to in paragraph 3 concerning the additional
area of use. The applicant shall submit the file to the Agency, which
shall, after following the procedures laid down in paragraphs 4 to 7,
issue an updated authorisation covering the extended area of use.
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for geographical or historical reasons, with a view to reducing admin
istrative burdens and costs to the applicant. Where such networks are
isolated from the rest of the Union rail system, such specific cooperation
arrangements may include the possibility of contracting tasks to the
relevant national safety authorities when this is necessary in order to
ensure the efficient and proportionate allocation of resources for auth
orisation. Those agreements shall be in place before the Agency shall
undertake the authorisation tasks in accordance with Article 54(4) of
this Directive.
15. In the case of those Member States whose rail networks have a
track gauge that is different from that of the main rail network within
the Union and share identical technical and operational requirements
with neighbouring third countries, in addition to the cooperation
agreements referred to in paragraph 14, all national safety authorities
concerned in those Member States shall conclude with the Agency a
multilateral agreement with a view to defining the conditions under
which a vehicle authorisation issued in one of those Member States is
also valid for the other Member States concerned.
17. A Member State may decide not to apply this Article to loco
motives or self-propelling trains arriving from third countries and
intended to run until a station that is situated close to the border in
its territory and designated for cross-border operations. The conformity
of such vehicles with the essential requirements of this Directive shall
be ensured by the railway undertaking concerned in the context of its
safety management system and, where relevant, in accordance with
Article 10(9) of Directive (EU) 2016/798.
Article 22
Registration of vehicles authorised to be placed on the market
1. Before a vehicle is used for the first time, and after the authoris
ation to be placed on the market in accordance with Article 21 is
granted, it shall be registered in a vehicle register as referred to in
Article 47 at the request of the keeper.
3. When the area of use of the vehicle covers the territory of more
than one Member State, it shall be registered in one of the Member
States concerned.
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Article 23
Checks before the use of authorised vehicles
(a) that the vehicle has been authorised for placing on the market in
accordance with Article 21 and is duly registered;
(b) that the vehicle is compatible with the route on the basis of the
infrastructure register, the relevant TSIs or any relevant information
to be provided by the infrastructure manager free of charge and
within a reasonable period of time, where such a register does not
exist or is incomplete; and
(c) that the vehicle is properly integrated in the composition of the train
where it is intended to operate, taking into account the safety
management system set out in Article 9 of Directive (EU)
2016/798 and the TSI on operation and traffic management.
Article 24
Type authorisation of vehicles
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(b) 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 (1).
Article 25
Conformity of vehicles with an authorised vehicle type
Article 26
Non-compliance of vehicles or vehicle types with essential
requirements
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3. When, in the cases set out in paragraphs 1 or 2 of this Article, the
corrective measures applied by the railway undertaking do not ensure
conformity with the applicable essential requirements and that non-
conformity leads to a serious safety risk, the national safety authority
concerned may apply temporary safety measures under its supervision
tasks, in accordance with Article 17(6) of Directive (EU) 2016/798.
Temporary safety measures in the form of a suspension of type auth
orisation of a vehicle may be applied in parallel by the national safety
authority or by the Agency and shall be subject to judicial review and
the arbitration procedure laid down in Article 21(7).
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same type as the vehicle or type subject to the revocation are properly
informed. Such railway undertakings shall first check whether the same
problem of non-compliance applies. In that event, the procedure
provided for in this Article shall apply.
CHAPTER VI
Article 27
Notifying authorities
5. The notifying authority shall take full responsibility for the tasks
performed by the body referred to in paragraph 3.
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Article 28
Requirements relating to notifying authorities
(d) not offer or provide any activities that are performed by conformity
assessment bodies or consultancy services on a commercial or
competitive basis;
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.
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:
(a) the necessary personnel with technical knowledge and sufficient and
appropriate experience to perform the conformity assessment tasks;
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(b) the relevant descriptions of procedures in accordance with which
conformity assessment is to be carried out, ensuring the trans
parency and the ability to apply those procedures. It shall have in
place appropriate policies and procedures that distinguish between
the tasks it carries out as a notified conformity assessment body and
other activities;
(c) the proper procedures for the performance of activities which take
due account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the product tech
nology in question and the mass or serial nature of the production
process.
Article 31
Impartiality of conformity assessment bodies
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2. The impartiality of the conformity assessment bodies, of their top-
level management and of the assessment personnel shall be guaranteed.
Article 32
Personnel of conformity assessment bodies
(a) sound technical and vocational training covering all the conformity
assessment activities in relation to which the conformity assessment
body has been notified;
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Article 33
Presumption of conformity of a conformity assessment body
Article 34
Subsidiaries of, and subcontracting by, notified bodies
Article 35
Accredited in-house bodies
(b) the body and its personnel shall, within the undertaking of which
they form a part, be organisationally identifiable and have reporting
methods which ensure their impartiality, and shall demonstrate it to
the competent national accreditation body;
(c) neither the body nor its personnel shall be responsible for the
design, manufacture, supply, installation, operation or maintenance
of the products they assess, nor shall they engage in any activity
that might conflict with their independence of judgement or
integrity in relation to their assessment activities;
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(d) 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
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Article 38
Identification numbers and lists of notified bodies
Article 39
Changes to notifications
Article 40
Challenges to the competence of notified bodies
1. The Commission shall investigate all cases where it has any doubt,
or where a doubt is brought to its attention, regarding the competence of
a notified body or the continued fulfilment by a notified body of the
requirements and responsibilities to which it is subject.
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Article 41
Operational obligations of notified bodies
Article 42
Obligation of notified bodies to provide information
(b) any circumstances affecting the scope of, and conditions for, notifi
cation;
(c) any request for information which they have received from market
surveillance authorities regarding conformity assessment activities;
2. Notified bodies shall provide the other bodies notified under this
Directive carrying out similar conformity assessment activities covering
the same products with relevant information on issues relating to
negative and, on request, positive conformity assessment results.
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3. Notified bodies shall provide the Agency with ‘EC’ certificates of
verification of subsystems, ‘EC’ certificates of conformity of interoper
ability constituents and ‘EC’ certificates of suitability of use of inter
operability constituents.
Article 43
Exchanges of best practice
Article 44
Coordination of notified bodies
Member States shall ensure that the bodies notified by them participate
in the work of that group, directly or by means of designated represen
tatives.
Article 45
Designated bodies
(a) in the case of skills required by its personnel under point (c) of
Article 32(1), where the designated body shall have appropriate
knowledge and understanding of national law;
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CHAPTER VII
REGISTERS
Article 46
Vehicle numbering system
Article 47
Vehicle registers
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(c) references to the European register of authorised vehicle types
referred to in Article 48;
Article 48
European register of authorised vehicle types
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(b) comply with the common specifications referred to in paragraph 2;
3. The register shall include at least the following elements for each
type of vehicle:
(c) the data of the authorisations related to the area of use for a vehicle
type, including any restrictions or withdrawals.
Article 49
Register of infrastructure
CHAPTER VIII
Article 50
Exercise of delegation
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2. The power to adopt delegated acts referred to in Article 5(1) shall
be conferred on the Commission for a period of five years from 15 June
2016. The Commission shall draw up a report in respect of the
delegation of power not later than nine months before the end of the
five-year period. The delegation of power shall be tacitly extended for
periods of an identical duration, unless the European Parliament or the
Council opposes such extension not later than three months before the
end of each period.
Article 51
Committee procedure
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Article 52
Motivation
Article 53
Reports and information
Article 54
Transitional regime for using vehicles
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3. Vehicles authorised for placing in service pursuant to paragraphs 1
and 2 shall receive a new vehicle authorisation for placing on the
market in order to operate on one or more networks which are not
yet covered by their authorisation. The placing on the market on
those additional networks shall be subject to Article 21.
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4. At the latest from 16 June 2019 the Agency shall carry out the
authorisation tasks pursuant to Articles 21 and 24 and the tasks referred
to in Article 19 in respect of areas of use in the Member States that
have not notified the Agency and the Commission in accordance with
Article 57(2). By way of derogation from Articles 21 and 24, national
safety authorities of Member States which have notified the Agency and
Commission pursuant to Article 57(2) may continue to issue authoris
ations in accordance with Directive 2008/57/EC until 16 June 2020. By
way of derogation from Articles 21 and 24, national safety authorities of
Member States which have notified the Agency and Commission
pursuant to Article 57(2a) may continue to issue authorisations in
accordance with Directive 2008/57/EC until 31 October 2020.
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Article 55
Other transitional provisions
Article 56
Recommendations and opinions of the Agency
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Article 57
Transposition
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with Articles 1 and 2,
Article 7(1) to (4) and (6), Article 8, Article 9(1), Article 10(5),
Article 11(1), (3) and (4), Articles 12, 13 and 14, Article 15(1) to
(8), Article 16, Article 18, Article 19(3), Articles 21 to 39, Article 40(2),
Articles 41, 42, 44, 45 and 46, Article 47(1), (3), (4) and (7),
Article 49(1) to (4), Article 54 and Annexes I, II, III and IV by
16 June 2019. They shall immediately communicate the text of those
measures to the Commission.
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2a. Member States that have extended the transposition period in
accordance with paragraph 2 may further extend it until 31 October
2020. Their transposition measures shall apply from that date. Those
Member States shall notify the Agency and the Commission thereof by
29 May 2020.
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3. When Member States adopt those measures, they shall contain a
reference to this Directive or be accompanied by such a reference on the
occasion of their official publication. They shall also include a statement
that references in existing laws, regulations and administrative
provisions to the Directives repealed by this Directive shall be
construed as references to this Directive. Member States shall
determine how such reference is to be made and how that statement
is to be formulated.
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Article 58
Repeal
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
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ANNEX I
1. Network
For the purposes of this Directive, the Union's network shall include the
following elements:
(a) specially built high-speed lines equipped for speeds generally equal to or
greater than 250 km/h;
(b) specially upgraded high-speed lines equipped for speeds of the order of
200 km/h;
(e) conventional lines intended for mixed traffic (passengers and freight);
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.
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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:
— infrastructure,
— energy,
— rolling stock; or
— maintenance,
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 elec
tricity consumption measuring and charging system.
The professional qualifications which may be required for carrying out any
type of railway service.
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2.6. Telematics applications
In accordance with Annex I, this subsystem comprises two elements:
2.8. Maintenance
The procedures, associated equipment, logistics centres for maintenance
work and reserves providing the mandatory corrective and preventive main
tenance to ensure the interoperability of the Union rail system and guarantee
the performance required.
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ANNEX III
ESSENTIAL REQUIREMENTS
1. General requirements
1.1. Safety
1.1.1. The design, construction or assembly, maintenance and monitoring of
safety-critical components, and more particularly of the components
involved in train movements, must be such as to guarantee safety at the
level corresponding to the aims laid down for the network, including those
for specific degraded situations.
1.1.2. The parameters involved in the wheel/rail contact must meet the stability
requirements needed in order to guarantee safe movement at the maximum
authorised speed. The parameters of brake equipment must guarantee that
it is possible to stop within a given brake distance at the maximum auth
orised speed.
1.1.3. The components used must withstand any normal or exceptional stresses
that have been specified during their period in service. The safety reper
cussions of any accidental failures must be limited by appropriate means.
1.1.4. The design of fixed installations and rolling stock and the choice of the
materials used must be aimed at limiting the generation, propagation and
effects of fire and smoke in the event of a fire.
1.3. Health
1.3.1. Materials likely, by virtue of the way they are used, to constitute a health
hazard to those having access to them must not be used in trains and
railway infrastructures.
1.3.2. Those materials must be selected, deployed and used in such a way as to
restrict the emission of harmful and dangerous fumes or gases, particularly
in the event of fire.
1.4.2. The materials used in the trains and infrastructures must prevent the
emission of fumes or gases which are harmful and dangerous to the
environment, particularly in the event of fire.
1.4.3. The rolling stock and energy-supply systems must be designed and manu
factured in such a way as to be electromagnetically compatible with the
installations, equipment and public or private networks with which they
might interfere.
1.4.4. The design and operation of the rail system must not lead to an inad
missible level of noise generated by it:
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— in the driver's cab.
1.4.5. Operation of the rail system must not give rise to an inadmissible level of
ground vibrations for the activities and areas close to the infrastructure and
in a normal state of maintenance.
1.6. Accessibility
1.6.1. The ‘infrastructure’ and ‘rolling stock’ subsystems must be accessible to
persons with disabilities and persons with reduced mobility in order to
ensure access on an equal basis with others by way of the prevention or
removal of barriers, and by way of other appropriate measures. This shall
include the design, construction, renewal, upgrade, maintenance and
operation of the relevant parts of the subsystems to which the public
has access.
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.).
2.1.2. A c c e s s i b i l i t y
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. S a f e t y
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. E n v i r o n m e n t a l p r o t e c t i o n
The functioning of the electrical or thermal energy-supply systems must
not interfere with the environment beyond the specified limits.
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2.2.3. T e c h n i c a l c o m p a t i b i l i t y
The electricity/thermal energy-supply systems used must:
2.3.2. T e c h n i c a l c o m p a t i b i l i t y
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 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.
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2.4.2. R e l i a b i l i t y a n d a v a i l a b i l i t y
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. T e c h n i c a l c o m p a t i b i l i t y
The electrical equipment must be compatible with the operation of the
control-command and signalling installations.
2.4.4. C o n t r o l s
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. A c c e s s i b i l i t y
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. H e a l t h a n d s a f e t y
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. E n v i r o n m e n t a l p r o t e c t i o n
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. T e c h n i c a l c o m p a t i b i l i t y
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.
2.6.2. R e l i a b i l i t y a n d a v a i l a b i l i t y
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 avail
ability.
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2.6.3. T e c h n i c a l c o m p a t i b i l i t y
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. A c c e s s i b i l i t y
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.
2.7.2. R e l i a b i l i t y a n d a v a i l a b i l i t y
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. H e a l t h
The interfaces between these systems and users must comply with the
minimum rules on ergonomics and health protection.
2.7.4. S a f e t y
Suitable levels of integrity and dependability must be provided for the
storage or transmission of safety-related information.
2.7.5. A c c e s s i b i l i t y
Appropriate steps must be taken to ensure that telematics applications for
passenger subsystems provide for the necessary functionality required to
ensure accessibility for persons with disabilities and persons with reduced
mobility.
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ANNEX IV
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.
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).
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Where a subsystem has not been assessed for its conformity with all
relevant TSI(s) (e.g. in the case of a derogation, partial application of
TSIs for upgrade or renewal, transitional period in a TSI or specific
case), the certificate of verification shall give the precise reference to
the TSI(s) or their parts whose conformity has not been examined by
the notified body during the verification procedure.
2.3.2. Where ISV have been issued, the notified body responsible for the verifi
cation 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
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.
(c) the files referred to in Article 15(4), compiled by each of the notified
bodies involved in the verification of the subsystem, which shall
include:
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(d) certificates of verification issued in accordance with other legal acts
of the Union;
2.5.2. The notified body responsible for checking implementation must period
ically 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.
2.6. Submission
A copy of the technical file accompanying the ‘EC’ declaration of verifi
cation 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.
2.7. Publication
Each notified body must periodically publish relevant information
concerning:
(b) request for assessment of conformity and suitability for use of ICs;
(d) certificates of verification and ‘EC’ certificates for suitability for use
issued or refused;
(1) 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).
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(e) certificates of verification issued or refused.
2.8. Language
The files and correspondence relating to the ‘EC’ verification procedure
must be written in a Union official language of the Member State in which
the applicant is established or in a Union official language accepted by the
applicant
3.3. File
The file compiled by the designated body and accompanying the certifi
cate 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.
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ANNEX V
PART A
PART B
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ANNEX VI
Correlation table
Article 1 Article 1
Article 2(a) to (z) Article 2(1) to (5), (7) to (17) and (19)
to (28)
Article 3 -
Article 4 Article 3
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 16 Article 12
Article 18 Article 15
Article 19 Article 16
- Article 17
Article 20 -
Article 21 -
Articles 22 to 25 -
Article 26 Article 24
- Article 26
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- Article 45
Article 29 Article 51
Articles 30 and 31 -
Article 32 Article 46
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 VI Annex IV
Annex X Annex V
Annex XI Annex VI