Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (Recast) (Text with EEA relevance)
Date: 2008-06-17
Institutions: Council of the European Union, European Parliament
Subjects: harmonisation of standards, high-speed transport, rail network, technical specification, trans-European network

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Official Journal of the European Union

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I

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)

DIRECTIVES

DIRECTIVE 2008/57/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 17 June 2008

on the interoperability of the rail system within the Community

(Recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-
nity, and in particular Articles 71 and 156 thereof,

50/EC of the European Parliament and of the Council (5).
As new amendments are now being introduced,
is
appropriate to recast the Directives for the sake of clarity
and merge their provisions together into a single instru-
ment with a view to simplification.

it

Having regard to the proposal from the Commission,

(2)

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in
Article 251 of the Treaty (2),

(3)

Whereas:

(1) Council Directive 96/48/EC of 23 July 1996 on the
the trans-European high-speed rail
interoperability of
system (3) and Directive 2001/16/EC of
the European
Parliament and of the Council of 19 March 2001 on the
interoperability of
the trans-European conventional rail
system (4) were substantially amended by Directive 2004/

(1) OJ C 256, 27.10.2007, p. 39.
(2) Position of the European Parliament of 11 December 2007 and

Council Decision of 14 May 2008.

(3) OJ L 235, 17.9.1996, p. 6. Directive as last amended by Commission

Directive 2007/32/EC (OJ L 141, 2.6.2007, p. 63).

(4) OJ L 110, 20.4.2001, p. 1. Directive as last amended by Directive

2007/32/EC.

to enable citizens of

In order
the Union, economic
operators and regional and local authorities to benefit to
the full from the advantages deriving from the establishing
of an area without internal frontiers, it is appropriate, in
particular, to improve the interlinking and interoperability
of the national rail networks as well as access thereto,
implementing any measures that may prove necessary in
the field of technical standardisation, as provided for in
Article 155 of the Treaty.

By signing the Protocol adopted in Kyoto on 12 December
1997 the European Union has undertaken to reduce its
greenhouse gas emissions. These objectives require an
adjustment to the balance between the various modes of
transport, and consequently an increase in the competi-
tiveness of rail transport.

(4)

The Community strategy for the integration of environ-
mental and sustainable development concerns into its
transport policy highlights the need to act to reduce the
environmental impact of transport.

(5) Directive 2004/50/EC of

the European Parliament and of

the
Council of 29 April 2004 amending Council Directive 96/48/EC on
the interoperability of the trans-European high-speed rail system and
Directive 2001/16/EC of
the
Council on the interoperability of the trans-European conventional
rail system (OJ L 164, 30.4.2004, p. 114. Corrected by OJ L 220,
21.6.2004, p. 40).

the European Parliament and of

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(5)

The commercial operation of trains throughout the rail
network requires
in particular excellent compatibility
between the characteristics of the infrastructure and those
of the vehicles, as well as efficient interconnection of the
information and communication systems of the different
infrastructure managers and railway undertakings. Perfor-
mance levels, safety, quality of service and cost depend
upon such compatibility and interconnection, as does, in
particular, the interoperability of the rail system.

impact on the implementation of interoperability. As in the
case of other transport modes, the extension of access
rights must be accompanied by the requisite harmonisation
measures. It is therefore necessary to implement interoper-
ability on the whole network by extending progressively the
It is also
geographical scope of Directive 2001/16/EC.
necessary to extend the legal basis of Directive 2001/16/EC
to Article 71 of the Treaty, on which Directive 2001/12/EC
is founded.

(6) Member States are responsible for ensuring compliance
with the safety, health and consumer protection rules
applying to the railway networks in general during the
design, construction, putting into service and operation of
those railways.

(7)

There are major differences between the national regula-
tions and between internal rules and technical specifica-
tions which the railways apply, since they incorporate
techniques that are specific to the national industries and
prescribe specific dimensions and devices and special
characteristics. This situation prevents trains from being
able to run without hindrance throughout the Community
network.

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

an open,

industries

(9)

is

It
therefore appropriate to define basic essential
requirements for the whole of the Community which will
apply to its rail system.

(10) To achieve these objectives an initial measure was taken by
the Council on 23 July 1996 with the adoption of Directive
96/48/EC. The European Parliament and the Council
subsequently adopted Directive 2001/16/EC.

(11) The entry into force of Directives 2001/12/EC of

the European Parliament and of

the
European Parliament and of the Council of 26 February
2001 amending Council Directive 91/440/EEC on the
development of the Community's railways (1), 2001/13/EC
of
the Council of
26 February 2001 amending Council Directive 95/18/EC
on the licensing of railway undertakings (2) and 2001/14/
EC of the European Parliament and of the Council of
26 February 2001 on the allocation of railway infra-
structure capacity and the levying of charges for the use of
railway infrastructure and safety certification (3) has had an

(12) The development of technical specifications for interoper-
ability (TSIs) has shown the need to clarify the relationship
between the essential requirements and the TSIs on the one
hand, and the European standards and other documents of
a normative nature on the other.
In particular, a clear
distinction should be drawn between the standards or parts
of standards which must be made mandatory in order to
achieve the objectives of this Directive, and the ‘harmo-
nised’ standards that have been developed in the spirit of
the new approach to technical harmonisation and
standardisation.

(13) As a rule, European specifications are developed in the
spirit of the new approach to technical harmonisation and
standardisation. They enable a presumption to be made of
conformity with certain essential requirements of
this
Directive, particularly in the case of
interoperability
constituents and interfaces. These European specifications,
or the applicable parts thereof, are not mandatory and no
explicit reference to these specifications may be made in the
TSIs. References
to these European specifications are
published in the Official Journal of the European Union, and
Member States publish the references to the national
standards transposing the European standards.

(14) TSIs may in certain cases make an explicit reference to
European standards or specifications where this is strictly
necessary in order
this
Directive. Such explicit reference has consequences which
must be made clear; in particular, these European standards
or specifications become mandatory from the moment the
TSI is applicable.

to achieve the objectives of

(15) A TSI sets all the conditions with which an interoperability
constituent must conform, and the procedure to be
followed in assessing conformity. In addition, it is necessary
to specify that every constituent must undergo the
procedure for assessing conformity and suitability for the
use indicated in the TSIs, and have the corresponding
certificate.

(1) OJ L 75, 15.3.2001, p. 1.
(2) OJ L 75, 15.3.2001, p. 26.
(3) OJ L 75, 15.3.2001, p. 29. Directive as last amended by Directive

2007/58/EC (OJ L 315, 3.12.2007, p. 44).

(16) When developing new TSIs the aim should always be to
ensure compatibility with the existing authorised system.
This will help to promote the competitiveness of rail
transport and prevent unnecessary additional costs through
renewal of existing
the requirement of upgrading or

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authorised subsystems to ensure backward compatibility. In
those exceptional cases where it will not be possible to
ensure compatibility, TSIs may establish the framework
necessary to decide whether the existing subsystem may
need to be re-authorised, and the corresponding deadlines.

consequently required for the adoption of TSIs, steps
should be taken to avoid a situation where Member States
adopt new national
rules or undertake projects that
increase the diversity of the present system.

(17)

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

(18) The procedure to be followed in the case of essential
requirements applicable to a subsystem which have not yet
been covered by detailed specifications in the correspond-
ing TSI should be specified.
the bodies
responsible for the conformity assessment and verification
procedures should be the notified bodies referred to in
Article 20 of Directives 96/48/EC and 2001/16/EC.

In such case,

(19) The distinction between a high-speed rail system and a
conventional rail system does not warrant two separate
directives. The procedures for developing TSIs are the same
for both systems, as are those for the certification of the
interoperability constituents and the subsystems. The
essential requirements are practically identical, as is the
subdivision of
the system into subsystems for which
technical specifications have to be prepared. Moreover,
since trains have to be able to move freely from the high-
speed network to the conventional network, the technical
specifications for the two systems overlap to a large extent.
Work on developing the TSIs has shown that, for certain
subsystems, a single TSI can serve both systems.
It is
therefore appropriate to combine Directives 96/48/EC and
2001/16/EC.

(20) Directive 2004/50/EC provided for the progressive exten-
sion of the scope of Directive 2001/16/EC as new TSIs
were adopted or existing ones revised. When this Directive
enters into force,
its scope will cover conventional and
high-speed European networks as defined in Decision
No 1692/96/EC of the European Parliament and of the
Council of 23 July 1996 on Community guidelines for the
development of the trans-European transport network (1),
and the vehicles likely to travel on those networks. The
scope will be progressively extended to the whole network
and all vehicles, provided that an impact assessment shows
the economic benefit of so doing.

(21)

In view of the gradual approach to eliminating obstacles to
the interoperability of the rail system and of the time

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

(23)

In its Legislative Resolutions of 10 March 1999 on the
railway package, the European Parliament asked that the
progressive opening up of the rail sector go hand-in-hand
with the fastest and most effective technical harmonisation
measures possible.

(24) The Council, at its meeting on 6 October 1999, asked the
Commission to propose a strategy on improving the
interoperability of rail transport and reducing bottlenecks
with a view to eliminating technical, administrative and
economic obstacles to the interoperability of networks
without delay while guaranteeing a high level of safety and
training and qualifications of the staff concerned.

infrastructure, equipment,

(25) Pursuant to Council Directive 91/440/EEC of 29 July 1991
the Community's railways (2),
on the development of
railway companies must have increased access to Member
States' rail networks, which in turn requires the interoper-
rolling stock and
ability of
including those
systems of management and operation,
staff qualifications and hygiene and safety conditions at
work required for the operation and maintenance of the
subsystems in question and for the implementation of each
TSI. However, it is not the aim of this Directive, directly or
indirectly, to harmonise working conditions in the rail
sector.

(26)

In view of the extent and complexity of the rail system, it
has proved necessary, for practical reasons, to break it down
into the following subsystems:
infrastructure, control-
command and signalling, energy, rolling stock, operation
and traffic management, maintenance and telematics
applications for passenger and freight services. For each
of these subsystems the essential requirements must be
specified and the technical specifications determined for the
the Community, particularly in respect of
whole of
constituents and interfaces, in order to meet these essential
requirements. The same system is broken down into fixed
and mobile elements comprising on the one hand, the

(1) OJ L 228, 9.9.1996, p. 1. Decision as last amended by Council
Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(2) OJ L 237, 24.8.1991, p. 25. Directive as last amended by Directive

2007/58/EC.

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network, composed of the lines, stations, terminals, and all
kinds of
fixed equipment needed to ensure safe and
continuous operation of the system and on the other hand,
all vehicles travelling on this network. Therefore, for the
purposes of this Directive, a vehicle is composed of one
subsystem (rolling stock) and where applicable one or more
parts of other subsystems (mainly the onboard part of the
control-command and signalling subsystem and the
onboard part of the energy subsystem).

(27)

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

terms to the preservation of

(28) TSIs also have an impact on the conditions of use of rail
transport by users, and it is therefore necessary to consult
these users on aspects concerning them.

(29) Each Member State concerned should be allowed not to
apply certain TSIs in special cases, provided that there are
procedures to ensure that these derogations are justified.
Article 155 of the Treaty requires Community activities in
the field of interoperability to take account of the potential
economic viability of projects.

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

(31) Advantage should be taken of the interoperability of the rail
system, particularly in the case of freight, to bring about the
conditions for greater interoperability between modes of
transport.

the European Parliament and of

(32) To comply with the appropriate provisions on procurement
procedures in the rail sector and in particular Directive
2004/17/EC of
the
Council (1), the contracting entities should include technical
specifications in the general documents or in the terms and
conditions for each contract. To this end it is necessary to
build up a body of European specifications in order to serve
as references for these technical specifications.

(33) An international system of standardisation capable of
generating standards which are actually used by those
the
involved in international

trade and which meet

(1) Directive 2004/17/EC of

the European Parliament and of

the
Council of 31 March 2004 coordinating the procurement
procedures of entities operating in the water, energy, transport and
postal services sectors (OJ L 134, 30.4.2004, p. 1). Directive as last
amended by Commission Regulation (EC) No 213/2008 (OJ L 74,
15.3.2008, p. 1).

requirements of Community policy would be in the
Community's interest. The European standardisation bodies
must
cooperation with the
international standardisation bodies.

therefore

continue

their

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

(35) The procedures governing the assessment of conformity or
of suitability of use of constituents should be based on the
use of the modules covered by Council Decision 93/465/
EEC (2). As far as possible and in order
to promote
industrial development, it is appropriate to draw up the
procedures involving a system of quality assurance.

(36) Conformity of constituents is mainly linked to their area of
use in order to guarantee the interoperability of the system
and not only to their free movement on the Community
the most critical
market. The suitability for use of
constituents as
system
economy should be assessed. It is therefore not necessary
for a manufacturer to affix the CE marking to constituents
that are subject to the provisions of this Directive. On the
basis of the assessment of conformity and/or suitability for
use, the manufacturer's declaration of conformity should be
sufficient.

safety, availability or

regards

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

(38) When a TSI enters into force, a number of interoperability
constituents are already on the market. A transition period
should be provided for so that these constituents can be
integrated into a subsystem even if they do not strictly
conform to that TSI.

(39) The subsystems constituting the rail system should be
subjected to a verification procedure. This verification must
enable the authorities responsible for authorising their
placing in service to be certain that, at
the design,
construction and putting into service stages, the result is
in line with the regulations and technical and operational
provisions in force. It must also enable manufacturers to be
able to count upon equality of treatment whatever the
country. It is therefore necessary to lay down one or more
modules defining the principles and conditions applying to
‘EC’ verification of subsystems.

(2) Council Decision 93/465/EEC of 22 July 1993 concerning the
the conformity assessment
modules for the various phases of
procedures and the rules for the affixing and use of
the CE
conformity marking, which are intended to be used in the technical
harmonisation directives (OJ L 220, 30.8.1993, p. 23).

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requirements

(40) After a subsystem is placed in service, care should be taken
to ensure that it is operated and maintained in accordance
with the essential
relating to it. Under
Directive 2004/49/EC of the European Parliament and of
the Council of 29 April 2004 on safety on the
Community's railways (Railway Safety Directive) (1), respon-
sibility for meeting these requirements lies,
their
respective subsystems, with the infrastructure manager or
the
can check
compliance with these requirements when granting safety
certificates and safety approvals pursuant to Articles 10 and
11 of the Railway Safety Directive.

railway undertaking. Member States

for

(41) As far as vehicles are concerned, the procedure for placing
in service should be clarified taking into account
the
definition of vehicle which is composed of one or more
subsystems. In addition, as Directives 96/48/EC and 2001/
16/EC deal with new and upgraded subsystems and
Directive 2004/49/EC deals with in-use vehicles, all
provisions regarding authorisations for placing in service
integrated in this Directive.
of vehicles
Furthermore, with a view to facilitating the placing in
service of vehicles and reducing administrative burdens, a
procedure for authorisation of vehicle types should be
added. In order to facilitate this procedure and help identify
vehicle types, a European register of authorised types of
vehicles should be set up and maintained by the European
Railway Agency (hereinafter referred to as the Agency).

should be

(42) Experience has shown that the implementation of such a
procedure at national level is often complicated and subject
to different national requirements that lack transparency, or
even duplicate each other. Consequently, this procedure
poses a major obstacle to the creation of new railway
undertakings, particularly in the freight sector. Steps should
therefore be taken to clarify and simplify the procedures for
authorising vehicles. Firstly, the general principle that one
authorisation is sufficient for the whole Community rail
network should be established. Secondly, the procedure for
authorising vehicles which are TSI conform should be
simpler and quicker than in the case of non-TSI conform.
Thirdly, the principle of mutual recognition should be
applied as far as possible: when a vehicle has already been
placed in service in one Member States, other Member
States
to impose
invoke national
unnecessary requirements and redundant verifications,
unless these are strictly necessary for verifying the technical
compatibility of the vehicle with the relevant network. To
this end national rules should be classified and compared
according to a check-list in order to determine to which
extent national rules can be declared as equivalent in terms
of requirements, performances and safety. Fourthly, the
principle of legal certainty as regards the outcome of the
procedure should be pursued. To this end, in the absence of
safety authority within the
a decision of a national
prescribed time limits an applicant should be authorised
to place in service a vehicle. Such an authorisation would
only be possible if the vehicle has already been authorised

should not

rules

(1) OJ L 164, 30.4.2004, p. 44. Corrected by OJ L 220, 21.6.2004,

p. 16.

in another Member State. In addition, it would only be
possible for a railway undertaking or an infrastructure
manager duly certified in accordance with Directive 2004/
49/EC to use such a vehicle under their full responsibility.

(43) The authorisation procedures for TSI conform and non-TSI
conform vehicles are different. There may be cases where
the choice of the procedure is not straightforward. Vehicles
which come within the scope of TSI conform vehicles
should be those vehicles where all the relevant TSIs have
entered into force,
including at least the TSI on rolling
the
stock. This would mean that a significant part of
essential requirements has been laid down. For example,
until such time that the conventional TSI on locomotives
has entered into force,
locomotives fall within scope of
non-TSI conform vehicles, even though they might comply
with other relevant TSIs in force at the time of their placing
in service.

(44)

If certain technical aspects corresponding to the essential
requirements cannot be explicitly covered in a TSI, they are
identified in an annex to the TSI as open points. When a
TSI conform vehicle has already been authorised in one
Member State, additional authorisations
should only
consider
relate to technical
those open points
compatibility between the vehicle and the network.

that

(45) The list of parameters to be checked in conjunction with the
placing in service of non-TSI conform vehicles is a key
element for the achievement of interoperability of railway
systems, in particular with regard to existing vehicles. This
list takes into account experience across a limited number
of networks. Therefore it is necessary that the Agency
review the parameters
in Annex VII and make the
recommendations it considers appropriate to the Commis-
sion.

(46) The ‘EC’ verification procedure should be based on TSIs.
These TSIs are subject to the provisions of Article 18 of
Directive 93/38/EEC. The notified bodies responsible for
examining the procedures for conformity assessment and
suitability for the use of constituents, together with the
procedure for
in
particular in the absence of any European specification,
coordinate their decisions as closely as possible.

the assessment of subsystems must,

(47) The notified bodies should be structured in such a way as to
meet the criteria which must apply to this type of body in
all sectors of the new approach to technical harmonisation
and conformity verification, especially criteria relating to
independence and competence.

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(48) TSIs will be revised at regular intervals. When errors are
discovered, an ad hoc rapid procedure should be set up in
such a way that a provisional corrigendum is first agreed in
the context of a committee and then published by the
Agency. This will allow an earlier use of this corrigendum
by all stakeholders, including industry, notified bodies and
authorities, pending a formal revision of the TSI by the
Commission.
In order to avoid confusion with official
corrigenda of the Commission, the term technical opinion
will be used. This procedure is in line with the mandate
adopted by the Commission in Decision of 13 July 2007
concerning a framework mandate to the European Railway
Agency for the performance of certain activities under
Directives 96/48/EC and 2001/16/EC. However, if the TSI
needs to be amended because of an important or critical
error, a revision procedure should be applied.

(49) The definition of the keeper should be as close as possible
to the definition used in the 1999 Convention concerning
International Carriage by Rail (COTIF). Many entities can be
identified as a keeper of a vehicle, such as the owner, a
company carrying on a business with a fleet of wagons, a
company leasing vehicles to a railway undertaking, a
railway undertaking or an infrastructure manager using
vehicles for maintaining its infrastructure. These entities
have control over the vehicle with a view to its use as a
means of transport by the railway undertakings and the
infrastructure managers. In order to avoid any doubt, the
keeper should be clearly identified in the national vehicle
registers.

(50) The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
the exercise of
conferred on the Commission (1).

for

(51)

In particular, the Commission should be empowered to
adopt and update the TSIs. Since those measures are of
general scope and are designed to amend non-essential
elements of this Directive, inter alia, by supplementing it
with new non-essential elements, they must be adopted in
accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

(52) When, on imperative grounds of urgency, the normal time-
limits for the regulatory procedure with scrutiny cannot be
complied with, the Commission should be able to apply the
urgency procedure provided for in Article 5a(6) of Decision
1999/468/EC for the adoption of measures designed to
amend non-essential elements of this Directive by supple-
menting it with TSIs or amendments thereto.

(53) Since the objective of this Directive, namely interoperability
within the rail system in Community-wide scale, cannot be
sufficiently achieved by the Member States
since no
individual Member State is in a position to take the action
needed in order to achieve such interoperability and can
the
therefore be better achieved at Community level,
Community may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the Treaty.
In accordance with the principle of proportionality, as set
out in that Article, this Directive does not go beyond what
is necessary in order to achieve that objective.

(54)

In accordance with point 34 of
the Interinstitutional
Agreement on better law-making (2), Member States are
encouraged to draw up, for themselves and in the interests
of the Community, their own tables illustrating, as far as
possible, the correlation between this Directive and the
transposition measures, and to make them public.

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

(56) Article 14 of Directive 2004/49/EC and Directives 96/48/

EC and 2001/16/EC should therefore be repealed,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Purpose and scope

1. This Directive sets out to establish the conditions to be met
to achieve interoperability within the Community rail system in a
manner compatible with the provisions of Directive 2004/49/EC.
These conditions concern the design, construction, placing in
service, upgrading, renewal, operation and maintenance of the
parts of this system as well as the professional qualifications and
health and safety conditions of the staff who contribute to its
operation and maintenance.

2. The pursuit of this objective must lead to the definition of an
optimal level of technical harmonisation and make it possible to:

(a)

facilitate, improve and develop international rail transport
services within the European Union and with third
countries;

(1) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/

512/EC (OJ L 200, 22.7.2006, p. 11).

(2) OJ C 321, 31.12.2003, p. 1.

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(b)

the internal
contribute to the progressive creation of
market in equipment and services for the construction,
renewal, upgrading and operation of the rail system within
the Community;

(c)

contribute to the interoperability of the rail system within
the Community.

3. Member States may exclude from the measures they adopt in
implementation of this Directive:

(a) metros, trams and other light rail systems;

(b)

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

(c)

privately owned railway infrastructure and vehicles exclu-
sively used on such infrastructure that exist solely for use by
the owner for its own freight operations;

(d)

infrastructure and vehicles reserved for a strictly local,
historical or touristic use.

4. The scope of the TSIs shall be progressively extended in
accordance with Article 8 to the whole rail system, including
track access to terminals and main port facilities serving or
potentially serving more than one user, without prejudice to the
derogations to the application of TSIs as listed in Article 9.

Article 2

Definitions

For the purposes of this Directive:

(e)

(f)

(g)

(h)

(i)

(j)

‘subsystems’ means the result of the division of the rail
system, as shown in Annex II. These subsystems, for which
essential requirements must be laid down, may be structural
or functional;

‘interoperability constituents’ means any elementary com-
ponent, group of components, subassembly or complete
assembly of equipment incorporated or intended to be
incorporated into a subsystem, upon which the interoper-
ability of the rail system depends directly or indirectly. The
concept of a ‘constituent’ covers both tangible objects and
intangible objects such as software;

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

common technical
‘European specification’ means
specification, a European technical approval or a national
standard transposing a European standard, as defined in
Annex XXI to Directive 2004/17/EC;

a

‘technical specification for interoperability’ (TSI) means a
specification adopted in accordance with this Directive by
which each subsystem or part subsystem is covered in order
to meet
the
interoperability of the rail system;

requirements and ensure

essential

the

‘notified bodies’ means the bodies which are responsible for
assessing the conformity or suitability for use of
the
interoperability constituents or for appraising the ‘EC’
procedure for verification of the subsystems;

‘trans-European rail system’ means the trans-European
conventional and high-speed rail systems as set out in
Annex I, points 1 and 2, respectively;

(k)

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

‘interoperability’ means the ability of a rail system to allow
trains which
the safe and uninterrupted movement of
accomplish the required levels of performance for these
lines. This ability depends on all the regulatory, technical
and operational conditions which must be met in order to
satisfy the essential requirements;

(l)

(c)

‘vehicle’ means a railway vehicle that runs on its own
wheels on railway lines, with or without traction. A vehicle
is composed of one or more structural and functional
subsystems or parts of such subsystems;

in the TSIs, either

‘specific case’ means any part of the rail system which needs
special provisions
temporary or
definitive, because of geographical, topographical or urban
environment constraints or those affecting compatibility
with the existing system. This may include in particular
railway lines and networks isolated from the rest of the
Community, 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;

(a)

(b)

(d)

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

(m)

‘upgrading’ means any major modification work on a
subsystem or part subsystem which improves the overall
performance of the subsystem;

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(n)

(o)

(p)

substitution work on a
‘renewal’ means any major
subsystem or part subsystem which does not change the
overall performance of the subsystem;

(x)

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

‘existing rail system’ means the structure composed of lines
and fixed installations of the existing rail system plus the
vehicles of all categories and origin 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;

(y)

(z)

‘Agency’ means the European Railway Agency, as estab-
lished by Regulation (EC) No 881/2004 of the European
Parliament and of the Council of 29 April 2004 establish-
ing a European railway agency (Agency Regulation) (2);

‘entity in charge of maintenance’ means an entity in charge
of maintenance of a vehicle, and registered as such in the
national vehicle register.

(q)

‘placing in service’ means all the operations by which a
subsystem or a vehicle is put into its design operating state;

(r)

(s)

(t)

(u)

‘contracting entity’ means any entity, whether public or
private, which orders the design and/or construction or the
renewal or upgrading of a subsystem. This entity may be a
railway undertaking, an infrastructure manager or a keeper,
or the concession holder responsible for carrying out a
project;

‘keeper’ means the person or entity that, being the owner of
a vehicle or having the right to use it, exploits the vehicle as
a means of transport and is registered as such in the
national vehicle register referred to in Article 33;

‘project at an advanced stage of development’ means any
project whose planning/construction stage has reached a
point where a change in the technical specifications would
be unacceptable to the Member State concerned. Such an
impediment may be legal, contractual, economic, financial,
social or environmental
in nature and must be duly
substantiated;

‘harmonised standard’ means any European standard
adopted by one of the European standardisation bodies
listed in Annex I to Directive 98/34/EC of the European
Parliament and of the Council of 22 June 1998 laying down
a procedure for the provision of information in the field of
technical
rules on
standards and regulations and of
Information Society services (1)
in connection with a
mandate by the Commission drawn up in accordance with
the procedure referred to in Article 6(3) of that Directive,
which, by itself or together with other standards, provides a
solution as regards compliance with a legal provision;

(v)

‘national safety authority’ means a safety authority as
defined in Article 3(g) of Directive 2004/49/EC;

Article 3

Overall compatibility

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

2. The provisions of
this Directive shall apply without
prejudice to any other relevant Community provisions. However,
in the case of interoperability constituents, including interfaces,
compliance with the essential requirements of this Directive may
require the use of individual European specifications drawn up
for that purpose.

Article 4

Essential requirements

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

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

CHAPTER II

TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY

Article 5

Content of TSIs

(w)

‘type’ means a vehicle type defining the basic design
characteristics of the vehicle as covered by a single type-
examination certificate described in module B of Decision
93/465/EEC;

Each of the subsystems shall be covered by one TSI. Where
1.
necessary, a subsystem may be covered by several TSIs and one
TSI may cover several subsystems. The decision to develop or to
revise a TSI and the choice of its technical and geographical
scope requires a mandate in accordance with Article 6(1).

(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council

Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

(2) OJ L 164, 30.4.2004, p. 1. Corrected by OJ L 220, 21.6.2004, p. 3.

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Subsystems shall comply with the TSIs in force at the time of
2.
their placing in service, upgrading or renewal, in accordance with
this Directive; this compliance shall be permanently maintained
while each subsystem is in use.

3. To the extent necessary to achieve the objective 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
concerned and its interfaces vis-à-vis other subsystems;

for each subsystem

requirements

establish the functional and technical specifications to be
met by the subsystem and its interfaces vis-à-vis other
these specifications may vary
subsystems.
according to the use of
for example
according to the categories of line, hub and/or vehicles
provided for in Annex I;

the subsystem,

If need be,

determine the interoperability constituents and interfaces
which must be
covered by European specifications,
including European standards, which are necessary to
achieve interoperability within the rail system;

state, in each case under consideration, which procedures
are to be used in order to assess the conformity or the
suitability for use of the interoperability constituents, on
the one hand, or the ‘EC’ verification of the subsystems, on
the other hand. These procedures shall be based on the
modules defined in Decision 93/465/EEC;

it

implementing the TSIs.

In
indicate the strategy for
particular,
is necessary to specify the stages to be
completed in order to make a gradual transition from the
existing situation to the final situation in which compliance
with the TSIs shall be the norm;

(a)

(b)

(c)

(d)

(e)

(f)

(g)

with regard to both network and vehicles; special attention must
be given to the loading gauge, the track gauge or space between
the tracks and vehicles originating from or destined for third
countries. For each specific case, the TSIs shall stipulate the
implementing rules of the elements of the TSIs indicated in
paragraph 3(c) to (g).

6.
If certain technical aspects corresponding to the essential
requirements cannot be explicitly covered in a TSI, they shall be
clearly identified in an annex to the TSI as open points.
Article 17(3) shall apply to these aspects.

7. TSIs shall not be an impediment to decisions by the Member
States concerning the use of infrastructures for the movement of
vehicles not covered by the TSIs.

8. TSIs may make an explicit, clearly identified reference to
European or international standards or specifications or technical
documents published by the Agency where this is strictly
necessary in order to achieve the objective of this Directive. In
such case, these standards or specifications (or the relevant parts)
or technical documents shall be regarded as annexes to the TSI
concerned and shall become mandatory from the moment the
TSI
such standards or
In the absence of
and pending their
technical documents
specifications or
development, reference may be made to other clearly identified
normative documents;
concern
documents that are easily accessible and in the public domain.

in such case,

is applicable.

shall

this

Article 6

Adoption, review and publication of TSIs

1. Draft TSIs and subsequent draft amendments to TSIs shall be
drafted by the Agency under a mandate from the Commission in
accordance with the regulatory procedure referred to in
Article 29(3) of
this Directive. They shall be drafted in
accordance with Articles 3 and 12 of Regulation (EC) No 881/
2004 and in cooperation with the working parties mentioned in
those Articles.

indicate, for the staff concerned, the professional qualifica-
tions and health and safety conditions at work required for
the operation and maintenance of the above subsystem, as
well as for the implementation of the TSIs.

Measures designed to amend non-essential elements of
this
Directive by supplementing it with TSIs or amendments thereto
shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 29(4).

Each TSI shall be drawn up on the basis of an examination
4.
of an existing subsystem and indicate a target subsystem that
may be obtained gradually within a reasonable time-scale.
Accordingly, the gradual adoption of the TSIs and compliance
therewith will help gradually to achieve the interoperability of
the rail system.

5. TSIs shall retain, in an appropriate manner, the compatibility
of the existing rail system of each Member State. With this
objective, provision may be made for specific cases for each TSI,

On imperative grounds of urgency, the Commission may use the
urgency procedure referred to in Article 29(5).

2. The Agency shall be responsible for preparing the review
and updating of TSIs and making any recommendations to the
Commission in order to take account of developments in
technology or social requirements. The Commission shall inform
the committee referred to in Article 29 of such recommenda-
tions.

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3.

Each draft TSI shall be drawn up in two stages.

Firstly, the Agency shall identify the basic parameters for the TSI
as well as the interfaces with the other subsystems and any other
specific cases that may be necessary. The most viable alternative
solutions accompanied by technical and economic justification
shall be put forward for each of these parameters and interfaces.

Secondly, the Agency shall draw up the draft TSI on the basis of
these basic parameters. Where appropriate, the Agency shall take
account of technical progress, of standardisation work already
carried out, of working parties already in place and of
acknowledged research work. An overall assessment of
the
estimated costs and benefits of the implementation of the TSIs
shall be attached to the draft TSI; this assessment shall indicate
the likely impact for all the operators and economic agents
involved.

4. The drafting, adoption and review of each TSI (including the
basic parameters) shall take account of the estimated costs and
benefits of all the technical solutions considered, together with
the interfaces between them, so as to establish and implement
the most viable solutions. The Member States shall participate in
this assessment by providing the requisite data.

5. The committee referred to in Article 29 shall be kept
regularly informed of the preparatory work on the TSIs. During
this work the Commission may, at the request of the committee,
formulate any terms of reference or useful recommendations
concerning the design of the TSIs and the cost-benefit analysis.
In particular, the Commission may, at the request of a Member
State, require that alternative solutions be examined and that the
assessment of the cost and benefits of these alternative solutions
be set out in the report annexed to the draft TSI.

6. On the adoption of each TSI, the date of entry into force of
that TSI shall be established in accordance with the regulatory
procedure with scrutiny referred to in Article 29(4). Where
different subsystems have to be placed in service simultaneously
for reasons of technical compatibility, the dates of entry into
force of the corresponding TSIs shall be the same.

7. The drafting, adoption and review of the TSIs shall take
account of the opinion of users, as regards the characteristics
which have a direct impact on the conditions in which they use
the subsystems. To that end the Agency shall consult associations
and bodies representing users during the drafting and review
phases of the TSIs. It shall enclose with the draft TSI a report on
the results of this consultation.

accordance with the advisory procedure referred to in Arti-
cle 29(2), and may be re-examined and updated at the request of
a Member State or upon the initiative of the Commission.

8. The drafting, adoption and review of the TSIs shall take
account of the opinion of the social partners as regards the
conditions referred to in Article 5(3)(g).

To this end, the social partners shall be consulted before the draft
TSI
is submitted, for adoption or review, to the committee
referred to in Article 29.

The social partners shall be consulted in the context of the
Sectoral Dialogue Committee set up in accordance with
Commission Decision 98/500/EC of 20 May 1998 on the
establishment of Sectoral Dialogue Committees promoting the
Dialogue between the social partners at European level (1). The
social partners shall issue their opinion within three months.

9. When revision of a TSI leads to a change of requirements,
the new TSI version shall ensure compatibility with subsystems
placed in service in accordance with former TSI versions.

In case a new authorisation, renewal or upgrading of these
subsystems is needed for duly justified safety or interoperability
reasons, corresponding deadlines shall be fixed either in the TSI
or, as appropriate, by the Member States.

10. TSIs shall be published by the Commission in the Official
Journal of the European Union.

Article 7

Deficiencies in TSIs

If, after its adoption, it appears that a TSI does not fully meet
1.
the essential
the committee referred to in
Article 29 may be consulted at the request of a Member State
or upon the initiative of the Commission.

requirements,

The Commission may request a technical opinion from the
Agency. The Commission, with the
the
committee, shall analyse the technical opinion.

involvement of

2.
If the TSI needs to be amended because of a minor error and
this does not justify an immediate revision, the Commission may
recommend that the technical opinion is used pending the
review of the TSI in accordance with Article 6(1). In that case, the
Agency shall publish the technical opinion.

3.
If the TSI needs to be amended because of an important or
critical error, the revision procedure referred to in Article 6(1)
shall be applied forthwith.

The list of associations and bodies to be consulted shall be drawn
up by the Commission, after consulting the committee in

(1) OJ L 225, 12.8.1998, p. 27. Decision as last amended by Regulation

(EC) No 1792/2006 (OJ L 362, 20.12.2006, p. 1).

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Article 8

Extension of the scope of TSIs

Article 9

Derogations

in accordance with the
1. The Commission shall adopt,
regulatory procedure referred to in Article 29(3), one or more
mandates aiming at the development of new TSIs and/or the
review of TSIs already adopted with a view to covering lines and
vehicles not yet covered.

2. The first such mandate shall indicate a first group of new
TSIs and/or amendments to TSIs to be adopted by January 2012,
without prejudice to Article 5(5) as regards the possibility of
providing for specific cases and without prejudice to Article 9
allowing for derogations in particular circumstances. This first
mandate shall be drawn up on the basis of a recommendation
from the Agency with a view to determining new TSIs to be
developed and/or existing TSIs to be amended in the light of the
expected cost-effectiveness of each proposed measure and on the
basis of the principle of proportionality of measures to be taken
at Community level. To this end, appropriate consideration shall
be given to Annex I, point 4 and the necessary balance between,
on the one hand, the objectives of uninterrupted movement of
trains and of technical harmonisation, and, on the other hand,
the trans-European, national, regional or local
level of traffic
concerned.

3. Until such time as the extension of the scope of the TSIs to
cover the whole of the rail network takes effect:

(d)

(a)

authorisations for the placing in service

— of vehicles and on-board control-command and
signalling subsystems to be used at least partially on
the part of the network that does not yet fall within
the scope of the TSIs, in respect of that part of the
network,

In the absence of relevant specific cases, a Member State
1.
need not apply one or more TSIs in accordance with this Article
in the following cases:

(a)

(b)

(c)

the renewal or
for a proposed new subsystem,
upgrading of an existing subsystem, or for any element
referred to in Article 1(1) at an advanced stage of
development or the subject of a contract in the course of
performance when these TSIs are published;

for

for any project concerning the renewal or upgrading of an
existing subsystem where the loading gauge, track gauge,
space between the tracks or electrification voltage in these
TSIs is not compatible with those of the existing subsystem;

for a proposed new subsystem or for the proposed renewal
or upgrading of an existing subsystem in the territory of
that Member State when its rail network is separated or
isolated by the sea or separated as a result of special
geographical conditions from the rail network of the rest of
the Community;

for any proposed renewal, extension or upgrading of an
existing subsystem, when the application of these TSIs
would compromise the economic viability of the project
and/or the compatibility of the rail system in that Member
State;

(e) where,

following an accident or a natural disaster, the
conditions for the rapid restoration of the network do not
economically or
total
application of the relevant TSIs;

technically allow for partial or

— of infrastructure, energy and trackside control-com-
mand and signalling subsystems on the parts of the
network that do not yet fall within the scope of the
TSIs,

(f)

for vehicles coming from or going to third countries the
track gauge of which is different from that of the main rail
network within the Community.

shall be granted in accordance with the national rules
referred to in Article 8 of Directive 2004/49/EC, or, where
applicable, Article 17(3) of this Directive;

(b)

authorisations for the placing in service of vehicles to be
used occasionally on the part of the network that does not
yet fall within the scope of the TSIs, in respect of that part
of
the network, shall be granted in accordance with
Articles 21 to 27 and the national rules referred to in
Article 8 of Directive 2004/49/EC, or, where applicable,
Article 17(3) of this Directive.

2.
In the cases referred to in paragraph 1, the Member State
concerned shall communicate to the Commission a file
containing the information set out in Annex IX. The Commis-
sion shall analyse the measures proposed by the Member State
and shall inform the committee referred to in Article 29.

3.
In the case referred to in paragraph 1(a), within one year of
entry into force of each TSI each Member State shall
communicate to the Commission a list of projects that are
taking place within its territory and are at an advanced stage of
development.

4. A Member State need not apply the new or revised TSIs
adopted in accordance with paragraph 2 in the case of projects at
an advanced stage of development or subject to a contract in the
course of performance when the relevant group of TSIs is
published.

4.
In the cases referred to in paragraph 1(a), (c) and (e), the
Commission shall check that the file is in conformity and shall
inform the Member State of the results of its analysis. Where
necessary, a recommendation shall be drawn up concerning the
specifications to be applied. The Member State may apply the
alternative provisions referred to in Annex IX without delay.

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In the cases referred to in paragraph 1(b), (d) and (f), the
5.
Commission shall decide,
in accordance with the regulatory
procedure referred to in Article 29(3), whether to accept a
request for a derogation. In the case referred to in paragraph 1(b),
the Commission's decision shall not cover the loading gauge and
the track gauge. The Commission shall give its decision within six
months of the submission of the request supported by the
complete file. In the absence of such a decision, the request shall
be deemed to have been accepted. Pending the Commission's
decision, in the case referred to in paragraph 1(f), a Member State
may apply the alternative provisions referred to in Annex IX.

6. All Member States shall be informed of the results of the
analyses and of
in
paragraphs 4 and 5.

the procedure set out

the outcome of

CHAPTER III

INTEROPERABILITY CONSTITUENTS

Article 10

Placing on the market of interoperability constituents

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

(a)

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

(b)

are used in their area of use as intended and are suitably
installed and maintained.

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

2. Member States may not, in their territory and on the basis of
this Directive, prohibit, restrict or hinder the placing on the
market of interoperability constituents for use in the rail system
where they comply with this Directive. In particular, they may
not require checks which have already been carried out as part of
the procedure of ‘EC’ declaration of conformity or suitability for
use, the components of which are set out in Annex IV.

Article 11

Conformity or suitability for use

1. Member States shall consider those interoperability con-
stituents which bear the ‘EC’ declaration of conformity or
suitability for use as complying with the essential requirements
of this Directive.

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

that an interoperability
3. Member States
constituent meets the essential requirements if it complies with

shall consider

the conditions laid down by the corresponding TSI or the
corresponding European specifications developed to comply
with these conditions.

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

5. TSIs may provide for a period of transition for rail products
identified by those TSIs as interoperability constituents which
have already been placed on the market when the TSIs enter into
satisfy the requirements of
force. Such constituents
Article 10(1).

shall

Article 12

Non-compliance of European specification with essential
requirements

Where it appears to a Member State or the Commission that
European specifications used directly or indirectly to achieve the
objectives of this Directive do not meet the essential require-
ments, the committee referred to in Article 29 shall be informed
thereof and the Commission shall adopt the most appropriate
measure, being:

(a)

partial or total withdrawal of the specifications concerned
from the publications containing them, or their amend-
ment, after consultation, where European standards are
involved, of the Committee set up under Directive 98/34/
EC, or

(b)

review of the TSI in accordance with Article 7.

Article 13

Procedure for ‘EC’ declaration of conformity or suitability
for use

In order to establish the ‘EC’ declaration of conformity or
1.
suitability for use of an interoperability constituent,
the
manufacturer or his authorised representative established in the
Community shall apply the provisions laid down by the relevant
TSIs.

2. Where the corresponding TSI so requires, assessment of the
conformity or suitability for use of an interoperability constituent
shall be carried out by the notified body with which the
manufacturer or his authorised representative established in the
Community has lodged the application.

3. Where interoperability constituents are the subject of other
Community directives covering other aspects, the ‘EC’ decla-
ration of conformity or suitability for use shall, in such cases,
the
state that
requirements of those other directives.

the interoperability constituents also meet

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the manufacturer nor his

authorised
4. Where neither
representative established in the Community has met
the
obligations of paragraphs 1 and 3, those obligations shall be
incumbent on any person who places interoperability constitu-
ents on the market. The same obligations shall apply to
whomsoever assembles interoperability constituents or parts of
interoperability constituents having diverse origins or manufac-
tures interoperability constituents for his own use,
for the
purposes of this Directive.

5. Without prejudice to the provisions of Article 14:

(a)

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

representative established within the Community thereof. Where
the decision referred to in paragraph 1 is justified by the
existence of a gap in European specifications, the procedure set
out in Article 12 shall apply.

3. Where an interoperability constituent bearing the ‘EC’
declaration of conformity fails
the competent
Member State shall take appropriate measures against whomso-
ever has drawn up the declaration and shall
inform the
Commission and the other Member States thereof.

to comply,

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

CHAPTER IV

SUBSYSTEMS

Article 15

(b) where non-conformity persists, the Member State shall take
all appropriate steps to restrict or prohibit the placing on
the market of the interoperability constituent in question,
or to ensure that it is withdrawn from the market in
accordance with the procedures provided for in Article 14.

Procedure for placing in service

1. Without prejudice to Chapter V, each Member State shall
authorise the placing in service of those structural subsystems
constituting the rail system which are located or operated in its
territory.

Article 14

Non-compliance of interoperability constituents with
essential requirements

that an interoperability
1. Where a Member State finds
constituent covered by the ‘EC’ declaration of conformity or
suitability for use and placed on the market is unlikely, when
used as intended, to meet the essential requirements, it shall take
all necessary steps to restrict its field of application, prohibit its
use or withdraw it from the market. The Member State shall
forthwith inform the Commission of the measures taken and
give the reasons for its decision, stating in particular whether
failure to conform is due to:

(a)

failure to meet the essential requirements;

To this end, Member States shall take all appropriate steps to
ensure that these subsystems may be placed in service only if
they are designed, constructed and installed in such a way as to
meet
concerning them when
integrated into the rail system. In particular, they shall check:

requirements

essential

the

— the technical compatibility of these subsystems with the

system into which they are being integrated,

— the safe integration of these subsystems in accordance with

Articles 4(3) and 6(3) of Directive 2004/49/EC.

Each Member State shall check, before these subsystems are
2.
placed in service, that they comply, where applicable, with the
relevant TSI provisions on operation and maintenance.

(b)

incorrect application of European specifications where
application of such specifications is relied upon;

3. After these subsystems have been placed in service, the
check shall be carried out:

(c)

inadequacy of European specifications.

following that consultation,

2. The Commission shall consult the parties concerned as
the
quickly as possible. Where,
Commission establishes that the measure is justified it shall
forthwith inform the Member State that has taken the initiative
as well as the other Member States thereof. Where, after that
consultation, the Commission establishes that the measure is
unjustified it shall forthwith inform the Member State that has
taken the initiative and the manufacturer or his authorised

(a)

(b)

the granting and
in the context of
for infrastructures,
supervision of safety authorisations under Article 11 of
Directive 2004/49/EC;

for vehicles, in the context of the granting and supervision
of safety certificates under Article 10 of Directive 2004/49/
EC.

To that end, the assessment and verification procedures laid
down in the relevant structural and functional TSIs shall be used.

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Article 16

Free movement of subsystems

The Commission shall communicate this information to the
Agency, which shall publish it.

Without prejudice to the provisions of Article 15(1), Member
States may not, in their territory and on grounds relating to this
Directive, prohibit, restrict or hinder the construction, placing in
service and operation of structural subsystems constituting the
rail system which meet the essential requirements. In particular,
they may not require checks which have already been carried out:

— either as part of

the procedure leading to the ‘EC’
declaration of verification, the components of which are
set out in Annex V,

— 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 17

Conformity with TSIs and national rules

1. Member States shall consider as being interoperable and
meeting the essential requirements concerning them,
those
structural subsystems constituting the rail system which are
covered by the ‘EC’ declaration of verification.

2. Verification of the interoperability, in accordance with the
essential requirements, of a structural subsystem constituting the
rail system shall be established by reference to TSIs, where they
exist.

3. Member States shall draw up, for each subsystem, a list of
the technical
implementing the essential
requirements and notify this list to the Commission when:

in use for

rules

— no relevant TSI exists, or

— a derogation has been notified under Article 9, or

— a specific case requires the application of technical rules not

included in the relevant TSI.

This list shall be notified either:

— each time the list of

technical rules that, pursuant to
Article 16(3) of Directive 96/48/EC and Article 16(3) of
Directive 2001/16/EC, was required to be notified by
30 April 2005 is changed, or

Member States shall make available the full text of the notified
rules at the request of the Commission. In order to prevent
further barriers from being created, and with a view to taking
forward the classification of national rules in accordance with
Article 27, the Commission shall monitor the introduction of
new rules by the Member States. If the Commission considers
that the new rule constitutes a means of arbitrary discrimination
or a disguised restriction on rail transport operations between
Member States, a decision, addressed to the Member State
concerned, shall be adopted in accordance with the regulatory
procedure referred to in Article 29(3).

Member States may choose not to notify rules and restrictions of
a strictly local nature. In such cases, Member States shall mention
such rules and restrictions in the infrastructure registers referred
to in Article 35.

Member States shall ensure that binding technical rules are
infrastructure managers,
published and made available to all
railway undertakings and applicants
for
placing in service in clear language that can be understood by
the parties concerned.

for authorisations

Article 18

Procedure for establishing the ‘EC’ declaration of
verification

1.
In order to establish the ‘EC’ declaration of verification, the
applicant shall invite the notified body that it has selected for that
purpose to apply the ‘EC’ verification procedure referred to in
Annex VI. The applicant may be the contracting entity or the
manufacturer, or
their authorised representative within the
Community.

2. 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 in service. It shall also cover
verification of the interfaces of the subsystem in question with
the system into which it
incorporated, based on the
is
information available in the relevant TSI and in the registers
provided for in Articles 34 and 35.

— after the derogation has been notified, or

— after publication of the TSI concerned.

On that occasion, Member States shall also designate the bodies
these technical
responsible for carrying out,
regulations, the verification procedure referred to in Article 18.

in the case of

3. The notified body shall be responsible for compiling the
technical file that has to accompany the ‘EC’ declaration of
verification. This technical file must contain all the necessary
documents relating to the characteristics of the subsystem and,
where appropriate, all the documents certifying conformity of
the interoperability constituents. It should also contain all the
elements relating to the conditions and limits of use and to the
instructions concerning servicing, constant or routine monitor-
ing, adjustment and maintenance.

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statement
4. The notified body may issue
verifications to cover certain stages of the verification procedure
or certain parts of the subsystem. In such a case, the procedure
set out in Annex VI shall apply.

intermediate

2. When a new authorisation is required and if the TSI is not
fully applied,
the Member States shall notify the following
information to the Commission:

If

5.
the relevant TSIs allow, the notified body may issue
certificates of conformity for a series of subsystems or certain
parts of those subsystems.

Article 19

Non-compliance of subsystems with essential requirements

1. Where a Member State finds that a structural subsystem
covered by the ‘EC’ declaration of verification accompanied by
the technical file does not fully comply with this Directive and in
it may
particular does not meet the essential requirements,
request that additional checks be carried out.

2. The Member State making the request shall forthwith inform
the Commission of any additional checks requested and set out
the reasons therefor. The Commission shall consult the interested
parties.

3. The Member State making the request shall state whether
the failure to fully comply with this Directive is due to:

(a)

(b)

non-compliance with the essential requirements or with a
TSI, or incorrect application of a TSI. In that case, the
Commission shall
forthwith inform the Member State
where the person who drew up the ‘EC’ declaration of
verification in error resides and shall request that Member
State to take the appropriate measures;

inadequacy of a TSI.
amending the TSI as referred to in Article 7 shall apply.

the procedure for

In that case,

— the reason why the TSI is not fully applied,

— the technical characteristics applicable in place of the TSI,

— the bodies responsible for applying, in the case of those
characteristics, the verification procedure referred to in
Article 18.

3. The Commission shall
information
referred to in paragraph 2 to the Agency, which shall publish it.

communicate

the

CHAPTER V

VEHICLES

Article 21

Authorisation for placing in service of vehicles

1. Before being used on a network, a vehicle shall be authorised
to be placed in service by the national safety authority which is
competent for this network, unless otherwise provided for in this
Chapter.

2. A TSI conform vehicle shall be authorised in accordance
with Articles 22 or 23.

3. A non-TSI
conform vehicle
accordance with Articles 24 or 25.

shall be

authorised in

Article 20

4. A vehicle which conforms to an authorised type shall be
authorised in accordance with Article 26.

Placing in service of existing subsystems after renewal or
upgrading

1.
In the event of renewal or upgrading, the contracting entity
or the manufacturer shall send the Member State concerned a file
describing the project. The Member State shall examine this file
and, taking account of the implementation strategy indicated in
the applicable TSI, shall decide whether the extent of the works
means that a new authorisation for placing in service within the
meaning of this Directive is needed.

Such new authorisation for placing in service shall be required
whenever the overall safety level of the subsystem concerned
may be adversely affected by the works envisaged. If a new
authorisation is needed, the Member State shall decide to what
extent the TSIs need to be applied to the project.

5. An authorisation granted by one Member State shall be valid
in all Member States, without prejudice to the provisions of
Articles 23 and 25 concerning additional authorisations.
Member States shall clarify, by adopting specific national rules
or through national provisions implementing this Directive,
whether additional authorisations are needed in accordance with
the relevant provisions of Article 23 in the case of TSI conform
vehicles or Article 25 in the case of non-TSI conform vehicles.

6. All applications for an authorisation to place in service shall
be the subject of a decision by the competent national safety
authority, pursuant to Articles 22 and 23 or Articles 24 and 25.
The authorisation to place in service may stipulate conditions of
use and other restrictions.

The Member State shall take its decision not later than four
months after submission of the complete file by the applicant.

7. Any decision by a competent national safety authority
refusing the placing in service of a vehicle shall be duly
substantiated. The applicant may within a period of one month

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from receipt of the negative decision request that the competent
national safety authority reviewed the decision for duly justified
reasons. The national safety authority shall
then have two
months starting from receipt of the appeal to confirm or reverse
its decision. If the negative decision is confirmed, the applicant
may request that the appeal body designated by the competent
Member State under Article 17(3) of Directive 2004/49/EC
review the decision for duly justified reasons. Member States may
designate the regulatory body set up in accordance with
Article 30 of Directive 2001/14/EC for the purpose of this
appeal procedure.

In the absence of a decision of the competent national safety
8.
authority as referred to in Articles 23(7) and 25(5) within the
prescribed time limits, the placing in service of the vehicle in
question shall be deemed to have been authorised after a period
of three months starting at the end of these time limits. The
authorisations granted pursuant to this paragraph are only valid
on the network for which the competent national safety
authority did not react within the prescribed limits.

9. A national safety authority which intends to revoke an
authorisation to place in service granted by itself or an
authorisation granted to the applicant pursuant to paragraph 8
shall use the procedure for revision of safety certificates referred
to in Article 10(5) of Directive 2004/49/EC or, where applicable,
the procedure for revision of safety authorisations referred to in
Article 11(2) of that Directive.

10.
In the case of an appeal procedure, the competent appeal
body referred to in paragraph 7 may request from the Agency an
opinion which, in that case, shall be issued within one month of
the request being filed and notified to the applicant, to the
competent appeal body and to the competent national safety
authority which refuses to grant the authorisation.

11.
In the case of vehicles running between a Member State
and a third country, on a network whose track gauge is different
from that of the main rail network within the Community and
for which a derogation may be granted in accordance with
Article 9(5) or which are subject to specific cases, the national
rules referred to in Articles 22 and 24 may include international
agreements in so far as they are compatible with Community
legislation.

12. Authorisations for placing in service which have been
granted before 19 July 2008, including authorisations delivered
under international agreements, in particular RIC (Regolamento
Internazionale Carrozze) and RIV (Regolamento Internazionale
Veicoli), shall remain valid in accordance with the conditions
under which the authorisations have been granted. This
provision takes precedence over Articles 22 to 25.

13. Member States may grant authorisations to place in service
a series of vehicles. To that end, the national safety authorities
shall notify the applicant of the procedure to be followed.

14. Authorisations for placing in service granted in accordance
with this Article shall be without prejudice to other conditions
imposed on railway undertakings and infrastructure managers
for operating such vehicles on the relevant network, pursuant to
Articles 9, 10 and 11 of Directive 2004/49/EC.

Article 22

First authorisation for placing in service of TSI conform
vehicles

1. This Article shall apply to vehicles which are in conformity
with all the relevant TSIs which are in force at the moment of
placing in service, provided that a significant part of the essential
requirements is laid down in these TSIs and that the relevant TSI
on rolling stock has entered into force and is applicable.

2. The first authorisation shall be granted by a national safety
authority as follows:

(a) where all the structural subsystems of a vehicle have been
authorised in conformity with the provisions of Chapter IV,
the authorisation shall be granted without further checks;

(b)

in the case of vehicles bearing all necessary ‘EC’ declarations
of verification as provided for in Article 18, the criteria
which a national safety authority may check with a view to
granting an authorisation for placing in service may
concern only:

— technical compatibility between the vehicle's relevant
subsystems and their safe integration in accordance
with Article 15(1),

— technical compatibility between the vehicle and the

network concerned,

— national rules applicable to the open points,

— national rules applicable to the specific cases duly

identified in the relevant TSIs.

Article 23

Additional authorisations for placing in service of TSI
conform vehicles

1. Vehicles in complete conformity with TSIs covering all
aspects of the relevant subsystems without specific cases and
without open points strictly related to technical compatibility
between vehicle and network, shall not be subject
to any
additional authorisation for placing in service as long as they run
on TSI conform networks in the other Member States or under
the conditions specified in the corresponding TSIs.

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In the case of vehicles placed in service in accordance with
2.
Article 22 but not covered by paragraph 1, Member States shall
decide if additional authorisations are necessary on their
territory. In this case, paragraphs 3 to 7 shall apply.

7. All applications for an authorisation to place in service
submitted in accordance with this Article shall be the subject of a
decision by the national safety authority, to be taken as soon as
possible and not later than:

3. The applicant shall submit to the national safety authority a
file on the vehicle or type of vehicle and the intended use thereof
on the network. The file shall contain the following information:

(a)

two months after submission of the file referred to in
paragraph 3;

(a)

(b)

(c)

(d)

documentary evidence that the placing in service of the
vehicle has been authorised in another Member State in
accordance with Article 22;

a copy of the technical file as referred to in Annex VI. This
shall include, in the case of vehicles equipped with data
information on the data collection procedure,
recorders,
this
permitting read out and evaluation, as
information is not harmonised by the corresponding TSI;

long as

records showing the vehicle's maintenance history and,
where applicable, technical modifications undertaken after
the authorisation;

evidence on technical and operational characteristics that
shows that the vehicle is compatible with the infrastructures
and fixed installations, including climate conditions, energy
supply system, control-command and signalling system,
track gauge and infrastructure gauges, maximum permitted
axle load and other constraints of the network.

4. The criteria checked by a national safety authority may
concern only:

— technical compatibility between the vehicle and the
network concerned, including the national rules applicable
to the open points needed to ensure such compatibility,

— the national rules applicable to the specific cases duly

identified in the relevant TSIs.

(b) where applicable, one month after provision of any
information requested by the national safety

additional
authority;

(c) where applicable, one month after provision of the results
of any tests requested by the national safety authority.

Article 24

First authorisation for placing in service of non-TSI
conform vehicles

in
1. This Article shall apply to vehicles which are not
conformity with all the relevant TSIs in force at the moment of
placing in service, including vehicles subject to derogations, or
where a significant part of the essential requirements is not laid
down in one or more TSIs.

2. The first authorisation shall be granted by a national safety
authority as follows:

— for the technical aspects covered by a TSI, if any, the ‘EC’

verification procedure shall apply,

— for the other technical aspects, national rules as notified
under Article 17(3) of this Directive and under Article 8 of
Directive 2004/49/EC shall apply.

This first authorisation shall be valid only on the network of the
Member State granting it.

Article 25

5. The national
safety authority may request additional
information to be supplied, risk analyses to be carried out in
accordance with Article 6(3)(a) of Directive 2004/49/EC or tests
to be conducted on the network in order to verify the criteria
referred to in paragraph 4. However, after the adoption of the
reference document referred to in Article 27 of this Directive, the
national safety authority may only carry out such verification on
the basis of the national rules relating to Group B or C featuring
in that document.

Additional authorisations for placing in service of non-TSI
conform vehicles

1.
In the case of vehicles that have been authorised to be placed
in service in one Member State in accordance with Article 21(12)
or Article 24, other Member States may decide in accordance
with this Article whether additional authorisations to place in
service are necessary on their territory.

6. The national safety authority shall define, after consultation
with the applicant, the scope and content of the additional
information,
the risk analyses and the tests requested. The
infrastructure manager, in consultation with the applicant, shall
make every effort to ensure that any tests take place within three
months of
the
national safety authority shall take measures to ensure that the
tests take place.

the applicant's request. Where appropriate,

2. The applicant shall submit to the national safety authority a
technical file on the vehicle or type of vehicle, together with
details of planned use on the network. The file shall contain the
following information:

(a)

documentary evidence that the placing in service of the
vehicle has been authorised in another Member State
together with documentation on the procedure followed in

(b)

(c)

(d)

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order to show that the vehicle complied with the safety
requirements in force, including, where applicable, infor-
mation on derogations enjoyed or granted in accordance
with Article 9;

(a)

four months after submission of the technical file referred
to in paragraph 2;

the technical data, the maintenance programme and the
operational characteristics. This shall include, in the case of
vehicles equipped with data recorders, information on the
and
collection procedure, permitting read out
data
evaluation as provided for in Article 20(2)(c) of Directive
2004/49/EC;

(b) where applicable,

the
additional information or risk analyses requested by the
national safety authority pursuant to paragraph 4;

two months after provision of

(c) where applicable, two months after provision of the results
the tests requested by the national safety authority

of
pursuant to paragraph 4.

records showing the vehicle's history of operation, main-
tenance and, where applicable,
technical modifications
undertaken after the authorisation;

Article 26

Authorisation for types of vehicles

evidence on technical and operational characteristics that
shows that the vehicle is compatible with the infrastructures
and fixed installations, including climate conditions, energy
supply system, control-command and signalling system,
track gauge and infrastructure gauges, maximum permitted
axle load and other constraints of the network.

3. The information referred to in paragraph 2(a) and (b) may
not be called into question by the national safety authority, save
where the latter is able to demonstrate without prejudice to
Article 16 the existence of a substantial safety risk. After the
adoption of the reference document referred to in Article 27, the
national safety authority may not invoke in this regard any
Group A rule listed in that document.

4. The national
safety authority may request additional
information to be supplied, risk analyses to be carried out in
accordance with Article 6(3)(a) of Directive 2004/49/EC or tests
to be conducted on the network in order to verify that the
information referred to in paragraph 2(c) and (d) of this Article
complies with the national rules in force as notified to the
Commission pursuant to Article 8 of Directive 2004/49/EC or to
Article 17 of this Directive. However, after the adoption of the
reference document referred to in Article 27 of this Directive, the
national safety authority may only carry out such verification on
the basis of the national rules relating to Group B or C listed in
that document.

the

the risk analyses or

scope and content of

The national safety authority shall define, after consultation with
the applicant,
the additional
information,
the tests requested. The
infrastructure manager, in consultation with the applicant, shall
make every effort to ensure that any tests take place within three
months of
the
national safety authority shall take measures to ensure that the
tests take place.

the applicant's request. Where appropriate,

1. Member States may grant authorisations for
vehicles.

types of

2. However, if Member States authorise a vehicle, they shall at
the same time authorise the type of vehicle.

3. A vehicle which conforms to a type already authorised in a
Member State shall be authorised by that Member State on the
basis of a declaration of conformity to this type submitted by the
applicant without further checks. However, where the relevant
provisions in TSIs and national rules on the basis of which a type
of vehicle was authorised have changed, Member States shall
decide if authorisations of type already granted remain valid or
need to be renewed. The criteria which a national safety authority
checks in the case of a renewed authorisation of type may only
concern the changed rules. The renewal of the type authorisation
does not affect authorisations of vehicles already granted on the
basis of previously authorised types.

4. The model of declaration of conformity to type shall be
adopted by the Commission by 19 July 2009 on the basis of a
draft prepared by the Agency and in accordance with the
regulatory procedure referred to in Article 29(3).

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

(a)

for TSI conform vehicles, the verification procedures of the
relevant TSIs;

(b)

for non-TSI conform vehicles, the verification procedures as
defined in modules D or E of Decision 93/465/EEC. Where
appropriate,
the Commission may adopt an ad hoc
verification procedure in accordance with the regulatory
procedure referred to in Article 29(3).

5. All applications for an authorisation to place in service
submitted in accordance with this Article shall be the subject of a
decision by the national safety authority, to be taken as soon as
possible and not later than:

6. The applicant may request a type authorisation in several
Member States at the same time. In this case, national safety
authorities shall cooperate with a view to simplifying the
procedure and minimising administrative efforts.

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7. Type authorisations shall be registered in the European
register of authorised types of vehicles referred to in Article 34.
This register shall specify the Member State or Member States in
which a type of vehicle is authorised.

Should a Member State or the Commission consider that a
4.
body notified by another Member State does not meet the
criteria referred to in Annex VIII, the Commission shall consult
the parties concerned. The Commission shall inform the latter
Member State of any changes that are necessary for the notified
body to retain the status conferred upon it.

Article 27

Classification of national rules

1.
In order to facilitate the procedure for authorising the
placing in service of vehicles referred to in Article 25, national
rules shall be classified pursuant to Annex VII.

2. Without prejudice to Article 30(3), the Agency shall, by
19 January 2009, review the parameters set out in section 1 of
it considers
Annex VII and make the recommendations
appropriate to the Commission.

3. The Agency shall draw up a recommendation for a reference
document cross-referencing all the national rules applied by the
Member States for placing vehicles in service. The national safety
authorities shall cooperate with the Agency in this task.

4. The Commission shall adopt the reference document, as well
as any decision to update it, on the basis of the Agency's
recommendation and in accordance with the
regulatory
procedure referred to in Article 29(3).

CHAPTER VI

NOTIFIED BODIES

Article 28

Notified bodies

1. Member States shall notify to the Commission and the other
Member States the bodies responsible for carrying out
the
procedure for the assessment of conformity or suitability for use
referred to in Article 13 and the verification procedure referred
to in Article 18, indicating each body's area of responsibility, and
the identification numbers obtained in advance from the
Commission. The Commission shall publish in the Official
Journal of the European Union the list of bodies, their identification
numbers and areas of responsibility, and shall keep this list
updated.

2. Member States shall apply the criteria provided for in
Annex VIII for the assessment of the bodies to be notified. Bodies
meeting the assessment criteria provided for in the relevant
European standards shall be deemed to meet those criteria.

5. The Commission shall set up a notified bodies coordination
group (hereinafter referred to as the Coordination Group) which
the
shall discuss any matter relating to the application of
procedures for assessing conformity or suitability for the use
referred to in Article 13 and the verification procedure referred
to in Article 18, or to application of the relevant TSIs. Member
the
States'
Coordination Group as observers.

representatives may take part

in the work of

The Commission and the observers shall inform the committee
in the
referred to in Article 29 of
framework of the Coordination Group. The Commission, when
appropriate, will propose the measures needed to remedy the
problems. Where necessary, coordination of the notified bodies
shall be implemented in accordance with Article 30(4).

the work carried out

6. The first of the reports referred to in Article 39 shall also
assess the implementation of the criteria specified in Annex VIII,
and, if necessary, propose appropriate measures.

CHAPTER VII

COMMITTEE AND WORK PROGRAMME

Article 29

Committee procedure

1. The Commission shall be assisted by the committee
established by Article 21 of Directive 96/48/EC (hereinafter
referred to as the Committee).

2. Where reference is made to this paragraph, Articles 3 and 7
of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1) to
(4) and Article 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

3. A Member State shall withdraw approval from a body which
no longer meets the criteria referred to in Annex VIII. It shall
forthwith inform the Commission and the other Member States
thereof.

5. Where reference is made to this paragraph, Article 5a(1), (2),
(4) and (6) and Article 7 of Decision 1999/468/EC shall apply,
having regard to the provisions of Article 8 thereof.

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Article 30

Complementary tasks

(g) management of the transition period between the date of
entry into force of Directive 2004/50/EC and publication of
the TSIs, including the adoption of the reference system
referred to in Article 36.

1. The Commission may submit to the Committee any matter
relating to the implementation of this Directive. If necessary, the
Commission shall adopt an implementing recommendation in
accordance with the advisory procedure referred to in Arti-
cle 29(2).

2. The Committee may discuss any matter relating to the
interoperability of the rail system, including questions relating to
interoperability between the rail system within the Community
and the rail system of third countries.

3. Measures designed to amend non-essential elements of this
Directive and relating to the adaptation of Annexes II to IX shall
be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 29(4).

Should it prove necessary,

the Committee may set up
4.
working parties to assist it in carrying out its tasks, in particular
with a view to coordinating the notified bodies.

CHAPTER VIII

REGISTERS OF NETWORK AND VEHICLES

Article 32

Vehicle numbering system

1. Any vehicle placed in service in the Community rail system
shall carry a European vehicle number (EVN) assigned when the
first authorisation for placing in service is granted.

2. The applicant for the first authorisation shall be responsible
for marking the vehicle in question with the EVN assigned to it.

3. The EVN shall be specified in the TSI on operation and
traffic management.

Article 31

Work programme

4. A vehicle shall be assigned an EVN only once, unless
otherwise specified in the TSI on operation and traffic manage-
ment.

1. The Commission shall draw up a work programme taking
account of the extension of the scope provided for in Article 8,
the amendment of the TSIs provided for in Article 6(1) and the
other obligations
imposed on it by this Directive. The
Commission shall keep the Committee fully informed on and
involved in the drawing up and updating of the programme.

5. Notwithstanding paragraph 1,
in the case of vehicles
operated or intended to be operated from or to third countries
the track gauge of which is different from that of the main rail
network within the Community, Member States may accept
vehicles clearly identified according to a different coding system.

2. The work programme shall consist of the following stages:

Article 33

(a)

development on the basis of a draft prepared by the Agency
of a model of the Community rail system, based on the list
of subsystems (Annex II), to guarantee consistency between
TSIs; this model must include in particular the various
constituents of the system and their interfaces and act as a
reference framework for defining the areas of use of each
TSI;

(b)

development of a model structure for developing TSIs;

(c)

development of a method of cost-benefit analysis of the
solutions set out in the TSIs;

(d)

adoption of the mandates needed to draw up the TSIs;

(e)

identification of the basic parameters for each TSI;

(f)

approval of draft standardisation programmes;

National vehicle registers

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

(a)

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

(b)

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

(c)

it
shall be accessible to the safety authorities and
investigating bodies designated in Articles 16 and 21 of
Directive 2004/49/EC; it shall also be made accessible, in
response to any legitimate request, to the regulatory bodies
designated in Article 30 of Directive 2001/14/EC, and to
the Agency, the railway undertaking and the infrastructure
managers, as well as those persons or organisations
registering vehicles or identified in the register.

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2. Common specifications for the register shall be adopted in
accordance with the regulatory procedure referred to in
Article 29(3) and on the basis of draft specifications prepared
by the Agency. Those draft specifications shall include content,
data format,
functional and technical architecture, operating
including arrangements for the exchange of data, and
mode,
rules for data input and consultation. For each vehicle, the
register shall contain at least the following information:

(a)

the EVN;

(b)

references to the ‘EC’ declaration of verification and the
issuing body;

(c)

references to the European register of authorised types of
vehicles referred to in Article 34;

(d)

identification of the owner of the vehicle and the keeper;

(e)

restrictions on how the vehicle may be used;

(f)

the entity in charge of maintenance.

shall

immediately declare any
3. The registration holder
modification to the data entered in the national vehicle register,
the destruction of a vehicle or its decision to no longer register a
vehicle, to the authority of any Member State where the vehicle
has been authorised.

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

5.
In the case of vehicles placed in service for the first time in a
third country and authorised in a Member State for placing in
service on its territory, that Member State shall ensure that the
data listed in paragraph 2(d) to (f) can be retrieved through the
national vehicle register. Data referred to in paragraph 2(f) may
be substituted by safety critical data relating to the maintenance
schedule.

Article 34

European register of authorised types of vehicles

1. The Agency shall set up and keep a register of types of
vehicles authorised by the Member States for placing in service
on the Community rail network. This register shall meet the
following criteria:

(a)

it shall be public and electronically accessible;

2. This register shall include the following details for each type
of vehicle:

(a)

the technical characteristics of
defined in the relevant TSIs;

the type of vehicle, as

(b)

the manufacturer's name;

(c)

the dates, references and Member States granting the
successive authorisations for this type of vehicle, including
any restrictions or withdrawals.

3. When an authorisation of
type is granted, modified,
suspended or withdrawn in a Member State, the national safety
authority of this Member State shall inform the Agency, so that
the latter may update the register.

4. Common specifications for the register shall be adopted in
accordance with the regulatory procedure referred to in
Article 29(3) and on the basis of draft specifications prepared
by the Agency. Those draft specifications shall include content,
data format,
functional and technical architecture, operating
mode and rules for data input and consultation.

Article 35

Register of infrastructure

a

that

shall

ensure

Each Member State

1.
register of
infrastructure is published and updated on the basis of the
revision cycle referred to in paragraph 2. This register shall
indicate the main features of each subsystem or part subsystem
involved (e.g. the basic parameters) and their correlation with the
features laid down under the applicable TSIs. To that end, each
TSI shall indicate precisely what information must be included in
the register of infrastructure.

for use,

2. The Agency shall prepare draft specifications on this register
regarding its presentation and format,
its revision cycle and
taking into account an appropriate
instructions
transition period for infrastructures placed in service before the
entry into force of this Directive. The Commission shall adopt
the specifications in accordance with the regulatory procedure
referred to in Article 29(3).

CHAPTER IX

TRANSITIONAL PROVISIONS

Article 36

Draft reference systems

(b)

it shall comply with the common specifications referred to
in paragraph 4;

(c)

it shall be linked with all national vehicle registers.

1. The Agency shall develop, in accordance with Articles 3 and
12 of Regulation (EC) No 881/2004 and on the basis of the
information notified by the Member States under Article 17(3) of
this Directive, technical documents from the profession and the

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technical

texts of the relevant international agreements, a draft reference
rules ensuring the current degree of
system of
interoperability of
the networks and vehicles that will be
brought within the scope of this Directive, as defined in Article 1
of this Directive. If necessary, the Commission shall adopt the
reference system in accordance with the regulatory procedure
referred to in Article 29(3) of this Directive.

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

Following adoption of this reference system, Member States
2.
shall inform the Commission of their intention to adopt any
national provision or of the development of any project in their
territory which diverges from the reference system.

Article 39

Reports and information

CHAPTER X

FINAL PROVISIONS

Article 37

Motivation

Any decision taken pursuant to this Directive concerning the
assessment of conformity or suitability for use of interoperability
constituents, the checking of subsystems constituting the rail
system or any decision taken pursuant to Articles 7, 12, 14 and
19 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 38

Transposition

1.
Every three years and for the first time 19 July 2011, the
Commission shall report to the European Parliament and the
Council on the progress made towards achieving interoperability
of the rail system. That report shall also include an analysis of the
cases set out in Article 9.

in the cross-acceptance of vehicles

2. The Commission shall, by 19 July 2013, publish a report
including an analysis of the application of Chapter V and of the
improvements
in the
Community in terms of length and costs of the procedures for
applicants. Where appropriate, the report shall also assess the
impact of various options for further simplifying procedures
relating to the authorisation of vehicles. In this case, several
options concerning cooperation between national safety auth-
orities and the Agency shall be analysed.

3. The Agency shall develop and regularly update a tool
capable of providing, at the request of a Member State or the
Commission, a chart of the interoperability level of the rail
system. That tool shall use the information included in the
registers provided for in Articles 33, 34 and 35.

Article 40

Repeal

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with Article 1,
Article 2, Article 4(2), Article 5(2), (5), (6) and (8), Article 6(1),
(2), (3), (9) and (10), Articles 7, 8, and 9, Article 11(4) and (5),
Article 12, Article 13(5), Articles 15, 16 and 17, Article 18(1),
(2), (4) and (5), Article 19(3), Articles 20 to 27, Article 28(4) and
(6), Articles 32 to 35 and Annexes I to IX not later than 19 July
2010. They shall forthwith communicate to the Commission the
text of those measures.

When Member States adopt those measures, they shall contain a
reference to this Directive or shall be accompanied by such
reference at the time of their official publication. The methods of
making such reference shall be laid down by the Member States.
Member States shall communicate to the Commission the text of
the main provisions of national law which they adopt in the field
covered by this Directive.

2. The obligation to transpose and implement Chapters IV, V,
VII and VIII of this Directive shall not apply to the Republic of
Cyprus and the Republic of Malta for as long as no railway
system is established within their territory.

Directives 96/48/EC and 2001/16/EC shall be repealed with
effect from 19 July 2010, without prejudice to the obligations of
the Member States concerning the time limits for transposition
into national law and application of those Directives.

References to the repealed Directives shall be construed as
references to this Directive and shall be read in accordance with
the correlation table set out in Annex XI.

Article 14 of Directive 2004/49/EC shall be repealed with effect
from 19 July 2008.

Article 41

Entry into force

This Directive shall enter into force on the day following its
publication in the Official Journal of the European Union.

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Article 42

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 17 June 2008.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

J. LENARČIČ

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ANNEX I

SCOPE

1.

Trans-European conventional rail system

1.1. Network

The network of the trans-European conventional rail system will be that on the conventional lines of the trans-
European transport network identified in Decision No 1692/96/EC.

For the purposes of this Directive, this network may be subdivided into the following categories:

— lines intended for passenger services,

— lines intended for mixed traffic (passengers and freight),

— lines specially designed or upgraded 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.

1.2. Vehicles

The trans-European conventional rail system shall comprise all the vehicles likely to travel on all or part of the trans-
European conventional rail network, including:

— self-propelling thermal or electric trains,

— thermal or electric traction units,

— passenger carriages,

— freight wagons, including vehicles designed to carry lorries.

Mobile railway infrastructure construction and maintenance equipment may be included.

Each of the above categories may be subdivided into:

— vehicles for international use,

— vehicles for national use.

2.

Trans-European high-speed rail system

2.1. Network

The network of the trans-European high-speed rail system shall be that of the high-speed lines of the trans-European
transport network identified in Decision No 1692/96/EC.

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The high-speed lines shall comprise:

— 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, on which the speed must be adapted to each case. This category also includes
interconnecting lines between the high-speed and conventional networks, lines through stations, accesses to
terminals, depots, etc. travelled at conventional speed by ‘high-speed’ rolling stock.

This network includes traffic management, tracking and navigation systems, technical installations for data processing
and telecommunications intended for services on these lines in order to guarantee the safe and harmonious operation
of the network and efficient traffic management.

2.2. Vehicles

The trans-European high-speed rail system shall comprise vehicles designed to operate:

— either at speeds of at least 250 km/h on lines specially built for high speeds, while enabling operation at speeds

exceeding 300 km/h in appropriate circumstances,

— or at speeds of the order of 200 km/h on the lines of section 2.1, where compatible with the performance levels

of these lines.

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

3.

Compatibility of the railway system

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

4.

Extension of the scope

4.1. Subcategories of network and vehicles

The scope of the TSIs shall be progressively extended to the whole rail system as referred to in Article 1(4). In order to
deliver interoperability cost-effectively further subcategories of all categories of network and vehicles mentioned in
this Annex will, where necessary, be developed. If necessary, the functional and technical specifications mentioned in
Article 5(3) may vary according to the subcategory.

4.2. Cost safeguards

The cost-benefit analysis of the proposed measures will take into consideration, among others, the following:

— cost of the proposed measure,

— benefits to interoperability of an extension of the scope to particular subcategories of networks and vehicles,

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— reduction of capital costs and charges due to economies of scale and better utilisation of vehicles,

— reduction of investment and maintenance/operating costs due to increased competition between manufacturers

and maintenance companies,

— environmental benefits, due to technical improvements of the rail system,

— increase of safety in operation.

In addition, this assessment will indicate the likely impact for all the operators and economic agents involved.

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ANNEX II

SUBSYSTEMS

1.

List of subsystems

For the purposes of this Directive, the system constituting the rail system may be broken down into the following
subsystems, either:

(a)

structural areas:

— infrastructure,

— energy,

— control-command and signalling,

— rolling stock;

(b)

functional areas:

— traffic operation and management,

— maintenance,

— telematics applications for passenger and freight services.

2.

Description of the subsystems

For each subsystem or part of a subsystem, the list of constituents and aspects relating to interoperability is proposed
by the Agency at the time of drawing up the relevant draft TSI.

Without prejudging the choice of aspects and constituents relating to interoperability or the order in which they will
be made subject to TSIs, the subsystems include, in particular:

2.1.

Infrastructure

The track, points, engineering structures (bridges, tunnels, etc.), associated station infrastructure (platforms, zones of
access, including the needs of persons with reduced mobility, etc.), safety and protective equipment.

2.2. Energy

The electrification system, including overhead lines and on-board parts of the electric consumptions measuring
equipment.

2.3. Control-command and signalling

All the equipment necessary to ensure safety and to command and control movements of trains authorised to travel
on the network.

2.4. Operation and traffic management

The procedures and related equipment enabling a coherent operation of the different structural subsystems, both
during normal and degraded operation,
including in particular training and train driving, traffic planning and
management.

The professional qualifications which may be required for carrying out cross-border services.

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2.5. Telematics applications

In accordance with Annex I, this subsystem comprises two elements:

(a)

(b)

applications for passenger services, including systems providing 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.

2.6. Rolling stock

Structure, command and control system for all train equipment, current-collection devices traction and energy
conversion units, braking, coupling and running gear (bogies, axles, etc.) and suspension, doors, man/machine
interfaces (driver, on-board staff and passengers, including the needs of persons with reduced mobility), passive or
active safety devices and requisites for the health of passengers and on-board staff.

2.7. Maintenance

The procedures, associated equipment, logistics centres for maintenance work and reserves allowing the mandatory
corrective and preventive maintenance to ensure the interoperability of the 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 authorised speed.

1.1.3.

The components used must withstand any normal or exceptional stresses that have been specified during their
period in service. The safety repercussions of any accidental failures must be limited by appropriate means.

1.1.4.

The design of fixed installations and rolling stock and the choice of the materials used must be aimed at limiting the
generation, propagation and effects of fire and smoke in the event of a fire.

1.1.5. Any devices intended to be handled by users must be so designed as not to impair the safe operation of the devices
or the health and safety of users if used in a foreseeable manner, albeit not in accordance with the posted
instructions.

1.2.

Reliability and availability

The monitoring and maintenance of fixed or movable components that are involved in train movements must be
organised, carried out and quantified in such a manner as to maintain their operation under the intended
conditions.

1.3.

Health

1.3.1. Materials likely, by virtue of the way they are used, to constitute a health hazard to those having access to them

must not be used in trains and railway infrastructures.

1.3.2.

Those materials must be selected, deployed and used in such a way as to restrict the emission of harmful and
dangerous fumes or gases, particularly in the event of fire.

1.4.

Environmental protection

1.4.1.

The environmental impact of establishment and operation of the rail system must be assessed and taken into
account at the design stage of the system in accordance with the Community provisions in force.

1.4.2.

The materials used in the trains and infrastructures must prevent the emission of fumes or gases which are harmful
and dangerous to the environment, particularly in the event of fire.

1.4.3.

The rolling stock and energy-supply systems must be designed and manufactured in such a way as to be
electromagnetically compatible with the installations, equipment and public or private networks with which they
might interfere.

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

1.4.5. Operation of the rail system must not give rise to an inadmissible level of ground vibrations for the activities and

areas close to the infrastructure and in a normal state of maintenance.

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1.5.

Technical compatibility

The technical characteristics of the infrastructure and fixed installations must be compatible with each other and
with those of the trains to be used on the rail system.

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

2.

Requirements specific to each subsystem

2.1.

Infrastructure

2.1.1.

Safety

Appropriate steps must be taken to prevent access to or undesirable intrusions into installations.

Steps must be taken to limit the dangers to which persons are exposed, particularly when trains pass through
stations.

Infrastructure to which the public has access must be designed and made in such a way as to limit any human safety
hazards (stability, fire, access, evacuation, platforms, etc.).

Appropriate provisions must be laid down to take account of the particular safety conditions in very long tunnels
and viaducts.

2.2.

Energy

2.2.1.

Safety

Operation of the energy-supply systems must not impair the safety either of trains or of persons (users, operating
staff, trackside dwellers and third parties).

2.2.2.

Environmental protection

The functioning of the electrical or thermal energy-supply systems must not interfere with the environment beyond
the specified limits.

2.2.3.

Technical compatibility

The electricity/thermal energy supply systems used must:

— enable trains to achieve the specified performance levels,

— in the case of electricity energy supply systems, be compatible with the collection devices fitted to the trains.

2.3.

Control-command and signalling

2.3.1.

Safety

The control-command and signalling installations and procedures used must enable trains to travel with a level of
safety which corresponds to the objectives set for the network. The control-command and signalling systems
should continue to provide for safe passage of trains permitted to run under degraded conditions.

2.3.2.

Technical compatibility

All new infrastructure and all new rolling stock manufactured or developed after adoption of compatible control-
command and signalling systems must be tailored to the use of those systems.

The control-command and signalling equipment installed in the train drivers' cabs must permit normal operation,
under the specified conditions, throughout the rail system.

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2.4.

Rolling stock

2.4.1.

Safety

The rolling-stock structures and those of the links between vehicles must be designed in such a way as to protect
the passenger and driving compartments in the event of collision or derailment.

The electrical equipment must not impair the safety and functioning of the control-command and signalling
installations.

The braking techniques and the stresses exerted must be compatible with the design of the tracks, engineering
structures and signalling systems.

Steps must be taken to prevent access to electrically-live constituents in order not to endanger the safety of persons.

In the event of danger devices must enable passengers to inform the driver and accompanying staff to contact him.

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.

2.4.2. Reliability and availability

The design of the vital equipment and the running, traction and braking equipment and also the control and
command system must, in a specific degraded situation, be such as to enable the train to continue without adverse
consequences for the equipment remaining in service.

2.4.3.

Technical compatibility

The electrical equipment must be compatible with the operation of
installations.

the control-command and signalling

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. Controls

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

2.5.

Maintenance

2.5.1. Health and safety

The technical installations and the procedures used in the centres must ensure the safe operation of the subsystem
and not constitute a danger to health and safety.

2.5.2.

Environmental protection

The technical installations and the procedures used in the maintenance centres must not exceed the permissible
levels of nuisance with regard to the surrounding environment.

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2.5.3.

Technical compatibility

The maintenance installations for rolling stock must be such as to enable safety, health and comfort operations to
be carried out on all stock for which they have been designed.

2.6.

Operation and traffic management

2.6.1.

Safety

Alignment of the network operating rules and the qualifications of drivers and on-board staff and of the staff in the
control centres must be such as to ensure safe operation, bearing in mind the different requirements of cross-border
and domestic services.

The maintenance operations and intervals, the training and qualifications of the maintenance and control centre
staff and the quality assurance system set up by the operators concerned in the control and maintenance centres
must be such as to ensure a high level of safety.

2.6.2. Reliability and availability

The maintenance operations and periods, the training and qualifications of the maintenance and control centre staff
and the quality assurance system set up by the operators concerned in the control and maintenance centres must be
such as to ensure a high level of system reliability and availability.

2.6.3.

Technical compatibility

Alignment of the network operating rules and the qualifications of drivers, on-board staff and traffic managers must
be such as to ensure operating efficiency on the rail system, bearing in mind the different requirements of cross-
border and domestic services.

2.7.

Telematics applications for freight and passengers

2.7.1.

Technical compatibility

The essential requirements for telematics applications guarantee a minimum quality of service for passengers and
carriers of goods, particularly in terms of technical compatibility.

Steps must be taken to ensure:

— that the databases, software and data communication protocols are developed in a manner allowing
maximum data interchange between different applications and operators, excluding confidential commercial
data,

— easy access to the information for users.

2.7.2. Reliability and availability

The methods of use, management, updating and maintenance of these databases, software and data communication
protocols must guarantee the efficiency of these systems and the quality of the service.

2.7.3. Health

The interfaces between these systems and users must comply with the minimum rules on ergonomics and health
protection.

2.7.4.

Safety

Suitable levels of integrity and dependability must be provided for the storage or transmission of safety-related
information.

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‘EC’ DECLARATION OF CONFORMITY AND SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS

ANNEX IV

1.

Interoperability constituents

The ‘EC’ declaration applies to the interoperability constituents involved in the interoperability of the rail system, as
referred to in Article 3. These interoperability constituents may be:

1.1. Multiple-use constituents

These are constituents that are not specific to the railway system and which may be used as such in other areas.

1.2. Multiple-use constituents having specific characteristics

These are constituents which are not, as such, specific to the railway system, but which must display specific
performance levels when used for railway purposes.

1.3. Specific constituents

These are constituents that are specific to railway applications.

2.

Scope

The ‘EC’ declaration covers:

— either the assessment by a notified body or bodies of the intrinsic conformity of an interoperability constituent,

considered in isolation, to the technical specifications to be met,

— or the assessment/judgement by a notified body or bodies of the suitability for use of an interoperability
constituent, considered within its railway environment and, in particular in cases where the interfaces are
involved, in relation to the technical specifications, particularly those of a functional nature, which are to be
checked.

The assessment procedures implemented by the notified bodies at the design and production stages will draw upon
the modules defined in Decision 93/465/EEC, in accordance with the conditions referred to in the TSIs.

3.

Contents of the ‘EC’ declaration

The ‘EC’ declaration of conformity or of suitability for use and the accompanying documents must be dated and
signed.

That declaration must be written in the same language as the instructions and must contain the following:

— the Directive references,

— name and address of the manufacturer or its authorised representative established within the Community (give
trade name and full address; in the case of the authorised representative, also give the trade name of the
manufacturer),

— description of interoperability constituent (make, type, etc.),

— description of the procedure followed in order to declare conformity or suitability for use (Article 13),

— all the relevant descriptions met by the interoperability constituent and, in particular, its conditions of use,

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— name and address of the notified body or bodies involved in the procedure followed in respect of conformity or
suitability for use and date of examination certificate together with, where appropriate, the duration and
conditions of validity of the certificate,

— where appropriate, reference to the European specifications,

— identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of the

manufacturer's authorised representative established within the Community.

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ANNEX V

‘EC’ DECLARATION OF VERIFICATION OF SUBSYSTEMS

The ‘EC’ declaration of verification and the accompanying documents must be dated and signed.

That declaration must be written in the same language as the technical file and must contain the following:

— the Directive references,

— name and address of the contracting entity or the manufacturer, or its authorised representative established within the
Community (give trade name and full address; in the case of the authorised representative, also give the trade name of
the contracting entity or the manufacturer),

— a brief description of the subsystem,

— name and address of the notified body which conducted the ‘EC’ verification referred to in Article 18,

— the references of the documents contained in the technical file,

— all the relevant temporary or definitive provisions to be complied with by the subsystems and in particular, where

appropriate, any operating restrictions or conditions,

— if temporary: duration of validity of the ‘EC’ declaration,

— identity of the signatory.

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ANNEX VI

‘EC’ VERIFICATION PROCEDURE FOR SUBSYSTEMS

1.

Introduction

‘EC’ verification is the procedure whereby a notified body checks and certifies that the subsystem:

— complies with the Directive,

— complies with the other regulations deriving from the Treaty, and may be put into operation.

2.

Stages

The subsystem is checked at each of the following stages:

— overall design,

— production: construction of subsystem,
constituent assembly, overall adjustment,

including,

in particular, civil-engineering activities, manufacturing,

— final testing of the subsystem.

For the design stage (including the type tests) and for the production stage the applicant may apply for an assessment
as a first step.

In this case, this assessment or assessments lead to one or more intermediate statement verifications (ISV) issued by
the notified body chosen by the applicant. The notified body in turn draws up an ‘EC’ declaration of intermediate
subsystem conformity for the relevant stages.

3.

Certificate

The notified body responsible for ‘EC’ verification assesses the design and production of the subsystem and draws up
the certificate of verification intended for the applicant, which in turn draws up the ‘EC’ declaration of verification
intended for the supervisory authority in the Member State in which the subsystem is located and/or operates.

If available, the notified body takes into account the ISVs, and, in order to issue the ‘EC’ certificate of verification, it:

— checks that the subsystem:

— is covered by relevant design and production ISVs, if the applicant has asked the notified body for these

two phases, or

— corresponds as produced to all aspects covered by the design ISV delivered to the applicant, if it has asked

the notified body only for the design phase,

— verifies that they cover correctly the requirement of the TSI and assesses the design and production elements

that are not covered by the design and/or production ISV(s).

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4.

Technical file

The technical file accompanying the declaration of verification must be made up as follows:

— for infrastructure: engineering-structure plans, approval records for excavations and reinforcement, testing and

inspection reports on concrete, etc.,

— for the other subsystems: general and detailed drawings in line with execution, electrical and hydraulic diagrams,
control-circuit diagrams, description of data-processing and automatic systems, operating and maintenance
manuals, etc.,

— list of interoperability constituents, as referred to in Article 3, incorporated into the subsystem,

— copies of the ‘EC’ declarations of conformity or suitability for use with which the abovementioned constituents
must be provided in accordance with Article 13 of the Directive accompanied, where appropriate, by the
corresponding calculation notes and a copy of the records of the tests and examinations carried out by the
notified bodies on the basis of the common technical specifications,

— if available, the ISV and, in such a case, the ‘EC’ declaration(s) of intermediate subsystem conformity, that
accompany the ‘EC’ certificate of verification, including the result of verification by the notified body of their
validity,

— certificate from the notified body responsible for ‘EC’ verification, accompanied by corresponding calculation
notes and countersigned by itself, stating that the project complies with this Directive and mentioning any
reservations recorded during performance of the activities and not withdrawn; the certificate should also be
accompanied by the inspection and audit reports drawn up by the same body in connection with its task, as
specified in sections 5.3 and 5.4.

5. Monitoring

5.1. The aim of ‘EC’ monitoring is to ensure that the obligations deriving from the technical file have been met during

production of the subsystem.

5.2. 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 applicant must send it or have sent to it all the documents
needed for that purpose and, in particular, the implementation plans and technical documentation concerning the
subsystem.

5.3. The notified body responsible for checking implementation must periodically carry out audits in order to confirm
compliance with the Directive. It must provide those responsible for implementation with an audit report. It may need
to be present at certain stages of the building operations.

5.4.

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.

5.5. With a view to deliver the ‘EC’ declaration of suitability for use referred to in section 2 of Annex IV, the notified body
shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where the
corresponding TSI so requires, its suitability for use in its intended railway environment.

6.

Submission

The complete file referred to in paragraph 4 must be lodged with the applicant in support of the ISV, if available,
issued by the notified body responsible for this or in support of the certificate of conformity issued by the notified
body responsible for verification of the subsystem in working order. The file must be attached to the ISV and/or to the
‘EC’ declaration of verification which the applicant sends to the supervisory authority in the Member State concerned.

A copy of the file must be kept by the applicant throughout the service life of the subsystem. It must be sent to any
other Member States which so request.

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7.

Publication

Each notified body must periodically publish relevant information concerning:

— requests for ‘EC’ verification received,

— ISVs issued or refused,

— certificates of verification issued or refused,

— certificates of conformity refused.

8.

Language

The files and correspondence relating to the ‘EC’ verification procedures must be written in an official language of the
Member State in which the applicant is established or in a language accepted by the applicant.

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L 191/39

ANNEX VII

PARAMETERS TO BE CHECKED IN CONJUNCTION WITH THE PLACING IN SERVICE OF NON-TSI CONFORM
VEHICLES AND THE CLASSIFICATION OF THE NATIONAL RULES

1.

List of parameters

1.

Background information

— information relating to the national legal framework in force,

— special national conditions,

— maintenance book,

— operational log book.

2.

Interfaces to infrastructure

— pantographs,

— on-board supply equipment and electromagnetic compatibility impact, loading gauge,

— miscellaneous safety equipment, e.g. control and command, track-to-train communication systems.

3.

Rolling stock characteristics

— vehicle dynamics,

— vehicle superstructure,

— draw and buffer gear,

— bogie and running gear,

— wheel set/wheel set bearing,

— brake equipment,

— technical systems requiring monitoring; e.g. compressed air system,

— front/side windows,

— doors,

— devices for passing,

— control systems (software),

— drinking water and wastewater systems,

— environmental protection,

— fire protection,

— health and safety in the workplace,

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— tank and tank wagons,

— pressure discharge containers,

— load securing,

— marking,

— welding techniques.

2.

Classification of the rules

The national rules relating to the parameters identified in section 1 shall be attributed to one of the following three
groups. Rules and restrictions of a strictly local nature are not involved; their verification involves checks to be put in
place by mutual agreement between the railway undertakings and the infrastructure managers.

Group A

Group A covers:

— international standards,

— national rules deemed to be equivalent, in railway safety terms, to national rules of other Member States.

Group B

Group B covers all rules that do not fall within the scope of Group A or Group C, or that it has not yet been possible
to classify in one of these groups.

Group C

Group C covers rules that are strictly necessary and are associated with technical infrastructure characteristics, in order
to ensure safe and interoperable use in the network concerned (e.g. the loading gauge).

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Official Journal of the European Union

L 191/41

ANNEX VIII

MINIMUM CRITERIA WHICH MUST BE TAKEN INTO ACCOUNT BY THE MEMBER STATES WHEN
NOTIFYING BODIES

1.
The body, its Director and the staff responsible for carrying out the checking operations may not become involved
either directly or as authorised representatives in the design, manufacture, construction, marketing or maintenance of the
interoperability constituents or subsystems or in their use. This does not exclude the possibility of an exchange of technical
information between the manufacturer and that body.

2.
The body and the staff responsible for the checks must carry out the checks with the greatest possible professional
integrity and the greatest possible technical competence and must be free of any pressure and incentive, in particular of a
financial type, which could affect their judgement or the results of their inspection, in particular from persons or groups of
persons affected by the results of the checks.

In particular, the body and the staff responsible for the checks must be functionally independent of the authorities
designated to issue authorisations for placing in service in the framework of this Directive, licences in the framework of
Directive 95/18/EC and safety certificates in the framework of Directive 2004/49/EC, and of the bodies in charge of
investigations in the event of accidents.

The body must employ staff and possess the means required to perform adequately the technical and administrative

3.
tasks linked with the checks; it should also have access to the equipment needed for exceptional checks.

4.

The staff responsible for the checks must possess:

— proper technical and vocational training,

— a satisfactory knowledge of the requirements relating to the checks that they carry out and sufficient practice in those

checks,

— the ability to draw up the certificates, records and reports which constitute the formal record of the inspections

conducted.

The independence of the staff responsible for inspections must be guaranteed. No official must be remunerated either

5.
on the basis of the number of inspections performed or of the results of those inspections.

The body must take out civil liability insurance unless that liability is covered by the State under national law or unless

6.
the checks are carried out directly by that Member State.

7.
The staff of the body are bound by professional secrecy with regard to everything they learn in the performance of
their duties (with the exception of the competent administrative authorities and accident investigation bodies in the State
where they perform those activities as well as accident investigation bodies responsible for the investigation of accidents
caused by the failure of the interoperability constituents or subsystems checked) in pursuance of this Directive or any
provision of national law implementing the Directive.

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ANNEX IX

FILE FOR SUBMITTING A DEROGATION

When submitting a request for a derogation, Member States must supply the following documents:

(a)

A formal letter communicating the proposed derogation to the Commission.

(b) A file, annexed to the letter, comprising at least:

— a description of the work, goods and services subject to the derogation, specifying the key dates, the

geographical location and the operational and technical area,

— a precise reference to the TSIs (or their parts) for which a derogation is requested,

— a precise reference to and details of the alternative provisions which will be applied,

— for requests made under Article 7(1)(a), justification of the advanced stage of development of the project,

— justification of the derogation, including the main reasons of a technical, economic, commercial, operational

and/or administrative nature,

— any other information justifying the request for a derogation,

— a description of the measures that the Member State proposes to take in order to promote the final

interoperability of the project. In the case of a minor derogation, this description is not required.

Documentation must be supplied in paper form and as electronic files, so that it can be distributed among the members of
the Committee.

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ANNEX X

PART A

Directives repealed

(referred to in Article 40)

Only Article 14

PART B

Directive 96/48/EC
Directive 2001/16/EC
Directive 2004/49/EC

Time limits for transposition into national law

(referred to in Article 40)

Directive

Deadline for transposition

96/48/EC
2001/16/EC
2004/49/EC

9 April 1999
20 April 2003
30 April 2006

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ANNEX XI

CORRELATION TABLE

Directive 96/48/EC

Directive 2001/16/EC

This Directive

Article 1(1)

Article 1(2)

—

—

Article 1(1)

Article 1(2)

—

Article 1(3)

Article 1(1)

Article 1(2)

Article 1(3)

Article 1(4)

Article 2, introductory wording

Article 2, introductory wording

Article 2, introductory wording

Article 2(a) to (l)

Article 2(a) to (l)

Article 2(a) to (b) and (e) to (m)

—

Article 2(n)

Article 2(o)

Article 2(m)

Article 2(p)

—

Articles 3, 4 and 5

Article 5(6)

—

—

—

Article 2(m)

Article 2(n)

Article 2(o)

Article 2(p)

—

Articles 3, 4 and 5

Article 5(7)

—

—

Article 6(1) to (8)

Article 6(1) to (8)

—

—

Article 7

Article 8

Article 9

—

—

Article 7

Article 8

Article 9

Article 2(c) and (d)

Article 2(n)

Article 2(o)

Article 2(p)

Article 2(q)

Article 2(r) to (z)

Articles 3, 4 and 5(1) to (5)

Article 5(7)

Article 5(6)

Article 5(8)

Article 6(1) to (8)

Article 6(9) to (10)

Articles 7 and 8

Article 9

Article 10(1)

Article 10(2)

Article 10(1) to (3)

Article 10(1) to (3)

Article 11(1) to (3)

—

—

Articles 11 to 13

Article 14(1) and (2)

Article 14(3)

Article 14(4) and (5)

—

Articles 15 and 16

Article 16(3)

—

Article 10(6)

—

Articles 11 to 13

Article 14(1) and (2)

Article 14(3)

Article 14(4) and (5)

—

Articles 15 and 16

Article 16(3)

—

Article 18(1) to (3)

Article 18(1) to (3)

—

Article 19

Article 20

—

—

Article 19

Article 20

—

Article 21(1) to (3)

Article 21(1) to (3)

—

—

Article 21a(1)

Article 21(4)

Article 21a(2)

Article 21b

Article 21c

—

—

Article 22

21(4)

Article 21a

—

Article 21b

Article 11(4)

Article 11(5)

Articles 12 to 14

Article 15(1) and (2)

Article 20

Article 33

Article 15(2) and (3)

Articles 16 and 17

Article 17(3)

—

Article 18(1) to (3)

Article 18(4) and (5)

Article 19

Article 28

Articles 21 to 27

Article 29(1) to (3)

Article 29(4) and (5)

—

Article 30(2)

Article 30(4)

Article 30(1)

—

Article 30(3)

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Directive 96/48/EC

Directive 2001/16/EC

This Directive

Article 22
Article 22a
—
—
—
Article 23
Article 24
—
Article 25
Article 26
Annexes I to VI
—
Annex VII
—

Article 26
Article 24
—
Article 23
Article 25
Article 27
Article 28
—
Article 29
Article 30
Annexes I to VI
—
Annex VII
—

Article 37
Articles 34 and 35
Article 32
Article 31
Article 36
Article 38
Article 39
Article 40
Article 41
Article 42
Annexes I to VI
Annex VII
Annex VIII
Annexes IX to XI