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2.3.2011 Official
Journal
of
the
European
Union L
57/21
DIRECTIVES
COMMISSION DIRECTIVE 2011/18/EU
of 1 March 2011
amending Annexes II, V and VI to Directive 2008/57/EC of the European Parliament and of the
Council on the interoperability of the rail system within the Community
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5) With
regard
to
Section
2
of
Annex
VI
to
Directive
2008/57/EC and recourse to intermediate statements of
verification (hereinafter ‘ISV’), the notified body should
first draw up an ‘EC’ certificate of intermediate
Having regard to the Treaty on the Functioning of the European
statement of verification and then the applicant should
Union,
draw up the related ‘EC’ declaration. Annexes V and VI to
Directive 2008/57/EC should therefore be amended
accordingly.
Having regard to Directive 2008/57/EC of the European
Parliament and of the Council of 17 June 2008 on the inter
operability of the rail system within the Community ( 1 ), and in
(6) The
measures
provided
for
in
this
Directive
are
in
particular Article 30.3 thereof,
accordance with the opinion of the Committee estab
lished pursuant to Article 29(1) of the Directive
2008/57/EC,
Whereas:
HAS ADOPTED THIS DIRECTIVE:
(1) Measures
designed
to
amend
non-essential
elements
of
Directive 2008/57/EC and relating to the adaptation of
Annexes II to IX to that Directive are to be adopted in
accordance with the regulatory procedure with scrutiny
Article 1
referred to in Article 29(4) of Directive 2008/57/EC.
Annexes II, V and VI to Directive 2008/57/EC are replaced by
the text set out in Annexes I, II and III to this Directive
respectively.
(2) The
control-command
and
signalling
subsystem
consist
of trackside and on-board equipment, which should be
considered as two separate subsystems. Annex II to
Directive 2008/57/EC should therefore be amended
Article 2
accordingly.
1. The
Member
States
shall
bring
into
force
the
laws,
regu
lation and administrative provisions necessary to comply with
this Directive by 31 December 2011 at the latest. They shall
forthwith communicate the text of those provisions to the
(3) The
electricity
consumption
measuring
equipment
is Commission.
physically integrated in the rolling stock. Annex II to
Directive 2008/57/EC should therefore be amended
accordingly.
2. When
Member
States
adopt
those
provisions,
they
shall
contain a reference to this Directive or be accompanied by such
(4) In
accordance with Article 17(3) of Directive reference on the occasion of their official publication. Member
2008/57/EC, Member States should designate the
States shall determine how such reference is to be made.
bodies responsible for carrying out the verification
procedures in the case of national rules. Annexes V
and VI to Directive 2008/57/EC should therefore be
amended to specify these procedures applied by these
3. The
obligations
for
transposition
and
implementation
of
bodies.
this Directive shall not apply to the Republic of Cyprus and the
Republic of Malta for as long as no railway system is established
( 1 ) OJ L 191, 18.7.2008, p. 1.
within their territories.

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L 57/22
EN
Official Journal of the European Union
2.3.2011
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 1 March 2011.
For the Commission
The President
José Manuel BARROSO

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EN
2.3.2011 Official
Journal
of
the
European
Union L
57/23
ANNEX I
‘ANNEX II
SUBSYSTEMS
1. List
of
subsystems
For the purposes of this Directive, the system constituting the rail system may be broken down into the following
subsystems, either:
(a) structural areas:
— infrastructure,
— energy,
— trackside control-command and signalling,
— on-board control-command and signalling,
— rolling stock,
(b) functional areas:
— operation and traffic management,
— maintenance,
— telematics applications for passenger and freight services.
2. Description
of
the
subsystems
For each subsystem or part of a subsystem, the list of constituents and aspects relating to interoperability is proposed
by the Agency at the time of drawing up the relevant draft TSI. Without prejudging the choice of aspects and
constituents relating to interoperability or the order in which they will be made subject to TSIs, the subsystems
include the following:
2.1. Infrastructure
The track, points, engineering structures (bridges, tunnels, etc.), 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 the trackside of the electricity consumption measuring
system.
2.3. Trackside control-command and signalling
All the trackside equipment required to ensure safety and to command and control movements of trains authorised
to travel on the network.
2.4. On-board control-command and signalling
All the on-board equipment required to ensure safety and to command and control movements of trains authorised
to travel on the network.
2.5. Operation and traffic management
The procedures and related equipment enabling coherent operation of the various structural subsystems, during both
normal and degraded operation, including in particular train composition and train driving, traffic planning and
management.
The professional qualifications which may be required for carrying out cross-border services.

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L 57/24
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Official Journal of the European Union
2.3.2011
2.6. Telematics applications
In accordance with Annex I, this subsystem comprises two elements:
(a) applications for passenger services, including systems which provide passengers with information before and
during the journey, reservation and payment systems, luggage management and management of connections
between trains and with other modes of transport;
(b) applications for freight services, including information systems (realtime monitoring of freight and trains),
marshalling and allocation systems, reservation, payment and invoicing systems, management of connections
with other modes of transport and production of electronic accompanying documents.
2.7. Rolling stock
Structure, command and control system for all train equipment, electric current collection devices, traction and
energy conversion units, on-board equipment for electricity consumption measuring, braking, coupling and running
gear (bogies, axles, etc.) and suspension, doors, man/machine interfaces (driver, on-board staff and passengers,
including the needs of persons with reduced mobility), passive or active safety devices and requisites for the
health of passengers and on-board staff.
2.8. Maintenance
The procedures, associated equipment, logistics centres for maintenance work and reserves providing the mandatory
corrective and preventive maintenance to ensure the interoperability of the rail system and guarantee the
performance required.’

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EN
2.3.2011 Official
Journal
of
the
European
Union L
57/25
ANNEX II
‘ANNEX V
DECLARATION OF VERIFICATION OF SUBSYSTEMS
1. “EC” declaration of verification of subsystems
The “EC” declaration of verification and the accompanying documents must be dated and signed.
The said declaration must be based on the information resulting from the “EC” verification procedure for subsystems
as defined in Section 2 of Annex VI. It must be written in the same language as the technical file and must contain at
least the following:
— the Directive references,
— name and address of the contracting entity or the manufacturer, or its authorised representative established within
the European Union (specify the trade name and full address; in the case of the authorised representative, specify
also 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 final 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.
Where reference is made in Annex VI to the “EC” ISV declaration, the provisions of this Section shall apply to this
declaration.
2. Declaration of verification of subsystems in the case of national rules
Where reference is made in Annex VI to the declaration of verification of subsystems in the case of national rules, the
provisions of Section 1 shall apply mutatis mutandi to that declaration.’

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L 57/26
EN
Official Journal of the European Union
2.3.2011
ANNEX III
‘ANNEX VI
VERIFICATION PROCEDURE FOR SUBSYSTEMS
1. GENERAL
PRINCIPLES
The verification procedure for a subsystem involves checking and certifying that a subsystem:
— is designed, constructed and installed in such a way as to meet the essential requirements concerning it, and
— may be authorised to be placed in service.
2. “EC”
VERIFICATION
PROCEDURE
2.1. Introduction
“EC” verification is the procedure whereby a notified body checks and certifies that the subsystem:
— complies with the relevant TSI(s),
— complies with the other regulations deriving from the Treaty.
2.2. Parts
of
the
subsystem
and
stages
2.2.1 Intermediate statement of verification (ISV)
If specified in the TSIs or, where appropriate, at the applicant’s request, the subsystem could be divided into certain
parts or checked at certain stages of the verification procedure.
The intermediate statement of verification (ISV) is the procedure whereby a notified body checks and certifies
certain parts of the subsystem or certain stages of the verification procedure.
Each ISV leads to the issuing of an “EC” ISV certificate by the notified body chosen by the applicant, which in turn,
where applicable, draws up an “EC” ISV declaration. The ISV certificate and ISV declaration must provide reference
to the TSIs with which the conformity has been assessed.
2.2.2 Parts of the subsystem
The applicant may apply for an ISV for each part. And each part shall be checked at each stage as described in
Section 2.2.3.
2.2.3 Stages of the verification procedure
The subsystem, or certain parts of the subsystem, shall be checked at each of the following stages:
— overall design,
— production: construction, including, in particular, civil-engineering activities, manufacturing, constituent
assembly and overall adjustment,
— final testing.
The applicant may apply for an ISV for the design stage (including the type tests) and for the production stage.
2.3. Certificate
of
verification
2.3.1. The notified body responsible for “EC” verification assesses the design, production and final testing of the
subsystem and draws up the “EC” certificate of verification intended for the applicant, who in turn draws up
the “EC” declaration of verification. The “EC” verification certificate must provide reference to the TSIs with which
the conformity has been assessed.
Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in the case of a
derogation, partial application of TSIs for upgrade or renewal, transitional period in a TSI or specific case), the
“EC” certificate shall give the precise reference to the TSI(s) or their parts whose conformity has not been examined
by the notified body during the “EC” verification procedure.

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EN
2.3.2011 Official
Journal
of
the
European
Union L
57/27
2.3.2. Where “EC” ISV certificates have been issued the notified body responsible for the “EC” verification of the
subsystem takes these “EC” ISV certificates into account, and, before issuing the “EC” certificate of verification, it:
— verifies that the “EC” ISV certificates cover correctly the relevant requirements of the TSI(s),
— checks all aspects that are not covered by the “EC” ISV certificate(s), and
— checks the final testing of the subsystem as a whole.
2.4. Technical
file
The technical file accompanying the “EC” declaration of verification must contain the following:
— technical characteristics linked to the design including general and detailed drawings with respect to execution,
electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic
systems, documentation on operation and maintenance, etc., relevant for the subsystem concerned,
— list of interoperability constituents, as referred to in Article 5(3)(d), 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,
— where available, the “EC” ISV certificate(s) and, in such a case, where relevant, the “EC” ISV declaration(s), that
accompany the “EC” certificate of verification, including the result of verification by the notified body of the
certificates validity,
— “EC” certificate of verification, accompanied by corresponding calculation notes and signed by the notified body
responsible for the “EC” verification, stating that the subsystem complies with the requirements of the relevant
TSI(s) and mentioning any reservations recorded during performance of the activities and not withdrawn; the
“EC” certificate of verification 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 2.5.3 and 2.5.4,
— “EC” certificates issued in accordance with other legislation deriving from the Treaty,
— when safe integration is required pursuant Commission Regulation (EC) No 352/2009 ( 1 ), the applicant shall
include in the technical file the assessor’s report on the Common Safety Methods (CSM) on risk assessment
referred to in Article 6(3) of Directive 2004/49/EC.
2.5. Monitoring
2.5.1. The aim of “EC” monitoring is to ensure that the obligations deriving from the technical file have been met during
the production of the subsystem.
2.5.2. 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 notified body must receive from the applicant all the
documents needed for that purpose and, in particular, the implementation plans and technical documentation
concerning the subsystem.
2.5.3. The notified body responsible for checking implementation must periodically carry out audits in order to confirm
compliance with the relevant TSI(s). It must provide those responsible for implementation with an audit report. Its
presence may be required at certain stages of the building operations.
2.5.4. 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.
( 1 ) OJ L 108, 22.4.2009, p 4.

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Official Journal of the European Union
2.3.2011
2.5.5. With a view to delivering 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 required by the corresponding TSI so requires, its suitability for use in its intended railway
environment.
2.6. Submission
The complete file referred to in paragraph 2.4 must be lodged with the applicant in support of the “EC” ISV
certificate(s), if available, issued by the notified body responsible for this or in support of the certificate of
verification issued by the notified body responsible for “EC” verification of the subsystem. The file must be
attached to the “EC” declaration of verification which the applicant sends to the competent authority with
which he lodges the application for authorisation for placing in service.
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.
2.7. Publication
Each notified body must periodically publish relevant information concerning:
— requests for “EC” verification and ISV received,
— request for assessment of conformity and/or suitability for use of ICs,
— “EC” ISV certificates issued or refused,
— “EC” certificates of conformity and/or suitability for use issued or refused,
— “EC” certificates of verification issued or refused.
2.8. Language
The files and correspondence relating to the “EC” verification procedures must be written in an EU official language
of the Member State in which the applicant is established or in an EU official language accepted by the applicant.
3. VERIFICATION
PROCEDURE
IN
THE
CASE
OF
NATIONAL
RULES
3.1. Introduction
The verification procedure in the case of national rules is the procedure whereby the body designated pursuant to
Article 17(3) (the designated body) checks and certifies that the subsystem complies with the national rules notified
in accordance with Article 17(3).
3.2. Certificate
of
verification
The designated body responsible for the verification procedure in the case of national rules draws up the certificate
of verification intended for the applicant.
The certificate shall contain a precise reference to the national rule(s) whose conformity has been examined by the
designated body in the verification process, including those related to parts subject to derogation from a TSI,
upgrade or renewal.
In the case of national rules related to the subsystems composing a vehicle, the designated body shall divide the
certificate into two parts, one part including the references to those national rules strictly related to the technical
compatibility between the vehicle and the network concerned, and the other part for all other national rules.
3.3. Technical
file
The technical file accompanying the certificate of verification in the case of national rules must be included in the
technical file referred to in point 2.4 and shall contain the technical data relevant for the assessment of the
conformity of the sub-system with the national rules.’

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