Commission Directive 2007/32/EC of 1 June 2007 amending Annex VI to Council Directive 96/48/EC on the interoperability of the trans-European high-speed rail system and Annex VI to Directive 2001/16/EC of the European Parliament and of the Council on the interoperability of the trans-European conventional rail system (Text with EEA relevance)
Date: 2007-06-01
Institutions: European Commission
Subjects: high-speed transport, rail transport, technical regulations, technical standard, testing, trans-European network

2.6.2007

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DIRECTIVES

COMMISSION DIRECTIVE 2007/32/EC

of 1 June 2007

amending Annex VI to Council Directive 96/48/EC on the interoperability of the trans-European
high-speed rail system and Annex VI to Directive 2001/16/EC of the European Parliament and of
the Council on the interoperability of the trans-European conventional rail system

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Directive 96/48/EC of 23 July 1996 of the
Council on the interoperability of
the trans-European high
speed rail system (1), and in particular Article 21c thereof,

Having regard to Directive 2001/16/EC of 19 March 2001 of
the European Parliament and of the Council on the interoper-
the conventional rail system (2), and in particular
ability of
Article 21b thereof,

Whereas:

(1)

(2)

(3)

In accordance with Article 18 of Directive 96/48/EC and
with Article 18 of Directive 2001/16/EC, the contracting
entity or its official representative shall invite the notified
body that it has selected for that purpose to apply the
‘EC’ verification procedure referred to in Annex VI of
those Directives.

On the basis of the certificate of conformity issued by the
notified body and of the technical file accompanying the
certificate, the contracting entity or its official represen-
tative draws up an ‘EC’ declaration of verification.

Point 2 of Annex VI to Directive 96/48/EC and point 2
of Annex VI to Directive 2001/16/EC stipulate that the
subsystem is checked at each of the following stages:
overall design; structure of the subsystem, including, in
constituent
particular,
assembly, overall adjustment; and final
the
subsystem.

engineering

testing of

activities,

civil

The current concept of ‘final testing of the subsystem’ is
not sufficiently clear and precise. It consists of checking
that the subsystem is in conformity with the provisions
of Directives 96/48/EC and 2001/16/EC and with the
other applicable regulatory provisions and that it can
in particular by checking the
be placed into service,
interfaces with the other
in operational
conditions.

subsystems

subsystem,

However,
there are tests which the manufacturer can
carry out on the isolated interoperability constituent
the final envi-
(IC) or
ronment in which the IC or subsystem will be installed
and will be exploited. These ‘stand alone’ tests, useful and
final, are independent of the rail network on which the
product will be put into service.

independently of

to apply for

It is therefore necessary to provide in Annex VI to both
Directives 96/48/EC and 2001/16/EC the possibility for
the manufacturer
first step (design or
production phase) assessments, which will lead to Inter-
issued by the
mediate Statements of Verification (ISV)
notified body. On the basis of
the main
contractor or the manufacturer will be able to draw up
an ‘EC declaration of
intermediate IC or subsystem
conformity’ for the relevant phase.

those ISV,

Directives 96/48/EC and 2001/16/EC should therefore be
amended accordingly.

The measures provided for
in this Directive are in
accordance with the opinion of the Committee set up
by Article 21 of Council Directive 96/48/EC,

(5)

(6)

(7)

(8)

HAS ADOPTED THIS DIRECTIVE:

(1) OJ L 235, 17.9.1996, p. 6. Directive as last amended by Directive
2004/50/EC of the European Parliament and of the Council
(OJ
L 164, 30.4.2004, p. 114, as corrected by OJ L 220, 21.6.2004,
p. 40).

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

2004/50/EC.

Article 1

Annex VI to Directive 96/48/EC is replaced by the text in the
Annex to this Directive.

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Article 2

Article 4

Annex VI to Directive 2001/16/EC is replaced by the text in the
Annex to this Directive.

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

Article 3

Article 5

Member States shall bring into force the laws, regulations and
administrative provisions needed to comply with this Directive
forthwith inform the
before 2 December 2007. They shall
Commission thereof.

When Member States adopt these measures, they shall contain a
reference to this Directive or be accompanied by such reference
on the occasion of their official publication. The methods of
making such reference shall be laid down by the Member States.

This Directive is addressed to the Member States.

Done at Brussels, 1 June 2007.

For the Commission

Jacques BARROT
Vice-President

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ANNEX

‘ANNEX VI

VERIFICATION PROCEDURE FOR SUBSYSTEMS

1.

INTRODUCTION
“EC” verification is the procedure whereby a notified body checks and certifies that a 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,

— final testing of the subsystem.

including,

for example civil-engineering activities, manufacturing,

For the design phase (including the type tests) and for the production phase the main contractor (or the manu-
facturer) or its authorised representative established within the Community may apply for an assessment as a first
step.

In this case, this (these) assessment(s) lead to intermediate statement verification(s) (ISV) issued by the Notified Body
chosen by the main contractor (or the manufacturer). This one in turn draws up an “EC declaration of intermediate
subsystem conformity” for the relevant phase(s).

3.

CERTIFICATE
The Notified Body responsible for the “EC” verification draws up the certificate of verification intended for the
contracting entity or its authorised representative established within the Community, 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.

The Notified Body responsible for “EC” verification assesses the design and production of the subsystem.

If available, the Notified Body takes into account the “Intermediate Statements of Verification” (ISV(s)), and, in order
to issue the “EC” certificate of verification, it:

— Checks that the subsystem:

— is covered by relevant design and production ISVs delivered to the main contractor (or the manufacturer) if it

has asked the Notified Body for these two phases,

— or corresponds as produced to all aspects covered by the design ISV delivered to the main contractor (or the

manufacturer) 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) delivered to the main contractor (or the manufacturer).

4.

TECHNICAL FILE

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

— for the 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.,

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— 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 above mentioned 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 intermediate statement(s) of verification (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 contracting entity or its authorised representative within
the Community 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
require 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.

6.

SUBMISSION

The complete file referred to in paragraph 4 must be lodged with the contracting entity or its authorised agent
established within the Community in support of the certificate of verification issued by the Notified Body responsible
for verification of the subsystem in working order. The file must be attached to the “EC” declaration of verification
which the contracting entity sends to the supervisory authority in the Member State concerned.

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

7.

PUBLICATION

Each Notified Body must periodically publish relevant information concerning:

— requests for “EC” verification received;

— intermediate statements of verification (ISVs) issued or refused;

— certificates of verification issued or 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 contracting entity or its authorised representative within the Community is estab-
lished or in a language accepted by the entity.’