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,
Having regard to the Treaty establishing the European Community,
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, and in particular Article 21c thereof,
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).
Having regard to Directive 2001/16/EC of 19 March 2001 of the European Parliament and of the Council on the interoperability of the conventional rail system, and in particular Article 21b thereof,
OJ L 110, 20.4.2001, p. 1. Directive as last amended by Directive 2004/50/EC.
Whereas:
(1) 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.
(2) 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 representative draws up an ‘EC’ declaration of verification.
(3) 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 particular, civil engineering activities, constituent assembly, overall adjustment; and final testing of the subsystem.
(4) 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 be placed into service, in particular by checking the interfaces with the other subsystems in operational conditions.
(5) However, there are tests which the manufacturer can carry out on the isolated interoperability constituent (IC) or subsystem, independently of the final environment 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.
(6) It is therefore necessary to provide in Annex VI to both Directives 96/48/EC and 2001/16/EC the possibility for the manufacturer to apply for first step (design or production phase) assessments, which will lead to Intermediate Statements of Verification (ISV) issued by the notified body. On the basis of those ISV, 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.
(7) Directives 96/48/EC and 2001/16/EC should therefore be amended accordingly.
(8) 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,
HAS ADOPTED THIS DIRECTIVE:

Article 1 Annex VI to Directive 96/48/EC is replaced by the text in the Annex to this Directive.
Article 2 Annex VI to Directive 2001/16/EC is replaced by the text in the Annex to this Directive.
Article 3 Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive before 2 December 2007. They shall forthwith inform the 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.
Article 4 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 5 This Directive is addressed to the Member States.
Done at Brussels, 1 June 2007.
For the Commission
Jacques Barrot
Vice-President
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, including, for example civil-engineering activities, manufacturing, constituent assembly, overall adjustment,
final testing of the subsystem.
For the design phase (including the type tests) and for the production phase the main contractor (or the manufacturer) 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.,
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 established or in a language accepted by the entity.’