Rail System (Amendment) Regulations, 2009

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,384, 3 ta’ Marzu, 2009

Taqsima B

L.N. 56 of 2009

PRODUCT SAFETY ACT

(CAP. 427)

Interoperability of the Trans-European High-speed

Rail System (Amendment) Regulations, 2009

IN exercise of the powers conferred by articles 38 to 40 of

the Product Safety Act, the Minister of Finance, the Economy and

Investment, on the advice of the Malta Standards Authority, has

made the following regulations:-

(1) The title of these regulations is the Interoperability

of the Trans-European High-speed Rail System (Amendment)

Regulations, 2009 and they shall be read and construed as one

with the Interoperability of the Trans-European High-speed Rail

System Regulations, 2002, hereinafter referred to as “the principal

regulations”.

(2) These regulations shall be deemed to have come

into force on the 30 April, 2006.

For Schedule VI to the principal regulations there shall be

substituted the following new Schedule

B

“Schedule VI

Based on Annex VI of the Directive

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).

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.

B

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).

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

B

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.

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.

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.

B

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.

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.”.