Interoperability of the Rail System Regulations, 2011

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,764, 14 ta’ Ġunju, 2011

L.N. 229 of 2011

PRODUCT SAFETY ACT

(CAP. 427)

Interoperability of the Rail System Regulations, 2011

IN exercise of the powers conferred by article 38 of the

Product Safety Act, the Prime Minister, on the advice of the Malta

Standards Authority, has made the following regulations:-

(1) The title of these regulations is the Interoperability Citation and scope

of the Rail System Regulations, 2011.

(2) These regulations transpose Directive 2008/57/EC,

as amended by Directive 2009/131/EC, and 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.

(3) These regulations concern 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.

(4) When a public or private entity submits an official

application for the purpose of building a new railway line which

is to be operated in Malta in accordance with the applicability of

these regulations and which will be regarded as forming part of

the Trans-European conventional rail system and, or as part of

the Trans-European high-speed rail system but excluding a metro

system, a tram system and any other light rail system, Chapters IV,

V, VII and VIII of Directive 2008/57/EC shall apply.

ESSENTIAL REQUIREMENTS

1. General requirements

1. General requirements

1.1

Safety

Safety

1.1.1

The design, construction or assembly, maintenance and monitoring of safety-

critical

components,

and more maintenance

particularly of and

the monitoring

components of involved

safety- in train

The design,

construction

or assembly,

critical components, and more particularly of the components involved in train to the

movements

must

be

such

as

to

guarantee

safety

at

the

level

corresponding

aims

laid be

down

such for

as the

network, including

those

for corresponding

specific degraded

situations.

movements

must

to guarantee

safety at the

level

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

contact safe

must movement

meet the at

the maximum

The parameters

involved

in the

wheel/rail

stability

requirements needed in order to guarantee safe movement at the maximum that it is

authorised

speed.

The

parameters

of

brake

equipment

must

guarantee

authorised possible

speed. to

stop parameters

within a given

brake equipment

distance at must

the maximum

guarantee authorised

that it is speed.

The

of brake

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

any period

in or

service.

The safety

repercussions

of

The components

used

must withstand

normal

exceptional

stresses

that

any

accidental

failures

must

be

limited

by

appropriate

means.

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

of must

fixed be

aimed at limiting

thegeneration,

propagation

choice of and

effects of fire and

The design

installations

and rolling

stock and the

the materials

smoke

in

the

event

of

a

fire.

used must be aimed at limiting thegeneration, 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

to be of

the devices

or the

health.

Any devices

intended

handled

by users

must

be so designed as not to impair

the safe operation of the devices or the health.

1.2

Reliability and availability

Reliability and availability

The monitoring and maintenance of fixed or movable components that are

involved and

in train

movements

must be

or organised,

carried out and

that quantified

in

The monitoring

maintenance

of fixed

movable components

are

such

a

manner

as

to

maintain

their

operation

under

the

intended

conditions.

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

Health

1.3.1

Materials likely, by virtue of the way they are used, to constitute a health hazard

Materials to likely,

those by having

virtue of access

to they

them are must

used, not

be used a in health

trains

and railway

the way

to constitute

hazard

infrastructures.

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 selected,

harmful and

dangerous

fumes

in or

gases,

particularly

in the event

Those materials

must be

deployed

and used

such

a way

as to restrict

of fire.

the emission

of harmful and dangerous fumes or gases, particularly in the event

of fire.

1.4

Environmental protection

Environmental protection

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.

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.

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.

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

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.

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

Infrastructure

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.

Energy

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).

Environmental protection

The functioning of the electrical or thermal energy-supply systems must not

interfere with the environment beyond the specified limits.

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.

Control-command and signaling

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.

Technical compatibility

All new infrastructure and all new rolling stock manufactured or developed after

adoption of compatible controlcommand 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.

Rolling stock

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 signaling 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.

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.

Technical compatibility

The electrical equipment must be compatible with the operation of the control-

command and signaling installations.

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.

Controls

Trains must be equipped with a recording device. The data collected by this

device and the processing of the information must be harmonised.

Maintenance

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.

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

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.

Operation and traffic management

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.

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.

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 crossborder and

domestic services.

Telematics applications for freight and passengers

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.

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.

Health

The interfaces between these systems and users must comply with the minimum

rules on ergonomics and health protection.

Safety

Suitable levels of integrity and dependability must be provided for the storage or

transmission of safety-related information.

Schedule IV

Schedule IV

‘EC’ DECLARATION

OF CONFORMITY

AND SUITABILITY

FOR USE FOR

OF USE OF

‘EC’ DECLARATION

OF CONFORMITY

AND SUITABILITY

INTEROPERABILITY

CONSTITUENTS

INTEROPERABILITY CONSTITUENTS

1. Interoperability

constituents

1. Interoperability

constituents

The ‘EC’ declaration

applies

to the interoperability

constituents constituents

involved in involved

The ‘EC’ declaration

applies to the

interoperability

the

interoperability

of

the

rail

system,

as

referred

to

in

regulations

1(3)

interoperability of the rail system, as referred to in regulations 1(3) and 2(1).

These interoperability

constituents constituents

may be: may be

These interoperability

1.1

Multiple-use

constituents constituents

Multiple-use

These are constituents

that are not that

are not

specific

to the

railway

and system

and which may

These are constituents

specific

to the

railway

system

which may

be

used

as

such

in

other

areas.

be used as such in other areas.

1.2

Multiple-use

constituents constituents

having

specific characteristics

Multiple-use

having specific

characteristics

These are constituents

which

are not,

as such,

specific

to the

railway

but system, but

These are constituents

which are not,

as such,

specific

to the

railway

system,

which must display specific performance levels when used for railway purposes. purposes.

which

must

display

specific

performance

levels

when

used

for

railway

1.3 constituents

Specific constituents

Specific

These are constituents

that are

specific applications.

to railway applications.

These are constituents

that are specific

to railway

2. Scope

2. Scope

The ‘EC’ declaration

covers

The ‘EC’ declaration

covers

- assessment

either the assessment

by body

a notified

body of or the

bodies

of the

intrinsic conformity

-

either the

by a notified

or bodies

intrinsic

conformity

of

an

interoperability

constituent,

considered

in

isolation,

to the technical

of an interoperability constituent, considered in isolation, to the technical

specifications

to be met, to be met,

specifications

- or the assessment

or by

judgement

by body

a notified

body of or the

bodies

of the suitability

-

or the assessment

or judgement

a notified

or bodies

suitability

for use of for

an use

of an interoperability

constituent, constituent,

considered considered

within its within

railway its railway

interoperability

environment

and,

in

particular

in

cases

where

the

interfaces

are in involved, in

environment and, in particular in cases where the interfaces are involved,

relation to relation

to the specifications,

technical specifications,

particularly particularly

those of a those

of a functional

the technical

functional

nature,

which

are

to

be

checked.

nature, which are to be checked.

The assessment

procedures procedures

implemented

by the

notified

bodies

at and

the design and

The assessment

implemented

by the notified

bodies

at the

design

production production

stages will stages

will draw

upon the defined

modules

defined in 93/465/EEC,

Decision 93/465/EEC,

draw upon

the modules

in Decision

in

accordance

with

the

conditions

referred

to

in

the

TSIs.

in accordance with the conditions referred to in the TSIs.

3. of Contents

the ‘EC’ of declaration

the ‘EC’ declaration

3. Contents

The ‘EC’ The

‘EC’ declaration

of conformity

or of suitability

for the

use and the

declaration

of conformity

or of suitability

for use and

accompanying

documents

must

be

dated

and

signed.

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 reference to applicable regulations,

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 (regulation 10),

all the relevant descriptions met by the interoperability constituent and, in

particular, its conditions of use,

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.

Schedule V

Schedule V

‘EC’ DECLARATION OF VERIFICATION OF SUBSYSTEMS

‘EC’ DECLARATION OF VERIFICATION OF SUBSYSTEMS

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

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

dated and signed.

dated and signed.

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

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

must contain the following

must contain the following

- the references to applicable regulations,

the references to applicable regulations,

- name and address of the contracting entity or the manufacturer, or its

name and address of the contracting entity or the manufacturer, or its

authorised representative established within the Community (give trade name

authorised representative established within the Community (give trade name

and full address; in the case of the authorised representative, also give the

and full address; in the case of the authorised representative, also give the

trade name of the contracting entity or the manufacturer),

trade name of the contracting entity or the manufacturer),

- a brief description of the subsystem,

a brief description of the subsystem,

- name and address of the notified body which conducted the ‘EC’ verification

name and address of the notified body which conducted the ‘EC’ verification

referred to in Article 18 of Directive 2008/57/EC,

referred to in Article 18 of Directive 2008/57/EC,

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

the references of the documents contained in the technical file,

- all the relevant temporary or definitive provisions to be complied with by the

all the relevant temporary or definitive provisions to be complied with by the

subsystems and in particular, where appropriate, any operating restrictions or

subsystems and in particular, where appropriate, any operating restrictions or

conditions,

conditions,

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

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

- identity of the signatory.

identity of the signatory.

Schedule VI

Schedule VI

‘EC’

VERIFICATION

PROCEDURE

FOR SUBSYSTEMS

‘EC’ VERIFICATION PROCEDURE FOR SUBSYSTEMS

1. Introduction

1. Introduction

‘EC’ verification

is the whereby

procedure a whereby

a notified

body

and checks

and certifies

‘EC’ verification

is the procedure

notified body

checks

certifies

that

the

subsystem

that the subsystem

- with

complies

with these Regulations,

-

complies

these Regulations,

- with

complies

with regulations

the other regulations

deriving

from the

and Treaty,

may be and

put may be put

-

complies

the other

deriving from

the Treaty,

into operation.

into operation.

2. Stages

2. Stages

The subsystem

is checked is

at checked

at each

of the stages

following stages

The subsystem

each of the

following

overall - design,

overall design,

-

- production

construction

of subsystem,

including, including,

in particular,

civil-

-

production

construction

of subsystem,

in particular,

civil-

engineering engineering

activities, activities,

manufacturing,

constituent constituent

assembly, assembly,

overall

manufacturing,

overall

adjustment,

adjustment,

- final

testing

of the subsystem.

-

final testing

of the

subsystem.

For the

design

stage (including

the type

tests)

the and

for the production

stage the stage the

For the design

stage

(including

the type tests)

and for

production

applicant

may

apply

for

an

assessment

as

a

first

step.

applicant may apply for an assessment as a first step.

In this

this assessment

case, this assessment

or assessments

lead to one lead

to one intermediate

or more intermediate

In this case,

or assessments

or more

statement verifications

(ISV)

issued

by the

notified

body

chosen

by the applicant.

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 subsystem

The

notified

body

in

turn

draws

up

an

‘EC’

declaration

of

intermediate

conformity conformity

for the

relevant stages.

for the relevant

stages.

3. Certificate

3. Certificate

The body

notified

body responsible

for ‘EC’ verification

assesses

design the

and design and

The notified

responsible

for ‘EC’ verification

assesses the

production production

of the subsystem

and draws and

draws

up the of

certificate

of verification

intended intended

of the subsystem

up the

certificate

verification

for

the

applicant,

which

in

turn

draws

up

the

‘EC’

declaration

of verification

for the applicant, which in turn draws up the ‘EC’ declaration of verification

intended for intended

for the Regulatory

Affairs Directorate.

the Regulatory

Affairs Directorate.

If available, If the

available,

notified the

notified

takes body

takes into

the account

the ISVs,

and,

to in

order to issue

body

into account

ISVs, and,

in order

issue

the

‘EC’

certificate

of

verification,

it

the ‘EC’ certificate of verification, it

checks - that checks

that the subsystem

-

the subsystem

- is

by covered

relevant by

relevant

and design

and production

ISVs, if the ISVs,

if the has

applicant

asked has asked

-

is covered

design

production

applicant

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).

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 regulations 1(3) and 2(1),

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

regulation 10 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 these Regulations 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

The aim of ‘EC’ monitoring is to ensure that the obligations deriving from the

technical file have been met during production of the subsystem.

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.

The notified body responsible for checking implementation must periodically

carry out audits in order to confirm compliance with these regulations. It must

provide those responsible for implementation with an audit report. It may need to

be present at certain stages of the building operations.

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.

With a view to deliver the ‘EC’ declaration of suitability for use referred to in

section 2 of Schedule 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 or to the ‘EC’ declaration of verification which the applicant sends to the

Regulatory Affairs Directorate.

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.

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 at least the English or Maltese language.

Er

Schedule Schedule

VII

VII

PARAMETERS

PARAMETERS

TO BE CHECKED

TO BE CHECKED

IN CONJUNCTION

IN CONJUNCTION

WITH THE

WITH

PLACING

THE PLACING

IN SERVICE

IN SERVICE

OF NON-TSI

OF NON-TSI

CONFORMING

CONFORMING

VEHICLES

VEHICLES

AND THE

AND

CLASSIFICATION

THE CLASSIFICATION

OF THE OF

NATIONAL

THE NATIONAL

RULES RULES

1.

1. of parameters

List

List of parameters

1.1

General

1.1

documentation

General documentation

General documentation

General documentation

(including (including

description description

of new, renewed

of new, or

renewed

upgraded

or upgraded

vehicle and

vehicle

its intended

and its intended

use, design,

use, repair,

design, operation

repair, operation

and maintenance

and maintenance

information,

information,

technical file,

technical

etc.). file, etc.).

1.2

Structure

1.2

Structure

and mechanical

and mechanical

parts

parts

Mechanical

Mechanical

integrity and

integrity

interface

and between

interface vehicles

between (including

vehicles (including

draw and draw

buffer and buffer

gear, gangways),

gear, gangways),

strength of

strength

vehicle of structure

vehicle and

structure

fittings

and (e.g.

fittings

seats),

(e.g.

loading

seats), loading

capability, capability,

passive safety

passive

(including

safety (including

interior and

interior

exterior

and crashworthiness).

exterior crashworthiness).

1.3

Track

1.3 interaction

Track interaction

and gauging

and gauging

Mechanical

Mechanical

interfaces interfaces

to the infrastructure

to the infrastructure

(including (including

static and static

dynamic

and dynamic

behaviour, behaviour,

clearances clearances

and fits, gauge,

and fits,

running

gauge, gear,

running

etc.). gear, etc.).

1.4

Braking

1.4 equipment

Braking equipment

Braking-related

Braking-related

items (including

items (including

wheel-slide

wheel-slide

protection, protection,

braking control,

braking and

control, and

braking performance

braking performance

in service, in emergency

service, emergency

and parking

and modes).

parking modes).

1.5

Passenger-related

1.5

Passenger-related

items

items

Passenger Passenger

facilities and

facilities

passenger

and passenger

environment

environment

(including (including

passenger passenger

windows windows

and doors, and

requirements

doors, requirements

for persons

for with

persons

reduced

with mobility,

reduced etc.).

mobility, etc.).

1.6

Environmental

1.6

Environmental

conditions conditions

and aerodynamic

and aerodynamic

effects effects

Impact of Impact

the environment

of the environment

on the vehicle

on the and

vehicle

impact

and of impact

the vehicle

of the on vehicle

the on the

environment

environment

(including (including

aerodynamic

aerodynamic

conditions conditions

and both and

the interface

both the between

interface between

the vehicle the

and

vehicle

the trackside

and the part

trackside

of the part

railway

of the system

railway

and

system

the interface

and the with

interface

the with the

external environment).

external environment).

1.7

External

1.7

warning,

External marking,

warning, functions

marking, and

functions

software

and integrity

software requirements

integrity requirements

External warnings,

External warnings,

markings, markings,

functions functions

and integrity

and of

integrity

software,

of software,

e.g. safety-

e.g. safety-

related functions

related functions

with an impact

with an

on impact

train behaviour

on train behaviour

including including

train bus. train bus.

E

Onboard power supply and control systems

Onboard propulsion, power and control systems, plus the interface of the vehicle

with the power supply infrastructure and all aspects of electromagnetic

compatibility.

Staff facilities, interfaces and environment

Onboard facilities, interfaces, working conditions and environment for staff

(including drivers cabs, driver machine interface).

Fire safety and evacuation

Servicing

Onboard facilities and interfaces for servicing.

Onboard control, command and signalling

All the onboard equipment necessary to ensure safety and to command and

control movements of trains authorised to travel on the network and its effects on

the trackside part of the railway system.

Specific operational requirements

Specific operational requirements for vehicles (including degraded mode, vehicle

recovery etc.).

Freight related items

Freight-specific requirements and environment (including facilities specifically

required for dangerous goods).

Explanations and examples in italics above are for information only and are not

definitions of the parameters.

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).

Schedule VIII

Schedule VIII

MINIMUM

CRITERIA

FOR NOTIFICATION

OF NOTIFIED

BODIES BODIES

MINIMUM

CRITERIA

FOR NOTIFICATION

OF NOTIFIED

The 1. body, The

body, its and

Director

and responsible

the staff responsible

for out

carrying

out the checking

1. its Director

the staff

for carrying

the checking

operations

may

not

become

involved

either

directly

or

as authorised

operations may not become involved either directly or as authorised

representatives

in the manufacture,

design, manufacture,

construction,

marketing marketing

representatives

in the design,

construction,

or

maintenance

of

the

interoperability

constituents

or

subsystems

or

in

their

maintenance of the interoperability constituents or subsystems or in their use.

This does This

does not the

exclude

the possibility

of an exchange

of information

technical information

not exclude

possibility

of an exchange

of technical

between

the manufacturer

and that body.

between the

manufacturer

and that body.

2. body and

The the

body

and responsible

the staff responsible

for the

checks

carry must

carry

out the

checks with

2. The

staff

for the checks

must

out the

checks

with

the greatest possible professional integrity and the greatest possible technical technical

the

greatest

possible

professional

integrity

and

the

greatest

possible

competence

and must and

must of be

free

of any and

pressure

and incentive,

in particular

competence

be free

any

pressure

incentive,

in particular

of a

financial

type,

which

could

affect

their

judgment

or

the

results

of

their

inspection,

financial type, which could affect their judgment or the results of their inspection,

in particular

from or persons

groups or

of groups

persons of affected

persons by

affected

by the

of results

in particular

from persons

the results

the

checks.

checks.

In particular,

the body the

and body

and the

staff responsible

for the must

checks

be must be

In particular,

the staff

responsible

for the checks

functionally

independent

of

the

authorities

designated

to

issue

authorisations

functionally independent of the authorities designated to issue authorisations for

placing in placing

service in in service

in the framework

of these of

these regulations,

licences

the in the

the framework

regulations,

licences in

framework

of

Directive

95/18/EC

and

safety

certificates

in

the

framework

framework of Directive 95/18/EC and safety certificates in the framework of

Directive 2004/49/EC,

and of the and

of the

bodies of

in charge

of investigations

in the event

Directive 2004/49/EC,

bodies

in charge

investigations

in the event

of

accidents.

of accidents.

The 3. body The

must body

must staff

employ

and staff

and the

possess

means the required

means to

required

to perform

3. employ

possess

perform

adequately adequately

the and

technical

and administrative

tasks

with linked

with the

checks; it should

the technical

administrative

tasks linked

the checks;

it should

also

have

access

to

the

equipment

needed

for

exceptional

checks.

also have access to the equipment needed for exceptional checks.

The 4. staff responsible

The staff responsible

for the

checks

must possess

4. for the checks

must

possess

proper - technical

proper and

technical

and vocational

training, training,

-

vocational

- a satisfactory

knowledge knowledge

of the requirements

relating to relating

to the

that checks

they that they

-

a satisfactory

of the requirements

the checks

carry

out

and

sufficient

practice

in

those

checks,

carry out and sufficient practice in those checks,

- the

ability

up to the

draw

up the certificates,

records

reports and

reports

which constitute

-

the ability

to draw

certificates,

records and

which

constitute

the

formal

record

of

the

inspections

conducted.

formal record of the inspections conducted.

The 5. independence

The independence

of the staff of responsible

the staff responsible

for inspections

must be guaranteed.

5. for inspections

must be guaranteed.

No

official

must be remunerated

either

on of

the the

basis

of the of number

of inspections

official must

be remunerated

either on the

basis

number

inspections

performed

or

of

the

results

of

those

inspections.

performed or of the results of those inspections.

The 6. body must

The body

take must

take liability

out civil insurance

liability unless

insurance

that unless

that is liability

covered is by covered by

6. out civil

liability

the State

under law

national

law the

or unless

checks the

are checks

carried are

out carried

out by directly

the State under

national

or unless

directly

the

Regulatory

Affairs

Directorate.

Regulatory Affairs Directorate.

The 7. staff of

The

the staff

body of are

the bound

body are

bound by professional

secrecy

regard with

regard to everything

7. by professional

secrecy with

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 these regulations or any

provision of national law implementing these regulations.

Schedule IX

Schedule IX

FILE FOR SUBMITTING A DEROGATION

FILE FOR SUBMITTING A DEROGATION

When submitting a request for a derogation, the Regulatory Affairs Directorate

When submitting a request for a derogation, the Regulatory Affairs Directorate

must supply the following documents

must supply the following documents

(a) A formal letter communicating the proposed derogation to the Commission.

(a)

A formal letter communicating the proposed derogation to the Commission.

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

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

a description of the work, goods and services subject to the

a description of the work, goods and services subject to the

derogation, specifying the key dates, the geographical location and

derogation, specifying the key dates, the geographical location and

the operational and technical area,

the operational and technical area,

a precise reference to the TSIs (or their parts) for which a derogation

a precise reference to the TSIs (or their parts) for which a derogation

is requested,

is requested,

a precise reference to and details of the alternative provisions which

a precise reference to and details of the alternative provisions which

will be applied,

will be applied,

for requests made under Article 7(1)(a) of Directive 2008/57/EC,

for requests made under Article 7(1)(a) of Directive 2008/57/EC,

justification of the advanced stage of development of the project,

justification of the advanced stage of development of the project,

justification of the derogation, including the main reasons of a

justification of the derogation, including the main reasons of a

technical, economic, commercial, operational and/or administrative

technical, economic, commercial, operational and/or administrative

nature,

any other information justifying the request for a derogation,

any other information justifying the request for a derogation,

a description of the measures that the Regulatory Affairs Directorate

a description of the measures that the Regulatory Affairs Directorate

proposes to take in order to promote the final interoperability of the

proposes to take in order to promote the final interoperability of the

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

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

required.

Documentation must be supplied in paper form and as electronic files.

Documentation must be supplied in paper form and as electronic files.

€1.80

(1) The provisions of these regulations shall apply

without prejudice to any other relevant local or Community

provisions. However, in the case of interoperability constituents,

including interfaces, compliance with the essential requirements

of these regulations may require the use of individual European

specifications drawn up for that purpose.

(2) The following shall be excluded from the scope of

these regulations

(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

exclusively 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.

(3) The scope of the TSIs shall be progressively

extended in accordance with regulation 7(1) 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 regulation

3. For the purposes of these regulations

“the Act” means the Product Safety Act;

“the Agency” means the European Railway Agency, as

established by Regulation (EC) No 881/2004;

“basic parameters” means any regulatory, technical or

operational condition which is critical to interoperability and

is specified in the relevant TSIs;

“the Community” means the European Community;

“contracting entity” means any entity, whether public

or private, which orders the design 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;

“entity in charge of maintenance” means an entity in

charge of maintenance of a vehicle, and registered as such in

the national vehicle register;

“essential requirements” means all the conditions set

out in Schedule III to these regulations which must be met

by the rail system, the subsystems, and the interoperability

constituents, including interfaces;

“European specification” means a common technical

specification, a European technical approval or a national

standard transposing a European standard, as defined in

Annex XXI to Directive 2004/17/EC;

“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;

“harmonised standard” means a standard adopted L.N. 373 of 2003.

by the Malta Standards Authority or one of the European

Standardisation bodies listed in Schedule I to the Notification

Procedure Regulations, 2003, on the basis of a request made

by the Commission in accordance with Article 6 of Directive

98/34/EC;

“interoperability” means the ability of a rail system to

allow the safe and uninterrupted movement of trains which

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;

“interoperability constituents” means any elementary

component, group of components, subassembly or complete

assembly of equipment incorporated or intended to be

incorporated into a subsystem, upon which the interoperability

of the rail system depends directly or indirectly. The concept

of a “constituent” covers both tangible objects and intangible

objects such as software;

“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 of Directive

2008/57/EC;

“Market Surveillance Directorate” means the Market

Surveillance Directorate of the Malta Standards Authority as

described in the Establishment of Directorates of the Malta

Standards Authority Order, 2008;

“national safety authority” means a safety authority as

defined in Article 3(g) of Directive 2004/49/EC;

“network” means the lines, stations, terminals, and

all kinds of fixed equipment needed to ensure safe and

continuous operation of the rail system;

“notified body” means a body designated in accordance

with the Method for Designating Conformity Assessment

Bodies Regulations, 2003, which is responsible for assessing

the conformity or suitability for use of the interoperability

constituents or for appraising the ‘EC’ procedure for

verification of the subsystems;

“placing in service” means all the operations by which a

subsystem or a vehicle is put into its design operating state;

“project at an advanced stage of development” means

any project whose planning or construction stage has reached

a point where a change in the technical specifications would

be unacceptable to the Regulatory Affairs Directorate.

Such an impediment may be legal, contractual, economic,

financial, social or environmental in nature and must be duly

substantiated;

“Regulatory Affairs Directorate” means the Regulatory

Affairs Directorate of the Malta Standards Authority as

described in the Establishment of Directorates of the Malta

Standards Authority Order, 2008;

“renewal” means any major substitution work on a

subsystem or part subsystem which does not change the

overall performance of the subsystem;

“series” means a number of identical vehicles of a

design type;

“specific case” means any part of a future planned

rail system which needs special provisions in the TSIs,

either temporary or definitive, because of geographical,

topographical or urban environment constraints or those

effecting compatibility with the existing European system,

especially taking into consideration the fact that Malta is

an archipelago of islands and does not, and will not, have a

railway which connects to mainland Europe or to any other

third country.

“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;

“subsystems” means the result of the division of the rail

system, as shown in Schedule II. These subsystems, for which

essential requirements must be laid down, may be structural

or functional;

“technical specification for interoperability” (TSI) means

a specification adopted in accordance with these regulations

by which each subsystem or part subsystem is covered in

order to meet the essential requirements and ensure the

interoperability of the rail system;

“trans-European rail system” means the trans-European

conventional and high-speed rail systems as set out in

Schedule I, points 1 and 2, respectively;

“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;

“upgrading” means any major modification work on

a subsystem or part subsystem which improves the overall

performance of the subsystem;

“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.

4. (1) The rail system, subsystems and interoperability

constituents including interfaces shall meet the relevant essential

requirements.

(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 locally

or within the Community must not conflict with the essential

requirements.

5. (1) Each of the subsystems shall be covered by one

TSI. Where 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

regulation 6(1).

(2) Subsystems shall comply with the TSIs in force

at the time of their placing in service, upgrading or renewal,

in accordance with these regulations; this compliance shall be

permanently maintained while each subsystem is in use.

(3) To the extent necessary to achieve the objective

referred to in regulation 1, each TSI shall

(a) indicate its intended scope (part of network or

vehicles referred to in Schedule I; subsystem or part of

subsystem referred to in Schedule II);

(b) lay down essential requirements for each subsystem

concerned and its interfaces vis-à-vis other subsystems;

(c) establish the functional and technical specifications

to be met by the subsystem and its interfaces vis-à-vis

other subsystems. If need be, these specifications may vary

according to the use of the subsystem, for example according

to the categories of line, hub or vehicles provided for in

Schedule I;

(d) 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;

(e) 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;

(f) indicate the strategy for implementing the TSIs. In

particular, it 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;

(g) indicate, for the staff concerned, the professional

qualifications 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.

(4) Each TSI shall be drawn up on the basis of

an examination 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 any existing rail system. With this objective,

provision may be made for specific cases for each TSI, 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 sub-regulations (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) of Directive 2008/57/EC shall apply to these aspects.

(7) TSIs shall not be an impediment to decisions by

any local Authority 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 these regulations. 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

is applicable. In the absence of such standards or specifications or

technical documents and pending their development, reference may

be made to other clearly identified normative documents; in such

case, this shall concern documents that are easily accessible and in

the public domain.

6. (1) Draft TSIs and subsequent draft amendments to

TSIs shall be drafted by the Agency under a mandate from the

Commission. The Regulatory Affairs Directorate shall participate

by providing the requisite data in the assessment during drafting,

adoption and review of each TSI (including the basic parameters).

(2) 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 Regulatory Affairs Directorate.

7. (1) Where the Commission adopts one or more

mandates aiming at the development of new TSIs or the review of

TSIs already adopted with a view to covering lines and vehicles

not yet covered, until such time as the extension of the scope of the

TSIs to cover the whole of the rail network takes effect

(a) authorisations for the placing in service

(i) 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,

(ii) of infrastructure, energy and trackside

control-command and signalling subsystems on the parts

of the network that do not yet fall within the scope of the

TSIs,

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 Directive 2008/57/EC;

(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 of Directive 2008/57/EC and the national rules

referred to in Article 8 of Directive 2004/49/EC, or, where

applicable, Article 17(3) of Directive 2008/57/EC.

(2) The adopted new or revised TSIs need not

be applied 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.

8. (1) In the absence of relevant specific cases, TSIs Derogations for TSIs.

need not apply in the following cases

(a) for a proposed new subsystem, for the renewal

or upgrading of an existing subsystem, or for any element

referred to in regulation 1(2) at an advanced stage of

development or the subject of a contract in the course of

performance when these TSIs are published;

(b) 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;

(c) for a proposed new subsystem or for the proposed

renewal or upgrading of an existing subsystem when the local

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;

(d) 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 or

the compatibility of the local rail;

(e) where, following an accident or a natural disaster,

the conditions for the rapid restoration of the network do

not economically or technically allow for partial or total

application of the relevant 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.

(2) In the cases referred to in sub-regulation (1),

the Regulatory Affairs Directorate shall communicate to the

Commission a file containing the information set out in Schedule

IX.

(3) In the case referred to in sub-regulation (1)(a),

within one year of entry into force of each TSI the Regulatory

Affairs Directorate 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) The alternative provisions referred to in Schedule

IX may be applied without delay in the cases referred to in sub-

regulations 1(a), (c) and (e).

(5) Pending the Commission’s decision, in the case

referred to in sub-regulation (1)(f), the alternative provisions

referred to in Schedule IX may be applied.

(1) Interoperability constituents shall only be placed

on the market if they enable interoperability to be achieved within

the rail system while at the same time meeting the essential

requirements.

(2) Interoperability constituents shall only be used

in their area of use as intended and shall be suitably installed and

maintained.

(3) These provisions shall not obstruct the placing on

the market of these constituents for other applications.

(4) The placing on the market of interoperability

constituents complying with these regulations for use in the rail

system shall not, on the basis of these regulations, be prohibited,

restricted or hindered. In particular, no 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 Schedule IV, shall be required.

(5) Interoperability constituents bearing the ‘EC’

declaration of conformity or suitability for use shall be considered

as complying with the essential requirements of these regulations.

(6) All interoperability constituents shall be subject

to the procedure for assessing conformity and suitability for the

use indicated in the relevant TSI and shall be accompanied by the

corresponding certificate.

(7) An interoperability constituent shall be

considered as meeting the essential requirements if it complies

with the conditions laid down by the corresponding TSI or the

corresponding European specifications developed to comply with

these conditions.

(8) Spare parts for subsystems that are already placed

in service when the corresponding TSI enters into force may be

installed in these subsystems without being subject to the procedure

referred to in regulation 9(6).

(9) 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 force. Such constituents shall satisfy the requirements of

regulation 9.

(1) In order to establish the ‘EC’ declaration of Procedure for

conformity or suitability for use of an interoperability constituent, EC

the manufacturer or his authorised representative established in the suitability for use.

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 regulations or Community legislation covering other

aspects, the ‘EC’ declaration of conformity or suitability for use

shall, in such cases, state that the interoperability constituents also

meet the requirements of those other directives.

(4) Where neither the manufacturer nor his

authorised representative established in the Community has met

the obligations of regulations 10(1) and 10(3), those obligations

shall be incumbent on any person who places interoperability

constituents on the market. The same obligations shall apply to

whomsoever assembles interoperability constituents or parts of

interoperability constituents having diverse origins or manufactures

interoperability constituents for his own use, for the purposes of

these regulations.

(5) Without prejudice to the provisions of regulation 11

(a) in each instance where the Market Surveillance

Directorate finds that the ‘EC’ declaration of conformity has

been drawn up improperly, the manufacturer or his authorised

representative established in the Community shall be required,

if necessary, to restore the interoperability constituent to a

state of conformity and to terminate the infringement under

the conditions laid down by the Act;

(b) where non-conformity persists, the Market

Surveillance Directorate 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 regulation 11.

(1) Where the Market Surveillance Directorate finds

that an interoperability 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 Market

Surveillance Directorate 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;

(b) incorrect application of European specifications

where application of such specifications is relied upon;

(c) inadequacy of European specifications.

(2) Where an interoperability constituent bearing

the ‘EC’ declaration of conformity fails to comply, the Market

Surveillance Directorate shall take appropriate measures against

whomsoever has drawn up the declaration and shall inform the

Commission and the other Member States thereof.

(3) Any decision taken pursuant to these regulations

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

regulation 11 or 12 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 Act and of the time limits allowed for the exercise of

such remedies.

(1) Where it appears to the Regulatory Affairs Non-compliance

Directorate that European specifications used directly or indirectly of

to achieve the objectives of these regulations do not meet the

essential requirements, it shall inform the Committee referred to in

Article 29 of Directive 2008/57/EC.

(1) For the purposes of notification under these Notified bodies.

regulations, a notified body shall meet the requirements laid down

hereunder and, in addition, the criteria provided for in Schedule

VIII and the Method for Designating Conformity Assessment

Bodies Regulations, 2003.

(2) The Regulatory Affairs Directorate 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 regulation 10 and

the verification procedure referred to in Article 18 of Directive

2008/57/EC, indicating each body’s area of responsibility, and the

identification numbers obtained in advance from the Commission.

(3) The Regulatory Affairs Directorate shall withdraw

approval from a body which no longer meets the criteria referred to

in Schedule VIII. It shall forthwith inform the Commission and the

other Member States thereof.

(1) Following the adoption of any draft reference Draft reference

system of technical rules developed by the Agency to ensure the systems.

current degree of interoperability of the networks and vehicles

that will be brought within the scope of these regulations, the

Regulatory Affairs Directorate shall inform the Commission of any

intention to adopt any national provision or of the development of

any project which diverges from the reference system.

The penalties applicable for the infringement of any of Penalties.

the provisions above shall be those provided for in Part IV of the

Act.

The Interoperability of the Trans-European High-Speed

Rail System Regulations, 2002, and the Interoperability of the

2002. Trans-European Conventional Rail System Regulations, 2002, are

being revoked.

References to the revoked regulations shall be construed

as references to these regulations.

Schedule I

SCOPE

1. Trans-European conventional rail system

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 these Regulations, 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.

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

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.

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.

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

fulfill 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.

4. Extension of the scope

Subcategories of network and vehicles

The scope of the TSIs shall be progressively extended to the whole rail system as

referred to in regulation 2(3). In order to deliver interoperability cost-effectively

further subcategories of all categories of network and vehicles mentioned in this

Schedule will, where necessary, be developed. If necessary, the functional and

technical specifications mentioned in regulation 5(3) may vary according to the

subcategory.

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,

-

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.

Schedule II

Schedule II

SUBSYSTEMS

SUBSYSTEMS

List 1. of subsystems

List of subsystems

1. For the of

purposes

of these regulations

the system the

system constituting

the rail

system may

For the purposes

these regulations

constituting

the rail system

may

be

broken

down

into

the

following

subsystems,

either

be broken down into the following subsystems, either

(a) areas

structural areas

(a)

structural

-

infrastructure,

-

infrastructure,

-

energy,

-

energy,

-

control-command

and signalling,

-

control-command

and signalling,

- stock;

rolling stock;

-

rolling

(b) functional

areas

(b) functional

areas

- operation

traffic and

operation

and management,

-

traffic

management,

-

maintenance,

-

maintenance,

-

telematics

applications

for passenger

and freight and

freight services.

-

telematics

applications

for passenger

services.

2. Description

of the subsystems

2. Description

of the subsystems

For each subsystem

or part of or

part of a subsystem,

the list of the

list of constituents

and aspects

For each subsystem

a subsystem,

constituents

and aspects

relating to interoperability is proposed by the Agency at the time of drawing up drawing up

relating

to

interoperability

is

proposed

by

the

Agency

at

the

time

of

the draft

relevant

TSI. draft TSI.

the relevant

Without prejudging

the of choice

aspects of and

aspects

and constituents

relating to

Without prejudging

the choice

constituents

relating to

interoperability or the order in which they will be made subject to TSIs, the TSIs, the

interoperability

or

the

order

in

which

they

will

be

made

subject

to

subsystems subsystems

include, in include,

in particular

particular

2.1

Infrastructure

Infrastructure

The track, The

track,

points, engineering

structures structures

(bridges, etc.),

tunnels,

etc.), associated

station station

points,

engineering

(bridges, tunnels,

associated

infrastructure

(platforms, (platforms,

zones of including

access, including

the needs the

needs of with

persons with

infrastructure

zones of access,

of persons

reduced

mobility,

etc.),

safety

and

protective

equipment.

reduced mobility, etc.), safety and protective equipment.

2.2

Energy

Energy

The electrification

system, including

overhead

and lines

and parts

on-board

parts of the

The electrification

system, including

overhead lines

on-board

of the

electric consumptions measuring equipment.

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.

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.

Telematics applications

In accordance with Schedule I, this subsystem comprises two elements

(a) 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;

(b) (b) 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.

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.

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.

Schedule III

ESSENTIAL