Interoperability of the Rail System Regulations, 2019

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,243, 2 ta’ Awwissu, 2019 B 1427

Taqsima B

L.N. 184 of 2019

PRODUCT SAFETY ACT

(CAP. 427)

Interoperability of the Rail System Regulations, 2019

IN EXERCISE of the powers conferred by articles 38 and 39 of

the Product Safety Act, the Minister for Justice, Culture and Local

Government on the advice of the Director General (Technical

Regulations) has made the following regulations: -

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

commencement.

the Rail System Regulations, 2019.

(2) These regulations transpose Directive (EU) 2016/797 and

establish the conditions to be met to achieve interoperability within the

Union rail system in a manner compatible with the provisions of

Directive (EU) 2016/798 in order to define an optimal level of

technical harmonisation, to make it possible to facilitate, improve and

develop rail transport services within the Union and with third

countries and to contribute to the completion of the single European

railway area and the progressive achievement of the internal market.

These conditions concern the design, construction, placing in service,

upgrading, renewal, operation and maintenance of the parts of that

system as well as the professional qualifications of, and health and

safety conditions applying to, the staff who contribute to its operation

and maintenance.

(3) These regulations concern the provisions relating to, for

each subsystem, the interoperability constituents, interfaces and

procedures, and the conditions of overall compatibility of the Union

rail system required in order 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 Union

rail system with a view to its operation by one or more railway

undertakings, but excluding a metro system, a tram, networks that are

functionally separate from the rest of the Union rail system and any

other light rail systems, Article 13, Article 14(1) to (8), (11) and (12),

Article 15(1) to (9), Article 16(1), Articles 19 to 26, Articles 45, 46

and 47, Article 49(1) to (4) and Article 54 of Directive (EU) 2016/797

shall apply.

(5) These regulations shall be deemed to have come into force

on 16 June 2019.

ELEMENTS OF THE UNION RAIL SYSTEM

1. Network

For the purposes of these regulations, the Union's network shall

include the following elements

(a)

specially built high-speed lines equipped for speeds

generally equal to or greater than 250 km/h;

(b)

specially upgraded high-speed lines equipped for speeds of

the order of 200 km/h;

(c)

specially upgraded high-speed lines which have special

features as a result of topographical, relief or town-

planning constraints, to which the speed must be adapted in

each case. This category includes interconnecting lines

between high-speed and conventional networks, lines

through stations, accesses to terminals, depots, etc.

travelled at conventional speed by ‘high-speed’ rolling

stock;

(d)

conventional lines intended for passenger services;

(e)

conventional lines intended for mixed traffic (passengers

and freight);

(f)

conventional lines intended for freight services;

(g)

passenger hubs;

(h)

freight hubs, including intermodal terminals;

(i)

lines connecting the above-mentioned 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.

2. Vehicles

For the purposes of these regulations, Union vehicles shall

comprise all vehicles likely to travel on all or part of the Union's

network

—

locomotives and passenger rolling stock, including thermal

or electric traction units, self-propelling thermal or electric

passenger trains, and passenger coaches;

—

freight wagons, including low-deck vehicles designed for

the entire network and vehicles designed to carry lorries;

—

special vehicles, such as on-track machines

This list of vehicles shall include those which are specially

designed to operate on the different types of high-speed lines

described in point 1.

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

these regulations

(a)

metros;

(b) trams and light rail vehicles, and infrastructure used

exclusively by those vehicles;

(c) networks that are functionally separate from the rest

of the Union rail system and intended only for the operation of

local, urban or suburban passenger services, as well as

undertakings operating solely on those networks;

(d) privately owned railway infrastructure, including

sidings, used by its owner or by an operator for the purpose of

their respective freight activities or for the transport of persons

for non-commercial purposes, and vehicles used exclusively on

such infrastructure;

(e) infrastructure and vehicles reserved for a strictly

local, historical or touristic use;

(f) light rail infrastructure occasionally used by heavy

rail vehicles under the operational conditions of the light rail

system, where it is necessary for the purposes of connectivity of

those vehicles only; and

(g) vehicles primarily used on light rail infrastructure but

equipped with some heavy rail components necessary to enable

transit to be effected on a confined and limited section of heavy

rail infrastructure for connectivity purposes only.

(2) In case of tram-trains operating in the Union rail system,

where there are no TSIs that apply to those tram-trains, the following

shall apply

(a) national rules or other relevant accessible measures

shall be adopted in order to ensure that such tram-trains meet the

relevant essential requirements;

(b) national rules may be adopted in order to specify the

authorisation procedure applicable to such tram-trains. The

authority issuing the vehicle authorisation shall consult the

relevant national safety authority in order to ensure that mixed

operation of tram-trains and heavy rail trains meet all essential

requirements as well as relevant common safety targets;

(c) by way of derogation from Article 21 of Directive

(EU) 2016/797, in the case of cross-border operation, the

relevant competent authorities shall cooperate with a view to

issuing the vehicle authorisations. This does not apply to

vehicles excluded from the scope of these regulations in

accordance with regulation 2(1).

SUBSYSTEMS

1. List of subsystems

For the purposes of these regulations, the system constituting the

Union rail system may be broken down into the following

subsystems, either

(a)

structural areas

—

infrastructure,

—

energy,

—

track-side control-command and signalling,

—

on-board control-command and signalling,

—

rolling stock; or

(b)

functional areas

—

operation and traffic management,

—

maintenance,

—

telematics applications for passenger and

freight services.

2. Description of the subsystems

For each subsystem or part of a subsystem, the list of constituents

and aspects relating to interoperability is proposed by the Agency

at the time of drawing up the relevant draft TSI. Without

prejudging the choice of aspects and constituents relating to

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

TSIs, the subsystems include the following

2.1. Infrastructure

The track, points, level crossings, engineering structures (bridges,

tunnels, etc.), rail-related elements of stations (including

entrances, platforms, zones of access, service venues, toilets and

information systems, as well as their accessibility features for

persons with disabilities and persons with reduced mobility),

safety and protective equipment.

2.2. Energy

The electrification system, including overhead lines and the

trackside electricity consumption measuring and charging

system.

2.3. Trackside control-command and signalling

All the trackside equipment required to ensure safety and to

command and control movements of trains authorised to travel on

the network.

2.4. On-board control-command and signalling

All the on-board equipment required to ensure safety and to

command and control movements of trains authorised to travel on

the network.

2.5. Operation and traffic management

The procedures and related equipment permitting coherent

operation of the various structural subsystems, during both

normal and degraded operation, including in particular train

composition and train driving, traffic planning and management.

The professional qualifications which may be required for

carrying out any type of railway service.

2.6. Telematics applications

In accordance with Schedule I, this subsystem comprises two

elements

(a)

applications for passenger services, including systems

which provide passengers with information before and

during the journey, reservation and payment systems,

luggage management and management of connections

between trains and with other modes of transport;

(b)

applications for freight services, including information

systems (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.

2.7. Rolling stock

Structural body, command and control system for all train

equipment, electric current collection devices, traction and

energy conversion units, on-board equipment for electricity

consumption measuring and charging, braking, coupling and

running gear (bogies, axles, etc.) and suspension, doors, man/

machine interfaces (driver, on-board staff and passengers,

including accessibility features for persons with disabilities and

persons with reduced mobility), passive or active safety devices

and requisites for the health of passengers and on-board staff.

2.8. Maintenance

The procedures, associated equipment, logistics centres for

maintenance work and reserves providing the mandatory

corrective and preventive maintenance to ensure the

interoperability of the Union rail system and guarantee the

performance required.

For the purposes of these regulations

Definitions.

"the Act" means the Product Safety Act;

"accreditation" means accreditation as defined in point (10)

of Article 2 of Regulation (EC) No 765/2008;

"the Agency" means the European Union Agency for

Railways as established by Regulation (EU) 2016/796;

"applicant" means a natural or legal person requesting an

authorisation, be it a railway undertaking, an infrastructure

manager or any other person or legal entity, such as a

manufacturer, an owner or a keeper; for the purpose of Article 15

of Directive (EU) 2016/797, the ‘applicant’ means a contracting

entity or a manufacturer, or its authorised representatives; for the

purpose of Article 19 of Directive (EU) 2016/797, the ‘applicant’

means a natural or legal person requesting the Agency's decision

for the approval of the technical solutions envisaged for the

ERTMS track-side equipment projects;

"authorised representative" means any natural or legal

person established within the Union who has received a written

mandate from a manufacturer or a contracting entity to act on

behalf of that manufacturer or contracting entity in relation to

specified tasks;

"conformity assessment" means the process demonstrating

whether specified requirements relating to a product, process,

service, subsystem, person or body have been fulfilled;

"conformity assessment body" means a body that has been

notified or designated to be responsible for conformity

assessment activities, including calibration, testing, certification

and inspection; a conformity assessment body is classified as a

‘notified body’ following notification by the Technical

Regulations Division; a conformity assessment body is classified

as a ‘designated body’ following designation by a the Technical

Regulations Division;

"contracting entity" means a public or private entity which

orders the design and/or construction or the renewal or

upgrading of a subsystem;

"design operating state" means the normal operating mode

and the foreseeable degraded conditions (including wear) within

the range and the conditions of use specified in the technical and

maintenance files;

"ERTMS" means the European Rail Traffic Management

System;

"essential requirements" means all the conditions set out in

Schedule III which must be met by the Union rail system, the

subsystems, and the interoperability constituents, including

interfaces;

"European specification" means a specification which falls

into one of the following categories

(a) a common technical specification as defined in

Annex VIII of Directive 2014/25/EU;

(b) a European technical approval as referred to in

Article 60 of Directive 2014/25/EU; or

(c) a European standard as defined in point (b) of

Article 2(1) of Regulation (EU) No 1025/2012;

"harmonised standard" means a European standard as

defined in point (c) of Article 2(1) of Regulation (EU) No 1025/

2012;

"infrastructure manager" means an infrastructure manager

as defined in point (2) of Article 3 of Directive 2012/34/EU;

"interoperability" means the ability of a rail system to allow

the safe and uninterrupted movement of trains which accomplish

the required levels of performance;

"interoperability constituents" means any elementary

component, group of components, sub-assembly 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, including both

tangible objects and intangible objects;

"keeper" means the natural or legal person 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 a

vehicle register referred to in Article 47 of Directive (EU) 2016/

797;

"light rail" means an urban and/or suburban rail transport

system with a crash-worthiness of C-III or C-IV (in accordance

with EN 15227:2011) and a maximum strength of vehicle of 800

kN (longitudinal compressive force in coupling area); light rail

systems may have their own right of way or share it with road

traffic and usually do not exchange vehicles with long-distance

passenger or freight traffic;

"manufacturer" means any natural or legal person who

manufactures a product in the form of interoperability

constituents, subsystems or vehicles, or has it designed or

manufactured, and markets it under his name or trademark;

"national accreditation body" means a national

accreditation body as defined in point (11) of Article 2 of

Regulation (EC) No 765/2008;

"national rules" means all binding rules adopted in a

Member State, irrespective of the body issuing them, which

contain railway safety or technical requirements, other than those

laid down by Union or international rules which are applicable

within that Member State to railway undertakings, infrastructure

managers or third parties;

"national safety authority" means a safety authority as

defined in point (7) of Article 3 of Directive (EU) 2016/798;

"network" means the lines, stations, terminals, and all kinds

of fixed equipment needed to ensure safe and continuous

operation of the Union rail system;

"placing in service" means all the operations by which a

subsystem is put into its operational service;

"placing on the market" means the first making available on

the Union's market of an interoperability constituent, subsystem

or vehicle ready to function in its design operating state;

"product" means a product obtained through a

manufacturing process, including interoperability constituents

and subsystems;

"railway undertaking" means a railway undertaking as

defined in point (1) of Article 3 of Directive 2012/34/EU, and

any other public or private undertaking, the activity of which is

to provide transport of goods and/or passengers by rail on the

basis that the undertaking is to ensure traction; this also includes

undertakings which provide traction only;

"renewal" means any major substitution work on a

subsystem or part of it which does not change the overall

performance of the subsystem;

"specific case" means any part of the rail system which

needs special provisions in the TSIs, either temporary or

permanent, because of geographical, topographical or urban

environment constraints or those affecting compatibility with the

existing system, in particular railway lines and networks isolated

from the rest of the Union, the loading gauge, the track gauge or

space between the tracks and vehicles strictly intended for local,

regional or historical use, as well as vehicles originating from or

destined for third countries;

"subsystems" means the structural or functional parts of the

Union rail system, as set out in Schedule II;

"Technical Regulations Division" means the entity as

established by article 19 of the Malta Competition and Consumer

Affairs Authority Act;

"technical specification for interoperability" or "TSI"

means a specification adopted in accordance with Directive (EU)

2016/797 by which each subsystem or part of a subsystem is

covered in order to meet the essential requirements and ensure

the interoperability of the Union rail system;

"tram-train" means a vehicle designed for combined use on

both a light-rail infrastructure and a heavy-rail infrastructure;

"type" means a vehicle type defining the basic design

characteristics of the vehicle as covered by a type or design

examination certificate described in the relevant verification

module;

"the Union rail system" refers to the Elements of the Union

Rail System set out in Schedule I;

"upgrading" means any major modification work on a

subsystem or part of it which results in a change in the technical

file accompanying the ‘EC’ declaration of verification, if that

technical file exists, and which improves the overall performance

of the subsystem; and

"vehicle" means a railway vehicle suitable for circulation

on wheels on railway lines, with or without traction; a vehicle is

composed of one or more structural and functional subsystems.

ESSENTIAL REQUIREMENTS

1. General requirements

1.1. Safety

1.1.1.The design, construction or assembly, maintenance and

monitoring of safety-critical components, and more particularly

of the components involved in train movements, must be such as

to guarantee safety at the level corresponding 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 safe

movement at the maximum authorised speed. The parameters of

brake equipment must guarantee that it is 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 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 must be aimed at limiting the generation,

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 designed in

such a way as not to impair the safe operation of the devices or

the health and safety of users if used in a foreseeable manner,

albeit not in accordance with the posted instructions.

1.2. Reliability and availability

The monitoring and maintenance of fixed or movable

components that are 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

1.3.1.Materials likely, by virtue of the way they are used, to constitute

a health hazard 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 harmful and dangerous fumes or

gases, particularly in the event of fire.

1.4. Environmental protection

1.4.1.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 Union law.

1.4.2.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.

1.4.3.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.

1.4.4.The design and operation of rail system must not lead to an

inadmissible level of noise generated by it

—

in areas close to railway infrastructure, as defined in point

(3) of Article 3 of Directive 2012/34/EU, and

—

in the driver's cab.

1.4.5.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.

1.5. 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. This requirement

includes the safe integration of the vehicle's subsystem with the

infrastructure.

If compliance with these characteristics proves difficult on

certain sections of the network, temporary solutions, which

ensure compatibility in the future, may be implemented.

1.6. Accessibility

1.6.1.The ‘infrastructure’ and ‘rolling stock’ subsystems must be

accessible to persons with disabilities and persons with reduced

mobility in order to ensure access on an equal basis with others

by way of the prevention or removal of barriers, and by way of

other appropriate measures. This shall include the design,

construction, renewal, upgrade, maintenance and operation of the

relevant parts of the subsystems to which the public has access.

1.6.2.The ‘operations’ and ‘telematics applications for passengers’

subsystems must provide for the necessary functionality required

to facilitate access for persons with disabilities and persons with

reduced mobility on an equal basis with others by way of the

prevention or removal of barriers, and by way of other

appropriate measures.

2. Requirements specific to each subsystem

2.1. Infrastructure

2.1.1.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.

2.1.2.Accessibility

Infrastructure subsystems to which the public has access must be

accessible for persons with disabilities and persons with reduced

mobility in accordance with point 1.6.

2.2. Energy

2.2.1.Safety

Operation of the energy-supply systems must not impair the

safety either of trains or of persons (users, operating staff, track-

side dwellers and third parties).

2.2.2.Environmental protection

The functioning of the electrical or thermal energy-supply

systems must not interfere with the environment beyond the

specified limits.

2.2.3.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.

2.3. Control-command and signalling

2.3.1.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 must continue to provide for

safe passage of trains permitted to run under degraded conditions.

2.3.2.Technical compatibility

All new infrastructure and all new rolling stock manufactured or

developed after adoption of compatible control-command 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.

2.4. Rolling stock

2.4.1.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 signalling 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 them.

The safety of passengers boarding and alighting from trains must

be ensured. 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.

Passengers must be given easily understandable and

comprehensive information about rules applicable to them both

in railway stations and in trains.

2.4.2.Reliability and availability

The design of the vital equipment and the running, traction and

braking equipment as well as the control- 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.

2.4.3.Technical compatibility

The electrical equipment must be compatible with the operation

of the control-command and signalling 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.

2.4.4.Controls

Trains must be equipped with a recording device. The data

collected by that device and the processing of the information

must be harmonised.

2.4.5.Accessibility

Rolling-stock subsystems to which the public has access must be

accessible for persons with disabilities and persons with reduced

mobility in accordance with point 1.6.

2.5. Maintenance

2.5.1.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.

2.5.2.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.

2.5.3.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.

2.6. Operation and traffic management

2.6.1.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.

2.6.2.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.

2.6.3.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 cross-border and domestic services.

2.6.4.Accessibility

Appropriate steps must be taken to ensure that operating rules

provide for the necessary functionality required to ensure

accessibility for persons with disabilities and persons with

reduced mobility.

2.7. Telematics applications for freight and passengers

2.7.1.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.

2.7.2. 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.

2.7.3. Health

The interfaces between these systems and users must comply

with the minimum rules on ergonomics and health protection.

2.7.4. Safety

Suitable levels of integrity and dependability must be provided

for the storage or transmission of safety-related information.

2.7.5. Accessibility

Appropriate steps must be taken to ensure that telematics

applications for passenger subsystems provide for the necessary

functionality required to ensure accessibility for persons with

disabilities and persons with reduced mobility.

(1) The Technical Regulations Division may allow the Non-application

applicant not to apply one or more TSIs or parts of them in the of TSIs.

following cases

(a) for a proposed new subsystem or part of it, for the

renewal or upgrading of an existing subsystem or part of it, or for

any element referred to in Regulation 1(2) which is at an

advanced stage of development or which is the subject of a

contract in the course of performance on the date of application

of the TSI(s) concerned;

(b) 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, in which case the non-application of the

TSIs shall be limited to the period before the restoration of the

network;

(c) for any proposed renewal, extension or upgrading of

an existing subsystem or part of it, when the application of the

TSI(s) concerned would compromise the economic viability of

the project and/or the compatibility of the rail system in Malta,

for example in relation to the loading gauge, track gauge, space

between tracks or electrification voltage;

(d) for vehicles arriving from or going to third countries

the track gauge of which is different from that of the main rail

network within the Union;

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

renewal or upgrading of an existing subsystem in Maltese

territory when its 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 Union.

(2) In the case referred to in sub-regulation (1)(a), Malta shall

communicate to the Commission, within one year of entry into force of

each TSI, a list of projects that are taking place within its territory and

which, in the view of the Technical Regulations Division, are at an

advanced stage of development.

(3)

In the cases referred to in sub-regulation (1)(a) and (b), the

Technical Regulations Division shall communicate to the Commission

its decision not to apply one or more TSIs or parts of them.

(4) In the cases referred to in sub-regulation (1) (a), (c), (d) and

(e), the Technical Regulations Division shall submit to the

Commission the request for non-application of the TSIs or parts of

them, accompanied by a file containing the justification for the

request, and specifying the alternative provisions that the Technical

Regulations Division intends to apply instead of the TSIs. In the case

referred to in sub-regulation (1)(e), the Commission shall analyse the

request and decide whether or not to accept it on the basis of the

completeness and coherence of the information contained in the file.

In the cases referred to in sub-regulation (1)(c) and (d), the

Commission shall adopt its decision by means of implementing acts on

the basis of such analysis. Those implementing acts shall be adopted in

accordance with the examination procedure referred to in Article 51(3)

of Directive (EU) 2016/797. In the cases referred to in the third sub-

paragraph of Article 21(6) of Directive (EU) 2016/797, the applicant

shall submit the file to the Agency. The Agency shall consult the

relevant safety authorities and give its final opinion to the

Commission.

(5) Pending the decision of the Commission, the Technical

Regulation Division may apply the alternative provisions referred to in

sub-regulation (4) without delay.

‘EC’ VERIFICATION PROCEDURE FOR SUBSYSTEMS

1. GENERAL PRINCIPLES

‘"EC" verification’ means a procedure carried out by the

applicant within the meaning of Article 15 to Directive (EU)

2016/797 to demonstrate that the requirements of the relevant

Union law and any relevant national rules relating to a subsystem

have been fulfilled and the subsystem may be authorised to be

placed in service.

2. CERTIFICATE OF VERIFICATION ISSUED BY A NOTIFIED

BODY

2.1. Introduction

For the purpose of these regulations, the verification by reference

to TSIs is the procedure whereby a notified body checks and

certifies that the subsystem complies with the relevant technical

specifications for interoperability (TSI).

This is without prejudice to the obligations of the applicant to

comply with the other applicable legal acts of the Union and any

verifications by the assessment bodies required by the other rules.

2.2. Intermediate statement of verification (ISV)

2.2.1 Principles

At the request of the applicant the verifications may be done for

parts of a subsystem or may be limited to certain stages of the

verification procedure. In these cases, the results of verification

may be documented in an ‘intermediate statement of verification’

(ISV) issued by the notified body chosen by the applicant. The

ISV must provide reference to the TSIs with which the

conformity has been assessed.

2.2.2 Parts of the subsystem

The applicant may apply for an ISV for any part into which he

decides to split the subsystem. Each part shall be checked at each

stage as set out in point 2.2.3.

2.2.3 Stages of the verification procedure

The subsystem, or certain parts of the subsystem, shall be

checked at each of the following stages

(a)

overall design;

(b)

production: construction, including, in particular, civil-

engineering activities, manufacturing, constituent assembly

and overall adjustment;

(c)

final testing.

The applicant may apply for an ISV for the design stage

(including the type tests) and for the production stage for the

whole subsystem or for any part into which the applicant decided

to split it (see point 2.2.2).

2.3. Certificate of verification

2.3.1.The notified bodies responsible for the verification assess the

design, production and final testing of the subsystem and draw up

the certificate of verification intended for the applicant who in

turn draws up the ‘EC’ declaration of verification. The certificate

of verification must provide reference to the TSIs with which the

conformity has been assessed.

Where a subsystem has not been assessed for its conformity with

all relevant TSI(s) (e.g. in the case of a derogation, partial

application of TSIs for upgrade or renewal, transitional period in

a TSI or specific case), the certificate of verification shall give

the precise reference to the TSI(s) or their parts whose

conformity has not been examined by the notified body during

the verification procedure.

2.3.2.Where ISV have been issued, the notified body responsible for

the verification of the subsystem takes these ISV into account,

and, before issuing its certificate of verification

(a)

verifies that the ISV cover correctly the relevant

requirements of the TSI(s);

(b)

checks all aspects that are not covered by the ISV; and

(c)

checks the final testing of the subsystem as a whole.

2.3.3.In the case of a modification to a subsystem already covered by a

certificate of verification, the notified body shall perform only

those examinations and tests that are relevant and necessary, i.e.

assessment shall relate only to the parts of the subsystem that are

changed and their interfaces to the unchanged parts of the

subsystem.

2.3.4Each notified body involved in the verification of a subsystem

shall draw up a file in accordance with Article 15(4) of Directive

(EU) 2016/797 covering the scope of its activities.

2.4. Technical file accompanying the ‘EC’ declaration of verification.

The technical file accompanying the ‘EC’ declaration of

verification shall be assembled by the applicant and must contain

the following

(a)

technical characteristics linked to the design including

general and detailed drawings with respect to execution,

electrical and hydraulic diagrams, control-circuit diagrams,

description of data-processing and automatic systems to the

level of detail sufficient for documenting the verification of

conformity carried out, documentation on operation and

maintenance, etc., relevant for the subsystem concerned;

(b)

a list of interoperability constituents, referred to in point (d)

of Article 4(3) of Directive (EU) 2016/797, incorporated

into the subsystem;

(c)

the files referred to in Article 15(4) of Directive (EU) 2016/

797, compiled by each of the notified bodies involved in

the verification of the subsystem, which shall include

copies of the ‘EC’ declarations of verification and,

where applicable, ‘EC’ declarations of suitability for

use established for interoperability constituents

referred to in point (d) of Article 4(3) of Directive

(EU) 2016/797 and accompanied, where appropriate,

by the corresponding calculation notes and a copy of

the records of the tests and examinations carried out

by the notified bodies on the basis of the common

technical specifications,

where available, the ISV that accompany the

certificate of verification, including the result of

verification by the notified body of the ISV validity,

the certificate of verification, accompanied by

corresponding calculation notes and signed by the

notified body responsible for the verification, stating

that the subsystem complies with the requirements of

the relevant TSI(s) and mentioning any reservations

recorded during performance of the activities and not

withdrawn; the certificate of verification should also

be accompanied by the inspection and audit reports

drawn up by the same body in connection with its

task, as specified in points 2.5.2 and 2.5.3;

(d)

certificates of verification issued in accordance with other

legal acts of the Union;

(e)

when verification of safe integration is required pursuant to

point (c) of regulation 12(4) and point (c) of Article 21(3)

of Directive (EU) 2016/797, the relevant technical file shall

include the assessors' report(s) on the CSMs on risk

assessment referred to in Article 6(3) of Directive 2004/49/

EC.

2.5. Surveillance by notified bodies.

2.5.1.The notified body responsible for checking production must have

permanent access to building sites, production workshops,

storage areas and, where appropriate, prefabrication or testing

facilities and, more generally, to all premises which it considers

necessary for its task. The notified body must receive from the

applicant all the documents needed for that purpose and, in

particular, the implementation plans and technical documentation

concerning the subsystem.

2.5.2.The notified body responsible for checking implementation must

periodically carry out audits in order to confirm compliance with

the relevant TSI(s). It must provide those responsible for

implementation with an audit report. Its presence may be required

at certain stages of the building operations.

2.5.3.In addition, the notified body may pay unexpected visits to the

work-site 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.

2.5.4.The notified body shall be able to monitor a subsystem on which

an interoperability constituent is mounted in order to assess,

where required by the corresponding TSI, its suitability for use in

its intended railway environment.

2.6. Submission

A copy of the technical file accompanying the ‘EC’ declaration

of verification must be kept by the applicant throughout the

service life of the subsystem. It must be sent to any Member State

or the Agency, upon request.

The documentation submitted for an application for an

authorisation for placing in service shall be submitted to the

authority where the authorisation is sought. The national safety

authority or the Agency may request that part(s) of the documents

submitted together with the authorisation is/are translated into its

own language.

2.7. Publication

Each notified body must

periodically

publish

relevant

information concerning

(a)

requests for verification and ISV received;

(b)

request for assessment of conformity and suitability for use

of ICs;

(c)

ISV issued or refused;

(d)

certificates of verification and ‘EC’ certificates for

suitability for use issued or refused;

(e)

certificates of verification issued or refused.

2.8. Language

The files and correspondence relating to the ‘EC’ verification

procedure must be written in Maltese or English.

3. CERTIFICATE OF VERIFICATION

ISSUED

BY

A

DESIGNATED BODY

3.1. Introduction

In the case where national rules apply, the verification shall

include a procedure whereby the body designated pursuant to

Article 15(8) of Directive (EU) 2016/797, (the designated body)

checks and certifies that the subsystem complies with the national

rules notified in accordance with Article 14 of Directive (EU)

2016/797 for each Member State in which the subsystem is

intended to be authorised to be placed in service.

3.2. Certificate of verification

The designated body draws up the certificate of verification

intended for the applicant.

The certificate shall contain a precise reference to the national

rule(s) whose conformity has been examined by the designated

body in the verification process.

In the case of national rules related to the subsystems composing

a vehicle, the designated body shall divide the certificate into two

parts, one part including the references to those national rules

strictly related to the technical compatibility between the vehicle

and the network concerned, and the other part for all other

national rules.

3.3. File

The file compiled by the designated body and accompanying the

certificate of verification in the case of national rules must be

included in the technical file accompanying the ‘EC’ declaration

of verification referred to in point 2.4 and shall contain the

technical data relevant for the assessment of the conformity of the

subsystem with those national rules.

3.4. Language

The files and correspondence relating to the ‘EC’ verification

procedure must be written in Maltese or English.

4. VERIFICATION OF PARTS OF SUBSYSTEMS IN

ACCORDANCE WITH ARTICLE 15(7) OF DIRECTIVE (EU)

2016/797

If a certificate of verification is to be issued for certain parts of a

subsystem, provisions for this Schedule shall apply mutatis

mutandis for those parts.

B

€1.71

(1) The Technical Regulations Division shall take all

necessary steps to ensure that interoperability constituents are

(a) placed on the market only if they enable

interoperability to be achieved within the Union rail system

while at the same time meeting the essential requirements

(b) used in their area of use as intended and suitably

installed and maintained.

Provided that sub-regulation 1(a) and (b) shall not

prevent the placing on the market of those constituents for other

applications.

(2) The Technical Regulations Division shall not, in Maltese

territory and on the basis of Directive (EU) 2016/797, prohibit, restrict

or hinder the placing on the market of interoperability constituents for

use in the Union rail system where these constituents comply with

these Regulations. In particular, they shall not require checks which

have already been carried out as part of the procedure for ‘EC’

declaration of conformity or suitability for use as provided for in

regulation 7.

The Technical Regulations Division and the Agency shall Conformity or

consider that an interoperability constituent meets the essential suitability

use.

requirements if it complies with the conditions laid down in the

corresponding TSI or the corresponding European specifications

developed to comply with those conditions. The ‘EC’ declaration of

conformity or suitability for use shall attest that the interoperability

constituents have been subject to the procedures laid down in the

corresponding TSI for assessing conformity or suitability for use.

If the Technical Regulations Division finds that the ‘EC’ Unsuitability of

declaration has been drawn up improperly, it shall ensure that the ‘EC’

declaration .

interoperability constituent is not placed on the market. In such a case,

the manufacturer or his authorised representative shall be required to

restore the interoperability constituent to a state of conformity under

the conditions laid down by the Technical Regulations Division.

(1) Where the Technical Regulations Division finds that Non-compliance

an interoperability constituent covered by the ‘EC’ declaration of of

interoperability

conformity or suitability for use and placed on the market is, when constituents

with essential

used as intended, unlikely to meet the essential requirements, the requirements.

Technical Regulations Division shall take all necessary steps to restrict

its field of application, prohibit its use, withdraw it from the market or

recall it. The Technical Regulations Division shall forthwith inform

the Commission, the Agency and the other Member States of the

measures taken and give reasons for its decision, stating in particular

whether the 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 the decision referred to in sub-regulation 1 results

from an inadequacy of European specifications, the Technical

Regulations Division, the Commission or the Agency, as appropriate,

shall apply one or more of the following measures

(a) partial or total withdrawal of the specification

concerned from the publications containing them;

(b) if the relevant specification is a harmonised standard,

restriction or withdrawal of that standard in accordance with

Article 11 of Regulation (EU) No 1025/2012;

(c) review of the TSI in accordance with Article 6 of

Directive (EU) 2016/797.

(3) Where an interoperability constituent bearing the ‘EC’

declaration of conformity fails to comply with the essential

requirements, the Technical Regulations Division shall take

appropriate measures against any entity which has drawn up the

declaration and shall inform the Commission and the other Member

States thereof.

Without prejudice to the provisions of Chapter V of

Directive (EU) 2016/797, the Technical Regulations Division shall

not, in Maltese territory and on grounds relating to Directive (EU)

2016/797, prohibit, restrict or hinder the construction, placing in

service and operation of structural subsystems constituting the rail

system which meet the essential requirements. In particular, the

Technical Regulations Division shall not require checks which have

already been carried out

(a) as part of the procedure leading to the ‘EC’

declaration of verification; or;

(b) in other Member Stats, before or after the entry into

force of Directive (EU) 2016/797, with a view to verifying

compliance with identical requirements under identical

operational conditions.

(1) Draft national rules and national rules referred to in

paragraph 1 of Article 14 of Directive (EU) 2016/797 shall be

examined by the Agency in accordance with the procedures laid down

in Articles 25 and 26 of Regulation (EU) 2016/796.

(2) The Commission shall establish, by means of implementing

acts, the classification of the notified national rules in different groups

with the aim of facilitating cross-acceptance in different Member

States and the placing on the market of vehicles, including

compatibility between fixed and mobile equipment. Those

implementing acts shall build on the progress achieved by the Agency

in the field of cross-acceptance and shall be adopted in accordance

with the examination procedure referred to in Article 51(3) of

Directive (EU) 2016/797.

The Agency shall classify, in accordance with the implementing

acts referred to in the first sub-paragraph, the national rules which are

notified in accordance with this Article 14 of Directive (EU) 2016/797.

(3) National rules not notified in accordance with this Article

14 of Directive (EU) 2016/797 shall not apply for the purposes of these

regulations.

(1) Technical Regulations Division shall forthwith Non-compliance

inform the Commission of any additional checks requested and set out of

with essential

the reasons therefor. The Commission shall consult the interested requirements.

parties.

(2) Technical Regulations Division shall state whether the

failure to fully comply with these regulations is due to

(a) non-compliance with the essential requirements or

with a TSI, or incorrect application of a TSI, in which case the

Commission shall forthwith inform the Technical Regulations

Division where the person who drew up the ‘EC’ declaration of

verification in error resides and shall request that Technical

Regulation Division to take the appropriate measures;

(b) inadequacy of a TSI, in which case the procedure for

amending the TSI as referred to in Article 6 of Directive (EU)

2016/797 shall apply.

(1) The track-side control-command and signalling, Authorisation

energy and infrastructure subsystems shall be placed in service only if for

in service of

they are designed, constructed and installed in such a way as to meet fixed

installations.

the essential requirements, and the relevant authorisation is received in

accordance with sub-regulations (3) and (4).

(2) The national safety authority shall authorise the placing in

service of the energy, infrastructure and track-side control-command

and signalling subsystems which are located or operated in the Maltese

territory.

(3) National safety authorities shall provide detailed guidance

on how to obtain the authorisations referred to in this regulation. An

application guidance document describing and explaining the

requirements for those authorisations and listing the documents

required shall be made available to applicants free of charge. The

Agency and the national safety authorities shall cooperate in

disseminating such information.

(4) The applicant shall submit a request for authorisation of the

placing in service of fixed installations to the national safety authority.

The application shall be accompanied by a file which includes

documentary evidence of

(a) the declarations of verification referred to in Article

15 of Directive (EU) 2016/797;

(b) the technical compatibility of the subsystems with the

system into which they are being integrated, established on the

basis of the relevant TSIs, national rules and registers;

(c) the safe integration of the subsystems, established on

the basis of the relevant TSIs, national rules, and the common

safety methods (‘CSMs’) set out in Article 6 of Directive (EU)

2016/798;

(d) in the case of track-side control-command and

signalling subsystems involving European Train Control System

(ETCS) and/or Global System for Mobile Communications -

Railway (GSM-R) equipment, the positive decision of the

Agency issued in accordance with Article 19 of Directive (EU)

2016/797; and, in the case of a change to the draft tender

specifications or to the description of the envisaged technical

solutions that occurred after the positive decision, the

compliance with the result of the procedure referred to in Article

30(2) of Regulation (EU) 2016/796.

(5) Within one month of receipt of the applicant's request, the

national safety authority shall inform the applicant that the file is

complete or ask for relevant supplementary information, setting a

reasonable deadline for the provision thereof.

The national safety authority shall verify the completeness,

relevance and consistency of the file, and, in the case of track-side

ERTMS equipment, compliance with the positive decision of the

Agency issued in accordance with Article 19 of Directive (EU) 2016/

797 and, where appropriate, compliance with the result of the

procedure referred to in Article 30(2) of Regulation (EU) 2016/796.

Following such verification, the national safety authority shall issue

the authorisation for placing in service of fixed installations, or inform

the applicant of its negative decision, within a pre-determined,

reasonable time, and, in any case, within four months of receipt of all

relevant information.

(6) In the event of renewal or upgrading of existing

subsystems, the applicant shall send a file describing the project to the

national safety authority. Within one month of receipt of the

applicant's request, the national safety authority shall inform the

applicant that the file is complete or ask for relevant supplementary

information, setting a reasonable deadline for the provision thereof.

The national safety authority, in close cooperation with the Agency in

the case of track-side ERTMS projects, shall examine the file and shall

decide whether a new authorisation for placing in service is needed, on

the basis of the following criteria

(a) the overall safety level of the subsystem concerned

may be adversely affected by the works envisaged;

(b)

it is required by the relevant TSIs;

(c) it is required by the national implementation plans

established by Malta; or

(d) changes are made to the values of the parameters on

the basis of which the authorisation was already granted.

The national safety authority shall take its decision within a

predetermined, reasonable time, and, in any case, within four months

of receipt of all relevant information.

(7) A decision refusing a request for an authorisation for the

placing in service of fixed installations shall be duly substantiated by

the national safety authority. The applicant may, within one month of

receipt of the negative decision, submit a request that the national

safety authority review its decision. The request shall be accompanied

by a justification. The national safety authority shall have two months

from the date of receipt of the request for review in which to confirm

or reverse its decision. If the negative decision of a national safety

authority is confirmed, the applicant may bring an appeal before the

appeal body designated by Malta under Article 18(3) of Directive (EU)

2016/798.

The Technical Regulations Division established by article Designation of

19 of the Malta Competition and Consumer Affairs Authority Act shall notifying

authority.

be the notifying authority for the purposes of articles 27, 28 and 29 of Cap. 510.

the Directive (EU) No. 2016/797

(1) The procedures for assessment and notification of Conformity

conformity assessment bodies, and the monitoring of notified bodies assessment

bodies.

shall be those prescribed in the Method for Designating Conformity S.L. 427.45.

Assessment bodies Regulations. In addition, a conformity assessment

body shall meet the requirements laid down in these regulations.

(2) The Technical Regulations Division shall notify the bodies

responsible for carrying out the procedure for the assessment of

conformity referred to in sub-regulation (1), to the Commission and

the other Member States using the electronic notification tool

developed and managed by the Commission and in accordance with the

provisions of Article 37 of Directive (EU) 2016/797.

(3) A conformity assessment body shall be capable of carrying

out all the conformity assessment tasks assigned to it by the relevant TSI

and in relation to which it has been notified, whether those tasks are

carried out by the conformity assessment body itself or on its behalf and

under its responsibility.

At all times and for each conformity assessment procedure and

each kind or category of product in relation to which it has been notified,

a conformity assessment body shall have at its disposal

(a) the necessary personnel with technical knowledge and

sufficient and appropriate experience to perform the conformity

assessment tasks;

(b) the relevant descriptions of procedures in accordance

with which conformity assessment is to be carried out, ensuring

the transparency and the ability to apply those procedures. It shall

have in place appropriate policies and procedures that distinguish

between tasks it carries out as a notified conformity assessment

body and other activities;

(c) the proper procedures for the performance of activities

which take due account of the size of an undertaking, the sector in

which it operates, its structure, the degree of complexity of the

product technology in question and the mass or serial nature of the

production process.

It shall have the means necessary to perform in an

appropriate manner the technical and administrative tasks

concerned with the conformity assessment activities and shall

have access to all necessary equipment or facilities.

(4) Conformity assessment bodies shall participate in, or

ensure that their assessment personnel are informed of, the relevant

standardisation activities and the activities of the notified conformity

bodies ‘coordination group established under the relevant Union Law,

and shall apply as a general guidance the administrative decisions and

documents produced as a result of the work of that group.

(5) Conformity assessment bodies that are notified for track-

side and/or on-board control-command and signalling subsystems

shall participate in, or shall ensure that their assessment personnel are

informed of, the activities of the ERTMS group referred to in Article

29 of Regulation (EU) 2016/796. They shall follow the guidelines

produced as a result of the work of that group. In the event that they

consider it inappropriate or impossible to apply them, the conformity

assessment bodies concerned shall submit their observations for

discussion to the ERTMS group for the continuous improvement of the

guidelines.

(6) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a subsidiary,

it shall ensure that the subcontractor or the subsidiary meets the

requirements set out in Articles 30 to 32 of Directive (EU) 2016/797

and shall inform the Technical Regulations Division accordingly.

(7) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are

established. Activities of notified bodies may be subcontracted or

carried out by a subsidiary only with the agreement of the client.

(8) Notified bodies shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of the subcontractor or the subsidiary

and the work carried out by them under the relevant TSI.

(9) A conformity assessment body, its top-level management

and the personnel responsible for carrying out the conformity

assessment tasks shall not be the designer, manufacturer, supplier,

installer, purchaser, owner, user or maintainer of the products which

they assess, or the authorised representative of any of those parties. This

shall not preclude the use of assessed products that are necessary for the

operations of the conformity assessment body or the use of such

products for personal purpose.

(10) A conformity assessment body, its top-level management

and the personnel responsible for carrying out the conformity

assessment tasks shall not be directly involved in the design,

manufacturer or construction, marketing, installation, use or

maintenance of those products, or represent the parties engaged in those

activities. They shall not engage in any activity that may conflict with

their independence of judgment or integrity in relation to conformity

assessment activities for which they are notified. This prohibition shall

apply, in particular, to consultancy services.

(11) Conformity assessment bodies shall ensure that the activities

of their subsidiaries or subcontractors do not affect the confidentiality,

objectivity or impartiality of their conformity assessment activities.

Where a conformity assessment body demonstrates its Presumption of

conformity with the criteria laid down in the relevant harmonised conformity

conformity

standards or parts thereof, the references of which have been published assessment

body.

in the Official Journal of the European Union, it shall be presumed to

comply with the requirements set out in Articles 30 to 32 of Directive

(EU) 2016/797, in so far as the applicable harmonised standards cover

those requirements.

(1) Applicants may use an accredited in-house body to

carry out conformity assessment activities for the purpose of

implementing the procedures set out in modules A1, A2, C1 or C2 laid

down in Annex II to Decision No 768/2008/EC and modules CA1 and

CA2 laid down in Annex I to Decision 2010/713/EU. That body shall

constitute a separate and distinct part of the applicant concerned and

shall not participate in the design, production, supply, installation, use

or maintenance of the product it assesses.

(2) An accredited in-house body shall meet the following

requirements

(a) it shall be accredited in accordance with Regulation

(EC) 765/2008;

(b) the body and its personnel shall, within the

undertaking of which they form a part, be organisationally

identifiable and have reporting methods which ensure their

impartiality, and shall demonstrate it to the competent national

accreditation body;

(c) neither the body nor its personnel shall be responsible

for the design, manufacture, supply, installation, operation or

maintenance of the products they assess, nor shall they engage in

any activity that might conflict with their independence of

judgement or integrity in relation to their assessment activities;

(d)

the body shall supply its services exclusively to the

undertaking of which it forms a part.

(3) An accredited in-house body shall not be notified to the

Member States or the Commission, but information concerning its

accreditation shall be given by the undertaking of which it forms a part

or by the national accreditation body to the Technical Regulations

Division at request.

(1) Where the Technical Regulations Division has

ascertained or has been informed that a notified body no longer meets

the requirements laid down in Articles 30 to 32 of Directive (EU)

2016/797, or that it is failing to fulfil its obligations, the Technical

Regulations Division shall restrict, suspend or withdraw notification as

appropriate, depending on the seriousness of the failure to meet those

requirements or fulfil those obligations. It shall immediately inform

the Commission and the other Member States accordingly

(2)

In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Technical Regulations Division shall take appropriate steps to ensure

that the files of that body are either processed by another notified body

or kept available for the responsible notifying and market surveillance

authorities at their request.

The Technical Regulations Division shall provide the Challenges to

Commission, on request, with all information relating to the basis for the

of notified

the notification or the maintenance of the competence of the body bodies.

concerned.

(1) Notified bodies shall carry out conformity Operational

assessments in accordance with the conformity assessment procedures obligations

notified bodies.

provided for in the relevant TSI.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Notified bodies, when performing their activities, shall take

due account of the size of an undertaking, the sector in which it

operates, its structure, the degree of complexity of the product

technology in question and the mass or serial nature of the production

process.

In so doing, they shall nevertheless operate with the aim of

assessing the compliance of the product with these regulations.

(3) Where a notified body finds that requirements laid down in

the relevant TSI or corresponding harmonised standards or technical

specifications have not been met by a manufacturer, it shall require

that manufacturer to take appropriate corrective measures and shall not

issue a conformity certificate.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that a product

no longer complies with the relevant TSI or corresponding harmonised

standards or technical specifications, it shall require the manufacturer

to take appropriate corrective measures and shall suspend or withdraw

the certificate if necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or withdraw

any certificates, as appropriate.

(1) Notified bodies shall inform the notifying authority Obligation of

notified bodies

of the following

to provide

information.

(a) any refusal, restriction, suspension or withdrawal of a

certificate;

(b) any circumstances affecting the scope of, and

conditions for, notification;

(c) any request for information which they have received

from market surveillance authorities regarding conformity

assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and any other

activity performed, including cross-border activities and

subcontracting.

The competent national safety authorities shall also be

informed of any refusal, restriction, suspension or withdrawal of

a certificate under sub-regulation (1)(a).

(2) Notified bodies shall provide the other bodies notified

under Directive (EU) 2016/797 carrying out similar conformity

assessment activities covering the same products with relevant

information on issues relating to negative and, on request, positive

conformity assessment results.

(3) Notified bodies shall provide the Agency with ‘EC’

certificates of verification of subsystems, ‘EC’ certificates of

conformity of interoperability constituents and ‘EC’ certificates of

suitability of use of interoperability constituents.

Bodies notified by the Technical Regulations Division shall

participate in the work of sectoral groups of notified bodies as

established by the Commission under Directive (EU) 2016/797,

directly or by means of designated representatives. The Agency shall

support the activities of notified bodies in accordance with Article 24

of Regulation (EU) 2016/796.

(1) Schedules IV, V, VII and IX to the Interoperability of

the Rail System Regulations shall apply until the date of application of

the corresponding implementing acts referred to in Article 7(5),

Article 9(4), Article 14(10) and Article 15(9) of Directive (EU) 2016/

797. (2) Directive 2008/57/EC shall continue to apply in relation to

ERTMS track-side projects which are to be placed before 16 June

2019. (3) Projects which have completed the tendering or contracting

phase prior to 16 June 2019 are not subject to the pre-authorisation by

the Agency referred to in Article 19 of Directive (EU) 2016/797.

(4) Until 16 June 2031 options included in contracts which

were signed before 15 June 2016 shall not be subject to the pre-

authorisation by the Agency referred to in Article 19 of Directive (EU)

2016/797, even if they are exercised after 15 June 2016.

(5) Before authorising the placing in service of any ERTMS

track-side equipment which was not subject to the pre- authorisation

by the Agency referred to in Article 19 of Directive (EU) 2016/797,

national safety authorities shall cooperate with the Agency in order to

ensure that the technical solutions are fully interoperable, in

accordance with Articles 30(3) and 31(2) of Regulation (EU) 2016/

796.

The penalties and proceedings applicable for infringement Penalties and

of any of the provisions of these regulations shall be those provided for Proceedings

in Part IV of the Product Safety Act.

The Interoperability of the Rail System Regulations shall Repeal of

be repealed with effect from 16 June 2020.