THE RAIL SYSTEM SUBSIDIARY LEGISLATION 427.99 INTEROPERABILITY
THE RAIL SYSTEM REGULATIONS 16th June, 2019 LEGAL NOTICE 184
2019. 1.
these regulations Interoperability
the Rail System Regulations. is the Title and scope.
Directive (EU) 2016/798 in order to define an optimal level
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
the single European railway area and the progressive achievement
the internal market. These conditions concern the design, construction, placing in service, upgrading, renewal, operation and maintenance
the parts
that system as well as the professional qualifications
, and health and safety conditions applying to, the staff who contribute to its operation and maintenance.
overall compatibility
the Union rail system required in order to achieve its interoperability.
ficial application for the purpose
building a new railway line which is to be operated in Malta in accordance with the applicability
these regulations and which will be regarded as forming part
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
the Union rail system and any other light rail systems, Article 13, Article 14
Directive (EU) 2016/797 shall apply. 2.
metros; (
the Union rail system and intended only for the operation Applicability. 1 2 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM
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
their respective freight activities or for the transport
persons for non-commercial purposes, and vehicles used exclusively on such infrastructure; (
the light rail system, where it is necessary for the purposes
connectivity
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
heavy rail infrastructure for connectivity purposes only.
tram-trains operating in the Union rail system, where there are no TSIs that apply to those tram-trains, the following shall apply: (
tram-trains and heavy rail trains meet all essential requirements as well as relevant common safety targets; (c) by way
derogation from Article 21
Directive (EU) 2016/797, in the case
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
these regulations in accordance with regulation 2
these regulations: "the Act" means the Product Safety Act; "accreditation" means accreditation as defined in point
Regulation (EC) No 765/2008; "the Agency" means the European Union Agency for INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 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
Directive (EU) 2016/797, the ‘applicant’ means a contracting entity or a manufacturer, or its authorised representatives; for the purpose
Directive (EU) 2016/797, the ‘applicant’ means a natural or legal person requesting the Agency's decision for the approval
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
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
a subsystem; "design operating state" means the normal operating mode and the foreseeable degraded conditions (including wear) within the range and the conditions
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 3 4 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM falls into one
the following categories: (a) a common technical specification as defined in Annex VIII
Directive 2014/25/EU; (b) a European technical approval as referred to in Article 60
Directive 2014/25/EU; or (c) a European standard as defined in point (b)
Regulation (EU) No 1025/2012; "harmonised standard" means a European standard as defined in point (c)
Regulation (EU) No 1025/ 2012; "infrastructure manager" means an infrastructure manager as defined in point
Directive 2012/ 34/EU; "interoperability" means the ability
a rail system to allow the safe and uninterrupted movement
trains which accomplish the required levels
performance; "interoperability constituents" means any elementary component, group
components, sub-assembly or complete assembly
equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability
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
a vehicle or having the right to use it, exploits the vehicle as a means
transport and is registered as such in a vehicle register referred to in Article 47
Directive (EU) 2016/797; "light rail" means an urban and/or suburban rail transport system with a crash-worthiness
C-III or C-IV (in accordance with EN 15227:2011) and a maximum strength
vehicle
800 kN (longitudinal compressive force in coupling area); light rail systems may have their own right
way or share it with road traffic and usually do not exchange vehicles with longdistance passenger or freight traffic; "manufacturer" means any natural or legal person who manufactures a product in the form
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
Regulation (EC) No 765/2008; INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 "national rules" means all binding rules adopted in a Member State, irrespective
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
Directive (EU) 2016/798; "network" means the lines, stations, terminals, and all kinds
fixed equipment needed to ensure safe and continuous operation
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
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
Directive 2012/34/EU, and any other public or private undertaking, the activity
which is to provide transport
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
it which does not change the overall performance
the subsystem; "specific case" means any part
the rail system which needs special provisions in the TSIs, either temporary or permanent, because
geographical, topographical or urban environment constraints or those affecting compatibility with the existing system, in particular railway lines and networks isolated from the rest
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
the Union rail system, as set out in Schedule II; "Technical Regulations Division" means the entity as established by article 19
the Malta Competition and Cap. 510. 5 6 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM 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
a subsystem is covered in order to meet the essential requirements and ensure the interoperability
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
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
the Union Rail System set out in Schedule I; "upgrading" means any major modification work on a subsystem or part
it which results in a change in the technical file accompanying the ‘EC’ declaration
verification, if that technical file exists, and which improves the overall performance
the subsystem; and "vehicle" means a railway vehicle suitable for circulation on wheels on railway lines, with or without traction; a vehicle is composed
one or more structural and functional subsystems. Non-application
TSIs. 4.
them in the following cases: (a) for a proposed new subsystem or part
it, for the renewal or upgrading
an existing subsystem or part
it, or for any element referred to in Regulation 1
development or which is the subject
a contract in the course
performance on the date
application
the TSI(
the network do not economically or technically allow for partial or total application
the relevant TSIs, in which case the non-application
the TSIs shall be limited to the period before the restoration
the network; (c) for any proposed renewal, extension or upgrading
an existing subsystem or part
it, when the application
the TSI(s) concerned would compromise the economic viability
the project and/or the compatibility
the rail system in INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 7 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
which is different from that
the main rail network within the Union; (e) for a proposed new subsystem or for the proposed renewal or upgrading
an existing subsystem in Maltese territory when its rail network is separated or isolated by the sea or separated as a result
special geographical conditions from the rail network
the rest
the Union.
entry into force
each TSI, a list
projects that are taking place within its territory and which, in the view
the Technical Regulations Division, are at an advanced stage
development.
them.
the TSIs or parts
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
the TSIs. In the case referred to in sub-regulation
the completeness and coherence
the information contained in the file. In the cases referred to in sub-regulation
implementing acts on the basis
such analysis. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51
Directive (EU) 2016/797. In the cases referred to in the third subparagraph
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.
the Commission, the Technical Regulation Division may apply the alternative provisions referred to in sub-regulation
interoperability constituents. 8 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM interoperability to be achieved within the Union rail system while at the same time meeting the essential requirements: (b) used in their area
use as intended and suitably installed and maintained. Provided that sub-regulation 1(a) and (b) shall not prevent the placing on the market
those constituents for other applications.
Directive (EU) 2016/797, prohibit, restrict or hinder the placing on the market
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
the procedure for ‘EC’ declaration
conformity or suitability for use as provided for in regulation
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. Unsuitability
‘EC’ declaration . 7. If the Technical Regulations Division finds that the ‘EC’ declaration has been drawn up improperly, it shall ensure that the 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
conformity under the conditions laid down by the Technical Regulations Division. Non-compliance
interoperability constituents with essential requirements. 8.
conformity or suitability for use and placed on the market is, when used as intended, unlikely to meet the essential requirements, the Technical Regulations Division shall take all necessary steps to restrict its field
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
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
European specifications where application
such specifications is relied upon; (c) inadequacy
European specifications. INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 9
European specifications, the Technical Regulations Division, the Commission or the Agency, as appropriate, shall apply one or more
the following measures: (a) partial or total withdrawal
the specification concerned from the publications containing them; (b) if the relevant specification is a harmonised standard, restriction or withdrawal
that standard in accordance with Article 11
Regulation (EU) No 1025/2012; (c) review
the TSI in accordance with Article 6
Directive (EU) 2016/797.
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. 9. Without prejudice to the provisions
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
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: Free movement
subsystems. (a) as part
the procedure leading to the ‘EC’ declaration
verification; or; (b) in other Member Stats, before or after the entry into force
Directive (EU) 2016/797, with a view to verifying compliance with identical requirements under identical operational conditions. 10.
Directive (EU) 2016/797 shall be examined by the Agency in accordance with the procedures laid down in Articles 25 and 26
Regulation (EU) 2016/796.
implementing acts, the classification
the notified national rules in different groups with the aim
facilitating cross-acceptance in different Member States and the placing on the market
vehicles, including compatibility between fixed and mobile equipment. Those implementing acts shall build on the progress achieved by the Agency in the field
cross-acceptance and shall be adopted in accordance with the examination procedure referred to in Article 51
Notification
national rules. 10 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM 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
Directive (EU) 2016/797.
Directive (EU) 2016/797 shall not apply for the purposes
these regulations. Non-compliance
subsystems with essential requirements. 11.
any additional checks requested and set out the reasons therefor. The Commission shall consult the interested parties.
a TSI, in which case the Commission shall forthwith inform the Technical Regulations Division where the person who drew up the ‘EC’ declaration
verification in error resides and shall request that Technical Regulation Division to take the appropriate measures; (b) inadequacy
a TSI, in which case the procedure for amending the TSI as referred to in Article 6
Directive (EU) 2016/797 shall apply. Authorisation for the placing in service
fixed installations. 12.
the energy, infrastructure and track-side controlcommand and signalling subsystems which are located or operated in the Maltese territory.
charge. The Agency and the national safety authorities shall cooperate in disseminating such information.
the placing in service
fixed installations to the national safety authority. The application shall be accompanied by a file which includes documentary evidence
: INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 (a) the declarations
verification referred to in Article 15
Directive (EU) 2016/797; (b) the technical compatibility
the subsystems with the system into which they are being integrated, established on the basis
the relevant TSIs, national rules and registers; (c) the safe integration
the subsystems, established on the basis
the relevant TSIs, national rules, and the common safety methods (‘CSMs’) set out in Article 6
Directive (EU) 2016/798; (d) in the case
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
the Agency issued in accordance with Article 19
Directive (EU) 2016/797; and, in the case
a change to the draft tender specifications or to the description
the envisaged technical solutions that occurred after the positive decision, the compliance with the result
the procedure referred to in Article 30
Regulation (EU) 2016/796.
receipt
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
the file, and, in the case
track-side ERTMS equipment, compliance with the positive decision
the Agency issued in accordance with Article 19
Directive (EU) 2016/ 797 and, where appropriate, compliance with the result
the procedure referred to in Article 30
Regulation (EU) 2016/796. Following such verification, the national safety authority shall issue the authorisation for placing in service
fixed installations, or inform the applicant
its negative decision, within a pre-determined, reasonable time, and, in any case, within four months
receipt
all relevant information.
renewal or upgrading
existing subsystems, the applicant shall send a file describing the project to the national safety authority. Within one month
receipt
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
track-side ERTMS projects, shall examine the file and shall decide whether a new authorisation for placing in service is needed, on the basis
the following criteria: 11 12 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM (a) the overall safety level
the subsystem concerned may be adversely affected by the works envisaged; (
the parameters on the basis
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
receipt
all relevant information.
fixed installations shall be duly substantiated by the national safety authority. The applicant may, within one month
receipt
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
receipt
the request for review in which to confirm or reverse its decision. If the negative decision
a national safety authority is confirmed, the applicant may bring an appeal before the appeal body designated by Malta under Article 18
Directive (EU) 2016/798. Designation
notifying authority. Cap.
the Malta Competition and Consumer Affairs Authority Act shall be the notifying authority for the purposes
articles 27, 28 and 29
the Directive (EU) No. 2016/797 Conformity assessment bodies. S.L. 427.45. 14.
conformity assessment bodies, and the monitoring
notified bodies shall be those prescribed in the Method for Designating Conformity Assessment bodies Regulations. In addition, a conformity assessment body shall meet the requirements laid down in these regulations.
conformity referred to in sub-regulation
Directive (EU) 2016/797.
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 INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 each kind or category
product in relation to which it has been notified, a conformity assessment body shall have at its disposal: (
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
activities which take due account
the size
an undertaking, the sector in which it operates, its structure, the degree
complexity
the product technology in question and the mass or serial nature
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.
, the relevant standardisation activities and the activities
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
the work
that group.
, the activities
the ERTMS group referred to in Article 29
Regulation (EU) 2016/796. They shall follow the guidelines produced as a result
the work
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
the guidelines.
Directive (EU) 2016/797 and shall inform the Technical Regulations Division accordingly.
THE RAIL SYSTEM performed by subcontractors or subsidiaries wherever these are established. Activities
notified bodies may be subcontracted or carried out by a subsidiary only with the agreement
the client.
the Technical Regulations Division the relevant documents concerning the assessment
the qualifications
the subcontractor or the subsidiary and the work carried out by them under the relevant TSI.
the products which they assess, or the authorised representative
any
those parties. This shall not preclude the use
assessed products that are necessary for the operations
the conformity assessment body or the use
such products for personal purpose.
those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence
judgment or integrity in relation to conformity assessment activities for which they are notified. This prohibition shall apply, in particular, to consultancy services.
their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality
their conformity assessment activities. Presumption
conformity
a conformity assessment body. 15. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references
which have been published in the
ficial Journal
the European Union, it shall be presumed to comply with the requirements set out in Articles 30 to 32
Directive (EU) 2016/797, in so far as the applicable harmonised standards cover those requirements. Accredited inhouse bodies. 16.
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
the applicant concerned and shall not participate in the design, production, supply, installation, use or maintenance
the product it assesses.
THE RAIL SYSTEM [ S.L. 427.99 15 requirements: (
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
the products they assess, nor shall they engage in any activity that might conflict with their independence
judgement or integrity in relation to their assessment activities; (d) the body shall supply its services exclusively to the undertaking
which it forms a part.
which it forms a part or by the national accreditation body to the Technical Regulations Division at request. 17.
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
the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly Changes to notifications.
restriction, suspension or withdrawal
notification, or where the notified body has ceased its activity, the Technical Regulations Division shall take appropriate steps to ensure that the files
that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request. 18. The Technical Regulations Division shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance
the competence
the body concerned. Challenges to the competence
notified bodies. 19.
notified bodies. 16 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM
the size
an undertaking, the sector in which it operates, its structure, the degree
complexity
the product technology in question and the mass or serial nature
the production process. In so doing, they shall nevertheless operate with the aim
assessing the compliance
the product with these regulations.
the monitoring
conformity following the issue
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.
notified bodies to provide information. 20.
the following: (a) any refusal, restriction, suspension or withdrawal
a certificate; (b) any circumstances affecting the scope
, and conditions for, notification; (
their notification and any other activity performed, including cross-border activities and subcontracting. The competent national safety authorities shall also be informed
any refusal, restriction, suspension or withdrawal
a certificate under sub-regulation
THE RAIL SYSTEM [ S.L. 427.99 17 assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.
verification
subsystems, ‘EC’ certificates
conformity
interoperability constituents and ‘EC’ certificates
suitability
use
interoperability constituents. 21. Bodies notified by the Technical Regulations Division shall participate in the work
sectoral groups
notified bodies as established by the Commission under Directive (EU) 2016/797, directly or by means
designated representatives. The Agency shall support the activities
notified bodies in accordance with Article 24
Regulation (EU) 2016/796. Coordination
notified bodies. 22.
the Rail System Regulations shall apply until the date
application
the corresponding implementing acts referred to in Article 7
Directive (EU) 2016/ 797. Other transitional provisions. S.L. 427.31.
Directive (EU) 2016/797.
Directive (EU) 2016/797, even if they are exercised after 15 June 2016.
any ERTMS track-side equipment which was not subject to the pre- authorisation by the Agency referred to in Article 19
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
Regulation (EU) 2016/
any
the provisions
these regulations shall be those provided for in Part IV
the Product Safety Act. Penalties and Proceedings Cap. 427. 24. The Interoperability
the Rail System Regulations shall be repealed with effect from 16 June 2020. Repeal
S.L. 427.31. 18 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM SCHEDULE I ELEMENTS
THE UNION RAIL SYSTEM 1. Network For the purposes
these regulations, the Union's network shall include the following elements: (
the order
200 km/h; (c) specially upgraded high-speed lines which have special features as a result
topographical, relief or townplanning 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; (
the network and efficient traffic management. 2. Vehicles For the purposes
these regulations, Union vehicles shall comprise all vehicles likely to travel on all or part
the Union's network: — locomotives and passenger rolling stock, including thermal or electric traction units, self-propelling thermal INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 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
vehicles shall include those which are specially designed to operate on the different types
high-speed lines described in point
subsystems For the purposes
these regulations, the system constituting the Union rail system may be broken down into the following subsystems, either: (
THE RAIL SYSTEM — 2. telematics applications for passenger and freight services. Description
the subsystems For each subsystem or part
a subsystem, the list
constituents and aspects relating to interoperability is proposed by the Agency at the time
drawing up the relevant draft TSI. Without prejudging the choice
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
stations (including entrances, platforms, zones
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.
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
trains authorised to travel on the network. 2.5. Operation and traffic management The procedures and related equipment permitting coherent operation
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
railway service. 2.6. Telematics applications In accordance with Schedule I, this subsystem comprises two INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 elements: 2.7. (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
connections between trains and with other modes
transport; (b) applications for freight services, including information systems (real-time monitoring
freight and trains), marshalling and allocation systems, reservation, payment and invoicing systems, management
connections with other modes
transport and production
electronic accompanying documents. 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
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
the Union rail system and guarantee the performance required. 21 22 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM SCHEDULE III ESSENTIAL REQUIREMENTS
safety-critical components, and more particularly
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
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
any accidental failures must be limited by appropriate means. 1.1.4. The design
fixed installations and rolling stock and the choice
the materials used must be aimed at limiting the generation, propagation and effects
fire and smoke in the event
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
the devices or the health and safety
users if used in a foreseeable manner, albeit not in accordance with the posted instructions. 1.2. Reliability and availability The monitoring and maintenance
fixed or movable components that are involved in train movements must be INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 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
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
harmful and dangerous fumes or gases, particularly in the event
fire. 1.
establishment and operation
the rail system must be assessed and taken into account at the design stage
the system in accordance with Union law. 1.4.2. The materials used in the trains and infrastructures must prevent the emission
fumes or gases which are harmful and dangerous to the environment, particularly in the event
fire. 1.4.
rail system must not lead to an inadmissible level
noise generated by it: — in areas close to railway infrastructure, as defined in point
Directive 2012/34/EU, and — in the driver's cab. 1.4.5. Operation
the rail system must not give rise to an inadmissible level
ground vibrations for the activities and areas close to the infrastructure and in a normal state
maintenance. 1.5. Technical compatibility The technical characteristics
the infrastructure and fixed installations must be compatible with each other and with those
the trains to be used on the rail system. This requirement includes the safe integration
the vehicle's subsystem with the infrastructure. If compliance with these characteristics proves difficult on certain sections
the network, temporary solutions, which ensure compatibility in the future, may be implemented. 23 24 [ S.L. 427.99 1.6. INTEROPERABILITY
THE RAIL SYSTEM 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
the prevention or removal
barriers, and by way
other appropriate measures. This shall include the design, construction, renewal, upgrade, maintenance and operation
the relevant parts
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
the prevention or removal
barriers, and by way
other appropriate measures.
the particular safety conditions in very long tunnels and viaducts. 2.1.
the energy-supply systems must not impair the safety either
trains or
persons (users, operating staff, trackside dwellers and third parties). 2.2.2. Environmental protection INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 The functioning
the electrical or thermal energy-supply systems must not interfere with the environment beyond the specified limits. 2.2.
electricity energy-supply systems, be compatible with the collection devices fitted to the trains. 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
safety which corresponds to the objectives set for the network. The control-command and signalling systems must continue to provide for safe passage
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
compatible control-command and signalling systems must be tailored to the use
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
the links between vehicles must be designed in such a way as to protect the passenger and driving compartments in the event
collision or derailment. The electrical equipment must not impair the safety and functioning
the control-command and signalling installations. The braking techniques and the stresses exerted must be compatible with the design
the tracks, engineering structures and signalling systems. 25 26 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM Steps must be taken to prevent access to electrically-live constituents in order not to endanger the safety
persons. In the event
danger, devices must enable passengers to inform the driver and accompanying staff to contact them. The safety
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
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
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
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
the control-command and signalling installations. In the case
electric traction, the characteristics
the currentcollection devices must be such as to enable trains to travel under the energy-supply systems for the rail system. The characteristics
the rolling stock must be such as to allow it to travel on any line on which it is expected to operate, taking account
relevant climatic conditions. 2.4.4. Controls Trains must be equipped with a recording device. The data INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 collected by that device and the processing
the information must be harmonised. 2.4.
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
nuisance with regard to the surrounding environment. 2.5.
the network operating rules and the qualifications
drivers and on-board staff and
the staff in the control centres must be such as to ensure safe operation, bearing in mind the different requirements
cross-border and domestic services. The maintenance operations and intervals, the training and qualifications
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
safety. 2.6.2. Reliability and availability The maintenance operations and periods, the training and qualifications
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 27 28 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM a high level
system reliability and availability. 2.6.3. Technical compatibility Alignment
the network operating rules and the qualifications
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
cross-border and domestic services. 2.6.
service for passengers and carriers
goods, particularly in terms
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
use, management, updating and maintenance
these databases, software and data communication protocols must guarantee the efficiency
these systems and the quality
the service. 2.7.
integrity and dependability must be provided for the storage or transmission
safety-related information. [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM 2.7.
to Directive (EU) 2016/797 to demonstrate that the requirements
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
NOTIFIED BODY VERIFICATION ISSUED BY A 29 30 [ S.L. 427.99 2.1. INTEROPERABILITY
THE RAIL SYSTEM Introduction For the purpose
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
the applicant to comply with the other applicable legal acts
the Union and any verifications by the assessment bodies required by the other rules. 2.2. Intermediate statement
verification (ISV) 2.2.1 Principles At the request
the applicant the verifications may be done for parts
a subsystem or may be limited to certain stages
the verification procedure. In these cases, the results
verification may be documented in an ‘intermediate statement
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
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
the verification procedure The subsystem, or certain parts
the subsystem, shall be checked at each
the following stages: (
verification 2.3.1. The notified bodies responsible for the verification assess the design, production and final testing
the subsystem and draw [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM up the certificate
verification intended for the applicant who in turn draws up the ‘EC’ declaration
verification. The certificate
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
a derogation, partial application
TSIs for upgrade or renewal, transitional period in a TSI or specific case), the certificate
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
the subsystem takes these ISV into account, and, before issuing its certificate
verification: (a) verifies that the ISV cover correctly the relevant requirements
the TSI(s); (
the subsystem as a whole. 2.3.3. In the case
a modification to a subsystem already covered by a certificate
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
the subsystem that are changed and their interfaces to the unchanged parts
the subsystem. 2.3.4 Each notified body involved in the verification
a subsystem shall draw up a file in accordance with Article 15
Directive (EU) 2016/797 covering the scope
its activities. 2.4. Technical file verification. accompanying the ‘EC’ declaration
The technical file accompanying the ‘EC’ declaration
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
data-processing and automatic systems to the level
detail sufficient for documenting the verification
conformity carried out, documentation on operation and maintenance, etc., relevant for the subsystem concerned; (b) a list
interoperability constituents, referred to in point 31 32 [ S.L. 427.99 INTEROPERABILITY
THE RAIL SYSTEM (d)
Directive (EU) 2016/797, incorporated into the subsystem; (c) 2.5. the files referred to in Article 15
Directive (EU) 2016/797, compiled by each
the notified bodies involved in the verification
the subsystem, which shall include: — copies
the ‘EC’ declarations
verification and, where applicable, ‘EC’ declarations
suitability for use established for interoperability constituents referred to in point (d)
Directive (EU) 2016/797 and accompanied, where appropriate, by the corresponding calculation notes and a copy
the records
the tests and examinations carried out by the notified bodies on the basis
the common technical specifications, — where available, the ISV that accompany the certificate
verification, including the result
verification by the notified body
the ISV validity, — the certificate
verification, accompanied by corresponding calculation notes and signed by the notified body responsible for the verification, stating that the subsystem complies with the requirements
the relevant TSI(s) and mentioning any reservations recorded during performance
the activities and not withdrawn; the certificate
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
verification issued in accordance with other legal acts
the Union; (e) when verification
safe integration is required pursuant to point (c)
regulation 12
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
Directive 2004/49/EC. 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 INTEROPERABILITY
THE RAIL SYSTEM [ S.L. 427.99 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
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
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.
the technical file accompanying the ‘EC’ declaration
verification must be kept by the applicant throughout the service life
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)
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
conformity and suitability for use
ICs; (c) ISV issued or refused; 33 34 [ S.L. 427.99 2.8. INTEROPERABILITY
THE RAIL SYSTEM (d) certificates
verification and ‘EC’ certificates for suitability for use issued or refused; (e) certificates
verification issued or refused. Language The files and correspondence relating to the ‘EC’ verification procedure must be written in Maltese or English. 3. CERTIFICATE
VERIFICATION DESIGNATED BODY 3.1. Introduction ISSUED BY A In the case where national rules apply, the verification shall include a procedure whereby the body designated pursuant to Article 15
Directive (EU) 2016/797, (the designated body) checks and certifies that the subsystem complies with the national rules notified in accordance with Article 14
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
verification The designated body draws up the certificate
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
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
verification in the case
national rules must be included in the technical file accompanying the ‘EC’ declaration
verification referred to in point 2.4 and shall contain the technical data relevant for the assessment
the conformity
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. INTEROPERABILITY
THE RAIL SYSTEM 4. [ S.L. 427.99 VERIFICATION
PARTS
SUBSYSTEMS IN ACCORDANCE WITH ARTICLE 15
DIRECTIVE (EU) 2016/797 If a certificate
verification is to be issued for certain parts
a subsystem, provisions for this Schedule shall apply mutatis mutandis for those parts. 35
AI explanation based on the official legal text. Indicative, not a substitute for legal advice.