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The Railways (Interoperability) Regulations 2011

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Regulation 48

SCHEDULE [F11] U.K.Amendments to legislation

1.  Section 182 of the Equality Act 2010 M1 (rail vehicle accessibility regulations) is amended as follows—U.K.

(a)in subsection (4), in the definition of “rail vehicle” for “high-speed rail system or the conventional TEN rail system” substitute “ trans-European rail system located in Great Britain ”, and

(b)in subsection (5)—

(i)omit the definition of “conventional TEN rail system” and the definition of “high-speed rail system”, and

(ii)at the end insert—

trans-European rail system” has the meaning given in regulation 2(1) of the Railways (Interoperability) Regulations 2011.

Marginal Citations

2.  In regulation 2(1) of the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010 M2 (interpretation)—U.K.

(a)omit the definitions of “conventional TEN rail system” and “high-speed rail system”,

(b)in the definition of “rail vehicle” for “high-speed rail system or the conventional TEN rail system” substitute “ trans-European rail system located in Great Britain ”, and

(c)after the definition of “tramway” insert—

trans-European rail system” has the meaning given in regulation 2(1) of the Railways (Interoperability) Regulations 2011;.

Marginal Citations

3.  The Railways and Other Guided Transport Systems (Safety) Regulations 2006 M3 are amended as follows—U.K.

(a)in regulation 2(1)—

(i)in the definition of “Interoperability Regulations” for “2006” substitute “ 2011 ”, and

(ii)in the definition of “National Vehicle Register” for “33” substitute “ 36 ”,

(b)in regulation 5(5) omit “regulation 4(1)(a) of”, and

(c)after regulation 5(5) insert—

(6) Paragraph (5) does not apply in respect of an authorisation deemed to be given under the Interoperability Regulations by operation of regulation 44 of those Regulations..

Marginal Citations

M3S.I. 2006/599, as amended by S.I. 2011/1860; there are other amending instruments but none is relevant.

Regulation 2

[F2SCHEDULE 2U.K.Essential Requirements

(This Schedule substantially reproduces Annex III to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.  General requirementsU.K.

1.1.  SafetyU.K.

(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 of 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 so designed 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 availabilityU.K.

  • The monitoring and maintenance of fixed or moveable 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.  HealthU.K.

(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 emission of harmful and dangerous fumes or gases, particularly in the event of fire.

1.4.  Environmental protectionU.K.

(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 any relevant enactment or rule of 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 the rail system must not lead to an inadmissible level of noise generated by it—

(i)in areas close to the railway infrastructure as defined in Article 3 of Directive 2012/34/EU, and

(ii)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 compatibilityU.K.

  • The technical characteristics of the infrastructure and fixed installations must be compatible with each other and with those of the trains to be used on the rail system.

  • If compliance with these characteristics proves difficult on certain sections of the network, temporary solutions, which ensure compatibility in the future, may be implemented.

1.6.  AccessibilityU.K.

(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 to 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 subsystemU.K.

2.1.  InfrastructureU.K.

(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 for the particular safety conditions in very long tunnels and viaducts.

(2.1.2) Accessibility

(2.1.2.1) Infrastructure subsystems to which the public has access must be accessible to persons with disabilities and persons with reduced mobility in accordance with paragraph 1.6.

2.2.  EnergyU.K.

(2.2.1) Safety

  • Operation of the energy-supply systems must not impair the safety either of trains or of persons (users, operating staff, trackside dwellers and third parties).

(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:

    (i)

    enable trains to achieve the specified performance levels,

    (ii)

    in the case of electricity energy supply systems, be compatible with the collection devices fitted to the trains.

2.3.  Control-command and signallingU.K.

(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 should 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 stockU.K.

(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 him.

  • The access doors must incorporate an opening and closing system which guarantees passenger safety.

  • Emergency exits must be provided and indicated.

  • Appropriate provisions must be laid down to take account of the particular safety conditions in very long tunnels.

  • All trains must have an emergency lighting system of sufficient intensity and duration on board.

  • Trains must be equipped with a public address system which provides a means of communication to the public from on-board staff.

(2.4.2) Reliability and availability

  • The design of the vital equipment and the running, traction and braking equipment and also the control and command system must, in a specific degraded situation, be such as to enable the train to continue without adverse consequences for the equipment remaining in service.

(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 this 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 to persons with disabilities and persons with reduced mobility in accordance with paragraph 1.6.

2.5.  MaintenanceU.K.

(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 managementU.K.

(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 operation 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 passengersU.K.

(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:

    (i)

    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,

    (ii)

    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 passengers subsystems provide for the necessary functionality required to ensure accessibility for persons with disabilities and persons with reduced mobility.]

Regulation 2

[F3SCHEDULE 3 U.K.Subsystems

(This Schedule substantially reproduces Annex II to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.    List of subsystemsU.K.

For the purposes of these Regulations, the system constituting the rail system may be broken down into the following subsystems, either—

(a)structural areas—

  • infrastructure,

  • energy,

  • trackside control-command and signalling,

  • on-board control-command and signalling,

  • rolling stock.

(b)functional areas—

  • operation and traffic management,

  • maintenance,

  • telematics applications for passenger and freight services.

2.    Description of the subsystemsU.K.

For each subsystem or part of a subsystem, the list of constituents and aspects relating to interoperability is proposed by the Secretary of State at the time of drawing up the relevant draft NTSN. Without prejudging the choice of aspects and constituents relating to interoperability or the order in which they will be made subject to NTSNs, the subsystems include the following—

2.1.  InfrastructureU.K.

The track, points, engineering structures (bridges, tunnels etc.), associated station infrastructure (platforms, zones of access, including the needs of persons with reduced mobility, etc.), safety and protective equipment.

2.2.  EnergyU.K.

The electrification system, including overhead lines and the trackside of the electricity consumption measuring system.

2.3.  Trackside control-command and signallingU.K.

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 signallingU.K.

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 managementU.K.

The procedures and related equipment enabling 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 cross-border services.

2.6.  Telematics applicationsU.K.

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 other modes of transport;

(b)applications for freight services, including information systems (realtime 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 stockU.K.

Structure, command and control system for all train equipment, electric current collection devices, traction and energy conversion units, on-board equipment for electricity consumption measuring, braking, coupling and running gear (bogies, axles, etc.) and suspension, doors, man/machine interfaces (driver, on-board staff and passengers, including the needs of persons with reduced mobility), passive or active safety devices and requisites for the health of passengers and on-board staff.

2.8.  MaintenanceU.K.

The procedures, associated equipment, logistics centres for maintenance work and reserves providing the mandatory corrective and preventive maintenance to ensure the interoperability of the rail system and guarantee the performance required.]

Regulation 6(9)

[F4SCHEDULE 4U.K.UK verification assessment procedure for subsystems

(This Schedule substantially reproduces Annex VI to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.  General principlesU.K.

“UK verification” means a procedure carried out by a project entity applying for an authorisation pursuant to regulation 6 or regulation 17, to demonstrate that the requirements of these Regulations and any NTSNs or relevant NTRs relating to a subsystem have been fulfilled and the subsystem may be authorised to be placed in service.

2.  UK certificate of verification issued by an approved bodyU.K.

2.1.  IntroductionU.K.

For the purpose of these Regulations, the verification by reference to NTSNs is the procedure whereby an approved body checks and certifies that the subsystem complies with the relevant NTSNs, save for any applicable UK specific cases contained in those NTSNs.

This is without prejudice to the obligations of the project entity to comply with any other enactment or rule of law, including any verifications by the assessment bodies required by other legislation.

2.2.  Intermediate statement of verification (ISV)U.K.

(2.2.1) Principles

At the request of the project entity, the verifications may be done for parts of a subsystem or may be limited to certain stages of the UK verification assessment procedure. In these cases, the results of UK verification may be documented in an “intermediate statement of verification” (ISV) issued by the approved body chosen by the project entity.

The ISV must provide reference to the NTSNs with which the conformity has been assessed.

(2.2.2) Parts of the subsystem

The project entity may apply for an ISV for any part into which they decide 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 UK 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 project entity may apply for an ISV for the design stage (including type tests) and for the production stage for the whole subsystem or for any part into which the project entity decided to split it (see point 2.2.2).

2.3.  UK certificate of verificationU.K.

(2.3.1)  The approved bodies responsible for the UK verification must assess the design, production and final testing of the subsystem and must draw up the UK certificate of verification intended for the project entity. In turn, the project entity must draw up the UK declaration of verification. The UK certificate of verification must provide reference to the NTSNs with which the conformity has been assessed.

Where a subsystem has not been assessed for its conformity with all relevant NTSNs (e.g. in the case of an exemption, partial application of NTSNs for upgrade or renewal, transitional period in an NTSN or UK specific case), the UK certificate of verification shall give the precise reference to the NTSNs or their parts whose conformity has not been examined by the approved body during the UK verification assessment procedure.

( 2.3.2) Where an ISV has been issued, whether by an approved body, an EU notified body, or a designated body, the approved body responsible for the verification of the subsystem must take the ISV into account, and before issuing its UK certificate of verification, must:

(a)verify that the ISV correctly covers the relevant requirements of the NTSNs,

(b)check all aspects that are not covered by the ISV, and

(c)check 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 approved 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.

(2.3.4) Each approved body involved in the verification of a subsystem shall draw up a technical file in accordance with regulation 17 covering the scope of its activities.

2.4.  Technical file accompanying the UK declaration of verificationU.K.

The technical file accompanying the UK declaration of verification shall be assembled by the project entity 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 incorporated into the subsystem;

(c)the technical files compiled by each of the EU notified bodies or approved bodies involved in the verification of the subsystem, which shall include:

(i)copies of the EC or UK declarations of conformity or suitability for use established for interoperability constituents and accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the approved body or EU notified body on the basis of the common technical specifications,

(ii)where available, the ISV that accompanies the certificate of verification, including the result of verification by the approved body or by the EU notified body of the ISV validity,

(iii)the certificate of verification, accompanied by corresponding calculation notes and signed by the EU notified body responsible for the verification, stating that the subsystem complies with the requirements of the relevant TSIs or by the approved body responsible for the verification, stating that the subsystem complies with the requirements of the relevant NTSNs, 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)any other certificates that may have been issued as part of a verification process in accordance with any other enactment or rule of law;

(e)when verification of safe integration is required pursuant to the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or the Railways (Safety Management) Regulations (Northern Ireland) 2006 the relevant technical file shall include the assessors’ report(s) on the common safety methods (CSM) on risk assessment.

2.5.  Surveillance by approved bodyU.K.

(2.5.1) The approved 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 approved body must receive from the project entity all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.

(2.5.2) The approved body responsible for checking implementation must periodically carry out audits in order to confirm compliance with the relevant NTSNs. 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 approved body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits the approved 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 approved body shall be able to monitor a subsystem on which an interoperability constituent is mounted in order to assess, where required by the corresponding NTSNs, its suitability for use in its intended railway environment.

2.6.  SubmissionU.K.

A copy of the technical file accompanying the UK declaration of verification must be kept by the project entity throughout the service life of the subsystem.

The documentation submitted for an application for an authorisation for placing in service shall be submitted to the Safety Authority.

2.7.  PublicationU.K.

Each approved body must periodically publish relevant information concerning:

(a)requests for verification and ISV received,

(b)requests for assessment of conformity or suitability for use of interoperability constituents,

(c)ISVs issued or refused,

(d)UK certificates of conformity or suitability for use issued or refused,

(e)UK certificates of verification issued or refused.

3.  UK certificate of verification issued by a designated bodyU.K.

3.1.  IntroductionU.K.

In any case where UK specific rules apply, the verification shall include a procedure whereby the designated body checks and certifies that that subsystem complies with the UK specific rules.

3.2.  Certificate of verificationU.K.

The designated body must draw up the UK certificate of verification intended for the project entity.

The certificate shall contain a precise reference to the UK specific rule(s) whose conformity has been examined by the designated body in the UK verification process.

In the case of UK specific 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 UK specific rules strictly related to the technical compatibility between the vehicle and the network concerned, and the other part for all other UK specific rules.

3.3.  Technical fileU.K.

The technical file compiled by the designated body and accompanying the UK certificate of verification in the case of UK specific rules must be included in the technical file accompanying the UK 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 UK specific rules.

4.  Verification of parts of subsystemsU.K.

If a UK certificate of verification is to be issued for certain parts of a subsystem, the provisions of this Schedule shall apply mutatis mutandis for those parts.]

Regulation 7(2)

[F5SCHEDULE 5U.K.UK declaration of verification of subsystems

(This Schedule substantially reproduces Annex V to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.  UK declaration of verification of subsystemsU.K.

The UK declaration of verification of subsystems is a declaration established by the project entity applying for an authorisation under these Regulations in which they declare on their sole responsibility that the subsystem concerned, which has been subject to the relevant verification procedures, satisfies the requirements of these Regulations, and any NTSNs or relevant NTRs.

The UK declaration of verification and accompanying documents must be dated and signed.

The UK declaration of verification must be based on the information resulting from the UK verification procedure for subsystems set out in Schedule 4. It must contain at least the following:

(a)the reference to these Regulations, NTSNs and applicable NTRs,

(b)the reference to the NTSN(s) or their parts to which conformity has not been examined during the UK verification procedure and to the UK specific rules which have been applied in the case of an exemption, partial application of NTSNs for upgrade or renewal, transitional period in an NTSN or UK specific case,

(c)name and address of the project entity applying for an authorisation under these Regulations (specifying the trade name and full address; in the case of the authorised representative, specifying also the trade name of the contracting entity or manufacturer),

(d)a brief description of the subsystem,

(e)name(s) and address(es) and the identification number(s) of the approved body or bodies which conducted the UK verification assessment procedure,

(f)if applicable, name(s) and address(es) and identification number(s) of the EU notified body or bodies which conducted the EC verification assessment procedure,

(g)name(s) and address(es) and the identification number(s) of the body or bodies which conducted an assessment of conformity with any other applicable enactment or rule of law,

(h)name(s) and address(es) of the designated body or bodies which conducted the UK verification assessment procedure in relation to UK specific rules,

(i)name and address of the assessment body or bodies which established the safety assessment reports related to the use of the CSM on risk assessment referred to in paragraph 2.4(e) of Schedule 4,

(j)the references of the documents contained in the technical file accompanying the UK declaration of verification,

(k)all the relevant temporary or final provisions to be complied with by the subsystems and in particular, where appropriate, any operating restrictions or conditions,

(l)the identity of the signatory (i.e. the physical person or persons authorised to sign the declaration).

Where reference is made in Schedule 4 to the “intermediate statement of verification” (ISV), the provisions of this Section shall apply to that declaration.

2.  Modification of subsystems with EC or UK declaration of verification issued before IP completion dayU.K.

In a case of a modification, which is not a substitution in the framework of maintenance, of a subsystem covered by a UK declaration of verification, or by an EC declaration of verification issued before IP completion day, without prejudice to regulations 12 and 13, the following provisions apply.

2.1.  If the entity introducing the modifications demonstrates that the modification does not affect the basic design characteristics of the subsystem which are relevant for the compliance with the requirements concerning the basic parameters:U.K.

(a)the entity introducing the modification shall update the references of the documents contained in the technical file accompanying the EC or UK declaration of verification, and

(b)no new UK declaration of verification needs to be established.

2.2.  If the entity introducing the modification demonstrates that the modification affects the basic design characteristic of the subsystem which are relevant for the compliance with the requirements concerning some basic parameters:U.K.

(a)the entity introducing the modification shall establish an additional UK declaration of verification with reference to the basic parameters concerned,

(b)the additional UK declaration of verification shall be accompanied by a list of documents of the original technical file accompanying the original UK declaration of verification or EC declaration of verification that are no longer valid,

(c)the technical file accompanying the additional UK declaration of verification shall include a demonstration that the impact of modifications is limited to the basic parameters referred to in point (a),

(d)the provisions of Section 1 of this Schedule shall apply mutatis mutandis to this additional UK declaration of verification,

(e)the original UK declaration of verification or EC declaration of verification shall be considered valid for the basic parameters not concerned by the modification.

3.  UK declaration of verification in the case of additional verificationsU.K.

Where additional UK verifications are carried out an additional UK declaration of verification may be required, in particular when such additional verifications are necessary for an additional authorisation for placing in service. In this case the scope of the additional UK declaration of verification shall be limited to the scope of the additional verifications.]

Regulation 9(5)]

[F6SCHEDULE 6U.K.Model declaration of conformity to an authorised type of vehicle

Regulation 25(2)

[F7SCHEDULE 7U.K.UK declaration of conformity or suitability for use of interoperability constituents

(This Schedule substantially reproduces Annex IV to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.  Interoperability constituentsU.K.

The UK declaration of conformity or suitability for use applies to the interoperability constituents involved in the interoperability of the rail system. These interoperability constituents may be:

(1.1) Multiple-use constituents

These are constituents that are not specific to the railway system and which may be used as such in other areas.

(1.2) Multiple-use constituents having specific characteristics

These are constituents which are not, as such, specific to the railway system, but which must display specific performance levels when used for railway purposes.

(1.3) Specific constituents

These are constituents that are specific to railway applications.

2.  ScopeU.K.

The UK declaration of conformity or suitability for use must cover:

(a)the assessment by an approved body or bodies or designated body or bodies of the intrinsic conformity of an interoperability constituent, considered in isolation, to the technical specifications to be met,

(b)the assessment/judgement by an approved body or bodies or designated body or bodies of the suitability for use of an interoperability constituent, considered within its railway environment and, in particular in cases where the interfaces are involved, in relation to the technical specifications, particularly those of a functional nature, which are to be checked, or

(c)the assessment by a designated body or bodies of the conformity or suitability for use of an interoperability constituent against applicable UK specific cases, where an EC declaration of conformity or suitability for use has been drawn up on or after IP completion day and there are applicable UK specific cases, or an EC declaration of conformity or suitability for use has been drawn up before IP completion day and any applicable UK specific cases are new or materially different to those against which the interoperability constituent was previously assessed.

The assessment procedures implemented by the approved bodies or the designated bodies at the design and production stages must draw upon the modules defined in the NTSN concerning modules for the procedures for assessment of conformity or suitability for use and UK verification, and in accordance with the conditions referred to in the NTSNs.

3.  Contents of the UK declaration of conformity or suitability for useU.K.

The UK declaration of conformity or suitability for use and the accompanying documents must be dated and signed.

That declaration must contain the following:

(a)references to the appropriate provisions of these Regulations,

(b)name and address of the manufacturer or its authorised representative or the manufacturer’s representative (give trade name and full address, in the case of the authorised representative, or the manufacturer’s representative, also give the trade name of the manufacturer),

(c)description of interoperability constituent (make, type, etc),

(d)description of the procedure followed in order to declare conformity or suitability for use,

(e)all the relevant descriptions met by the interoperability constituent and, in particular, its conditions of use,

(f)name and address of the UK approved body or bodies or the designated body or bodies involved in the procedure followed in respect of conformity or suitability for use and date of examination certificate together with, where appropriate, the duration and conditions of validity of the certificate,

(g)where appropriate, reference to any other relevant specifications,

(h)identification of the signatory empowered to enter into commitments on behalf of the manufacturer or of the manufacturer’s authorised representative or the manufacturer’s representative.

In this Schedule “examination certificate” means a certificate drawn up as part of an assessment of an interoperability constituent in accordance with one of the modules defined in the NTSN concerning modules for the procedures for assessment of conformity or suitability for use and UK verification.]

Regulation 31(3)

[F8SCHEDULE 8U.K.Minimum criteria which must be taken into account by the Secretary of State when approving bodies

(This Schedule substantially reproduces Annex VIII to the Directive with amendments to correct deficiencies arising from the UK’s withdrawal from the European Union.)U.K.

1.  The body, its Director and the staff responsible for carrying out the checking operations may not become involved either directly or as authorised representatives in the design, manufacture, construction, marketing or maintenance of the interoperability constituents or subsystems or in their use. This does not exclude the possibility of an exchange of technical information between the manufacturer and that body.U.K.

2.  The body and the staff responsible for the checks must carry out the checks with the greatest possible professional integrity and the greatest possible technical competence and must be free of any pressure and incentive, in particular of a financial type, which could affect their judgement or the results of their inspection, in particular from persons or groups of persons affected by the results of the checks.U.K.

In particular, the body and staff responsible for the checks must be functionally independent of the authorities designated to issue authorisations for placing into service in the framework of these Regulations, operator licences in the framework of the Railways (Licensing of Railway Undertakings) Regulations 2005 or the Railways Infrastructure (Access, Management and Licensing of Railway Undertakings) Regulations (Northern Ireland) 2016, safety certificates in the framework of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or the Railways (Safety Management) Regulations (Northern Ireland) 20006, and of bodies in charge of investigations in the event of accidents.

3.  The body must employ staff and possess the means required to perform adequately the technical and administrative tasks linked with the checks; it should also have access to the equipment needed for exceptional checks.U.K.

4.  The staff responsible for the checks must possess—U.K.

(a)proper technical and vocational training,

(b)a satisfactory knowledge of the requirements relating to the checks that they carry out and sufficient practice in those checks,

(c)the ability to draw up certificates, records and reports which constitute the formal record of the inspections conducted.

5.  The independence of the staff responsible for inspections must be guaranteed. No official must be remunerated either on the basis of the number of inspections performed or of the results of those inspections.U.K.

6.  The body must take out civil liability insurance unless that liability is covered by the UK Government under the law of the UK or of any part of the UK or unless the checks are carried out directly by the UK Government.U.K.

7.   The staff of the body must be bound by professional secrecy with regard to everything they learn in the performance of their duties (with the exception of the competent administrative authorities and accident investigation bodies in the UK as well as accident investigation bodies responsible for the investigation of accidents caused by the failure of the interoperability constituents or subsystems checked) in pursuance of these Regulations.]U.K.

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