The Railways (Interoperability) (Amendment) (EU Exit) Regulations 2019

SCHEDULE 4 (1) General principles “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 body (2.1) Introduction 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) (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 verification (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 verification 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 2006⁹, or the Railways (Safety Management) Regulations (Northern Ireland) 2006¹⁰ the relevant technical file shall include the assessors’ report(s) on the common safety methods (CSM) on risk assessment. (2.5) Surveillance by approved body (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) Submission 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) Publication 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 body (3.1) Introduction 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 verification 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 file 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 subsystems 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.

SCHEDULE 4

After Schedule 4 to the Regulations, insert—

SCHEDULE 5 (1) UK declaration of verification of subsystems 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 day 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: (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: (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 verifications 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.

SCHEDULE 5

After Schedule 5 to the Regulations insert—

SCHEDULE 6

SCHEDULE 6

After Schedule 6 to the Regulations insert—

SCHEDULE 7 (1) Interoperability constituents 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) Scope 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 use 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.

SCHEDULE 7

After Schedule 7 to the Regulations, insert—

SCHEDULE 8 (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. (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. 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 2005¹¹ or the Railways Infrastructure (Access, Management and Licensing of Railway Undertakings) Regulations (Northern Ireland) 2016¹², 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. (4) The staff responsible for the checks must possess— (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. (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. (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.

SCHEDULE 8 — Consequential amendments

1

In regulation 2 of the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010¹³ (Interpretation)—

• (a) omit the definition of “EU specifications”;

• (b) after the definition for “reference wheelchair”, insert—

• “relevant specifications” means—before IP completion day, section 4.2.2 of the technical specification for interoperability relating to “persons with reduced mobility” set out in the Annex to Decision 2008/164/EC of the European Commission of 21 December 2007 (as modified in section 7.4.1.3.2 for GB rolling stock); oron and after IP completion day, the corresponding section of the NTSN relating to “persons with reduced mobility” published by the Secretary of State under the Railways (Interoperability) Regulations 2011 as amended from time to time;

2

In regulation 3(4), (5) and (7), for “EU specifications”, substitute “relevant specifications”.

3

The Railways and Other Guided Transport Systems (Safety) Regulations 2006 are amended as follows—

• (a) in regulation 2—

• (i) in the definition of “national safety rules”, for “covered by a TSI” substitute “covered by an NTSN”;

• (ii) after the definition of “national safety rules”, insert—

• “NTSN” means a National Technical Specification Notice published by the Secretary of State pursuant to regulation 3B of the Interoperability Regulations;

• (b) in regulation 5—

• (i) in paragraph (1)(a)(ii) for “TSIs”, substitute “NTSNs”,

• (ii) in paragraph (7)(c)(i), for “TSIs”, substitute “NTSNs”;

• (c) in regulation 7(5)(a), for “TSIs”, substitute “NTSNs”;

• (d) in Schedule 1, paragraph 2(c)(i) after “TSIs”, insert “NTSNs”;

• (e) in Schedule 2, paragraph 2, where it occurs, for “TSI”, substitute “NTSNs”.

Signed

Signed by authority of the Secretary of State for Transport

Andrew Jones — Parliamentary Under Secretary of State — Department for Transport — 2019-02-21

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the Railways (Interoperability) Regulations 2011 which set out the framework for the assessment and authorisation of rail projects, to avoid deficiencies arising from the withdrawal of the United Kingdom from the European Union. These Regulations also make consequential amendments to the Rail Vehicle Accessibility (Non-interoperable Rail System) Regulations 2010, and the Railways and Other Guided Transport Systems (Safety) Regulations 2006 which are required as a consequence of the changes to the Railways (Interoperability) Regulations 2011.

An impact assessment has been produced for these Regulations and is available at www.legislation.gov.uk.

The NTSNs and a list of the NTRs applying in the United Kingdom can be found here www.gov.uk/government/publications/rail-interoperability. Hard copies of the NTSNs, and the list of the NTRs applying in the UK are available on request from the Department for Transport, Interoperability Team, Zone 4/26, Great Minster House, London, SW1P 4DR or by emailing interoperability@dft.gov.uk.

An Explanatory Memorandum is published alongside the instrument on www.legislation.gov.uk .

Footnotes

Editorial notes