xmlns:atom="http://www.w3.org/2005/Atom"

Statutory Instruments

2019 No. 345

Exiting The European Union

Transport

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

Made

21st February 2019

Laid before Parliament

26th February 2019

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 247 of the Transport Act 2000(1).

PART 1Introduction

Citation and commencement

1.—(1) These Regulations may be cited as the Railways (Interoperability) (Amendment) (EU Exit) Regulations 2019.

(2) These Regulations come into force on exit day.

PART 2Amendments to secondary legislation

Amendments to the Railways Interoperability Regulations 2011

2.—(1) The Railways (Interoperability) Regulations 2011(2) (“the Regulations”) are amended as follows.

(2) In regulation 2 (definitions)—

(a)after the definition of “the 1974 Act”, insert—

“approved body” has the meaning set out in regulation 30;

“authorised representative” means—

(a)

a person who—

(i)

immediately before exit day was established in an EEA state and appointed to act by a manufacturer or contracting entity to perform specified tasks for that manufacturer or contracting entity in relation to the Directive, and

(ii)

on or after exit day continues to be so established and appointed by the manufacturer or contracting entity to perform those tasks; or

(b)

a person who on or after exit day is appointed in accordance with regulation 3A;;

(b)for the definition of “certificate of verification”, substitute—

“certificate of verification” means an EC certificate of verification or a UK certificate of verification;;

(c)omit the definition of “the Commission”;

(d)in the definition of “Competent Authority”, for “DRDNI” substitute “DFI”;

(e)for the definition of “DRDNI”, substitute—

“DFI” means the Department for Infrastructure as established by section 1(6) of the Departments Act (Northern Ireland) 2016(3);;

(f)after the definition of “DFI”, insert—

“EC certificate of verification” means a certificate drawn up by an EU notified body as part of the EC verification assessment procedure for a structural subsystem;

(g)in the definition of “EC declaration of conformity or suitability for use”, for “regulation 25”, substitute “Article 13 and Annex IV of the Directive”;

(h)after the definition of “EC declaration of conformity or suitability for use”, insert—

“EC declaration of verification” means a declaration drawn up by a project entity in relation to a structural subsystem in accordance with Article 18 of and Annex V to the Directive;

“EC verification assessment procedure” means the procedure set out in Annex VI to the Directive;;

(i)in the definition of “essential requirements”, for “Annex III to the Directive”, substitute “Schedule 2”;

(j)after the definition of “essential requirements”, insert—

“European Commission” means the Commission of the European Union;;

(k)omit the definition of “European Railway Agency”;

(l)omit the definition of “European specification”;

(m)after the definition of “European vehicle number” insert—

“EU notified body” means a body which has been appointed by an EU Member State and notified by the EU Member State concerned to the European Commission and the other EU Member States pursuant to Article 20(1) of the Conventional Directive, Article 20(1) of the High-Speed Directive, or Article 28(1) of the Directive unless the appointment has been terminated;;

(n)in the definition of “functional subsystem” for “Annex II to the Directive”, substitute “Schedule 3”;

(o)omit the definition of “functional TSI”;

(p)for the definition of “interoperability”, substitute—

“interoperability” means the ability of the rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance for those lines;;

(q)after the definition of “interoperability constituent”, insert—

“ISV” means an intermediate statement of verification issued by—

(a)

an approved body in relation to the design stage or the production stage of a subsystem in accordance with section 2 of Schedule 4;

(b)

an EU notified body in relation to the design stage or the production stage of a subsystem in accordance with section 2 of Annex VI to the Directive;

(c)

a designated body at an intermediate stage of the UK verification assessment procedure referred to in section 3 of Schedule 4;

(d)

a designated body at an intermediate stage of the EC verification assessment procedure referred to in section 3 of Annex VI to the Directive;

“NTRs” means National Technical Rules setting out standards, technical specifications and technical rules in relation to the rail system, as amended or varied from time to time, a list of which is published by the Secretary of State in accordance with regulation 3C;

“NTSN” means a National Technical Specification Notice published by the Secretary of State pursuant to regulation 3B setting out the standards, technical specifications and technical rules in use in the United Kingdom as amended or varied from time to time;;

(r)omit the definition of “notified body”;

(s)in the definition of “notified national technical rules”, for “have been notified by the Secretary of State to the Commission”, substitute “were notified by the Secretary of State to the European Commission before exit day”;

(t)omit the definition of “Official Journal”;

(u)in the definition of “project entity”, omit “established in the EU”;

(v)for the definition of “rail system”, substitute—

“rail system” means the structure composed of lines and fixed installations of the existing rail system in the United Kingdom plus the vehicles of all categories and origin travelling on that infrastructure;;

(w)in the definition of “Safety Authority”, for “DRDNI”, substitute “DFI”;

(x)in the definition of “structural subsystem”, for “Annex II to the Directive”, substitute “Schedule 3”;

(y)in the definition of “subsystem”, for “Annex II to the Directive”, substitute “Schedule 3”;

(z)in the definition of “trans-European rail system”, omit “as those sections are amended from time to time”;

(aa)for the definition of “TSI”, substitute—

“TSI” means technical specifications for interoperability adopted from time to time by the European Commission pursuant to the Directive, or the Conventional Directive, or the High Speed Directive, as those TSIs have effect in EU law, and as they are amended from time to time;;

(bb)after the definition for “upgrading” insert—

“UK certificate of verification” means a certificate drawn up by an approved body or designated body as part of the UK verification assessment procedure for a structural subsystem;

“UK declaration of conformity or suitability for use” means a declaration drawn up in accordance with regulation 25 and Schedule 7;

“UK declaration of verification” means a declaration of verification drawn up by a project entity in relation to a structural subsystem pursuant to regulation 16(3) and Schedule 5;

“UK specific case” means a special provision in relation to the technical specifications for a subsystem or an interoperability constituent to allow for its compatibility with the rail system, which is set out in an NTSN or an NTR and described in that NTSN or that NTR as a “UK specific case”;

“UK specific rules” means all UK specific cases and NTRs, including any dispensation granted against NTRs under regulation 46(1);

“UK verification assessment procedure” means the procedure referred to in regulation 17 and Schedule 4;

(cc)omit the definition of “verification assessment procedure”;

(dd)omit the definition of “verification declaration”;

(ee)omit paragraph (2);

(ff)in paragraph (3), omit “Except for the references to the EU in the definitions of “the Commission” and “Official Journal””.

(3) Schedules 1 and 2 have effect.

(4) In regulation 3 (application)—

(a)for sub-paragraph (1)(a), substitute—

(a)the rail system;;

(b)in sub-paragraph (7), for “DRDNI”, substitute “DFI”.

(5) After regulation 3, insert—

Appointment and obligations of an authorised representative

3A.(1) A manufacturer or contracting entity may, in writing, appoint a person established in the United Kingdom as its authorised representative to perform certain tasks pursuant to these Regulations.

(2) A manufacturer or contracting entity who has appointed an authorised representative to perform, on behalf of that manufacturer or contracting entity, a task under these Regulations remains responsible for the proper performance of that task.

(3) An authorised representative must comply with all the duties imposed on the manufacturer or contracting entity in relation to each obligation under these Regulations that the representative is appointed to perform, and will be subject to the same penalties as a manufacturer or contracting entity for failure to comply with those duties..

(6) After new Regulation 3A, insert—

PART 1ANational Technical Specification Notices and National Technical Rules

Publication of National Technical Specification Notices

3B.(1) The Secretary of State may set standards to be complied with in relation to the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of the rail system, as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance.

(2) Those standards may be set out in National Technical Specification Notices (NTSNs), which must be published by the Secretary of State.

(3) NTSNs may be varied from time to time by the Secretary of State.

(4) Any variation must be published by the Secretary of State.

(5) Regulations 39 and 40 apply to the enforcement of the standards set out in NTSNs as they apply to the enforcement of these Regulations.

(6) When the Secretary of State publishes an NTSN for the first time, and the NTSN is intended to take the place of a particular TSI as it had effect immediately before exit day, the NTSN must specify the TSI it replaces.

(7) When the Secretary of State publishes an NTSN or a variation of an NTSN and that NTSN substantially reproduces the provisions of a TSI, the NTSN must specify the title of the TSI it substantially reproduces at the time of publication.

Publication of a list of National Technical Rules

3C.(1) The Secretary of State may set supplementary standards to be complied with in relation to the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of the rail system, as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance.

(2) Those standards may be set out in NTRs which supplement NTSNs.

(3) On exit day, the Secretary of State must publish a list of all NTRs applying in the United Kingdom.

(4) Where appropriate, the list must specify the notified national technical rule that an NTR replaces.

(5) The list of NTRs may be varied from time to time by the Secretary of State.

(6) Any variation to the list must be published by the Secretary of State.

(7) Regulations 39 and 40 apply to the enforcement of the standards set out in NTRs as they apply to the enforcement of these Regulations..

(7) In regulation 4 (requirement for authorisation)—

(a)in paragraph (1)—

(i)at the end of sub-paragraph (a), insert “or”,

(ii)at the end of sub-paragraph (b), omit “or”, and sub-paragraph (c);

(b)in paragraph (2), omit “in the United Kingdom”;

(c)in paragraph (3), before “verification assessment procedure”, insert “relevant EC or UK”;

(d)after paragraph 3, insert—

(4) The requirements set out in paragraph (1) apply to a vehicle even if there is an extant authorisation granted in an EU Member State. A person wishing to put a vehicle into use in the UK which has such an authorisation must apply for an authorisation under regulation 6..

(8) In regulation 5 (application for authorisation)—

(a)in paragraph (1)—

(i)at the end of sub-paragraph (a), insert “or”,

(ii)at the end of sub-paragraph (b), omit “or”, and sub-paragraph (c);

(b)for paragraph (2)(b), substitute—

(b)the UK declaration of verification;;

(c)in paragraph (3), before “verification assessment procedure”, insert “UK”;

(d)in paragraph (7), for “DRDNI”, substitute “DFI”;

(e)omit paragraph (8).

(9) In regulation 6 (authorisation for a vehicle already authorised for another Member State)—

(a)in the heading, for “another”, substitute “an EU”;

(b)for paragraph (1), substitute—

(1) This regulation applies where an authorisation is required under regulation 4(4).;

(c)in paragraph (3)—

(i)in sub-paragraph (a), for “4(1)(c)” substitute “4(4)”,

(ii)in sub-paragraph (b)(ii), after “applicable TSI”, insert “in force at the time when the vehicle was first authorised”,

(iii)at the end of sub-paragraph (b)(iv), omit “and”,

(iv)for sub-paragraph (b)(v), substitute—

(v)any UK certificate of verification in relation to UK specific rules; and,

(v)after sub-paragraph (b)(v), insert—

(vi)sufficient documentary evidence to satisfy the Safety Authority that the first authorisation has not been revoked;,

(vi)at the end of sub-paragraph (c)(iv), omit “and”,

(vii)for sub-paragraph (c)(v), substitute—

(v)any UK certificate of verification in relation to UK specific rules; and,

(viii)after sub-paragraph (c)(v), insert—

(vi)sufficient documentary evidence to satisfy the Safety Authority that the first authorisation has not been revoked;,

(ix)in sub-paragraph (e), for “verification declaration”, substitute “UK declaration of verification”;

(d)for paragraph (4), substitute—

(4) If the first authorisation is a TSI conform authorisation, the Safety Authority may, after consultation with the applicant, by notice in writing require the applicant to carry out additional tests on the network concerned or risk analysis and to provide any additional information which the Safety Authority considers necessary in order to check compatibility between the vehicle and the network concerned, including compatibility with UK specific rules.;

(e)in paragraph (5), for “notified national technical rules”, substitute “UK specific rules”;

(f)in paragraph (7)—

(i)for “notified national technical rules”, substitute “UK specific rules”,

(ii)omit the words from “or if the engagement”, to “notified body”;

(g)omit paragraph (8);

(h)for paragraph (9), substitute—

(9) If a body is engaged in accordance with paragraph (7), in order for the application to proceed, the project entity must draw up a UK declaration of verification in relation to the project subsystem in accordance with Schedule 5, after the body appointed under paragraph (7) has, in accordance with Schedule 4, drawn up a UK certificate of verification and compiled a technical file.;

(i)omit paragraphs (10) and (11).

(10) Schedule 3 has effect.

(11) In regulation 7 (authorisation decision)—

(a)in paragraph (2)(a)—

(i)for “verification declaration”, substitute “UK declaration of verification”,

(ii)for “Annex V to the Directive”, substitute “Schedule 5”;

(b)at the end of paragraph (2)(b), omit “and”;

(c)at the end of paragraph (2)(c), insert—

and,

(d)the project entity has satisfactorily completed any tests required by regulations 5(4), and 6(4) and 6(5).;

(d)in paragraph (5)—

(i)for “5(1)(c) submitted in accordance with regulation 6”, substitute “6(1)”,

(ii)in sub-paragraphs (a) and (b), for “another Member State”, substitute “an EU Member State”.

(12) Schedule 4 has effect.

(13) In regulation 8 (determination of type)—

(a)in paragraph (5), for “changes to TSIs or notified national technical rules”, substitute “material changes to the applicable standards”;

(b)for paragraph (6), substitute—

(6) The Safety Authority must publish and keep up to date a list of determinations of type for vehicles issued in accordance with this regulation (including those determinations issued by the Safety Authority before exit day) and any modification, suspension or withdrawal of such a determination.

(6A) In maintaining that list, the Safety Authority may have regard to the requirements set out in Annex II to Commission Implementing Decision 2011/665/EU of 4 October 2011 on the European register of authorised types of railway vehicles(4).;

(c)after paragraph (8), insert—

(9) In regulations 8, 9 and 10, “applicable standards” means the applicable standards in force at the time when type was determined, which are—

(a)before exit day, standards set out in TSIs and notified national technical rules;

(b)after exit day, standards set out in NTSNs and NTRs.

(10) In regulations 8, 9 and 10, any reference to “material” changes to standards does not include the replacement of the standards contained in TSIs or notified national technical rules by the standards published by the Secretary of State in accordance with regulations 3B and 3C on exit day and contained in NTSNs or NTRs..

(14) In regulation 9 (type authorisation)—

(a)in paragraphs (2)(b) and (3)(b), for “changes to the applicable TSI or notified national technical rules”, substitute “material changes to the applicable standards”;

(b)in paragraph (5), for the words “Commission Regulation” to the end of the sentence, substitute “Schedule 6”.

(15) Schedule 5 has effect.

(16) In regulation 10 (type authorisation: changes to TSIs etc)—

(a)in the heading, for “TSIs etc”, substitute “applicable standards”;

(b)in paragraphs (1) and (5) for “TSI or notified national technical rules”, substitute “standards”.

(17) In regulation 12(2)(c), for “TSI”, substitute “NTSN”.

(18) In regulation 13 (authorisation requirements for the renewal or upgrading of subsystems)—

(a)in paragraph (2)(c)—

(i)for “TSI, or part of a TSI”, substitute “NTSN, or part of an NTSN”,

(ii)for “derogations”, substitute “exemptions”;

(b)in paragraph (2)(d), for “TSI, or part of a TSI”, substitute “NTSN, or part of an NTSN”;

(c)in paragraph (5)(a)—

(i)for “strategy”, substitute “plan”,

(ii)for “TSI”, substitute “NTSN”;

(d)in paragraph (8)—

(i)for “derogations under regulation 14”, substitute “exemptions under regulations 14 and 14A”,

(ii)for “TSIs”, substitute “NTSNs”.

(19) In regulation 14 (exemption from need to conform with TSIs (derogations))—

(a)in the heading for “TSIs (derogations)”, substitute “NTSNs (exemptions)”;

(b)for “TSI” each time it occurs, substitute “NTSN”;

(c)in paragraph (1), for “a derogation”, substitute “an exemption”;

(d)in paragraph (2)—

(i)in sub-paragraph (a), for sub-paragraph (iii) substitute—

(iii)concerns the design, construction, placing in service, upgrading, renewal, operation and maintenance of the parts of the rail system as well as the professional qualifications and health and safety conditions of the staff who contribute to its operation and maintenance,,

(ii)omit sub-paragraph (c),

(iii)for sub-paragraph (f), substitute—

(f)a project which employs innovative solutions which either do not comply with the relevant NTSNs or to which the assessment methods in those NTSNs cannot be applied.;

(e)after paragraph (2), insert—

(2A) In this regulation and in regulation 14A, a reference to a project at an advanced stage of development means a project whose planning or construction stage has reached a point where the impact of a change in technical specifications would present a significant legal, contractual, economic, financial, social or environmental impediment to the project concerned.;

(f)omit paragraphs (3) to (6).

(20) After regulation 14, insert—

Application for exemptions

14A.(1) Where a project entity applies for an exemption under regulation 14, they must apply to the Competent Authority in writing.

(2) The following information must be included in the application for an exemption—

(a)a description of the work, goods and services subject to the exemption, specifying the key dates, the location, and the operational and technical area;

(b)a precise reference to the NTSN (or its parts) from which an exemption is sought;

(c)a precise reference to, and details of, the alternative provisions which will be applied;

(d)for requests made under regulation 14(2)(a), evidence in support of the fact that the project is at an advanced stage of development;

(e)for requests made under regulation 14(2)(f), information which outlines how the solution deviates from or complements the applicable NTSNs;

(f)justification of the exemption, including the main reasons of a technical, economic, commercial, operational and/or administrative nature; and

(g)any other information justifying the application for an exemption.

(3) After receipt of the information specified in paragraph (2), the Competent Authority must determine the application for an exemption.

(4) When the Competent Authority has made a determination it must inform the applicant of that determination.

(5) When the Competent Authority makes a determination of a case under regulation 14(2)(f) (innovative solutions), and informs the applicant of the outcome of the application, the Competent Authority must also publish its determination..

(21) In regulation 15 (essential requirements for project subsystems)—

(a)in paragraph (1)(a), for “TSIs”, substitute “NTSNs”;

(b)in paragraph (1)(b), for “notified national technical rules”, substitute “NTRs”;

(c)after paragraph (1), insert—

(1A) For the purposes of paragraph (1)(a), a project subsystem is deemed to conform with an applicable NTSN, save for any UK specific case set out in that NTSN, if—

(a)the person applying for an authorisation provides evidence that the project subsystem has been assessed under EU law as conforming with a TSI in force at the time when the application for authorisation is made; and

(b)the applicable NTSN specifies that it substantially reproduces the provisions of that TSI, in accordance with regulation 3B(6).;

(d)in paragraph (2)—

(i)in sub-paragraph (a), for “TSIs”, substitute “NTSNs”,

(ii)in sub-paragraph (b), for “TSI”, substitute “NTSN”,

(iii)for sub-paragraph (c), substitute—

(c)an exemption from conformity with the whole or part of a relevant NTSN has been granted in accordance with regulations 14 and 14A in relation to that subsystem; or,

(iv)in sub-paragraph (d), for “a TSI”, substitute “an NTSN”.

(22) In regulation 16 (role of project entity)—

(a)for “notified national technical rules” each time it occurs, substitute “UK specific rules”;

(b)for paragraph (1)(a) substitute—

(a)engage an EU notified body to carry out the EC verification assessment procedure, or engage an approved body to carry out the UK verification assessment procedure, other than in relation to UK specific rules;;

(c)in paragraph (1)(b) for “a notified body”, substitute “an EU notified body or an approved body”;

(d)in paragraph (1)(c)—

(i)omit the words from “or if the engagement is made before the day” to “or a notified body,”,

(ii)after “to carry out the”, insert “UK”,

(iii)after “regulation 17”, insert “and Schedule 4”;

(e)in paragraph (2), for “a notified body”, substitute “an EU notified body or an approved body”;

(f)in paragraph (3)—

(i)for “verification declaration”, substitute “UK declaration of verification”,

(ii)for sub-paragraph (b), substitute—

(b)either—

(i)the EC verification assessment procedure has been carried out by an EU notified body, or

(ii)the UK verification assessment procedure has been carried out by an approved body,

and, if applicable in either case, the UK verification assessment procedure has been carried out by a designated body;;

(g)for sub-paragraph (c), substitute—

(c)either—

(i)an EC certificate of verification has been drawn up by an EU notified body, or

(ii)a UK certificate of verification has been drawn up by an approved body,

and, if applicable in either case, a UK certificate of verification has been drawn up by a designated body; and;

(h)omit paragraph (4);

(i)in paragraph (5), for “5(1)(c)”, substitute “6(1)”.

(23) In regulation 17 (project subsystems: verification assessment procedure)—

(a)in the heading, after “Project subsystems:” insert “UK”;

(b)in paragraph (1)—

(i)in the opening words—

(aa)after “The”, insert “UK”,

(bb)for “a notified body”, substitute “an approved body”,

(cc)omit “other than in relation to notified national technical rules”,

(ii)in sub-paragraph (a), for “TSI” each time it occurs, substitute “NTSN”,

(iii)in sub-paragraph (b), for “Annex VI to the Directive”, substitute “Schedule 4”;

(c)in paragraph (2)—

(i)in the opening words—

(aa)for “notified body”, substitute “approved body”,

(bb)omit “other than in relation to notified national technical rules”,

(ii)in sub-paragraph (a)—

(aa)paragraph (i), for “Annex VI to the Directive”, substitute “Schedule 4”,

(bb)paragraph (v), for “TSI”, substitute “NTSN”,

(cc)for paragraph (vi) substitute—

(vi)documentation or records of a determination of the Competent Authority in relation to an exemption from an applicable NTSN, pursuant to regulations 14 and 14A; and;;

(d)in paragraph (3)—

(i)for “TSI”, substitute “NTSN”,

(ii)after “registers”, insert “or lists”,

(iii)for “Article 34” to the end of the sentence, substitute “regulations 8 (Determination of type), 35 (Register of infrastructure) and 36 (National vehicle register)”;

(e)in paragraph (4), at the start, after “The”, insert “UK”;

(f)in paragraphs (4) and (5)—

(i)for “notified national technical rules”, substitute “UK specific rules”, and

(ii)for “Annex VI to the Directive”, substitute “Schedule 4”.

(24) In regulation 18 (project subsystems: verification declaration)—

(a)in the heading, for “verification declaration”, substitute “UK declaration of verification”;

(b)in paragraph (1), for “verification declaration”, substitute “UK declaration of verification”;

(c)in paragraph (2), before “verification”, insert “UK”.

(25) In regulation 19(1)—

(a)for “Member State”, substitute “country”;

(b)for “verification declaration”, substitute “UK declaration of verification”;

(c)in sub-paragraph (a)—

(i)in sub-paragraph (i), after “regulations 6(3)(b)”, insert “or (c)”,

(ii)for sub-paragraph (ii), substitute—

(ii)the relevant UK declaration of verification, and;

(d)in sub-paragraph (b), for “any other Member State that requests one”, substitute “the national body responsible for railway safety in the country in which the project subsystem is used, in response to a reasonable request from that body.”.

(26) In regulation 20 (continuing duty on operator in relation to standards)—

(a)in paragraph (2)(a)—

(i)for “sub-paragraph (b)”, substitute “sub-paragraphs (b) and (ba)”,

(ii)for “the TSIs and notified national technical rules”, substitute “either the TSIs and notified national technical rules, or the NTSNs and NTRs”;

(b)in paragraph (2)(b)—

(i)for “a TSI or notified national technical rule”, substitute “an NTSN or NTR”,

(ii)for “TSI or rule” where it occurs, substitute “NTSN or NTR”;

(c)after paragraph (2)(b), insert—

(ba)where a TSI or notified national technical rule referred to in sub-paragraph (a) has been replaced by an NTSN or by an NTR, either in conformity with the relevant NTSN or NTR currently in force or in conformity with the original TSI or rule,;

(d)in paragraph (2)(c), for “TSI”, substitute “NTSN”;

(e)for paragraph (5), substitute—

(5) In this regulation—

“functional NTSN” means an NTSN applying to a functional subsystem;

“project subsystem” includes a vehicle deemed to be authorised under these Regulations by the operation of regulation 44..

(27) For regulation 23, substitute—

Prohibition on placing interoperability constituents on the market

23.(1) No person may place an interoperability constituent on the market for which there is an applicable NTSN with a view to its use on the rail system, unless—

(a)the interoperability constituent meets the essential requirements that are relevant to an interoperability constituent of that type;

(b)the appropriate procedure for assessing the conformity or suitability for use of the interoperability constituent has been carried out; and

(c)subject to paragraph (2), a UK declaration of conformity or suitability for use in relation to that interoperability constituent has been drawn up.

(2) A person may place an interoperability constituent on the market in reliance on an EC declaration of conformity or suitability for use drawn up in relation to that interoperability constituent where one of the following conditions applies—

(a)an EC declaration of conformity or suitability for use was drawn up before or after exit day, and there is no UK specific case applicable to the interoperability constituent; or

(b)all of the following apply—

(i)an EC declaration of conformity or suitability for use was drawn up before exit day,

(ii)there is a UK specific case applicable to the interoperability constituent,

(iii)there is no material difference between the technical specifications of the applicable UK specific case and a pre-exit specific case against which the interoperability constituent was previously assessed, and

(iv)there are no other applicable UK specific cases.

(3) In this regulation, “a pre-exit specific case” means special provision in relation to the technical specifications for subsystems and interoperability constituents to allow for their compatibility with the rail system, which was applicable to the interoperability constituent and was set out and described in a TSI or notified national technical rule before exit day.

(4) In this regulation, a “material difference” in relation to technical specifications does not include the replacement of the standards contained in TSIs or notified national technical rules by the standards set by the Secretary of State in accordance with regulations 3B and 3C, and contained (after exit day) in NTSNs or NTRs..

(28) In regulation 24 (assessment procedure for interoperability constituents)—

(a)for “applicable TSI” where it occurs, substitute “applicable NTSN”;

(b)at the start of paragraph (1), insert “Subject to paragraph (4),”;

(c)in paragraph (1) for “a notified body”, substitute “an approved body or, where assessment against an applicable UK specific case is required, a designated body”;

(d)in paragraph (3) for “TSI”, substitute “NTSN”;

(e)after paragraph (3), insert—

(4) Except for cases which fall within regulation 23(2), where an EC declaration of conformity or suitability for use has already been drawn up, an assessment of the conformity or suitability for use against an applicable UK specific case must be carried out by a designated body in accordance with the procedure set out in the NTSN concerning the further assessment of interoperability constituents which hold an EC declaration of conformity or suitability for use..

(29) In regulation 25 (EC declaration of conformity or suitability for use)—

(a)in the title to the regulation for “EC”, substitute “UK”;

(b)in paragraph (1) for the opening words, substitute—

(1) Where neither a UK declaration of conformity or suitability for use, nor an EC declaration of conformity or suitability for use which satisfies one of the conditions in regulation 23(2) has been drawn up by the manufacturer or the manufacturer’s representative, a UK declaration of conformity or suitability for use must be drawn up by any person who—;

(c)in paragraph (2)—

(i)at the start of the paragraph, for “An EC declaration”, substitute “A UK declaration”,

(ii)for “Annex IV to the Directive”, substitute “Schedule 7”;

(d)for paragraph (3), substitute—

(3) A person may only draw up a UK declaration of conformity or suitability for use if satisfied that the interoperability constituent satisfies the relevant conditions of the applicable NTSN, including any applicable UK specific case.;

(e)in paragraph (4)—

(i)for “an EU Directive”, substitute “any enactment or rule of law”,

(ii)for “an EC” substitute “a UK”;

(f)after paragraph (4), insert—

(5) In this regulation, and in Schedule 7, the “manufacturer’s representative” means either an authorised representative or a person appointed by the manufacturer to perform specified tasks relating to the conformity or suitability for use of interoperability constituents, on or after exit day..

(30) Schedule 6 has effect.

(31) In regulation 26 (effect of conformity and suitability declarations)—

(a)in the heading, for “conformity and suitability declarations”, substitute “declarations of conformity or suitability for use”;

(b)in paragraph (1)—

(i)in the opening words—

(aa)for “an EC”, substitute “a UK”;

(bb)after “suitability for use”, insert “or an EC declaration of conformity or suitability for use which satisfies the criteria set out in regulation 23(2)(a) or (b)”,

(ii)in sub-paragraph (b), for “TSI”, substitute “NTSN”.

(32) In regulation 27 (duties on operators)—

(a)for “TSI”, substitute “NTSN”;

(b)omit “located in the United Kingdom”.

(33) Omit regulation 28.

(34) In regulation 29 (notification to the Commission of incorrect declaration)—

(a)in the heading, before “Commission”, insert “European”;

(b)in paragraph (1)—

(i)for “must immediately”, substitute “may”,

(ii)for “Commission and the other Member States”, substitute “European Commission and EU Member States”;

(c)in paragraph (2), for “must”, substitute “may”;

(d)after paragraph (2), insert—

(3) This regulation does not apply in relation to the Channel Tunnel..

(35) For the heading to Part 4, substitute “Approved and Designated Bodies”.

(36) For regulation 30, substitute—

Approved bodies

30.(1) An approved body is a body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 31; or

(b)immediately before exit day was a notified body which has not received notice from the Secretary of State terminating its appointment as a notified body.

(2) In this Regulation, “a notified body” means a body which has been—

(a)appointed by the Strategic Rail Authority(5) as a notified body and notified to the European Commission and EU Member States pursuant to regulation 5 of the Railways (Interoperability) (High-Speed) Regulations 2002(6);

(b)appointed by the Secretary of State as a notified body and notified to the European Commission and EU Member States pursuant to regulation 25 of the Railways (Interoperability) Regulations 2006(7) or regulation 31 of these Regulations as they had effect immediately before exit day..

(37) In regulation 31 (appointment of notified bodies and designated bodies)—

(a)in the heading, for “notified bodies”, substitute “approved bodies”;

(b)for “a notified body” each time it occurs, substitute “an approved body’;

(c)for “notified” in paragraphs (6)(b), (8)(a) and (b), and (9)(a) and (b), each time it occurs, substitute “approved”;

(d)in paragraphs (2)(b), (3), and (7)(b) for “Annex VIII to the Directive”, substitute “Schedule 8”.

(38) Schedule 7 has effect.

(39) In regulation 32 (notified bodies and designated bodies: certificates etc)—

(a)in the heading, for “notified bodies”, substitute “approved bodies”;

(b)for “a notified body” each time it occurs, substitute “an approved body”;

(c)in paragraphs (1) and (2), before “certificate of verification”, insert “UK”;

(d)in paragraphs (1) and (3), for “an EC declaration”, substitute “a UK declaration”;

(e)in paragraph (2), for “Annex VI to the Directive”, substitute “Schedule 4”;

(f)in paragraph (3), for “European specifications or TSIs”, substitute “NTSNs”;

(g)after paragraph (3), insert—

(3A) A designated body must not confirm that a UK declaration of conformity or suitability for use can be drawn up in respect of an interoperability constituent unless satisfied that the constituent conforms to such of the UK specific cases as are required by regulation 25.;

(h)in paragraph (5), for “notified body”, substitute “approved body”.

(40) In regulation 33 (fees of notified bodies and designated bodies)—

(a)in the heading, for “notified bodies”, substitute “approved bodies”;

(b)in paragraph (1) for “a notified body”, substitute “an approved body”;

(c)in paragraphs (2)(a) and (2)(b)(i), for “notified body”, substitute “approved body”.

(41) After regulation 34, insert—

Register of approved bodies

34A.(1) The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification number;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2) The register referred to in paragraph (1) must be made publicly available.

UK national accreditation body

34B.(1) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a body meets the approved body or designated body requirements;

(b)exercising functions in accordance with regulation 31;

(c)compiling and maintaining the register of approved bodies in accordance with regulation 34A.

(2) In this regulation—

“RAMS” means Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS..

(42) In regulation 36 (national vehicle register)—

(a)omit paragraph (4);

(b)for paragraph (9), substitute—

(9) Where a vehicle is also registered in an EU Member State the registration entity may notify the entity responsible for the national vehicle register in that EU Member State of any relevant changes to the National Vehicle Register.;

(c)in paragraph (10)—

(i)for sub-paragraph (a), substitute—

(a)by the Safety Authority or the Rail Accident Investigation Branch(8);;

(ii)in sub-paragraph (b)—

(aa)for sub-paragraph (i), substitute—

(i)the Office of Rail and Road, DFI, the Intergovernmental Commission, or any EU regulatory body designated in accordance with relevant EU law,,

(bb)for sub-paragraph (ii), substitute—

(ii)the European Union Agency for Railways,

(cc)at the end of sub-paragraph (iv), omit “or”,

(dd)at the end of sub-paragraph (v), omit the full stop, and insert—

; or

(vi)the national body or bodies responsible for railway safety in the country where the project subsystem is used.;

(d)in paragraph (11), for “DRDNI”, substitute “DFI”;

(e)after paragraph (11), insert—

(12) In this regulation, “the European Union Agency for Railways” means the agency for railway safety and interoperability established by Regulation (EU) No 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004(9)..

(43) In regulation 37(10), for “DRDNI”, substitute “DFI”.

(44) In regulation 38, for “DRDNI” each time it occurs, substitute “DFI”.

(45) In regulation 40(5), for “DRDNI”, substitute “DFI”.

(46) In regulation 41(1) after “EC” insert “or UK”.

(47) In regulation 42 (notice of improper drawing up of the EC declaration of conformity or suitability for use for an interoperability constituent)—

(a)in the heading after “EC” insert “or UK”;

(b)in paragraphs (1) and (2)(a), for “the requirements of regulation 25”, substitute “relevant EU law, or the UK declaration of conformity or suitability for use has not been drawn up in accordance with the requirements of regulation 25 and Schedule 7”.

(48) In regulation 45 (accessibility for people with reduced mobility)—

(a)for paragraph (a), substitute—

(a)the TSI relating to persons with reduced mobility set out in the Annex to Decision 2008/164/EC of the European Commission of 21 December 2007, or any amended version of it, or Commission Regulation 1300/2014 of the European Commission of 18 November 2014 which replaced it, or the NTSN that replaced Commission Regulation 1300/2014, or any variation of that NTSN, or any NTSN which replaces it;;

(b)in paragraph (d)—

(i)after “TSI replacing it,”, insert “or the NTSN”,

(ii)in sub-paragraph (ii), for “has been granted under regulation 14”, substitute “was granted under regulation 14 before exit day, or an exemption from part of it has been granted under regulations 14 and 14A”.

(49) In regulation 46 (dispensations)—

(a)in paragraph (1), for “notified national technical rules”, substitute “NTRs”;

(b)in paragraph (2), omit “for the purposes of Article 17(3) of the Directive”.

(50) After regulation 47, insert—

Further savings and transitional arrangements

47A.(1) Where a structural subsystem was authorised to be placed in service on the rail system in accordance with regulation 7 or regulation 9 as they had effect before exit day and that authorisation has not been revoked, it is treated as authorised under these Regulations as they have effect on or after exit day.

(2) Where an application for authorisation was made pursuant to regulation 5 as it had effect before exit day and that authorisation was not issued before exit day, it is, on or after exit day, treated as a valid application under these Regulations and any EC declaration of verification and technical file submitted with that application are treated as a UK declaration of verification and technical file submitted in accordance with these Regulations as they have effect on or after exit day.

(3) Where an application for type authorisation was made pursuant to regulation 9 as it had effect before exit day and that authorisation was not issued before exit day, it is, on or after exit day, treated as a valid application under these Regulations and any reference to an applicable TSI or notified national technical rule in the documentation accompanying that application is treated as a reference to the applicable NTSN or NTR which replaces them.

(4) Where a Competent Authority has made a decision about the requirement for authorisation and the extent to which TSIs must apply to a project subsystem pursuant to regulation 13(8) before exit day, a reference to a TSI in that decision is treated as a reference to the NTSN that replaces it.

(5) Where an application for a decision by the Competent Authority as to whether an authorisation is required was made pursuant to regulation 13 as it had effect before exit day and the Competent Authority has not made the decision before exit day, it is treated as an application under regulation 13 as it has effect on or after exit day, and any reference in that application to TSIs or parts of TSIs is treated as a reference to the NTSNs or parts of NTSNs that replace them.

(6) A derogation granted against a TSI by the Competent Authority in accordance with Article 9 of the Directive and these Regulations as they had effect before exit day is treated on or after exit day as an exemption granted by the Competent Authority against the NTSN which replaces that TSI in accordance with regulations 14 and 14A.

(7) Except for a project subsystem authorised under regulation 9, if a project subsystem was authorised before exit day, the project entity must (in addition to the requirements of regulation 19(2)) keep the documents it was required to retain in accordance with regulation 19(1)(a) as it had effect before exit day.

(8) Where an interoperability constituent was placed on the market anywhere in the European Union before exit day, it is treated on or after exit day as an interoperability constituent placed on the UK market in accordance with Part 3.

(9) Where a notified body (as defined in regulation 30(2)) was engaged before exit day to carry out an EC verification assessment procedure in relation to TSIs or notified national technical rules pursuant to Annex VI of the Directive and regulation 16 as it had effect before exit day, the work carried out by that body before exit day is treated as work undertaken pursuant to regulation 16 and Schedule 4 as they have effect from exit day to carry out the UK verification assessment procedure in relation to NTSNs.

(10) Where a designated body was engaged before exit day to carry out an EC verification assessment procedure in relation to TSIs or notified national technical rules pursuant to Annex VI of the Directive and regulation 16 as it had effect before exit day, the work carried out by that body before exit day is treated as work undertaken pursuant to regulation 16 and Schedule 4 as they have effect from exit day to carry out the UK verification assessment procedure in relation to UK specific rules.

(11) A dispensation from a notified national technical rule granted by the Competent Authority pursuant to regulation 46 as it had effect before exit day, is treated on or after exit day as a dispensation from the NTR specified as replacing it..

(51) In the heading of the Schedule to the Regulations, after “Schedule” insert “1”.

Consequential amendments

3.  Schedule 8 has effect.

Signed by authority of the Secretary of State for Transport

Andrew Jones

Parliamentary Under Secretary of State

Department for Transport

21st February 2019

Regulation 2(3)

SCHEDULE 1

After Schedule 1 to the Regulations insert—

Regulation 2

SCHEDULE 2Essential 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.)

1.  General requirements

1.1.  Safety

(1.1.1) The design, construction or assembly, maintenance and monitoring of safety-critical components, and more particularly of the components involved in train movements, must be such as to guarantee safety at the level corresponding to the aims laid down for the network, including those for specific degraded situations.

(1.1.2) The parameters involved in the wheel/rail contact must meet the stability requirements needed in order to guarantee safe movement at the maximum authorised speed. The parameters of brake equipment must guarantee that it is possible to stop within a given brake distance at the maximum authorised speed.

(1.1.3) The components used must withstand any normal or exceptional stresses that have been specified during their period 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 availability

1.3.  Health

(1.3.1) Materials likely, by virtue of the way they are used, to constitute a health hazard to those having access to them must not be used in trains and railway infrastructures.

(1.3.2) Those materials must be selected, deployed and used in such a way as to restrict emission of harmful and dangerous fumes or gases, particularly in the event of fire.

1.4.  Environmental protection

(1.4.1) The environmental impact of establishment and operation of the rail system must be assessed and taken into account at the design stage of the system in accordance with 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 compatibility

1.6.  Accessibility

(1.6.1) The ‘infrastructure’ and ‘rolling stock’ subsystems must be accessible to persons with disabilities and persons with reduced mobility in order to ensure access on an equal basis with others by way of the prevention or removal of barriers, and by way of other appropriate measures. This shall include the design, construction, renewal, upgrade, maintenance and operation of the relevant parts of the subsystems to which the public has access.

(1.6.2) The ‘operations’ and ‘telematics applications for passengers’ subsystems must provide for the necessary functionality required to facilitate access 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 subsystem

2.1.  Infrastructure

(2.1.1) Safety

(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.  Energy

(2.2.1) Safety

(2.2.2) Environmental protection

(2.2.3) Technical compatibility

2.3.  Control-command and signalling

(2.3.1) Safety

(2.3.2) Technical compatibility

2.4.  Rolling stock

(2.4.1) Safety

(2.4.2) Reliability and availability

(2.4.3) Technical compatibility

(2.4.4) Controls

(2.4.5) Accessibility

2.5.  Maintenance

(2.5.1) Health and safety

(2.5.2) Environmental protection

(2.5.3) Technical compatibility

2.6.  Operation and traffic management

(2.6.1) Safety

(2.6.2) Reliability and availability

(2.6.3) Technical compatibility

(2.6.4) Accessibility

2.7.  Telematics applications for freight and passengers

(2.7.1) Technical compatibility

(2.7.2) Reliability and availability

(2.7.3) Health

(2.7.4) Safety

(2.7.5) Accessibility

Regulation 2(3)

SCHEDULE 2

After Schedule 2 to the Regulations, insert—

Regulation 2

SCHEDULE 3 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.)

1.    List of subsystems

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

(a)structural areas—

(b)functional areas—

2.    Description of the subsystems

For each subsystem or part of a subsystem, the list of constituents and aspects relating to interoperability is proposed by the 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.  Infrastructure

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.  Energy

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

2.3.  Trackside control-command and signalling

All the trackside equipment required to ensure safety and to command and control movements of trains authorised to travel on the network.

2.4.  On-board control-command and signalling

All the on-board equipment required to ensure safety and to command and control movements of trains authorised to travel on the network.

2.5.  Operation and traffic management

The procedures and related equipment 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 applications

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 stock

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.  Maintenance

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

Regulation 2(10)

SCHEDULE 3

After Schedule 3 to the Regulations, insert—

Regulation 6(9)

SCHEDULE 4UK 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.)

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 assess the design, production and final testing of the subsystem and draw up the UK certificate of verification intended for the project entity, which in turn draws 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, the approved body responsible for the verification of the subsystem takes the ISV into account, and, before issuing its UK certificate of verification:

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

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

(c)checks the final testing of the subsystem as a whole.

(2.3.3) In the case of a modification to a subsystem already covered by a certificate of verification, the 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 UK 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(10), or the Railways (Safety Management) Regulations (Northern Ireland) 2006(11) 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 draws 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.

Regulation 2(12)

SCHEDULE 4

After Schedule 4 to the Regulations, insert—

Regulation 7(2)

SCHEDULE 5UK 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.)

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 exit 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 exit 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.

Regulation 2(15)

SCHEDULE 5

After Schedule 5 to the Regulations insert—

Regulation 9(5)

SCHEDULE 6Model declaration of conformity to an authorised type of vehicle

Regulation 2(30)

SCHEDULE 6

After Schedule 6 to the Regulations insert—

Regulation 25(2)

SCHEDULE 7UK 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.)

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 covers:

(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 after exit day and there are applicable UK specific cases, or an EC declaration of conformity or suitability for use has been drawn up before exit 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 will 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.

Regulation 2(38)

SCHEDULE 7

After Schedule 7 to the Regulations, insert—

Regulation 31(3)

SCHEDULE 8Minimum 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.)

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 2005(12) or the Railways Infrastructure (Access, Management and Licensing of Railway Undertakings) Regulations (Northern Ireland) 2016(13), 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 are 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.

Regulation 3

SCHEDULE 8Consequential amendments

1.  In regulation 2 of the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010(14) (Interpretation)—

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

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

“relevant specifications” means—

(a)

before exit 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); or

(b)

on and after exit 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 “TSIs”, substitute “NTSNs”;

(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”.

EXPLANATORY NOTE

(This note is not part of the Regulations)

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 .

(4)

OJ L 264, 8.10.2011, p.32.

(5)

Established under section 201 of the Transport Act 2000 (c. 38) and abolished by S.I. 2006/2925.

(6)

S.I. 2002/1166, revoked with savings by S.I. 2006/397.

(7)

S.I. 2006/397, revoked with savings by S.I. 2011/3066.

(8)

The Rail Accident Investigation Branch was established by section 3 of the Railways and Transport Safety Act 2003 (c. 20).

(9)

OJ L 138, 26.5.2016, p.1.

(11)

S.R. 2006 No. 237, which has been amended by S.R. 2011 No. 261, 2013 No. 237 and 2016 No. 267.