Transport PART 1 Interpretation and Application Citation, commencement and extent 1 1 These Regulations may be cited as the Railways (Interoperability) Regulations 2011. 2 These Regulations come into force on 16th January 2012. Interpretation 2 1 In these Regulations— “ the 1974 Act ” means the Health and Safety at Work etc. Act 1974 ; “the 2016 Directive” means Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union; “approved body” has the meaning set out in regulation 30; “authorised representative” means— a person who— immediately before IP completion 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 on or after IP completion day continues to be so established and appointed by the manufacturer or contracting entity to perform those tasks; or a person who on or after IP completion day is appointed in accordance with regulation 3A; “certificate of verification” means an EC certificate of verification or a UK certificate of verification; “ the Channel Tunnel system ” has the meaning given by section 1(7) of the Channel Tunnel Act 1987 to the words “the tunnel system”; ... “ Competent Authority ” means— in Great Britain, the Secretary of State; and in Northern Ireland, the DFI ; “ contracting entity ” means the person who contracts or intends to contract with another person for that other person to design, construct, renew or upgrade a subsystem; “ Conventional Directive ” means Directive 2001/16/ EC of the European Parliament and the Council of 19th March 2001 on the interoperability of the trans-European conventional rail system ; “the Directive” means Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (Recast), as amended by— Commission Directive 2009/131/EC of 16 October 2009 amending Annex VII to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community, Commission Directive 2011/18/ EU of 1 March 2011 amending Annexes II , V and VI to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community, ... Commission Directive 2013/9/ EU of 11 March 2013 amending Annex III to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community; ... Commission Directive 2014/38/ EU of 10th March 2014 amending Annex III to Directive 2008/57/EC of the European Parliament and of the Council as far as noise pollution is concerned. and Commission Directive 2014/106/ EU of 5 December 2014 amending Annexes V and VI to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community; “ designated body ” means a person appointed under regulation 31 as a designated body; “ determination of type ” means a determination made by the Safety Authority pursuant to regulation 8; “DFI” means the Department for Infrastructure as established by section 1(6) of the Departments Act (Northern Ireland) 2016; “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; “EC declaration of conformity or suitability for use” is a declaration drawn up in accordance with Article 13 and Annex IV of the Directive or in accordance with Articles 9 and 10 of the 2016 Directive ; “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 or Annex IV to the 2016 Directive; “ essential requirements ” means all the conditions set out in Schedule 2 that must be met by the rail system, subsystems and interoperability constituents, including interfaces; “European Commission” means the Commission of the European Union; ... ... “European Union Agency for Railways” means the Agency established by Regulation (EU) 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 ; “ European vehicle number ” has the meaning given in regulation 36; “EU notified body” means a body which either— 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; or has been notified to the European Commission in accordance with Chapter VI of the 2016 Directive; unless its appointment has been terminated or its notification has been withdrawn; “ functional subsystem ” means a functional subsystem as specified in section 1(b) of Schedule 3 ; ... “ High-Speed Directive ” means Council Directive 96/48/EC of 23rd July 1996 on the interoperability of the trans-European high-speed rail system ; “ infrastructure register ” means a register kept in accordance with regulation 35; “ Intergovernmental Commission ” has the same meaning as in the Channel Tunnel Act 1987; “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; “ interoperability constituent ” means any elementary component, group of components, sub-assembly or complete assembly of equipment that is incorporated or intended to be incorporated into a subsystem upon which the interoperability of the rail system depends directly or indirectly; and the concept of a “constituent” covers both tangible objects and intangible objects such as software; “ISV” means an intermediate statement of verification issued by any one of the following— an approved body in relation to the design stage or the production stage of a subsystem in accordance with section 2 of Schedule 4; 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 or in accordance with section 2 of Annex IV to the 2016 Directive; a designated body at an intermediate stage of the UK verification assessment procedure referred to in section 3 of Schedule 4; 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; “ National Vehicle Register ” has the meaning given in regulation 36; “ network ” means the lines, stations, terminals, and all kinds of fixed equipment needed to ensure safe and continuous operation of the rail system; ... “ notified national technical rules ” means the standards, technical specifications and technical rules in use in the United Kingdom which were notified by the Secretary of State to the European Commission before IP completion day pursuant to article 17(3) of the Directive or Article 16(3) of the High-Speed Directive or Article 16(3) of the Conventional Directive, including any variations from time to time notified; ... “ operator ”, in relation to the use of an interoperability constituent or a project subsystem, means the infrastructure manager or railway undertaking having the management of that interoperability constituent or project subsystem for the time being; “ owner ”, in relation to a structural subsystem, means any person who has an estate or interest in, or right over that subsystem, and whose agreement is needed before another may use it; “ placing in service ” means all the operations by which a subsystem is put into its design operating state; and cognate expressions shall be construed accordingly; “ place on the market ” means making an interoperability constituent available for purchase with a view to its use on the rail system; and cognate expressions shall be construed accordingly; “ project ” means a scheme for the construction or upgrading or renewal of the whole or part of any subsystem of the rail system, and where it is intended to carry out that construction, upgrading or renewal in parts, each of which are to be placed in service on a permanent basis independently of the other parts, it means any such part; “ project entity ” means, in relation to a project, a contracting entity or manufacturer or the authorised representative ... of a contracting entity or manufacturer; “ project subsystem ” means— the whole of a structural subsystem which is subject to the requirement for authorisation under these Regulations, other than when the structural subsystem is subject to the requirement because part of it is being upgraded or renewed, in the case of a structural subsystem which is subject to the requirement for authorisation under these Regulations because part of it is being upgraded or renewed, that part of the subsystem, or a structural subsystem in respect of which a person has voluntarily made an application for authorisation under these Regulations; “ put into use ” has the meaning given in regulation 4(2); “ rail system ” has the same meaning as in the Directive ; “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; “ registration entity ” means the person designated under regulation 36(11); “ renewal ” means any major substitution work on a subsystem or part subsystem which does not change the overall performance of the subsystem; and cognate words shall be construed accordingly; “safety assessment report” means a report provided in accordance with Article 15 of Commission Implementing Regulation ( EU ) 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment; “ Safety Authority ” means the Office of Rail Regulation Office of Rail and Road except— in relation to Northern Ireland, where it means the DFI , and in relation to the Channel Tunnel system, where it means the Intergovernmental Commission; “ structural subsystem ” means a structural subsystem as specified in section 1(a) of Schedule 3 ; “ subsystem ” means the whole, or, as the context requires, part of a subdivision of the rail system as specified in sections 1(a) and 1(b) of Schedule 3 , namely structural subsystems and functional subsystems and includes a structural or functional subsystem that is intended to become the whole or part of a subdivision of the rail system; “ trans-European rail system ” means the trans-European conventional and high-speed rail systems as set out in sections 1 and 2 of Annex I to the Directive, ...; “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 or the 2016 Directive, as those TSIs have effect in EU law, and as they are amended from time to time; “ TSI conform authorisation ” means an authorisation given for a vehicle which was in conformity with all applicable TSIs when it was placed in service or placed on the market and where those TSIs covered a significant part of the essential requirements and included a TSI on rolling stock; “ upgrading ” means any major modification work on a subsystem or part of a subsystem which improves the overall performance of the subsystem; and cognate words shall be construed accordingly; “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 “ vehicle ” means a railway vehicle that runs on its own wheels on railway lines with or without traction and is composed of one or more structural and functional subsystems or parts of such subsystems; ... ... “ writing ” includes any text transmitted using electronic communications that is received, or accessible by the person to whom it is sent, in legible form. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 ... A reference to the EU includes a reference to the European Economic Area, and a reference to a Member State includes a reference to an EEA state. Application 3 1 Subject to paragraphs (2) and (5), these Regulations apply to— a the rail system; b subsystems located, operated or intended to be operated in the United Kingdom; and c interoperability constituents. 2 These Regulations do not apply to any part of the rail system that the Secretary of State determines falls within one or more of these categories— a metros, trams and other light rail systems; b networks that are functionally separate from the rest of the rail system and intended only for the operation of local, urban or suburban passenger services, as well as railway undertakings operating solely on these networks; c infrastructure and vehicles reserved for a strictly local, historical or touristic use. 3 A person may make an application to the Secretary of State for a determination under paragraph (2) and the Secretary of State must consider any such application. 4 The Secretary of State must publish and keep up to date a list of the parts of the rail system that are excluded from the scope of these Regulations by virtue of determinations made under paragraph (2). 5 These Regulations do not apply to— a privately owned railway infrastructure and vehicles exclusively used on such infrastructure that exist solely for use by the owner for its freight operations; or b railways the lines of which have a gauge of less than 350 millimetres and vehicles running on such lines. 6 Paragraphs (2) and (5)(a) are subject to the voluntary arrangements provided for in regulation 5(1)(b) and (c). 7 References in this regulation to the Secretary of State shall in their application to Northern Ireland have effect as references to DFI . 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. PART 1A National 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 IP completion 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 IP completion 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. PART 2 Subsystems Requirement for authorisation 4 1 No person is to put into use any structural subsystem unless— a the Safety Authority has given an authorisation under these Regulations for the placing in service of that subsystem; or b the Competent Authority has decided under regulation 13 that for the upgrading or renewal of the subsystem, an authorisation is not required for the subsystem to be put into use; ... c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 A structural subsystem is put into use when, having been constructed, upgraded or renewed, it is first used on or as part of the rail system ... for the transportation of passengers or freight or for the purpose for which it was designed. 3 For the purposes of paragraph (2) use of a structural subsystem does not include any testing or trials conducted in the relevant EC or UK verification assessment procedure or for additional checks required by the Safety Authority. 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 or by the European Union Agency for Railways. A person wishing to put a vehicle into use in the UK beyond the Channel Tunnel system which has such an authorisation must apply for an authorisation under regulation 6. Application for authorisation 5 1 A person may apply for an authorisation in respect of any structural subsystem to be placed in service if— a the authorisation is required under regulation 4(1); or b an authorisation is not required under regulation 4(1) because regulation 3(2) or (5)(a) applies, but the person nevertheless wants an authorisation; ... c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 In order for an application to be valid it must be made in writing to the Safety Authority and be accompanied by— a the technical file compiled in accordance with regulation 17; and b the UK declaration of verification; 3 Subject to paragraph (4), in considering an application the Safety Authority must not require checks already carried out under the UK verification assessment procedure to be carried out again. 4 The Safety Authority may require such additional checks which the Safety Authority considers necessary in relation to the project subsystem if that subsystem appears to the Safety Authority not to meet the essential requirements. 5 Where additional checks are required under paragraph (4) the Safety Authority must— a inform the applicant that the application cannot be determined before the additional checks are carried out; and b notify the Secretary of State in writing forthwith of the additional checks it requires and the reasons for requiring those checks. 6 Paragraphs (2) and (4) are subject to regulations 6, 9 and 10. 7 Paragraph (5)(b) does not apply to DFI . 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Authorisation for a vehicle already authorised for an EU Member State 6 1 This regulation applies where an authorisation is required under regulation 4(4). 2 When this regulation applies paragraph (3) applies instead of regulation 5(2) and paragraph (4) applies instead of regulation 5(4). 3 In order for the application to be valid the application must be made in writing to the Safety Authority and accompanied by— a a copy of the authorisation referred to in regulation 4(4) (“the first authorisation”); b if the first authorisation is a TSI conform authorisation, a technical file containing— i a copy of the technical file from the first authorisation; ii for a vehicle equipped with a data recorder not required by an applicable TSI in force at the time when the vehicle was first authorised , information on the procedures for collecting and evaluating the data; iii the documentation relating to the maintenance history and any technical modifications undertaken after the first authorisation; iv evidence on technical and operational characteristics that shows that the vehicle is compatible with the infrastructures and fixed installations, including climate conditions, energy supply system, control-command and signalling system, track gauge and infrastructure gauges, maximum permitted axle load and other constraints of the network; ... v any UK certificate of verification in relation to UK specific rules; and vi sufficient documentary evidence to satisfy the Safety Authority that the first authorisation has not been revoked; c if the first authorisation is not a TSI conform authorisation, a technical file containing— i information on the procedure followed in relation to the first authorisation in order to show that vehicle complied with the safety requirements in force and information on any derogation that applies; ii the technical data and information on the maintenance programme and operational characteristics, including, for a vehicle equipped with a data recorder, information on the procedures for collecting and evaluating the data; iii the documentation relating to the maintenance and operational history and any technical modifications undertaken after the first authorisation; iv evidence on technical and operational characteristics that shows that the vehicle is compatible with the infrastructures and fixed installations, including climate conditions, energy supply system, control-command and signalling system, track gauge and infrastructure gauges, maximum permitted axle load and other constraints of the network; ... v any UK certificate of verification in relation to UK specific rules; and vi sufficient documentary evidence to satisfy the Safety Authority that the first authorisation has not been revoked; d if the first authorisation was made, in accordance with Article 26 of the Directive or Article 24 of the 2016 Directive , on the basis of a declaration of conformity to type, a copy of the declaration; and e any UK declaration of verification from the project entity made under paragraph (9). 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. 5 If the first authorisation is not a TSI conform authorisation the Safety Authority may, after consultation with an applicant, require the applicant, by notice in writing, 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 verify that— a if there is a substantial safety risk, matters covered by the information referred to in paragraph (3)(c)(i) and (ii); and b matters covered by the information referred to in paragraph (3)(c)(iii) and (iv), comply with any applicable UK specific rules . 6 The infrastructure manager must, if requested by the applicant, make reasonable efforts to enable any tests required under paragraphs (4) and (5) to be completed before the date which is three months after the date on which the infrastructure manager received the request. 7 If there are any applicable UK specific rules that must be assessed against in order to comply with requirements made by the Safety Authority under paragraphs (4) or (5), the project entity must, in order for the application to proceed, engage a designated body, ... to assess conformity with those rules. 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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. 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 This regulation does not apply in relation to the Channel Tunnel system. Authorisation decision 7 1 The Safety Authority must determine an application by— a authorising the placing in service of the structural subsystem; or b refusing the application for authorisation. 2 The Safety Authority must, and may only, issue an authorisation for the placing in service of a structural subsystem, where it is satisfied that— a the UK declaration of verification , if required, has been drawn up in accordance with Schedule 5 ; b the project subsystem is technically compatible with the rail system into which it is being integrated; ... c the project subsystem has been so designed, constructed and installed as to meet the essential requirements relating to that subsystem when placed in service; and, d the project entity has satisfactorily completed any tests required by regulations 5(4), and 6(4) and 6(5). 3 The Safety Authority may include conditions in an authorisation. 4 In this regulation “ conditions ” means— a restrictions or limitations on the use of the structural subsystem; or b requirements that must be met by a time specified in the authorisation. 5 The Safety Authority must consider an application under regulation 6(1) as soon as possible and make the decision as to whether to issue an authorisation on or before— a in the case of a vehicle with a TSI conform authorisation from an EU Member State , the later of— i the date falling two months after the Safety Authority receives the technical file; and ii if the applicant receives a notice under regulation 6(4) before the date referred to in (i), the date falling one month after the provision of all the information, risk analysis and results of the checks required by the notice; and b in the case of a vehicle with an authorisation from an EU Member State which is not a TSI conform authorisation, the later of— i the date falling four months after the Safety Authority receives the technical file; and ii if the applicant receives a notice under regulation 6(5) before the date referred to in (i), the date falling two months after the provision of all the information, risk analysis and results of the checks required by the notice. 6 Where paragraph (5) applies and the Safety Authority fails to make a decision by the date required, the vehicle is deemed to be authorised with effect from the beginning of the day which is three months after that date. Determination of type 8 1 If the Safety Authority issues an authorisation for the placing in service of a vehicle, the Safety Authority must issue a determination of type in relation to the vehicle. 2 If the Safety Authority issues an authorisation for the placing in service of a structural subsystem that is not a vehicle, the Safety Authority may, with the consent of the person who applied for the authorisation, issue a determination of type in relation to that subsystem. 3 The person who applied for the authorisation may make an application to the Safety Authority requesting the Safety Authority to make a determination of type under paragraph (2) and the Safety Authority must consider any such application. 4 A determination of type must describe the basic design characteristics of the structural subsystem. 5 If the Safety Authority considers it necessary as a result of material changes to the applicable standards it may modify, suspend or withdraw a determination of type. 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 IP completion 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 as that Decision has been amended by Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013 , (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474. 7 Following an authorisation under regulation 9 the Safety Authority is not required to make a further determination under this regulation. 8 The Safety Authority must publish a list of the determination of types for structural subsystems that are not vehicles and keep the list up to date. 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 IP completion day, standards set out in TSIs and notified national technical rules; b on or after IP completion 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 IP completion day and contained in NTSNs or NTRs. Type authorisation 9 1 A person who proposes the placing in service of a structural subsystem that conforms to the description in a determination of type, as modified under regulation 8(5) if applicable, may make an application for an authorisation to the Safety Authority. 2 An application must be in writing and be accompanied by— a a declaration by the project entity that the structural subsystem conforms to the description set out in the determination of type; b a statement as to whether there have been any material changes to the applicable standards since the Safety Authority made or modified the determination of type; and c if there are any such changes, a description of them. 3 The Safety Authority must consider any application made under and in accordance with paragraphs (1) and (2) and must, and may only, issue an authorisation where it is satisfied that— a the project subsystem conforms to the description set out in the determination of type; b there have been no material changes to the applicable standards since the Safety Authority made or modified the determination of type which are material to the application; and c the project subsystem has been so designed, constructed and installed as to meet the essential requirements relating to that subsystem when placed in service. 4 Subject to regulation 10, regulations 5(2) and (4) and 7(2) do not apply to an application for an authorisation under this regulation. 5 If the application is for a vehicle the declaration referred to in paragraph (2)(a) must be consistent with Schedule 6 . 6 In this regulation “ conforms ” means conforms in all the respects which materially affect compliance with the applicable essential requirements. Type authorisation: changes to applicable standards 10 1 If in the Safety Authority's opinion there have been changes to the applicable standards that are material to an application made under regulation 9 the Safety Authority must give a notice in writing to the applicant specifying the changes that the Safety Authority considers to be material to the application. 2 If having received a notice issued by the Safety Authority under paragraph (1) the applicant wishes to continue with the application, the applicant must provide to the Safety Authority the documentation referred to in regulation 5(2)(a) and (b). 3 If the Safety Authority has received the further material referred to in paragraph (2), the Safety Authority may require additional tests in accordance with regulation 5(4) and (5). 4 If the applicant has provided the documentation in accordance with paragraph (2), the Safety Authority must determine the application in accordance with regulation 7 as read with paragraph (5) of this regulation. 5 For the purposes of paragraphs (2), (3) and (4) the documentation to be provided, the additional checks to be carried out and the authorisation to be issued must relate only to the changes to the applicable standards . Revocation of authorisations 11 1 The Safety Authority may revoke an authorisation before a structural subsystem is put into use if it is satisfied that the conditions of that authorisation are no longer met and that there is a significant safety risk arising as a result. 2 Before revoking an authorisation the Safety Authority must give notice in writing to the person to whom the authorisation was issued (“the holder”) that— a it is considering revoking that authorisation and the reasons why; and b within a period specified in the notice, which must be not less than 28 days from the date of the notice, the holder may make representations in writing to the Safety Authority or, if the holder so requests, may make oral representations to the Safety Authority. 3 The Safety Authority must not revoke the authorisation unless the Safety Authority has considered the representations (if any) from the holder made during the period specified in the notice. 4 Where the Safety Authority revokes an authorisation, it must give notice in writing of the revocation to the holder and include reasons for the revocation in the notice. List of projects for the renewal or upgrading of subsystems 12 1 The Competent Authority may from time to time publish a list under this regulation that names or describes projects or types of project that are, in the opinion of the Competent Authority, projects or types of projects for the renewal or upgrading of structural subsystems. 2 In deciding whether a project or type of project is for the renewal or upgrading of a structural subsystem factors to be taken into account by the Competent Authority must include— a the scale of the project assessed by reference to its economic cost and benefits; b the impact of the project on the rail system having regard to its effect on safety, reliability and availability, health, environmental protection and , technical compatibility and accessibility ; and c the impact of the application of any relevant NTSN to the subsystem and any interfacing subsystems. 3 If a project is named or described or is of a type named or described in accordance with this regulation it is for the purposes of these Regulations deemed to be a project for the renewal or upgrading of a structural subsystem. Authorisation requirements for the renewal or upgrading of subsystems 13 1 In relation to a project for the renewal or upgrading of a structural subsystem, the project entity may apply in writing to the Competent Authority for a decision as to whether an authorisation is required. 2 In order for an application made under paragraph (1) to be valid it must be accompanied by the following information— a a file setting out details of the project; b the project entity's assessment of whether there are any new or changed safety risks resulting from the works envisaged and how any such risks will be managed; c identification of any NTSN, or part of an NTSN , for which exemptions may or will be sought pursuant to regulation 14; and d an indication of any NTSN, or part of an NTSN , which it is proposed should not apply if the Competent Authority determines that the subsystem requires authorisation. 3 The Competent Authority may give notice in writing to the project entity requiring the project entity to provide, by a specified date, additional information that the Competent Authority considers necessary in order to make a decision. 4 The project entity must provide the Competent Authority with such additional information requested under paragraph (3) as the project entity is reasonably able to supply and the project entity must give an explanation in writing where the information requested is not supplied. 5 In making a decision as to the requirement for authorisation, factors to be taken into account by the Competent Authority must include— a the implementation plan provided in relation to any applicable NTSN ; and b the extent of the proposed works. 6 Except where the Competent Authority and the Safety Authority are the same person, the Competent Authority may only decide authorisation is not required if it has consulted the Safety Authority. 7 If it appears to the Competent Authority that the proposed works may adversely affect the overall safety of the subsystem the Competent Authority must decide that the subsystem requires authorisation. 8 Where the Competent Authority determines that the subsystem requires an authorisation the Competent Authority, subject to any exemptions under regulations 14 and 14A , must decide to what extent NTSNs must apply to the project subsystem. 9 The Competent Authority must make the decisions not later than four months after the submission of the information required by paragraph (2). Exemption from need to conform with NTSNs (exemptions) 14 1 The Competent Authority may determine that, in the circumstances or cases specified in paragraph (2), the whole or part of a relevant NTSN is not to apply in relation to a subsystem (“ an exemption ”). 2 The circumstances or cases are— a any project which— i is for a proposed new subsystem; ii is for the renewal or upgrading of an existing subsystem; or 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, and the project is at an advanced stage of development having regard to the impact that a change in technical specification would have on the project or the project is the subject of a contract in the course of performance when the applicable NTSN is published; b any project concerning the renewal or upgrading of an existing subsystem, where the loading gauge, track gauge, space between tracks or electrification voltage in the applicable NTSN is not compatible with those of the existing subsystem; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d any proposed renewal, extension or upgrading of an existing subsystem when the application of an applicable NTSN would compromise the economic viability of the project or the compatibility of the project with the rail system in the United Kingdom; e following an accident or natural disaster, where the conditions for the rapid restoration of the network do not economically or technically allow for partial or total application of an applicable NTSN ; and 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. 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. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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. Essential requirements for project subsystems 15 1 For the purposes of these Regulations, the essential requirements for a project subsystem are deemed to be met if the project subsystem conforms with — a all applicable NTSNs ; b where paragraph (2) applies, the requirements of all applicable NTRs , subject to any dispensation granted under regulation 46(1); and c where such a dispensation applies, any conditions of that dispensation. 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(7). 2 This paragraph applies to a project subsystem where— a there are no applicable NTSNs ; b a relevant NTSN does not govern all elements of the project subsystem; 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 d the Competent Authority has determined under regulation 13 that the whole or part of an NTSN does not apply to that subsystem. Role of project entity 16 1 In order for an application for an authorisation to be valid a project entity must— 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; b ensure that an EU notified body or an approved body (whether that originally engaged or another) continues to be engaged until authorisation under these Regulations is given or refused; and c if there are applicable UK specific rules , engage a designated body, ... to carry out the UK verification assessment procedure in relation to the UK specific rules in accordance with regulation 17 and Schedule 4 . 2 The engagement of an EU notified body or an approved body under paragraph (1)(a) must be made— a before completion of the design stage of the project subsystem; or b before commencement of the manufacture stage of the project subsystem, whichever is the earlier. 3 A project entity must not draw up a UK declaration of verification in relation to that project subsystem unless— a the project entity is satisfied the essential requirements are met (including interfaces with the rail system); 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; 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 d a technical file has been prepared containing the information and documents specified in regulation 17(2) and, if applicable, regulation 17(5). 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 This regulation and regulation 17 do not apply where an authorisation is being applied for under regulation 6(1) . 6 Where regulation 9 or 10 applies, this regulation and regulation 17 only apply to the extent necessary to satisfy the Safety Authority that an authorisation must be granted under these Regulations. Project subsystems: UK verification assessment procedure 17 1 The UK verification assessment procedure for an approved body carrying out an assessment ... is— a in so far as that subsystem is required to conform with all or part of a NTSN , the procedures specified in the NTSN or part of the NTSN with which that subsystem is required to conform; and b the applicable procedure set out in Schedule 4 . 2 The approved body carrying out an assessment ... must— a compile a technical file containing— i the items required by section 2.4 of Schedule 4 , including the certificate of verification; ii documents relating to the conditions and limits of use of the project subsystem; iii documents relating to the characteristics of the project subsystem; iv manuals and instructions relating to the servicing, constant or routine monitoring, adjustment and maintenance of the project subsystem; v documentation or records of any decision of the Competent Authority under regulation 13(8) as to the extent to which any NTSN applies to the project subsystem; and 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; b assess the interface between the project subsystem and the rail system to the extent that such an assessment is possible based on the available information referred to in paragraph (3). 3 The assessment under paragraph (2)(b) must be based on information available in the relevant NTSN and in any registers or lists kept in accordance with regulations 8 (Determination of type), 35 (Register of infrastructure) and 36 (National vehicle register) . 4 The UK verification assessment procedure for a body carrying out an assessment in relation to UK specific rules is the applicable procedure set out in Schedule 4 . 5 The body carrying out an assessment in relation to UK specific rules must compile a technical file in accordance with Schedule 4 . Project subsystems: UK declaration of verification 18 1 A project subsystem in relation to which a UK declaration of verification has been drawn up is presumed for the purposes of these Regulations to meet the essential requirements unless there are reasonable grounds for believing that it does not so conform. 2 The presumption set out in paragraph (1) does not apply where a person fails or refuses to make available to the Safety Authority the documentation which the person is required to retain by the UK verification assessment procedure applying to the project subsystem or pursuant to regulation 19, or a copy of that documentation. Retention of documents 19 1 From the time a project subsystem authorised under these Regulations is placed in service until it is permanently withdrawn from service (whether such service is in the United Kingdom or another country ), the project entity who made the UK declaration of verification must— a keep the following documents— i the technical file compiled in accordance with regulations 6(3)(b) or (c) or 17(2)(a) or (5) (where there is more than one file the project entity must combine the files and keep them as one); ii the relevant UK declaration of verification, and; iii any declaration made in accordance with regulation 9(2)(a); and b provide a copy of the technical file to 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. 2 The project entity must ensure that— a any alterations made to the project subsystem are documented; b the documentation recording any alterations and any maintenance manuals in relation to the project subsystem are added to and kept as part of the technical file; and c any safety assessment report is added to and kept as part of the technical file. 3 Where the project entity is not the owner of the project subsystem when it is authorised under these Regulations, the project entity must within 60 days of the date of authorisation transfer the documents referred to in paragraphs (1) and (2) to the owner of the subsystem, and once this is done for the purpose of paragraphs (1) and (2) the owner is to be regarded for the purposes of this regulation as the project entity. 4 Where an owner of the project subsystem disposes of the owner's interest in it, the owner must within 60 days of the disposal transfer the documents referred to in paragraphs (1) and (2) to the person acquiring that interest, and once this is done for the purpose of paragraphs (1) and (2) and this paragraph, the person acquiring that interest is to be regarded for the purposes of this regulation as the project entity. 5 The project entity must make the technical file, or the documents kept in accordance with paragraph (7)(b), available to the Safety Authority on demand. 6 The duties of the project entity, or an owner of a project subsystem, under paragraphs (1), (2)(b) and (c) and (3) to (5) do not apply in respect of an authorisation deemed to be given under these Regulations by the operation of regulation 44. 7 In respect of a project subsystem authorised under regulation 9 the duties of the project entity under paragraphs (1) and (2) are limited to keeping— a the declaration made in accordance with regulation 9(2)(a); and b documentation recording any alterations and any maintenance manuals in relation to the project subsystem. Continuing duty on operator in relation to standards 20 1 This regulation applies where a project subsystem is in use on, or is part of, the rail system with an authorisation under these Regulations. 2 Subject to paragraph (3), the operator of the project subsystem must ensure that the project subsystem is operated and maintained— a subject to sub-paragraphs (b) and (ba) , in conformity with either the TSIs and notified national technical rules, or the NTSNs and NTRs against which the subsystem was assessed for that authorisation; b where an NTSN or NTR referred to in sub-paragraph (a) has been varied or replaced, either in conformity with the varied or replaced NTSN or NTR or in conformity with the original NTSN or NTR ; 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, c in conformity with any functional NTSN applying to that subsystem; and d in accordance with any condition in the authorisation to the extent that the condition still applies. 3 Where— a a project subsystem— i was assessed for authorisation against notified national technical rules that were the Rail Vehicle Accessibility Regulations 1998 as in force when the project was assessed, or ii is deemed under regulation 44(1)(b) to have been assessed against the requirements referred to in that sub-paragraph, and b an exemption order made or treated as having been made under section 183 of the Equality Act 2010 has effect in relation to that project subsystem, the duty in paragraph (2)(a) to ensure that the project subsystem is operated and maintained in conformity with those Regulations or requirements is a duty to do so save to the extent the order exempted it from those Regulations or requirements, even though the order may include a provision for the expiry of such exemption. 4 Paragraph (2) is without prejudice to regulation 45. 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. Fees payable to the Safety Authority 21 1 The Safety Authority may charge a person applying for an authorisation a fee that must— a not exceed the sum of the costs reasonably incurred by the Safety Authority in carrying out the work relating to the application; and b be set out in an invoice that includes a statement of the work done and the costs reasonably incurred and specifies the period to which the statement relates. 2 A fee charged under this regulation must be paid on or before the 30th day after the date of the invoice that the Safety Authority has sent or given to the person who is required to pay the fee, or on such later day as the Safety Authority has specified. 3 A fee that has not been paid in accordance with paragraph (2) is recoverable as a civil debt. 4 Failure to pay a fee does not constitute an offence. 5 This regulation does not apply where the Intergovernmental Commission is the Safety Authority. Fees payable to the Competent Authority 22 The Competent Authority may charge such reasonable fee in connection with, or incidental to, carrying out its functions under regulations 13 and 14, as it may determine. PART 3 Interoperability Constituents 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, on or before or after IP completion 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 IP completion 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 IP completion 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 (on or after IP completion day) in NTSNs or NTRs. Assessment procedure for interoperability constituents 24 1 Subject to paragraph (4), if required by the applicable NTSN , the procedures for assessing the conformity or suitability for use of an interoperability constituent must be carried out by an approved body or, where assessment against an applicable UK specific case is required, a designated body . 2 The appropriate procedures for assessing the conformity or suitability for use of an interoperability constituent are, subject to paragraph (3), the procedures indicated in the applicable NTSN . 3 Spare parts for subsystems that were placed in service before the applicable NTSN came into force are not subject to the procedures referred to in paragraph (2). 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. UK declaration of conformity or suitability for use 25 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— a places that interoperability constituent on the market; or b uses that interoperability constituent, or any part of it, in any other interoperability constituent that the person is manufacturing or assembling, or in any project subsystem that the person is constructing, upgrading or renewing before the person places the interoperability constituent on the market with a view to its use on the rail system or uses it or any part of it on the rail system. 2 A UK declaration of conformity or suitability for use must be drawn up in accordance with the requirements of Schedule 7 . 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. 4 If an interoperability constituent is subject to other requirements of any enactment or rule of law , a person may only draw up a UK declaration of conformity or suitability for use if satisfied that the interoperability constituent meets those other requirements and the person must state in the declaration that the interoperability constituent meets those other requirements. 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 IP completion day. Effect of declarations of conformity or suitability for use 26 1 An interoperability constituent in relation to which a UK declaration of conformity or suitability for use or an EC declaration of conformity or suitability for use which satisfies the criteria set out in regulation 23(2)(a) or (b) has been drawn up is presumed for the purpose of these Regulations to— a meet such of the essential requirements as relate to an interoperability constituent of that type; and b conform to the applicable NTSN , unless there are reasonable grounds for believing that it does not so conform. 2 The presumption set out in paragraph (1) does not apply where a person fails or refuses to make available to the Safety Authority the documentation which the person is required to retain by any of the procedures for assessing the conformity or suitability for use of that interoperability constituent or a copy of that documentation. Duties on operators 27 The operator of any interoperability constituent for which there is an applicable NTSN that is in use on, or is part of, the rail system ... must ensure that it is— a correctly installed for the purpose for which it is intended to be used; b not used for any purpose other than the purpose for which it was designed; and c maintained in effective working order and good repair. Recognition of assessments of other Member States 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Notification to the European Commission of incorrect declaration 29 1 Where it appears to the Safety Authority that an interoperability constituent in relation to which an EC declaration of conformity or suitability for use has been drawn up fails to meet the essential requirements relating to it, it may give notice of that fact in writing to the European Commission and EU Member States . 2 That notice may specify— a whether the failure to comply was due to the inadequacy of a TSI; and b if it was not— i the steps taken to prohibit or restrict the use of that interoperability constituent or withdraw or recall the interoperability constituent; ii the reasons for taking those steps; and iii any measures taken against a person who drew up the declaration. 3 This regulation does not apply in relation to the Channel Tunnel system. PART 4 Approved and Designated Bodies 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 IP completion 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 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; 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 or regulation 31 of these Regulations as they had effect immediately before IP completion day. Appointment of approved bodies and designated bodies 31 1 The Secretary of State may from time to time appoint by notice in writing (an “appointment”) such persons as the Secretary of State thinks fit to be an approved body or a designated body for the purposes of these Regulations. 2 The Secretary of State must not appoint any person as an approved body or a designated body in accordance with paragraph (1) unless— a the person has applied to be so appointed; and b the Secretary of State is satisfied that the person is capable of meeting the criteria specified in Schedule 8 . 3 For the purposes of this regulation, Schedule 8 applies to a designated body as it applies to an approved body . 4 An appointment— a relates to such descriptions of structural subsystems and interoperability constituents of the rail system as the Secretary of State may specify; and b is subject to such conditions as the Secretary of State may specify, including such conditions as are to apply upon or following termination of the appointment. 5 Subject to paragraphs (6)(b) and (c) and (7), an appointment is for such period as may be specified in the appointment. 6 An appointment terminates— a upon the expiry of any period specified in the appointment pursuant to paragraph (5); b upon the expiry of 90 days notice in writing given by the approved body or the designated body to the Secretary of State; or c on any date specified for the termination of the appointment in accordance with paragraph (7), whichever is the earliest. 7 If at any time it appears to the Secretary of State in relation to an approved body appointed by the Secretary of State or the Strategic Rail Authority or in relation to a designated body that— a any of the conditions of the appointment of that body are not being complied with; or b the body is not meeting the criteria specified in Schedule 8 , the Secretary of State may, by notice in writing to that body, specify a date on which the appointment of that person as a body is to terminate. 8 Before terminating the appointment of a person as an approved body or designated body pursuant to the grounds specified in paragraph (7) the Secretary of State must— a notify the approved body or designated body in writing that— i the Secretary of State is considering terminating the appointment and the reasons why; and ii the approved or designated body may make representations in writing within 14 days beginning with the day on which such notice is given; and b consider any representations made within that period by the approved body or the designated body before making a decision. 9 When the appointment of an approved body is terminated in accordance with paragraph (6) the Secretary of State may— a give such directions as the Secretary of State considers appropriate, to that approved body or to another approved body, for the purpose of making such arrangements as may be necessary or expedient for the determination of any matters which would, apart from the termination, have fallen to be determined by the approved body whose appointment has terminated; and b without prejudice to the generality of sub-paragraph (a), authorise another approved body, to take over the functions of the approved body whose appointment has terminated, in respect of such matters as the Secretary of State may specify. 10 When the appointment of a designated body is terminated in accordance with paragraph (6) the Secretary of State may— a give such directions as the Secretary of State considers appropriate, to that designated body or to another designated body, for the purpose of making such arrangements as may be necessary or expedient for the determination of any matters which would, apart from the termination, have fallen to be determined by the designated body whose appointment has terminated; and b without prejudice to the generality of sub-paragraph (a), authorise another designated body, to take over the functions of the designated body whose appointment has terminated, in respect of such matters as the Secretary of State may specify. Approved bodies and designated bodies: certificates etc. 32 1 Where an approved body or designated body proposes to decline to draw up a UK certificate of verification or an ISV in relation to a project subsystem, or proposes to decline to confirm that a UK declaration of conformity or suitability for use can be drawn up in respect of an interoperability constituent, it must— a give notice in writing to the relevant person of the reasons why it proposes to do so; b give the relevant person the opportunity to make representations in writing within a period of 28 days beginning with the day on which such notice is given; and c consider any representations made within that period by the relevant person before making its decision. 2 An approved body or designated body must not draw up a UK certificate of verification unless it is drawn up in accordance with the applicable part of Schedule 4 . 3 An approved 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 that constituent conforms to such of the NTSNs as are required by regulation 25. 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. 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 The “ relevant person ” means the person who engaged the approved body or designated body for the relevant matter. Fees of approved bodies and designated bodies 33 1 Subject to paragraph (2), an approved body or a designated body may charge such a fee in connection with, or incidental to, carrying out its functions in relation to these Regulations as it may determine. 2 The fee charged pursuant to paragraph (1) must not exceed the sum of the following— a the costs incurred or to be incurred by the approved body or the designated body in carrying out relevant work; and b an amount of profit which is reasonable in the circumstances having regard to— i the character and extent of the work carried out by the approved body or the designated body on behalf of the person commissioning the work; and ii the commercial rate normally charged on account of profit for that work or similar work. 3 Subject to paragraph (4) the power in paragraph (1) includes the power to require the payment of a fee, or a reasonable estimate of the fee, in respect of the work commissioned in advance of carrying out that work. 4 Unless the parties otherwise agree, an amount charged in accordance with paragraph (3) must not exceed a reasonable estimate of the fee for the work for the three months subsequent to the request for the advance payment. Fees of the Secretary of State 34 The Secretary of State may charge such reasonable fee in connection with, or incidental to, carrying out the Secretary of State's functions under regulation 31 as the Secretary of State may determine. 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. PART 5 Registers Register of infrastructure 35 1 An owner of infrastructure must keep a register of its infrastructure or procure that the register is kept. 2 The owner must ensure that in relation to its infrastructure— a the infrastructure register is maintained in accordance with the infrastructure specifications, subject to the transitional arrangements set out in Article 3 of the specifications Regulation ; b refer in the infrastructure register to any rules or restrictions that have been notified to the owner in accordance with regulation 46(2); and c the infrastructure register is available on request by an applicant for authorisation under these Regulations, or by an approved body . 2A The owner must make the information requested under paragraph (2)(c) available within 28 days of receiving the request. 3 In this regulation— a “ infrastructure ” means any structural subsystem within the scope of the infrastructure specifications; b “the infrastructure specifications”, means the specifications set out in the Annex to the specifications Regulation ; and c “the specifications Regulation” means Commission Implementing Regulation (EU) 2019/777 of 16 May 2019 on the common specifications for the register of infrastructure and repealing Implementing Decision 2014/880/EU . National vehicle register 36 1 This regulation applies to a vehicle for which there is an authorisation under these Regulations for it to be placed in service. 2 If the Safety Authority issues an authorisation, the person who applied for the authorisation must apply to the registration entity for it to assign a European vehicle number before the vehicle is placed in service. 3 The registration entity must assign a unique alphanumeric identification code (a “European vehicle number”) to each vehicle for which an application is made and maintain a register of vehicles (“National Vehicle Register”). 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Any person who places in service a vehicle must ensure it is marked with the European vehicle number assigned to it. 6 The person who applied for the authorisation must, no later than 14 days after the date of authorisation, provide particulars to the registration entity to enable the registration entity to enter the information on the National Vehicle Register that is necessary to conform to the common specifications referred to in paragraph (7), and such further information as the registration entity may reasonably require. 7 In respect of particulars provided under paragraph (6) the registration entity must ensure that the National Vehicle Register conforms to the common specifications as set out in the Annex to Commission Decision 2007/756/EC as amended from time to time. 8 Where there is a material change to any of the particulars provided under paragraph (6) or to any of the particulars provided under regulation 33(7) or (10) of the Railways (Interoperability) Regulations 2006 , the owner of the vehicle must ensure that the registration entity is given the particulars of the change and the registration entity must alter the National Vehicle Register accordingly. 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. 10 The registration entity must make the National Vehicle Register available for inspection— a by the Safety Authority or the Rail Accident Investigation Branch; b in response to a reasonable request by— i the Office of Rail and Road, DFI, the Intergovernmental Commission, or any EU regulatory body designated in accordance with relevant EU law, ii the European Union Agency for Railways iii railway undertakings; iv infrastructure managers; ... v owners of project subsystems ; or vi the national body or bodies responsible for railway safety in the country where the project subsystem is used. 11 In Great Britain the Secretary of State and in Northern Ireland the DFI must designate a person, who must be independent of any railway undertaking, to be the registration entity from time to time; and different persons may be designated to maintain the register in different parts of the United Kingdom. PART 6 Appeals and Enforcement Appeals in Great Britain 37 1 A person who is aggrieved by a decision of the Safety Authority under regulations 5 to 11 may appeal to the Secretary of State. 2 The Secretary of State may, in such cases as the Secretary of State considers it appropriate to do so, having regard to the nature of the questions which appear to the Secretary of State to arise, direct that an appeal under this regulation is determined on the Secretary of State's behalf by a person appointed by the Secretary of State for that purpose. 3 Before the determination of an appeal the Secretary of State must ask the appellant and the Safety Authority whether they wish to appear and be heard on the appeal and— a the appeal may be determined without a hearing of the parties if both of them express a wish not to appear and be heard; b the Secretary of State must, if either of the parties expresses a wish to appear and be heard, afford to both of them an opportunity of doing so. 4 The Tribunals and Inquiries Act 1992 applies to a hearing held by a person appointed in pursuance of paragraph (2) to determine an appeal as it applies to a statutory inquiry held by the Secretary of State, but as if in section 10(1) of that Act (statement of reasons for decisions) the reference to any decision taken by the Secretary of State included a reference to a decision taken on the Secretary of State's behalf by that person. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Without prejudice to the right of any person to make an application for judicial review— a a determination by the Secretary of State, or by a person appointed to make a determination on the Secretary of State's behalf, on an appeal brought under this regulation is binding on all parties affected by that determination; b the Secretary of State, or person so appointed, may give such directions as they consider appropriate to give effect to the determination; and c it is the duty of any person to whom a direction is given under this regulation to comply with and give effect to that direction. 7 The Secretary of State may pay to any person appointed to determine an appeal under paragraph (2) on the Secretary of State's behalf such remuneration and allowances as the Secretary of State may with the approval of the Treasury determine. 8 Where under paragraph (3)(b) a party expresses a wish to appear and be heard, for hearings held in England and Wales, the Health and Safety Licensing Appeals (Hearing Procedure) Rules 1974 , and for hearings held in Scotland, the Health and Safety Licensing Appeals (Hearing Procedure)(Scotland) Rules 1974 , apply to an appeal under paragraph (1) as they apply to an appeal under section 44(1) of the 1974 Act, but with the modification that references to a licensing authority in those rules are to be read as references to the Safety Authority. 9 Where an appeal is made under this regulation, the decision in question is suspended pending the final determination of the appeal. 10 This regulation does not apply to a decision of DFI under regulations 5 to 11. Appeals in Northern Ireland 38 1 A person who is aggrieved by a decision of the Safety Authority in Northern Ireland under regulations 5 to 11 may appeal to DFI . 2 The appellant must lodge the appeal by way of an application in such form or manner as DFI may decide. 3 DFI must within two months of the date of receipt of the information necessary for DFI to make its determination— a make a determination; and b where DFI considers it appropriate in order to give effect to the determination— i arrange for the Safety Authority to take any necessary action; and ii give directions. 4 Without prejudice to the right of any person to make an application for judicial review— a a determination by DFI on appeal brought under this regulation is binding on all parties affected by that determination; and b it is the duty of any person to whom a direction is given under this regulation to comply with and give effect to that direction. 5 Where an appeal is made under this regulation, the decision in question is suspended pending the final determination of the appeal. Enforcement in Great Britain 39 1 It is the duty of the Office of Rail Regulation Office of Rail and Road to make adequate arrangements for the enforcement of these Regulations in Great Britain. 2 Subject to paragraph (5), the provisions of the 1974 Act specified in paragraph (3) (the “specified provisions”) apply for the purposes of the enforcement of these Regulations in Great Britain as if in the specified provision— a a reference to the “ enforcing authority ” was a reference to the Office of Rail Regulation Office of Rail and Road ; b a reference to the “ relevant statutory provisions ” was a reference to these Regulations and to the specified provisions; and c a reference to “health and safety regulations” was a reference to these Regulations. 3 The provisions of the 1974 Act referred to in paragraph (2) are— a sections 19 and 20 (appointment and powers of inspectors) , excluding section 20(3); b sections 21 and 22 (improvement and prohibition notices) ; c section 23 (provisions supplementary to sections 21 and 22) , excluding section 23(3) and (6); d section 24 (appeal against improvement and prohibition notices) ; e section 26 (power to indemnify inspectors); f section 28 (restrictions on disclosure of information); g sections 33(1)(c), (e) to (h), (j) to (o), 34(2) to (5), 36(1) and (2), 37 to 41 and 42(1) to (3) (provision as to offences) ; and h section 46 (service of notices). 4 The mode of trial and maximum penalty applicable to each offence under section 33 of the 1974 Act so applied and listed in the first column of the following table are set out opposite that offence in the subsequent columns of the table. Offence Mode of trial Penalty on summary conviction Penalty on conviction on indictment An offence under section 33(1)(c), (e), (f), (g), (j), (k), (l), (m) or (o). Summarily or on indictment. Imprisonment for a term not exceeding 3 months, or a fine not exceeding level 5 on the standard scale as it has effect from time to time (as if the offence was triable only summarily), or both. Imprisonment for a term not exceeding two years, or a fine, or both. An offence under section 33(1)(h). Summarily only. Imprisonment for a term not exceeding 3 months, or a fine not exceeding level 5 on the standard scale as it has effect from time to time, or both. An offence under section 33(1)(n). Summarily only. A fine not exceeding level 5 on the standard scale as it has effect from time to time. 5 A failure to discharge a duty placed on the Office of Rail Regulation Office of Rail and Road , the Secretary of State, or the Intergovernmental Commission by these Regulations is not an offence under section 33(1)(c) of the 1974 Act. Enforcement in Northern Ireland 40 1 It is the duty of the Health and Safety Executive for Northern Ireland to make adequate arrangements for the enforcement of these Regulations in Northern Ireland. 2 Subject to paragraph (5), the provisions of the Health and Safety at Work (Northern Ireland) Order 1978 (“ the 1978 Order ”) specified in paragraph (3) (the “specified provisions”) apply for the purposes of the enforcement in Northern Ireland of these Regulations as if in the specified provision— a a reference to the “ enforcing authority ” was a reference to the Health and Safety Executive for Northern Ireland; b a reference to the “ relevant statutory provisions ” was a reference to these Regulations and to the specified provisions; and c a reference to “health and safety regulations” was a reference to these Regulations. 3 The provisions of the 1978 Order referred to in paragraph (2) are— a articles 21 and 22 (appointment and powers of inspectors), excluding article 22(3); b articles 23 and 24 (improvement and prohibition notices); c article 25 (provisions supplementary to articles 23 and 24), excluding article 25(3); d article 26 (appeal against improvement and prohibition notices); e article 28 (power to indemnify inspectors); f article 30 (restrictions on disclosure of information); and g articles 31(1)(c), (e) to (h), (j) to (o), 32(2) to (4), 34 (1) and (2), 34A to 38 and 39(1) to (3) (provision as to offences). 4 The mode of trial and maximum penalty applicable to each offence under article 31 of the 1978 Order so applied and listed in the first column of the following table are set out opposite that offence in the subsequent columns of the table. Offence Mode of trial Penalty on summary conviction Penalty on conviction on indictment An offence under article 31(1)(c), (e), (f), (g), (k), (j), (l), (m) or (o). Summarily or on indictment. Imprisonment for a term not exceeding 3 months, or a fine not exceeding level 5 on the standard scale as it has effect from time to time (as if the offence was triable only summarily), or both. Imprisonment for a term not exceeding two years, or a fine, or both. An offence under article 31(1)(h). Summarily only. Imprisonment for a term not exceeding 3 months, or a fine not exceeding level 5 on the standard scale as it has effect from time to time, or both. An offence under article 31(1)(n). Summarily only. A fine not exceeding level 5 on the standard scale as it has effect from time to time. 5 A failure to discharge a duty placed on the Health and Safety Executive for Northern Ireland, DFI or the Secretary of State by these Regulations is not an offence under article 31(1)(c) of the 1978 Order. Notices relating to interoperability constituents not meeting the essential requirements 41 1 If the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland is of the opinion that an interoperability constituent in relation to which an EC or UK declaration of conformity or suitability for use has been drawn up is unlikely when used as intended to meet the essential requirements relating to it, the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland may serve a notice in writing on any person who is using or intending to use that interoperability constituent in a project subsystem— a prohibiting the use of or restricting the area of use of that interoperability constituent; or b where there is a serious safety risk, requiring the recall or withdrawal of the interoperability constituent. 2 The information to be contained in a notice served under paragraph (1) is— a a statement that the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland is of the opinion referred to in paragraph (1); b the reasons for that opinion; c a direction that the interoperability constituent to which that notice relates must not be used, or that its area of use shall be restricted, or that it must be recalled or withdrawn; and d the date by which the person must comply with the notice. 3 Any notice served under paragraph (1) may be withdrawn by the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland by serving notice of the withdrawal on the person. 4 Where a notice has been served on a person (“P”) in accordance with this regulation P must— a comply with that notice; and b notify the person (if any) who supplied P with the interoperability constituent in relation to which the notice under paragraph (1) was served— i that a notice under paragraph (1) has been served; ii of what the notice says; and iii that P requires that person in turn to notify the supplier (if any) with the same information contained in the notice from P. Notice of improper drawing up of the EC or UK declaration of conformity or suitability for use for an interoperability constituent 42 1 Where the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland has reasonable grounds for suspecting that the EC declaration of conformity or suitability for use has not been drawn up in accordance with the requirements of 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 , it may give notice in writing to any person who made the declaration. 2 A notice which is given under paragraph (1) must— a state that the Office of Rail and Road or the Health and Safety Executive for Northern Ireland considers that the EC declaration of conformity or suitability for use has not been drawn up in accordance with the requirements of 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; b specify the respect in which it is so considered and give particulars; c require the person who made the declaration to— i secure that any interoperability constituent to which the notice relates conforms as regards the provisions concerning the proper drawing up of the declaration within such period as may be specified in the notice; and ii provide evidence within that period, to the satisfaction of the Office of Rail Regulation Office of Rail and Road or the Health and Safety Executive for Northern Ireland, as the case may be, that the declaration has been properly drawn up; and d inform the relevant person that if the non-conformity continues (or if satisfactory evidence of conformity has not been provided) within the period specified in the notice, further action may be taken in respect of that non-conformity under these Regulations. 3 Where a notice has been served under this regulation on a person, the person served must comply or secure compliance with the notice. Defence of due diligence 43 1 Subject to the following provisions of this regulation, if proceedings are brought against a person (“P”) for an offence under these Regulations it is a defence for P to show that P took all reasonable steps and exercised all due diligence to avoid committing the offence. 2 Where P's defence involves an allegation that the commission of the offence was due to— a the act or default of another; or b reliance on information given by another, P is not, without the leave of the court, entitled to rely on the defence unless, within a period ending 7 clear days before the commencement of the hearing of the proceedings (or in Scotland, the trial diet), P has served a notice under paragraph (3) on the person bringing the proceedings. 3 A notice under this paragraph must give such information identifying, or assisting in the identification of, the person who committed the act or default or gave the information as is in the possession of P serving the notice at the time it is served. 4 P is not entitled to rely on the defence provided by paragraph (1) by reason P's reliance on information supplied by another, unless P shows that it was reasonable in all the circumstances to have relied on the information, having regard in particular— a to the steps which P took, and those which might reasonably have been taken, for the purpose of verifying the information; and b to whether P had any reason to disbelieve the information. PART 7 Supplementary Deemed authorisation 44 1 Subject to paragraph (4), a vehicle to which this paragraph applies is deemed— a to have been authorised under these Regulations; and b to have been assessed against the requirements of Part 1 of Schedule 1 to the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010 , as notified national technical rules, for the purposes of that authorisation. 2 Subject to paragraph (3), paragraph (1) applies to a vehicle which— a is constructed or adapted to transport passengers; and b was first brought into use after 31st December 1998 and before 1st August 2006; and c is used in the provision of a service for the carriage of passengers on the trans-European rail system located in Great Britain. 3 Paragraph (1) does not apply to— a a vehicle to the extent that immediately before 7th July 2008 the vehicle— i was authorised or treated as having been authorised under the Railways (Interoperability) Regulations 2006 ; and ii had been assessed against the Rail Vehicle Accessibility Regulations 1998 as in force when the unit was assessed for that authorisation; or b a vehicle which belongs to a class of vehicles first brought into use on or before 31st December 1998. 4 The deeming provisions of paragraph (1) do not apply for the purposes of— a regulation 45; and b regulation 4(1) in so far as that regulation applies in relation to any upgrading or renewal of a vehicle to which paragraph (2) applies. Accessibility for people with reduced mobility 45 No person is to use a vehicle in the provision of a service for the carriage of passengers on the trans-European rail system located in the United Kingdom on or after 1st January 2020 unless it has been constructed, renewed, upgraded or modified to comply with the technical standards, and is operated to comply with the operational standards, required by— 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 Part 1 of Schedule 1 to the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010; c the Rail Vehicle Accessibility Regulations (Northern Ireland) 2001; or d the TSI, or amended version of it or TSI replacing it or the NTSN , referred to in paragraph (a) except to the extent that— i the vehicle or its operation complies with the technical or operational standards required by the provisions referred to in paragraphs (b) or (c), ii a derogation from part of it was granted under regulation 14 before IP completion day, or an exemption from part of it has been granted under regulations 14 and 14A , iii a determination that part of it does not apply has been made under regulation 13(8), and iv a dispensation that part of it does not apply for the purposes of this regulation has been granted under regulation 46. Dispensations 46 1 The Competent Authority may grant a conditional or unconditional dispensation from NTRs for a particular case or description of case if the Competent Authority is satisfied that the dispensation is consistent with the essential requirements. 2 If the Competent Authority has granted a dispensation that the Competent Authority considers has created ... a rule or restriction of a strictly local nature the Competent Authority must notify the relevant owner that the rule or restriction must be referred to in the infrastructure register. 3 Paragraph (1) does not apply in relation to the requirements of the Rail Vehicle Accessibility (Non-Interoperable Rail System) Regulations 2010 or the Rail Vehicle Accessibility Regulations (Northern Ireland) 2001. 4 The Secretary of State may grant for a particular case or description of case a dispensation for the purposes of regulation 45(d)(iv). Revocation and savings 47 1 The Railways (Interoperability) Regulations 2006, the Railways (Interoperability) (Amendment) Regulations 2007 and regulation 4 of the Rail Vehicle Accessibility (Interoperable Rail System) 2008 are revoked. 2 Where immediately before the coming into force of these Regulations an appointment of a notified body had effect as an appointment under the Railways (Interoperability) Regulations 2006, it continues to have effect as if made as an appointment under regulation 31 of these Regulations for the period specified when appointed. 3 Where, under the Railways (Interoperability) Regulations 2006, a structural subsystem has been authorised to be placed in service on the rail system, it is from the coming into force of these Regulations treated as authorised under these Regulations. 4 Regulation 4(8), (9) and (9A) of the Railways (Interoperability) Regulations 2006 continue to have effect in relation to a contract made before the coming into force of these Regulations. 5 A derogation in force immediately before the coming into force of these Regulations and granted by the Secretary of State in accordance with the High-Speed Directive or a derogation granted by the Competent Authority in accordance with the Conventional Directive is treated as a derogation granted under regulation 14 in accordance Article 9 of the Directive. 6 Any person who immediately before the coming into force of these Regulations is the registration body designated under regulation 33(12) of the Railways (Interoperability) Regulations 2006 is treated on and from the coming into force of these Regulations as if the person was designated as the registration entity under regulation 36(11). 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 IP completion day and that authorisation has not been revoked, it is treated as authorised under these Regulations as they have effect on or after IP completion day. 2 Where an application for authorisation was made pursuant to regulation 5 as it had effect before IP completion day and that authorisation was not issued before IP completion day, it is, on or after IP completion 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 IP completion day. 3 Where an application for type authorisation was made pursuant to regulation 9 as it had effect before IP completion day and that authorisation was not issued before IP completion day, it is, on or after IP completion 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 IP completion 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 IP completion day and the Competent Authority has not made the decision before IP completion day, it is treated as an application under regulation 13 as it has effect on or after IP completion 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 IP completion day is treated on or after IP completion 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 IP completion 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 IP completion day. 8 Where an interoperability constituent was placed on the market anywhere in the European Union before IP completion day, it is treated on or after IP completion 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 IP completion 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 IP completion day, the work carried out by that body before IP completion day is treated as work undertaken pursuant to regulation 16 and Schedule 4 as they have effect from IP completion day to carry out the UK verification assessment procedure in relation to NTSNs. 10 Where a designated body was engaged before IP completion 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 IP completion day, the work carried out by that body before IP completion day is treated as work undertaken pursuant to regulation 16 and Schedule 4 as they have effect from IP completion 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 IP completion day, is treated on or after IP completion day as a dispensation from the NTR specified as replacing it. Amendments to legislation 48 The Schedule has effect. Review 49 1 The Secretary of State must from time to time— a carry out a review of these Regulations, b set out the conclusions of the review in a report, and c publish the report. 2 In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in other Member States. 3 The report must in particular— a set out the objectives intended to be achieved by the regulatory system established by these Regulations, b assess the extent to which those objectives are achieved, and c assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation. 4 The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force. 5 Reports under this regulation are afterwards to be published at intervals not exceeding five years. Signed by authority of the Secretary of State for Transport Theresa Villiers Minister of State Department for Transport