I, Seamus Brennan, Minister for Transport, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 ( No.27 of 1972 ), and for the purposes of giving effect to Council Directive 2001/16 of 19 March 2001¹ hereby make the following Regulations.

1. Citation

These Regulations may be cited as the European Communities (Interoperability of the Trans-European conventional rail system) Regulations, 2004.

2. Interpretation

(1) For the purposes of these regulations:

“Commission” means the European Commission;

“Committee” means the committee established under Article 21 of Directive 96/48/EC concerning the interoperability of the trans-European high-speed rail system² ;

“Certificate of conformity” is a certificate drawn up by a notified body in accordance with Schedule 6;

“Conformity declaration” is an EC declaration of conformity drawn up by a manufacturer or its authorised representative in the State in accordance with Schedule 4;

“Contracting entity” means, in relation to a structural subsystem used, or intended for use, in the construction, upgrading, renewal, maintenance or operation of any part of the railway system in the State forming part of the trans-European conventional rail system, any person who:-

(a) has contracted with another person for the manufacture, construction, upgrading, renewal, maintenance or operation by that other person of that structural subsystem or

(b) manufactures, constructs, upgrades, renews, maintains or operates that structural subsystem for his or her own use, or for sale to, or use by, another person but not where he or she is contracted to do so by a person falling under paragraph (a);

“Directive” means Council Directive 2001/16 of 19 March 2001 on the interoperability of the trans-European conventional rail system³ ;

“Essential requirements” means all the conditions set out in Schedule 3 that must be met by the subsystems and interoperability constituents, including interfaces, of the railway system in the State forming part of the trans-European conventional rail system;

“European specification” means a common technical specification, a European technical approval or a national standard implementing a European standard, as defined in points 8 to 12 of Article 1 of Directive 93/38/EEC coordinating the procurement procedures of entities operating in the water, energy, transport, and telecommunications sectors⁴ ;

“European standard” means a standard approved by the European Committee for Standardisation or by the European Committee for Electrical Standardisation as a European Standard or a Harmonisation Document, according to the Common Rules of those organisations or by the European Telecommunications Standards Institute according to its own rules as a “European Telecommunications Standard”;

“Heritage railway” means a railway undertaking that only operates train services or railway infrastructure of historical or touristic interest;

“Interoperability” means the ability of the trans-European conventional rail system to allow the safe and uninterrupted movement of conventional trains that accomplish the required levels of performance for these lines. This ability rests on all the regulatory, technical, and operational conditions that must be met in order to satisfy the essential requirements;

“Interoperability constituents” means any elementary component, group of components, subassembly, or complete assembly of equipment incorporated, or intended to be incorporated, into a subsystem upon which the interoperability of the trans-European conventional rail system depends either directly or indirectly. The concept of a constituent covers both tangible and intangible objects such as software;

“Member State” means a Member State of the European Community;

“Minister” means Minister for Transport;

“Notified body” has the meaning given by Regulation 13;

“Official Journal” means the Official Journal of the European Communities;

“Operator” in relation to the use of an interoperability constituent or subsystem means the person having the management of that interoperability constituent or subsystem for the time being;

“Person responsible” in relation to an interoperability constituent means the manufacturer of that interoperability constituent or his or her authorised representative established in the State or, where neither the manufacturer nor his or her authorised representative established in the State places an interoperability constituent on the market, the person who places that interoperability constituent on the market;

“railway undertaking” means any private or public undertaking who owns or manages railway infrastructure or the main business of which is to provide rail services for goods and/or passengers, with a requirement that the undertaking must ensure traction;

“renewal” means any major substitution work on a subsystem or part of a subsystem which requires fresh authorisation for putting into service within the meaning of Regulation 7;

“screening decision” has the meaning given to it in Regulation 10;

“staged works decision” has the meaning given to it in Regulation 11;

“specific case” means any part of the trans-European conventional rail system which needs special provisions in the TSIs, either temporary or definitive, because of geographical, topographical, or urban environment constraints or those affecting compatibility with an existing rail system. This may include in particular railway lines and networks isolated from the rest of the Community, including isolation by sea, the loading gauge, the track gauge, space between the tracks, and rolling stock strictly intended for local, regional or historical use.

“subsystems” means the individual subsystems described in Schedule 2 comprising structural and operational subsystems for which essential requirements must be laid down;

“suitability declaration” is an EC declaration of suitability for use drawn up by a manufacturer or its authorised representative in the State in accordance with Schedule 4;

“technical file” means a record in relation to a subsystem containing the items required by paragraph 4 of Schedule 6;

“technical specifications for interoperability” (hereinafter TSIs) means the specifications, adopted by the Community and published in the Official Journal of the European Community, by which each subsystem or part of a subsystem is covered in order to meet the essential requirements and ensure the interoperability of the trans-European conventional rail system;

“track gauge” means the distance between the inside edge or running edge of the two rails in a railway line;

“trans-European conventional rail system” means the structure described in Schedule 1 and Decision No. 1692/96⁴ of the European Parliament and of the Council of 23 July 1996 on Community Guidelines for the development of the trans-European transport network, as amended, on the interoperability of the trans-European conventional rail system, comprising lines and fixed installations of the trans-European transport network, constructed or upgraded for conventional rail transport and combined rail transport, and rolling stock designed for travelling on those infrastructures;

“upgrading” means any major modification work on a subsystem or part of a subsystem which requires fresh authorisation for putting into service within the meaning of Regulation 7;

“verification declaration” is an EC declaration of verification drawn up by a contracting entity or its authorised representative in the State in accordance with Schedule 5;

(2) A word or expression which is used in these Regulations and which is also used in the Directive, has unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

(3) In these Regulations--

(a) a reference to a Regulation is a reference to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended,

(b) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the provision occurs, unless it is indicated that reference to some other provisions is intended,

(d) A reference to a Schedule in these Regulations is a reference to a Schedule of these Regulations.

3. Application and Scope

(1) These Regulations establish the conditions to be met in the State to achieve interoperability of the trans-European conventional rail system as described in Schedule 1.

(2) These Regulations apply:

(a) in respect of each subsystem, to the interoperability constituents, the interfaces, procedures, and overall compatibility of those parts of the rail system in the State forming part of the trans-European conventional rail system put into service after the commencement of these Regulations,

(b) to the design, construction, maintenance, upgrading, renewal, operation and placing into service of subsystems in the State forming, or intended to form, part of the trans-European conventional rail system after the commencement of these Regulations,

(d) to the use of interoperability constituents in any subsystem after the commencement of these Regulations,

(e) rolling stock designed for travelling and used or intended for use on rail systems in the State forming part of the trans-European conventional rail system put into service after the commencement of these Regulations,

(f) to the appointment in the State of notified bodies, and

(g) to the carrying out in the State of conformity assessment procedures in relation to interoperability constituents and verification procedures in relation to subsystems used, or intended for use, in the design, construction, maintenance, upgrading, renewal, operation of the Trans-European conventional rail system.

(3) The provisions of these Regulations do not apply to rolling stock or railway infrastructure operated, or used exclusively, by heritage railways.

4. Derogations

(1) The Minister may decide not to apply any TSI or part of any TSI in relation to parts of the railway system in the State forming part of the trans-European conventional railway system, in the following cases and circumstances:

(a) For a proposed new line, for the upgrading of an existing line, or for any element referred to in Article 1(1) at an advanced stage of development or the subject of a contract in the course of performance when the relevant TSI is published.

(b) For any project concerning the renewal or upgrading of an existing line where the loading gauge, track gauge, space between tracks, or electrification voltage in the relevant TSI is not compatible with those of the existing line.

(c) For a proposed new line or for the proposed renewal or upgrading of an existing line in the State where the rail network in the State is not linked to, or is isolated by the sea from, the rail network of the rest of the Community.

(d) For any proposed renewal, extension, or upgrading of an existing line, when the application of the relevant TSIs would compromise the economic viability of the project or the compatibility of the rail system of the State.

(e) Where following an accident or a natural disaster, the conditions for the rapid restoration of the network do not economically or technically allow for partial or total application of the relevant TSIs.

(2) In all cases referred to in paragraph (1) the Minister shall serve prior notice of any intended derogation to the Commission and shall forward to it a file setting out the TSIs or parts thereof that he or she does not wish to be applied as well as the corresponding specifications that the Minister does wish to be applied.

(3) With reference to paragraph (2), the Minister shall comply with any decision or recommendation of the Commission made pursuant to Article 7.

5. Interoperability constituents

(1) No person who is the person responsible shall place on the market any interoperability constituent unless:

(a) the interoperability constituent conforms to such European specifications as have been published in the Official Journal in relation to interoperability constituents of that type,

(b) the interoperability constituent enables interoperability to be achieved within the trans-European conventional rail system,

(c) the interoperability constituent, including interfaces, meets such of the relevant essential requirements as relate to an interoperability constituent of that type,

(d) the appropriate conformity or suitability for use assessment procedures in respect of the interoperability constituent have been carried out, and

(e) either an EC conformity declaration or an EC suitability declaration, or both (as the case may be) has been prepared in relation to the interoperability constituent by the person responsible in accordance with the requirements of Schedule 4 to these Regulations.

(f) the interoperability constituent conforms to such TSIs that are relevant to an interoperability constituent of that type.

(2) Compliance of an interoperability constituent with the essential requirements will be established with reference to relevant TSIs, including any relevant European specifications.

(3) Where no European specifications referred to in paragraph 1(a) have been published, a person shall not place on the market an interoperability constituent unless it conforms to such standards and technical specifications relating to interoperability constituents of that type as may be notified by the Minister to the Commission pursuant to Article 10(5) of the Directive as being in use in the State,

(4) Where there is a requirement to prepare a conformity declaration or suitability declaration (as the case may be) in relation to any interoperability constituent and that interoperability constituent is also subject to other requirements pursuant to a European Community Directive other than the Directive, the person who prepares that conformity declaration or suitability declaration shall state in that declaration whether or not the interoperability constituent in question meets those other requirements.

(5) Where any of the requirements of paragraphs (1), (2) and (3) to be fulfilled by the manufacturer or his or her authorised representative in the State have not been fulfilled, such requirements shall be fulfilled by any person who: --

(a) places that interoperability constituent on the market,

(b) uses that interoperability constituent, or any part of it, in any interoperability constituent or subsystem that he or she is manufacturing or otherwise constructing, assembling, or in any subsystem he or she is constructing, upgrading, maintaining, renewing or operating, or

(6) Notwithstanding the provisions of this Regulation, interoperability constituents may be placed on the market for other purposes, including their use on conventional railway lines in the State.

(7) Where an interoperability constituent, including interfaces, in respect of which a conformity declaration or suitability declaration has been drawn up, is placed on the market and, in the view of the Minister, it is unlikely to meet the essential requirements, the Minister shall take all necessary steps to restrict its field of application, prohibit its use, or withdraw it from the market and the Minister shall take appropriate measures against whomsoever has drawn up the declaration. The Minister shall inform the Commission and the other Member States of the measures that have been taken in respect of the interoperability constituent to restrict its field of application, prohibit its use, or withdraw it from the market and the reasons for taking those steps as specified in Article 12 and any measures taken against the person who drew up the conformity declaration or suitability declaration.

(8) In relation to any interoperability constituent, the operator of that interoperability constituent shall ensure that while it is in use it is :-

(a) correctly installed for the purpose for which it is intended,

(b) not used for any purpose other than the purpose for which it was designed, and

(9) A conformity declaration or suitability declaration shall be drawn up in accordance with Schedule 4.

(10) There is no requirement to carry out checks on interoperability constituents if those checks have already been carried out in another Member State as part of the EC declaration of conformity or suitability for use as outlined in Article 13.

(11) A person who contravenes this Regulation is guilty of an offence and is liable on summary conviction to a fine not exceeding €3000 or imprisonment for a term not exceeding 6 months, or both.

6. Conformity assessment procedures for interoperability constituents

(1) For the purposes of Regulation 5, the appropriate conformity or suitability for use assessment procedures in relation to an interoperability constituent shall be:-

(a) the procedure specified:

(i) in the TSI (if any) with which the interoperability constituent must comply, or

(ii) by any relevant European specification (if any) with which the interoperability constituent must comply;

or,

(b) in the absence of such a TSI or such a European specification,

(i) such conformity or suitability for use assessment procedure that is considered appropriate by the notified body, and

(ii) the procedures set out in Schedule 4.

(2) (a) Without prejudice to the provisions of Regulation 5, where a conformity declaration or suitability declaration has been drawn up improperly, the Minister may instruct the manufacturer or his or her authorised representative established within the State to ensure that such declaration be properly drawn up.

(b) Where failure to properly draw up the declaration persists, the Minister may take appropriate steps to restrict or prohibit the placing on the market in the State of the interoperability constituent or to ensure that it is withdrawn from the market.

7. Subsystems authorisation

(1) No person shall place into service on the rail system in the State forming part of the trans-European conventional rail system a structural subsystem that he or she has constructed, upgraded or renewed unless the Minister has given an authorisation for the placing into service of that subsystem.

(2) An application for an authorisation under paragraph (1) shall be made in writing to the Minister and, in relation to the structural subsystem, be accompanied by: -

(a) the certificate of conformity,

(b) the technical file, and

(3) The Minister shall not issue an authorisation for the placing into service of a structural subsystem unless he or she is satisfied that: --

(a) the verification declaration has been drawn up in accordance with Schedule 5,

(b) the technical file is complete, and

(c) the structural subsystem has been designed, constructed, and installed in such a way as to meet the essential requirements concerning that subsystem and to ensure that it is compatible with the rail systems into which it is being integrated.

(4) The Minister shall not refuse to give an authorisation for placing into service of a structural subsystem if it: --

(a) satisfies the conditions set out in paragraphs 3(a) and 3(b); and

(b) meets the essential requirements relating to the structural subsystem.

(5) Subject to paragraph (6), after receiving an application for an authorisation under paragraph (2), the Minister may require the applicant to carry out any additional checks which the Minister considers necessary in relation to the structural subsystem if that subsystem appears to the Minister not to meet the requirements of Regulations 9(4) and 9(8).

(6) There is no requirement to carry out checks on structural subsystems that have already been carried out in another Member State as part of the EC declaration of conformity or suitability for use as outlined in Article 13.

(7) After receiving an application for authorisation under paragraph (2) the Minister shall either: --

(i) authorise the placing into service of the structural subsystem,

(ii) inform the contracting entity that additional checks will be required pursuant to paragraph (5) before the application can be considered further, or

(iii) refuse the request for authorisation.

(8) Subject to Regulation 4 a structural subsystem that is placed into service must conform with any TSI relating to that subsystem which has been published in the Official Journal.

(9) In the case of a structural subsystem where:-

(a) a TSI has not been published in the Official Journal in respect of that subsystem,

(b) a published TSI does not govern all elements of that subsystem, or

that subsystem must conform to such technical rules in use in the State, if any, for implementing essential requirements as may be notified by the Minister to the Commission pursuant to Article 16(3) and must meet such of the requirements as relate to that type of subsystem.

(10) Without prejudice to Article 19, the Minister may not prohibit, restrict or hinder the construction, placing in service, and operation of structural subsystems forming, or intended to form, part of the trans-European conventional rail system in the State where such subsystems comply with the essential requirements.

(11) When a structural subsystem is placed into service in accordance with these Regulations, the Minister shall carry out, or cause to be carried out, periodic checks to ensure that it is operated and maintained in compliance with the relevant essential requirements.

(12) The activities and duties of a notified body responsible for the EC verification of a subsystem, as set out in Schedule 6, shall begin at the design stage and shall cover all of the manufacturing period up to the type-approval stage before a subsystem is placed in service and shall also cover verification of the interfaces of the subsystem with the system into which it is incorporated.

(13) A person who contravenes this Regulation is guilty of an offence and is liable on summary conviction to a fine not exceeding £3000 or to a term of imprisonment not exceeding 6 months, or both.

8. Subsystems verification procedures

(1) For the purposes of these Regulations, the appropriate verification assessment procedure in relation to a structural subsystem shall be -

(a) insofar as that subsystem is required to conform with part or all of a TSI, the procedures specified in the TSI or part of the TSI with which it is required to conform;

(b) insofar as that structural subsystem is required to conform with notified standards, such procedures as the notified body considers appropriate to assess that structural subsystem against the notified standards with which it is required to conform;

and in either case,

(2) The relevant notified body shall compile the technical file.

(3) Where a contracting entity has already commenced work on the construction, upgrade, or renewal of a structural subsystem prior to the commencement of these Regulations, a notified body may, with the agreement of the contracting entity and having regard to documentation or other evidence produced by the contracting entity in respect of that work, decide that there is no need for it to assess the work that was carried out prior to its notification as a notified body. In such circumstances, the notified body need not assess that work.

(4) Where a relevant TSI permits non-compliance with part or all of its provisions on the basis that compliance with those provisions would result in the structural subsystem being technically incompatible with the existing railway system in which it is to be placed into service, the Minister may exempt that subsystem from the relevant provisions.

9. Duties of a contracting entity

(1) This regulation applies where a contracting entity -

(a) is intending to contract with another person for the design, manufacture, or construction by that other person of a structural subsystem,

(b) is proposing that it design, manufacture, or construct a structural subsystem,

(d) has itself commenced work on the design, manufacture or construction of a structural subsystem.

(2) The contracting entity may select a notified body in relation to the structural subsystem in question -

(a) forthwith, when contracting with another person who is to design the structural subsystem,

(b) before selecting or completing the design for the structural subsystem, where he or she is designing that structural subsystem

(3) Where the contracting entity selects a notified body under paragraph (2), that contracting entity shall ensure that a notified body (whether that originally appointed or another) continues to be appointed in relation to the structural subsystem in question until authorisation pursuant to Regulation 7 is given.

(4) The contracting entity shall ensure that the structural subsystem conforms to all relevant TSIs, except where -

(a) there are no relevant TSIs,

(b) the relevant TSI does not govern all elements of the structural subsystem,

(c) the structural subsystem is not required to conform to the whole or part of a relevant TSI pursuant to a derogation under Regulation 4, or

(d) an exemption has been granted by the Minister in accordance with Regulation 8(4).

(5) The contracting entity shall ensure that the structural subsystem, or part of the structural subsystem, not governed by any relevant TSI conforms with any notified standards that relate to it.

(6) Where a relevant TSI permits non-conformity with part or all of its provisions on the basis that conformity with those provisions would result in the structural subsystem being technically incompatible with the existing railway system in which it is to be placed into service, a contracting entity may apply to the Minister for an exemption from those provisions.

(7) Provided that the contracting entity has ensured that the requirements of paragraphs (4) and (8) are satisfied, he or she shall draw up a verification declaration in relation to the structural subsystem in accordance with the procedure required by Schedule 5.

(8) For the purposes of paragraph (7) a structural subsystem must:

(a) meet such essential requirements as relate to that type of structural subsystem,

(b) have the appropriate verification assessment procedure carried out in accordance with Regulation 8,

(d) have a technical file prepared in respect of it containing the information and documents required by paragraph (4) of schedule 6.

10. Screening decisions

(1) Before commencing major works, or entering into a contract with another person for major works to carried out, on an existing structural subsystem, a contracting entity shall, unless satisfied that those works constitute upgrading or renewal of any part of the rail system in the State forming part of the trans-European conventional rail system, make a request in writing to the Minister for a decision as to whether or not those works constitute upgrading or renewal of any part of the rail system in the State forming part of the trans-European conventional rail system. For the purpose of these Regulations, this decision is called a “screening decision”.

(2) A request made pursuant to paragraph (1) shall be accompanied by the following information: --

(a) a file setting out details of the project;

(b) a description of the nature and scope of the proposed works;

(d) identification of any derogation or derogations that may, or will, be sought pursuant to Regulation 4, the grounds for such derogation or derogations;

(e) identification of the TSI, TSIs, or parts thereof, for which derogations may, or will, be sought pursuant to Regulation (4); and

(f) an implementation plan in respect of the works.

(3) If the Minister considers that the information provided by the contracting entity under paragraph (2) is insufficient to enable the Minister to make a screening decision, he or she shall notify the contracting entity in writing of the additional information considered necessary in order to make that decision.

(4) In making the screening decision, the factors the Minister shall take into account shall include: -

(a) the implementation strategy provided in any relevant TSI; and

(b) the scale, size or nature of the proposed works.

(5) If the Minister considers that the proposed works would be likely to affect the overall level of safety of the railway system referred to in paragraph (1) or any part of it, the screening decision shall be that the works constitute an upgrade or renewal of that structural subsystem for the purpose of these Regulations.

(6) The Minister shall notify the contracting entity of its screening decision in writing.

(7) If the Minister decides that the proposed works constitute an upgrading or renewal of the railway system for the purpose of these Regulations, he or she shall give reasons for that decision in the notification given under paragraph (7).

(8) If at any stage of the execution of the works there is a change in circumstances that materially affect the information provided by the contracting entity under paragraphs (2) or (3), the contracting entity shall notify the Minister of that change and the Minister shall consider whether that change affects the screening decision notified under paragraph (7).

(9) If the Minister considers that the change notified under paragraph (9) affects the screening decision, he or she shall confirm or vary that decision and the requirements of paragraphs (7) and (8) will apply to that confirmation or variation.

(10) For the purpose of this Regulation, “implementation plan” means a description of how a contracting entity will manage and undertake the works, the interface of infrastructure with rolling stock, and the impact of the works on other persons who may be affected by those works.

11. Staged works decisions

(1) Notwithstanding the provisions of Regulation 7, a stage of a relevant upgrading or renewal project may be placed into service prior to an authorisation being given pursuant to Regulation 7 if it is placed into service in accordance with the provisions of this Regulation.

(2) A contracting entity may at any time during an upgrading or renewal project make a request in writing to the Minister for a decision on whether a stage of that project may be placed into service prior to an authorisation being given pursuant to Regulation 7.

(3) A request made under paragraph (2) shall be accompanied by the following information --

(a) a description of the upgrading or renewal project;

(b) the dates when each stage of the project is due to commence and finish and be placed into service;

(d) the arrangements to be put in place by the contracting entity to ensure the continued safety of any part of a railway system affected by the upgrading or renewal project for the duration of that project; and

(e) the date when an authorisation under Regulation 7 will be sought.

(4) If the Minister considers that the information provided by a contracting entity in a request made under paragraph (2) is insufficient to enable the Minister to make a staged works decision, he or she shall notify the contracting entity in writing of the additional information considered necessary in order to make that decision.

(5) The Minister shall notify the contracting entity in writing of its staged works decision.

(6) The staged works decision may contain such conditions as the Minister considers necessary to ensure that the overall level of safety of the relevant part of a railway system is not adversely affected.

(7) If at any stage of the upgrading or renewal project there is a change in circumstances that materially affect the information provided by the contracting entity to the Minister under paragraphs (3) or (4), the contracting entity shall notify the Minister of that change and the Minister shall consider whether that change affects the staged works decision given under paragraph (5) or the conditions attached to that decision under paragraph (6).

(8) If a change notified under paragraph (7) affects the staged works decision, or the conditions attached to that decision, the Minister -

(a) shall confirm or vary the staged works decision; and

(b) may remove or amend the conditions given under paragraph (7) or attach new conditions to the staged works decision,

and the requirements of paragraphs (5) and (6) shall apply to any action taken by the Minister under this paragraph.

(9) For the purpose of this regulation “a relevant upgrading or renewal project” means a project to upgrade an infrastructure subsystem, an energy subsystem, or a control and command and signalling subsystem.

12. Registers of infrastructure and rolling stock

(1) The owner of all relevant rolling stock shall create and maintain a register in accordance with paragraph (3) (“the rolling stock register”).

(2) The owner of all relevant railway infrastructure shall create and maintain a register in accordance with paragraph (4) (“the infrastructure register”).

(3) The rolling stock register shall contain the following information in respect of relevant rolling stock -

(a) all the information required by any relevant TSI; and

(b) where conformity with the whole or part of a TSI is not required pursuant to Regulation 4, or in the circumstances provided for in Regulation 9(3), details of the part of the TSI for which conformity is not required.

(4) The infrastructure register shall contain the following information in respect of relevant infrastructure -

(a) all the information required by any relevant TSI; and

(b) where conformity with the whole or part of a TSI is not required pursuant to Regulation 4, or in the circumstances provided for in regulation 9(3), details of the part of the TSI with which conformity is not required.

(5) The owners of rolling stock and infrastructure shall update annually any register that they are required to create and maintain in accordance with this Regulation.

(6) The owners of rolling stock and infrastructure shall: -

(a) send to the Minister and the Committee: -

(i) any register that they are required to create under this Regulation; and

(ii) any information that they are required to add to any register in accordance with paragraph (5),

and

(b) shall ensure that the said registers are made publicly available.

13. Notified Bodies

(1) The Minister may notify to the Commission from time to time such persons or bodies as he or she thinks fit to be notified bodies for the purposes of these Regulations.

(2) The Minister must verify the competence of bodies seeking notification taking into account the criteria set out in Schedules 7 and 9.

(3) A notification: -

(a) shall relate to such descriptions of structural subsystems and interoperability constituents as the Minister may specify, and

(b) shall be made subject to such conditions as the Minister may specify, including any such conditions as are to apply upon, or following, withdrawal of the notification.

(4) The duration of the notification shall be at the discretion of the Minister, or shall be agreed between the Minister and the notified body.

(5) The Minister may decide to notify a body for a limited period of time, and renew or withdraw the notification as appropriate.

(6) Subject to paragraph (7), a notification under this Regulation shall be for such period as may be specified in the notification.

(7) A notification shall be withdrawn : --

(a) upon the expiry of any period specified in the notification pursuant to paragraph (6),

(b) upon the expiry of 90 days notice in writing given by the notified body to the Minister, or

(8) The functions of notified bodies in the State shall include: -

(a) assessing the conformity or suitability for use of interoperability constituents, including interfaces, against the relevant essential requirements by applying the procedures referred to in Regulation 7,

(b) applying the procedures for verification of structural subsystems referred to in Regulation 8,

(d) consulting notified bodies notified by other Member States in relation to the functions referred to in paragraphs 2(a) and 2(b) on relevant matters including ensuring that, in the absence of TSIs, the procedures for assessment and verification required under the Directive are consistently applied throughout the European Community.

(9) An EC declaration of conformity, an EC declaration of suitability for use, or an EC declaration of verification approved by a body notified by another Member State shall be acceptable in the State as if approved by a body notified by the Minister.

(10) A notified body shall be responsible for compiling the technical file that has to accompany the verification declaration in accordance with Schedule 5. The technical file must contain all the necessary documents relating to the characteristics of the subsystem and, where appropriate, all the documents certifying conformity of the interoperability constituents. It must also contain all of the elements relating to the conditions and limits of use and to the instructions concerning servicing, constant or routine monitoring, adjustment, and maintenance.

(11) The general criteria provided for in Schedules 7 and 9 shall apply in respect of the assessment by the Minister of the bodies to be notified as notified bodies.

(12) To effect notification, the Minister shall inform the Commission and the other Member States that a body which fulfils the necessary requirements has been designated to carry out conformity, suitability for use and verification assessment procedures in accordance with these Regulations and the Directive.

(13) Official notification of a body shall only take place when all the information required and the identification number which has been allocated to the notified body by the Commission is sent by the Minister to the other Member States and to the Commission.

(14) The Minister shall publish in Iris Oifigiuil the relevant information concerning all notified bodies notified by the Minister.

(15) A notified body can have part of its work carried out, or sub-contracted, by another body subject to the provisions of Schedule 10.

(16) The Minister shall ensure that notified bodies maintain their competence at all times and are capable of carrying out the work for which they are notified. For this purpose the Minister, or a body designated by the Minister, may carry out surveillance and re-assessment of notified bodies.

(17) A notified body notified to the Commission by another Member State shall be recognised in the State as shall the assessment for conformity or suitability for use as referred to in Article 13 and the checking procedure referred to in Article 18 carried out by such notified bodies.

(18) In relation to paragraph (16), the Minister may require as necessary that the notified body be familiar with the special characteristics of the existing railway system and operations in the State.

(19) Where the Minister considers that a body notified by another Member State no longer meets the relevant criteria, the Minister shall refer the matter to the Committee.

14. Refusal to give a Certificate of Conformity

(1) Where a notified body is proposing to decline to draw up a certificate of conformity in relation to a structural subsystem, or is proposing to decline to confirm that a conformity declaration or suitability declaration can be drawn up in respect of an interoperability constituent, it shall--

(a) give notice in writing to the applicant of the reasons why it is proposing to do so;

(b) give the applicant the opportunity to make representations within a period of 21 days beginning with the day on which such notice is given; and

(2) If the notified body rejects these representations the applicant shall have a further 21 days to appeal to the Minister, whose decision in the matter shall be final.

(3) A notified body shall not draw up a certificate of conformity in relation to a structural subsystem unless satisfied that that subsystem conforms to such of the TSIs or notified standards as that subsystem is required to conform with pursuant to Regulation 9(3).

(4) A notified body shall not confirm that a conformity declaration or suitability declaration can be drawn up in respect of an interoperability constituent unless satisfied that that constituent conforms to such of the European specifications, TSIs or notified standards as are required pursuant to Regulation 5(1).

15. Withdrawal or suspension of Notification of a Notified Body

(1) Where, in the opinion of the Minister a notified body ceases to fulfil the requirements or its obligations, the Minister may withdraw, or if appropriate, suspend the notification having contacted the body in question. If this course of action is undertaken, the Minister shall have this information published, and shall inform the Commission and the other Member States following a procedure similar to that of the notification.

(2) The Minister is solely entitled to withdraw notification of a notified body notified by the Minister.

(3) The body whose notification has been withdrawn shall have the right to appeal the decision.

(4) In the event of a withdrawal or suspension of notification the Minister shall notify the body in question that the body has 21 days from the date of notification to make written representations to the Minister, which the Minister shall consider.

(5) If the Minister having considered representations made under paragraph (4) is subsequently satisfied that there are no longer grounds for withdrawal and/or suspension the notified body having established that it has the necessary competence to carry out its functions the Minister may revoke the withdrawal and/or suspension by means of a written notice to the body in question.

(6) If the Minister rejects the representations made under paragraph (4) the body may appeal in writing, within 21 days of the decision, to a judge of the District Court, and the withdrawal or suspension shall not take effect until the time allowed for such appeal has elapsed and, in the event of an appeal, until the appeal is determined.

(7) On hearing an appeal under Regulation 9(4) the District Court may either confirm or vary the decision of the Minister or allow the appeal.

(8) A decision of the District Court shall be final, save that by leave of the Court, an appeal from the decision shall be to the High Court on a specified point, or points, of law.

(9) Where the Committee has delivered an opinion in respect of a notified body referred to it pursuant to Article 20(4) and the Commission has informed the Minister of the changes necessary for the notified body to retain its status as a notified body, the Minister shall give notice in writing to the notified body of the necessary changes.

(10) Where a notified body has been given notice in writing by the Minister pursuant to paragraph (9), the notified body shall take all necessary steps to effect the changes referred to in the notice.

(11) For the purposes of paragraph (10), the Minister shall specify in the notice referred to in that paragraph the period of time in which the notified body must take the necessary steps to effect the changes referred to in the notice.

(12) Where the notified body fails to effect the necessary changes within the period of time specified in the notice, the Minister shall withdraw the notification of the notified body. The Minister shall communicate the fact of this withdrawal to the Commission and to the other Member States.

16. Inspectors

(1) The Minister may appoint such person or persons as the Minister thinks fit to be an inspector for the purposes of these Regulations and may revoke any such appointment.

(2) The Minister shall issue to every inspector appointed by him or her under paragraph (1) a warrant of appointment and, when exercising his or her powers under these Regulations, the inspector shall, if requested by any person thereby affected, produce the warrant of appointment or a duly authenticated copy of the warrant of appointment.

(3) An inspector may, in accordance with his or her warrant of appointment, for the purposes of ascertaining whether these Regulations are being complied with, do any or all of the following:

(a) enter, inspect, examine and search at all reasonable times, any place or premises which he or she has reasonable cause to believe-

(i) is part of a rail system which forms part of the trans-European conventional rail system,

(ii) contains interoperability constituents or records, documents, or information relating to such constituents, or

(iii) contains any records, documents or information relating to the matters referred to in Regulation 3(2).

(b) bring with him or her any other person authorised by the Minister or any equipment or materials required for any purpose for which the power of entry is being exercised,

(c) be accompanied by a member of the Garda Siochana if the inspector has reasonable cause to apprehend a serious obstruction in the execution of his or her duty,

(d) require any person to produce to the inspector any report, document or record (including in the case of information in a non-legible form a copy of an extract from such information in permanent legible form) which relates to any matter to which these Regulations apply,

(e) carry out checks on or take samples for examination, testing or analysis, of any infrastructure, rolling stock, interoperability constituent or any of the subsystems, including basic parameters, referred to in Schedule 2,

(f) inspect, examine and take copies of or extracts from or take away, if necessary, for the purposes of inspection or examination, any report, document or record (including in the case of information in a non-legible form a copy of an extract from such information in permanent legible form) kept or used in connection with the operation of a conventional rail system and require the person by whom such document or record is kept to certify a copy thereof as a true copy,

(g) request the production of, examine and take copies of any relevant training certificate of staff involved in the operation of a conventional rail system or employed or engaged on contract by a notified body,

(h) take any measurements or photographs or make any tape, electronic or other recordings which the inspector considers necessary for the purposes of any inspection, examination or inquiry made by him or her under these Regulations,

(i) require any person to afford the inspector such facilities and assistance within his or her control or responsibilities as are necessary to enable him or her to exercise any of the powers conferred on him or her by these Regulations,

(j) exercise such other powers as may be necessary for the carrying out of his or her functions or duties,

(k) investigate any accident which occurs on a conventional rail system in accordance with section 7 of the Railway Regulations 1871, and

(l) require the attendance before him or her of any person in the jurisdiction for the purpose of providing to the inspector any information which may be known to the person and which, in the inspector's opinion may be necessary to enable the inspector perform his or her functions or duties, and the person concerned shall comply with the requirement.

(4) (a) It shall be an offence for any person or body to wilfully prevent, obstruct, impede or delay an inspector from exercising any functions conferred on him or her by these Regulations and it shall be an offence for any person or body wilfully to fail to comply with a bona fide request or instruction from an inspector in the exercise of his or her functions.

(b) A person guilty of an offence under subparagraph (a) is liable on summary conviction to a fine not exceeding £3,000 or to imprisonment for a term not exceeding 6 months, or both.

(5) Where the Minister is satisfied that an inspector appointed by him or her has, in a bona fide manner, exercised a power conferred on the inspector by these Regulations, the Minister shall indemnify the inspector against all actions or claims however arising in respect of the exercise by the inspector of that power.

17. Prohibition notice

(1) If an inspector, appointed under Regulation 16, is of the opinion that a person: -

(a) has placed into service, constructed, upgraded or renewed a subsystem, or

(b) has placed on the market an interoperability constituent,

in contravention of these Regulations, or

the inspector may serve on that person a notice signed by the inspector, referred to in these Regulations as a “prohibition notice”.

(2) If an inspector is of the opinion that an interoperability constituent that is covered by a conformity or suitability declaration (as the case may be) is unlikely to meet the essential requirements the inspector may by notice prohibit or restrict the use of that interoperability constituent.

(3) A prohibition notice shall: --

(a) be in writing,

(b) state that the inspector has formed the relevant opinion,

(d) direct that the activities which are taking place in contravention of these Regulations should cease.

(4) A prohibition notice shall take effect on one of the following dates: --

(a) Upon receipt by the person to whom it is directed if the notice specifies that it is to have immediate effect,

(b) On the day specified in the notice,

(c) if no appeal is taken against the notice, on the expiration of the period during which such an appeal may be taken, or the day specified in the notice as that on which it comes into effect, whichever is the later, or

(d) where an appeal is taken, on the day following the day on which the notice is confirmed on appeal or the appeal is withdrawn or the day specified in the notice as that on which it is to come into effect, whichever is the later.

(5) A person who is aggrieved by a prohibition notice may, within 10 days beginning on the day on which the notice is served, appeal to the District Court in the District Court district in which the principal place of business in the State of the person to whom the prohibition notice is directed is situated.

(6) The bringing of an appeal against a prohibition notice shall not have the effect of suspending the operation of the notice provided, however, that the appellant may apply to the Court to have the operation of the notice suspended until the appeal is disposed of and, on such application, the Court may, if it thinks proper to do so, direct that the operation of the notice be suspended until the appeal is determined.

(7) In determining the appeal, the Court may, if satisfied that in the circumstances of the case it is reasonable to so, confirm the notice, with or without modification, or, cancel the notice.

(8) Notwithstanding paragraph 4(d), where a prohibition notice is confirmed on appeal, the Court may on the application of the appellant, suspend the operation of the notice for such period as, in the circumstances of the case, it is considered appropriate by the Court.

(9) An inspector may revoke a prohibition notice.

(10) Where a prohibition notice has been served and activities are being carried on in contravention of the notice, the High Court may, on the application of an inspector, by order prohibit the continuance of the activities.

(11) An application to the High Court under paragraph (10) shall be by motion on notice and the Court, when considering the matter, may make such interim or interlocutory order as it considers appropriate and the order by which an application under paragraph (10) is determined may contain such terms and conditions as to the payment of costs as the Court considers appropriate.

(12) The Minister shall inform the Commission of any measures taken under this Regulation and shall furnish reasons stating in particular whether the failure to conform is due to-

(a) failure to meet the essential requirements;

(b) incorrect application of the European specifications where application of the specifications is invoked;

(d) any other reason which the Minister considers relevant.

(13) A person or body who fails to comply with a Prohibition Notice is guilty of an offence and is liable on summary conviction to a fine not exceeding €3,000 or to a term of imprisonment for a term not exceeding 6 months, or both.

18. Notices relating to interoperability constituents, including interfaces, not meeting the essential requirements

(1) If the Minister is of the opinion that an interoperability constituent, including interfaces, in relation to which a conformity declaration or suitability declaration has been drawn up does not meet the essential requirements relating to it, the Minister may serve a notice on the person who is using, or intending to use, that interoperability constituent in the construction, upgrading, or renewal of a structural subsystem in relation to which that person is a contracting entity, to prohibit the use, or restrict the area of use, of that interoperability constituent.

(2) The information to be contained in a notice served under paragraph (1) is -

(a) a statement that the Minister 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 shall not be used, or that its area of use shall be restricted as specified in the notice, in the construction, upgrading, or renewal, and

(d) the date by which the contracting entity shall comply with the notice.

(3) Any notice served under paragraph (1) may be withdrawn by the Minister serving written notice of the withdrawl on the contracting entity.

(4) Where a notice has been served on the contracting entity in accordance with this regulation, the contracting entity shall -

(a) comply with that notice; and

(b) notify the person who supplied him 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) the contents of the notice, and

(iii) that he or she requires that person in turn to notify his or her supplier with the same information required by this paragraph.

19. Fees payable to notified bodies

(1) Subject to paragraph (2) a notified body appointed by the Minister may charge such fees in connection with or incidental to, carrying out functions referred to in Regulation 12 as it may determine.

(2) The fees charged pursuant to paragraph (1) shall not exceed the sum of the following:

(a) the costs incurred or to be incurred by the notified body in performing its duties under these Regulations,

(b) an amount of profit which is reasonable in the circumstances having regard to the character and extent of the work done by the body on behalf of the applicant, and the commercial rate normally charged on account of profit for that work or similar work.

(3) The power in paragraph (1) includes the power to require the payment of fees in advance of carrying out the work requested by the applicant.

20. Fees payable to Minister

(1) A fee may be payable by the contracting entity to the Minister for work carried out in the State by or on behalf of the Minister in relation to: -

(a) an application pursuant Regulation 7 for an authorisation,

(b) a request pursuant to Regulation10 for a screening decision,

(2) The fees payable under paragraph (1) shall not exceed the sum of the costs incurred by the Minister in carrying out the work referred to in paragraph (1).

(3) The Minister may charge such reasonable fee in connection with, or incidental to, carrying out functions under Regulation 12.

21. Prosecution of offences

(1) An offence under these Regulations may be prosecuted by the Minister.

(2) Where an offence is committed under these Regulations by a body corporate and is proved to have been committed with the consent, connivance, or approval of any person, being a director, manager, secretary, other officer, or a person who was purporting to act in any such capacity or is attributable to the wilful neglect of any such person, that person, as well as the body corporate, is guilty of an offence and isliable to be prosecuted and punished as if he or she was guilty of the first-mentioned offence.

SCHEDULE 1

THE TRANS-EUROPEAN CONVENTIONAL RAIL SYSTEM

INFRASTRUCTURE

1. The infrastructure of the trans-European conventional rail system shall be that on the lines of the trans-European transport network identified in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the trans-European transport network⁵ or listed in any update to the same Decision as a result of the revision provided for in Article 21 of that Decision

2. For the purposes of these Regulations, this railway system may be subdivided into the following categories:

- lines intended for passenger services;

- lines intended for mixed traffic (passengers and freight);

- lines specially designed or upgraded for freight services;

- passenger hubs;

- freight hubs, including intermodal terminals;

- lines connecting the abovementioned components.

3. This infrastructure includes traffic management, tracking, and navigation systems: technical installations for data processing and telecommunications intended for long-distance passenger services and freight services on the network in order to guarantee the safe and harmonious operation of the network and efficient traffic management.

ROLLING STOCK

2. The rolling stock shall comprise all the stock likely to travel on all part of the railway system in the State forming part of the trans-European conventional rail network, including:

- self-propelling thermal or electric trains;

- thermal or electric traction units;

- passenger carriages;

- freight wagons, including rolling stock designed to carry lorries.

2. Each of the above categories must be subdivided into:

- rolling stock for international use;

- rolling stock for national use;

taking due account of the local, regional or long-distance use of the stock.

3. COMPATIBILITY OF THE TRANS-EUROPEAN CONVENTIONAL RAILWAY SYSTEM

The quality of rail services in Europe depends, inter alia, on excellent compatibility between the characteristics of the infrastructure (in the broadest sense, i.e. the fixed parts of all the subsystems concerned) and those of the rolling stock (including the onboard components of all the subsystems concerned). Performance levels, safety, quality of service and cost depend upon that compatibility.

SCHEDULE 2

SUBSYSTEMS

1. LIST OF SUBSYSTEMS

For the purposes of these Regulations, the railway system in the State forming part of the trans-European conventional rail system may be broken down into the following two subsystems, either:

(a) structural areas:

- infrastructure;

- energy;

- control and command and signalling;

- traffic operation and management;

- rolling stock; or

(b) operational areas:

- maintenance;

- telematics applications for passenger and freight services.

2. DESCRIPTION OF THE SUBSYSTEMS

2.1. Infrastructure:

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

2.2. Energy:

The electrification system, overhead lines and current collectors.

2.3. Control and command and signalling:

All the equipment necessary to ensure safety and to command and control movements of trains authorised to travel on the railway system in the State forming part of the trans-European conventional rail system.

2.4. Traffic operation and management:

The procedures and related equipment enabling a coherent operation of the different structural subsystems, both during normal and degraded operation, including in particular train driving, traffic planning and management.

The professional qualifications which may be required for carrying out cross-border services.

2.5. Telematics applications:

In accordance with Schedule 1, this subsystem comprises two elements:

(a) applications for passenger services, including systems providing passengers with information before and during the journey, reservation and payment systems, luggage management and management of connections between trains and with other modes of transport;

(b) applications for freight services, including information systems (real-time monitoring of freight and trains), marshalling and allocation systems, reservation, payment and invoicing systems, management of connections with other modes of transport and production of electronic accompanying documents.

2.6. Rolling stock:

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

2.7. Maintenance:

The procedures, associated equipment, logistics centres for maintenance work and reserves allowing the mandatory corrective and preventive maintenance to ensure the interoperability of the rail system in the State forming part of the trans-European conventional rail system and guarantee the performance required.

SCHEDULE 3

ESSENTIAL REQUIREMENTS

1. GENERAL REQUIREMENTS

1.1. Safety

1.1.1. The design, construction or assembly, maintenance and monitoring of safety-critical components and, more particularly, of the components involved in train movements must be such as to guarantee safety at the level corresponding to the aims laid down for the railway system in the State forming part of the trans-European conventional rail system, including those for specific degraded situations.

1.1.2. The parameters involved in the wheel/rail contact must meet the stability requirements needed in order to guarantee safe movement at the maximum authorised speed.

1.1.3. The components used must withstand any normal or exceptional stresses that have been specified during their period in service. The safety repercussions of any accidental failures must be limited by appropriate means.

1.1.4. The design of fixed installations and rolling stock and the choice of the materials used must be aimed at limiting the generation, propagation and effects of fire and smoke in the event of a fire.

1.1.5. Any devices intended to be handled by users must be so designed as not to impair the safe operation of the devices or the health and safety of users if used foreseeably in a manner not in accordance with the posted instructions.

1.2. Reliability and availability

The monitoring and maintenance of fixed or moveable components that are involved in train movements must be organised, carried out and quantified in such a manner as to maintain their operation under the intended conditions.

1.3. Health

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

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

1.4. Environmental protection

1.4.1. The environmental impact of establishment and operation of the railway system in the State forming part of the trans-European conventional rail system must be assessed and taken into account at the design stage of the system in accordance with national and Community provisions in force.

1.4.2. The materials used in the trains and infrastructure must prevent the emission of fumes or gases which are harmful and dangerous to the environment, particularly in the event of fire.

1.4.3. The rolling stock and energy-supply systems must be designed and manufactured in such a way as to be electromagnetically compatible with the installations, equipment and public or private networks with which they might interfere.

1.4.4. Operation of the railway system in the State forming part of the trans-European conventional rail system must respect existing legislation on noise pollution.

1.4.5. Operation of the railway system in the State forming part of the trans-European conventional rail system must not give rise to an impermissible level of ground vibrations for the activities and areas close to the infrastructure and in a normal state of maintenance.

1.5. Technical compatibility

The technical characteristics of the infrastructure and fixed installations must be compatible with each other and with those of the trains to be used on the railway system in the State forming part of the trans-European conventional rail system. If compliance with these characteristics proves difficult on certain sections of the railway system in the State forming part of the trans-European conventional rail system, temporary solutions, which ensure compatibility in the future, may be implemented.

2. REQUIREMENTS SPECIFIC TO EACH SUBSYSTEM

2.1. Infrastructure

2.1.1. Safety

Appropriate steps must be taken to prevent access to or undesirable intrusions into installations.

Steps must be taken to limit the dangers to which persons are exposed, particularly when trains pass through stations.

Infrastructure to which the public has access must be designed and made in such a way as to limit any human safety hazards (stability, fire, access, evacuation, platforms, etc.).

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

2.2. Energy

2.2.1. Safety

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

2.2.2. Environmental protection

The functioning of the electrical or thermal energy-supply systems must not interfere with the environment beyond the specified limits.

2.2.3. Technical compatibility

The electricity/thermal energy supply systems used must:

- enable trains to achieve the specified performance levels;

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

2.3. Control and command and signalling

2.3.1. Safety

The control and command and signalling installations and procedures used must enable trains to travel with a level of safety which corresponds to the objectives set for the railway system in the State forming part of the trans-European conventional rail system. The control and command and signalling systems should continue to provide for safe passage of trains permitted to run under degraded conditions.

2.3.2. Technical compatibility

All new infrastructure and all new rolling stock manufactured or developed after adoption of compatible control and command and signalling systems must be tailored to use of those systems.

The control and command and signalling equipment installed in the train drivers' cabs must permit normal operation, under the specified conditions, throughout the trans-European conventional rail system.

2.4. Rolling stock

2.4.1 Safety

The structure of the rolling stock and of the links between vehicles must be designed in such a way as to protect the passenger and driving compartments in the event of collision or derailment.

The electrical equipment must not impair the safety and functioning of the control and command and signalling installations.

The braking techniques and the stresses exerted must be compatible with the design of the track, engineering structures and signalling systems.

Steps must be taken to prevent access to electrically-live constituents in order not to endanger the safety of persons.

In the event of danger, devices must enable passengers to inform the driver and accompanying staff to contact him.

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

Emergency exits must be provided and indicated.

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

An emergency lighting system of sufficient intensity and duration is compulsory on board trains.

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

2.4.2. Reliability and availability

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

2.4.3. Technical compatibility

The electrical equipment must be compatible with the operation of the control and command and signalling installations.

In the case of electric traction, the characteristics of the current-collection devices must be such as to enable trains to travel under the energy-supply systems for the trans-European conventional rail system.

The characteristics of the rolling stock must be such as to allow it to travel on any line on which it is expected to operate.

2.5. Maintenance

2.5.1. Health and safety

The technical installations and the procedures used in the centres must ensure the safe operation of the subsystem and not constitute a danger to health and safety.

2.5.2. Environmental protection

The technical installations and the procedures used in the maintenance centres must not exceed the permissible levels of nuisance with regard to the surrounding environment.

2.5.3. Technical compatibility

The maintenance installations for conventional rolling stock must be such as to enable safety, health and comfort operations to be carried out on all stock for which they have been designed.

2.6. Operation and traffic management

2.6.1. Safety

Alignment of the trans-European conventional rail system operating rules and the qualifications of drivers and on-board staff and of the staff in the control centres must be such as to ensure safe operation, bearing in mind the different requirements of cross-border and domestic services.

The maintenance operations and intervals, the training and qualifications of the maintenance and control centre staff and the quality assurance system set up by the operators concerned in the control and maintenance centres must be such as to ensure a high level of safety.

2.6.2. Reliability and availability

The maintenance operations and periods, the training and qualifications of the maintenance and control centre staff and the quality assurance system set up by the operators concerned in the control and maintenance centres must be such as to ensure a high level of system reliability and availability.

2.6.3. Technical compatibility

Alignment of the trans-European conventional rail system operating rules and the qualifications of drivers, on-board staff and traffic managers must be such as to ensure operating efficiency on the trans-European conventional rail system, bearing in mind the different requirements of cross-border and domestic services.

2.7. Telematics applications for freight and passengers

2.7.1. Technical compatibility

The essential requirements for telematics applications guarantee a minimum quality of service for passengers and carriers of goods, particularly in terms of technical compatibility.

Steps must be taken to ensure:

- that the databases, software and data communication protocols are developed in a manner allowing maximum data interchange between different applications and operators, excluding confidential commercial data;

- easy access to the information for users.

2.7.2. Reliability and availability

The methods of use, management, updating and maintenance of these databases, software and data communication protocols must guarantee the efficiency of these systems and the quality of the service.

2.7.3. Health

The interfaces between these systems and users must comply with the minimum rules on ergonomics and health protection.

2.7.4. Safety

Suitable levels of integrity and dependability must be provided for the storage or transmission of safety-related information.

SCHEDULE 4

CONFORMITY AND SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS

1. INTEROPERABILITY CONSTITUENTS

The “EC” declaration applies to the interoperability constituents involved in the interoperability of the trans-European conventional rail system, as referred to in Article 3. These interoperability constituents may be:

1.1. Multiple-use constituents

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

1.2. Multiple-use constituents having specific characteristics

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

1.3. Specific constituents

These are constituents that are specific to railway applications.

2. SCOPE

The “EC” declaration covers:

- either the assessment by a notified body or bodies of the intrinsic conformity of an interoperability constituent, considered in isolation, to the technical specifications to be met;

- or the assessment/judgement by a notified body or bodies of the suitability for use of an interoperability constituent, considered within its railway environment and, in particular in cases where the interfaces are involved, in relation to the technical specifications, particularly those of a functional nature, which are to be checked. The assessment procedures implemented by the notified bodies at the design and production stages will draw upon the modules defined in Decision 93/465/EEC⁶ , in accordance with the conditions referred to in the TSIs.

3. CONTENTS OF THE “EC” DECLARATION

A conformity declaration or suitability declaration and the accompanying documents must be dated and signed.

That declaration must be written in the same language as the instructions and must contain the following information:

- the Regulation and Directive references;

- the name and address of the manufacturer or his authorised representative established within the State (give trade name and full address, in the case of the authorised representative, also give the trade name of the manufacturer or constructor);

- a description of interoperability constituent (make, type, etc.);

- a description of the procedure followed in order to declare conformity or suitability for use;

- all the relevant descriptions met by the interoperability constituent and, in particular, its conditions of use;

- the name and address of the notified body or bodies involved in the procedure followed in respect of conformity or suitability for use and date of examination certificate together with, where appropriate, the duration and conditions of validity of the certificate;

- where appropriate, reference to the European specifications;

- identification of the signatory empowered to enter into commitments on behalf of the manufacturer or the manufacturer's representative established within the State.

SCHEDULE 5

DECLARATION OF VERIFICATION OF SUBSYSTEMS

A verification declaration and the accompanying documents must be dated and signed.

That declaration must be written in the same language as the technical file and must contain the following information:

- the Regulation and Directive references;

- the name and address of the contracting entity or its authorised representative established within the State (give trade name and full address; in the case of the authorised representative, also give the trade name of the contracting entity);

- a brief description of the subsystem;

- the name and address of the notified body which conducted the verification referred to in Regulation 8;

- the references of the documents contained in the technical file;

- all the relevant temporary or definitive provisions to be complied with by the subsystems and in particular, where appropriate, any operating restrictions or conditions;

- the duration of validity of the verification declaration, if temporary;

- the identity of the signatory.

SCHEDULE 6

VERIFICATION PROCEDURE FOR SUBSYSTEMS

1. INTRODUCTION

Verification is the procedure whereby a notified body checks and certifies, at the request of a contracting entity or of its authorised representative established within the State, that a subsystem:

- complies with these Regulations and the Directive,

- complies with other relevant national and European legislation, and

- may be put into operation.

2. STAGES

The subsystem is checked at each of the following stages:

- overall design;

- construction of subsystem, including, in particular, civil-engineering activities, constituent assembly, overall adjustment;

- final testing of the subsystem.

3. CERTIFICATE

The notified body responsible for “EC” verification shall draw up the certificate of conformity intended for the contracting entity or its authorised representative established within the State, which in turn shall draw up the verification declaration intended for the Minister.

4. TECHNICAL FILE

The technical file accompanying the verfication declaration shall contain the following documents and information:

- for infrastructure, the engineering-structure plans, approval records for excavations and reinforcement, testing and inspection reports on concrete;

- for the other subsystems, the general and detailed drawings in line with execution, electrical and hydraulic diagrams, control-circuit diagrams, description of data-processing and automatic systems, operating and maintenance manuals, etc.;

- the list of interoperability constituents, as referred to in Article 3, incorporated into the subsystem;

- copies of the conformity declarations or suitability declarations with which the abovementioned interoperability constituents must be provided in accordance with Regulations 5 and 6 and accompanied, where appropriate, by the corresponding calculation notes and a copy of the records of the tests and examinations carried out by the notified bodies on the basis of the common technical specifications;

- the certificate of conformity from the notified body responsible for verification, accompanied by corresponding calculation notes and countersigned by the notified body, stating that the project complies with these Regulations and the Directive and mentioning any reservations recorded during performance of the activities and not withdrawn. The certificate should also be accompanied by the inspection and audit reports drawn up by the notified body in connection with its task, as specified in sections 5.3 and 5.4.

5. MONITORING

5.1. The aim of “EC” monitoring is to ensure that the obligations deriving from the technical file have been met during production of the subsystem.

5.2. The notified body responsible for checking production must have permanent access to building sites, production workshops, storage areas and, where appropriate, prefabrication or testing facilities and, more generally, to all premises which it considers necessary for its task. The contracting entity or its authorised representative within the State must send it or have sent to it all the documents needed for that purpose and, in particular, the implementation plans and technical documentation concerning the subsystem.

5.3. The notified body responsible for checking implementation must periodically carry out audits in order to confirm compliance with these Regulations and the Directive. It must provide those responsible for implementation with an audit report. The notified body may require to be present at certain stages of the building operations.

5.4 In addition, the notified body may pay unexpected visits to the worksite or to the production workshops. At the time of such visits, the notified body may conduct complete or partial audits. It must provide those responsible for implementation with an inspection report and, if appropriate, an audit report.

6. SUBMISSION

The complete technical file referred to above must be lodged with the contracting entity or its authorised representative established within the State in support of the certificate of conformity issued by the notified body responsible for verification of the subsystem. The file must be attached to the verification declaration that the contracting entity or its authorised representative within the State sends to the Minister.

A copy of the file must be kept by the contracting entity or its authorised representative within the State throughout the service life of the subsystem. The file must be sent to any other Member State that requests a copy.

7. PUBLICATION

Each notified body must periodically publish relevant information concerning:

- requests for verification received;

- certificates of conformity issued;

- certificates of conformity refused.

8. LANGUAGE

The files and correspondence relating to the verification procedures must be written in English, Irish or in a language accepted by the contracting entity.

SCHEDULE 7

MINIMUM CRITERIA THAT MUST BE TAKEN INTO ACCOUNT BY THE MINISTER WHEN NOTIFYING BODIES

1. A notified body, and its servants or agent responsible for carrying out the checks, may not become involved, either directly or as authorised representatives, in the design, manufacture, construction, marketing, maintenance, or use of the interoperability constituents or subsystems in respect of which they act as, or on behalf of, the notified body. This does not exclude the possibility of an exchange of technical information between the manufacturer or constructor and that body.

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

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

4. The servants or agents of the notified body responsible for the checks must possess:

- proper technical and vocational training;

- a satisfactory knowledge of the requirements relating to the checks that they carry out and sufficient practice in those checks;

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

5. The independence of the servants or agents responsible for the checks must be guaranteed. No official must be remunerated either on the basis of the number of checks performed or of the results of those checks.

6. The notified body must take out civil liability insurance unless that liability is covered by the State.

7. The servants or agents of the notified body are bound by professional secrecy with regard to everything they learn in the performance of their duties (with the exception of the competent administrative authorities in the State where they perform those activities) in pursuance of these Regulation and the Directive.

SCHEDULE 8

Additional criteria that must be met by notified bodies appointed by the Minister.

A notified body notified by the Minister under these Regulations shall:

1. Be a legal entity established in the State and be under the jurisdiction of the State, although it may have activities or personnel outside the State.

2. Keep the Minister informed of its activities and, if requested, provide the Minister with all information concerning the proper implementation of the conditions under which they were notified.

3. Generally adhere to the obligation to inform other notified bodies and the Minister, who shall act as supervisory authority of notified bodies in the State,.

4. At all times remain, independent of their clients and other interested parties.

5. Be free of any commercial, financial or other pressure that might influence their judgement.

6. Ensure that it safeguards impartiality, especially if the notified body is engaged in other activities than those of a notified body. Where a notified body is engaged in such other activities, it shall make clear, particularly in its marketing activities, the distinction between its activities as a notified body, and such other activities.

7. Have procedures for the identification, review, and resolution of all cases where a conflict of interests is suspected or proven.

8. Ensure confidentiality of the information obtained in the course of the performance of its duties as a notified body under these Regulations.

9. Be adequately insured.

10. Take part in co-ordination activities and working groups in association with the other notified bodies, including bodies notified by other Member States.

SCHEDULE 9

Conditions that must be complied with by a notified body seeking to sub-contract part of its work.

1. The Minister must be informed prior to the work being sub-contracted.

2. The work sub-contracted must be confined to limited technical tasks, such as tests and examinations, provided these tasks can be defined as substantial and coherent parts of the technical operation and sub-contracting can be carried out in the field of certification of quality systems by using external persons as auditors, provided that the notified body carries out the evaluation of the audit results.

3. The work carried out shall be on the basis of established and regularly monitored competence.

4. The body sub-contracted with by the notified body shall be technically competent and display independence and objectivity according to the same criteria and under the same conditions as the notified body, but the body sub-contracted with does not need to be notified. The Minister and the notified body shall ensure that there is effective monitoring of the competence of the body sub-contracted.

5. There must be a written contract between the notified body and the body with which it has sub-contracted.

6. A notified body which has sub-contracted part of its work:-

(a) shall remain responsible for all the activities covered by its notification,

(b) sub-contracting shall not entail the delegation of powers or responsibilities, and

7. The conditions for sub-contracting shall apply to all sub-contractors whether or not such sub-contractor is established within the State..

GIVEN under my Official Seal,

this 18^th day of February, 2004

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SEAMUS BRENNAN, T.D.,

Minister for Transport

Explanatory Note

(This not is not part of the Instrument and does not purport to be a legal interpretation)

The purpose of these Regulations is to give effect to Council Directive 2001/16/EC of 19 March 2001 on the interoperability of the trans-European conventional rail system. The aim of Council Directive 2001/16/EC is to remove obstacles to interoperability on the rail lines of the trans-European conventional rail system. Technical Specifications for interoperability (TSIs), provided for in the Directive, and agreed by Member States provide the basis for the achievement of interoperability.

¹ OJ L110, 20.4.2001, p.1

² OJ L 235, 17.9.1996, p.6

³ OJ L110, 20.4.2001, p.1

⁴ OJ L199, 9.8.1993, p.84

⁴ OJ LO15, 17/01/97, P.01

⁵ OJ L228, 9.9.1996, p.1

⁶ OJ L220, 30/08/93, P. 23-39

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Irish Statutory Instruments

S.I. No. 61/2004 -- European Communities (Interoperability of the Trans-European Conventional Rail System) Regulations 2004