I, Mary O'Rourke, Minister for Public Enterprise, 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 96/48/EC¹ of 23 July 1996 hereby make the following regulations:

Citation

1. These Regulations may be cited as the European Communities (Interoperability of the Trans-European High-Speed Rail System) Regulations 2002.

Interpretation

2. (1) In these Regulations:

“Commission” means Commission of the European Communities;

“conformity certificate” means a certificate drawn up by the notified body in relation to a subsystem as part of the procedure for drawing up the EC verification declaration for that subsystem;

“conformity declaration” means an EC declaration of conformity prepared in accordance with the procedures set out in any TSI relevant to the subsystem or interoperability constituent in question;

“Directive” means Council Directive 96/48/EC of 23 July 1996 ² on the interoperability of the trans-European high-speed rail system;

“essential requirements” means all the conditions set out in Annex III which must be met by the high-speed rail system, subsystems and their interoperability constituents;

“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 Article 1 of Directive 93/38/EEC³ ;

“European standard” has the same meaning as it has in Council Directive 93/38/EEC;

“high-speed rail system” means a rail system, or part thereof, in the State which meets the criteria described in Annex I, and composed of the railway infrastructures comprising lines and fixed installations constructed or upgraded to be travelled on at high speeds, and rolling stock designed for travelling on those infrastructures;

“interoperability” means the ability of the high-speed rail system to allow the safe and uninterrupted movement of high-speed trains which accomplish the specified levels of performance and this ability rests on all the regulatory, technical and operational conditions which must be met in order to satisfy essential requirements;

“interoperability constituent” 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 high-speed rail system depends either directly or indirectly, and a constituent which has been specified by a TSI as being an interoperability constituent shall be deemed to be an interoperability constituent for the purposes of this definition;

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

“Minister” means Minister for Public Enterprise;

“notified body” means a body responsible for assessing the conformity or suitability for use of the interoperability constituents or for appraising the EC procedure for verification of the subsystems in accordance with Regulation 10;

“notified standards” means any standards, technical specifications or technical rules which may be notified to the Commission pursuant to Regulation 7(4)(a)(ii);

“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 charge of the management of that interoperability constituent or subsystem for the time being;

“owner” in relation to a structural subsystem means the person with legal title to that structural subsystem;

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

“subsystems” means the individual systems described in Annex II, comprising structural and operational subsystems for which essential requirements must be laid down;

“suitability declaration” means an EC declaration of suitability for use of an interoperability constituent in respect of that interoperability constituent;

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

“technical specification for interoperability” (in these Regulations referred to as TSIs) means the specifications, that have been adopted by the Community and published in the Official Journal of the European Communities, by which each subsystem is covered in order to meet the essential requirements by establishing the necessary reciprocal functional relations between the subsystems of the trans-European high-speed rail system and by ensuring the latter's compatibility;

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

“trans-European high-speed rail system” means the structure described in Annex I composed of the railway infrastructures comprising lines and fixed installations, of the trans-European transport network, constructed or upgraded to be travelled on at high speeds, and rolling stock designed for travelling on those infrastructures;

“verification declaration” means an EC declaration of verification prepared in accordance with the procedures set out in Annex VI.

(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 reference occurs, unless it is indicated that reference to some other provision is intended,

(d) a reference to an Annex is a reference to an Annex to the Directive.

Application and Scope

3. (1) These Regulations establish the conditions to be met in the State to achieve interoperability of the trans-European high-speed rail system as described in Annex I.

(2) These Regulations apply to:

(a) the construction, upgrading and operation of subsystems which form or are intended to form part of the trans-European high-speed rail system,

(b) the placing on the market of interoperability constituents,

(c) high-speed rolling stock designed for travelling on rail systems which form part of the trans-European high-speed rail system,

(d) the appointment in the State of notified bodies,

(e) the carrying out in the State of conformity assessment procedures in relation to interoperability constituents and verification assessment procedures in relation to subsystems used or intended for use in the construction, upgrading or operation of the trans-European high-speed rail system,

Derogations

4. (1) The Minister may decide not to apply one or more TSIs, including those relating to rolling stock, in the following cases and circumstances, in relation to parts of the rail system in the State which form part of the trans-European high-speed rail system:

(a) where an existing line is being upgraded for high speed and where the loading gauge, track gauge or space between the tracks of the line are different from those on the majority of the European rail network, and where the line does not form a direct connection with the high-speed network of another Member State which is a part of the trans-European high-speed network,

(b) where new lines are being constructed for high speed or existing lines are being upgraded for high speed in the State, where the rail network in the State is not linked to or is isolated by sea from the high-speed rail network of the rest of the Community,

(c) in the case of a project for upgrading an existing line for high speed, where application of the TSI concerned would compromise the economic viability of the project.

(2) Where the Minister proposes to make a decision under paragraph (1) (a) or (b), the Minister shall notify the proposal to the Commission in advance and shall forward to it a file containing details of the proposals setting out the physical parameter or parameters of the TSIs or relevant parts which the Minister wishes not to apply, the provisions that it is proposed to apply in carrying out the project in order to promote its eventual interoperability, the transitional measures it is proposed to take to guarantee compatibility of operation, and the technical, administrative or economic reasons which justify the derogation.

(3) Where the Minister proposes to make a decision under paragraph 1(c), the Minister shall notify the proposal to the Commission in advance and shall forward to it a file setting out the technical specifications or parts of specifications for interoperability which the Minister wishes not to apply and the Minister shall comply with the decision of the Commission.

Interoperability constituents

5.(1) A person shall not place on the market any interoperability constituent unless-

(a) the said 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 high-speed rail system,

(c) the interoperability constituent meets such of the relevant essential requirements as relate to the interoperability constituent concerned,

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

(e) either an EC declaration of conformity or an EC declaration of suitability for use, or both (as required by the circumstances) has been prepared in relation to the interoperability constituent by the person responsible in accordance with the requirements of Annex IV.

(2) Where no relevant European specification referred to in paragraph (1)(a) has been so published, a person shall not place on the market within the State any interoperability constituent unless it conforms to such standards and technical specification relating to such interoperability constituents as may have been notified by the Minister to the Commission pursuant to Article 10(5) of the Directive as being in use in the State.

(3) Where there is a requirement to prepare an EC declaration of conformity or EC declaration of suitability for use (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 such EC declaration of conformity or declaration of suitability for use shall state in that declaration whether or not the interoperability constituent in question meets those other requirements.

(4) In the case of an interoperability constituent to which paragraph 1 refers an EC declaration of conformity must be prepared in relation to the interoperability constituent by the person responsible for placing such constituent on the market.

(5) (a) Where, in the case of an interoperability constituent, any of the requirements of paragraphs (1), (3) or (4) to be fulfilled by the manufacturer or his or her authorised representative in the Community have not been so fulfilled, such requirements shall be fulfilled by any person who -

(i) places that interoperability constituent on the market,

(ii) uses that interoperability constituent, or any part of it, in any interoperability constituent or subsystem that he or she is manufacturing or otherwise constructing,

(iii) uses that interoperability constituent himself or herself as part of the trans-European high-speed rail system.

(b) Nothing in this paragraph shall affect-

(i) the power of the Minister, or

(ii) an inspector appointed under Regulation 13, or on whom powers are conferred under Regulation 14,

to take action in respect of the manufacturer of the interoperability constituent or his or her authorised representative established in the Community in respect of a contravention of or a failure to comply with any of those requirements.

(6) Notwithstanding the provisions of this Regulation, interoperability constituents may be placed on the market for purposes other than use on the trans-European high-speed rail system, including their use on conventional railway lines.

(7) Nothing in these Regulations shall preclude a person drawing up an EC declaration of conformity or an EC declaration of suitability for use, or both (as the case may be in relation to an interoperability constituent provided that the person has complied with the requirements of these Regulations and the Directive in relation to such interoperability constituent.

(8) The placing on the market of an interoperability constituent for use on a high-speed rail system shall not be restricted or prohibited if the interoperability constituent conforms to the requirements of paragraph 1, and if it conforms to the requirements of the TSIs as published in the Official Journal.

(9) Where an interoperability constituent bearing the EC declaration of conformity fails to comply with the essential requirements, the Minister may take the appropriate measures against whomsoever has drawn up the declaration, including if the Minister thinks it appropriate, the withdrawal of notification of a body, in accordance with the procedures set out in Regulation 12 and shall inform the Commission and the other Member States of the measures that have been taken, the steps taken to prohibit or restrict the use of that interoperability constituent, the reasons for taking those steps and any measures taken against the person or persons who drew up the EC declaration of conformity or the EC declaration of suitability for use (as the case may be).

(10) 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

(11) An EC declaration of conformity or an EC declaration of suitability for use shall comply with Article 13 of the Directive.

(12) Subject to the Directive and these Regulations nothing shall preclude any person from placing on the market an interoperability constituent that has successfully completed conformity assessment procedures in force in another Member State for the purpose of implementing the Directive.

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

(14) A person who issues an EC declaration of conformity or an EC declaration of suitability for use in respect of an interoperability constituent which does not comply with the essential requirements shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €3000 or imprisonment for a term not exceeding 6 months or both.

Assessment procedures for interoperability constituents

6.(1) For the purposes of Regulation 5 the appropriate conformity assessment or suitability for use 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; and

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

(b) in the absence of such a TSI or such a European specification, such conformity or suitability for use assessment procedure that is considered to be appropriate by the notified body; and

in any such case any relevant procedure set out in Annex IV.

(2) (a) Without prejudice to the provisions of Regulation 5 where an EC declaration of conformity has been drawn up improperly, the Minister may instruct the manufacturer or his authorized representative established within the Community to ensure that the conformity of the interoperability constituent is re-established.

(b) Where the non-conformity persists, the Minister may take appropriate steps to restrict or prohibit the placing on the market of the interoperability constituent concerned, or to ensure that it is withdrawn from the market.

Subsystems

7.(1) (a) A person shall not put into service on a high-speed rail system in the State which forms part of the trans-European high-speed rail system any structural subsystem or part of a structural subsystem unless the Minister has given authorisation for the placing into service of the subsystem.

(b) When seeking the authorisation referred to in subparagraph (a) the person intending to place the structural subsystem into service shall provide the Minister with the conformity certificate, a copy of the verification declaration relating to that subsystem, and the technical file.

(2) The Minister shall not prohibit, restrict or hinder the construction, placing in service and operation of structural subsystems in the State forming part of the trans-European high-speed rail system, which comply with the essential requirements and the provisions of these Regulations.

(3) The Minister shall grant an authorisation referred to in paragraph (1)(a) where the structural subsystem or part of a structural subsystem meets the essential requirements and complies with this Regulation

(4) The requirements in respect of a subsystem which is placed into service in the State are that -

(a) the subsystem-

(i) conforms to any TSI relating to that subsystem which has been published in the Official Journal,

(ii) in the absence of any TSIs relating to that subsystem, it conforms to such technical rules in use in the State, if any, used for implementing essential requirements, as may be notified by the Minister to the Commission pursuant to Article 16(3) of the Directive,

(iii) meets such of the requirements as relate to that type of subsystem,

(iv) has been designed, constructed and installed in such a way so as not to hinder compliance with the essential requirements when it is placed into service.

(b) the proper procedures for verification in respect of the subsystem have been carried out in accordance with Regulation 9,

(d) the verification declaration has been drawn up in relation to the subsystem in accordance with Annex V and VI.

(5) In relation to any subsystem, the operator of that subsystem shall ensure that while the subsystem is in use that it,

(a) meets the essential requirements,

(b) continues to conform to the relevant TSIs as published in the Official Journal.

(6) Structural subsystems constituting the trans-European high-speed rail system which are covered by an EC declaration of verification, as described in Annex V and VI to the Directive, shall be considered as being interoperable and meeting the essential requirements concerning them.

(7) When an EC declaration of verification is being drawn up, the Minister shall ensure that the EC checking procedure is evaluated and assessed by a notified body notified for that purpose.

(8) The activities and the duties of a notified body in the State, responsible for the EC verification of a subsystem, as set out in Annex V and VI to the Directive, 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.

(9) The Minister may require additional checks, which the Minister considers to be necessary, to be carried out in relation to a subsystem covered by a verification declaration but which appears to the Minister not to meet the essential requirements.

(10) In relation to the additional checks referred to in paragraph (8) the Minister shall inform the Commission and the reasons that it has been decided to make the checks.

(11) A subsystem need not conform to the TSI relating to that type of subsystem where a derogation relating to that subsystem has been notified by the Minister to the Commission as provided for in Article 7(a), (b) or (c) of the Directive, or notified by the Minister to the Commission and permitted by the Commission as provided for in Article 7(d) of the Directive.

(12) A person who contravenes this Regulation shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €3,000 or to a term of imprisonment not exceeding 6 months or both.

Duties on the owner of a structural subsystem

8. In relation to a structural subsystem, the owner of that structural subsystem shall ensure that while it remains under his or her ownership and in use on any part of the rail system in the State which forms part of the trans-European high-speed rail system-

(a) it continues to conform to all relevant TSIs and all notified standards against which it was assessed except where it is no longer possible to apply those TSIs or notified standards because they have been updated in which case that it conforms to those updated TSIs or notified standards,

(b) all maintenance records in relation to that structural subsystem are added to and kept as part of the technical file, and

(c) all alterations made to the structural subsystem are documented and that documentation is added to and kept as part of the technical file.

Verification assessment procedures for structural subsystems

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

(a) in so far 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) in so far 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

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

(3) 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 rail network forming part of the trans-European high-speed rail system in which it is proposed to be placed into service, the Minister may exempt a subsystem from the relevant provisions.

Notified bodies

10. (1) If the Minister-

(a) is of the opinion that it is necessary to do so, and

(b) is of the opinion that a person with the necessary competence is in existence in the State,

the Minister may appoint such a person as a notified body for the purposes of these Regulations and the Directive.

(2) The functions of notified bodies in the State for the purposes of these Regulations shall be :-

(a) to assess the conformity or suitability for use of interoperability constituents against the relevant essential requirements by applying the procedures referred to in Regulation 6,

(b) to apply the procedures for verification of structural subsystems referred to in Regulation 9,

(c) to consult other notified bodies appointed pursuant to the Directive throughout the European Community in relation to the functions referred to in subparagraphs (a) and (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 within the European Communities.

(3) An EC declaration of conformity or an EC declaration of suitability for use of an interoperability constituent or an EC declaration of verification of a structural subsystem provided by a notified body notified by another Member State shall be acceptable in the State.

(4) A notified body shall be responsible for compiling the technical file that has to accompany the EC declaration of verification as described in Annex V to the Directive and the technical file shall contain all the necessary documents relating to the characteristics of the subsystem and, where appropriate, all the documents certifying conformity of the constituents of interoperability and shall 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.

(5) The general criteria provided for in Annex VII shall apply in respect of the assessment of the bodies to be notified as notified bodies.

(6) A notified body shall meet the requirements specified in Schedule 1 to these Regulations.

(7) To effect notification the Minister shall notify the Commission and other Member States that a body, which fulfils the requirements, has been designated to carry out conformity assessment in accordance with the Directive.

(8) 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.

(9) The Minister shall publish in the Iris Oifigiúil the relevant information concerning all notified bodies, including those notified by the Minister and notified by other Member States.

(10) The Minister may decide to notify a body in respect of a specified period of time and to renew or not to renew the notification as appropriate.

(11) A notified body may have part of its work carried out, by sub-contract or otherwise, by another person subject to compliance with the provisions of Schedule 2 to these Regulations.

(12) 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 and for this purpose the Minister or a designated accreditation body may carry out re-assessment of notified bodies.

(13) 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.

(14) 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 provided for in Article 21.

Notified bodies' refusal to give EC Declaration

11. (1) Where a notified body refuses to give a verification declaration or a conformity declaration or suitability declaration it shall:-

(a) give notice in writing to the applicant of the reasons for the refusal,

(b) give notice in writing to the applicant that the applicant has 21 days from the date of notification of the refusal to make representations to the notified body,

(2) If the notified body rejects the representations made by the applicant pursuant to paragraph (1) (b), the applicant shall have a further 21 days to appeal to the Minister from the date of notification of such rejection, and the decision of the Minister in the matter shall be final.

Withdrawal or suspension of notification of a notified body

12.(1) Where, in the opinion of the Minister, a notified body ceases to fulfil the requirements or its obligations, the Minister may withdraw or suspend the notification having informed the body in question, and the Minister shall take all steps to give appropriate publicity to his or her decision, and shall inform the Commission and the other Member States.

(2) Where the Minister withdraws or suspends the notification of a body the Minister shall at the same time as he or she informs the body of such withdrawal or suspension inform the body concerned that the body has 21 days, from the date of the issue of the notice so informing the body, to make written representations to the Minister, which the Minister shall consider.

(3) If the Minister, having considered representations made under paragraph (2), is subsequently satisfied that there are no longer grounds for withdrawal or suspension the Minister may revoke the withdrawal or suspension by means of a written notice to the body in question.

(4) If the Minister rejects the representations made under paragraph (2) the Minister shall so inform the body by notice in writing and the body may appeal in writing, within 21 days of the issue of the notice referred to in this paragraph, to the District Court in the District Court district in which the principal place of business in the State of the body concerned is situated, and the withdrawal or suspension shall not take effect until the time allowed for such appeal has elapsed or, in the event of an appeal, until the appeal is determined whichever be the later date.

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

(6) 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 of law.

(7) (a) Where under paragraph (3) the Minister revokes a withdrawal or suspension, the Minister shall inform the Commission and other Member States to that effect.

(b) Where the District Court pursuant to paragraph (5) or the High Court pursuant to paragraph (6) allows an appeal against a decision of the Minister, the Minister shall as soon as practicable after receiving the order of the Court, notify the Commission and the other Member States of that fact.

Inspectors

13. (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 times, any place or premises which he or she has reasonable cause to believe-

(i) is part of a rail system which is part of the trans-European high-speed 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),

and therein carry out such inspections and examinations as he or she considers reasonable or necessary,

(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) when exercising a power under this Regulation, 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 Annex II,

(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 high-speed 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 high-speed 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 high-speed rail system, 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) shall be 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 or under 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.

Prohibition notice

14. (1) If an inspector, appointed under Regulation 13, is of the opinion that a person-

(a) has placed into service in the State a subsystem, or

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

which does not meet the essential requirements or does not conform to the relevant TSIs 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) state that the inspector is of the said opinion,

(b) be in writing,

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

(4) A prohibition notice shall take effect -

(a) if the notice so declares, immediately the notice is received by the person body, undertaking to whom it is directed,

(b) in any other case

(i) 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,

(ii) 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) 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 disposed of.

(6) 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.

(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) Where on hearing an appeal under this Regulation a prohibition notice is confirmed, notwithstanding paragraph (4)(b)(ii) the Court which heard the appeal 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 (if any) as it considers appropriate and the order by which an application under paragraph (10) is determined may contain such terms and conditions (if any) 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 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding €3,000 or to a term of imprisonment for a term not exceeding 12 months or to both.

Fees payable to notified bodies

15. (1) Subject to paragraph (2) a notified body appointed by the Minister may charge such fees in connection with or incidental to, the carrying out of the functions referred to in Regulation 10 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, and

(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) A notified body shall be entitled to seek payment of fees which it is authorised to charge by this Regulation from the person requesting the work to be carried out prior to the carrying out of the work concerned.

Fees payable to Minister

16. The Minister may charge fees in respect of the carrying out of his or her functions and duties under Regulation 7, but any such fees shall not exceed the costs incurred by the Minister in carrying out his or her functions and duties in respect of that Regulation.

Prosecution of Offences

17. (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 so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director manager, secretary or other officer of the body corporate or a person who was purporting to act in any such capacity, that person, as well as the body corporate, is guilty of an offence and is liable to be proceeded against and punished as if he or she was guilty of the first-mentioned offence.

SCHEDULE 1

Requirements to be met by notified bodies appointed by the Minister.

Regulation 10

1. It shall be a legal entity established on the territory of the State and be under the jurisdiction of the State, although it may have activities or personnel outside the State or the Community.

2. It shall keep the Minister informed of its activities and provide if requested to the Minister all information concerning the proper implementation of the conditions under which they were notified.

3. It shall adhere to the obligation to inform other notified bodies and the Minister, in respect of all certificates issued and refused by it.

4. It shall at all times remain a third party, independent of their clients and other interested parties.

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

6. It shall ensure that it safeguards impartiality, especially if the body has other activities than those of a notified body and it shall make clear, particularly in its marketing activities, the distinction between its activities as a notified body, and other activities.

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

8. It shall ensure confidentiality of the information obtained in the course of conformity assessment.

9. It shall be adequately insured.

10. It shall take part in co-ordination activities and working groups in association with the other notified bodies.

SCHEDULE 2

Conditions which must be complied with by notified bodies who wish to sub-contract.

Regulation 10

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

2. The work sub-contracted shall 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 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 does not need to be notified and the Minister and the notified body shall ensure that there is effective monitoring of the competence of the body sub-contracted.

5. There shall be a formal contract between the notified body and the body 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 Community.

GIVEN under my Official Seal,

28th March 2002.

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__________________________

Mary O'Rourke, J.D.

Minister for Public Enterprise.

Explanatory Note

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

The purpose of these Regulations is to give effect to Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high speed rail system. The aim of Council Directive 96/48/EC is to remove obstacles to interoperability on the rail lines of the trans-European high speed 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.

¹OJ No. L 235, 17.9.96, p.6

² OJ No. L 235, 17.9.96, p.6.

³ OJ No. L 199, 9.8.93, p.84.