Government Regulation No. 88 / 2012 Coll.
Government Regulation amending Government Regulation No. 133 / 2005 Coll., on technical requirements for the operational and technical interconnection of the European rail system, as amended
Valid
Effective from 06.04.2012
88
GOVERNMENT REGULATION
of 15 February 2012
amending Government Regulation No 133 / 2005 Coll., on technical requirements for the operational and technical interconnection of the European rail system, as amended
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 205 / 2002 Coll. and Act No. 34 / 2011 Coll.:
Government Regulation No. 133 / 2005 Coll., on technical requirements for the operational and technical interconnection of the European rail system, as amended by Government Regulation No. 371 / 2007 Coll. and Government Regulation No. 289 / 2010 Coll., is amended as follows:
1. footnote 1 shall read:
"(1) Directive 2008 / 57 / EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community. Commission Directive 2011 / 18 / EU of 1 March 2011 amending Annexes II, V and VI to Directive 2008 / 57 / EC of the European Parliament and of the Council on the interoperability of the rail system within the Community. '.
2. In Article 1 (b), the words "and suitability for use of the specified products' are replaced by the words" specified products and their suitability for use '.
3. In Article 2, paragraphs 2 and 5 are deleted.
Paragraphs 3, 4 and 6 shall become paragraphs 2, 3 and 4.
4. In Paragraph 2 (3), the word "by which 'is replaced by the word" by' and the words "in the regulations of the European Communities' are replaced by the words" in special legislation5 '.
5. in Article 3 (2) (a), the words "technical specifications of interoperability and" shall be inserted after the words "comply."
6.
(1) Components of interoperability under this Regulation are specified products within the meaning of Article 12 (1) (a) of the Act.
(2) Compliance with the requirements referred to in Article 3 (2) (a) shall be verified by the conformity assessment procedure for interoperability constituents. If the technical specification for interoperability so provides, the assessment of the conformity of the interoperability component shall also include an assessment of its suitability for use in the relevant subsystems.
(3) The conformity assessment of the interoperability component or its suitability for use shall be carried out in accordance with the technical specification of interoperability relating to the interoperability component, and shall be carried out in accordance with:
(a) a decision on a common framework for the marketing of products (12), where the relevant technical specification for interoperability has entered into force by 31 December 2010 at the latest; or
(b) a decision on modules for conformity assessment, suitability for use and EC verification procedures in the field of rail transport13) where the relevant technical specification for interoperability has entered into force after the date referred to in (a).
(4) Assessment of conformity or suitability for use shall be carried out by the notified person. Where the interoperability component and the activity related to its production and, where applicable, the application of the requirements referred to in Article 3 (2) (a), the notified person shall issue a type-examination certificate, a certificate of conformity, a certificate of suitability for use or any other document provided for in the regulations referred to in paragraph 3. A non-notified person may carry out an assessment of conformity or suitability for use only if the provisions referred to in paragraph 3 so permit.
(5) On the basis of a type review certificate, a certificate of conformity, a certificate of suitability for use, or of another document issued by a notified person, or on the basis of the manufacturer's internal control report on the conformity of the product with the technical specifications of interoperability, the manufacturer or his authorised representative shall demonstrate the conformity of the interoperability component by issuing an EC declaration of conformity with the technical specifications of interoperability, European specifications or conformity with the type under examination (hereinafter referred to as "EC declaration of conformity ') and, for the identified interoperability components referred to in paragraph 2, demonstrate their suitability for use by issuing an EC declaration of suitability for use. The content of these declarations is set out in Annex 1 to this Regulation. Such declarations shall be subject to the application of the provisions of the technical specifications of interoperability in the production and, where appropriate, the verification of conformity of the component.
(6) Components of interoperability for which an EC declaration of conformity or an EC declaration of suitability for use has been issued shall be considered to comply with the essential requirements and conditions set out in the relevant technical specifications of interoperability. Users and notified persons shall not be entitled to impede the placing on the market of such components or restrict their use on a runway forming part of the conventional or high-speed European rail system; in the absence of new serious circumstances to prevent the use of those components, users and notified persons shall not be entitled to require the carrying out of identical checks already carried out as part of the procedure prior to the issue of the EC declaration of conformity or the EC declaration of suitability for use.
(7) For spare parts to subsystems already put into service at the time of entry into force of the relevant interoperability technical specification, the assessment of conformity and suitability for use shall not be required.
13) Commission Decision 2010 / 713 / EU of 9 November 2010 on the modules for conformity assessment procedures, suitability for use and EC verification to be used in the technical specifications for interoperability adopted pursuant to Directive 2008 / 57 / EC of the European Parliament and of the Council. '
7. In Article 5, paragraphs 2 and 3 are deleted.
Paragraphs 4 and 5 shall be renumbered paragraphs 2 and 3.
8. In Article 5 (2), the first sentence is replaced by the sentence "The procedure for the assessment of conformity of interoperability components by a notified person at the stages of the overall project and the implementation of the subsystem shall comply with the conditions set out in the technical specifications for interoperability."
9. In the third sentence of Article 5 (2), "certificate 'is replaced by" EC declaration of conformity or EC declaration of suitability for use'.
10.
Verification of subsystem
(1) Prior to the entry into service of the subsystem, a certificate of review of the subsystem type, a certificate of verification of the subsystem, or another document set out in the relevant technical specification of interoperability, a decision on a common framework for the placing of products on the market (12) or a decision on modules for conformity assessment procedures, suitability for use and EC verification in the field of railway transport13 (hereinafter referred to as the "certificate of verification of the subsystem ') shall be issued. The certificate of verification of the subsystem shall be issued by the notified person at the request of the subsystem operator or his authorised representative. The subsystem operator or his authorised representative shall issue a declaration of verification of the subsystem which shall be forwarded to the Dresden Office for registration on the basis of the EC subsystem verification certificate issued.
(2) When drawing up the certificate of verification of the subsystem, the notified person shall assess the project and its respect during production and production only after acceptance, before putting the subsystem into service, and shall be responsible for the accuracy and reliability of the subsystem. They shall also verify the interface of the subsystem concerned with the system in which it is integrated, based on the information available in the relevant technical specification of interoperability and in the registers of parts of the European rail system. The verification of interoperability of the structural subsystem which constitutes the European rail system in accordance with the essential requirements shall be carried out on the basis of a reference to the technical specifications of interoperability, if any; If the interoperability technical specifications are not issued, the subsystem shall comply with the European specifications.
(3) Structural subsystems which are part of the European rail system have been assessed in accordance with the directly applicable European Union11 Regulation) and the relevant technical specifications of interoperability and have been issued with the EC declaration of verification of the subsystem shall be considered as interoperable and essential requirements satisfying.
(4) If the subsystem complies with the technical requirements notified to the European Commission under the Railways Act (14), the authorised person shall, at the request of the subsystem operator or his authorised representative, issue a certificate of verification of compliance with the national requirements.
(5) The procedure for the verification of the subsystem referred to in paragraphs 1 and 4 and the content of the EC declaration of verification of the subsystem are set out in Annex 2 to this Regulation.
14) § 49e (5) of Act No. 266 / 1994 Coll., on Railways, as amended by Act No. 134 / 2011 Coll. '.
11. footnote 10 is deleted;
12. in Article 6a (1) and (2):
"(1) The subsystem operator or its authorised representative may, at the stage of the overall project or the stage of the implementation of the subsystem, request the notified person to issue a provisional opinion on the examination of the subsystem type or provisional opinion on the verification of the subsystem. The subsystem operator or his authorised representative shall request the notified person to give an interim opinion whenever the technical specifications for interoperability so provide.
(2) The Notified Person shall carry out a preliminary verification of the subsystem for those subsystem elements whose characteristics can be verified at a given stage before the subsystem is put into service. When drawing up the provisional opinion on the examination of the subsystem type or the provisional opinion on the verification of the subsystem, the notified person shall assess the subsystem project, its compliance during production and the quality of its own production. The preliminary verification of the subsystem shall be carried out in accordance with Annex 2 to this Regulation. ';
13. Annexes 1 and 2 shall read as follows:
"Annex No 1 to Government Decree No. 133 / 2005 Coll.
EC DECLARATION OF CONFORMITY AND EC DECLARATION OF SUPPORT FOR USE
The EC declaration of conformity and the EC declaration of suitability for use shall contain:
(a) a description of the interoperability component (model, type, etc.),
(b) the business name and / or the name and / or registered office of the manufacturer or his authorised representative in the European Union (the business name and / or the name and full address of the registered office, and, in the case of the authorised representative, the business name and surname or name of the manufacturer or designer);
(c) a description of the procedure used in the examination of the type, conformity assessment or suitability for use;
(d) references to European Union rules and the legislation under which conformity or suitability for use is assessed and, where appropriate, a reference to European specifications;
(e) any description of the relevant use to which the interoperability component complies, and in particular the conditions for its use;
(f) the name and address of the notified person or persons involved in the procedure used to assess the conformity or suitability for use;
(g) the date of certification of the component, together with, where appropriate, the duration and conditions of the certificate;
(h) the signature of the person authorised to act for the manufacturer, indicating the name, surname and function and the date of issue of the EC declaration of conformity or of the EC declaration of suitability for use.
Příloha č. 2
Annex No 2 to Decree No 133 / 2005 Coll.
VERIFICATION PROCEDURE FOR SUBSYSTEMS AND EC DECLARATION OF VERIFICATION OF SUBSYSTEMS
I. Verification procedure for subsystems
1. INTRODUCTION
The verification of the subsystem is a procedure whereby the notified person assesses conformity and confirms that the subsystem complies with the requirements of the technical interoperability specifications for the operation of the subsystem and the requirements of the specific legislature5) and can be put into service.
2. ETAPES
The verification of the subsystem shall be carried out at each of these stages:
(a) the overall project;
(b) the implementation of the subsystem, in particular construction and civil engineering works, production processes, assembly parts and general adaptations;
(c) the final examination of the subsystem.
In the verification of the subsystem, the persons involved in the design, manufacture, assembly and testing of the subsystem shall proceed in accordance with the technical specification of the interoperability relating to the subsystem concerned and shall also:
(a) a decision on a common framework for the marketing of products (12), where the relevant interoperability technical specification has entered into force by 31 December 2010 at the latest; or
(b) a decision on modules for conformity assessment, suitability for use and EC verification procedures in the field of rail transport13) where the relevant technical specification for interoperability has entered into force after the date referred to in (a).
3. CERTIFICATE
3.1. When issuing the certificate of verification of the subsystem, the person shall take into account the provisional opinions on the examination of the subsystem type or the provisional opinion on the verification of the subsystem and shall check that the provisional opinions issued conform to the technical specifications of interoperability, shall review the technical requirements set out for the subsystem, the compliance of which is not demonstrated by the provisional opinions issued and shall check the final examination of the subsystem. Where the subsystem has not been assessed for conformity with the technical specifications of interoperability, the certificate of verification of the subsystem shall include a reference to the technical specifications of interoperability or parts thereof which have not been assessed.
3.2. The certificate of verification of compliance with the national requirements shall contain precise references to the national requirements with which the authorised person examines compliance during the verification procedure, including those relating to parts which are subject to a derogation from the technical specifications for interoperability, upgrading or renewal of the subsystem. In the case of application of national requirements for subsystems forming a runway vehicle, the authorised person shall divide the certificate of verification into two parts. The first part shall contain references to national requirements which relate exclusively to the technical compatibility of the vehicle and the network concerned, while the second part concerns all other national requirements.
4. TECHNICAL DOCUMENTATION
4.1. The technical file accompanying the EC declaration of verification of the subsystem shall contain:
(a) for infrastructure: in particular the plans of construction buildings, the approval of excavations and reinforcements, the examination and control of concrete;
(b) for other subsystems: general and detailed drawings in accordance with implementation, electrical and hydraulic diagrams, control circuit diagrams, description of data processing and automatic systems, operating and maintenance manuals, etc.,
(c) the list of interoperability constituents included in the subsystem;
(d) copies of the EC declaration of conformity or, where appropriate, of the EC declaration of suitability for use by which those components must be equipped and accompanied, where appropriate, by appropriate calculations and copies of the test report and tests carried out by notified persons on the basis of technical interoperability specifications;
(e) a certificate of verification of the subsystem issued by the notified person responsible for the verification, accompanied by appropriate calculations by that person certified; the certificate shall state that the project complies with the legislation and technical documentation and shall state all outstanding reservations of the notified persons registered during the verification activities of the subsystem; an annex to the certificate is an inspection report and audit report drawn up by the notified person in relation to its tasks;
(f) the interim opinions on the review of the subsystem type or the interim opinion on the verification of the subsystem, where available, including the EC declaration of provisional verification of the subsystem and the results of the check on its validity by the notified person;
(g) documents relating to the subsystem under consideration issued under other regulations, including a safety assessment report under the directly applicable European Union Regulation (11).
4.2. The technical file accompanying the certificate of verification of compliance with national requirements shall be part of the technical file accompanying the EC declaration of verification and shall contain technical information concerning the verification of the subsystem with national requirements.
5. CONTROL
5.1. The purpose of the check is to ensure that during the production, installation or installation of the subsystem the obligations derived from the technical documentation are fulfilled.
5.2. The person responsible for the production control must have permanent access to the construction site, to the production workshops, storage facilities and, where appropriate, to the assembly facilities and to the testing facilities and, in general, to all the objects which he considers necessary to visit in the performance of his tasks. The subsystem operator or its authorised representative shall send or have the notified person sent all documents necessary for this purpose and in particular the implementation plans and technical documentation relating to the subsystem.
5.3. The person responsible for the assessment of the subsystem must carry out regular audits during the design or construction, manufacture and installation of the subsystem in order to confirm compliance with the legislation and technical documentation. It shall provide audit reports to the subsystem operator responsible for drawing up the EC declaration of verification of the subsystem. The subsystem operator may require the presence of a notified person at construction stage.
5.4. The person may make random visits to the workplace or production workshops. During such visits, the notified person may conduct complete or partial audits. The subsystem operator shall provide the inspection report and, where appropriate, the audit report.
6. TRANSMISSION OF DOCUMENTS
6.1. The complete technical file of the subsystem shall be kept with the subsystem operator as an annex to the EC declaration of verification of the subsystem. The technical file shall be attached to a copy of the EC declaration of verification of the subsystem which the subsystem operator sends to the Dresden Office for registration.
6.2. The EC declaration of verification of the subsystem, including the complete technical file, shall be kept by the subsystem operator for the operational life of the subsystem. A copy of the Annex to the EC declaration of verification of the subsystem shall be sent to the authority of each Member State of the European Union for its cargo if it so requests.
7. DISCLOSURE
Each notified person shall publish on a quarterly basis relevant information on:
(a) the requirements for conformity assessment of the interoperability component, suitability for use of the interoperability component, type review and verification of the subsystem received;
(b) certificates issued;
(c) rejected applications for certification;
(d) provisional opinions on verification of the subsystem issued,
(e) rejected applications for provisional opinions on verification of the subsystem.
8. LANGUAGE
The technical file and correspondence relating to the verification procedures shall be drawn up in the Czech language or in the official language of the State in which the subsystem operator is established.
II. Content of the EC declaration of verification of subsystem
The EC declaration of verification of the subsystem shall be written in the same language as the technical file and shall include:
(a) a business firm or name and surname or name of the operator of the subsystem established in the European Union who has a legal interest in the verification of the subsystem (the business firm or name and surname, or name and full address of the registered office, and, in the case of an authorised representative, the name and surname or full address of the registered office of the contracting entity),
(b) a brief description of the subsystem,
(c) the name and registered office of the notified person who issued the certificate;
(d) references to the relevant legislation, European Union rules and international treaties;
(e) references to documents contained in the technical file;
(f) any relevant temporary or final provisions to be complied with by the subsystems and, in particular, any operational restrictions or conditions;
(g) in the case of limited validity of the EC declaration of verification of the subsystem - the duration of the subsystem,
(h) the signature of the person authorised to act for the manufacturer, stating the name, surname and function and the date of issue of the EC declaration of verification of the subsystem. ';
Transitional provision
Assessment of the conformity of a interoperability component or its suitability for use or verification of subsystems which have commenced before the date of entry into force of this Regulation shall be completed in accordance with the existing legislation.
Efficacy
This Regulation shall take effect on the 15th day following its publication.
Prime Minister:
RNDr. Netime v. r.
Minister for Transport:
Mgr.
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Regulation Information
| Citation | Government Regulation No. 88 / 2012 Coll., amending Government Regulation No. 133 / 2005 Coll., on technical requirements for the operational and technical interconnection of the European rail system, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.03.2012 |
|---|---|
| Effective from | 06.04.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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