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Royal Decree 1434/2010 of 5 November 2010 on the interoperability of the rail system of the general interest railway network was incorporated into the internal legal order of Directive 2008 /57/EC of the European Parliament. European and Council of 17 June 2008 on the interoperability of the rail system within the Community, as well as on Commission Directive 2009 /131/EC of 16 October 2009 amending Annex VII to that Directive 2008 /57/EC.

The fourth final provision of Royal Decree 1434/2010 of 5 November authorizes the Minister of Public Works to amend its annexes where necessary as a result of the provisions of Community legislation. By virtue of that authorization, the said Royal Decree has been amended by Order FOM/3218/2011 of 7 November amending Annexes II, V and VI to the Royal Decree; by Order FOMO/421/2014 of 3 March amending the Annex III thereto and, by Order FOM/22/2015 of 19 January, amending Annex III to the Royal Decree of Reference again.

Commission Directive 2014 /106/EU of 5 December 2014 amending Annexes V and VI to Directive 2008 /57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community. Directive 2014 /106/EU, which is incorporated into the Spanish legal order through the present ministerial order, seeks to better define the scope and content of the EC declaration of verification of the subsystems, in particular the responsibility of the signatory of that declaration; to clarify the procedures relating to the declaration of verification in the event of modification of the existing subsystems and in the case of additional verifications carried out by the bodies notified; clarify the objective of the subsystem verification procedure, as well as define the principles governing the verification procedure in case of modification of existing subsystems.

On 1 April 2015, the Council of the European Union proceeded to a correction of errors of several versions of Directive 2008 /57/EC, including the Spanish one, which concerns the wording of Annex I, point 1.2, second paragraph, also incorporated into our legal order through the present ministerial order.

During the processing of the provision, as provided for in Law 50/1997, of 27 November, the railway undertakings and the candidates, the railway infrastructure managers, the centres of rolling stock, rolling stock manufacturers, rolling stock holders, notified bodies, as well as certification and safety assessors, entities related to the European rail traffic management system (ERTMS), and constructors and associations of rolling stock. Likewise, and in compliance with the third final provision of Law 38/2015, of 29 September, of the Railway Sector, has been submitted to the National Council of Land Transports, as well as the Ministry of Industry, Energy and Tourism.

This ministerial order is issued under the fourth final provision of Royal Decree 1434/2010 of 5 November on the interoperability of the rail system of the General Interest Railway Network.

In its virtue, on the proposal of the Secretary General of Infrastructures, with the agreement of the Secretary of State for Infrastructures, Transport and Housing and in agreement with the State Council, I have:

Single item. Amendment of Annexes I, V and VI to Royal Decree 1434/2010 of 5 November on the interoperability of the rail system of the general interest railway network.

One. The second subparagraph of paragraph 1.2 of Annex I is amended, as follows:

" The mobile construction and maintenance of railway infrastructure may be included. "

Two. Annex V is worded as follows:

" ANNEX V

EC declaration of verification of subsystems

1. "CE" declaration of subsystem verification.

The EC declaration of verification of a subsystem is a declaration made by the "applicant" in accordance with Article 13, in which it declares, under its sole responsibility, that the subsystem in question, which has been subject to the relevant verification procedures, complies with the requirements of the relevant Union legislation, including, where appropriate, the relevant national rules.

The EC declaration of verification and the accompanying documents shall be duly dated and signed.

The "EC" declaration of verification shall be based on the information resulting from the "EC" verification procedure of the subsystems defined in Annex VI. It shall be in the same language as the technical file accompanying the EC declaration of verification and shall contain at least the following elements:

(a) The reference to Directive 2014 /106/EU of 5 December 2014 of the Commission of 5 December 2014 and the applicable national rules;

(b) The reference to the TSIs or parts thereof the conformity of which has not been examined during the EC verification procedure and the national rules applied in the case of derogation, partial application of the TSIs in the case of rehabilitation or renewal, a transitional period in a specific TSI or case;

(c) The name and address of the "applicant" (the social reason and the full address shall be indicated; in the case of a representative, the social reason of the contracting entity or the manufacturer shall also be entered);

d) A brief description of the subsystem;

(e) The name (s), address (s) and number (s) of identification of the notified body (s) which have carried out the 'EC' verification or verifications provided for in Article 13;

(f) The name (s), address (s) and number (s) of identification of the notified body (s) that have carried out the conformity assessment with other regulatory provisions derived from the Treaty;

g) The name (s) and address (s) of the designated body (s) or bodies which have carried out the verification or verifications in accordance with the national rules referred to in paragraph 3 of the Article 12;

(h) The name and address of the assessment body or bodies that have developed the safety assessment reports in relation to the use of the common security methods (CSMs) relating to the risk assessment referred to in Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013.

i) The references of the documents contained in the technical file accompanying the "EC" declaration of verification;

(j) All relevant, provisional or definitive provisions to be complied with by the subsystem, and in particular, where applicable, restrictions or operating conditions;

k) The identification of the signatory (i.e. the person or natural persons authorized to sign the declaration). Where reference is made in Annex VI to the 'Intermediate Verification Declaration' (DVI), the provisions of this Section shall apply.

2. 'EC' declaration of verification of subsystems in case of modifications.

In the case of a modification which is not a replacement within the framework of the maintenance of a subsystem covered by an EC declaration of verification, the amendments shall apply, without prejudice to Article 15, The following provisions:

2.1 If the entity that introduces the modification demonstrates that the modification does not affect the basic design characteristics of the subsystem that are relevant to the compliance with the requirements for the parameters fundamentals:

(a) The entity introducing the amendment shall update the references of the documents contained in the technical file accompanying the "EC" declaration of verification;

b) You will not need to make a new "CE" declaration of verification.

2.2 If the entity that introduces the modification demonstrates that the modification affects the basic design characteristics of the subsystem that are relevant for compliance with the requirements for some parameters fundamentals:

(a) The entity introducing the amendment shall make an "EC" declaration of supplementary verification with reference to the fundamental parameters concerned;

(b) The EC declaration of supplementary verification must be accompanied by a list of the documents in the original technical file accompanying the "EC" declaration of verification which are no longer valid;

(c) The technical file accompanying the 'EC' declaration of verification shall include evidence that the impact of the modifications is limited to the fundamental parameters referred to in point (a)

(d) The provisions of Section 1 of this Annex shall apply mutatis mutandis to this "EC" declaration of supplementary

;

e) The original "CE" declaration of verification will be considered valid for the fundamental parameters to which the modification does not affect.

3. 'EC' declaration of verification of subsystems in the case of additional verifications.

An EC declaration of verification of a subsystem may be supplemented in the event that additional verifications have been carried out, in particular where such additional verifications are necessary for the purpose of obtain an additional authorisation for putting into service. In this case, the scope of the supplementary declaration shall be limited to the scope of the additional verifications. '

Three. Annex VI is worded as follows:

" ANNEX VI

CE "CE" Verification Procedure

1. General principles.

EC 'verification' means the procedure carried out by the applicant in accordance with Article 13 to verify whether the requirements of the relevant Union legislation, including, where applicable, have been complied with; the relevant national rules for a subsystem, and the putting into service of the subsystem may be authorised.

2. Certificate of Verification issued by a notified body.

2.1 Introduction:

The verification by reference to the TSIs is the procedure by which a notified body checks and certifies that the subsystem complies with the relevant technical interoperability specifications (TSIs).

This is without prejudice to the applicant's obligation to comply with any other applicable Community legislation, including, where appropriate, the verifications carried out by the assessment bodies required by others. applicable provisions.

2.2 Intermediate Verification Statement (DVI):

2.2.1 Principles:

At the request of the applicant, the verifications may be carried out for parts of a subsystem or be limited to certain stages of the verification procedure. In such cases, the results of the verification may be documented in an "intermediate verification declaration" (DVI) issued by the notified body chosen by the applicant.

The DVI must refer to the TSIs for which compliance has been assessed.

2.2.2 Subsystem Parts:

The requester can order a DVI for any party that decides to split the subsystem. Each part shall be checked at each stage described in paragraph 2.2.3

2.2.3 Stages of the verification procedure:

The subsystem or certain parts of the subsystem will be checked at each of the following stages:

a) General design phase;

(b) Production: Construction, including, in particular, the execution of civil engineering works, the manufacture, assembly of components and the setting of the assembly;

c) Final test.

The applicant may request a DVI for the design stage (including type testing) and for the production stage for the subsystem as a whole or for any party to which the applicant has decided to divide it (see point 2.2.2).

2.3 Certificate of Verification:

2.3.1 The notified bodies responsible for the verification shall evaluate the design, production and final test of the subsystem and issue the certificate of verification intended for the applicant, which shall in turn draw up the 'EC' declaration of verification. The certificate of verification should refer to the TSIs for which conformity has been assessed.

When a subsystem has not been evaluated to check its compliance with all applicable TSIs (for example, in the case of an exception, a partial application of the TSIs in the case of a rehabilitation or renovation, a transition period in a TSI or a specific case), the certificate of verification shall indicate the exact reference to the TSIs or parts thereof for which the notified body has not examined conformity during the procedure verification.

2.3.2 Where DVI has been issued, the notified body responsible for the verification of the subsystem shall take into account these DVI and, before issuing its certificate of verification:

a) Verify that the relevant requirements of the TSIs are correctly covered by the DVI;

b) Check all aspects that are not covered by the DVI, and

c) Test the final test of the subsystem as a whole.

2.3.3 In the case of a modification of a subsystem already covered by a certificate of verification, the notified body shall carry out only the relevant and necessary examinations and tests, that is, the assessment Only those parts of the subsystem that have been modified and their interfaces with the unmodified parts of the subsystem.

2.3.4 Each notified body that has participated in the verification of a subsystem shall draw up a technical file in accordance with Article 13 (3) covering the scope of its activities.

2.4 Technical file accompanying the "EC" declaration of verification:

The technical file accompanying the "EC" declaration of verification must be compiled by the applicant and include the following elements:

a) Technical characteristics related to the design, including general and detailed plans in relation to the execution, electrical and hydraulic schemes, schemes of the control system, description of the systems computer and automatisms at the level of detail sufficient to document the verification of conformity carried out, documentation on operation and maintenance, etc., relevant to the subsystem concerned;

b) A list of the interoperability components incorporated into the subsystem;

(c) The technical files referred to in paragraph 2.3.4 above, drawn up by each of the bodies involved in the verification of the subsystem, which shall include:

-Copies of the "EC" declarations of conformity and, where applicable, of the "EC" declarations of suitability for use established for the interoperability constituents and accompanied, where appropriate, by the calculations and a copy of the test reports and examinations carried out by the notified bodies on the basis of the common technical specifications,

-Where available, the DVI accompanying the certificate of verification, including the result of the verification of its validity by the notified body,

-The certificate of verification, accompanied by the corresponding calculations and signed by the notified body responsible for the verification, where it is stated that the subsystem complies with the requirements of the TSIs Any reservation made during the implementation of the activities and which has not been withdrawn is mentioned; the certificate of verification must also be accompanied by the reports of the inspections and audits carried out by the same body. has been prepared in compliance with its mission as referred to in points 2.5.2 and 2.5.3;

(d) Certificates of verification issued in accordance with other Community rules of application.

(e) Where the verification of safe integration is required in accordance with Article 10, the relevant technical file shall include the report or reports of the evaluators on the common methods of security (MCS) relating to the risk assessment referred to in Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013.

2.5 Surveillance by notified bodies.

2.5.1 The notified body responsible for verifying the performance must have permanent access to the works, manufacturing workshops, storage and pre-manufacturing areas, to the test facilities and, in general, to any place deemed necessary for the performance of its function. The applicant shall forward to the notified body all the necessary documents for that purpose, and in particular the implementation plans and the technical documentation of the subsystem.

2.5.2 The notified body responsible for verifying the implementation shall carry out periodic audits to confirm that the provisions of the applicable TSI or TSIs are complied with. It will present an audit report to the implementation managers. Their presence may be required in certain phases of the work.

2.5.3 The notified body may visit without notice the works or the manufacturing workshops. On the occasion of these visits, you will be able to carry out full or partial audits. The notified body shall provide a report of the inspection and, where appropriate, an audit report to the professionals responsible for the performance.

2.5.4 The notified body must be in a position to monitor a subsystem in which an interoperability constituent has been mounted in order to assess, when required by the relevant TSI, its suitability for the use within the railway environment in which you would like to use it.

2.6 Presentation:

The applicant shall keep a copy of the technical file accompanying the 'EC' declaration of verification throughout the life of the subsystem. This documentation shall be forwarded to any Member State requesting it.

Applications for placing in service shall be filed with the State Agency for Railway Safety, which, as well as the documents submitted, shall be written in or translated into the Spanish language.

2.7 Publication:

All notified bodies shall publish on a regular basis the relevant information related to:

a) The received verification requests and DVI;

b) The application for conformity assessment and suitability for the use of the interoperability constituents;

c) DVI issued or denied;

(d) Certificates of conformity and "EC" certificates of suitability for use issued or denied;

e) Verification certificates issued or denied.

2.8 Language:

The files and correspondence relating to the "EC" verification procedure will be written in Spanish when the applicant is established in Spain.

3. Verification Certificate Issued by a Designated Body.

3.1 Introduction:

Where national rules are applied, the verification shall include a procedure whereby the designated body checks and certifies that the subsystem complies with the national rules notified pursuant to paragraph 3 of the Article 12.

3.2 Certificate of Verification:

The designated body shall issue the certificate of verification intended for the applicant. This certificate shall contain a precise reference to the national standard or standards whose conformity has been examined by the notified body in the verification process. In the case of national rules relating to subsystems consisting of a vehicle, the designated body shall divide the certificate into two parts: one where references to the national rules strictly relating to the vehicle are established. technical compatibility between the vehicle and the network and another on all other national rules.

3.3 Technical file:

The technical file compiled by the designated body accompanying the certificate of verification in the case of national standards shall be included in the technical file accompanying the EC declaration of verification referred to in point 2.4 and containing the relevant technical data for the assessment of the conformity of the subsystem with those national standards.

3.4 Language:

The files and correspondence relating to the "EC" verification procedure will be written in Spanish when the applicant is established in Spain.

4. Verification of parts of Subsystems in accordance with Article 13 (5).

If a verification certificate is to be issued for certain parts of a subsystem, the provisions of this Annex shall apply, mutatis mutandis, to those parts. "

Final disposition first. Competence title.

This ministerial order is issued in accordance with the provisions of Article 149.1.21. of the Spanish Constitution, which attributes to the State exclusive competence in the field of railways and land transports that elapse the territory of more than one autonomous community.

Final disposition second. Incorporation of European Union law.

By this ministerial order is incorporated into Spanish law, Commission Directive 2014 /106/EU of 5 December 2014 amending Annexes V and VI to Directive 2008 /57/EC of the European Parliament and of the Council Council, on the interoperability of the rail system within the Community, as well as the correction of errors made by the Council of the European Union on 1 April 2015 in relation to Annex I to Directive 2008 /57/EC.

Final disposition third. Entry into force.

This ministerial order will enter into force on the day following its publication in the "Official State Gazette".

Madrid, 13 November 2015. -Minister for Development, Ana Maria Pastor Julian.