Commission Implementing Regulation (EU) 2019/250 of 12 February 2019 on the templates for ‘EC’ declarations and certificates for railway interoperability constituents and subsystems, on the model of declaration of conformity to an authorised railway vehicle type and on the ‘EC’ verification procedures for subsystems in accordance with Directive (EU) 2016/797 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 201/2011 (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union^f1, and in particular Article 9(4), Article 15(9) and Article 24(4) thereof,

Whereas:

Manufacturers or their authorised representatives, applicants, notified bodies and designated bodies should use harmonised templates for documents that accompany the application for an authorisation for the placing in service of fixed installations or a vehicle authorisation for placing on the market in order to streamline the assessment by the European Union Agency for Railways (‘the Agency’) or a national safety authority of those applications and in order to facilitate the supervision of the Union rail system by national safety authorities.

There is a need to facilitate the establishment of ‘EC’ declarations provided for in Directive (EU) 2016/797. In particular, there is a need to facilitate the establishment of ‘EC’ declaration of conformity or suitability for use of interoperability constituents, ‘EC’ declaration of verification of subsystems, intermediate statement of verification of subsystems, declaration of conformity to an authorised vehicle type.

There is also a need to facilitate the establishment of the technical file that is to accompany the ‘EC’ declarations by setting templates for ‘EC’ certificate of conformity or suitability for use of an interoperability constituent, ‘EC’ certificate of verification of a subsystem delivered by a notified body and certificate delivered by a designated body.

‘EC’ declaration of conformity and ‘EC’ declaration of suitability for use and their accompanying documents should provide evidence that the interoperability constituents have been subject to the procedures laid down in the corresponding technical specifications for interoperability (‘TSI’) for assessing conformity or suitability for use and indicate the references of those TSIs and other relevant Union acts.

An ‘EC’ declaration of suitability for use of interoperability constituents being issued on the basis of in-service experience should be considered as a supplementary declaration to the ‘EC’ declaration of conformity of interoperability constituent.

The nature of information to be provided should allow for one template to be used to accommodate both ‘EC’ declaration of the conformity of the interoperability constituent and ‘EC’ declaration of the suitability for use of the interoperability constituent.

‘EC’ declaration of verification of subsystems and its accompanying documents should provide evidence of the completion of the relevant procedures for verification in accordance with the applicable Union law and relevant national rules, and indicate the references of the Directives, TSIs and other relevant Union acts as well as relevant national rules.

In order to ensure that a subsystem continues to meet the essential requirements over time the ‘EC’ declaration of verification should reflect any change which affects it and the applicant should have procedures in place to continuously update the ‘EC’ declaration of verification.

‘EC’ verification procedure for a modified subsystem should be in accordance with Article 15 of Directive (EU) 2016/797 and provisions applicable to existing subsystems and vehicles which are set out in TSIs. Existing subsystems may have been placed in service before ‘EC’ verification procedure was applicable to them and thus without an ‘EC’ declaration of verification. ‘EC’ verification procedure regarding changes to those subsystems placed in service without an ‘EC’ declaration of verification should be limited to the parts of the subsystem that are changed, and their interfaces to the unchanged parts of the subsystem. An ‘EC’ declaration of verification should then cover the changed subsystem.

One template should be used to accommodate the ‘EC’ declaration of verification and potential changes that could affect its elements during the lifecycle of the subsystem.

Intermediate Statement of Verification of subsystem, its annex and accompanying documentation should provide evidence of the completion of a stage of the relevant verification procedure of a subsystem, or of a part of a subsystem, in accordance with the applicable Union law and relevant national rules. It should also indicate the references of the Directives, TSIs and other relevant Union acts as well as relevant national rules.

The nature of information to be provided allows for one template to be used to accommodate ‘EC’ certificate of verification delivered by a notified body for a subsystem, ‘EC’ certificate of conformity delivered by a notified body for an interoperability constituent, ‘EC’ certificate of suitability for use delivered by a notified body for an interoperability constituent as well as certificate delivered by a designated body for a subsystem.

The annexes to the declaration of conformity to an authorised vehicle type should provide evidence of the completion of the relevant procedures for verification in accordance with the applicable Union law and relevant national rules, and indicate the references of the Directives, TSIs and other relevant Union acts as well as relevant national rules.

On 19 December 2017, the Agency issued a recommendation on ‘EC’ declaration of verification of subsystems and templates referred to in Article 9(4), Article 15(9) and Article 24(4) of Directive (EU) 2016/797.

Annexes IV and V to Directive 2008/57/EC of the European Parliament and of the Council^f2 on the content of ‘EC’ declaration of conformity or suitability for use and ‘EC’ declaration of verification are repealed by Directive (EU) 2016/797, the provisions concerned should therefore be replaced.

Commission Regulation (EU) No 201/2011^f3 should be repealed.

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 51(1) of Directive (EU) 2016/797,

HAS ADOPTED THIS REGULATION: