Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474 (Text with EEA relevance.)

27.5.2019	EN	Official Journal of the European Union	LI 139/108

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 ¹, and in particular Articles 5(11) and 48(2) thereof,

Whereas:

• (1) In accordance with Article 19 of Regulation (EU) 2016/796 of the European Parliament and of the Council ² the European Union Agency for Railways (the ‘Agency’) is required to address recommendations to the Commission on the technical specifications for interoperability (TSIs) and their revision and to ensure that TSIs are adapted to technical progress, market trends and social requirements.

• (2) TSIs should be amended in order to indicate provisions applicable to existing subsystems and vehicles, in particular in the event of their upgrading and renewal as well as to indicate the parameters of the vehicles and fixed subsystems to be checked by the railway undertaking to ensure compatibility between vehicles and the routes on which they are to be operated and the procedures to be applied to check those parameters after the vehicle authorisation for placing on the market and before the first use of the vehicle.

• (3) Commission Delegated Decision (EU) 2017/1474 ³ sets out specific objectives for the drafting, adoption and review of TSIs. On 22 September 2017, the Commission asked the Agency to prepare recommendations implementing a number of those objectives.

• (4) Under Decision (EU) 2017/1474, TSIs should be reviewed in order to take into account developments of the Union railway system relating to research and innovation activities, and update references to standards.

• (5) Furthermore TSIs should be reviewed in order to close the remaining open points. In particular, open points as regards specifications on the design of track to be compatible with the use of eddy current brake and the minimum factor for traffic codes should be closed in Commission Regulation (EU) No 1299/2014 ⁴. Open points as regards specifications on aerodynamic effects, passive safety and variable gauge systems and braking systems should be closed in Commission Regulation (EU) No 1302/2014 ⁵. Open points as regards specifications on test conditions for on-track tests and variable gauge systems should be closed in Commission Regulation (EU) No 321/2013 ⁶.

• (6) Decision (EU) 2017/1474 also sets out specific objectives applicable to the TSI relating to the subsystem ‘rolling stock — locomotives and passenger rolling stock’ and the TSI relating to the subsystem ‘rolling stock — freight wagons’. In particular the provisions on automatic variable gauge systems should be reviewed and access to passenger coaches, the authorisation of passenger vehicles in large areas of use and the composition of passenger trains should be facilitated.

• (7) Certain components for which a single failure has potential to lead directly to a serious accident are critical for the safety of the rail system and should be labelled as ‘safety-critical’ on a case-by-case basis. The manufacturer should identify safety-critical components in the vehicle maintenance file.

• (8) Trackside and on-board investments should be protected by guaranteeing compatibility and stability of the specifications of the European rail traffic management system (ERTMS), giving legal and technical certainty that a compliant Baseline 3 ERTMS on-board unit can safely run on compliant ERTMS line with an acceptable level of performance. In order to keep pace with technological progress and encourage modernisation such as ERTMS game changers, as specified in the Agency's report on ERTMS longer-term perspective (ERA-REP-150), their implementation should, under certain conditions, be allowed. Where the Agency issues draft released specifications of ERTMS game changers before the planned legal release in 2022, suppliers and early implementers should use the specifications in their pilot phase, provided that any Baseline 3 on-board unit can safely run on any infrastructure implementing a game changer.

• (9) On the basis of the system architecture research and innovation work of the Shift2Rail Joint Undertaking, the Agency work on the game changer related to the evolution of the radio communication system aims at proposing solutions that would allow independent life cycle management for the radio communication system and the train protection system, while facilitating the integration of the new radio communication system with the European Train Control system (ETCS) on-boards that follow the set#3 of specifications listed in Table 2.3 of Annex A to Commission Regulation (EU) 2016/919 ⁷.

• (10) Even a successful certification process cannot always exclude that, when an on-board CCS subsystem interacts with a trackside CCS subsystem, one of the subsystems repeatedly fails to function or perform as intended under certain conditions. This may be due to variance in national control-command and signalling equipment (e.g. interlockings), engineering and operational rules, deficiencies in the specifications, different interpretations, design errors or equipment being installed incorrectly. Therefore, checks might need to be carried out to demonstrate the technical compatibility of the control-command and signalling subsystems in the area of use for a vehicle. The necessity of these checks should be considered as a temporary measure to increase the confidence on the technical compatibility between the subsystems. In addition, Regulation (EU) 2016/919 should specify the procedure for those checks. In particular, the principles applicable to those checks should be transparent and prepare the ground for further harmonisation. The possibility of executing those checks in a laboratory representing the trackside configuration to be made available by the Infrastructure Manager should be prioritised.

• (11) To limit to a minimum the checks each Member State should promote harmonisation within its infrastructure. Following this principle, only one single set of compatibility checks for radio (one for voice transmission and another one for data transmission), if at all needed, should be requested per Member State.

• (12) Consideration should be given on the necessary steps in the shortest possible time to increase the confidence on the technical compatibility and to reduce and eliminate the tests or checks to prove technical compatibility of on-board units with different European rail traffic management system trackside implementations. Therefore, the Agency should assess the underlying technical divergences and define the necessary steps to eliminate the tests or checks to prove technical compatibility of on-board units with different trackside implementations.

• (13) Certain TSIs may provide transitional measures in order to keep the railway sector competitive and to prevent undue costs triggered by too frequent changes in the legal framework. Such transitional measures apply to contracts in course of performance and to projects at an advanced stage of development on the date of application of the relevant TSI. As long as these transitional measures apply, requests for application of Article 7(1) of Directive 2016/797/EC should not be needed. Once these transitional measures expire, applicants requesting non-application of TSIs or part of them should do so pursuant to Article 7(1) of Directive (EU) 2016/797. Such requests should however only in duly justified cases be based on Article 7(1)(a) of Directive 2016/797/EC.

• (14) Directive (EU) 2016/797 and Commission Implementing Regulation (EU) 2018/545 ⁸ set out the Agency's role as authorising entity. In addition, Implementing Regulation (EU) 2018/545 sets out the procedure applicable in the event of a change to existing vehicle types, in particular for the creation of versions of a vehicle type and versions of a vehicle type variant. The Agency's role in registering data in the European register of authorised types of railway vehicles (ERATV) and the tasks of authorising entities as regards versions of a vehicle type and versions of a vehicle type variant should be adapted accordingly.

• (15) Regulations (EU) No 321/2013, (EU) No 1302/2014, and (EU) 2016/919 should take into account changes in the procedure for placing mobile subsystems on the market, as provided for in Articles 20 to 26 of Directive (EU) 2016/797. Those TSIs should therefore list the basic design characteristics used to identify the vehicle type and set out requirements regarding changes that impact them. The list of ERATV parameters should be amended accordingly.

• (16) Under Decision (EU) 2017/1474, TSIs should indicate whether it is necessary to re-notify the conformity assessment bodies that were notified on the basis of a previous version of the TSI and whether a simplified notification process should be applied. This Regulation brings about limited changes and it should not be necessary to re-notify bodies notified on the basis of a previous version of the TSIs.

• (17) This Regulation amends TSIs so as to further achieve interoperability within the Union rail system, improve and develop international rail transport, contribute to the progressive creation of the internal market and complement TSIs in view of covering essential requirements. It enables to achieve the objectives and to meet the essential requirements of Directive 2008/57/EC of the European Parliament and of the Council ⁹ and Directive (EU) 2016/797. Therefore this Regulation should be directly applicable in all Member States including Member States which have notified the Agency and the Commission under Article 57(2) of Directive (EU) 2016/797 that they have extended the transposition period and thus continue to apply Directive 2008/57/EC until 15 June 2020 at the latest. Notified Bodies exercising under Directive 2008/57/EC in the Member States that have extended the transposition period should be able to issue ‘EC’ certificate in accordance with this Regulation as long as Directive 2008/57/EC applies in the Member State where they are established.

• (18) On 17 December 2015, 6 January 2016 and 14 November 2017, the Agency issued three recommendations to amend Regulation (EU) No 1302/2014 covering the conditions for having an authorisation for placing on the market not limited to particular national networks, the closing of open-points, requirements regarding safety critical components and the revision of provisions on automatic variable gauge systems.

• (19) On 11 April 2016, the Agency issued a recommendation on the amendment to Regulation (EU) No 321/2013 covering the closing of open-points.

• (20) On 4 October 2017, the Agency issued a recommendation on the amendment to Regulation (EU) No 1299/2014 covering the closing of open-points.

• (21) On 19 July 2018, the Agency issued a recommendation on the amendment to Regulations (EU) No 321/2013 and (EU) No 1302/2014 and Commission Implementing Decision 2011/665/EU ¹⁰ covering the changes in the procedure for placing mobile subsystems on the market, including the checking of vehicle-route compatibility after the vehicle authorisation and before the first use of authorised vehicles and provisions applicable to existing subsystems and vehicles, in particular in the event of their upgrading and renewal.

• (22) On 19 October 2018, the Agency issued a recommendation on the amendment to Regulation (EU) 2016/919 covering the changes in the procedure for placing mobile subsystems on the market, including the checking of vehicle-route compatibility before the first use of authorised vehicles and provisions applicable to existing subsystems and vehicles, in particular in the event of their upgrading and renewal.

• (23) On 15 November 2018, the Agency issued a recommendation on the amendment to Regulation (EU) No 1303/2014 covering the changes to align that Regulation with Directive (EU) 2016/797.

• (24) On 29 November 2018, the Agency issued a recommendation on the amendment to Regulations (EU) No 1299/2014 and (EU) No 1301/2014 covering the changes to align those Regulations with Directive (EU) 2016/797.

• (25) Regulation (EU) No 321/2013, Regulation (EU) No 1299/2014, Regulation (EU) No 1301/2014, Regulation (EU) No 1302/2014, Regulation (EU) No 1303/2014, Regulation (EU) 2016/919 and Implementing Decision 2011/665/EU should therefore be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 321/2013 is amended as follows:

• (1) in Article 2(1), the reference to ‘point 2.7 of Annex II to Directive 2008/57/EC’ is replaced by a reference to ‘point 2.7 of Annex II to Directive (EU) 2016/797 of the European Parliament and of the Council (*)

• (*) 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 (OJ L 138, 26.5.2016, p. 44).’;

• (2) in Article 3, the second subparagraph is amended as follows:

• (a) point (a) is replaced by the following:

• ‘(a) when it is renewed and upgraded in accordance with section 7.2.2 of the Annex to this Regulation’;

• (b) point (c) is replaced by the following:

• ‘(c) with regards to the marking “GE” as depicted in point 5 of Appendix C of the Annex, wagons of the existing fleet which have been authorised in accordance with Commission Decision 2006/861/EC as amended by Decision 2009/107/EC or with Decision 2006/861/EC as amended by Decisions 2009/107/EC and 2012/464/EU and meeting the conditions set out in point 7.6.4 of Decision 2009/107/EC may receive this marking “GE” without any additional third party assessment or new authorisation for placing on the market. The use of this marking in wagons in operation remains under the responsibility of the railway undertakings.’;

• (3) Article 4 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to “open points” set out in Appendix A, the conditions to be complied with for the verification of the essential requirements of Directive (EU) 2016/797 shall be those laid down by national rules in force in the Member State which is part of the area of use of the vehicles covered by this Regulation’;

• (b) point (c) of paragraph 2 is replaced as follows:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures with respect to the open points’;

• (4) Article 5 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to specific cases set out in Section 7.3 of the Annex, the conditions to be met for the verification of the essential requirements of Directive (EU) 2016/797 shall be those laid down in Section 7.3 of the Annex or by national rules in force in the Member State which is part of the area of use of the vehicles covered by this Regulation’;

• (b) point (c) of paragraph 2 is replaced as follows:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures for the national rules relating to the specific cases set out in point 7.3 of the Annex’;

• (5) Article 8 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   An EC certificate of verification for a subsystem that contains interoperability constituents which do not have an EC declaration of conformity or suitability for use may be issued during a transition period ending on 1 January 2024, provided the provisions set out in Section 6.3 of the Annex are met.’;

• (b) paragraph 2 is replaced by the following:

‘2.   The production or upgrade/renewal of the subsystem using non-certified interoperability constituents shall be completed within the transition period set out in paragraph 1, including placing on the market.’;

• (c) in point (b) of paragraph 3, the reference to ‘Article 18 of Directive 2004/49/EC’ is replaced by a reference to ‘Article 19 of Directive (EU) 2016/798 of the European Parliament and of the Council (*)

• (*) Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).’;

• (d) paragraph 4 is replaced by the following:

‘4.   After a transition period ending on 1 January 2015, newly produced interoperability constituents of “rear-end signals”, shall be covered by the required EC declaration of conformity.’;

• (6) Article 8a is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   Notwithstanding the provisions in Section 6.3 of the Annex, an EC certificate of verification may be issued for a subsystem containing components corresponding to the “friction element for wheel tread brakes” interoperability constituent that does not have an EC declaration of conformity during a transition period ending on 1 January 2024, if the following conditions are met:

• (a) the component was manufactured before the date of application of this Regulation; and

• (b) the interoperability constituent has been used in a subsystem that had been approved and placed on the market in at least one Member State before the date of application of this Regulation.’;

• (b) paragraph 2 is replaced by the following:

‘2.   The production, upgrade or renewal of any subsystem using non-certified interoperability constituents shall be completed, including granting authorisation for placing on the market, before the transition period set out in paragraph 1 expires.’;

• (c) in point (b) of paragraph 3, the reference to ‘Article 18 of Directive 2004/49/EC’ is replaced by a reference to ‘Article 19 of Directive (EU) 2016/798’;

• (7) Article 8 c is amended as follows:

• (a) point (b) of paragraph 1 is replaced by the following:

• ‘(b) the interoperability constituent has been used in a subsystem that had been approved and placed on the market in at least one Member State before the expiry of its approval period.’;

• (b) paragraph 2 is replaced by the following:

‘2.   The production, upgrade or renewal of any subsystem using non-certified interoperability constituents shall be completed, including granting authorisation for placing on the market, before the transition period set out in paragraph 1 expires.’;

• (c) in point (b) of paragraph 3, the reference to ‘Article 18 of Directive 2004/49/EC’ is replaced by a reference to ‘Article 19 of Directive (EU) 2016/798’;

• (8) Article 9 is amended as follows:

‘The declaration of verification and/or conformity to type of a new vehicle established in accordance with Decision 2006/861/EC shall be considered valid until the end of a transition period ending on 1 January 2017.’;

• (9) Article 10a is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 6 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 5 of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘Directive 2008/57/EC’ is replaced by a reference to ‘Directive (EU) 2016/797’;

• (10) the Annex is amended in accordance with Annex I to this Regulation.

Article 2

Regulation (EU) No 1299/2014 is amended as follows:

• (1) Article 2 is amended as follows:

• (a) in paragraph 1, the reference to ‘point 2.1 of Annex I to Directive 2008/57/EC’ is replaced by a reference to ‘point 2.1 of Annex II to Directive (EU) 2016/797 of the European Parliament and of the Council (*)

• (*) 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 (OJ L 138, 26.5.2016, p. 44).’;

• (b) in paragraph 3, the reference to ‘Article 20 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 18 of Directive (EU) 2016/797’;

• (c) paragraph 4 is replaced as follows:

‘4.   The TSI shall apply to the network of the Union rail system as described in Annex I of Directive (EU) 2016/797 with the exclusion of cases referred to in Article 1(3) and (4) of Directive (EU) 2016/797’;

• (2) Article 3 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to the aspects listed as “open points” in Appendix R to the Annex to this Regulation, the conditions to be complied with for verifying the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down by national rules in force in the Member State which authorises the placing in service of the subsystem covered by this Regulation.’;

• (b) point (c) of paragraph 2 is replaced as follows:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures with respect to the open points’;

• (3) in Article 4, paragraph 1 is replaced by the following:

‘1.   With regard to specific cases listed in Section 7.7 of the Annex, the conditions to be met for the verification of the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down in Section 7.7 of the Annex or by national rules in force in the Member State which authorises the placing in service of the subsystem covered by this Regulation’;

• (4) point (c) of paragraph 2 of Article 4 is replaced by the following:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures for the national rules relating to the specific cases set out in point 7.7 of the Annex’;

• (5) Article 7(3) is amended as follows;

• (a) in point (a), the reference to ‘Article 18 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 15 of Directive (EU) 2016/797’;

• (b) in point (b), the references to ‘Article 16(2)(c) of Directive 2004/49/EC’ and ‘Article 18 of Directive 2004/49/EC’ are replaced by references to ‘Article 16(2)(d) of Directive (EU) 2016/798 of the European Parliament and of the Council (*)

• (*) Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).’

and ‘Article 19 of Directive (EU) 2016/798’ respectively;

• (6) in Article 9, paragraph 2 is deleted;

• (7) Article 10 is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 6 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 5 of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘Directive 2008/57/EC’ is replaced by a reference to ‘Directive (EU) 2016/797’;

• (8) the Annex is amended in accordance with Annex II to this Regulation.

Article 3

Regulation (EU) No 1301/2014 is amended as follows:

• (1) Article 2 is amended as follows:

• (a) in paragraph 1, the reference to ‘point 2.2 of Annex II to Directive 2008/57/EC’ is replaced by a reference to ‘point 2.2 of Annex II to Directive (EU) 2016/797 of the European Parliament and of the Council (*)

• (*) 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 (OJ L 138, 26.5.2016, p. 44).’;

• (b) in paragraph 3, the reference to ‘Article 20 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 18 of Directive (EU) 2016/797’;

• (c) paragraph 4 is replaced as follows:

‘4.   The TSI shall apply to the network of the Union rail system as described in Annex I of Directive (EU) 2016/797 with the exclusion of cases referred to in Article 1(3) and (4) of Directive (EU) 2016/797’;

• (2) Article 4 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to specific cases listed in Section 7.4.2 of the Annex, the conditions to be met for the verification of compliance with the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down in Section 7.4.2 of the Annex or by national rules in force in the Member State which authorises the placing in service of the subsystem covered by this Regulation.’;

• (b) point (c) of paragraph 2 is replaced by the following:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures for the national rules relating to the specific cases set out in point 7.4.2 of the Annex’;

• (3) Article 7(3) is amended as follows:

• (a) in point (a), the reference to ‘Article 18 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 15 of Directive (EU) 2016/797’;

• (b) in point (b), the references to ‘Article 16(2)(c) of Directive 2004/49/EC’ and ‘Article 18 of Directive 2004/49/EC’ are replaced by references to ‘Article 16(2)(d) of Directive (EU) 2016/798 of the European Parliament and of the Council (*)

• (*) Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).’

and ‘Article 19 of Directive (EU) 2016/798’ respectively;

• (4) in Article 9, paragraph 2 is deleted;

• (5) Article 10 is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 6 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 5 of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘Directive 2008/57/EC’ is replaced by a reference to ‘Directive (EU) 2016/797’;

• (6) the Annex is amended in accordance with Annex III to this Regulation.

Article 4

Regulation (EU) No 1302/2014 is amended as follows:

• (1) in Article 2(1), the reference to ‘point 2.7 of Annex II to Directive 2008/57/EC’ is replaced by a reference to ‘point 2.7 of Annex II to Directive (EU) 2016/797 of the European Parliament and of the Council (*)

• (*) 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 (OJ L 138, 26.5.2016, p. 44).’;

• (2) in Article 3, paragraph 2 is replaced by the following:

‘2.   The TSI shall not apply to existing rolling stock of the rail system in the Union which is already placed in service on all or part of the network of any Member State on 1 January 2015, except when it is subject to renewal or upgrading in accordance with Section 7.1.2 of the Annex.’;

• (3) Article 4 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to the aspects listed as “open points” in Appendix I of the Annex, the conditions to be complied with for verifying the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down by national rules in force in the Member States which are part of the area of use of the vehicles covered by this Regulation.’;

• (b) point (c) of paragraph 2 is replaced as follows:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures with respect to the open points’;

• (4) in Article 5, paragraph 1 is replaced by the following:

‘1.   With regard to specific cases listed in Section 7.3 of the Annex, the conditions to be met for the verification of the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down in Section 7.3 of the Annex or by national rules in force in the Member States which are part of the area of use of the vehicles covered by this Regulation’;

• (5) point (c) of paragraph 2 of Article 5 is replaced by the following:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures for the national rules relating to the specific cases set out in point 7.3 of the Annex’;

• (6) Article 8(3) is amended as follows:

• (a) in point (a), the references to ‘Article 18 of Directive 2008/57/EC’ and ‘Article 16(2)(c) of Directive 2004/49/EC’ are replaced by a reference to ‘Article 15 of Directive (EU) 2016/797’;

• (b) in point (b) the references to ‘Article 16(2)(c) of Directive 2004/49/EC’ and ‘Article 18 of Directive 2004/49/EC’ are replaced by references to ‘Article 16(2)(d) of Directive (EU) 2016/798 of the European Parliament and of the Council (*)

• (*) Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).’

and ‘Article 19 of Directive (EU) 2016/798’ respectively;

• (7) in Article 9, the references to ‘Articles 16 to 18 of Directive 2008/57/EC’ and ‘Article 26 of Directive 2008/57/EC’ are replaced by references to ‘Articles 13 to 15 of Directive (EU) 2016/797’ and ‘Article 24 of Directive (EU) 2016/797’ respectively;

• (8) Article 10 is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 6 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 5 of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘Directive 2008/57/EC’ is replaced by a reference to ‘Directive (EU) 2016/797’;

• (9) the following paragraph 3 is added in Article 11:

‘3.   Section 7.1.3.1 of the Annex to this Regulation shall not apply for vehicles placed on the market after 31 December 2028. Vehicles placed on the market after that date shall be conform to chapters 4, 5 and 6 of the Annex to the present Regulation.’;

• (10) the following paragraph 4 is added in Article 11:

‘4.   Member States may only in duly justified cases permit applicants not to apply this Regulation or parts of it pursuant to Article 7(1)(a) of Directive 2016/797/EC for projects for which the possibility to apply sections 7.1.1.2 or 7.1.3.1 of the Annex exists or has expired. The application of sections 7.1.1.2 or 7.1.3.1 of the Annex does not require the application of Article 7(1)(a) of Directive 2016/797/EC.’;

• (11) the Annex is amended in accordance with Annex IV to this Regulation.

Article 5

Regulation (EU) No 1303/2014 is amended as follows:

• (1) in Article 2, the reference to ‘Annex II to Directive 2008/57/EC’ is replaced by a reference to ‘Annex II to Directive (EU) 2016/797 (*)

• (*) 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 (OJ L 138, 26.5.2016, p. 44).’;

• (2) Article 4 is amended as follows:

• (a) paragraph 1 is replaced by the following:

‘1.   With regard to specific cases listed in Section 7.3 of the Annex, the conditions to be met for the verification of the essential requirements set out in Annex III to Directive (EU) 2016/797 shall be those laid down in Section 7.3 of the Annex or by national rules in force in the Member State which authorises the placing in service of the fixed subsystems or which is part of the area of use of the vehicles covered by this Regulation.’;

• (b) point (c) of paragraph 2 is replaced by the following:

• ‘(c) the bodies designated to carry out the conformity assessment and verification procedures for the national rules relating to the specific cases set out in point 7.3 of the Annex’;

• (3) Article 8 is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 6 of Directive 2008/57/EC’ is replaced by a reference to ‘Article 5 of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘Directive 2008/57/EC’ is replaced by a reference to ‘Directive (EU) 2016/797’;

• (4) the Annex is amended in accordance with Annex V to this Regulation.

Article 6

Regulation (EU) 2016/919 is amended as follows:

• (1) Article 2 is amended as follows:

• (a) paragraph 1 is replaced by:

‘1.   The TSI shall apply to all new, upgraded or renewed “trackside control-command and signalling” and “on-board control-command and signalling subsystems of the rail system as defined in points 2.3 and 2.4 of Annex II to Directive (EU) 2016/797 of the European Parliament and of the Council[^ntr*1-LI2019139EN.01010801-E0011]. Section 7.2.1a of the Annex shall apply to all changes to an existing On-Board subsystem.

[^ntr*1-LI2019139EN.01010801-E0011]: 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 (OJ L 138, 26.5.2016, p. 44).’;"

• (b) in paragraph 2, the words ‘Article 20 of Directive 2008/57/EC and’ are deleted;

• (c) paragraph 3 is deleted;

• (2) in Article 3(1), the reference to ‘Article 17(3) of Directive 2008/57/EC’ is replaced by a reference to ‘Article 14 of Directive (EU) 2016/797’;

• (3) Article 5 is deleted;

• (4) Article 6 is amended as follows:

• (a) in paragraph 2, the reference to ‘Articles 13 and 18 of Directive 2008/57/EC’ is replaced by the reference to ‘Articles 10 and 15 of Directive (EU) 2016/797’;

• (b) in paragraph 3, the reference to ‘Article 16 of Directive 2004/49/EC’ is replaced by a reference to ‘Article 16 of Directive (EU) 2016/798 of the European Parliament and of the Council (*).

• (*) Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).’;

• (5) Article 9 is amended as follows:

• (a) in paragraph 4, the reference to ‘Article 29(1) of Directive 2008/57/EC’ is replaced by a reference to ‘Article 51(1) of Directive (EU) 2016/797’;

• (b) in paragraph 5, the reference to ‘points 7.3.2.1, 7.3.2.2 and 7.3.2.3 of Decision 2012/88/EU’ is replaced by a reference to ‘Article 2(1) of Commission Implementing Regulation (EU) 2017/6 (*) and point 7.4.1.1 of the Annex to this Regulation.

• (*) Commission Implementing Regulation (EU) 2017/6 of 5 January 2017 on the European Rail Traffic Management System European deployment plan (OJ L 3, 6.1.2017, p. 6)’;

• (6) Articles 10 and 11 are replaced by the following:

‘Article 10

Error corrections

If errors that do not allow the system to provide a normal service are detected, the Agency shall of its own motion or at the request of the Commission identify as soon as possible solutions to correct them and an evaluation of their impact on the compatibility and stability of the existing ERTMS deployment. In such cases, the Agency shall send to the Commission an opinion on such solutions and the evaluation. The Commission shall analyse the Agency's opinion, assisted by the committee referred to in Article 51(1) of Directive (EU) 2016/797, and may recommend that the solutions specified in the Agency's opinion apply until the next revision of the TSI.

Article 11

ERTMS game changers

1. By June 2021, taking into consideration the input from Shift2Rail and the Agency, the Commission shall issue a report on the definition of the next generation communication system. The report shall include the conditions and possible strategies for the migration to that system with due considerations for the coexistence of the system and spectrum requirements.

1. Where the Agency has issued an opinion with the draft release specifications relating to an ERTMS game changer as identified within ERA-REP-150, suppliers and early implementers shall use those specifications in their pilots and shall inform the Agency.’;

• (7) the following Article 11a is inserted:

‘Article 11a

ERTMS compatibility and future revision

1. By 1 June 2020, the Agency shall send a report to the Commission on the implementation of ETCS system compatibility (ESC) and radio system compatibility (RSC). The report shall include an assessment of the differing types of ESC and RSC, and the potential for reducing the underlying technical divergences of ESC and RSC types. Member States shall provide the Agency with the necessary information to complete the analysis.

1. By 1 December 2021, the Commission shall, based on input from the Agency, define the necessary steps to eliminate the tests or checks to prove technical compatibility of on-board units with different ERTMS trackside implementations, in particular to achieve harmonisation of engineering and operational rules at Member State level and between Member States. Member States shall provide the Commission and the Agency with the necessary information to complete the analysis.

1. By 1 December 2020, the Agency shall send a report to the Commission on the potential for including further elements of trackside and vehicle control-command and signalling system architecture, in particular to achieve a future proof design, facilitating the use of state of the art technology and ensuring backward compatibility.’;

• (8) the following paragraphs 2 and 3 are added in Article 13:

‘2.   Member States may only in duly justified cases permit applicants not to apply Section 7.4.2.1 of the Annex pursuant to Article 7(1)(a) of Directive 2016/797/EC for projects for which the possibility to apply section 7.4.2.3 of the Annex exists or has expired. The application of section 7.4.2.3 of the Annex does not require the application of Article 7(1)(a) of Directive 2016/797/EC.

1. Without prejudice to sections 6.1.2.4 and 6.1.2.5 of the Annex, applicants may continue to apply the provisions of the original version of Regulation (EU) 2016/919 (and relevant Agency opinions) when applying for authorisation of:

• (a) trackside projects which are at an advanced stage of development at the date of entry into force of this Regulation; and

• (b) on-board projects developed in accordance with ERTMS specifications #2 or #3 listed in Table A.2 of Annex A which are at an advanced stage of development at the date of entry into force of this Regulation’;

• (9) the Annex is amended in accordance with Annex VII to this Regulation.’.

Article 7

Implementing Decision 2011/665/EU is amended as follows:

• (1) the following Article 2a is inserted:

‘Article 2a

Information to be inserted by the Agency

The Agency shall insert in the European register of authorised types of vehicles information on the vehicle type authorisations or vehicle type variants it has granted and on new versions of a vehicle type or of a vehicle type variant in accordance with Article 50 of Commission Implementing Regulation (EU) 2018/545[^ntr*2-LI2019139EN.01010801-E0012], as set out in Annex II to this Decision.

[^ntr*2-LI2019139EN.01010801-E0012]: Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (OJ L 90, 6.4.2018, p. 66).’;"

• (2) in Article 3, paragraph 1 is replaced by the following:

‘1.   Member States shall ensure that the national safety authorities provide the information on the vehicle type authorisations or vehicle type variants they have granted and on the new version of a vehicle type or of a vehicle type variant in accordance with Article 50 of Regulation (EU) 2018/545, as set out in Annex II to this Decision.’;

• (3) Article 4 is replaced by the following:

‘Article 4

Restriction codes

Harmonised restriction codes shall be applicable in all Member States.

The list of harmonised restriction codes shall be the list referred to in Commission Implementing Decision (EU) 2018/1614[^ntr*3-LI2019139EN.01010801-E0013].

[^ntr*3-LI2019139EN.01010801-E0013]: Commission Implementing Decision (EU) 2018/1614 of 25 October 2018 laying down specifications for the vehicle registers referred to in Article 47 of Directive (EU) 2016/797 of the European Parliament and of the Council and amending and repealing Commission Decision 2007/756/EC (OJ L 268, 26.10.2018, p. 53).’;"

• (4) Annex I is amended in accordance with Annex VIII to this Regulation;

• (5) Annex II is replaced by Annex IX to this Regulation.

Article 8

In accordance with Regulations (EU) No 1299/2014 and (EU) No 1303/2014, each Member State shall update its national implementation plan for the INF TSI and SRT TSI. Each Member State shall forward its updated implementation plan to the other Member States and the Commission by 1 January 2020.

Article 9

Article 10

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 16 June 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 May 2019.

For the Commission

The President

Jean-Claude JUNCKER

ANNEX I

The Annex to Regulation (EU) No 321/2013 is amended as follows:

• (1) in sections 1, 1.3, 3, 4.1, 4.2.1, 4.7, 5.1, 6.1.2.3, the references to ‘Directive 2008/57/EC’ are replaced by references to ‘Directive (EU) 2016/797’;

• (2) section 1.2 is replaced by the following:

‘1.2.   Geographical scope

The geographical scope of this TSI is the entire European Union's rail system as set out in the section 1 of Annex I to Directive (EU) 2016/797, taking into account the limitations concerning the track gauge set out in Article 2.’;

• (3) Section 2 is replaced as follows:

‘2.   SCOPE AND DEFINITION OF SUBSYSTEM

2.1.   Scope

This TSI is applicable to “freight wagons including vehicles designed to carry lorries” as referred to in Annex I Section 2 to Directive (EU) 2016/797 taking into account the limitations as set out in Article 2. In the following this part of the subsystem rolling stock is called “freight wagon” and belongs to the subsystem “rolling stock” as set out in Annex II to Directive 2016/797/EC.

The other vehicles listed in Section 2 of Annex I to Directive (EU) 2016/797 are excluded from the scope of this TSI; this is especially the case for:

• (a) mobile railway infrastructure construction and maintenance equipment;

• (b) vehicles designed to carry:

— motor vehicles with their passengers on board, or

— motor vehicles without passengers on board but intended to be integrated in passenger trains (car carriers);

• (c) vehicles which

— increase their length in loaded configuration, and

— their payload itself is part of the vehicle structure.

Note: See also section 7.1 for particular cases.

2.2.   Definitions

In the present TSI the following definitions are used:

• (a) A “unit” is the generic term used to name the rolling stock. It is subject to the application of this TSI, and therefore subject to the EC verification procedure.

A unit can consist of:

— a “wagon” that can be operated separately, featuring an individual frame mounted on its own set of wheels, or

— a rake of permanently connected “elements”, those elements cannot be operated separately, or

— “separate rail bogies connected to compatible road vehicle(s)” the combination of which forms a rake of a rail compatible system.

• (b) A “train” is an operational formation consisting of several units.

• (c) The “design operating state” covers all conditions under which the unit is intended to operate and its technical boundaries. This design operating state may go beyond the specifications of this TSI in order that units may be used together in a train on the network under the safety management system of a railway undertaking.’;

• (4) Section 3, row 4.2.3.6.6 of Table 1 is replaced as follows:

‘4.2.3.6.6	Automatic variable gauge systems	1.1.1, 1.1.2, 1.1.3	1.2			1.5’

• (5) Section 4.2.2.2 is replaced as follows:

• ‘4.2.2.2 The structure of a unit body, any equipment attachments and lifting and jacking points shall be designed such that no cracks, no significant permanent deformation or ruptures occur under the load cases defined in Chapter 5 of EN 12663-2:2010.

In case of a rake of a rail compatible system composed of separate rail bogies connected to compatible road vehicles, the load cases may differ from those mentioned above, due to their bi- modal specification; in such a case, the load cases considered shall be described by the applicant based on a consistent set of specifications with consideration of the specific conditions of use related to train composition, shunting and operation.

The demonstration of conformity is described in point 6.2.2.1.

The lifting and jacking positions shall be marked on the unit. The marking shall comply with point 4.5.14 of EN 15877-1:2012.

Note: Joining techniques are deemed to be covered as well by the demonstration of conformity in accordance to point 6.2.2.1.’;

• (6) in the second and third paragraph of section 4.2.3.1, the text ‘EN 15273-2:2009’ is replaced by ‘EN 15273-2:2013+A1:2016’;

• (7) in section 4.2.3.1, the text ‘GIC1 and GIC2’ is replaced by ‘GI1 and GI2’;

• (8) in section 4.2.3.2, the text ‘EN 15528:2008’ is replaced by ‘EN 15528:2015’;

• (9) in section 4.2.3.3, the text ‘Commission Decision 2012/88/EU (1)’ is replaced by ‘ERA/ERTMS/033281 rev. 4.0’;

• (10) in point 4.2.3.3 the footnote ‘(¹) OJ L 51, 23.2.2012, p. 1.’ is deleted;

• (11) in section 4.2.3.4, the text ‘The specifications of the design and the conformity assessment of on-board equipment is an open point in this TSI.’ is replaced as follows:

‘If the unit is intended to be capable of being monitored by on-board equipment, the following requirements shall apply:

— This equipment shall be able to detect a deterioration of any of the axle box bearings of the unit.

— The bearing condition shall be evaluated either by monitoring its temperature, or its dynamic frequencies or some other suitable bearing condition characteristic.

— The detection system shall be located entirely on board the unit, and diagnosis messages shall be available on board the unit.

— The diagnosis messages delivered and how they are made available shall be described in the operating documentation set out in section 4.4 of this TSI, and in the maintenance rules described in section 4.5 of this TSI.’;

• (12) in section 4.2.3.5.2 the text ‘Chapter 5 of EN 14363:2005’ is replaced by ‘chapters 4, 5 and 7 of EN 14363:2016’;

• (13) section 4.2.3.6.6 is replaced as follows:

‘4.2.3.6.6.   Automatic variable gauge systems

This requirement is applicable to units equipped with an automatic variable gauge system with changeover mechanism of the axial position of the wheels allowing the unit to be compatible with 1 435 mm track gauge and other track gauge(s) within the scope of this TSI by means of passage through a track gauge changeover facility.

The changeover mechanism shall ensure the locking in the correct intended axial position of the wheel.

After passage through the track gauge changeover facility, the verification of the state of the locking system (locked or unlocked) and of the position of the wheels shall be performed by one or more of the following means: visual control, on-board control system or infrastructure/facility control system. In case of on-board control system, a continuous monitoring shall be possible.

If a running gear is equipped with brake equipment subject to a change in position during the gauge change operation, the automatic variable gauge system shall ensure the position and safe locking in the correct position of this equipment simultaneously to those of the wheels.

The failure of the locking of the position of the wheels and braking equipment (if relevant) during operation has typical credible potential to lead directly to a catastrophic accident (resulting in multiple fatalities); considering this severity of the failure consequence, it shall be demonstrated that the risk is controlled to an acceptable level.

The automatic variable gauge system is defined as an interoperability constituent (point 5.3.4b) and is part of the interoperability constituent wheelset (point 5.3.2). The conformity assessment procedure is specified in point 6.1.2.6 (interoperability constituent level), point 6.1.2.2 (safety requirement) and in point 6.2.2.4a (subsystem level) of this TSI.

The track gauges the unit is compatible with shall be recorded in the technical documentation.

A description of the changeover operation in normal mode, including the type(s) of track gauge changeover facility(ies) the unit is compatible with, shall be part of the technical documentation (see also section 4.4 of this TSI).

The requirements and conformity assessments required in other sections of this TSI apply independently for each wheel position corresponding to one track gauge and have to be documented accordingly.’;

• (14) in section 4.2.4.2 the text ‘Commission Regulation (EC) No 352/2009 (¹)’ is replaced by the text ‘Commission Implementing Regulation (EU) No 402/20131 (¹)’;

• (15) in section 4.2.4.2 the footnote ‘(¹) OJ L 108, 29.4.2009, p. 4.’ is replaced by the footnote ‘(¹) OJ L 121, 3.5.2013, p. 8.’;

• (16) in section 4.2.4.3.2.1, the text ‘UIC leaflet 544-1:2013’ and ‘UIC 544-1:2013’ is replaced by the text ‘UIC 544-1:2014’;

• (17) in section 4.2.4.3.2.2, the text ‘the minimum parking brake performance’ is replaced by the text ‘the minimum parking brake force’

• (18) in section 4.2.4.3.2.2, the text ‘the minimum performance of the parking brake shall be marked on the unit. The marking shall comply with clause 4.5.25 of EN 15877- 1:2012.’ is deleted;

• (19) in section 4.2.5, the text ‘EN 50125-1:1999’ is replaced by ‘EN 50125-1:2014’;

• (20) in section 4.2.6.2.1, the text ‘EN 50153:2002’ is replaced by ‘EN 50153:2014’;

• (21) in section 6.2.2.8.4, the text ‘TS 45545-7:2009’ is replaced by ‘EN 45545-7:2013’;

• (22) in section 4.2.6.2.2, the text ‘EN 50153:2002’ is replaced by ‘EN 50153:2014’;

• (23) in section 4.2.6.3, the text ‘chapter 1 of ERA technical document ERA/TD/2012-04/INT version 1.2 of 18.1.2013 published on the ERA website (http://www.era.europa.eu)’ is replaced by ‘Figure 11 of EN 16116-2:2013’;

• (24) in Table 7 of section 4.3.3, the text ‘Reference Commission Decision 2012/88/EU Annex A, Table A2, index 77’ is replaced by ‘Reference ERA/ERTMS/033281 rev. 4.0’;

• (25) Section 4.4 is replaced as follows:

‘4.4   Operating rules

Operating rules are developed within the procedures described in the railway undertaking safety management system. These rules take into account the documentation related to operation which forms a part of the technical file as required in Article 15(4) of and as set out in Annex IV to Directive (EU) 2016/797.

For the safety critical components (see also 4.5), the specific operational and operational traceability requirements are developed by the designers/manufacturers at design phase and through a collaboration between designers/manufacturers and the concerned railway undertakings or the concerned wagon keeper after vehicles have entered into operation.

The documentation related to operation describes the characteristics of the unit in relation to the design operating state to be considered in order to define the operating rules in normal and in various reasonably foreseeable degraded modes.

The documentation related to operation is composed of:

— a description of operation in normal mode, including the operational characteristics and limitations of the unit (e.g. vehicle gauge, maximum design speed, axle loads, brake performance, compatibility with train detection systems, permitted environmental conditions, type(s) and operation of track gauge changeover facility(ies) the unit is compatible with),

— a description of operation in degraded mode (when equipment or functions described in this TSI suffer safety failures) as far as can reasonably predicted, together with the related acceptable limits and operating conditions of the unit that could be experienced,

— a safety critical components list: The safety critical components list shall contain the specific operational and operational traceability requirements.

The applicant shall provide the initial version of the documentation related to operating rules. This documentation might be modified later in accordance with the corresponding Union legislation, taking into account the existing operating and maintenance conditions of the unit. The Notified Body shall verify only that the documentation on operation is provided.’;

• (26) Section 4.5 is replaced as follows:

‘4.5   Maintenance rules

Maintenance is a set of activities intended to keep a functional unit in, or to restore it to a state in which it can perform its required function.

The following documents being part of the technical file as required in Article 15(4) of and as set out in Annex IV to Directive (EU) 2016/797 are necessary to undertake maintenance activities on the units:

— general documentation (point 4.5.1),

— the maintenance design justification file (point 4.5.2), and

— the maintenance description file (point 4.5.3).

The applicant shall provide the three documents described in 4.5.1, 4.5.2. and 4.5.3. This documentation might be modified later in accordance with the corresponding EU legislation, taking into account the existing operating and maintenance conditions of the unit. The Notified Body shall verify only that the documentation on maintenance is provided.

The applicant or any entity authorised by the applicant (e.g. a keeper) shall provide this documentation to the entity in charge of maintenance as soon as it is assigned for the maintenance of the unit.

On the basis of these three documents, the entity in charge of maintenance shall define a maintenance plan and appropriate maintenance requirements at maintenance operational level under its sole responsibility (not in the scope of the assessment against this TSI).

The documentation includes a list of safety critical components. Safety critical components are components for which a single failure has a credible potential to lead directly to a serious accident as defined in Article 3(12) of Directive (EU) 2016/798.

The safety critical components and their specific servicing, maintenance and maintenance traceability requirements are identified by the designers/manufacturers at design phase and through a collaboration between designers/manufacturers and the concerned entities in charge of maintenance after vehicles have entered into operation.

4.5.1   General documentation

The general documentation comprises of:

— Drawings and description of the unit and its components.

— Any legal requirement concerning the maintenance of the unit.

— Drawing of systems (electrical, pneumatic, hydraulic and control-circuit diagrams).

— Additional on-board systems (description of the systems including description of functionality, specification of interfaces and data processing and protocols).

— Configuration files for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities.

4.5.2   Maintenance design justification file

The maintenance design justification file explains how maintenance activities are defined and designed in order to ensure that the rolling stock characteristics will be kept within permissible limits of use during its lifetime. The file shall give input data in order to determine the criteria for inspection and the periodicity of maintenance activities. The maintenance design justification file consists of:

— Precedents, principles and methods used to design the maintenance of the unit.

— Precedents, principles and methods used to identify the safety critical components and their specific operational, servicing, maintenance and traceability requirements.

— Limits of the normal use of the unit (e.g. km/month, climatic limits, foreseen types of loads, etc.).

— Relevant data used to design the maintenance and origin of these data (return of experience).

— Tests, investigations and calculations carried out to design the maintenance.

4.5.3   Maintenance description file

The maintenance description file describes how maintenance activities can be conducted. Maintenance activities include, among others, inspections, monitoring, tests, measurements, replacements, adjustments and repairs.

Maintenance activities are split into:

— preventive maintenance (scheduled and controlled), and

— corrective maintenance.

The maintenance description file includes the following:

— Component hierarchy and functional description which sets up the boundaries of the rolling stock by listing all the items belonging to the product structure of that rolling stock and using an appropriate number of discrete levels. The lowest item of the hierarchy shall be a replaceable component.

— Parts list which shall contain the technical and functional descriptions of the spare parts (replaceable units). The list shall include all parts specified for changing based on condition, which may require a replacement following electrical or mechanical malfunction or which will foreseeable require a replacement after an accidental damage. Interoperability constituents shall be indicated and referenced to their corresponding declaration of conformity.

— Safety critical components list: The safety critical components list shall contain the specific servicing, maintenance and servicing/maintenance traceability requirements.

— Limit values for components which are not to be exceeded in service. It is permitted to specify operational restrictions in degraded mode (limit value reached).

— List of reference to the European legal obligations to which components or subsystems are subject.

— Maintenance plan[^ntr*1-LI2019139EN.01012001-E0001] i.e. the structured set of tasks to perform the maintenance including the activities, procedures and means. The description of this set of tasks includes:

• (a) Disassembly/assembly instructions drawings necessary for correct assembly/disassembly of replaceable parts.

• (b) Maintenance criteria.

• (c) Checks and tests in particular of safety relevant parts; these include visual inspection and non-destructive tests (where appropriate e.g. to detect deficiencies that may impair safety).

• (d) Tools and materials required to undertake the task.

• (e) Consumables required to undertake the task.

• (f) Personal protective safety provision and equipment.

— Necessary tests and procedures to be undertaken after each maintenance operation before re-entry into service of rolling stock.

[^ntr*1-LI2019139EN.01012001-E0001]: The maintenance plan shall take into accounts the findings of the ERA Task force on Freight Maintenance (see “Final report on the activities of the Task Force Freight Wagon Maintenance” published on the ERA website http://www.era.europa.eu).’;"

• (27) in section 4.8, the text ‘GIC1 and GIC2’ is replaced by ‘GI1 and GI2’;

• (28) a new section 4.9 is added as follows:

‘4.9   Route compatibility checks before the use of authorised vehicles

The parameters of the subsystem “rolling stock — freight wagons” to be used by the railway undertaking, for the purpose of route compatibility check, are described in Appendix D1 of Commission Implementing Regulation (EU) 2019/773[^ntr*2-LI2019139EN.01012001-E0002]

[^ntr*2-LI2019139EN.01012001-E0002]: Commission Implementing Regulation (EU) 2019/773 of 16 May 2019 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union and repealing Decision 2012/757/EU (OJ L 139 I, 27.5.2019, p. 5).’;"

• (29) in section 5.3.1, the text ‘The running gear shall be designed for an application range, the area of use, as defined by the following parameters:’ is replaced as follows:

‘The running gear shall be designed for all application ranges, the areas of use, as defined by the following parameters:

— Track gauge’;

• (30) in section 5.3.2, the text ‘The wheelset shall be assessed and designed for the area of use as defined by’ is replaced as follows:

‘For the purpose of this TSI, wheelsets include the main parts ensuring the mechanical interface with the track (wheels and connecting elements: e.g. transverse axle, independent wheel axle). Accessories parts (axle bearings, axle boxes and brake discs) are assessed at subsystem level.

The wheelset shall be assessed and designed for the area of use as defined by:

— track gauge,’;

• (31) in section 5.3.3, the text: ‘— maximum speed and service life, and’ is replaced as follows:

• ‘— maximum speed,

— in-service limits, and’

• (32) a new section 5.3.4b is added below section 5.3.4a:

‘5.3.4b.   Automatic variable gauge system

An IC “automatic variable gauge system” shall be designed and assessed for an area of use defined by:

— the track gauges the system is designed for,

— the range of maximum static axle loads,

— the range of nominal wheel tread diameters,

— the maximum design speed of the unit, and

— the types of track gauge changeover facility(ies) the system is designed for, including the nominal speed through the track changeover facility(ies) and the maximum axial forces during the automatic gauge changeover process.

An automatic variable gauge system shall comply with the requirements set out in point 4.2.3.6.6; these requirements shall be assessed at IC level as set out in point 6.1.2.6.’

• (33) in section 6.1.2, Table 9, a new row 4.2.3.6.6 is added below the row ‘4.2.3.6.4 Axle’

‘4.2.3.6.6	Automatic variable gauge system	X (*)	X	X	X (*)	X	X (**)’

• (34) in section 6.1.2, the following text is added after the last paragraph:

‘In case of a specific case applicable to a component defined as interoperability constituent in section 5.3 of this TSI, the corresponding requirement can be part of the verification at interoperability constituent level only in the case where the component remains compliant to the chapters 4 and 5 of this TSI and where the specific case does not refer to a national rule (i.e. additional requirement compatible with the core TSI and fully specified in the TSI).

In other cases, the verification shall be made at subsystem level; when a national rule applies to a component, the concerned Member State may define relevant applicable conformity assessment procedures.’;

• (35) the section 6.1.2.1 is replaced as follows:

‘6.1.2.1.   Running gear

The demonstration of conformity for running dynamic behaviour is set out in EN 16235:2013.

Units equipped with an established running gear as described in chapter 6 of EN 16235:2013 are presumed to be in conformity with the relevant requirement provided that the running gears are operated within their established area of use.

The assessment of the bogie frame strength shall be based on clause 6.2 of EN 13749:2011.’;

• (36) in section 6.1.2.2, the last paragraph is replaced as follows:

‘A verification procedure shall exist to ensure at the assembly phase that no defects may detrimentally affect safety due to any change in the mechanical characteristics of the fitted parts of the axle. This procedure shall contain the determination of the interference values and, in case of press-fitted wheelsets, the corresponding press-fitting diagram.’;

• (37) in section 6.1.2.5, four instances of text ‘ERA/TD/2013-02/INT version 2.0 of XX.XX.2014’ are replaced by the text ‘ERA/TD/2013-02/INT version 3.0 of 27.11.2015’;

• (38) a new section 6.1.2.6 is added below the section 6.1.2.5:

‘6.1.2.6.   Automatic variable gauge system

The assessment procedure shall be based on a validation plan covering all aspects mentioned in points 4.2.3.6.6 and 5.3.4b.

The validation plan shall be consistent with the safety analysis required in clause 4.2.3.6.6 and shall define the assessment needed in all the following different phases:

— Design review

— Static tests (bench tests and integration-in-the-wheelset/unit tests)

— Test on track gauge changeover facility(ies), representative of in-service conditions

— On-track tests, representative of in-service conditions.

Regarding the demonstration of compliance to the safety level required in point 4.2.3.6.6, the assumptions considered for the safety analysis related to the unit the system is intended to be integrated in, and related to the mission profile of that unit, shall be clearly documented.

The automatic variable gauge system may be subject to an assessment of suitability for use (module CV). Before commencing in-service tests, a suitable module (CB or CH1) shall be used to certify the design of the interoperability constituent. The in-service tests shall be organised on request from the manufacturer, who must obtain an agreement from a railway undertaking for its contribution to such assessment.

The certificate delivered by the notified body in charge of the conformity assessment shall include both the conditions for use as per clause 5.3.4b and the type(s) and operating conditions of the track gauge changeover facility(ies) the automatic variable gauge system has been assessed for.’;

• (39) In section 6.2.2.1, the text ‘The demonstration of conformity shall be in accordance with Chapters 6 and 7 of EN 12663-2:2010.’ is replaced by ‘The demonstration of conformity shall be in accordance with chapters 6 and 7 of EN 12663-2:2010, or alternatively with chapter 9.2 of EN 12663-1:2010+A1:2014.’;

• (40) section 6.2.2.2 is replaced as follows: