QUESTION / CLARIFICATION

QUESTION / CLARIFICATION CO-ORDINATION BETWEEN NOTIFIED BODIES INTEROPERABILITY DIRECTIVE AND SUBSEQUENT AMENDMENTS ON THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE UNION QC-RST-015 Issue 02 Date: 15/09/2016 Page 1 of 3 TITLE INTEROPERABILITY CONSTITUENTS ASSESSMENT ON SUBSYSTEM LEVEL (TSI_HS_RST, TSI_CR_LOC+PAS, TSI_CR_WAG, TSI_PRM) SCONRAIL LTD ORIGINATOR SUBJECT RELATED TO TSI_HS_RST (2008/232/EC) TSI_CR_LOC+PAS (2011/291/EU) TSI_CR_WAG (2006/861 + 2009/107/EC) TSI_PRM (2008/164/EC) DESCRIPTION AND BACKGROUND EXPLANATION Scope Procedure with regard to the assessment of Interoperability Constituents IC on a subsystem level. Introduction The question arises frequently in the certification process of railway vehicles, if Interoperability Constituents IC could be certified as part of the assessment process of the subsystem. The ERA guide for the application of TSIs (ERA/GUI/07-2011/INT; Version in ERA: 1.01) defines: [G 10] The interoperability constituents and their interoperable characteristics are defined in the TSIs. One of the objectives is to create a European industrial market for railway products. To avoid an unnecessary repetition of assessment procedures and related costs, components or subassemblies of a subsystem necessary for interoperability, which are manufactured to an identical design as serial products, to be later sold in quantity and incorporated in subsystems, have been defined as interoperability constituents. [G 11] Generally speaking, interoperability constituents have the following common points: the interoperability constituents characteristics can be evaluated by reference to a European standard or another relevant document, independently of the subsystem in which the constituents will be integrated; interoperability constituents can be used in isolation as spare parts and placed on the European market by the manufacturer, before their integration into a subsystem; interoperability constituents are elements whose design can be developed and assessed individually. QUESTION & CLARIFICATION

QUESTION / CLARIFICATION CO-ORDINATION BETWEEN NOTIFIED BODIES INTEROPERABILITY DIRECTIVE AND SUBSEQUENT AMENDMENTS ON THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE UNION QC-RST-015 Issue 02 Date: 15/09/2016 Page 2 of 3 [G 69] If the IC is assessed at the same time as the subsystem and placed on the EU market through the placing in service of this subsystem, a specific EC declaration of conformity is still required for the IC, unless the relevant TSI provides otherwise (e.g. for a transitional period). The placing on the market of an IC cannot be covered by the EC declaration of verification of the subsystem in which the IC is integrated. From the formal point of view, the process of conformity assessment of the IC is separate from the verification process of the subsystem. [G 70] In particular situations (where the obligations relating to the EC declaration of conformity or suitability for use has not been met by the manufacturer or its authorised representative), it is possible for the organisation that uses ICs (e.g. a vehicle manufacturer that incorporates ICs in a vehicle, a civil works contractor that uses ICs for the infrastructure, or the contracting entity) to issue an EC declaration of conformity or suitability for use for an IC in place of the manufacturer. In this case, the organisation has to arrange for the EC conformity assessment, and will be considered to be the entity that placed this IC on the market ([Article 13(4)]). Technical Problem Some of the IC meet the objectives as defined e.g. in [G 10] as being a component, that can freely been used on various vehicles without additional assessment. Some constituents, defined as IC, are really no IC in accordance with the objective, defined in [G 10] and [G 11]: Pantograph: Must be assessed, taking the boundary conditions of the vehicle, the infrastructure and the energy system into account Toilet: Is designed to meet the specific installation requirements into the vehicle and is generally not designed to be produced in an identical configuration for other vehicles ( * see detailed example below) Freight car bogie: Some bogies are specifically designed for an application under a specific vehicle and are not designed to be used freely For some of the IC the complete assessment on the IC level as stipulated in the concept of [G 10] and [G 11] is not possible because the requirements for the IC include requirements for its installation (which is part of the assessment of the complete vehicle): Driver s cab windscreen: Section 4.2.2.7. of the TSI_HS_RST defines requirements for the IC which only can be assessed on a subsystem level: o the windscreen shall be equipped with external cleaning facilities; o the front end of the train shall be capable of resisting the same impact as the window in order to protect persons travelling in the front vehicle; o the inside face of the windscreen shall be supported along its edges to limit intrusion in case of an accident. QUESTION & CLARIFICATION

QUESTION / CLARIFICATION CO-ORDINATION BETWEEN NOTIFIED BODIES INTEROPERABILITY DIRECTIVE AND SUBSEQUENT AMENDMENTS ON THE INTEROPERABILITY OF THE RAIL SYSTEM WITHIN THE UNION QC-RST-015 Issue 02 Date: 15/09/2016 Page 3 of 3 SUGGESTED RESOLUTION / INTERPRETATION Concept The NoBo must assess an IC on the subsystem level in cases, where an IC can not be assessed completely on the IC level and therefore does not meet the concept as defined in [G 10] and [G 11]. In these cases of ICs without certificate the respective assessment of the compliance with all requirements (on IC and subsystem level) shall be performed by the NoBo on the subsystem level; the results of the assessment shall be included in the Technical File of the vehicle but no EC type examination certificate and EC declaration of conformity for the IC needs to be issued. (*) Example IC Toilet: The way to implement toilet systems in passenger vehicles can be quite different. As long as the vehicle manufacturer buys the toilet system as a complete unit from a supplier, it shall be handled as an IC. But especially for smaller batches of vehicles, it is possible, that the vehicle manufacturer buys components and integrates them while assembling the vehicle. In such a case, the toilet system is in fact a part of the subsystem and cannot be put on the market as an individual unit. In such a second case, it is proposed to allow assessment of the toilet as a part of the subsystem. ORGANISATION(S) REQUESTED TO RESPOND (E.G. TSI GROUP, RISC, ERA ETC.) ERA / EUROPEAN COMMISSION PM37, 06/02/13 DATE OF AGREEMENT AT NB RAIL PLENARY MEETING RESPONSE FROM ORGANISATION ABOVE ERA issue the TO ERA/OPI/2014-1 on 30/01/2015 QUESTION & CLARIFICATION

61 59307 European Railway Agency Executive Director OPINION ERA/OPI/2014-1 OF THE EUROPEAN RAILWAY AGENCY FOR EUROPEAN COMMISSION REGARDING QUESTION AND CLARIFICATION NB RAIL - QC-RST-015 Disclaimer: The present document is a non-legally binding opinion of the European Railway Agency. It does not represent the view of other EU institutions and bodies, and is without prejudice to the decision-making processes foreseen by the applicable EU legislation. Furthermore, a binding interpretation of EU law is the sole competence of the Court of Justice of the European Union. European Railway Agency 120 rue Marc Lefrancq 20392 - Valenciennes Cedex Tél +33 (3) 2709 6500 Fax: +33 (3) 27 3340 65- www.era.europa.eu E-mail: marcel.verslype@era.europa.eu

freight OPINION ERA/OPI/2014-1 General Context 1. In its letter MOVE/B2/LV/fz Ares (2014) dated l1ti February 2014 (Ref.Ares(2014)338925) addressed to the Executive Director of the European Railway Agency ( ERA ), the European Commission requested ERA to prepare the technical opinion regarding the question / clarification issued by NB-RAIL numbered Q&C-RST-015 Issue 01 dated l2t December 2012. 2. The question is related to the conformity assessment of interoperability constituents, and to the possibility to assess them at subsystem level instead of at component level. 3. The question is raised for application of the following Technical Specifications for Interoperabilty: a. Commission decision 2008/232/EC relating to the rolling stock subsystem of the trans European high speed rail system. b. Commission decision 2008/164/EC relating to persons with reduced mobility in the trans European conventional and high-speed rail system 2. c. Commission decision 2006/861/EC amended by decision 2009/107/EC relating to rolling stock - freight wagons of the trans-european conventional rail system 3. d. Commission decision 2011/291/Eu relating to the rolling stock subsystem Locomotives and Passenger rolling stock of the trans-european conventional rail system 4. 4. NB-RAIL proposal is to assess interoperability constituents at subsystem level in case a complete assessment at component level is considered as not possible, due to the interfaces between the constituent and the vehicle (subsystem). 5. In such a case, NB-RAIL view is that the component does not meet the concept of Interoperability Constituent as defined in the guide for application of TSls published on ERA website (ERA/Gul/07-2011/INT), in particular its points GlO and G 11. 2 Legal Background 1. In its Article 3(f), Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community 5 ( Interoperability Directive ) defines the interoperability constituents as follows: any elementary component, group of Di L 84, 28.3.2008, P. 132. 2 oj L 64, 7.3.2008, p. 72. Di L 344, 8.12.2006, p. 1. Commission decision 2006/861/EC has been repealed by Commission Regulation (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem rolling stock wagons of the rail system in the European Union (OJ L 104, 12.4.2013, p. 1). Di L 139, 26.5.2011, p. 1. Di L 191, 18.7.2008, p.1 Page 2 of 6

freight OPINION ERA/OPI/2014-1 components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly. The concept of a constituent covers both tangible objects and intangible objects such as software;. 2. Legal provisions applicable to placing on the market and for EC declaration of conformity or suitability for use of interoperability constituents are defined in the chapter III of the directive 2008/57/EC. These legal provisions are different from those applicable to placing in service and for establishing the EC declaration of verification of subsystems in the chapter IV of the same directive. 3. The guide for application of TSIs provides details in line with these legal provisions. 4. TSls are drafted in accordance with the requirements of the Interoperability Directive, in particular by determining the interoperability constituents and interfaces which are necessary to achieve interoperability within the rail system and which procedures are to be used in order to assess the conformity or the suitability for use of the interoperability constituents, on the one hand, or the EC verification of the subsystems, on the other hand. 5. In particular, the TSls include a specific clause or article defining conditions under which a subsystem may contain interoperability constituents not holding an EC declaration, i.e. conditions under which they may be assessed at subsystem level: a. Commission decision 2008/232/EC relating to the rolling stock subsystem of the trans European high speed rail system: See clause 6.3.2, defining a transition period from 15/04/2008 to 14/04/2014. b. Commission decision 2008/164/EC relating to persons with reduced mobility : See clause 6.3.3, defining a transition period from 29/03/2008 to 28/03/2014. c. Commission decision 2006/861/EC amended by decision 2009/107/EC relating to rolling stock - wagons of the trans-european conventional rail system: This decision is repealed by the Commission regulation 2013/321/EU applicable from 01/01/2014; see article 8 defining a transition period from 13/04/2014 to 12/04/2023. d. Commission decision 2011/291/EU relating to the rolling stock subsystem Locomotives and Passenger rolling stock of the trans-european conventional rail system: See article 6 and clause.6.3 defining a transition period from 01/06/2011 to 31/05/2017. Page3 of6

OPINION ERA/OPI/2014-1 3 Analysis 1. From the legal requirements listed above, it appears that strict conditions have to be met in order to be exempted from a conformity assessment at the level of interoperability constituents. Additionally, this exemption is a transition measure limited in time. 2. In the document Q&C-RST-015, NB-RAIL does not refer to the legal provisions listed in 2 above. 3. NB-RAIL mentions a technical problem and questions the relevance of having certain components specified as interoperability constituents in the TSIs. 4. The definition of interoperability constituents is made during the drafting process of the TSls, with the involvement of the railway sector according to working methods of ERA. 5. ERA reminds that during the drafting of conventional rail TSIs from 2007 to 2010, clarifications were brought regarding interoperability constituents; in particular, in line with Article 10(1.(b) of the interoperability Directive (..ensure that interoperability constituents are used in their area of use as intended and are suitably installed and maintained ), it was clarified that: a. Having an interoperability constituent specified in a TSI does not mean that any constituent having an EC declaration of conformity or suitability for use can be integrated in any subsystem having an EC declaration of verification. b. The area of use of an interoperability constituent shall be defined. This means that at subsystem level, this area of use has to be considered in order to select a proper interoperability constituent. c. The characteristics to be checked at the level of the interoperability constituent and those to be checked at subsystem level after integration of the constituent shall be clearly defined. 6. For TSIs drafted before 2006, in particular those listed in points a) and b) of 1 and 2 above, there are cases where the principles above are not sufficiently explicitly described. These TSIs were recently revised, and were improved; in particular, it has been proposed to abandon or give flexibility for the following interoperability constituents: a. Windscreen: this constituent is no more retained as interoperability constituent in the revised TSI LOC&PAS that received a positive vote during the RISC 68 in October 2013 (item 06-STO2OENO6). b. Toilet module: the following clause is added in the revised TSI PRM that received a positive vote during the RISC 69 in January 2014 (item 03-ST27ENO3): 6.1.3.2 Toilet Module and Universal Toilet Module Page4 of6

OPINION ERA/OPI/2014-1 When a toilet module or a universal toilet module is not built as an independent comnpartnment, its characteristics can be assessed at subsystem level. The corresponding Commission regulations are planned to enter into force before the end of 2014. 7. Considering that the transition phases reminded in points a) and b) of 2 above ended respectively on 14/04/2014 and 28/03/2014, the components listed in point 6 above require now an assessment of conformity or of suitability for use as interoperability constituents, which will become useless and irrelevant after the entry into force of revised TSls. This situation create additional technical and administrative burden to manfacturers or applicants that should be avoided. 4 The opinion 1. Whereas it cannot be considered that there is any error in TSIs listed in points a) and b) of 1 above, but considering the planned revision of the TSIs, the end of the transition period for allowance of non-certified interoperability constituents listed in 3 point 6 above creates a source of unnecessary administrative burden and cost. 2. Consequently, the technical opinion of the Agency is the following: a. Commission decision 2008/232/EC relating to the rolling stock subsystem of the trans European high speed rail system: As long as this decision is applied, it should be allowed to incorporate into subsystems the interoperability constituent Driver s cab windscreens listed in chapter 5 and specified in clause 4.2.2.7 not holding an EC declaration under the conditions set out in clause.6.3.2 b. Commission decision 2008/164/EC relating to persons with reduced mobility : As long as this decision is applied, it should be allowed to incorporate into subsystems the interoperability constituent Standard and universal toilet modules listed in clause 5.3.2 and specified in clause 4.2.2.6. not holding an EC declaration under the conditions set out in clause 6.3.3. c. In other cases, interoperability constituents shall hold and EC declaration according to the conditions specified in the applicable TSI. Valenciennes, 2 0 MA I 2014 lverslype - Executive Director Page5of6

1 OPINIoN ERA/OPI/2014-1 ANNEX Letter MOVE/B2/LV/fz Ares (2014) dated 11 th February 2014 (Ref.Ares(2014)338925), including request to the Agency and Q&C-RST-015. Page 6 of 6