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-STR-007 Issue 02 Date: 15/09/2016 Page 1 of 2 TITLE LIST OF HARMONIZED STANDARDS ORIGINATOR SUBGROUP STRATEGY (SUBGROUP INFRASTRUCTURE) SUBJECT RELATED TO All TSIs and 2013/C 345/03 List of harmonised standards DESCRIPTION AND BACKGROUND EXPLANATION Standards that are referenced directly in the TSI become part of this TSI and are therefore mandatory. Reminder: (text from application guide ERA/GUI/07-2011/INT of 26 August 2011) References in the TSIs to existing standards or other documents may be either: strict references whereby the reference explicitly identifies a particular version of the document (e.g. with reference to the version number, date, etc.), or slipping references (i.e. with no explicit identification of a particular version of the document) whereby the reference is to the version of the document in force at the time of adoption of the latest amendment of the TSI in question. As far as possible, only strict references appear to have been made in the TSIs. In both cases, the version of the standard (or document) referred to in a TSI is the binding one. If, after the adoption of a TSI, a new version of this standard (or document) is adopted, the old version referred to in the TSI is still the binding one. That is, in both cases nothing actually slips. Where a TSI refers to a standard or document, the complete standard or document is mandatory. Where a TSI refers to a part of a standard or document, only the part referred to is mandatory. If an Omnibus procedure is published, then text of TSIs can be changed and also standards can be updated (as it was done for example with 2012/464/EU). Note: Harmonised standards give presumption of conformity with the essential requirements according to the directives for which they are published. The current list of harmonised standards relating to 2008/57/EC is published in the Official Journal of the European Union (OJEU) (e.g. 2013/C 345/03 or a later version of this list). Some standards in this list are marked as no longer giving presumption of conformity (see note 2.1 in the document), but remain quoted in the TSIs which is seen as a contradiction by industry. 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-STR-007 Issue 02 Date: 15/09/2016 Page 2 of 2 Question: The industry has approached NB Rail with a concern that the inability to update Mandatory Standards as quoted in the TSIs will lead to significant economic burden at design, production and authorisation of railway products. Can an applicant and a NoBo assume that the publication of an updated reference of a Harmonised Standard may replace a reference to a previous version of the same standard as quoted in the TSI? The existing legal provisions for this topic are considered to be known by the EC and ERA and are therefore not replicated here. Solution 1) Yes, the list of harmonised standards relating to 2008/57/EC is published in the Official Journal of the European Union and is an official legally binding document. Therefore it changes and updates the referenced standards given in the TSIs. Solution 2) No, the referenced standards given in the TSIs cannot be changed by Official Journal of the European Union (OJEU) (e.g. 2013/C 345/03 or a later version of this list) and therefore the direct reference to standards remains unchanged until next Omnibus procedure or new revision of TSI is published. Solution 3) The referenced standard as well as the replaced standard are both considered to be applicable upon the choice of the applicant. SUGGESTED RESOLUTION / INTERPRETATION NB-Rail understands that Solution 2) is the most common interpretation. However, NBRail supports Solution 1) as an innovative way forward. ORGANISATION(S) REQUESTED TO RESPOND (E.G. TSI GROUP, RISC, ERA ETC.) ERA / EUROPEAN COMMISSION PM42, 15/10/14 DATE OF AGREEMENT AT NB RAIL PLENARY MEETING RESPONSE FROM ORGANISATION ABOVE ERA issue the TO ERA/OPI/2014-10 on 17/04/15 QUESTION & CLARIFICATION

I European Railway Agency Executive Director OPINION ERA/OPI/2014-1 0 OF THE EUROPEAN RAILWAY AGENCY FOR EUROPEAN COMMISSION REGARDING QUESTION AND CLARIFICATION NB RAIL - QC-STR-007 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 BP 20392-59307 Valenciennes cedex Tél +33 (3) 27 09 65 00 Fax +33 (3) 27 33 40 65 - www.era,europaeu E-mail: osef.doppelbauer(aera.europa.eu

OPsNoN ERA/OP 1/2014-10 General Context 1. In its letter referenced as MOVE B2/AA/fz Ares(2014)4206707 and dated 15 tb December 2014 addressed to the European Railway Agency ( ERA ), the European Commission ( EC ) requested ERA to evaluat[e], technical opinion, draft answer to QC-5 TR-007 from NB-Rail. In the same request, the EC asks ERA to ensure dialog with NB-Rail to understand their concerns and therefore provide an appropriate answer. 2. The QC-STR-007 raises the issue of the updates of mandatory European standards quoted in the TSIs and their relations with the list of harmonised standards published by the EC in the Official Journal of the European Union. The question raised by NB-Rail is the following: The industry has approached NB Rail with a concern that the inability to update Mandatory Standards as quoted in the TSls will lead to significant economic burden at design, production and authorisation of railway products. Can an applicant and a NoBo assume that the publication of an updated reference of a Harmonised Standard may replace a reference to a previous version of the same standard as quoted in the TSl? 3. The text of the NB-Rail U-C contains also three suggested solutions; Solution 1) Yes, the list of harmonised standards relating to 2008/57/EC is published in the Official Journal of the European Union and is an official legally binding document. Therefore it changes and updates the referenced standards given in the TSls. Solution 2) No, the referenced standards given in the TSls cannot be changed by Official Journal of the European Union (OJEU) (e.g. 2013/C 345/03 or a later version of this list) and therefore the direct reference to stondords remains unchanged until next Omnibus procedure or new revision of TSI is published. Solution 3) The referenced standard as well as the replaced standard are both considered to be applicable upon the choke of the applicant. 4. Furthermore the document QC-STR-007 from NB-Rail contains a note referring to the list of harmonised standards published in the OJEU: Harm onised standards give presumption of conformity with the essential requirements according to the directives for which they are published. The current list of harm onised standards relating to 2008/57/EC is published in the Official Journal of the European Union (OJEU) (e.g. 2013/C 345/03 or a Page 2 ci 5

OPINION ERA/OPI/2014-10 later version of this list). Some standards in this list are marked as no longer giving presumption of conformity (see note 2.1 in the document), but remain quoted in the TSls which is seen as a contradiction by industry. In a dialogue between ERA and NB-Rail-chairman on 12 March 2015, NB- Rail expressed its wish that ERA includes this note in its technical opinion. 2 Legal Background 1. Article 2(14(c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, provides definitions for the terms standard, European standard and harmonised standard : 1.1. Standards are defined as technical specifications, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory. 1.2. European standards are standards adopted by the European standardisation organisations (ESO5) listed in Annex I of Regulation (EU) No 1025/2012 (i.e. CEN, CENELEC, ETSI). 1.3. Harmonised standards are European standards adopted by the European Commission for the application of the Union harmonisation legislation. 2. Regulation (EU) No 1025/2012 on European standardisation also provides that Where a harmonised standard satisfies the requirements which it aims to cover and which are set out in the corresponding Union harmonisation legislation, the Commission shall publish a reference of such harmonised standard without deloy in the Official Journal of the European Union (article 10(6)). Therefore, the process of identifying a European standard as harmonized (as defined by art 2(1)(c ) of Regulation (EU) 1025/2012) shall start only after the publication of the corresponding Union harmonisation legislation 2 (ref. art 10(5) and 10(6) of the Regulation (EU) 1025/2012). 3. Article 5(8) of 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 3 (the Interoperability Directive ) provides that TSIs may make an explicit, clearly identified reference to Euro peon or international standards or specifications or technical documents published by the Agency where this is strictly 1 amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJEU, L 316, 14.11.2012, p. 12). 2 Clause 4.1.2.2. Role of harmonised standards of the Blue Guide 2014 provides description of this process. Blue Guide 2014 available at EC website at this link: http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item id=7326 OJ L 191, 18.7.2003, p. 1. Page 3 of 5

OPINION ERA/OPI/2014-10 necessary in order to achieve the objective of this Directive. In such case, these standards or specifications (or the relevant parts) or technical documents shall be regarded as annexes to the TSI concerned and shall become mandatory from the moment the TSl is applicable 4. The Interoperability Directive defines a harmonised standard as any European standard adopted by one of the European standardisation bodies [...]which, by itself or together with other standards, provides a solution as regards compliance with a legal provision (article 2(u)). S. Commission Recommendation 2014/897/Eu of 5 December 2014 on matters related to the placing in service and use of structural subsystems and vehicles under Directives 2008/57/EC and 2004/49/EC of the European Parliament and of the Council European standards and harmonized standards in TSls. 4 contains useful clarifications concerning the use of 3 Analysis 1. Technical specifications for interoperability ( TSls ), including the standards or parts of standards they refer to, are adopted by the Commission through Commission Decisions or Commission Regulations which are binding on the Member States of the EU (Directive 2008/57/EC, art 5(8)) and need therefore to be legitimated by the applicable legislative process. Any change of the references to standards in the TSls must therefore be considered as a change of EU law and the update of the respective reference in the TSI requires again this legitimation. 2. However, to facilitate the update of references in TSIs the so called omnibus procedure has been developed and introduced. Thi5 procedure provides the possibility to amend several TSls simultaneously in order to correct deficiencies in the TSls previously addressed by ERA Technical Opinions, as well as to correct several other minor identified deficiencies for which alone an amendment of the TSIs would not be proportionate. Therefore it is also used for correcting and updating references to standards in the TSls. 3. The contradiction perceived by the industry and reflected in a note in the document QC-STR-007 refers to cases of harmonised standards for which a new version of the standard has been included in the list of harmonised standards and the old version is listed in the column titled Reference of superseded standard. The column Date of cessation of presumption of conformity of superseded standard gives information about the date on which the superseded harmonised standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation. OJEU L 355, 12.12.2014, p. 59. Page 4 of 5

OPINION ERA/OPI/2014-1O 4. The list of EU harmonised standards published in the Official Journal of the European Union (OJEU) 2013 C345 03 Information and Notice shall be considered as one of the complementary specification which could facilitate the industry in using the European standards in applying the TSls. Manufacturers, other economic operators, or conformity assessment bodies are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements. These specifications should remain as complementary to the TSls (ref. Commission recommendation 2014/897/EU, point 30). 5. Additionally, there might be cases of superseded harmonised standards marked as no longer giving presumption of conformity, which nevertheless remain quoted in the TSls. This is possible, due to the fact that the same standard can be (in full or in part) at the same time harmonised (Le. voluntary and giving presumption of conformity) and mandatory (he. referred to as such in the TS1J. As a consequence, the standard will appear in the list of the harm onised standards published on the OJEU as well as in the list of mandatory standards referred to in the TSls (TSI Application Guide. General Part, ERA/GUI/07-2011/INT, section 3.1.5.). This indicates two different applications of the same standard in the technical regulation in EU (Commission Recommendation 2014/897/EU, point 31). 6. The publication of updated lists of harmonised standards is subject to the procedure according to Regulation (EU) N 1025/2012 (ref. art 10(6)) and the updating of the references to standards in the TSI falls under Art. 6 and Art. 7 of the Directive 2008/57/EC without a direct link between the two procedures. However, should the reference to a superseded harmonised standard in the T5l result in an important or critical error in the T5l, the procedure for important or critical errors in TSls described in Art 7.3 of Directive 2008/57/EC applies. 4 Opinion The Agency is of the opinion that: 1. The standards referred to in ISIs are not changed by an updated version of standards listed in the Official Journal of the European Union (OJEU), The direct reference to standards remains unchanged and the quoted standard in the TSI remains valid for the purposes of the TSl. 2. NB-Rail proposed solution 2) meets the main concept of the ERA opinion. Valenciennes, 40. L1 2041 Page 5 ci 5