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1 Page 1 of 5 TITLE Scope of Assessment Requirements for Conformity Assessment by NoBos ORIGINATOR Luxcontrol Nederland B.V 2008/57/EC 2010/713/EU 765/ /2008 SUBJECT RELATED TO DESCRIPTION AND BACKGROUND EXPLANATION Introduction The legal provisions relating to NoBo assessment are considered to be complex and complicated. Therefore different interpretations have been developed over time. To avoid any contradictions in approach and clarify the situation, this RFU summarises the relevant issues and arguments. In the framework of the EC verification process according to Directive 2008/57/EC various Conformity Assessment Requirements for the product (Subsystem or IC) are established. Each can be assigned to one of the following scopes of s: Scope 1) Essential Requirement (as defined in the Annex of 2008/57/EC) Scope 2) TSI text on basic Parameters formulated as directly assessable Scope 3) TSI text on basic Parameters not formulated as directly assessable Scope 4) Requirements contained within a) (parts of) Harmonised Standards or b) (parts of) Voluntary Standards or c) (parts of) Alternative Solutions as defined by the Applicant and related to the TSI text on parameters under scope 3) Note that 2008/57/EC defines that the European Rail System consists of Subsystems. Subsystems in turn are defined to consist of basic Parameters (2008/57/EC Art 2(k)). TSI s should therefore be formulated against basic Parameters. If the TSI refers to the mandatory use of a Standard or part of a Standard, these s contained in that Standard must be considered themselves to be falling under Scope2) or Scope3).

2 Page 2 of 5 For clarity, examples for the scopes of s are given here: Scope1) The Subsystem Locomotive of Type xyz including all its parts, interfaces as well as it s operational and maintenance and decommissioning provisions shall be meeting the Essential Requirement Safety. Scope 2) The standard distance between buffer centrelines shall be nominally 1750 mm ± 10 mm symmetrically about the centreline of the vehicle. Scope3) Buffers shall be sized so that in horizontal curves and reverse curves, it is not possible for vehicles to lock buffers. Scope4) UIC (especially Annex B&C) provides detailed assessment criteria for the contained in example for Scope3) above. This part of the UIC may therefore be considered as a Scope 4c). Definition of Assessment Scope for NoBos Are NoBos obliged to assess a Subsystem/IC against: Scope 1) all essential s of 2008/57/EC? Answer 1> NO The assessment of NoBos is limited to the assessment of the Essential Requirements indirectly through those s contained in the applicable TSIs only. In discussion with ERA, it was advised by ERA, that the systematic assessment of a product against all Essential Requirements of 2008/57/EC must be performed as selfassessment by the Applicant, fully independent of any NoBo activities. This differs from the standard task for Notified Bodies to assess directly against the Essential Requirements as defined by the New Approach within 768/2008 (see R18 and the standard Modules) and is caused by certain distinctly different provisions: /57/EC was made only in the spirit of the new approach, and includes specific definitions and solutions /57/EC is interfacing with 2004/49/EC in relation to safe operation, maintenance and decommissioning. This results in large areas of safety aspects not being subject to NoBo assessment, as these safety aspects are subject to the related provisions under 2004/49/EC /57/EC defines mandatory TSIs as additional source of assessment s to the Harmonised Standards (which are referenced by 765/2008, 2008/57/EC and 2010/713/EU) /713/EU (or where relevant, the Module annexes to TSIs) define specific assessment Modules for Conformity Assessment, different from the standard modules of 768/2008.

3 Page 3 of 5 Scope 2) TSI text on Parameters formulated as directly assessable? Answer2 > YES Scope 3) TSI text on Parameters not formulated as directly assessable? Answer3 > YES, BUT Conformity Assessment of this must be done in combination with further and more specific s defined under scope 4) below. Scope 4) Requirements contained within Harmonised Standards or Voluntary Standards or Alternative Solutions - as defined by the Applicant and related to the TSI text on parameters under scope 3)? Answer4 > YES It is considered, that the application of Harmonised Standards or Voluntary Standards gives direct presumption of conformity with the TSI s. Lists of these standards are published as follows: a. the current list of Harmonised Standards relating to 2008/57/EC published in the Official Journal of the EU (e.g. 2013/C 345/03 or a later version of this list). b. within the ERA Lists of Voluntary Standards in the Tables of Applicable Standards for the initial generation of TSIs (on ERA webpage). c. within the ERA Lists of Voluntary Standards in the User Guides for the recent generation of the TSIs (on ERA webpage). In case of contradiction between the lists, it is considered, that the Publication of Harmonised Standards in the Official Journal takes precedence over any other publications. 2010/713/EU requires either the application of Harmonised Standards or Alternative Solutions consistent with the TSI Requirements. As Voluntary Standards (published by ERA) are not specifically mentioned in 2010/713/EU, it is considered, that they fall within the scope of Alternative Solutions, but because they are identified and published by ERA, the Applicant and the NoBo may assume that their application allows also presumption of conformity with the Requirements of the TSIs. If the Applicant defines an Alternative Solution, which is not included in the aforementioned lists of standards, the Applicant MUST justify to the satisfaction of the NoBo, that this Alternative Solution is conform with any related TSI Requirements. The NoBo must than assess the product against the TSI Requirement in combination with the Alternative Solution as defined by the Applicant. (See 2010/713/EC on Moduls

4 Page 4 of 5 or the Module Annexes of the initial TSIs) For clarity: The Applicant is not required to demonstrate to the satisfaction of the NoBo that the proposed Alternative Solution complies also with the Essential Requirements of 2008/57/EC, as ERA advised this to be outside of the scope of NoBo Assessment. The NoBo has therefore no obligation to assess this. Additional Information 1. Often a single TSI section/ functional description (of a Parameter) as worded in a TSI may contain a large number of individual s. These may relate individually to scope 2) or scope 3). 2. It is recommended, that when the NoBo uses checklists, it identifies the individual s as separate CL points and in case of scope3) s assigns the related detailed assessment s clearly (e.g. (part of) Harmonised Standard, (part of) Voluntary Standard, Alternative Solution). 3. For any individual s under scope 3), a related (part of) Harmonised Standard or (part of) Voluntary Standard or Alternative Solution - must be defined by the Applicant. (The NoBo may support this process by identifying/ explaining/ discussing relevant appropriate options with the applicant.) 4. The term Voluntary is indicating, that the application of this standard gives direct presumption of conformity, but it s application is voluntary in the sense, that an Alternative Solution is equally acceptable, if equivalency with the (part of) Voluntary Standard it replaces can be justified. Equivalency MUST be justified in relation to fulfilment of all applicable TSI Requirements (see 2010/713/EC and the EC Blue Guide 2014). 5. The choice of any Alternative Solutions under 4) must be justified by the Applicant to the Satisfaction of the NoBo who must confirm that the Alternative Solution complies with the TSI Requirements and that the Alternative Solution is equivalent to a (part of) Harmonised Standard or (part of) Voluntary Standard relevant for this basic Parameter. 6. All (parts of) Standards or Alternative Solutions used for assessment under scope 4) must be listed in the Technical File under section 5.1, as this is required by EU legislative documents (2008/57/EC in combination with 2010/713/EU). 7. If only parts of a Standard are relevant and applied during the assessment, these parts must likewise be indicated in the Technical File under section 5.1. (2008/57/EC in combination with 2010/713/EU). 8. Should the lists of Standards not define any (part of) Standard which may be applied in connection with a given scope 3) TSI Requirement, the Applicant can directly proceed to define an Alternative Solution detailing the assessment s. In this case, Applicant justifies the applicability of the Alternative Solution against the scope 3) TSI Requirement to the satisfaction of the NoBo.

5 Page 5 of 5 9. An Alternative Solution may also be a code of practice not contained in the lists, e.g. UIC or ERRI leaflets or pren or NTRs. A project specific Alternative Solution may also be developed and validated by the Applicant, provided this can be justified to be equivalent with a standard from the published lists. 10. It should be understood by all stakeholders, that the application of Alternative Solutions requires typically more effort - e.g. by demonstration the equivalency and its subsequent assessment by the NoBo - than a direct application of a (part of) standard from the published lists. (Applying a (part of) Standard from the lists may be considered as the preferred solution from an EU common market point of view.) RFU PROPOSAL NoBos are not obliged to assess a Subsystem/IC against: - Scope 1) all Essential Requirements of 2008/57/EC. NoBos are obliged to assess a Subsystem/IC against: - Scope 2) TSI text on Parameters formulated as directly assessable - Scope 3) TSI text on Parameters not formulated as directly assessable. In this case assessment must be done in combination with further and more specific s defined under scope 4) below. - Scope 4) Requirements contained within (parts of) Harmonised Standards or (parts of) Voluntary Standards or Alternative Solutions - as defined by the Applicant and related to the TSI text on parameters under scope 3) Note: The main text of this RFU summarises conditions on the definition and assessment of Alternative Solutions and identifies lists of Harmonised or Voluntary Standards. 07/05/2014 DATE OF AGREEMENT AT NB RAIL PLENARY MEETING