QUESTION / CLARIFICATION

Transcription

1 Page 1 of 5 TITLE CERTIFICATION OF SUBSYSTEMS INCORPORATING INTEROPERABILITY CONSTITUENTS, WHICH HOLD NO EC DECLARATION OF CONFORMITY OR EC DECLARATION SUITABILITY FOR USE ORIGINATOR LLOYD S REGISTER VERIFICATION; NOTIFIED BODY ID:0038 SUBJECT RELATED TO 96/48/EC Article 13(4) and Annex VI DESCRIPTION QUESTION TO A21C, REGARDING THE ACTION OF A NOTIFIED BODY UNDERTAKING EC VERIFICATION ACTIVITIES RELATING TO CERTIFICATION OF A STRUCTURAL SUBSYSTEM THAT INCORPORATES INTEROPERABILITY CONSTITUENTS, WHICH HOLD NO EC DECLARATION OF CONFORMITY OR EC DECLARATION OF SUITABILITY FOR USE BACKGROUND EXPLANATION Structural Subsystems are undergoing EC Verification that incorporate Interoperability Constituents, which do not hold EC Declarations of Conformity or Suitability for Use. There are many reasons why Interoperability Constituents continue to be available on the market without the appropriate declarations. These reasons are not addressed in this question. 96/48/EC, Article 13(4), implies that where neither the manufacturer nor his authorized representative has fulfilled his obligations regarding conformity of an Interoperability Constituent this duty falls to the assembler of the subsystem. This is often the Contracting Entity. Annex VI requires that subsystem verifications must include declarations for all ICs contained therein. What is the correct action that Notified Bodies should take when considering certification of such subsystems? SUGGESTED RESOLUTION / INTERPRETATION There are four identified courses of action that Notified Bodies may take: 1) The Notified Body should refuse to issue a certificate for the subsystem until all ICs hold the appropriate declarations. (This solution may force the Notified Body to withhold a certificate on administrative grounds only. It is possible to verify that the subsystem assembly meets the essential requirements without the appropriate declarations for individual interoperability constituents) 2) The Notified Body should treat the assembler of the subsystem as the responsible body and accept EC Declarations from the assembler. Where necessary, these might be supported by Notified Body Certification. (This solution is implied by the directive but is highly undesirable where the assembler does not have control of changes to the design or the production process for a product. While the assessment may be robust for any one given item, subsequently manufactured products may differ from that originally assessed and may no longer conform.)

2 Page 2 of 5 3) The subsystem Notified Body should not assess these interoperability constituents as discrete products but make additional assessments, of the subsystem assembly, as necessary, to ensure that the subsystem meets the essential requirements. (this solution is consistent with that described in chapter 2 of the Guide to the Implementation of New Approach and Global Approach Directives but may be in conflict with Annex VI of 96/48/EC) 4) The Notified Body should make assessments as in Option 3 but also be obliged to list clearly in the technical file any Interoperability Constituents for which no Declaration of Conformity has been made available to the Notified Body and the Contracting Entity s reasons for this. This information may be referred to directly on the Subsystem Certificate. The Member State could then take this information into account when authorising the subsystem into service and, if necessary, to support any further action taken to address potential breaches of the Directive relating to placing those constituents on the market. Each of the above solutions may have an impact on the timing of certification where Interoperability Constituents are undergoing service trials as part of a suitability for use assessment. Supporting background relating to each of the proposed options is given in annex 1. A21C ORGANISATION(S) REQUESTED TO RESPOND (E.G. TSI GROUP, A21C, AEIF ETC.) COMMENTS From: European Commission Commission Documents DV77 addresses this Q&C. Please note that DV77 refers to IQ07, which is not yet finalised. Answered. FINAL DECISION DATE OF AGREEMENT AT NB RAIL PLENARY MEETING 16 th February 2006

3 Annex 1 Background information Page 3 of 5 The Directive as applied to Interoperability Constituents relates to placing those constituents on the Market for use on the high-speed Routes. These provisions do not exclude the placing on the market of these constituents for other purposes, nor their use for conventional railway lines. (Article 8). It is a duty of Member States to take all necessary steps to ensure that interoperability constituents are placed on the market only if they enable interoperability to be achieved within the trans-european high-speed rail system while at the same time meeting the essential requirements. Member States shall consider as complying with the essential requirements of this Directive applying to them those interoperability constituents which bear the EC declaration of conformity or suitability for use. Depending on the design of a subsystem, however, it is possible for the assembled subsystem to enable interoperability to be achieved and meet the essential requirements while using Interoperability constituents that do not comply fully with the specific requirements for individual products. This is taken into account by the Guide to the implementation of directives based on the New Approach and the Global Approach. This states. a combination of different products and parts designed or put together by the same person is considered as one finished product which, as such, has to comply with the directive. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the directives concerned, and for fulfilling all the requirements of the directive in relation to the assembly... A subsystem is an assembly of components, which may include Interoperability Constituents. There are many valid reasons why defined Interoperability constituents may not hold a Declaration of Conformity. For example: A new, novel, product may have intrinsic characteristics that are different from those provided for in the TSI; The specifications of existing products that are necessary for interoperability of upgraded routes are not those described in the TSI for the constituent under evaluation; The TSI requirements are unclear, unworkable or known to be in error, e.g. Energy TSI Clause Elasticity and uniformity of elasticity; The cost of certification may outweigh the cost of a small production run, e.g. specialist bearers. The latter of these examples is particularly relevant where an Interoperability Constituent, designed primarily for use on the conventional railway or for other

4 Page 4 of 5 purposes, is chosen by the Contracting Entity to deliver the most effective solution for a high speed route. The Manufacturer may have no incentive to Declare Conformity or Suitability for Use for the small proportion of a large number of products that the Contracting Entity may wish to use on a highspeed route. He may then continue to market the product for purposes other than for use on high speed routes. Four options are proposed: of these, Option 2 is most undesirable. In option 2 the Notified Body treats the assembler of the subsystem as the authorised representative of the manufacturer of the Interoperability Constituent, for purposes of conformity assessment. The Notified Body would accept EC Declarations from the assembler. The Directive implies this solution. It is most undesirable where the assembler has little or no control of changes to the design or the production process for a product. Indeed, he may wish only to use that product for his own purpose rather than the full range of requirements relevant to placing the interoperability Constituent on the open market, for example he may have no further interest in subsequently manufactured products of that type. While the assessment may be robust for any one given unit, subsequently manufactured products may differ from that originally assessed and may no longer conform. The assurance of compliance of the product may depend heavily on the quality control measures used by the assembler of the subsystem. A Declaration of Conformity of this type may have little relevance outside the control of the specific project that incorporated the product. Option 1 is a workable solution but is not ideal. The issues for the subsystem Notified Body would be simple. No Declaration for any Interoperability Constituent would result in the Notified Body not issuing certification for the subsystem. This would be the case even if the subsystem, as an assembly, proved to be fully interoperable and meet the essential requirements of the Directive. This appears contrary to the principles of the New Approach and Article 15 (Member States may not, in their territory and on grounds of this Directive, prohibit, restrict or hinder the construction, placing in service and operation of structural subsystems constituting the trans-european highspeed rail system which satisfy the essential requirements). This option puts the Notified Body s in a policing role that is the duty of the Member State, since it will always be the Notified Body that is first to spot that Interoperability Constituent declarations are missing. Option 3 is a workable solution but is not ideal. This would allow the subsystem to be authorised into service where it has been verified to be interoperable and meet the essential requirements of the. This solution, however, would not directly address the issues relating to placing Interoperability Constituents on the market and would allow the status quo to continue. It would, however give an incentive to Contracting Entities to put pressure on Manufacturers to get the Interoperability Constituent certification

5 Page 5 of 5 done, since the alternative will be repeat assessments, with their associated cost, for the use of the same Interoperability Constituent in subsequent sub systems. Option 4 builds on Option 3 but provides the Member State with additional information. This option places a new duty on the Notified Bodies which is not defined in the Directive or TSI modules with respect to the content of the technical file. The Member State may use this additional information to initiate investigations that it deems necessary relating to the placing on the Market of Interoperability Constituents that do not hold a Declaration of Conformity, etc. If the reason for using an Interoperability Constituent without a Declaration of Conformity is unacceptable, the Member State can exercise its role as enforcer by refusing authorisation, yet allowing for justifiable cases to be allowed