Eurolab Position Paper

EUROLAB POSITION PAPER

ON THE SELECTION AND SURVEILLANCE OF NOTIFIED BODIES AND ON THE CO-ORDINATION AND COOPERATION BETWEEN THEM, AS WELL AS WITH THE

EU COMMISSION AND THE MEMBER STATES;

(Document CERTIF. 94/6 rev.2)

SUMMARY

This note presents EUROLAB's position on the proposal contained in DOC/CERTIF. 94/6 rev.2 presented by the EU Commission (DGIII) on the selection and surveillance of notified bodies and on the co-ordination and cooperation between them, as well as with the EU Commission and the member states. It gives first an overview of the relations ship between testing and legislation. The analysis is made in particular in connection with the "new approach for harmonizing European legislation and the use of accreditation as a requisite for the notification of conformity assessment operators for the implementation of EU directives. EUROLAB's position on the above mentioned document is presented, expressing the following wishes:

the charter that will be developed for notified bodies should describe the requirements that they should fulfill in such a way that those which may be assessed by accreditation bodies be clearly identified and that these requirements induce equivalent economic consequences on the notified bodies,

the groups of notified bodies to be formed for each directive may have an input on the interpretation and implementation of EN 45001 in the corresponding fields of testing,

intercomparison and proficiency testing be organized on a European scale as a means to monitor the homogeneous implementation of Directives,

the revision of the EN 45000 series of standards be achieved as soon as possible, on the basis of the functions' approach, of full coherence of QA aspects with the requirements of the ISO-EN 9000 and also between functions, so as to optimize assessments for bodies operating several functions (testing and certification in particular,

a clearer correspondence between the modules and the EN 45000 standards be achieved,

 financing should also be allocated for performing the technical secretariat of the co-ordination of notified bodies,

the overall organization should not lead to an unnecessary multiplication of separate European legal entities.

Note: the latest version to date of DOC/CERTIF. 94/6 is revision 4b, but it has not been circulated officially and it appears that it does not change fundamentally the proposed set up, and therefore EUROLAB's comments on the matter.

EUROLAB has a number of notified bodies in the membership of its national associations and committees. It has therefore welcomed and supported the efforts of the EU Commission to ensure homogeneity of the conditions under which bodies are notified by the member states for the implementation of EU Directives and to organize the cooperation between the notified bodies, and also with itself and the competent regulatory authorities of the member states.

The following note recalls first some aspects of the relationship between testing and legislation in general, underlines the specific issues relating to European legislation being harmonized under the new approach, shows the border line between accreditation and legislation and comments on the document CERTIF. 94/6 rev.2.

This document presents proposals from the EU Commission DG III to the member states on a framework for co-ordination and cooperation between notified bodies, member states and the EU Commission under the community harmonization directives based on the new approach and the global approach. It is welcomed by EUROLAB as a substantial step forward and as a good basis for discussing the measures to be taken and the organization to be set up, with the corresponding logistics and financing.

1. Testing and Legislation

Testing is often performed as part of the process for determining the compliance of products to requirements set by legislation before they are put on the market. It may be carried out by the manufacturer himself, or by his authorized representative, or by an external laboratory designated by the administration responsible for implementing the legislation, or even sometimes by the administration itself. Testing may be applied to a specimen or sample representative of the production for which demonstration of conformity is sought ("type examination"), or on all individual products before they are marketed ("unit verification") or it may be performed on samples or specimen on a periodic basis and coupled with the assessment of the quality control of the production ("product certification").

Key issues to determine the adequacy of the tests involved for an effective implementation of the legislation prescribing them are:

the identification of the tests to be applied, usually, but not always, described in regulatory documents and/or in national, European or international standards,

the determination and selection of the specimen or sample to be tested,

the technical competence and independence of the staff performing the tests,

the adequacy of the equipment and laboratory facilities and procedures,

the ability of the laboratory to interpret the test results (and tolerances) and conclude on the compliance of the tested item(s) to the requirements of the legislation and the repeatability of such ability for the laboratory and also between laboratories when several are designated, which implies the establishment and maintenance of a jurisprudence o f interpretation,

the principle, extent and conditions of acceptance of test data generated or produced by the manufacturer or performed by the third party laboratory at the manufacturer's premises and using his testing facilities.

These issues determine the content, and therefore the cost, of testing services associated to legislation. Homogeneity and transparency of interpretation is thus crucial when several laboratories are designated to operate for the implementation of a given legislation, in order that fairness of competition between them and between their customers is ensured, as well as to ascertain that market control will not be faced with (too much) controversy about the results of tests.

These are precisely the issues that the European Union has been and is confronted with in the context of the development of the unified internal market, for which the new, global and modular approaches have been designed to enable"one stop testing- one stop certification"for products being marketed in our region. The necessity to respect our commitments with the international community in this field (GATT agreements i.a.) and to interface the corresponding measures with the international scene adds an extra and difficult dimension to the problem.

2.Testing and European legislation

The objectives of the new and modular approach to harmonize technical regulations in order to support the creation of the unified EU internal market are:

to limit EU legislation to the definition (in EU Directives) of the essential requirements for safety, health or other matters of public interest that products must comply with before being put on the market,

to encourage the harmonization of the criteria for determining compliance to these essential requirements through European or international standards,

to delegate to "notified bodies" the role of assisting manufacturers in determining the compliance of their products to the essential requirements and to accept as equivalent the services provided by these notified bodies, thereby enabling one stop conformity assessment and, de facto, delegating to the notified bodies some responsibility as to the interpretation of the legislation,

to facilitate market control by requiring the materialization, by an individual marking of the products (CE marking), of the declaration of compliance, for which the manufacturer remains responsible.

Amongst the voluminous official literature generated by the implementation of these objectives, the following documents seem the most relevant in connection with testing and with the designation of the notified bodies when testing is involved and the corresponding determination of their ability and competence to perform it:

ref.1: DOC.CERTIF 91/7 rev.3 (1992.6.11) on notified bodies,

ref.2: the Council decision 93/465/EEC of July 22, 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives,

ref.3: DOC.CERTIF. 94/6 rev.2 (1994.10.10) on the framework for co-ordination and cooperation between notified bodies, member states and the European Commission under the Community harmonization directives based on the new approach and the global approach.

In addition, the individual product directives may set specific or general requirements for the designation of notified bodies, with the interesting case of the EMC directive which has introduced an intermediate concept of "competent body" distinct from a notified body.

Ref.2 defines the various routes that may be referred to in EU Directives to enable a manufacturer to affix the CE marking, the so-called modules. Modules A (and its variation Aa), B, C, F, G AND H mention explicitly testing by the manufacturer for module A and by a notified body for all the others.

All documents indicate that it is the responsibility of the members states to select and designate the notified bodies, and, to this aim, ascertain and survey their compliance to the technical and legal criteria defined for such notification. Member states can only notify bodies established on their territory. Ref.2 however indicates that "notified bodies which can prove their conformity with harmonized standards (EN 45000 series), by submitting an accreditation certificate or other documentary evidence, are presumed to conform to the requirements of the directives. Member states having notified bodies unable to prove their conformity with the harmonized standards (EN 45000 series) may be requested to provide the Commission with the appropriate supporting documents on the basis of which notification was carried out".

It is interesting to note that Ref.2 does not make reference to "inspection" as a route for demonstrating compliance to essential requirements, nor does any other official document for the implementation of the new approach. When the word is used, it is in relation with the intervention of the national authorities, e.g. for the verification of the documentation supporting the CE marking. For that matter, it is to be noted also that the individual EN 45000 standards are not mentioned at all in Ref.2 in relation to the modules.

Some 500 bodies have been notified so far for the dozen of new approach directives currently implemented on a mandatory or provisionally voluntary (e.g. EMC, medical devices,...) basis. There is a great diversity of statutes and sizes of notified bodies and, obviously, the member states (and sometimes the national regulatory authorities competent for the various directives) have different policies in terms of selection of the bodies they notify.

Seen from the market place of the laboratories and when testing is involved, a number of difficulties are being experienced and, were they to remain unsolved, they would eventually put the CE marking under serious question as to its effectiveness to ensure both an adequate level of safety for products marketed in the EU and the fairness of competition between the notified bodies, and also, consequently, between their customers. These difficulties relate to the heterogeneity of the conditions under which bodies are notified by the national authorities, the content of the testing services associated to their intervention and the obligations put on them in terms of demonstrating their competence and being associated to European cooperation aimed at the harmonization and interpretation of the requirements stemming from EU Directives. They are all the more a source of concern to the European laboratories (and their customers) as negotiations with third countries have already been undertaken by the EU Commission that could lead to the recognition of organizations in these countries to perform similar conformity assessment functions as those entrusted to the notified bodies operating in the EU.

3.European legislation and accreditation

As a means of demonstrating technical competence and ensuring the quality of the corresponding services, third party accreditation is obviously encouraged by the EU Commission as a prerequisite to notification of operators by national authorities. It is hoped that the cooperation between national accreditation bodies, the harmonization of their assessment and surveillance practices and procedures and the mutual recognition agreements which are developed in the context of EAL and EAC will ensure that this prerequisite is fulfilled in a homogeneous manner. It should be noted that accreditation has a significant internal and external cost for laboratories and that it is essential that accreditation, if it is to be de facto required for providing testing services in the regulated sphere, be optimized, both technically and economically.

On the basis of the experience of laboratories, of EUROLAB studies (cf. the study and intercomparison for the implementation of the "toys directive"), of the exchanges taking place in the groups of notified bodies which have already been formed for some directives and the symposium on notified bodies organized by the EU Commission in October 1994, the main difficulties encountered so far in relation with the use of accreditation as a prerequisite for notification are the following:

the extent to which accreditation requirements cover the issues listed in §1 above, although it is clear that accreditation, being usually performed by private or non governmental entities, will never be able to cover all of them, as they address not only technical aspects but also requirements having legal or financial implications,

the correspondence between the scope of accreditation and the scope for which a laboratory is notified,

the fact that laboratories are usually accredited to perform tests described in standards, whereas for a number of Directives, third party laboratories are notified to determine compliance with their essential requirements when the product assessed does not comply with a harmonized standard, or when there are no harmonized standards at all,

the lack of intercomparisons and proficiency testing organized on a European basis for tests performed in the context of Directives,

the ambiguity between testing, inspection and certification,

The question of the true equivalence of accreditation procedures implemented by the accreditation bodies having entered the EAL multilateral agreement and the exact implication and impact of this agreement (and its corollaries with third countries) remains open, as this agreement is fairly recent.

Whereas EUROLAB, as a general rule can support accreditation as a prerequisite for notification, as an element of demonstration of technical competence, it is however clear that it can not be entirely substituted to the responsibility of governments for the designation of organisations involved in the implementation of legislation.

4.EUROLAB comments on CERTIF. 94/6 rev.2

This document announces that the EU Commission will propose in the near future to the national authorities a "common charter containing the fundamental rights and obligations of notified bodies" and suggests ways to organize the cooperation between notified bodies, national authorities and the EU Commission in order "to ensure a correct and uniform implementation of the technical requirements of the Directives". In particular, it introduces the concept of formally constituted "groups of notified bodies" for each directive, together with the possibility of having "intersectoral groups" in the case of simultaneous application of two or more directives to one product or for the treatment of horizontal issues. It proposes the organization and responsibilities of these groups, and solutions for providing and financing their secretariats, distinguishing between administrative and technical secretariat.

In relation with these proposals and when testing is involved, EUROLAB expresses the following wishes, that:

the proposed charter describes the requirements for notified bodies in such a way that those which may be assessed by accreditation bodies be clearly identified and that these requirements induce equivalent economic consequences on the notified bodies,

the groups of notified bodies to be formed for each directive may have an input on the interpretation and implementation of EN 45001 in the corresponding fields of testing,

intercomparison and proficiency testing be organized on a European scale as a means to monitor the homogeneous implementation of Directives,

a clearer correspondence between the modules and the EN 45000 standards be achieved.

Unless it has the clear purpose to enable concentrating the administrative secretariats in a single organization, e.g. EOTC, the separation between the administrative and the technical secretariats seems artificial and does not correspond to what has already been set up for some directive, such as for medical devices or gas appliances . If the reason is indeed that the Commission has EOTC in mind for providing all administrative secretariats, then the aims, objectives and articles of EOTC should be amended in order to allow it to undertake this task, as it was created primarily to serve the voluntary field of testing and certification. An alternative could be that EOTC could provide such a service through its European members, using the framework contract it has signed with the EU Commission.

As for financing, it seems unfair that no EU financing should be allocated to provide the technical secretariats. For that matter, CERTIF. 94/6 rev.2 does not indicate how the technical secretariat should be financed. If no EU financing is allocated, this could only be done through fees collected from the notified bodies and an obligation to take part in the co-ordination should then be imposed on them, which does not seem to be the proposal. Or else, one could imagine that a notified body proposes its services for the secretariat free of charge, and one would then ponder on its motivation... Financing, be it only in part, the technical secretariat, would provide the Commission with a means of controlling the operation of the technical secretariats and of avoiding possible distortion of competition.

As for EUROLAB, a major concern is that the proposed (complex) structure does not lead to an unnecessary inflation of sectoral organizations set up independently to which its members would have to pay fees. With its legally incorporated national associations in 15 of the 18 countries of the EU and EFTA and its central secretariat, EUROLAB now offers an infrastructure that may be used in connection with the co-ordination of notified bodies for the directives where testing is a major issue. For instance, considering its previous initiatives and actions in this field, it could provide the secretariat for the co-ordination for the toys directive. EUROLAB being a European active member of EOTC, this could be done by using the framework contract between EOTC and the Commission.