90/683/EEC: Council Decision of 13 December 1990 concerning the modules for the various phases of the conformity assesment procedures which are intended to be used in the technical harmonization directives

Published date31 December 1990
Subject MatterInternal market - Principles,Industry,Technical barriers,Information and verification
Official Gazette PublicationOfficial Journal of the European Communities, L 380, 31 December 1990
EUR-Lex - 31990D0683 - EN

90/683/EEC: Council Decision of 13 December 1990 concerning the modules for the various phases of the conformity assesment procedures which are intended to be used in the technical harmonization directives

Official Journal L 380 , 31/12/1990 P. 0013 - 0026

COUNCIL DECISION of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives (90/683/EEC)


Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas the Council adopted a resolution on 21 December 1989 concerning a global approach to conformity assessment (4);

Whereas the introduction of harmonized methods for the assessment of conformity and the adoption of a common doctrine for their implementation are likely to facilitate the adoption of future technical harmonization directives concerning the placing on the market of industrial products and thus be conducive to the completion of the internal market by 31 December 1992;

Whereas such methods should ensure that products are in full conformity with the essential requirements laid down in the technical harmonization directives, in order to provide, in particular, for the health and safety of users and consumers;

Whereas such conformity should be assured without imposing unneccessarily onerous conditions on manufacturers, and by means of clear and comprehensible procedures;

Whereas limited flexibility should be introduced as regards use of additional modules, or variations in the modules, when the specific circumstances of a particular sector or directive so warrant, but not to such a degree as to undercut the purpose of the current Decision and only when explicitly justified,


Sole Article

The procedures for conformity assessment which are to be used in the technical harmonization directives relating to the marketing of industrial products will be chosen from among the modules listed in the Annex and in accordance with the criteria set out in this Decision and in the general guidelines in the Annex. These procedures may only depart from the modules when the specific circumstances of a particular sector or directive so warrant. Such departures from the modules must be limited in extent and must be explicitly justified in the relevant directive. The Commission will report periodically on the functioning of this Decision, and on whether conformity assessment procedures are working satisfactorily or need to be modified.

Done at Brussels, 13 December 1990.

For the Council

The President

P. ROMITA (1) OJ No C 231, 8.9.1989, p. 3. (2) OJ No C 149, 18.6.1990, p. 162 and Decision of 21 November 1990 (not yet published in the Official Journal). (3) OJ No C 112, 7.5.1990, p. 4. (4) OJ No C 10, 16.1.1990, p. 1.



The principal guidelines for the use of conformity assessment procedures in technical harmonization directives are the following: (a) the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers;

(b) conformity assessment can be subdivided into modules which relate to the design phase of products and to their production phase;

(c) as a general rule a product should be subject to both phases before being able to be placed on the market if the results are positive (*);

(d) there are a variety of modules which cover the two phases in a variety of ways. The directives shall set the range of possible choices which can be considered by the Council to give the public authorities the high level of safety they seek, for a given product or product sector;

(e) in setting the range of possible choices open to the manufacturer, the directives, will take into consideration, in particular, such issues as the appropriateness of the modules to the type of products, the nature of the risks involved, the economic infrastructures of the given sector (e.g. existence or non-existence of third parties), the types and importance of production, etc. The factors that have been taken into account must be explicitly spelled out by the Commission in these directives;

(f) the directives will, in setting the range of possible modules for a given product or product sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring compliance with the requirements.

The Directives will set out the criteria governing the conditions in which the manufacturer shall choose the most appropriate modules for his production from the modules laid down by the directives;

(g) the directives should avoid imposing unnecessarily modules which would be too onerous relative to the objectives of the directive concerned;

(h) notified bodies should be encouraged to apply the modules without unnecessary burden for the economic operators. The Commission, in cooperation with the Member States, shall ensure that close cooperation is organized between the notified bodies in order to ensure consistent technical application of the modules;

(i) in order to protect the manufacturers, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessment of conformity. Legal protection of confidential information shall be required;

(j) whenever directives provide the manufacturer with the possibility of using modules based on quality assurance techniques, the manufacturer must also be able to have recourse to a combination of modules not using quality assurance, and vice versa, except where compliance with the requirements laid down by the directives requires the exclusive application of a certain procedure;

(k) for the purposes of operating the modules, Member States shall notify on their own responsibility bodies under their jurisdiction which they have chosen from the technically competent bodies complying with the requirements of the directives. This responsibility involves the obligation for the Member States to ensure that the notified bodies permanently have the technical qualifications required by the directives and that the latter keep their competent national authorities informed of the performance of their tasks. Where a Member State withdraws its notification of a body, it shall take appropriate steps to ensure that the dossiers are processed by another notified body to ensure continuity;

(l) in addition, with regard to conformity assessment, the sub-contracting of work shall be subject to certain conditions guaranteeing; - the competence of the establishment operating as sub-contractor, on the basis of conformity with series EN 45 000 standards, and the capability of the Member State that has notified the sub-contracting body to ensure effective monitoring of such compliance, (*) The specific directives may provide for different arrangements.

- the ability of the body notified to exercise effective responsibility for the work carried out under sub-contract;

(m) notified bodies which can prove their conformity with harmonized standards (EN 45 000 series), by submitting an accreditation certificate or other documentary evidence, shall be presumed to conform to the requirements of the directives. Member States having notified bodies unable to prove their conformity with the harmonized standards (EN 45 000 series) may be requested to provide the Commission with the appropriate supporting documents on the basis of which notification was carried out;

(n) a list of notified bodies shall be published by the Commission in the Official Journal of the European Communities and constantly updated.


Explanatory notes

Specific directives may allow the CE mark to be affixed to the packaging or the accompanying documentation, instead of to the product itself.

The declaration of conformity or the certificate of conformity (whichever of the two applies in the directive concerned) shall cover either individual or several products and shall either accompany the product(s) covered or be kept by the manufacturer. The appropriate solution for the directive concerned will be specified.

References to articles refer to the standard paragraphs of Annex II.B to the Council resolution of 7 May 1985 (OJ No C 136, 4.6.1985, p. 1), which have become standard articles in the "new approach" directives.

The development of computerized communication of certificates and other documents issued by notified bodies is envisaged within INSIS.

Specific directives may use modules A, C and H with additional provisions containing supplementary requirements which figure in the boxes in the modules.

Module C is designed to be used in combination with module B (EC type examination). Modules D, E and F will also normally be used in combination with module B ; however, in...

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