considerings of machinery directive 1998/37/CE

Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery

Official Journal L 207 , 23/07/1998 P. 0001 - 0046

DIRECTIVE 98/37/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 June 1998 on the approximation of the laws of the Member States relating to machinery

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 189b of the Treaty (2),

(1) Whereas Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (3) has been frequently and substantially amended; whereas for reasons of clarity and rationality the said Directive should be consolidated;

(2) Whereas the internal market consists of an area without internal frontiers within which the free movement of goods, persons, services and capital is guaranteed;

(3) Whereas the machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy;

(4) Whereas the social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installations and maintenance;

(5) Whereas Member States are responsible for ensuring the health and safety on their territory of persons and, where appropriate, of domestic animals and goods and, in particular, of workers, notably in relation to the risks arising out of the use of machinery;

(6) Whereas, in the Member States, the legislative systems regarding accident prevention are very different; whereas the relevant compulsory provisions, frequently supplemented by de facto mandatory technical specifications and/or voluntary standards, do not necessarily lead to different levels of health and safety, but nevertheless, owing to their disparities, constitute barriers to trade within the Community; whereas, furthermore, conformity certification and national certification systems for machinery differ considerably;

(7) Whereas existing national health and safety provisions providing protection against the risks caused by machinery must be approximated to ensure free movement on the market of machinery without lowering existing justified levels of protection in the Member States; whereas the provisions of this Directive concerning the design and construction of machinery, essential for a safer working environment, shall be accompanied by specific provisions concerning the prevention of certain risks to which workers can be exposed at work, as well as by provisions based on the organisation of safety of workers in the working environment;

(8) Whereas Community law, in its present form, provides - by way of derogation from one of the fundamental rules of the Community, namely the free movement of goods - that obstacles to movement within the Community resulting from disparities in national legislation relating to the marketing of products must be accepted in so far as the provisions concerned can be recognised as being necessary to satisfy imperative requirements;

(9) Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, approved by the European Council in June 1985, provide for a new approach to legislative harmonisation; whereas, therefore, the harmonisation of laws in this case must be limited to those requirements necessary to satisfy the imperative and essential health and safety requirements relating to machinery; whereas these requirements must replace the relevant national provisions because they are essential;

(10) Whereas the maintenance or improvement of the level of safety attained by the Member States constitutes one of the essential aims of this Directive and of the principle of safety as defined by the essential requirements;

(11) Whereas the field of application of this Directive must be based on a general definition of the term 'machinery so as to allow the technical development of products; whereas the development of complex installations and the risks they involve are of an equivalent nature and their express inclusion in the Directive is therefore justified;

(12) Whereas it is also necessary to deal with safety components which are placed on the market separately and the safety function of which is declared by the manufacturer or his authorised representative established in the Community;

(13) Whereas, for trade fairs, exhibitions, etc., it must be possible to exhibit machinery which does not conform to this Directive; whereas, however, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition;

(14) Whereas the essential health and safety requirements must be observed in order to ensure that machinery is safe; whereas these requirements must be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements;

(15) Whereas the putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself as intended by the manufacturer; whereas this does not preclude the laying-down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive;

(16) Whereas it is necessary not only to ensure the free movement and putting into service of machinery bearing the 'CE marking and having an EC conformity certificate but also to ensure free movement of machinery not bearing the 'CE marking where it is to be incorporated into other machinery or assembled with other machinery to form a complex installation;

(17) Whereas, therefore, this Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery; whereas, in order to help manufacturers to prove conformity to these essential requirements and in order to allow inspection for conformity to the essential requirements, it is desirable to have standards harmonised at European level for the prevention of risks arising out of the design and construction of machinery; whereas these standards harmonised at European level are drawn up by private-law bodies and must retain their non-binding status; whereas for this purpose the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are the bodies recognised as competent to adopt harmonised standards in accordance with the general guidelines for cooperation between the Commission and these two bodies signed on 13 November 1984; whereas, within the meaning of this Directive, a harmonised standard is a technical specification (European standard or harmonisation document) adopted by either or both of these bodies, on the basis of a remit from the Commission in accordance with the provisions of Directive 83/189/EEC (4) and on the basis of general guidelines referred to above;

(18) Whereas it was found necessary to improve the legislative framework in order to ensure an effective and appropriate contribution by employers and employees to the standardisation process;

(19) Whereas the Member States' responsibility for safety, health and the other aspects covered by the essential requirements on their territory must be recognised in a safeguard clause providing for adequate Community protection procedures;

(20) Whereas, as is currently the practice in Member States, manufacturers should retain the responsibility for certifying the conformity of their machinery to the relevant essential requirements; whereas conformity to harmonised standards creates a presumption of conformity to the relevant essential requirements; whereas it is left to the sole discretion of the manufacturer, where he feels the need, to have his products examined and certified by a third party;

(21) Whereas, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable; whereas the EC type-examination procedure adopted may result in an EC declaration being given by the manufacturer without any stricter requirement such as a guarantee of quality, EC verification or EC supervision;

(22) Whereas it is essential that, before issuing an EC declaration of conformity, the manufacturer or his authorised representative established in the Community should provide a technical construction file; whereas it is not, however, essential that all documentation be permanently available in a material manner, but it must be made available on demand; whereas it need not include detailed plans of the sub-assemblies used in manufacturing the machines, unless knowledge of these is indispensable in order to ascertain conformity with essential safety requirements;

(23) Whereas, in its communication of 15 June 1989 on a global approach to certification and testing (5), the Commission proposed that common rules be drawn up concerning a 'CE conformity marking with a single design; whereas, in its resolution of 21 December 1989 on a global approach to conformity assessment (6), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the 'CE` marking; whereas the two basic elements of the new approach which must be applied are therefore the essential requirements and the conformity assessment procedures;

(24) Whereas the addressees of any decision taken under this Directive must be informed of the reasons for such a decision and the legal remedies open to them;

(25) Whereas this Directive must not affect the obligations of the Member States concerning the deadlines for transposition and application of the Directives set out in Annex VIII, part B,