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,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT
Article 1
1. This Directive applies to machinery and lays down the essential health and safety requirements therefor, as defined in Annex I.
It shall also apply to safety components placed on the market separately.
2. For the purposes of this Directive:
(a) 'machinery` means:
- an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
- an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
- interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool;
(b) 'safety components` means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.
3. The following are excluded from the scope of this Directive:
- machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads,
- machinery for medical use used in direct contact with patients,
- special equipment for use in fairgrounds and/or amusement parks,
- steam boilers, tanks and pressure vessels,
- machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity,
- radioactive sources forming part of a machine,
- firearms,
- storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances,
- means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units,
- cableways, including funicular railways, for the public or private transportation of persons,
- agricultural and forestry tractors, as defined in Article 1(1) of Directive 74/150/EEC (7),
- machines specially designed and constructed for military or police purposes,
- lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of:
(i) persons;
(ii) persons and goods;
(iii) goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside,
- means of transport of persons using rack and pinion rail mounted vehicles,
- mine winding gear,
- theatre elevators,
- construction site hoists intended for lifting persons or persons and goods.
4. Where, for machinery or safety components, the risks referred to in this Directive are wholly or partly covered by specific Community Directives, this Directive shall not apply, or shall cease to apply, in the case of such machinery or safety components and of such risks on the implementation of these specific Directives.
5. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Directive 73/23/EEC (8).
Article 2
1. Member States shall take all appropriate measures to ensure that machinery or safety components covered by this Directive may be placed on the market and put into service only if they do not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for their intended purpose.
2. This Directive shall not affect Member States' entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the machinery or safety components in question, provided that this does not mean that the machinery or safety components are modified in a way not specified in the Directive.
3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machinery or safety components which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery or safety components do not conform and that they are not for sale until they have been brought into conformity by the manufacturer or his authorised representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.
Article 3
Machinery and safety components covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I.
Article 4
1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery and safety components which comply with this Directive.
2. Member States shall not prohibit, restrict or impede the placing on the market of machinery where the manufacturer or his authorised representative established in the Community declares in accordance with point B of Annex II that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive, except where it can function independently.
'Interchangeable equipment`, as referred to in the third indent of Article 1(2)(a), must in all cases bear the CE marking and be accompanied by the EC declaration of conformity referred to in Annex II, point A.
3. Member States may not prohibit, restrict or impede the placing on the market of safety components as defined in Article 1(2) where they are accompanied by an EC declaration of conformity by the manufacturer or his authorised representative established in the Community as referred to in Annex II, point C.
Article 5
1. Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II:
- machinery bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II, point A,
- safety components accompanied by the EC declaration of conformity referred to in Annex II, point C.
In the absence of harmonised standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I.
2. Where a national standard transposing a harmonised standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery or safety components constructed in accordance with this standard shall be presumed to comply with the relevant essential requirements.
Member States shall publish the references of national standards transposing harmonised standards.
3. Member States shall ensure that appropriate measures are taken to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.
Article 6
1. Where a Member State or the Commission considers that the harmonised standards referred to in Article 5(2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee set up under Directive 83/189/EEC, giving the reasons therefor. The committee shall deliver an opinion without delay.
Upon receipt of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5(2).
2. A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission.
The standing committee shall draw up its own rules of procedure.
Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure:
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
Article 7
1. Where a Member State ascertains that:
- machinery bearing the CE marking, or
- safety components accompanied by the EC declaration of conformity,
used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof.
Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5(2);
(c) shortcomings in the standards themselves referred to in Article 5(2).
2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the committee in order to initiate the procedures referred to in Article 6(1).
3. Where:
- machinery which does not comply bears the CE marking,
- a safety component which does not comply is accompanied by an EC declaration of conformity,
the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.
4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.
CHAPTER II CONFORMITY ASSESSMENT PROCEDURES
Article 8
1. The manufacturer or his authorised representative established in the Community must, in order to certify that machinery and safety components are in conformity with this Directive, draw up for all machinery or safety components manufactured an EC declaration of conformity based on the model given in Annex II, point A or C as appropriate.
In addition, for machinery alone, the manufacturer or his authorised representatives established in the Community must affix to the machine the CE marking.
2. Before placing on the market, the manufacturer, or his authorised representative established in the Community, shall:
(a) if the machinery is not referred to in Annex IV, draw up the file provided for in Annex V;
(b) if the machinery is referred to in Annex IV and its manufacturer does not comply, or only partly complies, with the standards referred to in Article 5(2) or if there are no such standards, submit an example of the machinery for the EC type-examination referred to in Annex VI;
(c) if the machinery is referred to in Annex IV and is manufactured in accordance with the standards referred to in Article 5(2):
- either draw up the file referred to in Annex VI and forward it to a notified body, which will acknowledge receipt of the file as soon as possible and keep it,
- submit the file referred to in Annex VI to the notified body, which will simply verify that the standards referred to in Article 5(2) have been correctly applied and will draw up a certificate of adequacy for the file,
- or submit the example of the machinery for the EC type-examination referred to in Annex VI.
3. Where the first indent of paragraph 2(c) of this Article applies, the provisions of the first sentence of paragraphs 5 and 7 of Annex VI shall also apply.
Where the second indent of paragraph 2(c) of this Article applies, the provisions of paragraphs 5, 6 and 7 of Annex VI shall also apply.
4. Where paragraph 2(a) and the first and second indents of paragraph 2(c) apply, the EC declaration of conformity shall solely state conformity with the essential requirements of the Directive.
Where paragraph 2(b) and the third indent of paragraph 2(c) apply, the EC declaration of conformity shall state conformity with the example that underwent EC type-examination.
5. Safety components shall be subject to the certification procedures applicable to machinery pursuant to paragraphs 2, 3 and 4. Furthermore, during EC type-examination, the notified body shall verify the suitability of the safety component for fulfilling the safety functions declared by the manufacturer.
6. (a) Where the machinery is subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the machinery is also presumed to conform to the provisions of those other Directives.
(b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such machinery.
7. Where neither the manufacturer nor his authorised representative established in the Community fulfils the obligations of paragraphs 1 to 6, these obligations shall fall to any person placing the machinery or safety component on the market in the Community. The same obligations shall apply to any person assembling machinery or parts thereof or safety components of various origins or constructing machinery or safety components for his own use.
8. The obligations referred to in paragraph 7 shall not apply to persons who assemble with a machine or tractor interchangeable equipment as provided for in Article 1, provided that the parts are compatible and each of the constituent parts of the assembled machine bears the CE marking and is accompanied by the EC declaration of conformity.
Article 9
1. Member States shall notify the Commission and the other Member States of the approved bodies which they have appointed to carry out the procedures referred to in Article 8 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria laid down in Annex VII in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant harmonised standards shall be presumed to fulfil those criteria.
3. A Member State which has approved a body must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex VII. It shall immediately inform the Commission and the other Member States accordingly.
CHAPTER III CE MARKING
Article 10
1. The CE conformity marking shall consist of the initials 'CE`. The form of the marking to be used is shown in Annex III.
2. The CE marking shall be affixed to machinery distinctly and visibly in accordance with point 1.7.3 of Annex I.
3. The affixing of markings on the machinery which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility and legibility of the CE marking is not thereby reduced.
4. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;
(b) where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 7.
CHAPTER IV FINAL PROVISIONS
Article 11
Any decision taken pursuant to this Directive which restricts the placing on the market and putting into service of machinery or a safety component shall state the exact grounds on which it is based. Such a decision shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.
Article 12
The Commission will take the necessary steps to have information on all the relevant decisions relating to the management of this Directive made available.
Article 13
1. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
2. The Commission shall, before 1 January 1994, examine the progress made in the standardisation work relating to this Directive and propose any appropriate measures.
Article 14
1. The Directives listed in Annex VIII, Part A, are hereby repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition and application of the said Directives, as set out in Annex VIII, Part B.
2. References to the repealed Directives shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex IX.
Article 15
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 16
This Directive is addressed to the Member States.
Done at Luxembourg, 22 June 1998.