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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B 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
(OJ L 207, 23.7.1998, p. 1)
Corrected by:
►C1 Corrigendum, OJ L 16, 21.1.1999, p. 36 (98/37)
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DIRECTIVE 98/37/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 22 June 1998
ontheapproximationofthelawsoftheMemberStatesrelatingto
machinery
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN 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 theapproximation of the laws of the Member States relating tomachinery (
3) has been frequently and substantially amended;
whereas for reasons of clarity and rationality the said Directiveshould be consolidated;
(2) Whereas the internal market consists of an area without internalfrontiers within which the free movement of goods, persons,services and capital is guaranteed;
(3) Whereas the machinery sector is an important part of the engin-eering industry and is one of the industrial mainstays of theCommunity economy;
(4) Whereas the social cost of the large number of accidents causeddirectly by the use of machinery can be reduced by inherentlysafe design and construction of machinery and by proper installa-tions and maintenance;
(5) Whereas Member States are responsible for ensuring the healthand safety on their territory of persons and, where appropriate, ofdomestic animals and goods and, in particular, of workers,notably in relation to the risks arising out of the use of machi-nery;
(6) Whereas, in the Member States, the legislative systems regardingaccident prevention are very different; whereas the relevantcompulsory provisions, frequently supplemented by de facto
mandatory technical specifications and/or voluntary standards, donot necessarily lead to different levels of health and safety, butnevertheless, owing to their disparities, constitute barriers to tradewithin the Community; whereas, furthermore, conformity certi-fication and national certification systems for machinery differconsiderably;
(7) Whereas existing national health and safety provisions providingprotection against the risks caused by machinery must beapproximated to ensure free movement on the market of machi-nery without lowering existing justified levels of protection in theMember States; whereas the provisions of this Directiveconcerning the design and construction of machinery, essentialfor a safer working environment, shall be accompanied byspecific provisions concerning the prevention of certain risks to
(1) OJ C 133, 28.4.1997, p. 6.
(2) Opinion of the European Parliament of 17 September 1997 (OJ C 304,
6.10.1997, p. 79), Council common position of 24 March 1998 (OJ C161, 27.5.1998, p. 54) and Decision of the European Parliament of 30April 1998 (OJ C 152, 18.5.1998). Council Decision of 25 May 1998.
(
3) OJ L 183, 29.6.1989, p. 9. Directive as last amended by Directive 93/
68/EEC (OJ L 220, 30.8.1993, p. 1).
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which workers can be exposed at work, as well as by provisions
based on the organisation of safety of workers in the workingenvironment;
(8) Whereas Community law, in its present form, provides — byway of derogation from one of the fundamental rules of theCommunity, namely the free movement of goods — thatobstacles to movement within the Community resulting fromdisparities in national legislation relating to the marketing ofproducts must be accepted in so far as the provisions concernedcan be recognised as being necessary to satisfy imperativerequirements;
(9) Whereas paragraphs 65 and 68 of the White Paper on thecompletion of the internal market, approved by the EuropeanCouncil in June 1985, provide for a new approach to legislativeharmonisation; whereas, therefore, the harmonisation of laws inthis case must be limited to those requirements necessary tosatisfy the imperative and essential health and safety require-ments relating to machinery; whereas these requirements mustreplace the relevant national provisions because they are essen-tial;
(10) Whereas the maintenance or improvement of the level of safetyattained by the Member States constitutes one of the essentialaims of this Directive and of the principle of safety as defined bythe essential requirements;
(11) Whereas the field of application of this Directive must be basedon a general definition of the term ‘machinery' so as to allow thetechnical development of products; whereas the development ofcomplex installations and the risks they involve are of an equiva-lent nature and their express inclusion in the Directive is there-fore justified;
(12) Whereas it is also necessary to deal with safety componentswhich are placed on the market separately and the safety functionof which is declared by the manufacturer or his authorised repres-entative established in the Community;
(13) Whereas, for trade fairs, exhibitions, etc., it must be possible toexhibit machinery which does not conform to this Directive;whereas, however, interested parties should be properly informedthat the machinery does not conform and cannot be purchased inthat condition;
(14) Whereas the essential health and safety requirements must beobserved in order to ensure that machinery is safe; whereas theserequirements must be applied with discernment to take account ofthe state of the art at the time of construction and of technical andeconomic requirements;
(15) Whereas the putting into service of machinery within themeaning of this Directive can relate only to the use of themachinery itself as intended by the manufacturer; whereas thisdoes not preclude the laying-down of conditions of use externalto the machinery, provided that it is not thereby modified in away not specified in this Directive;
(16) Whereas it is necessary not only to ensure the free movement andputting into service of machinery bearing the ‘CE' marking andhaving an EC conformity certificate but also to ensure free move-ment of machinery not bearing the ‘CE' marking where it is to beincorporated into other machinery or assembled with othermachinery to form a complex installation;
(17) Whereas, therefore, this Directive defines only the essentialhealth and safety requirements of general application, supple-mented by a number of more specific requirements for certaincategories of machinery; whereas, in order to help manufacturersto prove conformity to these essential requirements and in orderto allow inspection for conformity to the essential requirements,it is desirable to have standards harmonised at European level forthe prevention of risks arising out of the design and construction
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of machinery; whereas these standards harmonised at European
level are drawn up by private-law bodies and must retain theirnon-binding status; whereas for this purpose the EuropeanCommittee for Standardisation (CEN) and the EuropeanCommittee for Electrotechnical Standardisation (Cenelec) are thebodies recognised as competent to adopt harmonised standards inaccordance with the general guidelines for cooperation betweenthe Commission and these two bodies signed on 13 November1984; whereas, within the meaning of this Directive, a harmo-nised standard is a technical specification (European standard orharmonisation document) adopted by either or both of thesebodies, on the basis of a remit from the Commission in accord-ance with the provisions of Directive 83/189/EEC (
1) and on the
basis of general guidelines referred to above;
(18) Whereas it was found necessary to improve the legislative frame-work in order to ensure an effective and appropriate contributionby employers and employees to the standardisation process;
(19) Whereas the Member States’ responsibility for safety, health andthe other aspects covered by the essential requirements on theirterritory must be recognised in a safeguard clause providing foradequate Community protection procedures;
(20) Whereas, as is currently the practice in Member States, manufac-turers should retain the responsibility for certifying theconformity of their machinery to the relevant essential require-ments; whereas conformity to harmonised standards creates apresumption of conformity to the relevant essential requirements;whereas it is left to the sole discretion of the manufacturer, wherehe feels the need, to have his products examined and certified bya third party;
(21) Whereas, for certain types of machinery having a higher riskfactor, a stricter certification procedure is desirable; whereas theEC type-examination procedure adopted may result in an ECdeclaration being given by the manufacturer without any stricterrequirement such as a guarantee of quality, EC verification or ECsupervision;
(22) Whereas it is essential that, before issuing an EC declaration ofconformity, the manufacturer or his authorised representativeestablished in the Community should provide a technicalconstruction file; whereas it is not, however, essential that alldocumentation be permanently available in a material manner,but it must be made available on demand; whereas it need notinclude detailed plans of the sub-assemblies used in manufac-turing the machines, unless knowledge of these is indispensablein order to ascertain conformity with essential safety require-ments;
(23) Whereas, in its communication of 15 June 1989 on a globalapproach to certification and testing (
2), the Commission
proposed that common rules be drawn up concerning a ‘CE'conformity marking with a single design; whereas, in its resolu-tion of 21 December 1989 on a global approach to conformityassessment (
3), the Council approved as a guiding principle the
adoption of a consistent approach such as this with regard to theuse of the ‘CE' marking; whereas the two basic elements of thenew approach which must be applied are therefore the essentialrequirements and the conformity assessment procedures;
(1) Council Directive 83/189/EEC of 28 March 1983 laying down a procedure
for the provision of information in the field of technical standards andregulations (OJ L 109, 26.4.1983, p. 8). Directive as last amended byCommission Decision 96/139/EC (OJ L 32, 10.2.1996, p. 31).
(
2) OJ C 231, 8.9.1989, p. 3, and OJ C 267, 19.10.1989, p. 3.
(3) OJ C 10, 16.1.1990, p. 1.
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(24) Whereas the addressees of any decision taken under this
Directive must be informed of the reasons for such a decision andthe legal remedies open to them;
(25) Whereas this Directive must not affect the obligations of theMember States concerning the deadlines for transposition andapplication of the Directives set out in Annex VIII, part B,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVE-
MENT
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 powercircuits, etc., joined together for a specific application, in partic-ular for the processing, treatment, moving or packaging of amaterial,
— an assembly of machines which, in order to achieve the same
end, are arranged and controlled so that they function as anintegral whole,
— interchangeable equipment modifying the function of a machine,
which is placed on the market for the purpose of beingassembled with a machine or a series of different machines orwith a tractor by the operator himself in so far as this equipmentis 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 author-ised representative established in the Community places on themarket to fulfil a safety function when in use and the failure ormalfunctioning of which endangers the safety or health of exposedpersons.
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 ofradioactivity,
— 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, aswell as means of transport in so far as such means are designed fortransporting goods by air, on public road or rail networks or onwater. Vehicles used in the mineral extraction industry shall not beexcluded,
— seagoing vessels and mobile offshore units together with equipment
on board such vessels or units,
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— 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 (1),
— 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 rigidand inclined at an angle of more than 15 degrees to the horizontaland 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 situatedinside 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 CommunityDirectives, this Directive shall not apply, or shall cease to apply, in thecase of such machinery or safety components and of such risks on theimplementation 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 (
2).
Article 2
1. Member States shall take all appropriate measures to ensure that
machinery or safety components covered by this Directive may beplaced on the market and put into service only if they do not endangerthe health or safety of persons and, where appropriate, domestic animalsor property, when properly installed and maintained and used for theirintended purpose.
2. This Directive shall not affect Member States’ entitlement to lay
down, in due observance of the Treaty, such requirements as they maydeem necessary to ensure that persons and in particular workers areprotected when using the machinery or safety components in question,provided that this does not mean that the machinery or safety compo-nents 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 whichdo not conform to the provisions of this Directive, provided that avisible sign clearly indicates that such machinery or safety componentsdo not conform and that they are not for sale until they have beenbrought into conformity by the manufacturer or his authorised repres-entative established in the Community. During demonstrations,adequate safety measures shall be taken to ensure the protection ofpersons.
(1) Council Directive 74/150/EEC of 4 March 1974 on the approximation of
the laws of the Member States relating to the type-approval of wheeledagricultural or forestry tractors (OJ L 84, 28.3.1974, p. 10). Directive aslast amended by Decision 95/1/EC, Euratom, ECSC (OJ L 1, 1.1.1995, p.1).
(
2) Council Directive 73/23/EEC of 19 February 1973 on the harmonisation
of the laws of Member States relating to electrical equipment designed foruse within certain voltage limits (OJ L 77, 26.3.1973, p. 29). Directive aslast amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).
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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 andsafety 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 authorisedrepresentative established in the Community declares in accordancewith point B of Annex II that it is intended to be incorporated intomachinery or assembled with other machinery to constitute machinerycovered 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 bythe 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 theyare accompanied by an EC declaration of conformity by the manufac-turer or his authorised representative established in the Community asreferred 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 theconformity 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 partiesconcerned the existing national technical standards and specificationswhich are regarded as important or relevant to the proper implementa-tion 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 accord-ance with this standard shall be presumed to comply with the relevantessential requirements.
Member States shall publish the references of national standards trans-
posing 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 theprocess 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 satisfythe essential requirements referred to in Article 3, the Commission orthe Member State concerned shall bring the matter before the committeeset up under Directive 83/189/EEC, giving the reasons therefor. Thecommittee 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 thosestandards from the published information referred to in Article 5(2).
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2. A standing committee shall be set up, consisting of representatives
appointed by the Member States and chaired by a representative of theCommission.
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 accord-ance 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 itsopinion on the draft, within a time limit which the chairman may laydown according to the urgency of the matter, if necessary by taking avote.
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 theminutes.
The Commission shall take the utmost account of the opinion delivered
by the committee. It shall inform the committee of the manner in whichits 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 orproperty, it shall take all appropriate measures to withdraw such machi-nery or safety components from the market, to prohibit the placing onthe market, putting into service or use thereof, or to restrict free move-ment 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 thisconsultation, that the measure is justified, it shall immediately so informthe Member State which took the initiative and the other MemberStates. Where the Commission considers, after this consultation, that theaction is unjustified, it shall immediately so inform the Member Statewhich took the initiative and the manufacturer or his authorised repres-entative established within the Community. Where the decision referredto in paragraph 1 is based on a shortcoming in the standards, and wherethe Member State at the origin of the decision maintains its position, theCommission shall immediately inform the committee in order to initiatethe 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 soinform 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.
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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 safetycomponents are in conformity with this Directive, draw up for allmachinery or safety components manufactured an EC declaration ofconformity based on the model given in Annex II, point A or C asappropriate.
In addition, for machinery alone, the manufacturer or his authorised
representatives established in the Community must affix to the machinethe 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 standardsreferred to in Article 5(2) or if there are no such standards, submitan example of the machinery for the EC type-examination referredto 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 assoon 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 Article5(2) have been correctly applied and will draw up a certificateof adequacy for the file,
— or submit the example of the machinery for the EC type-exam-
ination 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 shallalso 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 para-
graph 2(c) apply, the EC declaration of conformity shall solely stateconformity 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 examplethat 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 suit-ability of the safety component for fulfilling the safety functionsdeclared 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 CEmarking, the latter shall indicate that the machinery is alsopresumed 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 whicharrangements to apply, the CE marking shall indicate conformityonly 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
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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 to6, these obligations shall fall to any person placing the machinery orsafety component on the market in the Community. The same obliga-tions shall apply to any person assembling machinery or parts thereof orsafety components of various origins or constructing machinery orsafety 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 equip-ment as provided for in Article 1, provided that the parts are compatibleand each of the constituent parts of the assembled machine bears the CEmarking 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 outthe procedures referred to in Article 8 together with the specific taskswhich these bodies have been appointed to carry out and the identifica-tion 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 Commis-sion 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 meetingthe assessment criteria laid down in the relevant harmonised standardsshall 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 referredto in Annex VII. It shall immediately inform the Commission and theother 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 markingshall be prohibited. Any other marking may be affixed to the machineryprovided that the visibility and legibility of the CE marking is notthereby 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 representativeestablished within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CEmarking and to end the infringement under the conditions imposedby the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is withdrawnfrom the market in accordance with the procedure laid down inArticle 7.
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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 compo-nent shall state the exact grounds on which it is based. Such a decisionshall be notified as soon as possible to the party concerned, who shall atthe same time be informed of the legal remedies available to him underthe laws in force in the Member State concerned and of the time limitsto 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 Directivemade 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 bythis Directive.
2. The Commission shall, before 1 January 1994, examine the
progress made in the standardisation work relating to this Directive andpropose 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 concerningthe deadlines for transposition and application of the said Directives, asset out in Annex VIII, Part B.
2. References to the repealed Directives shall be construed as refer-
ences to this Directive and be read in accordance with the correlationtable 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.
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ANNEX I
ESSENTIALHEALTHANDSAFETYREQUIREMENTSRELATINGTO
THE DESIGN AND CONSTRUCTION OF MACHINERY AND SAFETY
COMPONENTS
For the purposes of this Annex ‘machinery' means either ‘machinery' or ‘safety
component' as defined in Article 1(2).
PRELIMINARY OBSERVATIONS
1. The obligations laid down by the essential health and safety requirements
apply only when the corresponding hazard exists for the machinery in ques-tion when it is used under the conditions foreseen by the manufacturer. Inany event, requirements 1.1.2, 1.7.3 and 1.7.4 apply to all machinery coveredby this Directive.
2. The essential health and safety requirements laid down in this Directive are
mandatory. However, taking into account the state of the art, it may not bepossible to meet the objectives set by them. In this case, the machinery mustas far as possible be designed and constructed with the purpose ofapproaching those objectives.
3. The essential health and safety requirements have been grouped according to
the hazards which they cover.
Machinery presents a series of hazards which may be indicated under more
than one heading in this Annex.
The manufacturer is under an obligation to assess the hazards in order to
identify all of those which apply to his machine; he must then design andconstruct it taking account of his assessment.
1 ESSENTIAL HEALTH AND SAFETY REQUIREMENTS1.1.General remarks
1.1.1.Definitions
For the purpose of this Directive:
1. ‘danger zone' means any zone within and/or around machinery in
which an exposed person is subject to a risk to his health or safety;
2. ‘exposed person' means any person wholly or partially in a danger
zone;
3. ‘operator' means the person or persons given the task of installing,
operating, adjusting, maintaining, cleaning, repairing or trans-porting machinery.
▼
C1
1.1.2.Principles of safety integration
▼B (a) Machinery must be so constructed that it is fitted for its function,
and can be adjusted and maintained without putting persons at riskwhen these operations are carried out under the conditions fore-seen by the manufacturer.
The aim of measures taken must be to eliminate any risk of
accident throughout the foreseeable lifetime of the machinery,including the phases of assembly and dismantling, even whererisks of accident arise from foreseeable abnormal situations.
(b) In selecting the most appropriate methods, the manufacturer must
apply the following principles, in the order given:
— eliminate or reduce risks as far as possible (inherently safe
machinery design and construction),
— take the necessary protection measures in relation to risks that
cannot be eliminated,
— inform users of the residual risks due to any shortcomings of
the protection measures adopted, indicate whether any partic-ular training is required and specify any need to providepersonal protection equipment.
(c) When designing and constructing machinery, and when drafting
the instructions, the manufacturer must envisage not only the
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normal use of the machinery but also uses which could reasonably
be expected.
The machinery must be designed to prevent abnormal use if such
use would engender a risk. In other cases the instructions mustdraw the user’s attention to ways — which experience has shownmight occur — in which the machinery should not be used.
(d) Under the intended conditions of use, the discomfort, fatigue and
psychological stress faced by the operator must be reduced to theminimum possible taking ergonomic principles into account.
(e) When designing and constructing machinery, the manufacturer
must take account of the constraints to which the operator issubject as a result of the necessary or foreseeable use of personalprotection equipment (such as footwear, gloves, etc.).
(f) Machinery must be supplied with all the essential special equip-
ment and accessories to enable it to be adjusted, maintained andused without risk.
1.1.3.Materials and products
The materials used to construct machinery or products used and
created during its use must not endanger exposed persons’ safety orhealth.
In particular, where fluids are used, machinery must be designed and
constructed for use without risks due to filling, use, recovery ordraining.
1.1.4.Lighting
The manufacturer must supply integral lighting suitable for the opera-
tions concerned where its lack is likely to cause a risk despite ambientlighting of normal intensity.
The manufacturer must ensure that there is no area of shadow likely to
cause nuisance, that there is no irritating dazzle and that there are nodangerous stroboscopic effects due to the lighting provided by themanufacturer.
Internal parts requiring frequent inspection, and adjustment and main-
tenance areas, must be provided with appropriate lighting.
1.1.5.Design of machinery to facilitate its handling
Machinery or each component part thereof must:
— be capable of being handled safely,
— be packaged or designed so that it can be stored safely and without
damage (e.g. adequate stability, special supports, etc.).
Where the weight, size or shape of machinery or its various component
parts prevents them from being moved by hand, the machinery or eachcomponent part must;
— either be fitted with attachments for lifting gear, or
— be designed so that it can be fitted with such attachments (e.g.
threaded holes), or
— be shaped in such a way that standard lifting gear can easily be
attached.
Where machinery or one of its component parts is to be moved by
hand, it must:
— either be easily movable, or
— be equipped for picking up (e.g. hand-grips, etc.) and moving in
complete safety.
Special arrangements must be made for the handling of tools and/or
machinery parts, even if lightweight, which could be dangerous (shape,material, etc.).
1.2.Controls
1.2.1.Safety and reliability of control systems
Control systems must be designed and constructed so that they are safe
and reliable, in a way that will prevent a dangerous situation arising.Above all they must be designed and constructed in such a way that:
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— they can withstand the rigours of normal use and external factors,
— errors in logic do not lead to dangerous situations.
1.2.2.Control devices
Control devices must be:
— clearly visible and identifiable and appropriately marked where
necessary,
— positioned for safe operation without hesitation or loss of time, and
without ambiguity,
— designed so that the movement of the control is consistent with its
effect,
— located outside the danger zones, except for certain controls where
necessary, such as emergency stop, console for training of robots,
— positioned so that their operation cannot cause additional risk,— designed or protected so that the desired effect, where a risk is
involved, cannot occur without an intentional operation,
— made so as to withstand foreseeable strain; particular attention
must be paid to emergency stop devices liable to be subjected toconsiderable strain.
Where a control is designed and constructed to perform several
different actions, namely where there is no one-to-one correspondence(e.g. keyboards, etc.), the action to be performed must be clearlydisplayed and subject to confirmation where necessary.
Controls must be so arranged that their layout, travel and resistance to
operation are compatible with the action to be performed, takingaccount of ergonomic principles. Constraints due to the necessary orforeseeable use of personal protection equipment (such as footwear,gloves, etc.) must be taken into account.
Machinery must be fitted with indicators (dials, signals, etc.) as
required for safe operation. The operator must be able to read themfrom the control position.
From the main control position the operator must be able to ensure that
there are no exposed persons in the danger zones.
If this is impossible, the control system must be designed and
constructed so that an acoustic and/or visual warning signal is givenwhenever the machinery is about to start. The exposed person musthave the time and the means to take rapid action to prevent themachinery starting up.
1.2.3.Starting
It must be possible to start machinery only by voluntary actuation of a
control provided for the purpose.
The same requirement applies:
— when restarting the machinery after a stop-page, whatever the
cause,
— when effecting a significant change in the operating conditions
(e.g. speed, pressure, etc.),
unless such restarting or change in operating conditions is without risk
to exposed persons.
This essential requirement does not apply to the restarting of the
machinery or to the change in operating conditions resulting from thenormal sequence of an automatic cycle.
Where machinery has several starting controls and the operators can
therefore put each other in danger, additional devices (e.g. enablingdevices or selectors allowing only one part of the starting meachanismto be actuated at any one time) must be fitted to rule out such risks.
It must be possible for automated plant functioning in automatic mode
to be restarted easily after a stoppage once the safety conditions havebeen fulfilled.
1.2.4.Stopping device
Normal stopping
Each machine must be fitted with a control whereby the machine can
be brought safely to a complete stop.
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Each workstation must be fitted with a control to stop some or all of
the moving parts of the machinery, depending on the type of hazard, sothat the machinery is rendered safe. The machinery’s stop control musthave priority over the start controls.
Once the machinery or its dangerous parts have stopped, the energy
supply to the actuators concerned must be cut off.
Emergency stop
Each machine must be fitted with one or more emergency stop devices
to enable actual or impending danger to be averted. The followingexceptions apply:
— machines in which an emergency stop device would not lessen the
risk, either because it would not reduce the stopping time orbecause it would not enable the special measures required to dealwith the risk to be taken,
— hand-held portable machines and hand-guided machines.
This device must:
— have clearly identifiable, clearly visible and quickly accessible
controls,
— stop the dangerous process as quickly as possible, without creating
additional hazards,
— where necessary, trigger or permit the triggering of certain safe-
guard movements.
Once active operation of the emergency stop control has ceased
following a stop command, that command must be sustained byengagement of the emergency stop device until that engagement isspecifically overridden; it must not be possible to engage the devicewithout triggering a stop command; it must be possible to disengagethe device only by an appropriate operation, and disengaging thedevice must not restart the machinery but only permit restarting.
Complex installations
In the case of machinery or parts of machinery designed to work
together, the manufacturer must so design and construct the machinerythat the stop controls, including the emergency stop, can stop not onlythe machinery itself but also all equipment upstream and/or down-stream if its continued operation can be dangerous.
1.2.5.Mode selection
The control mode selected must override all other control systems with
the exception of the emergency stop.
If machinery has been designed and built to allow for its use in several
control or operating modes presenting different safety levels (e.g. toallow for adjustment, maintenance, inspection, etc.), it must be fittedwith a mode selector which can be locked in each position. Eachposition of the selector must correspond to a single operating orcontrol mode.
The selector may be replaced by another selection method which
restricts the use of certain functions of the machinery to certain catego-ries of operator (e.g. access codes for certain numerically controlledfunctions, etc.).
If, for certain operations, the machinery must be able to operate with
its protection devices neutralised, the mode selector must simultane-ously:
— disable the automatic control mode,
— permit movements only by controls requiring sustained action,— permit the operation of dangerous moving parts only in enhanced
safety conditions (e.g. reduced speed, reduced power, step-by-step,or other adequate provision) while preventing hazards from linkedsequences,
— prevent any movement liable to pose a danger by acting voluntarily
or involuntarily on the machine’s internal sensors.
In addition, the operator must be able to control operation of the parts
he is working on at the adjustment point.
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1.2.6.Failure of the power supply
The interruption, re-establishment after an interruption or fluctuation in
whatever manner of the power supply to the machinery must not leadto a dangerous situation.
In particular:
— the machinery must not start unexpectedly,
— the machinery must not be prevented from stopping if the
command has already been given,
— no moving part of the machinery or piece held by the machinery
must fall or be ejected,
— automatic or manual stopping of the moving parts whatever they
may be must be unimpeded,
— the protection devices must remain fully effective.
1.2.7.Failure of the control circuit
A fault in the control circuit logic, or failure of or damage to the
control circuit must not lead to dangerous situations.
In particular:
— the machinery must not start unexpectedly,
— the machinery must not be prevented from stopping if the
command has already been given,
— no moving part of the machinery or piece held by the machinery
must fall or be ejected,
— automatic or manual stopping of the moving parts whatever they
may be must be unimpeded,
— the protection devices must remain fully effective.
1.2.8.Software
Interactive software between the operator and the command or control
system of a machine must be user-friendly.
1.3.Protection against mechanical hazards
1.3.1.Stability
Machinery, components and fittings thereof must be so designed and
constructed that they are stable enough, under the foreseen operatingconditions (if necessary taking climatic conditions into account) foruse without risk of overturning, falling or unexpected movement.
If the shape of the machinery itself or its intended installation does not
offer sufficient stability, appropriate means of anchorage must beincorporated and indicated in the instructions.
1.3.2.Risk of break-up during operation
The various parts of machinery and their linkages must be able to
withstand the stresses to which they are subject when used as foreseenby the manufacturer.
The durability of the materials used must be adequate for the nature of
the work place foreseen by the manufacturer, in particular as regardsthe phenomena of fatigue, ageing, corrosion and abrasion.
The manufacturer must indicate in the instructions the type and
frequency of inspection and maintenance required for safety reasons.He must, where appropriate, indicate the parts subject to wear and thecriteria for replacement.
Where a risk of rupture or disintegration remains despite the measures
taken (e.g. as with grinding wheels) the moving parts must be mountedand positioned in such a way that in case of rupture their fragmentswill be contained.
Both rigid and flexible pipes carrying fluids, particularly those under
high pressure, must be able to withstand the foreseen internal andexternal stresses and must be firmly attached and/or protected againstall manner of external stresses and strains; precautions must be takento ensure that no risk is posed by a rupture (sudden movement,high-pressure jets, etc.).
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Where the material to be processed is fed to the tool automatically, the
following conditions must be fulfilled to avoid risks to the personsexposed (e.g. tool breakage):
— when the workpiece comes into contact with the tool the latter
must have attained its normal working conditions,
— when the tool starts and/or stops (intentionally or accidentally) the
feed movement and the tool movement must be coordinated.
1.3.3.Risks due to falling or ejected objects
Precautions must be taken to prevent risks from falling or ejected
objects (e.g. workpieces, tools, cuttings, fragments, waste, etc.).
1.3.4.Risks due to surfaces, edges or angles
In so far as their purpose allows, accessible parts of the machinery
must have no sharp edges, no sharp angles, and no rough surfaceslikely to cause injury.
1.3.5.Risks related to combined machinery
Where the machinery is intended to carry out several different opera-
tions with the manual removal of the piece between each operation(combined machinery), it must be designed and constructed in such away as to enable each element to be used separately without the otherelements constituting a danger or risk for the exposed person.
For this purpose, it must be possible to start and stop separately any
elements that are not protected.
1.3.6.Risks relating to variations in the rotational speed of tools
When the machine is designed to perform operations under different
conditioins of use (e.g. different speeds or energy supply), it must bedesigned and constructed in such a way that selection and adjustmentof these conditions can be carried out safely and reliably.
1.3.7.Prevention of risks related to moving parts
The moving parts of machinery must be designed, built and laid out to
avoid hazards or, where hazards persist, fixed with guards or protectivedevices in such a way as to prevent all risk of contact which could leadto accidents.
All necessary steps must be taken to prevent accidental blockage of
moving parts involved in the work. In cases where, despite the precau-tions taken, a blockage is likely to occur, specific protection devices ortools, the instruction handbook and possibly a sign on the machineryshould be provided by the manufacturer to enable the equipment to besafely unblocked.
1.3.8.Choice of protection against risks related to moving parts
Guards or protection devices used to protect against the risks related to
moving parts must be selected on the basis of the type of risk. Thefollowing guidelines must be used to help make the choice.
A. Moving transmission parts
Guards designed to protect exposed persons against the risks asso-
ciated with moving transmission parts (such as pulleys, belts, gears,rack and pinions, shafts, etc.) must be:
— either fixed, complying with requirements 1.4.1 and 1.4.2.1, or
— movable, complying with requirements 1.4.1 and 1.4.2.2.A.
Movable guards should be used where frequent access is foreseen.
B. Moving parts directly involved in the process
Guards or protection devices designed to protect exposed persons
against the risks associated with moving parts contributing to the work(such as cutting tools, moving parts of presses, cylinders, parts in theprocess of being machined, etc.) must be:
— wherever possible fixed guards complying with requirements 1.4.1
and 1.4.2.1,
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— otherwise, movable guards complying with requirements 1.4.1 and
1.4.2.2.B or protection devices such as sensing devices (e.g. non-material barriers, sensor mats), remote-hold protection devices (e.g.two-hand controls), or protection devices intended automatically toprevent all or part of the operator’s body from encroaching on thedanger zone in accordance with requirements 1.4.1 and 1.4.3.
However, when certain moving parts directly involved in the process
cannot be made completely or partially inaccessible during operationowing to operations requiring nearby operator intervention, wheretechnically possible such parts must be fitted with:
— fixed guards, complying with requirements 1.4.1 and 1.4.2.1
preventing access to those sections of the parts that are not used inthe work,
— adjustable guards, complying with requirements 1.4.1 and 1.4.2.3
restricting access to those sections of the moving parts that arestrictly for the work.
1.4.Required characteristics of guards and protection devices
1.4.1.General requirements
Guards and protection devices must:
— be of robust construction,
— not give rise to any additional risk,— not be easy to by-pass or render non-operational,— be located at an adequate distance from the danger zone,— cause minimum obstruction to the view of the production process,— enable essential work to be carried out on installation and/or
replacement of tools and also for maintenance by restricting accessonly to the area where the work has to be done, if possible withoutthe guard or protection device having to be dismantled.
1.4.2.Special requirements for guards
1.4.2.1. Fixed guards
Fixed guards must be securely held in place.They must be fixed by systems that can be opened only with tools.Where possible, guards must be unable to remain in place without their
fixings.
1.4.2.2. Movable guards
A. Type A movable guards must:
— as far as possible remain fixed to the machinery when open,
— be associated with a locking device to prevent moving parts
starting up as long as these parts can be accessed and to give a stopcommand whenever they are no longer closed.
B. Type B movable guards must be designed and incorporated into the
control system so that:
— moving parts cannot start up while they are within the operator’s
reach,
— the exposed person cannot reach moving parts once they have
started up,
— they can be adjusted only by means of an intentional action, such
as the use of a tool, key, etc.,
— the absence or failure of one of their components prevents starting
or stops the moving parts,
— protection against any risk of ejection is proved by means of an
appropriate barrier.
1.4.2.3. Adjustable guards restricting access
Adjustable guards restricting access to those areas of the moving parts
strictly necessary for the work must:
— be adjustable manually or automatically according to the type of
work involved,
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— be readily adjustable without the use of tools,
— reduce as far as possible the risk of ejection.
1.4.3.Special requirements for protection devices
Protection devices must be designed and incorporated into the control
system so that:
— moving parts cannot start up while they are within the operator’s
reach,
— the exposed person cannot reach moving parts once they have
started up,
— they can be adjusted only by means of an intentional action, such
as the use of a tool, key, etc.,
— the absence or failure of one of their components prevents starting
or stops the moving parts.
1.5.Protection against other hazards
1.5.1.Electricity supply
Where machinery has an electricity supply it must be designed,
constructed and equipped so that all hazards of an electrical nature areor can be prevented.
The specific rules in force relating to electrical equipment designed for
use within certain voltage limits must apply to machinery which issubject to those limits.
1.5.2.Static electricity
Machinery must be so designed and constructed as to prevent or limit
the build-up of potentially dangerous electrostatic charges and/or befitted with a discharging system.
1.5.3.Energy supply other than electricity
Where machinery is powered by an energy other than electricity (e.g.
hydraulic, pneumatic or thermal energy, etc.), it must be so designed,constructed and equipped as to avoid all potential hazards associatedwith these types of energy.
1.5.4.Errors of fitting
Errors, likely to be made when fitting or refitting certain parts which
could be a source of risk must be made impossible by the design ofsuch parts or, failing this, by information given on the parts themselvesand/or the housings. The same information must be given on movingparts and/or their housings where the direction of movement must beknown to avoid a risk. Any further information that may be necessarymust be given in the instructions.
Where a faulty connection can be the source of risk, incorrect fluid
connections, including electrical conductors, must be made impossibleby the design or, failing this, by information given on the pipes, cables,etc. and/or connector blocks.
1.5.5.Extreme temperatures
Steps must be taken to eliminate any risk of injury caused by contact
with or proximity to machinery parts or materials at high or very lowtemperatures.
The risk of hot or very cold material being ejected should be assessed.
Where this risk exists, the necessary steps must be taken to prevent itor, if this is not technically possible, to render it non-dangerous.
1.5.6.Fire
Machinery must be designed and constructed to avoid all risk of fire or
overheating posed by the machinery itself or by gases, liquids, dust,vapours or other substances produced or used by the machinery.
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1.5.7.Explosion
Machinery must be designed and constructed to avoid any risk of
explosion posed by the machinery itself or by gases, liquids, dust,vapours or other substances produced or used by the machinery.
To that end the manufacturer must take steps to:
— avoid a dangerous concentration of products,
— prevent combustion of the potentially explosive atmosphere,— minimise any explosion which may occur so that it does not
endanger the surroundings.
The same precautions must be taken if the manufacturer foresees the
use of the machinery in a potentially explosive atmosphere.
Electrical equipment forming part of the machinery must conform, as
far as the risk from explosion is concerned, to the provision of thespecific Directives in force.
1.5.8.Noise
Machinery must be so designed and constructed that risks resulting
from the emission of airborne noise are reduced to the lowest leveltaking account of technical progress and the availability of means ofreducing noise, in particular at source.
1.5.9.Vibration
Machinery must be so designed and constructed that risks resulting
from vibrations produced by the machinery are reduced to the lowestlevel, taking account of technical progress and the availability ofmeans of reducing vibration, in particular at source.
1.5.10.Radiation
Machinery must be so designed and constructed that any emission of
radiation is limited to the extent necessary for its operation and that theeffects on exposed persons are non-existent or reduced to non-dangerous proportions.
1.5.11.External radiation
Machinery must be so designed and constructed that external radiation
does not interfere with its operation.
1.5.12.Laser equipment
Where laser equipment is used, the following provisions should be
taken into account:
— laser equipment on machinery must be designed and constructed so
as to prevent any accidental radiation,
— laser equipment on machinery must be protected so that effective
radiation, radiation produced by reflection or diffusion and secon-dary radiation do not damage health,
— optical equipment for the observation or adjustment of laser equip-
ment on machinery must be such that no health risk is created bythe laser rays.
1.5.13.Emissions of dust, gases, etc.
Machinery must be so designed, constructed and/or equipped that risks
due to gases, liquids, dust, vapours and other waste materials which itproduces can be avoided.
Where a hazard exists, the machinery must be so equipped that the
said substances can be contained and/or evacuated.
Where machinery is not enclosed during normal operation, the devices
for containment and/or evacuation must be situated as close as possibleto the source emission.
1.5.14.Risk of being trapped in a machine
Machinery must be designed, constructed or fitted with a means of
preventing an exposed person from being enclosed within it or, if thatis impossible, with a means of summoning help.
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1.5.15.Risk of slipping, tripping or falling
Parts of the machinery where persons are liable to move about or stand
must be designed and constructed to prevent persons slipping, trippingor falling on or off these parts.
1.6.Maintenance
1.6.1.Machinery maintenance
Adjustment, lubrication and maintenance points must be located
outside danger zones. It must be possible to carry out adjustment,maintenance, repair, cleaning and servicing operations while machi-nery is at a standstill.
If one or more of the above conditions cannot be satisfied for technical
reasons, these operations must be possible without risk (see 1.2.5).
In the case of automated machinery and, where necessary, other
machinery, the manufacturer must make provision for a connectingdevice for mounting diagnostic fault-finding equipment.
Automated machine components which have to be changed frequently,
in particular for a change in manufacture or where they are liable towear or likely to deteriorate following an accident, must be capable ofbeing removed and replaced easily and in safety. Access to the compo-nents must enable these tasks to be carried out with the necessarytechnical means (tools, measuring instruments, etc.) in accordance withan operating method specified by the manufacturer.
1.6.2.Access to operating position and servicing points
The manufacturer must provide means of access (stairs, ladders,
catwalks, etc.) to allow access in safety to all areas used for produc-tion, adjustment and maintenance operations.
1.6.3.Isolation of energy sources
All machinery must be fitted with means to isolate it from all energy
sources. Such isolators must be clearly identified. They must becapable of being locked if reconnection could endanger exposedpersons. In the case of machinery supplied with electricity through aplug capable of being plugged into a circuit, separation of the plug issufficient.
The isolator must be capable of being locked also where an operator is
unable, from any of the points to which he has access, to check that theenergy is still cut off.
After the energy is cut off, it must be possible to dissipate normally
any energy remaining or stored in the circuits of the machinery withoutrisk to exposed persons.
As an exception to the above requirements, certain circuits may remain
connected to their energy sources in order, for example, to hold parts,protect information, light interiors, etc. In this case, special steps mustbe taken to ensure operator safety.
1.6.4.Operator intervention
Machinery must be so designed, constructed and equipped that the
need for operator intervention is limited.
If operator intervention cannot be avoided, it must be possible to carry
it out easily and in safety.
1.6.5.Cleaning of internal parts
The machinery must be designed and constructed in such a way that it
is possible to clean internal parts which have contained dangeroussubstances or preparations without entering them; any necessaryunblocking must also be possible from the outside. If it is absolutelyimpossible to avoid entering the machinery, the manufacturer musttake steps during its construction to allow cleaning to take place withthe minimum of danger.
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1.7.Indicators
1.7.0.Information devices
The information needed to control machinery must be unambiguous
and easily understood.
It must not be excessive to the extent of overloading the operator.Where the health and safety of exposed persons may be endangered by
a fault in the operation of unsupervised machinery, the machinery mustbe equipped to give an appropriate acoustic or light signal as awarning.
1.7.1.Warning devices
Where machinery is equipped with warning devices (such as signals,
etc.), these must be unambiguous and easily perceived.
The operator must have facilities to check the operation of such
warning devices at all times.
The requirements of the specific Directives concerning colours and
safety signals must be complied with.
1.7.2.Warning of residual risks
Where risks remain despite all the measures adopted or in the case of
potential risks which are not evident (e.g. electrical cabinets, radioac-tive sources, bleeding of a hydraulic circuit, hazard in an unseen area,etc.), the manufacturer must provide warnings.
Such warnings should preferably use readily understandable picto-
grams and/or be drawn up in one of the languages of the country inwhich the machinery is to be used, accompanied, on request, by thelanguages understood by the operators.
1.7.3.Marking
All machinery must be marked legibly and indelibly with the following
minimum particulars:
— name and address of the manufacturer,
— the CE marking (see Annex III),— designation of series or type,— serial number, if any,— the year of construction.
Furthermore, where the manufacturer constructs machinery intended
for use in a potentially explosive atmosphere, this must be indicated onthe machinery.
Machinery must also bear full information relevant to its type and
essential to its safe use (e.g. maximum speed of certain rotating parts,maximum diameter of tools to be fitted, mass, etc.).
Where a machine part must be handled during use with lifting equip-
ment, its mass must be indicated legibly, indelibly and unambiguously.
The interchangeable equipment referred to in the third indent of Article
1(2)(a), must bear the same information.
1.7.4.Instructions
(a) All machinery must be accompanied by instructions including at
least the following:
— a repeat of the information with which the machinery is
marked, except the serial number (see 1.7.3) together with anyappropriate additional information to facilitate maintenance(e.g. addresses of the importer, repairers, etc.),
— foreseen use of the machinery within the meaning of 1.1.2(c),— workstation(s) likely to be occupied by operators,— instructions for safe:
— putting into service,
— use,— handling, giving the mass of the machinery and its various
parts where they are regularly to be transported separately,
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— assembly, dismantling,
— adjustment,— maintenance (servicing and repair),
— where necessary, training instructions,— where necessary, the essential characteristics of tools which
may be fitted to the machinery.
Where necessary, the instructions should draw attention to ways in
which the machinery should not be used.
(b) The instructions must be drawn up in one of the Community
languages by the manufacturer or his authorised representativeestablished in the Community. On being put into service, allmachinery must be accompanied by a translation of the instruc-tions in the language or languages of the country in which themachinery is to be used any by the instructions in the originallanguage. This translation must be done either by the manufactureror his authorised representative established in the Community orby the person introducing the machinery into the language area inquestion. By way of derogation from this requirement, the mainte-nance instructions for use by specialised personnel employed bythe manufacturer or his authorised representative established in theCommunity may be drawn up in only one of the Communitylanguages understood by that personnel.
(c) The instructions must contain the drawings and diagrams neces-
sary for putting into service, maintenance, inspection, checking ofcorrect operation and, where appropriate, repair of the machinery,and all useful instructions in particular with regard to safety.
(d) Any literature describing the machinery must not contradict the
instructions as regards safety aspects. The technical documentationdescribing the machinery must give information regarding theairborne noise emissions referred to in (f) and, in the case ofhand-held and/or hand-guided machinery, information regardingvibration as referred to in 2.2.
(e) Where necessary, the instructions must give the requirements
relating to installation and assembly for reducing noise or vibra-tion (e.g. use of dampers, type and mass of foundation block, etc.).
(f) The instructions must give the following information concerning
airborne noise emissions by the machinery, either the actual valueor a value established on the basis of measurements made onidentical machinery:
— equivalent continuous A-weighted sound pressure level at
workstations, where this exceeds 70 dB(A); where this leveldoes not exceed 70 dB(A), this fact must be indicated,
— peak C-weighted instantaneous sound pressure value at work-
stations, where this exceeds 63 Pa (130 dB in relation to20 µPa),
— sound power level emitted by the machinery where the equiva-
lent continuous A-weighted sound pressure level at worksta-tions exceeds 85 dB(A).
In the case of very large machinery, instead of the sound power
level, the equivalent continuous sound pressure levels at specifiedpositions around the machinery may be indicated.
Where the harmonised standards are not applied, sound levels
must be measured using the most appropriate method for themachinery.
The manufacturer must indicate the operating conditions of the
machinery during measurement and what methods have been usedfor the measurement.
Where the workstation(s) are undefined or cannot be defined,
sound pressure levels must be measured at a distance of 1 metrefrom the surface of the machinery and at a height of 1,60 metresfrom the floor or access platform. The position and value of themaximum sound pressure must be indicated.
(g) If the manufacturer foresees that the machinery will be used in a
potentially explosive atmosphere, the instructions must give all thenecessary information.
(h) In the case of machinery which may also be intended for use by
non-professional operators, the wording and layout of the instruc-tions for use, whilst respecting the other essential requirementsmentioned above, must take into account the level of general
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education and acumen that can reasonably be expected from such
operators.
2. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR
CERTAIN CATEGORIES OF MACHINERY
2.1.Agri-foodstuffs machinery
Where machinery is intended to prepare and process foodstuffs (e.g.
cooking, refrigeration, thawing, washing, handling, packaging, storage,transport or distribution), it must be so designed and constructed as toavoid any risk of infection, sickness or contagion and the followinghygiene rules must be observed:
(a) materials in contact, or intended to come into contact, with the
foodstuffs must satisfy the conditions set down in the relevantDirectives. The machinery must be so designed and constructedthat these materials can be clean before each use;
(b) all surfaces including their joinings must be smooth, and must
have neither ridges nor crevices which could harbour organicmaterials;
(c) assemblies must be designed in such a way as to reduce projec-
tions, edges and recesses to a minimum. They should preferably bemade by welding or continuous bonding. Screws, screwheads andrivets may not be used except where technically unavoidable;
(d) all surfaces in contact with the foodstuffs must be easily cleaned
and disinfected, where possible after removing easily dismantledparts. The inside surfaces must have curves of a radius sufficientto allow thorough cleaning;
(e) liquid deriving from foodstuffs as well as cleaning, disinfecting
and rinsing fluids should be able to be discharged from themachine without impediment (possible in a ‘clean' position);
(f) machinery must be so designed and constructed as to prevent any
liquids or living creatures, in particular insects, entering, or anyorganic matter accumulating in areas that cannot be cleaned (e.g.for machinery not mounted on feet or casters, by placing a sealbetween the machinery and its base, by the use of sealed units,etc.);
(g) machinery must be so designed and constructed that no ancillary
substances (e.g. lubricants, etc.) can come into contact with food-stuffs. Where necessary, machinery must be designed andconstructed so that continuing compliance with this requirementcan be checked.
Instructions
In addition to the information required in section 1, the instructions
must indicate recommended products and methods for cleaning, disin-fecting and rinsing (not only for easily accessible areas but also whereareas to which access is impossible or unadvisable, such as piping,have to be cleaned in situ ).
2.2.Portable hand-held and/or hand-guided machinery
Portable hand-held and/or hand-guided machinery must conform to the
following essential health and safety requirements:
— according to the type of machinery, it must have a supporting
surface of sufficient size and have a sufficient number of handlesand supports of an appropriate size and arranged to ensure thestability of the machinery under the operating conditions foreseenby the manufacturer,
— except where technically impossible or where there is an indepen-
dent control, in the case of handles which cannot be released incomplete safety, it must be fitted with start and stop controlsarranged in such a way that the operator can operate them withoutreleasing the handles,
— it must be designed, constructed or equipped to eliminate the risks
of accidental starting and/or continued operation after the operatorhas released the handles. Equivalent steps must be taken if thisrequirement is not technically feasible,
— portable hand-held machinery must be designed and constructed to
allow, where necessary, a visual check of the contact of the toolwith the material being processed.
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Instructions
The instructions must give the following information concerning vibra-
tions transmitted by hand-held and hand-guided machinery:
— the weighted root mean square acceleration value to which the
arms are subjected, if it exceeds 2,5 m/s2as determined by the
appropriate test code. Where the acceleration does not exceed2,5 m/s
2, this must be mentioned.
If there is no applicable test code, the manufacturer must indicate the
measurement methods and conditions under which measurements weremade.
2.3.Machinery for working wood and analogous materials
Machinery for working wood and machinery for working materials
with physical and technological characteristics similar to those ofwood, such as cork, bone, hardened rubber, hardened plastic materialand other similar stiff material must conform to the following essentialhealth and safety requirements:
(a) the machinery must be designed, constructed or equipped so that
the piece being machined can be placed and guided in safety;where the piece is hand-held on a work-bench the latter must besufficiently stable during the work and must not impede the move-ment of the piece;
(b) where the machinery is likely to be used in conditions involving
the risk of ejection of pieces of wood, it must be designed,constructed, or equipped to eliminate this ejection, or, if this is notthe case, so that the ejection does not engender risks for theoperator and/or exposed persons;
(c) the machinery must be equipped with an automatic brake that
stops the tool in a sufficiently short time if there is a risk ofcontact with the tool whilst it runs down;
(d) where the tool is incorporated into a non-fully automated machine,
the latter must be so designed and constructed as to eliminate orreduce the risk of serious accidental injury, for example by usingcylindrical cutter blocks, restricting depth of cut, etc.
3. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO
OFFSET THE PARTICULAR HAZARDS DUE TO THE MOBILITYOF MACHINERY
Machinery presenting hazards due to mobility must be designed and
constructed to meet the requirements set out below.
Risks due to mobility always exist in the case of machinery which is
self-propelled, towed or pushed or carried by other machinery ortractors, is operated in working areas and whose operation requireseither mobility while working, be it continuous or semi-continuousmovement, between a succession of fixed working positions.
Risks due to mobility may also exist in the case of machinery operated
without being moved, but equipped in such a way as to enable it to bemoved more easily from one place to another (machinery fitted withwheels, rollers, runners, etc. or placed on gantries, trolleys, etc.).
In order to verify that rotary cultivators and power harrows do not
present unacceptable risks to the exposed persons, the manufacturer orhis authorised representative established within the Community must,for each type of machinery concerned, perform the appropriate tests orhave such tests performed.
3.1.General
3.1.1.Definition
‘Driver' means an operator responsible for the movement of machi-
nery. The driver may be transported by the machinery or may be onfoot, accompanying the machinery, or may be guiding the machineryby remote control (cables, radio, etc.).
3.1.2.Lighting
If intended by the manufacturer to be used in dark places, self-
propelled machinery must be fitted with a lighting device appropriate
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to the work to be carried out, without prejudice to any other regula-
tions applicable (road traffic regulations, navigation rules, etc.).
3.1.3.Design of machinery to facilitate its handling
During the handling of the machine and/or its parts, there must be no
possibility of sudden movements or of hazards due to instability aslong as the machine and/or its parts are handled in accordance with themanufacturer’s instructions.
3.2.Work stations
3.2.1.Driving position
The driving position must be designed with due regard to ergonomic
principles. There may be two or more driving positions and, in suchcases, each driving position must be provided with all the requisitecontrols. Where there is more than one driving position, the machinerymust be designed so that the use of one of them precludes the use ofthe others, except in emergency stops. Visibility from the drivingposition must be such that the driver can in complete safety for himselfand the exposed persons, operate the machinery and its tools in theirintended conditions of use. Where necessary, appropriate devices mustbe provided to remedy hazards due to inadequate direct vision.
Machinery must be so designed and constructed that, from the driving
position, there can be no risk to the driver and operators on board frominadvertent contact with the wheels or tracks.
The driving position must be designed and constructed so as to avoid
any health risk due to exhaust gases and/or lack of oxygen.
The driving position of ride-on drivers must be so designed and
constructed that a driver’s cab may be fitted as long as there is room.In that case, the cab must incorporate a place for the instructionsneeded for the driver and/or operators. The driving position must befitted with an adequate cab where there is a hazard due to a dangerousenvironment.
Where the machinery is fitted with a cab, this must be designed,
constructed and/or equipped to ensure that the driver has good oper-ating conditions and is protected against any hazards that might exist(for instance: inadequate heating and ventilation, inadequate visibility,excessive noise and vibration, falling objects, penetration by objects,rolling over, etc.). The exit must allow rapid evacuation. Moreover, anemergency exit must be provided in a direction which is different fromthe usual exit.
The materials used for the cab and its fittings must be fire-resistant.
3.2.2.Seating
The driving seat of any machinery must enable the driver to maintain a
stable position and be designed with due regard to ergonomic princi-ples.
The seat must be designed to reduce vibrations transmitted to the
driver to the lowest level that can be reasonably achieved. The seatmountings must withstand all stresses to which they can be subjected,notably in the event of rollover. Where there is no floor beneath thedriver’s feet, the driver must have footrests covered with a slip-resistant material.
Where machinery is fitted with provision for a rollover protection
structure, the seat must be equipped with a safety belt or equivalentdevice which keeps the driver in his seat without restricting anymovements necessary for driving or any movements caused by thesuspension.
3.2.3.Other places
If the conditions of use provide that operators other than the driver are
occasionally or regularly transported by the machinery, or work on it,appropriate places must be provided which enable them to be trans-ported or to work on it without risk, particularly the risk of falling.
Where the working conditions so permit, these work places must be
equipped with seats.
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Should the driving position have to be fitted with a cab, the other
places must also be protected against the hazards which justified theprotection of the driving position.
3.3.Controls
3.3.1.Control devices
The driver must be able to actuate all control devices required to
operate the machinery from the driving position, except for functionswhich can be safely activated only by using control devices locatedaway from the driving position. This refers in particular to workingpositions other than the driving position, for which operators otherthan the driver are responsible or for which the driver has to leave hisdriving position in order to carry out the manoeuvre in safety.
Where there are pedals they must be so designed, constructed and
fitted to allow operation by the driver in safety with the minimum riskof confusion; they must have a slip-resistant surface and be easy toclean.
Where their operation can lead to hazards, notably dangerous move-
ments, the machinery’s controls, except for those with preset positions,must return to the neutral position as soon as they are released by theoperator.
In the case of wheeled machinery, the steering system must be
designed and constructed to reduce the force of sudden movements ofthe steering wheel or steering lever caused by shocks to the guidewheels.
Any control that locks the differential must be so designed and
arranged that it allows the differential to be unlocked when the machi-nery is moving.
The last sentence of section 1.2.2 does not apply to the mobility
function.
3.3.2.Starting/moving
Self-propelled machinery with a ride-on driver must be so equipped as
to deter unauthorised persons from starting the engine.
Travel movements of self-propelled machinery with a ride-on driver
must be possible only if the driver is at the controls.
Where, for operating purposes, machinery must be fitted with devices
which exceed its normal clearance zone (e.g. stabilisers, jib, etc.), thedriver must be provided with the means of checking easily, beforemoving the machinery, that such devices are in a particular positionwhich allows safe movement.
This also applies to all other parts which, to allow safe movement,
have to be in particular positions, locked if necessary.
Where it is technically and economically feasible, movement of the
machinery must depend on safe positioning of the aforementionedparts.
It must not be possible for movement of the machinery to occur while
the engine is being started.
3.3.3.Travelling function
Without prejudice to the provisions of road traffic regulations, self-
propelled machinery and its trailers must meet the requirements forslowing down, stopping, braking and immobilisation so as to ensuresafety under all the operating, loading, speed, ground and gradientconditions allowed for by the manufacturer and corresponding toconditions encountered in normal use.
The driver must be able to slow down and stop self-propelled machi-
nery by means of a main device. Where safety so requires in the eventof a failure of the main device, or in the absence of the energy supplyto actuate the main device, an emergency device with fully indepen-dent and easily accessible controls must be provided for slowing downand stopping.
Where safety so requires, a parking device must be provided to render
stationary machinery immobile. This device may be combined with
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one of the devices referred to in the second paragraph, provided that it
is purely mechanical.
Remote-controlled machinery must be designed and constructed to
stop automatically if the driver loses control.
Section 1.2.4 does not apply to the travelling function.
3.3.4.Movement of pedestrian-controlled machinery
Movement of pedestrian-controlled self-propelled machinery must be
possible only through sustained action on the relevant control by thedriver. In particular, it must not be possible for movement to occurwhile the engine is being started.
The control systems for pedestrian-controlled machinery must be
designed to minimise the hazards arising from inadvertent movementof the machine towards the driver. In particular:
(a) crushing;
(b) injury from rotating tools.
Also, the speed of normal travel of the machine must be compatible
with the pace of a driver on foot.
In the case of machinery on which a rotary tool may be fitted, it must
not be possible to actuate that tool when the reversing control isengaged, except where movement of the machinery results from move-ment of the tool. In the latter case, the reversing speed must be suchthat it does not endanger the driver.
3.3.5.Control circuit failure
A failure in the power supply to the power-assisted steering, where
fitted, must not prevent machinery from being steered during the timerequired to stop it.
3.4.Protection against mechanical hazards
3.4.1.Uncontrolled movements
When a part of a machine has been stopped, any drift away from the
stopping position, for whatever reason other than action at the controls,must be such that it is not a hazard to exposed persons.
Machinery must be so designed, constructed and where appropriate
placed on its mobile support so as to ensure that when moved theuncontrolled oscillations of its centre of gravity do not affect itsstability or exert excessive strain on its structure.
3.4.2.Risk of break-up during operation
Parts of machinery rotating at high speed which, despite the measures
taken, may break up or disintegrate, must be mounted and guarded insuch a way that, in case of breakage, their fragments will be containedor, if that is not possible, cannot be projected towards the drivingand/or operation positions.
3.4.3.Rollover
Where, in the case of self-propelled machinery with a ride-on driver
and possibly ride-on operators, there is a risk of rolling over, themachinery must be designed for and be fitted with anchorage pointsallowing it to be equipped with a rollover protective structure (ROPS).
This structure must be such that in case of rolling over it affords the
ride-on driver and where appropriate the ride-on operators an adequatedeflection-limiting volume (DLV).
In order to verify that the structure complies with the requirement laid
down in the second paragraph, the manufacturer or his authorisedrepresentative established within the Community must, for each typeof structure concerned, perform appropriate tests or have such testsperformed.
In addition, the earth-moving machinery listed below with a capacity
exceeding 15 kW must be fitted with a rollover protective structure:
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— crawler loaders or wheel loaders,
— backhoe loaders,— crawler tractors or wheel tractors,— scrapers, self-loading or not,— graders,— articulated steer dumpers.
3.4.4.Falling objects
Where, in the case of machinery with a ride-on driver and possibly
ride-on operators, there is a risk due to falling objects or material, themachinery should be designed for, and fitted with, if its size allows,anchorage points allowing it to be equipped with a falling-objectprotective structure (FOPS).
This structure must be such that in the case of falling objects or
material, it guarantees the ride-on operators an adequate deflection-limiting volume (DLV).
In order to verify that the structure complies with the requirement laid
down in the second paragraph, the manufacturer or his authorisedrepresentative established within the Community must, for each typeof structure concerned, perform appropriate tests or have such testsperformed.
3.4.5.Means of access
Handholds and steps must be designed, constructed and arranged in
such a way that the operators use them instinctively and do not use thecontrols for that purpose.
3.4.6.Towing devices
All machinery used to tow or to be towed must be fitted with towing
or coupling devices designed, constructed and arranged to ensure easyand safe connection and disconnection, and to prevent accidentaldisconnection during use.
In so far as the towbar load requires, such machinery must be equipped
with a support with a bearing surface suited to the load and the ground.
3.4.7.Transmission of power between self-propelled machinery (or tractor)
and recipient machinery
Transmission shafts with universal joints linking self-propelled machi-
nery (or tractor) to the first fixed bearing of recipient machinery mustbe guarded on the self-propelled machinery side and the recipientmachinery side over the whole length of the shaft and associateduniversal joints.
On the side of the self-propelled machinery (or tractor), the power
take-off to which the transmission shaft is attached must be guardedeither by a screen fixed to the self-propelled machinery (or tractor) orby any other device offering equivalent protection.
On the towed machinery side, the input shaft must be enclosed in a
protective casing fixed to the machinery.
Torque limiters or freewheels may be fitted to universal joint transmis-
sions only on the side adjoining the driven machine. The universal-joint transmission shaft must be marked accordingly.
All towed machinery whose operation requires a transmission shaft to
connect it to self-propelled machinery or a tractor must have a systemfor attaching the transmission shaft so that when the machinery isuncoupled the transmission shaft and its guard are not damaged bycontact with the ground or part of the machinery.
The outside parts of the guard must be so designed, constructed and
arranged that they cannot turn with the transmission shaft. The guardmust cover the transmission shaft to the ends of the inner jaws in thecase of simple universal joints and at least to the centre of the outerjoint or joints in the case of ‘wide-angle' universal joints.
Manufacturers providing means of access to working positions near to
the universal joint transmission shaft must ensure that shaft guards asdescribed in the sixth paragraph cannot be used as steps unlessdesigned and constructed for that purpose
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3.4.8.Moving transmission parts
By way of derogation from section 1.3.8.A, in the case of internal
combustion engines, removable guards preventing access to themoving parts in the engine compartment need not have locking devicesif they have to be opened either by the use of a tool or key or by acontrol located in the driving position if the latter is in a fully enclosedcab with a lock to prevent unauthorised access.
3.5.Protection against other hazards
3.5.1.Batteries
The battery housing must be constructed and located and the battery
installed so as to avoid as far as possible the chance of electrolytebeing ejected on to the operator in the event of rollover and/or to avoidthe accumulation of vapours in places occupied by operators.
Machinery must be so designed and constructed that the battery can be
disconnected with the aid of an easily accessible device provided forthat purpose.
3.5.2.Fire
Depending on the hazards anticipated by the manufacturer when in
use, machinery must, where its size permits:
— either allow easily accessible fire extinguishers to be fitted,
— or be provided with built-in extinguisher systems.
3.5.3.Emissions of dust, gases, etc.
Where such hazards exist, the containment equipment provided for in
section 1.5.13 may be replaced by other means, for example precipita-tion by water spraying.
The second and third paragraphs of section 1.5.13 do not apply where
the main function of the machinery is the spraying of products.
3.6.Indications
3.6.1.Signs and warning
Machinery must have means of signalling and/or instruction plates
concerning use, adjustment and maintenance, wherever necessary, toensure the health and safety of exposed persons. They must be chosen,designed and constructed in such a way as to be clearly visible andindelible.
Without prejudice to the requirements to be observed for travelling on
the public highway, machinery with a ride-on driver must have thefollowing equipment:
— an acoustic warning device to alert exposed persons,
— a system of light signals relevant to the intended conditions of use
such as stop lamps, reversing lamps and rotating beacons. Thelatter requirement does not apply to machinery intended solely forunderground working and having no electrical power.
Remote-controlled machinery which under normal conditions of use
exposes persons to the hazards of impact or crushing must be fittedwith appropriate means to signal its movements or with means toprotect exposed persons against such hazards. The same applies tomachinery which involves, when in use, the constant repetition of aforward and backward movement on a single axis where the back ofthe machine is not directly visible to the driver.
Machinery must be so constructed that the warning and signalling
devices cannot all be disabled unintentionally. Where this is essentialfor safety, such devices must be provided with the means to check thatthey are in good working order and their failure must be madeapparent to the operator.
Where the movement of machinery or its tools is particularly hazar-
dous, signs on the machinery must be provided to warn againstapproaching the machinery while it is working; the signs must belegible at a sufficient distance to ensure the safety of persons who haveto be in the vicinity.
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3.6.2.Marking
The minimum requirements set out in 1.7.3 must be supplemented by
the following:
— nominal power expressed in kW,
— mass in kg of the most usual configuration and, where appropriate:
— maximum drawbar pull provided for by the manufacturer at the
coupling hook, in N,
— maximum vertical load provided for by the manufacturer on
the coupling hook, in N.
3.6.3.Instruction handbook
Apart from the minimum requirements set out in 1.7.4, the instruction
handbook must contain the following information:
(a) regarding the vibrations emitted by the machinery, either the
actual value or a figure calculated from measurements performedon identical machinery:
— the weighted root mean square acceleration value to which the
arms are subjected, if it exceeds 2,5 m/s
2, should it not exceed
2,5 m/s2, this must be mentioned,
— the weighted root mean square acceleration value to which the
body (feet or posterior) is subjected, if it exceeds 0,5 m/s2,
should it not exceed 0,5 m/s2, this must be mentioned.
Where the harmonised standards are not applied, the vibration
must be measured using the most appropriate method for themachinery concerned.
The manufacturer must indicate the operating conditions of the
machinery during measurement and which methods were used fortaking the measurements;
(b) in the case of machinery allowing several uses depending on the
equipment used, manufacturers of basic machinery to which inter-changeable equipment may be attached and manufacturers of theinterchangeable equipment must provide the necessary informationto enable the equipment to be fitted and used safely.
4. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO
OFFSET THE PARTICULAR HAZARDS DUE TO A LIFTINGOPERATION
Machinery presenting hazards due to lifting operations — mainly
hazards of load falls and collisions or hazards of tipping caused by alifting operation — must be designed and constructed to meet therequirements set out below.
Risks due to a lifting operation exist particularly in the case of machi-
nery designed to move a unit load involving a change in level duringthe movement. The load may consist of objects, materials or goods.
4.1.General remarks
4.1.1.Definitions
(a) ‘lifting accessories' means components or equipment not attached
to the machine and placed between the machinery and the load oron the load in order to attach it;
(b) ‘separate lifting accessories'means accessories which help to make
up or use a slinging device, such as eyehooks, shackles, rings,eyebolts, etc.;
(c) ‘guided load' means the load where the total movement is made
along rigid or flexible guides, whose position is determined byfixed points;
(d) ‘working coefficient' means the arithmetic ratio between the load
guaranteed by the manufacturer up to which a piece of equipment,an accessory or machinery is able to hold it and the maximumworking load marked on the equipment, accessory or machineryrespectively;
(e) ‘test coefficient' means the arithmetic ratio between the load used
to carry out the static or dynamic tests on a piece of equipment, anaccessory or machinery and the maximum working load markedon the piece of equipment, accessory or machinery;
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(f) ‘static test' means the test during which the machinery or the
lifting accessory is first inspected and subjected to a force corre-sponding to the maximum working load multiplied by the appro-priate static test coefficient and then re-inspected once the saidload has been released to ensure no damage has occurred;
(g) ‘dynamic test' means the test during which the machinery is oper-
ated in all its possible configurations at maximum working loadwith account being taken of the dynamic behaviour of the machi-nery in order to check that the machinery and safety features arefunctioning properly.
4.1.2.Protection against mechanical hazards
4.1.2.1. Risks due to lack of stability
Machinery must be so designed and constructed that the stability
required in 1.3.1 is maintained both in service and out of service,including all stages of transportation, assembly and dismantling, duringforeseeable component failures and also during the tests carried out inaccordance with the instruction handbook.
To that end, the manufacturer or his authorised representative estab-
lished within the Community must use the appropriate verificationmethods; in particular, for self-propelled industrial trucks with liftexceeding 1,80 m, the manufacturer or his authorised representativeestablished within the Community must, for each type of industrialtruck concerned, perform a platform stability test or similar test, orhave such tests performed.
4.1.2.2. Guide rails and rail tracks
Machinery must be provided with devices which act on the guide rails
or tracks to prevent derailment.
However, if derailment occurs despite such devices, or if there is a
failure of a rail or of a running component, devices must be providedwhich prevent the equipment, component or load from falling or themachine overturning.
4.1.2.3. Mechanical strength
Machinery, lifting accessories and removable components must be
capable of withstanding the stresses to which they are subjected, bothin and, where applicable, out of use, under the installation and oper-ating conditions provided for by the manufacturer, and in all relevantconfigurations, with due regard, where appropriate, to the effects ofatmospheric factors and forces exerted by persons. This requirementmust also be satisfied during transport, assembly and dismantling.
Machinery and lifting accessories must be designed and constructed so
as to prevent failure from fatigue or wear, taking due account of theirintended use.
The materials used must be chosen on the basis of the working
environments provided for by the manufacturer, with special referenceto corrosion, abrasion, impacts, cold brittleness and ageing.
The machinery and the lifting accessories must be designed and
constructed to withstand the overload in the static tests without perma-nent deformation or patent defect. The calculation must take accountof the values of the static test coefficient chosen to guarantee anadequate level of safety: that coefficient has, as a general rule, thefollowing values:
(a) manually-operated machinery and lifting accessories: 1,5;
(b) other machinery: 1,25.
Machinery must be designed and constructed to undergo, without
failure, the dynamic tests carried out using the maximum working loadmultiplied by the dynamic test coefficient. This dynamic test coeffi-cient is chosen so as to guarantee an adequate level of safety: thecoefficient is, as a general rule, equal to 1,1.
The dynamic tests must be performed on machinery ready to be put
into service under normal conditions of use. As a general rule, the testswill be performed at the nominal speeds laid down by the manufac-turer. Should the control circuit of the machinery allow for a numberof simultaneous movements (for example, rotation and displacement ofthe load), the tests must be carried out under the least favourable
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conditions, i.e. as a general rule, by combining the movements
concerned.
4.1.2.4. Pulleys, drums, chains or ropes
Pulleys, drums and wheels must have a diameter commensurate with
the size of rope or chains with which they can be fitted.
Drums and wheels must be so designed, constructed and installed that
the ropes or chains with which they are equipped can wind roundwithout falling off.
Ropes used directly for lifting or supporting the load must not include
any splicing other than at their ends (splicings are tolerated in installa-tions which are intended from their design to be modified regularlyaccording to needs of use). Complete ropes and their endings have aworking coefficient chosen so as to guarantee an adequate level ofsafety; as a general rule, this coefficient is equal to five.
Lifting chains have a working coefficient chosen so as to guarantee an
adequate level of safety; as a general rule, this coefficient is equal tofour.
In order to verify that an adequate working coefficient has been
attained, the manufacturer or his authorised representative establishedwithin the Community must, for each type of chain and rope useddirectly for lifting the load, and for the rope ends, perform the appro-priate tests or have such tests performed.
4.1.2.5. Separate lifting accessories
Lifting accessories must be sized with due regard to fatigue and ageing
processes for a number of operating cycles consistent with theirexpected life-span as specified in the operating conditions for a givenapplication.
Moreover:
(a) the working coefficient of the metallic rope/rope-end combination
is chosen so as to guarantee an adequate level of safety; thiscoefficient is, as a general rule, equal to five. Ropes must notcomprise any splices or loops other than at their ends;
(b) where chains with welded links are used, they must be of the
short-link type. The working coefficient of chains of any type ischosen so as to guarantee an adequate level of safety; this coeffi-cient is, as a general rule, equal to four;
(c) the working coefficient for textile ropes or slings is dependent on
the material, method of manufacture, dimensions and use. Thiscoefficient is chosen so as to guarantee an adequate level of safety;it is, as a general rule, equal to seven, provided the materials usedare shown to be of very good quality and the method of manufac-ture is appropriate to the intended use. Should this not be the case,the coefficient is, as a general rule, set at a higher level in order tosecure an equivalent level of safety.
Textile ropes and slings must not include any knots, connections
or splicing other than at the ends of the sling, except in the case ofan endless sling;
(d) all metallic components making up, or used with, a sling must
have a working coefficient chosen so as to guarantee an adequatelevel of safety; this coefficient is, as a general rule, equal to four;
(e) the maximum working capacity of a multilegged sling is deter-
mined on the basis of the safety coefficient of the weakest leg, thenumber of legs and a reduction factor which depends on theslinging configuration;
(f) in order to verify that an adequate working coefficient has been
attained, the manufacturer or his authorised representative estab-lished within the Community must, for each type of componentreffered to in (a), (b), (c) and (d) perform the appropriate tests orhave such tests performed.
4.1.2.6. Control of movements
Devices for controlling movements must act in such a way that the
machinery on which they are installed is kept safe:
(a) machinery must be so designed or fitted with devices that the
amplitude of movement of its components is kept within the
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specified limits. The operation of such devices must, where appro-
priate, be preceded by a warning;
(b) where several fixed or rail-mounted machines can be manoeuvred
simultaneously in the same place, with risks of collision, suchmachines must be so designed and constructed as to make itpossible to fit systems enabling these risks to be avoided;
(c) the mechanisms of machinery must be so designed and constructed
that the loads cannot creep dangerously or fall freely and unex-pectedly, even in the event of partial or total failure of the powersupply or when the operator stops operating the machine;
(d) it must not be possible, under normal operating conditions, to
lower the load solely by friction brake, except in the case ofmachinery whose function requires it to operate in that way;
(e) holding devices must be so designed and constructed that inadver-
tent dropping of the loads is avoided.
4.1.2.7. Handling of loads
The driving position of machinery must be located in such a way as to
ensure the widest possible view of trajectories of the moving parts, inorder to avoid possible collisions with persons or equipment or othermachinery which might be manoeuvring at the same time and liable toconstitute a hazard.
Machinery with guided loads fixed in one place must be designed and
constructed so as to prevent exposed persons from being hit by theload or the counter-weights.
4.1.2.8. Lightning
Machinery in need of protection against the effects of lightning while
being used must be fitted with a system for conducting the resultantelectrical charges to earth.
4.2.Special requirements for machinery whose power source is other
than manual effort
4.2.1.Controls
4.2.1.1. Driving position
The requirements laid down in section 3.2.1 also apply to non-mobile
machinery.
4.2.1.2. Seating
The requirements laid down in section 3.2.2, first and second para-
graphs, and those laid down in section 3.2.3 also apply to non-mobilemachinery.
4.2.1.3. Control devices
The devices controlling movements of the machinery or its equipment
must return to their neutral position as soon as they are released by theoperator. However, for partial or complete movements in which thereis no risk of the load or the machinery colliding, the said devices maybe replaced by controls authorising automatic stops at preselectedlevels without holding a hold-to-run control device.
4.2.1.4. Loading control
Machinery with a maximum working load of not less than 1 000 kilo-
grams or an overturning moment of not less than 40 000 Nm must befitted with devices to warn the driver and prevent dangerous move-ments of the load in the event of:
— overloading the machinery:
— either as a result of maximum working loads being exceeded,
or
— as a result of the moments due to the loads being exceeded,
— the moments conducive to overturning being exceeded as a result
of the load being lifted.
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4.2.2.Installation guided by cables
Cable carriers, tractors or tractor carriers must be held by counter-
weights or by a device allowing permanent control of the tension.
4.2.3.Risks to exposed persons. Means of access to driving position and
intervention points
Machinery with guided loads and machinery whose load supports
follow a clearly defined path must be equipped with devices to preventany risks to exposed persons.
Machinery serving specific levels at which operators can gain access to
the load platform in order to stack or secure the load must be designedand constructed to prevent uncontrolled movement of the load plat-form, in particular while being loaded or unloaded.
4.2.4.Fitness for purpose
When machinery is placed on the market or is first put into service, the
manufacturer or his authorised representative established within theCommunity must ensure, by taking appropriate measures or havingthem taken, that lifting accessories and machinery which are ready foruse — whether manually or power-operated — can fulfil their speci-fied functions safely. The said measures must take into account thestatic and dynamic aspects of the machinery.
Where the machinery cannot be assembled in the manufacturer’s prem-
ises, or in the premises of his authorised representative establishedwithin the Community, appropriate measures must be taken at theplace of use. Otherwise, the measures may be taken either in themanufacturer’s premises or at the place of use.
4.3.Marking
4.3.1.Chains and ropes
Each length of lifting chain, rope or webbing not forming part of an
assembly must bear a mark or, where this is not possible, a plate orirremovable ring bearing the name and address of the manufacturer orhis authorised representative established in the Community and theidentifying reference of the relevant certificate.
The certificate should show the information required by the harmo-
nised standards or, should those not exist, at least the following infor-mation:
— the name of the manufacturer or his authorised representative
established within the Community,
— the address within the Community of the manufacturer or his
authorised representative, as appropriate,
— a description of the chain or rope which includes:
— its nominal size,
— its construction,— the material from which it is made, and— any special metallurgical treatment applied to the material,
— if tested, the standard used,— a maximum load to which the chain or rope should be subjected in
service. A range of values may be given for specified applications.
4.3.2.Lifting accessories
All lifting accessories must show the following particulars:
— identification of the manufacturer,
— identification of the material (e.g. international classification)
where this information is needed for dimensional compatibility,
— identification of the maximum working load,— CE marking.
In the case of accessories including components such as cables or
ropes, on which marking is physically impossible, the particularsreferred to in the first paragraph must be displayed on a plate or bysome other means and securely affixed to the accessory.
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The particulars must be legible and located in a place where they are
not liable to disappear as a result of machining, wear, etc., or jeopar-dise the strength of the accessory.
4.3.3.Machinery
In addition to the minimum information provided for in 1.7.3, each
machine must bear, legibly and indelibly, information concerning thenominal load:
(i) displayed in uncoded form and prominently on the equipment in
the case of machinery which has only one possible value;
(ii) where the nominal load depends on the configuration of the
machine, each driving position must be provided with a load plateindicating, preferably in diagrammatic form or by means of tables,the nominal loads for each configuration.
Machinery equipped with a load support which allows access to
persons and involves a risk of falling must bear a clear and indeliblewarning prohibiting the lifting of persons. This warning must bevisible at each place where access is possible.
4.4.Instruction handbook
4.4.1.Lifting accessories
Each lifting accessory or each commercially indivisible batch of lifting
accessories must be accompanied with an instruction handbook settingout at least the following particulars:
— normal conditions of use,
— instructions for use, assembly and maintenance,— the limits of use (particularly for the accessories which cannot
comply with 4.1.2.6(e)).
4.4.2.Machinery
In addition to section 1.7.4, the instruction handbook must include the
following information:
(a) the technical characteristics of the machinery, and in particular:
— where appropriate, a copy of the load table described in
section 4.3.3(ii),
— the reactions at the supports or anchors and characteristics of
the tracks,
— where appropriate, the definition and the means of installation
of the ballast;
(b) the contents of the logbook, if the latter is not supplied with the
machinery;
(c) advice for use, particularly to offset the lack of direct sight of the
load by the operator;
(d) the necessary instructions for performing the tests before first
putting into service machinery which is not assembled on themanufacturer’s premises in the form in which it is to be used.
5. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR
MACHINERY INTENDED FOR UNDERGROUND WORK
Machinery intended for underground work must be designed and
constructed to meet the requirements set out below.
5.1.Risks due to lack of stability
Powered roof supports must be so designed and constructed as to
maintain a given direction when moving and not slip before and whilethey come under load and after the load has been removed. They mustbe equipped with anchorages for the top plates of the individualhydraulic props.
5.2.Movement
Powered roof supports must allow for unhindered movement of
exposed persons.
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5.3.Lighting
The requirements laid down in the third paragraph of section 1.1.4 do
not apply.
5.4.Control devices
The accelerator and brake controls for the movement of machinery
running on rails must be manual. The deadman’s control may befoot-operated, however.
The control devices of powered roof supports must be designed and
laid out so that, during displacement operations, operators are shelteredby a support in place. The control devices must be protected againstany accidental release.
5.5.Stopping
Self-propelled machinery running on rails for use in underground work
must be equipped with a deadman’s control acting on the circuitcontrolling the movement of the machinery.
5.6.Fire
The second indent of 3.5.2 is mandatory in respect of machinery which
comprises highly flammable parts.
The braking system of machinery meant for use in underground
working must be designed and constructed so as not to produce sparksor cause fires.
Machinery with heat engines for use in underground working must be
fitted only with internal combustion engines using fuel with a lowvaporising pressure and which exclude any spark of electrical origin.
5.7.Emissions of dust, gases, etc.
Exhaust gases from internal combustion engines must not be
discharged upwards.
6. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO
OFFSET THE PARTICULAR HAZARDS DUE TO THE LIFTINGOR MOVING OF PERSONS
Machinery presenting hazards due to the lifting or moving of persons
must be designed and constructed to meet the requirements set outbelow.
6.1.General
6.1.1.Definition
For the purposes of this Chapter, ‘carrier' means the device by which
persons are supported in order to be lifted, lowered or moved.
6.1.2.Mechanical strength
The working coefficients defined in heading 4 are inadequate for
machinery intended for the lifting or moving of persons and must, as ageneral rule, be doubled. The floor of the carrier must be designed andconstructed to offer the space and strength corresponding to themaximum number of persons and the maximum working load set bythe manufacturer.
6.1.3.Loadingcontrolfortypesofdevicemovedbypowerotherthanhuman
strength
The requirements of 4.2.1.4 apply regardless of the maximum working
load figure. This requirement does not apply to machinery in respect ofwhich the manufacturer can demonstrate that there is no risk of over-loading and/or overturning.
6.2.Controls
6.2.1. Where safety requirements do not impose other solutions:
The carrier must, as a general rule, be designed and constructed so that
persons inside have means of controlling movements upwards and
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downwards and, if appropriate, of moving the carrier horizontally in
relation to the machinery.
In operation, those controls must override the other devices controlling
the same movement, with the exception of the emergency stop devices.
The controls for these movements must be of the maintained command
type, except in the case of machinery serving specific levels.
6.2.2. If machinery for the lifting or moving of persons can be moved with
the carrier in a position other than the rest position, it must be designedand constructed so that the person or persons in the carrier have themeans of preventing hazards produced by the movement of the machi-nery.
6.2.3. Machinery for the lifting or moving of persons must be designed,
constructed or equipped so that excess speeds of the carrier do notcause hazards.
6.3.Risks of persons falling from the carrier
6.3.1. If the measures referred to in 1.1.15 are not adequate, carriers must be
fitted with a sufficient number of anchorage points for the number ofpersons possibly using the carrier, strong enough for the attachment ofpersonal protective equipment against the danger of falling.
6.3.2. Any trapdoors in floors or ceilings or side doors must open in a
direction which obviates any risk of falling should they open unexpect-edly.
6.3.3. Machinery for lifting or moving must be designed and constructed to
ensure that the floor of the carrier does not tilt to an extent whichcreates a risk of the occupants falling, including when moving.
The floor of the carrier must be slip-resistant.
6.4.Risks of the carrier falling or overturning
6.4.1. Machinery for the lifting or moving of persons must be designed and
constructed to prevent the carrier falling or overturning.
6.4.2. Acceleration and braking of the carrier or carrying vehicle, under the
control of the operator or triggered by a safety device and under themaximum load and speed conditions laid down by the manufacturer,must not cause any danger to exposed persons.
6.5.Markings
Where necessary to ensure safety, the carrier must bear the relevant
essential information.
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ANNEX II
A.Contents of the EC declaration of conformity for machinery(1)
The EC declaration of conformity must contain the following particulars:
— name and address of the manufacturer or his authorised representative
established in the Community (2),
— description of the machinery (3),
— all relevant provisions complied with by the machinery,— where appropriate, name and address of the notified body and number of
the EC type-examination certificate,
— where appropriate, the name and address of the notified body to which
the file has been forwarded in accordance with the first indent of Article8(2)(c),
— where appropriate, the name and address of the notified body which has
carried out the verification referred to in the second indent of Article8(2)(c),
— where appropriate, a reference to the harmonised standards,— where appropriate, the national technical standards and specifications
used,
— identification of the person empowered to sign on behalf of the manufac-
turer or his authorised representatives.
B.Contentsofthedeclarationbythemanufacturerorhisauthorisedrepre-
sentatives established in the Community (Article 4(2))
The manufacturer’s declaration referred to in Article 4(2) must contain the
following particulars:
— name and address of the manufacturer or the authorised representative,
— description of the machinery or machinery parts,— where appropriate, the name and address of the notified body and the
number of the EC type-examination certificate,
— where appropriate, the name and address of the notified body to which
the file has been forwarded in accordance with the first indent of Article8(2)(c),
— where appropriate, the name and address of the notified body which has
carried out the verification referred to in the second indent of Article8(2)(c),
— where appropriate, a reference to the harmonised standards,— a statement that the machinery must not be put into service until the
machinery into which it is to be incorporated has been declared inconformity with the provisions of the Directive,
— identification of the person signing.
C.Contents of the EC declaration of conformity for safety components
placed on the market separately(
1)
The EC declaration of conformity must contain the following particulars:
— name and address of the manufacturer or his authorised representative
established in the Community (2),
— description of the safety component (4),
— safety function fulfilled by the safety component, if not obvious from the
description,
— where appropriate, the name and address of the notified body and the
number of the EC type-examination certificate,
(1) This declaration must be drawn up in the same language as the original instructions
(see Annex I, section 1.7.4(b)) and must be either typewritten or handwritten in blockcapitals. It must be accompanied by a translation in one of the official languages ofthe country in which the machinery is to be used. This translation must be done inaccordance with the same conditions as for the translation of the instructions.
(
2) Business name and full address; authorised representatives must also give the busi-
ness name and address of the manufacturer.
(3) Description of the machinery (make, type, serial number, etc.).
(4) Description of the safety component (make, type, serial number, if any, etc.).
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— where appropriate, the name and address of the notified body to which
the file was forwarded in accordance with the first indent of Article8(2)(c),
— where appropriate, the name and address of the notified body which
carried out the verification referred to in the second indent of Article8(2)(c),
— where appropriate, a reference to the harmonised standards,— where appropriate, the national technical standards and specifications
used,
— identification of the person empowered to sign on behalf of the manufac-
turer or his authorised representative established in the Community.
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ANNEX III
CE CONFORMITY MARKING
— The CE conformity marking shall consist of the initials ‘CE' taking the
following form:
— if the CE marking is reduced or enlarged the proportions given in the above
drawing must be respected,
— the various components of the CE marking must have substantially the same
vertical dimension, which may not be less than 5 mm. This minimum dimen-sion may be waived for small-scale machinery.
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ANNEX IV
TYPES OF MACHINERY AND SAFETY COMPONENTS FOR WHICH
THEPROCEDUREREFERREDTOINARTICLE8(2)(b)AND(c)MUST
BE APPLIED
A.Machinery
1. Circular saws (single or multi-blade) for working with wood and
analogous materials or for working with meat and analogous materials.
1.1. Sawing machines with fixed tool during operation, having a fixed bed
with manual feed of the workpiece or with a demountable power feed.
1.2. Sawing machines with fixed tool during operation, having a manually
operated reciprocating saw-bench or carriage.
1.3. Sawing machines with fixed tool during operation, having a built-in
mechanical feed device for the work-pieces, with manual loadingand/or unloading.
1.4. Sawing machines with movable tool during operation, with a mechan-
ical feed device and manual loading and/or unloading.
2. Hand-fed surface planing machines for woodworking.3. Thicknessers for one-side dressing with manual loading and/or
unloading for woodworking.
4. Band-saws with a fixed or mobile bed and band-saws with a mobile
carriage, with manual loading and/or unloading, for working withwood and analogous materials or for working with meat and analogousmaterials.
5. Combined machines of the types referred to in 1 to 4 and 7 for working
with wood and analogous materials.
6. Hand-fed tenoning machines with several tool holders for wood-
working.
7. Hand-fed vertical spindle moulding machines for working with wood
and analogous materials.
8. Portable chainsaws for woodworking.9. Presses, including press-brakes, for the cold working of metals, with
manual loading and/or unloading, whose movable working parts mayhave a travel exceeding 6 mm and a speed exceeding 30 mm/s.
10. Injection or compression plastics-moulding machines with manual
loading or unloading.
11. Injection or compression rubber-moulding machines with manual
loading or unloading.
12. Machinery for underground working of the following types:
— machinery on rails: locomotivies and brake-vans,
— hydraulic-powered roof supports,— internal combustion engines to be fitted to machinery for under-
ground working.
13. Manually-loaded trucks for the collection of household refuse incorpor-
ating a compression mechanism.
14. Guards and detachable transmission shafts with universal joints as
described in section 3.4.7.
15. Vehicles servicing lifts.16. Devices for the lifting of persons involving a risk of falling from a
vertical height of more than three metres.
17. Machines for the manufacture of pyrotechnics.
B.Safety components
1. Electro-sensitive devices designed specifically to detect persons in
order to ensure their safety (non-material barriers, sensor mats, electro-magnetic detectors, etc.).
2. Logic units which ensure the safety functions of bimanual controls.3. Automatic movable screens to protect the presses referred to in 9, 10
and 11.
4. Roll-over protection structures (ROPS).5. Falling-object protective structures (FOPS).
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ANNEX V
EC DECLARATION OF CONFORMITY
For the purposes of this Annex, ‘machinery' means either ‘machinery' or ‘safety
component' as defined in Article 1(2).
1. The EC declaration of conformity is the procedure by which the manufac-
turer, or his authorised representative established in the Community declaresthat the machinery being placed on the market complies with all the essentialhealth and safety requirements applying to it.
2. Signature of the EC declaration of conformity authorises the manufacturer, or
his authorised representative in the Community, to affix the CE marking tothe machinery.
3. Before drawing up the EC declaration of conformity, the manufacturer, or his
authorised representative in the Community, shall have ensured and be able toguarantee that the documentation listed below is and will remain available onhis premises for any inspection purposes:
(a) a technical construction file comprising:
— an overall drawing of the machinery together with drawings of the
control circuits,
— full detailed drawings, accompanied by any calculation notes, test
results, etc., required to check the conformity of the machinery withthe essential health and safety requirements,
— a list of:
— the essential requirements of this Directive,
— standards, and— other technical specifications, which were used when the machi-
nery was designed,
— a description of methods adopted to eliminate hazards presented by
the machinery,
— if he so desires, any technical report or certificate obtained from a
competent body or laboratory (
1),
— if he declares conformity with a harmonised standard which provides
therefor, any technical report giving the results of tests carried out athis choice either by himself or by a competent body or laboratory (
1),
— a copy of the instructions for the machinery;
b) for series manufacture, the internal measures that will be implemented to
ensure that the machinery remains in conformity with the provisions ofthe Directive.
The manufacturer must carry out necessary research or tests on components,
fittings or the completed machine to determine whether by its design orconstruction, the machine is capable of being erected and put into servicesafely.
Failure to present the documentation in response to a duly substantiated
request by the competent national authorities may constitute sufficientgrounds for doubting the presumption of conformity with the requirements ofthe Directive.
4. (a) The documentation referred to in 3 above need not permanently exist in a
material manner but it must be possible to assemble it and make itavailable within a period of time commensurate with its importance.
It does not have to include detailed plans or any other specific informa-
tion as regards the sub-assemblies used for the manufacture of the machi-nery unless a knowledge of them is essential for verification ofconformity with the basic safety requirements.
(b) The documentation referred to in 3 above shall be retained and kept
available for the competent national authorities for at least 10 yearsfollowing the date of manufacture of the machinery or of the last unitproduced, in the case of series manufacture.
(c) The documentation referred to in 3 above shall be drawn up in one of the
official languages of the Communities, with the exception of the instruc-tions for the machinery.
(1) A body or laboratory is presumed competent if it meets the assessment criteria laid
down in the relevant harmonised standards.
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ANNEX VI
EC TYPE-EXAMINATION
For the purposes of this Annex, ‘machinery' means either ‘machinery' or ‘safety
component' as defined in Article 1(2).
1. EC type-examination is the procedure by which a notified body ascertains and
certifies that an example of machinery satisfies the provisions of thisDirective which apply to it.
2. The application for EC type-examination shall be lodged by the manufacturer
or by his authorised representative established in the Community, with asingle notified body in respect of an example of the machinery.
The application shall include:
— the name and address of the manufacturer or his authorised representative
established in the Community and the place of manufacture of the machi-nery,
— a technical file comprising at least:
— an overall drawing of the machinery together with drawings of the
control circuits,
— full detailed drawings, accompanied by any calculation notes, test
results, etc., required to check the conformity of the machinery withthe essential health and safety requirements,
— a description of methods adopted to eliminate hazards presented by
the machinery and a list of standards used,
— a copy of the instructions for the machinery,— for series manufacture, the internal measures that will be implemented
to ensure that the machinery remains in conformity with the provi-sions of the Directive.
It shall be accompanied by a machine representative of the production
planned or, where appropriate, a statement of where the machine may beexamined.
The documentation referred to above does not have to include detailed plans
or any other specific information as regards the sub-assemblies used for themanufacture of the machinery unless a knowledge of them is essential forverification of conformity with the basic safety requirements.
3. The notified body shall carry out the EC type-examination in the manner
described below:
— it shall examine the technical construction file to verify its appropriateness
and the machine supplied or made available to it,
— during the examination of the machine, the body shall:
(a) ensure that it has been manufactured in conformity with the technical
construction file and may safely be used under its intended workingconditions;
(b) check that standards, if used, have been properly applied;
(c) perform appropriate examinations and tests to check that the machine
complies with the essential health and safety requirements applicableto it.
4. If the example complies with the provisions applicable to it the body shall
draw up an EC type-examination certificate which shall be forwarded to theapplicant. That certificate shall state the conclusions of the examination,indicate any conditions to which its issue may be subject and be accompaniedby the descriptions and drawings necessary for identification of the approvedexample.
The Commission, the Member States and the other approved bodies may
obtain a copy of the certificate and, on a reasoned request, a copy of thetechnical construction file and of the reports on the examinations and testscarried out.
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5. The manufacturer or his authorised representative established in the
Community shall inform the notified body of any modifications, even of aminor nature, which he has made or plans to make to the machine to whichthe example relates. The notified body shall examine those modifications andinform the manufacturer or his authorised representative established in theCommunity whether the EC type-examination certificate remains valid.
6. A body which refuses to issue an EC type-examination certificate shall so
inform the other notified bodies. A body which withdraws an EC type-exam-ination certificate shall so inform the Member State which notified it. Thelatter shall inform the other Member States and the Commission thereof,giving the reasons for the decision.
7. The files and correspondence referring to the EC type-examination procedures
shall be drawn up in an official language of the Member State where thenotified body is established or in a language acceptable to it.
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ANNEX VII
MINIMUMCRITERIATOBETAKENINTOACCOUNTBYMEMBER
STATES FOR THE NOTIFICATION OF BODIES
For the purposes of this Annex, ‘machinery' means either ‘machinery' or ‘safety
component' as defined in Article 1(2).
1. The body, its director and the staff responsible for carrying out the verifica-
tion tests shall not be the designer, manufacturer, supplier or installer ofmachinery which they inspect, nor the authorised representative of any ofthese parties. They shall not become either involved directly or as authorisedrepresentatives in the design, construction, marketing or maintenance of themachinery. This does not preclude the possibility of exchanges of technicalinformation between the manufacturer and the body.
2. The body and its staff shall carry out the verification tests with the highest
degree of professional integrity and technical competence and shall be freefrom all pressures and inducements, particularly financial, which might influ-ence their judgement or the results of the inspection, especially from personsor groups of persons with an interest in the result of verifications.
3. The body shall have at its disposal the necessary staff and possess the
necessary facilities to enable it to perform properly the administrative andtechnical tasks connected with verification; it shall also have access to theequipment required for special verification.
4. The staff responsible for inspection shall have:
— sound technical and professional training,
— satisfactory knowledge of the requirements of the tests they carry out and
adequate experience of such tests,
— the ability to draw up the certificates, records and reports required to
authenticate the performance of the tests.
5. The impartiality of inspection staff shall be guaranteed. Their remuneration
shall not depend on the number of tests carried out or on the results of suchtests.
6. The body shall take out liability insurance unless its liability is assumed by
the State in accordance with national law, or the Member State itself isdirectly responsible for the tests.
7. The staff of the body shall be bound to observe professional secrecy with
regard to all information gained in carrying out its tasks (except vis-à-vis the
competent administrative authorities of the State in which its activities arecarried out) under this Directive or any provision of national law giving effectto it.
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ANNEX VIII
Part A
Repealed Directives
(referred to by Article 14)
Directive 89/392/EEC and its following amendments:
— Directive 91/368/EEC only Article 1
— Directive 93/44/EEC— Directive 93/68/EEC only Article 6
Part B
List of deadlines for transposition into and application in national law
(referred to by Article 14)
DirectiveDeadline for trans-
positionDate of application
Directive 89/392/EEC (OJ L
183, 29.6.1989, p. 9)1 January 1992 Starting from 1 January
1993; for the productsreferred to by Directives86/295/EEC, 86/296/EECand 86/663EEC: startingfrom 1 July 1995 (
1)
Directive 91/368/EEC (OJ L198, 22.7.1991, p. 16) 1 January 1992 Starting from 1 January
1993
Directive 93/44/EEC (OJ L175, 19.7.1993, p. 12) 1 July 1994 — Starting from 1 January
1995 (2)
— Starting from 1 July
1994 (2)
— Article 1(10), with
the exception ofpoints (a), (b) and(q)
— Article 1(11)(a) and
(b)
— Article 1(12)(c),
(d), (e) and (f)
Directive 93/68/EEC (OJ L220, 30.8.1993, p. 1) 1 July 1994 Starting from 1 January1995 (
3)
(1) For the period ending on 31 December 1994, the Member States should have authorised,
except for the products referred to by Directives 86/295/EEC, 86/296/EEC and 86/663/EEC for which this period was ending on 31 December 1995, the placing on themarket and putting into service of machinery which comply with the national provisionsin force in their territories on 31 December 1992.
(
2) For the period ending on 31 December 1996, the Member States shall allow the placing
on the market and putting into service of machinery for the lifting or moving of personsas well as safety components which comply with the national provisions in force in theirterritories on 14 June 1993.
(
3) Until 1 January 1997 Member States shall allow the placing on the market and putting
into service of products which comply with the marking arrangements in force before 1January 1995.
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ANNEX IX
CORRELATION TABLE
Directive 89/392/EEC This Directive
Article 1(1) Article 1(1)
Article 1(2), first subparagraph Article 1(2), point (a), first indent
Article 1(2), second subparagraph Article 1(2), point (a), second indent
Article 1(2), third subparagraph Article 1(2), point (a), third indent
Article 1(2), fourth subparagraph Article 1(2), point (b)
Article 1(3) Article 1(3)
Article 1(4) Article 1(4)
Article 1(5) Article 1(5)
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 5
Article 6 Article 6
Article 7 Article 7
Article 8(1) Article 8(1)
Article 8(2) Article 8(2)
Article 8(3) Article 8(3)
Article 8(4) Article 8(4)
Article 8(4a) Article 8(5)
Article 8(5) Article 8(6)
Article 8(6) Article 8(7)
Article 8(7) Article 8(8)
Article 9 Article 9
Article 10 Article 10
Article 11 Article 11
Article 12 Article 12
Article 13(1) —
Article 13(2) —
Article 13(3) Article 13(1)
Article 13(4) Article 13(2)
— Article 14
— Article 15
— Article 16
Annex I Annex I
Annex II Annex II
Annex III Annex III
Annex IV Annex IV
Annex V Annex V
Annex VI Annex VI
Annex VII Annex VII
— Annex VIII
— Annex IX