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31998L0037
Directive 98/37/EC of the European Parliament and of the
Council of 22
June 1998 on the approximation of the laws of the Member States
relating to machinery
Official Journal L 207 , 23/07/1998 P. 0001 - 0046
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DIRECTIVE 98/37/EC OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 22
June 1998 on the approximation of the laws of the Member States
relating to machinery
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
particular Article 100a thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 189b of
the Treaty (2),
(1)
Whereas Council Directive 89/392/EEC of 14 June 1989 on the
approximation of the laws of the Member States relating to machinery
(3) has been frequently and substantially amended; whereas for reasons
of clarity and rationality the said Directive should be consolidated;
(2)
Whereas the internal market consists of an area without internal
frontiers within which the free movement of goods, persons, services
and capital is guaranteed;
(3) Whereas the machinery sector is an
important part of the engineering industry and is one of the industrial
mainstays of the Community economy;
(4) Whereas the social cost of
the large number of accidents caused directly by the use of machinery
can be reduced by inherently safe design and construction of machinery
and by proper installations and maintenance;
(5) Whereas Member
States are responsible for ensuring the health and safety on their
territory of persons and, where appropriate, of domestic animals and
goods and, in particular, of workers, notably in relation to the risks
arising out of the use of machinery;
(6) Whereas, in the Member
States, the legislative systems regarding accident prevention are very
different; whereas the relevant compulsory provisions, frequently
supplemented by de facto mandatory technical specifications and/or
voluntary standards, do not necessarily lead to different levels of
health and safety, but nevertheless, owing to their disparities,
constitute barriers to trade within the Community; whereas,
furthermore, conformity certification and national certification
systems for machinery differ considerably;
(7) Whereas existing
national health and safety provisions providing protection against the
risks caused by machinery must be approximated to ensure free movement
on the market of machinery without lowering existing justified levels
of protection in the Member States; whereas the provisions of this
Directive concerning the design and construction of machinery,
essential for a safer working environment, shall be accompanied by
specific provisions concerning the prevention of certain risks to which
workers can be exposed at work, as well as by provisions based on the
organisation of safety of workers in the working environment;
(8)
Whereas Community law, in its present form, provides - by way of
derogation from one of the fundamental rules of the Community, namely
the free movement of goods - that obstacles to movement within the
Community resulting from disparities in national legislation relating
to the marketing of products must be accepted in so far as the
provisions concerned can be recognised as being necessary to satisfy
imperative requirements;
(9) Whereas paragraphs 65 and 68 of the
White Paper on the completion of the internal market, approved by the
European Council in June 1985, provide for a new approach to
legislative harmonisation; whereas, therefore, the harmonisation of
laws in this case must be limited to those requirements necessary to
satisfy the imperative and essential health and safety requirements
relating to machinery; whereas these requirements must replace the
relevant national provisions because they are essential;
(10)
Whereas the maintenance or improvement of the level of safety attained
by the Member States constitutes one of the essential aims of this
Directive and of the principle of safety as defined by the essential
requirements;
(11) Whereas the field of application of this
Directive must be based on a general definition of the term 'machinery`
so as to allow the technical development of products; whereas the
development of complex installations and the risks they involve are of
an equivalent nature and their express inclusion in the Directive is
therefore justified;
(12) Whereas it is also necessary to deal
with safety components which are placed on the market separately and
the safety function of which is declared by the manufacturer or his
authorised representative established in the Community;
(13)
Whereas, for trade fairs, exhibitions, etc., it must be possible to
exhibit machinery which does not conform to this Directive; whereas,
however, interested parties should be properly informed that the
machinery does not conform and cannot be purchased in that condition;
(14)
Whereas the essential health and safety requirements must be observed
in order to ensure that machinery is safe; whereas these requirements
must be applied with discernment to take account of the state of the
art at the time of construction and of technical and economic
requirements;
(15) Whereas the putting into service of machinery
within the meaning of this Directive can relate only to the use of the
machinery itself as intended by the manufacturer; whereas this does not
preclude the laying-down of conditions of use external to the
machinery, provided that it is not thereby modified in a way not
specified in this Directive;
(16) Whereas it is necessary not only
to ensure the free movement and putting into service of machinery
bearing the 'CE` marking and having an EC conformity certificate but
also to ensure free movement of machinery not bearing the 'CE` marking
where it is to be incorporated into other machinery or assembled with
other machinery to form a complex installation;
(17) Whereas,
therefore, this Directive defines only the essential health and safety
requirements of general application, supplemented by a number of more
specific requirements for certain categories of machinery; whereas, in
order to help manufacturers to prove conformity to these essential
requirements and in order to allow inspection for conformity to the
essential requirements, it is desirable to have standards harmonised at
European level for the prevention of risks arising out of the design
and construction of machinery; whereas these standards harmonised at
European level are drawn up by private-law bodies and must retain their
non-binding status; whereas for this purpose the European Committee for
Standardisation (CEN) and the European Committee for Electrotechnical
Standardisation (Cenelec) are the bodies recognised as competent to
adopt harmonised standards in accordance with the general guidelines
for cooperation between the Commission and these two bodies signed on
13 November 1984; whereas, within the meaning of this Directive, a
harmonised standard is a technical specification (European standard or
harmonisation document) adopted by either or both of these bodies, on
the basis of a remit from the Commission in accordance with the
provisions of Directive 83/189/EEC (4) and on the basis of general
guidelines referred to above;
(18) Whereas it was found necessary
to improve the legislative framework in order to ensure an effective
and appropriate contribution by employers and employees to the
standardisation process;
(19) Whereas the Member States'
responsibility for safety, health and the other aspects covered by the
essential requirements on their territory must be recognised in a
safeguard clause providing for adequate Community protection
procedures;
(20) Whereas, as is currently the practice in Member
States, manufacturers should retain the responsibility for certifying
the conformity of their machinery to the relevant essential
requirements; whereas conformity to harmonised standards creates a
presumption of conformity to the relevant essential requirements;
whereas it is left to the sole discretion of the manufacturer, where he
feels the need, to have his products examined and certified by a third
party;
(21) Whereas, for certain types of machinery having a
higher risk factor, a stricter certification procedure is desirable;
whereas the EC type-examination procedure adopted may result in an EC
declaration being given by the manufacturer without any stricter
requirement such as a guarantee of quality, EC verification or EC
supervision;
(22) Whereas it is essential that, before issuing an
EC declaration of conformity, the manufacturer or his authorised
representative established in the Community should provide a technical
construction file; whereas it is not, however, essential that all
documentation be permanently available in a material manner, but it
must be made available on demand; whereas it need not include detailed
plans of the sub-assemblies used in manufacturing the machines, unless
knowledge of these is indispensable in order to ascertain conformity
with essential safety requirements;
(23) Whereas, in its
communication of 15 June 1989 on a global approach to certification and
testing (5), the Commission proposed that common rules be drawn up
concerning a 'CE` conformity marking with a single design; whereas, in
its resolution of 21 December 1989 on a global approach to conformity
assessment (6), the Council approved as a guiding principle the
adoption of a consistent approach such as this with regard to the use
of the 'CE` marking; whereas the two basic elements of the new approach
which must be applied are therefore the essential requirements and the
conformity assessment procedures;
(24) Whereas the addressees of
any decision taken under this Directive must be informed of the reasons
for such a decision and the legal remedies open to them;
(25)
Whereas this Directive must not affect the obligations of the Member
States concerning the deadlines for transposition and application of
the Directives set out in Annex VIII, part B,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT
Article 1
1.
This Directive applies to machinery and lays down the essential health
and safety requirements therefor, as defined in Annex I.
It shall also apply to safety components placed on the market
separately.
2. For the purposes of this Directive:
(a) 'machinery` means:
-
an assembly of linked parts or components, at least one of which moves,
with the appropriate actuators, control and power circuits, etc.,
joined together for a specific application, in particular for the
processing, treatment, moving or packaging of a material,
- an
assembly of machines which, in order to achieve the same end, are
arranged and controlled so that they function as an integral whole,
-
interchangeable equipment modifying the function of a machine, which is
placed on the market for the purpose of being assembled with a machine
or a series of different machines or with a tractor by the operator
himself in so far as this equipment is not a spare part or a tool;
(b)
'safety components` means a component, provided that it is not
interchangeable equipment, which the manufacturer or his authorised
representative established in the Community places on the market to
fulfil a safety function when in use and the failure or malfunctioning
of which endangers the safety or health of exposed persons.
3. The following are excluded from the scope of this Directive:
-
machinery whose only power source is directly applied manual effort,
unless it is a machine used for lifting or lowering loads,
- machinery for medical use used in direct contact with patients,
- special equipment for use in fairgrounds and/or amusement parks,
- steam boilers, tanks and pressure vessels,
-
machinery specially designed or put into service for nuclear purposes
which, in the event of failure, may result in an emission of
radioactivity,
- radioactive sources forming part of a machine,
- firearms,
- storage tanks and pipelines for petrol, diesel fuel, inflammable
liquids and dangerous substances,
-
means of transport, i.e. vehicles and their trailers intended solely
for transporting passengers by air or on road, rail or water networks,
as well as means of transport in so far as such means are designed for
transporting goods by air, on public road or rail networks or on water.
Vehicles used in the mineral extraction industry shall not be excluded,
- seagoing vessels and mobile offshore units together with equipment on
board such vessels or units,
- cableways, including funicular railways, for the public or private
transportation of persons,
- agricultural and forestry tractors, as defined in Article 1(1) of
Directive 74/150/EEC (7),
- machines specially designed and constructed for military or police
purposes,
-
lifts which permanently serve specific levels of buildings and
constructions, having a car moving between guides which are rigid and
inclined at an angle of more than 15 degrees to the horizontal and
designed for the transport of:
(i) persons;
(ii) persons and goods;
(iii)
goods alone if the car is accessible, that is to say, a person may
enter it without difficulty, and fitted with controls situated inside
the car or within reach of a person inside,
- means of transport of persons using rack and pinion rail mounted
vehicles,
- mine winding gear,
- theatre elevators,
- construction site hoists intended for lifting persons or persons and
goods.
4.
Where, for machinery or safety components, the risks referred to in
this Directive are wholly or partly covered by specific Community
Directives, this Directive shall not apply, or shall cease to apply, in
the case of such machinery or safety components and of such risks on
the implementation of these specific Directives.
5. Where, for
machinery, the risks are mainly of electrical origin, such machinery
shall be covered exclusively by Directive 73/23/EEC (8).
Article 2
1.
Member States shall take all appropriate measures to ensure that
machinery or safety components covered by this Directive may be placed
on the market and put into service only if they do not endanger the
health or safety of persons and, where appropriate, domestic animals or
property, when properly installed and maintained and used for their
intended purpose.
2. This Directive shall not affect Member States'
entitlement to lay down, in due observance of the Treaty, such
requirements as they may deem necessary to ensure that persons and in
particular workers are protected when using the machinery or safety
components in question, provided that this does not mean that the
machinery or safety components are modified in a way not specified in
the Directive.
3. At trade fairs, exhibitions, demonstrations, etc.,
Member States shall not prevent the showing of machinery or safety
components which do not conform to the provisions of this Directive,
provided that a visible sign clearly indicates that such machinery or
safety components do not conform and that they are not for sale until
they have been brought into conformity by the manufacturer or his
authorised representative established in the Community. During
demonstrations, adequate safety measures shall be taken to ensure the
protection of persons.
Article 3
Machinery and safety
components covered by this Directive shall satisfy the essential health
and safety requirements set out in Annex I.
Article 4
1.
Member States shall not prohibit, restrict or impede the placing on the
market and putting into service in their territory of machinery and
safety components which comply with this Directive.
2. Member States
shall not prohibit, restrict or impede the placing on the market of
machinery where the manufacturer or his authorised representative
established in the Community declares in accordance with point B of
Annex II that it is intended to be incorporated into machinery or
assembled with other machinery to constitute machinery covered by this
Directive, except where it can function independently.
'Interchangeable
equipment`, as referred to in the third indent of Article 1(2)(a), must
in all cases bear the CE marking and be accompanied by the EC
declaration of conformity referred to in Annex II, point A.
3.
Member States may not prohibit, restrict or impede the placing on the
market of safety components as defined in Article 1(2) where they are
accompanied by an EC declaration of conformity by the manufacturer or
his authorised representative established in the Community as referred
to in Annex II, point C.
Article 5
1. Member States shall
regard the following as conforming to all the provisions of this
Directive, including the procedures for checking the conformity
provided for in Chapter II:
- machinery bearing the CE marking and accompanied by the EC
declaration of conformity referred to in Annex II, point A,
- safety components accompanied by the EC declaration of conformity
referred to in Annex II, point C.
In
the absence of harmonised standards, Member States shall take any steps
they deem necessary to bring to the attention of the parties concerned
the existing national technical standards and specifications which are
regarded as important or relevant to the proper implementation of the
essential safety and health requirements in Annex I.
2. Where a
national standard transposing a harmonised standard, the reference for
which has been published in the Official Journal of the European
Communities, covers one or more of the essential safety requirements,
machinery or safety components constructed in accordance with this
standard shall be presumed to comply with the relevant essential
requirements.
Member States shall publish the references of national standards
transposing harmonised standards.
3.
Member States shall ensure that appropriate measures are taken to
enable the social partners to have an influence at national level on
the process of preparing and monitoring the harmonised standards.
Article 6
1.
Where a Member State or the Commission considers that the harmonised
standards referred to in Article 5(2) do not entirely satisfy the
essential requirements referred to in Article 3, the Commission or the
Member State concerned shall bring the matter before the committee set
up under Directive 83/189/EEC, giving the reasons therefor. The
committee shall deliver an opinion without delay.
Upon receipt of
the committee's opinion, the Commission shall inform the Member States
whether or not it is necessary to withdraw those standards from the
published information referred to in Article 5(2).
2. A standing
committee shall be set up, consisting of representatives appointed by
the Member States and chaired by a representative of the Commission.
The standing committee shall draw up its own rules of procedure.
Any
matter relating to the implementation and practical application of this
Directive may be brought before the standing committee, in accordance
with the following procedure:
The representative of the Commission
shall submit to the committee a draft of the measures to be taken. The
committee shall deliver its opinion on the draft, within a time limit
which the chairman may lay down according to the urgency of the matter,
if necessary by taking a vote.
The opinion shall be recorded in the
minutes; in addition, each Member State shall have the right to ask to
have its position recorded in the minutes.
The Commission shall take
the utmost account of the opinion delivered by the committee. It shall
inform the committee of the manner in which its opinion has been taken
into account.
Article 7
1. Where a Member State ascertains that:
- machinery bearing the CE marking, or
- safety components accompanied by the EC declaration of conformity,
used
in accordance with their intended purpose are liable to endanger the
safety of persons, and, where appropriate, domestic animals or
property, it shall take all appropriate measures to withdraw such
machinery or safety components from the market, to prohibit the placing
on the market, putting into service or use thereof, or to restrict free
movement thereof.
Member States shall immediately inform the
Commission of any such measure, indicating the reason for its decision
and, in particular, whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in
Article 3;
(b) incorrect application of the standards referred to in Article 5(2);
(c) shortcomings in the standards themselves referred to in Article
5(2).
2.
The Commission shall enter into consultation with the parties concerned
without delay. Where the Commission considers, after this consultation,
that the measure is justified, it shall immediately so inform the
Member State which took the initiative and the other Member States.
Where the Commission considers, after this consultation, that the
action is unjustified, it shall immediately so inform the Member State
which took the initiative and the manufacturer or his authorised
representative established within the Community. Where the decision
referred to in paragraph 1 is based on a shortcoming in the standards,
and where the Member State at the origin of the decision maintains its
position, the Commission shall immediately inform the committee in
order to initiate the procedures referred to in Article 6(1).
3. Where:
- machinery which does not comply bears the CE marking,
- a safety component which does not comply is accompanied by an EC
declaration of conformity,
the
competent Member State shall take appropriate action against whom so
ever has affixed the marking or drawn up the declaration and shall so
inform the Commission and other Member States.
4. The Commission shall ensure that Member States are kept informed of
the progress and outcome of this procedure.
CHAPTER II CONFORMITY ASSESSMENT PROCEDURES
Article 8
1.
The manufacturer or his authorised representative established in the
Community must, in order to certify that machinery and safety
components are in conformity with this Directive, draw up for all
machinery or safety components manufactured an EC declaration of
conformity based on the model given in Annex II, point A or C as
appropriate.
In addition, for machinery alone, the manufacturer or
his authorised representatives established in the Community must affix
to the machine the CE marking.
2. Before placing on the market, the manufacturer, or his authorised
representative established in the Community, shall:
(a) if the machinery is not referred to in Annex IV, draw up the file
provided for in Annex V;
(b)
if the machinery is referred to in Annex IV and its manufacturer does
not comply, or only partly complies, with the standards referred to in
Article 5(2) or if there are no such standards, submit an example of
the machinery for the EC type-examination referred to in Annex VI;
(c)
if the machinery is referred to in Annex IV and is manufactured in
accordance with the standards referred to in Article 5(2):
- either
draw up the file referred to in Annex VI and forward it to a notified
body, which will acknowledge receipt of the file as soon as possible
and keep it,
- submit the file referred to in Annex VI to the
notified body, which will simply verify that the standards referred to
in Article 5(2) have been correctly applied and will draw up a
certificate of adequacy for the file,
- or submit the example of the machinery for the EC type-examination
referred to in Annex VI.
3.
Where the first indent of paragraph 2(c) of this Article applies, the
provisions of the first sentence of paragraphs 5 and 7 of Annex VI
shall also apply.
Where the second indent of paragraph 2(c) of this
Article applies, the provisions of paragraphs 5, 6 and 7 of Annex VI
shall also apply.
4. Where paragraph 2(a) and the first and second
indents of paragraph 2(c) apply, the EC declaration of conformity shall
solely state conformity with the essential requirements of the
Directive.
Where paragraph 2(b) and the third indent of paragraph
2(c) apply, the EC declaration of conformity shall state conformity
with the example that underwent EC type-examination.
5. Safety
components shall be subject to the certification procedures applicable
to machinery pursuant to paragraphs 2, 3 and 4. Furthermore, during EC
type-examination, the notified body shall verify the suitability of the
safety component for fulfilling the safety functions declared by the
manufacturer.
6. (a) Where the machinery is subject to other
Directives concerning other aspects and which also provide for the
affixing of the CE marking, the latter shall indicate that the
machinery is also presumed to conform to the provisions of those other
Directives.
(b) However, where one or more of those Directives allow
the manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate conformity only to
the Directives applied by the manufacturer. In this case, particulars
of the Directives applied, as published in the Official Journal of the
European Communities, must be given in the documents, notices or
instructions required by the directives and accompanying such machinery.
7.
Where neither the manufacturer nor his authorised representative
established in the Community fulfils the obligations of paragraphs 1 to
6, these obligations shall fall to any person placing the machinery or
safety component on the market in the Community. The same obligations
shall apply to any person assembling machinery or parts thereof or
safety components of various origins or constructing machinery or
safety components for his own use.
8. The obligations referred to in
paragraph 7 shall not apply to persons who assemble with a machine or
tractor interchangeable equipment as provided for in Article 1,
provided that the parts are compatible and each of the constituent
parts of the assembled machine bears the CE marking and is accompanied
by the EC declaration of conformity.
Article 9
1. Member
States shall notify the Commission and the other Member States of the
approved bodies which they have appointed to carry out the procedures
referred to in Article 8 together with the specific tasks which these
bodies have been appointed to carry out and the identification numbers
assigned to them beforehand by the Commission.
The Commission shall
publish in the Official Journal of the European Communities a list of
the notified bodies and their identification numbers and the tasks for
which they have been notified. The Commission shall ensure that this
list is kept up to date.
2. Member States shall apply the criteria
laid down in Annex VII in assessing the bodies to be indicated in such
notification. Bodies meeting the assessment criteria laid down in the
relevant harmonised standards shall be presumed to fulfil those
criteria.
3. A Member State which has approved a body must withdraw
its notification if it finds that the body no longer meets the criteria
referred to in Annex VII. It shall immediately inform the Commission
and the other Member States accordingly.
CHAPTER III CE MARKING
Article 10
1. The CE conformity marking shall consist of the initials 'CE`. The
form of the marking to be used is shown in Annex III.
2. The CE marking shall be affixed to machinery distinctly and visibly
in accordance with point 1.7.3 of Annex I.
3.
The affixing of markings on the machinery which are likely to deceive
third parties as to the meaning and form of the CE marking shall be
prohibited. Any other marking may be affixed to the machinery provided
that the visibility and legibility of the CE marking is not thereby
reduced.
4. Without prejudice to Article 7:
(a) where a Member
State establishes that the CE marking has been affixed unduly, the
manufacturer or his authorised representative established within the
Community shall be obliged to make the product conform as regards the
provisions concerning the CE marking and to end the infringement under
the conditions imposed by the Member State;
(b) where
non-conformity continues, the Member State must take all appropriate
measures to restrict or prohibit the placing on the market of the
product in question or to ensure that it is withdrawn from the market
in accordance with the procedure laid down in Article 7.
CHAPTER IV FINAL PROVISIONS
Article 11
Any
decision taken pursuant to this Directive which restricts the placing
on the market and putting into service of machinery or a safety
component shall state the exact grounds on which it is based. Such a
decision shall be notified as soon as possible to the party concerned,
who shall at the same time be informed of the legal remedies available
to him under the laws in force in the Member State concerned and of the
time limits to which such remedies are subject.
Article 12
The
Commission will take the necessary steps to have information on all the
relevant decisions relating to the management of this Directive made
available.
Article 13
1. Member States shall communicate to
the Commission the texts of the provisions of national law which they
adopt in the field governed by this Directive.
2. The Commission
shall, before 1 January 1994, examine the progress made in the
standardisation work relating to this Directive and propose any
appropriate measures.
Article 14
1. The Directives listed in
Annex VIII, Part A, are hereby repealed, without prejudice to the
obligations of the Member States concerning the deadlines for
transposition and application of the said Directives, as set out in
Annex VIII, Part B.
2. References to the repealed Directives shall
be construed as references to this Directive and be read in accordance
with the correlation table set out in Annex IX.
Article 15
This
Directive shall enter into force on the 20th day following that of its
publication in the Official Journal of the European Communities.
Article 16
This Directive is addressed to the Member States.
Done at Luxembourg, 22 June 1998.
For the European Parliament
The President
J. M. GIL-ROBLES
For the Council
The President
J. CUNNINGHAM
(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 C 161,
27.5.1998, p. 54) and Decision of the European Parliament of 30 April
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).
(4)
Council Directive 83/189/EEC of 28 March 1983 laying down a procedure
for the provision of information in the field of technical standards
and regulations (OJ L 109, 26.4.1983, p. 8). Directive as last amended
by Commission Decision 96/139/EC (OJ L 32, 10.2.1996, p. 31).
(5) OJ C 231, 8.9.1989, p. 3, and OJ C 267, 19.10.1989, p. 3.
(6) OJ C 10, 16.1.1990, p. 1.
(7)
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 wheeled
agricultural or forestry tractors (OJ L 84, 28.3.1974, p. 10).
Directive as last amended by Decision 95/1/EC, Euratom, ECSC (OJ L
1.1.1995, p. 1).
(8) Council Directive 73/23/EEC of 19 February 1973
on the harmonisation of the laws of Member States relating to
electrical equipment designed for use within certain voltage limits (OJ
L 77, 26.3.1973, p. 29). Directive as last amended by Directive
93/68/EEC (OJ L 220, 30.8.1993, p. 1).
ANNEX I
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO 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 question when it is used under the conditions foreseen by
the manufacturer. In any event, requirements 1.1.2, 1.7.3 and 1.7.4
apply to all machinery covered by 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 be possible to meet the objectives set by them. In this case, the
machinery must as far as possible be designed and constructed with the
purpose of approaching 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
and construct it taking account of his assessment.
1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
1.1. 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 transporting
machinery.
1.2.2. Principles of safety integration
(a)
Machinery must be so constructed that it is fitted for its function,
and can be adjusted and maintained without putting persons at risk when
these operations are carried out under the conditions foreseen 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 where risks 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 particular training
is required and specify any need to provide personal protection
equipment.
(c) When designing and constructing machinery, and when
drafting the instructions, the manufacturer must envisage not only the
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 must
draw the user's attention to ways - which experience has shown might
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 the minimum possible
taking ergonomic principles into account.
(e) When designing and
constructing machinery, the manufacturer must take account of the
constraints to which the operator is subject as a result of the
necessary or foreseeable use of personal protection equipment (such as
footwear, gloves, etc.).
(f) Machinery must be supplied with all the
essential special equipment and accessories to enable it to be
adjusted, maintained and used 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 or health.
In
particular, where fluids are used, machinery must be designed and
constructed for use without risks due to filling, use, recovery or
draining.
1.1.4. Lighting
The manufacturer must supply
integral lighting suitable for the operations concerned where its lack
is likely to cause a risk despite ambient lighting 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
no dangerous stroboscopic effects due to the lighting provided by the
manufacturer.
Internal parts requiring frequent inspection, and adjustment and
maintenance 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 each component
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:
- 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 to
considerable 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 clearly displayed 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, taking
account of ergonomic principles. Constraints due to the necessary or
foreseeable 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 them from 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 given whenever the
machinery is about to start. The exposed person must have the time and
the means to take rapid action to prevent the machinery 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 the normal
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. enabling devices or selectors allowing only
one part of the starting mechanism to 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 have been 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.
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, so that
the machinery is rendered safe. The machinery's stop control must have
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 following
exceptions apply:
- machines in which an emergency stop device would
not lessen the risk, either because it would not reduce the stopping
time or because it would not enable the special measures required to
deal with 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
safeguard movements.
Once
active operation of the emergency stop control has ceased following a
stop command, that command must be sustained by engagement of the
emergency stop device until that engagement is specifically overridden;
it must not be possible to engage the device without triggering a stop
command; it must be possible to disengage the device only by an
appropriate operation, and disengaging the device 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 machinery that the
stop controls, including the emergency stop, can stop not only the
machinery itself but also all equipment upstream and/or downstream 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. to
allow for adjustment, maintenance, inspection, etc.), it must be fitted
with a mode selector which can be locked in each position. Each
position of the selector must correspond to a single operating or
control mode.
The selector may be replaced by another selection
method which restricts the use of certain functions of the machinery to
certain categories of operator (e.g. access codes for certain
numerically controlled functions, etc.).
If, for certain operations,
the machinery must be able to operate with its protection devices
neutralised, the mode selector must simultaneously:
- 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 linked sequences,
- 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.
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 lead to 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 operating conditions
(if necessary taking climatic conditions into account) for use 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 be
incorporated 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 foreseen by 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 regards the 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 the criteria 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 mounted and positioned in
such a way that in case of rupture their fragments will be contained.
Both
rigid and flexible pipes carrying fluids, particularly those under high
pressure, must be able to withstand the foreseen internal and external
stresses and must be firmly attached and/or protected against all
manner of external stresses and strains; precautions must be taken to
ensure that no risk is posed by a rupture (sudden movement,
high-pressure jets, etc.).
Where the material to be processed is fed
to the tool automatically, the following conditions must be fulfilled
to avoid risks to the persons exposed (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 surfaces likely to
cause injury.
1.3.5. Risks related to combined machinery
Where
the machinery is intended to carry out several different operations
with the manual removal of the piece between each operation (combined
machinery), it must be designed and constructed in such a way as to
enable each element to be used separately without the other elements
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
conditions of use (e.g. different speeds or energy supply), it must be
designed and constructed in such a way that selection and adjustment of
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 protective
devices in such a way as to prevent all risk of contact which could
lead to accidents.
All necessary steps must be taken to prevent
accidental blockage of moving parts involved in the work. In cases
where, despite the precautions taken, a blockage is likely to occur,
specific protection devices or tools, the instruction handbook and
possibly a sign on the machinery should be provided by the manufacturer
to enable the equipment to be safely 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. The
following guidelines must be used to help make the choice.
A. Moving transmission parts
Guards
designed to protect exposed persons against the risks associated 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 the process
of being machined, etc.) must be:
- wherever possible fixed guards complying with requirements 1.4.1 and
1.4.2.1,
-
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
to prevent all or part of the operator's body from encroaching on the
danger 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 operation owing to
operations requiring nearby operator intervention, where technically
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 in the work,
- adjustable guards,
complying with requirements 1.4.1 and 1.4.2.3 restricting access to
those sections of the moving parts that are strictly 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 access
only to the area where the work has to be done, if possible without the
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 stop command
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,
- 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 are or can be
prevented.
The specific rules in force relating to electrical
equipment designed for use within certain voltage limits must apply to
machinery which is subject 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 be fitted 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 associated
with 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 of such parts
or, failing this, by information given on the parts themselves and/or
the housings. The same information must be given on moving parts and/or
their housings where the direction of movement must be known to avoid a
risk. Any further information that may be necessary must be given in
the instructions.
Where a faulty connection can be the source of
risk, incorrect fluid connections, including electrical conductors,
must be made impossible by 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 low
temperatures.
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 it or, 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.
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 the specific
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 level taking account of
technical progress and the availability of means of reducing 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 lowest level, taking account of
technical progress and the availability of means 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 the effects 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 secondary
radiation do not damage health,
- optical equipment for the
observation or adjustment of laser equipment on machinery must be such
that no health risk is created by the 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 it
produces 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 possible to
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 that is impossible,
with a means of summoning help.
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, tripping or
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 machinery 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 connecting device 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 to wear or likely
to deteriorate following an accident, must be capable of being removed
and replaced easily and in safety. Access to the components must enable
these tasks to be carried out with the necessary technical means
(tools, measuring instruments, etc.) in accordance with an 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 production,
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 be
capable of being locked if reconnection could endanger exposed persons.
In the case of machinery supplied with electricity through a plug
capable of being plugged into a circuit, separation of the plug is
sufficient.
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 the energy 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 without risk 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
must be 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 dangerous
substances or preparations without entering them; any necessary
unblocking must also be possible from the outside. If it is absolutely
impossible to avoid entering the machinery, the manufacturer must take
steps during its construction to allow cleaning to take place with the
minimum of danger.
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 must be
equipped to give an appropriate acoustic or light signal as a warning.
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,
radioactive sources, bleeding of a hydraulic circuit, hazard in an
unseen area, etc.), the manufacturer must provide warnings.
Such
warnings should preferably use readily understandable pictograms and/or
be drawn up in one of the languages of the country in which the
machinery is to be used, accompanied, on request, by the languages
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 on the
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 equipment, 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 any appropriate 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,
- 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 representative established in the
Community. On being put into service, all machinery must be accompanied
by a translation of the instructions in the language or languages of
the country in which the machinery is to be used and by the
instructions in the original language. This translation must be done
either by the manufacturer or his authorised representative established
in the Community or by the person introducing the machinery into the
language area in question. By way of derogation from this requirement,
the maintenance instructions for use by specialised personnel employed
by the manufacturer or his authorised representative established in the
Community may be drawn up in only one of the Community languages
understood by that personnel.
(c) The instructions must contain the
drawings and diagrams necessary for putting into service, maintenance,
inspection, checking of correct 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 documentation describing the machinery must give information
regarding the airborne noise emissions referred to in (f) and, in the
case of hand-held and/or hand-guided machinery, information regarding
vibration as referred to in 2.2.
(e) Where necessary, the
instructions must give the requirements relating to installation and
assembly for reducing noise or vibration (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 value or a value established on the basis
of measurements made on identical machinery:
- equivalent continuous
A-weighted sound pressure level at workstations, where this exceeds 70
dB(A); where this level does not exceed 70 dB(A), this fact must be
indicated,
- peak C-weighted instantaneous sound pressure value at workstations,
where this exceeds 63 Pa (130 dB in relation to 20 ìPa),
-
sound power level emitted by the machinery where the equivalent
continuous A-weighted sound pressure level at workstations exceeds 85
dB(A).
In the case of very large machinery, instead of the sound
power level, the equivalent continuous sound pressure levels at
specified positions around the machinery may be indicated.
Where the
harmonised standards are not applied, sound levels must be measured
using the most appropriate method for the machinery.
The
manufacturer must indicate the operating conditions of the machinery
during measurement and what methods have been used for the measurement.
Where
the workstation(s) are undefined or cannot be defined, sound pressure
levels must be measured at a distance of 1 metre from the surface of
the machinery and at a height of 1,60 metres from the floor or access
platform. The position and value of the maximum 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 the necessary information.
(h) In the case of machinery
which may also be intended for use by non-professional operators, the
wording and layout of the instructions for use, whilst respecting the
other essential requirements mentioned above, must take into account
the level of general 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
to avoid any risk of infection, sickness or contagion and the following
hygiene 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 relevant Directives. The machinery must be
so designed and constructed that 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
organic materials;
(c) assemblies must be designed in such a way
as to reduce projections, edges and recesses to a minimum. They should
preferably be made by welding or continuous bonding. Screws, screwheads
and rivets 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 dismantled parts. The
inside surfaces must have curves of a radius sufficient to allow
thorough cleaning;
(e) liquid deriving from foodstuffs as well as
cleaning, disinfecting and rinsing fluids should be able to be
discharged from the machine 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 any organic matter accumulating in areas that cannot be
cleaned (e.g. for machinery not mounted on feet or casters, by placing
a seal between 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
foodstuffs. Where necessary, machinery must be designed and constructed
so that continuing compliance with this requirement can be checked.
Instructions
In
addition to the information required in section 1, the instructions
must indicate recommended products and methods for cleaning,
disinfecting and rinsing (not only for easily accessible areas but also
where areas 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 handles and supports
of an appropriate size and arranged to ensure the stability of the
machinery under the operating conditions foreseen by the manufacturer,
-
except where technically impossible or where there is an independent
control, in the case of handles which cannot be released in complete
safety, it must be fitted with start and stop controls arranged in such
a way that the operator can operate them without releasing the handles,
-
it must be designed, constructed or equipped to eliminate the risks of
accidental starting and/or continued operation after the operator has
released the handles. Equivalent steps must be taken if this
requirement 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 tool with the material being
processed.
Instructions
The instructions must give the following information concerning
vibrations 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/s² as determined by the appropriate
test
code. Where the acceleration does not exceed 2,5 m/s², this must
be
mentioned.
If there is no applicable test code, the manufacturer
must indicate the measurement methods and conditions under which
measurements were made.
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 of wood, such as cork,
bone, hardened rubber, hardened plastic material and other similar
stiff material must conform to the following essential health 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
be sufficiently stable during the work and must not impede the movement
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 not the case, so that the ejection does not engender risks for
the operator 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 of contact 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 or reduce the risk of serious accidental injury, for example
by using cylindrical cutter blocks, restricting depth of cut, etc.
3. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR
HAZARDS DUE TO THE MOBILITY OF 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 or
tractors, is operated in working areas and whose operation requires
either mobility while working, be it continuous or semi-continuous
movement, 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 be moved
more easily from one place to another (machinery fitted with wheels,
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 or
his authorised representative established within the Community must,
for each type of machinery concerned, perform the appropriate tests or
have such tests performed.
3.1. General
3.1.1. Definition
'Driver`
means an operator responsible for the movement of machinery. The driver
may be transported by the machinery or may be on foot, accompanying the
machinery, or may be guiding the machinery by 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 to the work to be carried
out, without prejudice to any other regulations 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 as
long as the machine and/or its parts are handled in accordance with the
manufacturer'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 such
cases, each driving position must be provided with all the requisite
controls. Where there is more than one driving position, the machinery
must be designed so that the use of one of them precludes the use of
the others, except in emergency stops. Visibility from the driving
position must be such that the driver can in complete safety for
himself and the exposed persons, operate the machinery and its tools in
their intended conditions of use. Where necessary, appropriate devices
must be 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 from
inadvertent 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 instructions needed for
the driver and/or operators. The driving position must be fitted with
an adequate cab where there is a hazard due to a dangerous environment.
Where
the machinery is fitted with a cab, this must be designed, constructed
and/or equipped to ensure that the driver has good operating 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, an
emergency exit must be provided in a direction which is different from
the 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 principles.
The
seat must be designed to reduce vibrations transmitted to the driver to
the lowest level that can be reasonably achieved. The seat mountings
must withstand all stresses to which they can be subjected, notably in
the event of rollover. Where there is no floor beneath the driver'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
equivalent device which keeps the driver in his seat without
restricting any movements necessary for driving or any movements caused
by the suspension.
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 transported 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.
Should
the driving position have to be fitted with a cab, the other places
must also be protected against the hazards which justified the
protection 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 functions which can
be safely activated only by using control devices located away from the
driving position. This refers in particular to working positions other
than the driving position, for which operators other than the driver
are responsible or for which the driver has to leave his driving
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 risk of confusion;
they must have a slip-resistant surface and be easy to clean.
Where
their operation can lead to hazards, notably dangerous movements, the
machinery's controls, except for those with preset positions, must
return to the neutral position as soon as they are released by the
operator.
In the case of wheeled machinery, the steering system must
be designed and constructed to reduce the force of sudden movements of
the steering wheel or steering lever caused by shocks to the guide
wheels.
Any control that locks the differential must be so designed
and arranged that it allows the differential to be unlocked when the
machinery 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.), the
driver must be provided with the means of checking easily, before
moving the machinery, that such devices are in a particular position
which 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 aforementioned parts.
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 for slowing down,
stopping, braking and immobilisation so as to ensure safety under all
the operating, loading, speed, ground and gradient conditions allowed
for by the manufacturer and corresponding to conditions encountered in
normal use.
The driver must be able to slow down and stop
self-propelled machinery by means of a main device. Where safety so
requires in the event of a failure of the main device, or in the
absence of the energy supply to actuate the main device, an emergency
device with fully independent and easily accessible controls must be
provided for slowing down and stopping.
Where safety so requires, a
parking device must be provided to render stationary machinery
immobile. This device may be combined with 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 the driver. In
particular, it must not be possible for movement to occur while the
engine is being started.
The control systems for
pedestrian-controlled machinery must be designed to minimise the
hazards arising from inadvertent movement of 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 is engaged,
except where movement of the machinery results from movement of the
tool. In the latter case, the reversing speed must be such that 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 time
required 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 the uncontrolled oscillations
of its centre of gravity do not affect its stability 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 in such a way
that, in case of breakage, their fragments will be contained or, if
that is not possible, cannot be projected towards the driving and/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, the machinery must be
designed for and be fitted with anchorage points allowing 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 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 authorised representative
established within the Community must, for each type of structure
concerned, perform appropriate tests or have such tests performed.
In
addition, the earth-moving machinery listed below with a capacity
exceeding 15 kW must be fitted with a rollover protective structure:
- 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, the
machinery should be designed for, and fitted with, if its size allows,
anchorage points allowing it to be equipped with a falling-object
protective 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 authorised representative
established within the Community must, for each type of structure
concerned, perform appropriate tests or have such tests performed.
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 the controls 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 easy and safe connection
and disconnection, and to prevent accidental disconnection 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 machinery (or
tractor) to the first fixed bearing of recipient machinery must be
guarded on the self-propelled machinery side and the recipient
machinery side over the whole length of the shaft and associated
universal joints.
On the side of the self-propelled machinery (or
tractor), the power take-off to which the transmission shaft is
attached must be guarded either by a screen fixed to the self-propelled
machinery (or tractor) or by 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 transmissions
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 system for attaching
the transmission shaft so that when the machinery is uncoupled the
transmission shaft and its guard are not damaged by contact 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 guard must cover the transmission shaft to the
ends of the inner jaws in the case of simple universal joints and at
least to the centre of the outer joint 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 as described in the sixth paragraph
cannot be used as steps unless designed and constructed for that purpose
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 the moving
parts in the engine compartment need not have locking devices if they
have to be opened either by the use of a tool or key or by a control
located in the driving position if the latter is in a fully enclosed
cab 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 electrolyte
being ejected on to the operator in the event of rollover and/or to
avoid the 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 for
that 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 precipitation 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, to ensure the health
and safety of exposed persons. They must be chosen, designed and
constructed in such a way as to be clearly visible and indelible.
Without
prejudice to the requirements to be observed for travelling on the
public highway, machinery with a ride-on driver must have the following
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. The latter
requirement does not apply to machinery intended solely for underground
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 fitted with appropriate means to signal its
movements or with means to protect exposed persons against such
hazards. The same applies to machinery which involves, when in use, the
constant repetition of a forward and backward movement on a single axis
where the back of the 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 essential for safety,
such devices must be provided with the means to check that they are in
good working order and their failure must be made apparent to the
operator.
Where the movement of machinery or its tools is
particularly hazardous, signs on the machinery must be provided to warn
against approaching the machinery while it is working; the signs must
be legible at a sufficient distance to ensure the safety of persons who
have to be in the vicinity.
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 performed on identical
machinery:
- the weighted root mean square acceleration value to
which the arms are subjected, if it exceeds 2,5 m/s², 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
the machinery concerned.
The manufacturer must indicate the
operating conditions of the machinery during measurement and which
methods were used for taking the measurements;
(b) in the case of
machinery allowing several uses depending on the equipment used,
manufacturers of basic machinery to which interchangeable equipment may
be attached and manufacturers of the interchangeable equipment must
provide the necessary information to enable the equipment to be fitted
and used safely.
4. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR
HAZARDS DUE TO A LIFTING OPERATION
Machinery
presenting hazards due to lifting operations - mainly hazards of load
falls and collisions or hazards of tipping caused by a lifting
operation - must be designed and constructed to meet the requirements
set out below.
Risks due to a lifting operation exist particularly
in the case of machinery designed to move a unit load involving a
change in level during the 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 or on 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 by fixed 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 maximum working load marked on the
equipment, accessory or machinery respectively;
(e) 'test
coefficient` means the arithmetic ratio between the load used to carry
out the static or dynamic tests on a piece of equipment, an accessory
or machinery and the maximum working load marked on the piece of
equipment, accessory or machinery;
(f) 'static test` means the
test during which the machinery or the lifting accessory is first
inspected and subjected to a force corresponding to the maximum working
load multiplied by the appropriate static test coefficient and then
re-inspected once the said load has been released to ensure no damage
has occurred;
(g) 'dynamic test` means the test during which the
machinery is operated in all its possible configurations at maximum
working load with account being taken of the dynamic behaviour of the
machinery in order to check that the machinery and safety features are
functioning 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, during foreseeable
component failures and also during the tests carried out in accordance
with the instruction handbook.
To that end, the manufacturer or his
authorised representative established within the Community must use the
appropriate verification methods; in particular, for self-propelled
industrial trucks with lift exceeding 1,80 m, the manufacturer or his
authorised representative established within the Community must, for
each type of industrial truck concerned, perform a platform stability
test or similar test, or have 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 provided which
prevent the equipment, component or load from falling or the machine
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, both in and, where
applicable, out of use, under the installation and operating conditions
provided for by the manufacturer, and in all relevant configurations,
with due regard, where appropriate, to the effects of atmospheric
factors and forces exerted by persons. This requirement must 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 their intended use.
The
materials used must be chosen on the basis of the working environments
provided for by the manufacturer, with special reference to 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 permanent deformation or
patent defect. The calculation must take account of the values of the
static test coefficient chosen to guarantee an adequate level of
safety: that coefficient has, as a general rule, the following 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 load multiplied by
the dynamic test coefficient. This dynamic test coefficient is chosen
so as to guarantee an adequate level of safety: the coefficient 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 tests will be performed at the nominal speeds
laid down by the manufacturer. Should the control circuit of the
machinery allow for a number of simultaneous movements (for example,
rotation and displacement of the load), the tests must be carried out
under the least favourable 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 round without
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 installations which are intended from their design to be
modified regularly according to needs of use). Complete ropes and their
endings have a working coefficient chosen so as to guarantee an
adequate level of safety; 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 to four.
In order to verify that an adequate
working coefficient has been attained, the manufacturer or his
authorised representative established within the Community must, for
each type of chain and rope used directly for lifting the load, and for
the rope ends, perform the appropriate 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 their
expected life-span as specified in the operating conditions for a given
application.
Moreover:
(a) the working coefficient of the
metallic rope/rope-end combination is chosen so as to guarantee an
adequate level of safety; this coefficient is, as a general rule, equal
to five. Ropes must not comprise 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 is chosen so as to guarantee an adequate level of safety; this
coefficient 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. This coefficient is chosen
so as to guarantee an adequate level of safety; it is, as a general
rule, equal to seven, provided the materials used are shown to be of
very good quality and the method of manufacture 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 to secure 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 of an endless sling;
(d) all metallic
components making up, or used with, a sling must have a working
coefficient chosen so as to guarantee an adequate level of safety; this
coefficient is, as a general rule, equal to four;
(e) the maximum
working capacity of a multilegged sling is determined on the basis of
the safety coefficient of the weakest leg, the number of legs and a
reduction factor which depends on the slinging configuration;
(f)
in order to verify that an adequate working coefficient has been
attained, the manufacturer or his authorised representative established
within the Community must, for each type of component referred to in
(a), (b), (c) and (d) perform the appropriate tests or have 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 specified limits. The
operation of such devices must, where appropriate, 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,
such machines must be so designed and constructed as to make it
possible 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 unexpectedly,
even in the event of partial or total failure of the power supply 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 of machinery whose function
requires it to operate in that way;
(e) holding devices must be so designed and constructed that
inadvertent 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, in
order to avoid possible collisions with persons or equipment or other
machinery which might be manoeuvring at the same time and liable to
constitute 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 the load 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 resultant electrical
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 paragraphs,
and those laid down in section 3.2.3 also apply to non-mobile machinery.
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 the
operator. However, for partial or complete movements in which there is
no risk of the load or the machinery colliding, the said devices may be
replaced by controls authorising automatic stops at preselected levels
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 kilograms or an
overturning moment of not less than 40 000 Nm must be fitted with
devices to warn the driver and prevent dangerous movements 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.
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 prevent any 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 designed and constructed to prevent
uncontrolled movement of the load platform, 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 the
Community must ensure, by taking appropriate measures or having them
taken, that lifting accessories and machinery which are ready for use -
whether manually or power-operated - can fulfil their specified
functions safely. The said measures must take into account the static
and dynamic aspects of the machinery.
Where the machinery cannot be
assembled in the manufacturer's premises, or in the premises of his
authorised representative established within the Community, appropriate
measures must be taken at the place of use. Otherwise, the measures may
be taken either in the manufacturer'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 or
irremovable ring bearing the name and address of the manufacturer or
his authorised representative established in the Community and the
identifying reference of the relevant certificate.
The certificate
should show the information required by the harmonised standards or,
should those not exist, at least the following information:
- 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 particulars referred to
in the first paragraph must be displayed on a plate or by some other
means and securely affixed to the accessory.
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 jeopardise 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 the nominal 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 plate indicating,
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 indelible warning prohibiting the lifting of persons. This
warning must be visible 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 setting
out 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 the
manufacturer'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 while they come
under load and after the load has been removed. They must be equipped
with anchorages for the top plates of the individual hydraulic props.
5.2. Movement
Powered roof supports must allow for unhindered movement of exposed
persons.
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 be foot-operated,
however.
The control devices of powered roof supports must be
designed and laid out so that, during displacement operations,
operators are sheltered by a support in place. The control devices must
be protected against any 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 circuit controlling 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 sparks or cause fires.
Machinery
with heat engines for use in underground working must be fitted only
with internal combustion engines using fuel with a low vaporising
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 LIFTING OR MOVING OF PERSONS
Machinery
presenting hazards due to the lifting or moving of persons must be
designed and constructed to meet the requirements set out below.
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 a general
rule, be doubled. The floor of the carrier must be designed and
constructed to offer the space and strength corresponding to the
maximum number of persons and the maximum working load set by the
manufacturer.
6.1.3. Loading control for types of device moved by power other than
human 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 of
which the manufacturer can demonstrate that there is no risk of
overloading 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
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 designed and
constructed so that the person or persons in the carrier have the means
of preventing hazards produced by the movement of the machinery.
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 not
cause 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
of persons possibly using the carrier, strong enough for the attachment
of personal 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
unexpectedly.
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 which creates 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 the
maximum 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.
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
Article 8(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 Article 8(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
manufacturer or his authorised representatives.
B.
Contents of the declaration by the manufacturer or his authorised
representatives 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
Article 8(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 Article 8(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 in
conformity 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 (4)
The EC declaration of conformity must contain the following particulars:
- name and address of the manufacturer or his authorised representative
established in the Community (5),
- description of the safety component (6),
- 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,
-
where appropriate, the name and address of the notified body to which
the file was forwarded in accordance with the first indent of Article
8(2)(c),
- where appropriate, the name and address of the notified
body which carried out the verification referred to in the second
indent of Article 8(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
manufacturer or his authorised representative established in the
Community.
(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 block capitals. It
must be accompanied by a translation in one of the official languages
of the country in which the machinery is to be used. This translation
must be done in accordance with the same conditions as for the
translation of the instructions.
(2) Business name and full address; authorised representatives must
also give the business 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.).
ANNEX III
CE CONFORMITY MARKING
- The CE conformity marking shall consist of the initials 'CE` taking
the following form:
>REFERENCE TO A GRAPHIC>
- 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
dimension may be waived for small-scale machinery.
ANNEX IV
TYPES OF MACHINERY AND SAFETY COMPONENTS FOR WHICH THE PROCEDURE
REFERRED TO IN ARTICLE 8(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 loading and/or
unloading.
1.4. Sawing machines with movable tool during operation, with a
mechanical 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 with wood
and analogous materials or for working with meat and analogous
materials.
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 woodworking.
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 may have 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: locomotives and brake-vans,
- hydraulic-powered roof supports,
- internal combustion engines to be fitted to machinery for underground
working.
13. Manually-loaded trucks for the collection of household refuse
incorporating 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,
electromagnetic 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).
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
manufacturer, or his authorised representative established in the
Community declares that the machinery being placed on the market
complies with all the essential health 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 to the 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 to
guarantee that the documentation listed below is and will remain
available on his 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 with
the essential health and safety requirements,
- a list of:
- the essential requirements of this Directive,
- standards, and
- other technical specifications, which were used when the machinery
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
at his choice either by himself or by a competent body or laboratory
(2),
- 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 of
the Directive.
The manufacturer must carry out necessary research or
tests on components, fittings or the completed machine to determine
whether by its design or construction, the machine is capable of being
erected and put into service safely.
Failure to present the
documentation in response to a duly substantiated request by the
competent national authorities may constitute sufficient grounds for
doubting the presumption of conformity with the requirements of the
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 it available within a period of time commensurate
with its importance.
It does not have to include detailed plans or
any other specific information as regards the sub-assemblies used for
the manufacture of the machinery unless a knowledge of them is
essential for verification of conformity 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 years following the date of manufacture of the machinery or
of the last unit produced, 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
instructions for the machinery.
(1) A body or laboratory is presumed
competent if it meets the assessment criteria laid down in the relevant
harmonised standards.
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 this Directive 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 a single
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 machinery,
- 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 with
the 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 provisions
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 be examined.
The documentation
referred to above does not have to include detailed plans or any other
specific information as regards the sub-assemblies used for the
manufacture of the machinery unless a knowledge of them is essential
for verification 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 working
conditions;
(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 applicable
to 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 the applicant. That certificate shall state the
conclusions of the examination, indicate any conditions to which its
issue may be subject and be accompanied by the descriptions and
drawings necessary for identification of the approved example.
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 the
technical construction file and of the reports on the examinations and
tests carried out.
5. The manufacturer or his authorised
representative established in the Community shall inform the notified
body of any modifications, even of a minor nature, which he has made or
plans to make to the machine to which the example relates. The notified
body shall examine those modifications and inform the manufacturer or
his authorised representative established in the Community 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-examination
certificate shall so inform the Member State which notified it. The
latter 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 the notified body is
established or in a language acceptable to it.
ANNEX VII
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER 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
verification tests shall not be the designer, manufacturer, supplier or
installer of machinery which they inspect, nor the authorised
representative of any of these parties. They shall not become either
involved directly or as authorised representatives in the design,
construction, marketing or maintenance of the machinery. This does not
preclude the possibility of exchanges of technical information 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 free from all pressures
and inducements, particularly financial, which might influence their
judgement or the results of the inspection, especially from persons or
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 and technical tasks connected with verification; it
shall also have access to the equipment 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 such tests.
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 is directly 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 are carried out) under
this Directive or any provision of national law giving effect to it.
ANNEX VIII
Part A
Repealed Directives (referred to by Article 14)
>TABLE POSITION>
Part B
List of deadlines for transposition into and application in national
law (referred to by Article 14)
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ANNEX IX
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