MT
MACHINERY REGULATIONS
Table of Provisions (35)
Statutory Text (35 Articles)
MACHINERY
SUBSIDIARY LEGISLATION 427.36
MACHINERY REGULATIONS
29th December, 2009
LEGAL NOTICE 147 of 2009, as amended by Legal Notice 131 of 2011.
(1) The title of these regulations is the Machinery
Regulations.
(2) These regulations implement the requirements of Directive
2006/42/EC of the European Parliament and of the Council of 17th
May 2006 on the approximation of the laws of the Member States
relating to machinery.
(3) Until 29th June 2011, the placing on the market and the
putting into service of portable cartridge operated fixing and other
impact machinery which are in conformity with the national
provisions in force upon the adoption of these regulations, may be
allowed.
L.N. 131 of 2011.
[Regulations 4, 6(1)(a) and (3), 9(1) and (2)]
Essential health and safety requirements relating to the design
and construction of machinery
GENERAL PRINCIPLES
1. The manufacturer of machinery or his authorised representative must ensure
that a risk assessment is carried out in order to determine the health and safety
requirements which apply to the machinery. The machinery must then be designed
and constructed taking into account the results of the risk assessment.
By the iterative process of risk assessment and risk reduction referred to above,
the manufacturer or his authorised representative shall
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determine the limits of the machinery, which include the intended use
and any reasonably foreseeable misuse thereof,
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identify the hazards that can be generated by the machinery and the
associated hazardous situations,
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estimate the risks, taking into account the severity of the possible injury
or damage to health and the probability of its occurrence,
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evaluate the risks, with a view to determining whether risk reduction is
required, in accordance with the objective of these regulations,
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eliminate the hazards or reduce the risks associated with these hazards
by application of protective measures, in the order of priority
established in paragraph 1.1.2(b).
2. The obligations laid down by the essential health and safety requirements
only apply when the corresponding hazard exists for the machinery in question when
it is used under the conditions foreseen by the manufacturer or his authorised
representative or in foreseeable abnormal situations. In any event, the principles of
safety integration referred to in paragraph 1.1.2 and the obligations concerning
marking of machinery and instructions referred to in paragraphs 1.7.3 and 1.7.4
apply.
3. The essential health and safety requirements laid down in this Schedule are
mandatory; however, taking into account the state of the art, it may not be possible
to meet the objectives set by them. In that event, the machinery must, as far as
possible, be designed and constructed with the purpose of approaching these
objectives.
4. This Schedule is organised in several parts. The first one is of general scope
and applicable to all kinds of machinery. The other parts refer to certain kinds of
more specific hazards. Nevertheless, it is essential to examine the whole of this
Schedule in order to be sure of meeting all the relevant essential requirements. When
machinery is being designed, the requirements of the general part and the
requirements of one or more of the other parts shall be taken into account, depending
on the results of the risk assessment carried out in accordance with point 1 of these
General Principles. Essential health and safety requirements for the protection of the
environment are applicable only to the machinery referred to in section 2.4.
1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
1.1.
GENERAL REMARKS
1.1.1
Definitions
For the purpose of this Schedule
(a) ‘hazard’ means a potential source of injury or damage to health;
(b) ‘danger zone’ means any zone within and, or around machinery in
which a person is subject to a risk to his health or safety;
(c) ‘exposed person’ means any person wholly or partially in a danger
zone;
(d) ‘operator’ means the person or persons installing, operating, adjusting,
maintaining, cleaning, repairing or moving machinery;
(e) ‘risk’ means a combination of the probability and the degree of an
injury or damage to health that can arise in a hazardous situation;
(f)
‘guard’ means a part of the machinery used specifically to provide
protection by means of a physical barrier;
(g) ‘protective device’ means a device (other than a guard) which reduces
the risk, either alone or in conjunction with a guard;
(h) ‘intended use’ means the use of machinery in accordance with the
information provided in the instructions for use;
(i)
‘reasonably foreseeable misuse’ means the use of machinery in a way
not intended in the instructions for use, but which may result from
readily predictable human behaviour.
1.1.2. Principles of safety integration
(a) Machinery must be designed and constructed so that it is fitted for its
function, and can be operated, adjusted and maintained without putting
persons at risk when these operations are carried out under the
conditions foreseen but also taking into account any reasonably
foreseeable misuse thereof.
The aim of measures taken must be to eliminate any risk throughout the
foreseeable lifetime of the machinery including the phases of transport,
assembly, dismantling, disabling and scrapping.
(b) In selecting the most appropriate methods, the manufacturer or his
authorised representative must apply the following principles, in the
order given
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eliminate or reduce risks as far as possible (inherently safe
machinery design and construction),
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take the necessary protective measures in relation to risks that
cannot be eliminated,
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inform users of the residual risks due to any shortcomings of the
protective measures adopted, indicate whether any particular
training is required and specify any need to provide personal
protective equipment.
(c) When designing and constructing machinery and when drafting the
instructions, the manufacturer or his authorised representative must
envisage not only the intended use of the machinery but also any
reasonably foreseeable misuse thereof.
The machinery must be designed and constructed in such a way as to
prevent abnormal use if such use would engender a risk. Where
appropriate, the instructions must draw the user’s attention to ways in
which the machinery should not be used.
MACHINERY
(d) Machinery must be designed and constructed to take account of the
constraints to which the operator is subject as a result of the necessary
or foreseeable use of personal protective equipment.
(e) Machinery must be supplied with all the special equipment and
accessories essential to enable it to be adjusted, maintained and used
safely.
1.1.3. Materials and products
The materials used to construct machinery or products used or created during its
use must not endanger persons' safety or health. In particular, where fluids are used,
machinery must be designed and constructed to prevent risks due to filling, use,
recovery or draining.
1.1.4. Lighting
Machinery must be supplied with integral lighting suitable for the operations
concerned where the absence thereof is likely to cause a risk despite ambient
lighting of normal intensity.
Machinery must be designed and constructed so 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 on moving parts due to the lighting.
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
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be capable of being handled and transported safely,
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be packaged or designed so that it can be stored safely and without
damage.
During the transportation of the machinery and, or its component parts, there must
be no possibility of sudden movements or of hazards due to instability as long as the
machinery and, or its component parts are handled in accordance with the
instructions.
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
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either be fitted with attachments for lifting gear, or
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be designed so that it can be fitted with such attachments, or
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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
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either be easily moveable, or
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be equipped for picking up and moving safely.
Special arrangements must be made for the handling of tools and, or machinery
parts which, even if lightweight, could be hazardous.
1.1.6. Ergonomics
Under the intended conditions of use, the discomfort, fatigue and physical and
psychological stress faced by the operator must be reduced to the minimum possible,
taking into account ergonomic principles such as
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allowing for the variability of the operator's physical dimensions,
strength and stamina,
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providing enough space for movements of the parts of the operator’s
body,
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avoiding a machine-determined work rate,
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avoiding monitoring that requires lengthy concentration,
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adapting the man/machinery interface to the foreseeable characteristics
of the operators.
1.1.7. Operating positions
The operating position must be designed and constructed in such a way as to avoid
any risk due to exhaust gases and, or lack of oxygen.
If the machinery is intended to be used in a hazardous environment presenting
risks to the health and safety of the operator or if the machinery itself gives rise to a
hazardous environment, adequate means must be provided to ensure that the operator
has good working conditions and is protected against any foreseeable hazards.
Where appropriate, the operating position must be fitted with an adequate cabin
designed, constructed and, or equipped to fulfil the above requirements. The exit
must allow rapid evacuation. Moreover, when applicable, an emergency exit must be
provided in a direction which is different from the usual exit.
1.1.8. Seating
Where appropriate and where the working conditions so permit, work stations
constituting an integral part of the machinery must be designed for the installation of
seats.
If the operator is intended to sit during operation and the operating position is an
integral part of the machinery, the seat must be provided with the machinery.
The operator’s seat must enable him to maintain a stable position. Furthermore,
the seat and its distance from the control devices must be capable of being adapted to
the operator.
If the machinery is subject to vibrations, the seat must be designed and
constructed in such a way as to reduce the vibrations transmitted to the operator to
the lowest level that is reasonably possible. The seat mountings must withstand all
stresses to which they can be subjected. Where there is no floor beneath the feet of
the operator, footrests covered with a slip-resistant material must be provided.
1.2.
CONTROL SYSTEMS
1.2.1. Safety and reliability of control systems
Control systems must be designed and constructed in such a way as to prevent
hazardous situations from arising. Above all, they must be designed and constructed
in such a way that
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they can withstand the intended operating stresses and external
influences,
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a fault in the hardware or the software of the control system does not
lead to hazardous situations,
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errors in the control system logic do not lead to hazardous situations,
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reasonably foreseeable human error during operation does not lead to
hazardous situations.
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Particular attention must be given to the following points
the machinery must not start unexpectedly,
the parameters of the machinery must not change in an uncontrolled
way, where such change may lead to hazardous situations,
the machinery must not be prevented from stopping if the stop
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 protective devices must remain fully effective or give a stop
command,
the safety-related parts of the control system must apply in a coherent
way to the whole of an assembly of machinery and, or partly completed
machinery.
For cable-less control, an automatic stop must be activated when correct control
signals are not received, including loss of communication.
1.2.2. Control devices
(a) Control devices must be
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clearly visible and identifiable, using pictograms where
appropriate,
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positioned in such a way as to be safely operated without
hesitation or loss of time and without ambiguity,
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designed in such a way that the movement of the control device is
consistent with its effect,
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located outside the danger zones, except where necessary for
certain control devices such as an emergency stop or a teach
pendant,
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positioned in such a way that their operation cannot cause
additional risk,
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designed or protected in such a way that the desired effect, where
a hazard is involved, can only be achieved by a deliberate action,
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made in such a way as to withstand foreseeable forces; particular
attention must be paid to emergency stop devices liable to be
subjected to considerable forces.
(b) Where a control device is designed and constructed to perform several
different actions, namely where there is no one-to-one correspondence,
the action to be performed must be clearly displayed and subject to
confirmation, where necessary.
(c) Control devices 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.
(d) Machinery must be fitted with indicators as required for safe operation.
The operator must be able to read them from the control position.
(e) From each control position, the operator must be able to ensure that no
one is in the danger zones, or the control system must be designed and
constructed in such a way that starting is prevented while someone is in
the danger zone.
(f)
If neither of these possibilities is applicable, before the machinery
starts, an acoustic and, or visual warning signal must be given. The
exposed persons must have time to leave the danger zone or prevent the
machinery starting up.
(g) If necessary, means must be provided to ensure that the machinery can
be controlled only from control positions located in one or more
predetermined zones or locations.
(h) Where there is more than one control position, the control system must
be designed in such a way that the use of one of them precludes the use
of the others, except for stop controls and emergency stops.
(i)
When machinery has two or more operating positions, each position
must be provided with all the required control devices without the
operators hindering or putting each other into a hazardous situation.
1.2.3. Starting
It must be possible to start machinery only by voluntary actuation of a control
device provided for the purpose.
The same requirement applies
when restarting the machinery after a stoppage, whatever the cause,
when effecting a significant change in the operating conditions.
However, the restarting of the machinery or a change in operating conditions may
be effected by voluntary actuation of a device other than the control device provided
for the purpose, on condition that this does not lead to a hazardous situation.
For machinery functioning in automatic mode, the starting of the machinery,
restarting after a stoppage, or a change in operating conditions may be possible
without intervention, provided this does not lead to a hazardous situation.
Where machinery has several starting control devices and the operators can
therefore put each other in danger, additional devices must be fitted to rule out such
risks. If safety requires that starting and, or stopping must be performed in a specific
sequence, there must be devices which ensure that these operations are performed in
the correct order.
1.2.4. Stopping
1.2.4.1. Normal stop
Machinery must be fitted with a control device whereby the machinery can be
brought safely to a complete stop.
Each workstation must be fitted with a control device to stop some or all of the
functions of the machinery, depending on the existing hazards, so that the machinery
is rendered safe.
The machinery’s stop control must have priority over the start controls.
Once the machinery or its hazardous functions have stopped, the energy supply to
the actuators concerned must be cut off.
1.2.4.2. Operational stop
Where, for operational reasons, a stop control that does not cut off the energy
supply to the actuators is required, the stop condition must be monitored and
maintained.
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1.2.4.3. Emergency stop
Machinery must be fitted with one or more emergency stop devices to enable
actual or impending danger to be averted.
The following exceptions apply
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machinery 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,
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portable hand-held and, or hand-guided machinery.
The device must
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have clearly identifiable, clearly visible and quickly accessible control
devices,
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stop the hazardous process as quickly as possible, without creating
additional risks,
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where necessary, trigger or permit the triggering of certain safeguard
movements.
Once active operation of the emergency stop device 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.
The emergency stop function must be available and operational at all times,
regardless of the operating mode.
Emergency stop devices must be a back-up to other safeguarding measures and not
a substitute for them.
1.2.4.4. Assembly of machinery
In the case of machinery or parts of machinery designed to work together, the
machinery must be designed and constructed in such a way that the stop controls,
including the emergency stop devices, can stop not only the machinery itself but also
all related equipment, if its continued operation may be dangerous.
1.2.5. Selection of control or operating modes
The control or operating mode selected must override all other control or
operating modes, with the exception of the emergency stop.
If machinery has been designed and constructed to allow its use in several control
or operating modes requiring different protective measures and, or work procedures,
it must be fitted with a mode selector which can be locked in each position. Each
position of the selector must be clearly identifiable and 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.
If, for certain operations, the machinery must be able to operate with a guard
displaced or removed and, or a protective device disabled, the control or operating
mode selector must simultaneously
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disable all other control or operating modes,
permit the operation of hazardous functions only by control devices
requiring sustained action,
permit the operation of hazardous functions only in reduced risk
conditions while preventing hazards from linked sequences,
prevent any operation of hazardous functions by voluntary or
involuntary action on the machine’s sensors.
If these four conditions cannot be fulfilled simultaneously, the control or
operating mode selector must activate other protective measures designed and
constructed to ensure a safe intervention zone.
In addition, the operator must be able to control operation of the parts he is
working on from the adjustment point.
1.2.6. Failure of the power supply
The interruption, the re-establishment after an interruption or the fluctuation in
whatever manner of the power supply to the machinery must not lead to dangerous
Particular attention must be given to the following points
the machinery must not start unexpectedly,
the parameters of the machinery must not change in an uncontrolled
way when such change can lead to hazardous situations,
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 protective devices must remain fully effective or give a stop
command.
PROTECTION AGAINST MECHANICAL HAZARDS
1.3.1. Risk of loss of stability
Machinery and its components and fittings must be stable enough to avoid
overturning, falling or uncontrolled movements during transportation, assembly,
dismantling and any other action involving the machinery.
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.
The durability of the materials used must be adequate for the nature of the
working environment foreseen by the manufacturer or his authorised representative,
in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.
The instructions must indicate the type and frequency of inspections and
maintenance required for safety reasons. They 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, the
MACHINERY
parts concerned must be mounted, positioned and, or guarded in such a way that any
fragments will be contained, preventing hazardous situations.
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 to ensure that no risk is posed by a rupture.
Where the material to be processed is fed to the tool automatically, the following
conditions must be fulfilled to avoid risks to persons
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when the workpiece comes into contact with the tool, the latter must
have attained its normal working condition,
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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.
1.3.4. Risks due to surfaces, edges or angles
Insofar 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
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 risk for exposed persons.
For this purpose, it must be possible to start and stop separately any elements that
are not protected.
1.3.6. Risks related to variations in operating conditions Where the machinery
performs operations under different conditions of use, 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. Risks related to moving parts
The moving parts of machinery must be designed and constructed in such a way as
to prevent risks of contact which could lead to accidents or must, where risks persist,
be fitted with guards or protective devices.
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, the necessary specific protective devices and tools must, when
appropriate, be provided to enable the equipment to be safely unblocked.
The instructions and, where possible, a sign on the machinery shall identify these
specific protective devices and how they are to be used.
1.3.8. Choice of protection against risks arising from moving parts
Guards or protective devices designed to protect against risks arising from moving
parts must be selected on the basis of the type of risk. The following guidelines must
be used to help to make the choice.
1.3.8.1. Moving transmission parts
Guards designed to protect persons against the hazards generated by moving
transmission parts must be
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either fixed guards as referred to in paragraph 1.4.2.1, or
interlocking movable guards as referred to in paragraph 1.4.2.2.
Interlocking movable guards should be used where frequent access is envisaged.
1.3.8.2. Moving parts involved in the process
Guards or protective devices designed to protect persons against the hazards
generated by moving parts involved in the process must be
either fixed guards as referred to in paragraph 1.4.2.1, or
interlocking movable guards as referred to in paragraph 1.4.2.2, or
protective devices as referred to in paragraph 1.4.3, or
a combination of the above.
However, when certain moving parts directly involved in the process cannot be
made completely inaccessible during operation owing to operations requiring
operator intervention, such parts must be fitted with
fixed guards or interlocking movable guards preventing access to those
sections of the parts that are not used in the work, and
adjustable guards as referred to in paragraph 1.4.2.3 restricting access
to those sections of the moving parts where access is necessary.
1.3.9. Risks of uncontrolled movements
When a part of the machinery has been stopped, any drift away from the stopping
position, for whatever reason other than action on the control devices, must be
prevented or must be such that it does not present a hazard.
REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE
1.4.1. General requirements
Guards and protective devices must
be of robust construction,
be securely held in place,
not give rise to any additional hazard,
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, and
enable essential work to be carried out on the installation and, or
replacement of tools and for maintenance purposes by restricting access
exclusively to the area where the work has to be done, if possible
without the guard having to be removed or the protective device having
to be disabled.
In addition, guards must, where possible, protect against the ejection or falling of
materials or objects and against emissions generated by the machinery.
1.4.2. Special requirements for guards
1.4.2.1. Fixed guards
Fixed guards must be fixed by systems that can be opened or removed only with
Their fixing systems must remain attached to the guards or to the machinery when
the guards are removed.
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Where possible, guards must be incapable of remaining in place without their
1.4.2.2. Interlocking movable guards
Interlocking movable guards must
as far as possible remain attached to the machinery when open,
be designed and constructed in such a way that they can be adjusted
only by means of an intentional action.
Interlocking movable guards must be associated with an interlocking device that
prevents the start of hazardous machinery functions until they are
closed and
gives a stop command whenever they are no longer closed.
Where it is possible for an operator to reach the danger zone before the risk due to
the hazardous machinery functions has ceased, movable guards must be associated
with a guard locking device in addition to an interlocking device that
prevents the start of hazardous machinery functions until the guard is
closed and locked, and
keeps the guard closed and locked until the risk of injury from the
hazardous machinery functions has ceased.
Interlocking movable guards must be designed in such a way that the absence or
failure of one of their components prevents starting or stops the hazardous
machinery functions.
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, depending on the type of work
involved, and
readily adjustable without the use of tools.
1.4.3. Special requirements for protective devices
Protective devices must be designed and incorporated into the control system in
such a way that
moving parts cannot start up while they are within the operator’s reach,
persons cannot reach moving parts while the parts are moving, and
the absence or failure of one of their components prevents starting or
stops the moving parts.
Protective devices must be adjustable only by means of an intentional action.
RISKS DUE TO OTHER HAZARDS
1.5.1. Electricity supply
Where machinery has an electricity supply, it must be designed, constructed and
equipped in such a way that all hazards of an electrical nature are or can be
The safety objectives set out in the Low Voltage Electrical Equipment Regulations
shall apply to machinery. However, the obligations concerning conformity
assessment and the placing on the market and, or putting into service of machinery
with regard to electrical hazards are governed solely by these regulations.
1.5.2. Static electricity
Machinery must be designed and constructed 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 source of energy other than electricity, it must be
so designed, constructed and equipped as to avoid all potential risks associated with
such sources 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 and construction of such parts
or, failing this, by information given on the parts themselves and, or their housings.
The same information must be given on moving parts and, or their housings where
the direction of movement needs to be known in order to avoid a risk.
Where necessary, the instructions must give further information on these risks.
Where a faulty connection can be the source of risk, incorrect connections must be
made impossible by design or, failing this, by information given on the elements to
be connected and, where appropriate, on the means of connection.
1.5.5. Extreme temperatures
Steps must be taken to eliminate any risk of injury arising from contact with or
proximity to machinery parts or materials at high or very low temperatures.
The necessary steps must also be taken to avoid or protect against the risk of hot
or very cold material being ejected.
1.5.6. Fire
Machinery must be designed and constructed in such a way as to avoid any 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 in such a way as 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.
Machinery must comply, as far as the risk of explosion due to its use in a
potentially explosive atmosphere is concerned, with the provisions of the specific
Community legislation.
1.5.8. Noise
Machinery must be designed and constructed in such a way 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.
The level of noise emission may be assessed with reference to comparative
emission data for similar machinery.
1.5.9. Vibrations
Machinery must be designed and constructed in such a way that risks resulting
from vibrations produced by the machinery are reduced to the lowest level, taking
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account of technical progress and the availability of means of reducing vibration, in
particular at source.
The level of vibration emission may be assessed with reference to comparative
emission data for similar machinery.
1.5.10. Radiation
Undesirable radiation emissions from the machinery must be eliminated or be
reduced to levels that do not have adverse effects on persons.
Any functional ionising radiation emissions must be limited to the lowest level
which is sufficient for the proper functioning of the machinery during setting,
operation and cleaning. Where a risk exists, the necessary protective measures must
Any functional non-ionising radiation emissions during setting, operation and
cleaning must be limited to levels that do not have adverse effects on persons.
1.5.11. External radiation
Machinery must be designed and constructed in such a way that external radiation
does not interfere with its operation.
1.5.12. Laser radiation
Where laser equipment is used, the following should be taken into account
laser equipment on machinery must be designed and constructed in such
a way as to prevent any accidental radiation,
laser equipment on machinery must be protected in such a way 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 laser
radiation.
1.5.13. Emissions of hazardous materials and substances
(a) Machinery must be designed and constructed in such a way that risks of
inhalation, ingestion, contact with the skin, eyes and mucous
membranes and penetration through the skin of hazardous materials and
substances which it produces can be avoided.
(b) Where a hazard cannot be eliminated, the machinery must be so
equipped that hazardous materials and substances can be contained,
evacuated, precipitated by water spraying, filtered or treated by another
equally effective method.
(c) Where the process is not totally enclosed during normal operation of the
machinery, the devices for containment and, or evacuation must be
situated in such a way as to have the maximum effect.
1.5.14. Risk of being trapped in a machine
Machinery must be designed, constructed or fitted with a means of preventing a
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 in such a way as to prevent persons slipping, tripping or
falling on or off these parts.
Where appropriate, these parts must be fitted with handholds that are fixed
relative to the user and that enable them to maintain their stability.
1.5.16. 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 charge to earth.
1.6.
MAINTENANCE
1.6.1. Machinery maintenance
Adjustment 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,
measures must be taken to ensure that these operations can be carried out safely (see
paragraph 1.2.5).
In the case of automated machinery and, where necessary, other machinery, a
connecting device for mounting diagnostic fault-finding equipment must be
provided.
Automated machinery components which have to be changed frequently must be
capable of being removed and replaced easily and safely. Access to the components
must enable these tasks to be carried out with the necessary technical means in
accordance with a specified operating method.
1.6.2. Access to operating positions and servicing points Machinery must be
designed and constructed in such a way as to allow access in safety to all areas
where intervention is necessary during operation, adjustment and maintenance of the
machinery.
1.6.3. Isolation of energy sources
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 persons. Isolators must also be capable of being locked
where an operator is unable, from any of the points to which he has access, to check
that the energy is still cut off.
In the case of machinery capable of being plugged into an electricity supply,
removal of the plug is sufficient, provided that the operator can check from any of
the points to which he has access that the plug remains removed.
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 persons.
As an exception to the requirement laid down in the previous paragraphs, certain
circuits may remain connected to their energy sources in order, for example, to hold
parts, to protect information, to light interiors, and related matters. 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 safely.
1.6.5. Cleaning of internal parts
The machinery must be designed and constructed in such a way that it is possible
MACHINERY
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 impossible to avoid entering the machinery, it must be designed and
constructed in such a way as to allow cleaning to take place safely.
1.7.
INFORMATION
1.7.1. Information and warnings on the machinery
Information and warnings on the machinery should preferably be provided in the
form of readily understandable symbols or pictograms. Any written or verbal
information and warnings must be expressed in the Maltese language or in any other
official Community language or languages, which may be determined in accordance
with the Treaty by the Member State in which the machinery is placed on the market
and, or put into service and may be accompanied, on request, by versions in any
other official Community language or languages understood by the operators.
1.7.1.1. Information and information devices
The information needed to control machinery must be provided in a form that is
unambiguous and easily understood. It must not be excessive to the extent of
overloading the operator.
Visual display units or any other interactive means of communication between the
operator and the machine must be easily understood and easy to use.
1.7.1.2. Warning devices
Where the health and safety of persons may be endangered by a fault in the
operation of unsupervised machinery, the machinery must be equipped in such a way
as to give an appropriate acoustic or light signal as a warning.
Where machinery is equipped with warning devices 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 Community legislation concerning colours and
safety signals must be complied with.
1.7.2. Warning of residual risks
Where risks remain despite the inherent safe design measures, safeguarding and
complementary protective measures adopted, the necessary warnings, including
warning devices, must be provided.
1.7.3. Marking of machinery
All machinery must be marked visibly, legibly and indelibly with the following
minimum particulars
-
the business name and full address of the manufacturer and, where
applicable, his authorised representative,
-
designation of the machinery,
-
the CE Marking (see Schedule III),
-
designation of series or type,
-
serial number, if any,
-
the year of construction, that is the year in which the manufacturing
process is completed.
It is prohibited to pre-date or post-date the machinery when affixing the CE
marking.
Furthermore, machinery designed and constructed for use in a potentially
explosive atmosphere must be marked accordingly.
Machinery must also bear full information relevant to its type and essential for
safe use. Such information is subject to the requirements set out in paragraph 1.7.1.
Where a machine part must be handled during use with lifting equipment, its mass
must be indicated legibly, indelibly and unambiguously.
1.7.4. Instructions
All machinery must be accompanied by instructions in the official Community
language or languages of the Member State in which it is placed on the market and,
or put into service.
T h e i n s t r u ct i o n s a cc o m p an y i n g t h e m a c hi n e r y m u st b e ei t h er ‘ Or ig i n a l
instructions’ or a ‘Translation of the original instructions’, in which case the
translation must be accompanied by the original instructions.
By way of exception, the maintenance instructions intended for use by specialised
personnel mandated by the manufacturer or his authorised representative may be
supplied in only one Community language which the specialised personnel
understand.
The instructions must be drafted in accordance with the principles set out below.
1.7.4.1. General principles for the drafting of instructions
(a) The instructions must be drafted in the Maltese language or in any other
one or more official Community languages. The words ‘Original
instructions’ must appear on the language version(s) verified by the
manufacturer or his authorised representative.
(b) Where no ‘Original instructions’ exist in the official language(s) of the
country where the machinery is to be used, a translation into that/those
language(s) must be provided by the manufacturer or his authorized
representative or by the person bringing the machinery into the
language area in question. The translations must bear the words
‘Translation of the original instructions’.
(c) The contents of the instructions must cover not only the intended use of
the machinery but also take into account any reasonably foreseeable
misuse thereof.
(d) In the case of machinery intended for use by non-professional operators,
the wording and layout of the instructions for use must take into account
the level of general education and acumen that can reasonably be
expected from such operators.
1.7.4.2. Contents of the instructions
Each instruction manual must contain, where applicable, at least the following
information
(a) the business name and full address of the manufacturer and of his
authorised representative;
(b) the designation of the machinery as marked on the machinery itself,
except for the serial number (see paragraph 1.7.3);
(c) the EC declaration of conformity, or a document setting out the contents
of the EC declaration of conformity, showing the particulars of the
machinery, not necessarily including the serial number and the
signature;
MACHINERY
(d) a general description of the machinery;
(e) the drawings, diagrams, descriptions and explanations necessary for the
use, maintenance and repair of the machinery and for checking its
correct functioning;
(f)
a description of the workstation(s) likely to be occupied by operators;
(g) a description of the intended use of the machinery;
(h) warnings concerning ways in which the machinery must not be used that
experience has shown might occur;
(i)
assembly, installation and connection instructions, including drawings,
diagrams and the means of attachment and the designation of the chassis
or installation on which the machinery is to be mounted;
(j)
instructions relating to installation and assembly for reducing noise or
vibration;
(k) instructions for the putting into service and use of the machinery and, if
necessary, instructions for the training of operators;
(l)
information about the residual risks that remain despite the inherent
safe design measures, safeguarding and complementary protective
measures adopted;
(m) instructions on the protective measures to be taken by the user,
including, where appropriate, the personal protective equipment to be
provided;
(n) the essential characteristics of tools which may be fitted to the
machinery;
(o) the conditions in which the machinery meets the requirement of
stability during use, transportation, assembly, dismantling when out of
service, testing or foreseeable breakdowns;
(p) instructions with a view to ensuring that transport, handling and storage
operations can be made safely, giving the mass of the machinery and of
its various parts where these are regularly to be transported separately;
(q) the operating method to be followed in the event of accident or
breakdown; if a blockage is likely to occur, the operating method to be
followed so as to enable the equipment to be safely unblocked;
(r) the description of the adjustment and maintenance operations that
should be carried out by the user and the preventive maintenance
measures that should be observed;
(s) instructions designed to enable adjustment and maintenance to be
carried out safely, including the protective measures that should be
taken during these operations;
(t)
the specifications of the spare parts to be used, when these affect the
health and safety of operators;
(u) the following information on airborne noise emissions
-
the A-weighted emission 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,
-
the peak C-weighted instantaneous sound pressure value at
workstations, where this exceeds 63 Pa (130 dB in relation to 20
µPa),
-
the A-weighted sound power level emitted by the machinery,
where the A-weighted emission sound pressure level at
workstations exceeds 80 dB(A).
These values must be either those actually measured for the machinery
in question or those established on the basis of measurements taken for
technically comparable machinery which is representative of the
machinery to be produced.
In the case of very large machinery, instead of the A-weighted sound
power level, the A-weighted emission 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.
Whenever sound emission values are indicated the uncertainties
surrounding these values must be specified. The operating conditions of
the machinery during measurement and the measuring methods used
must be described.
Where the workstation(s) are undefined or cannot be defined, A-
weighted sound pressure levels must be measured at a distance of 1
metre from the surface of the machinery and at a height of 1,6 metres
from the floor or access platform. The position and value of the
maximum sound pressure must be indicated.
Where specific Community legislation lay down other requirements for
the measurement of sound pressure levels or sound power levels, those
Community legislation must be applied and the corresponding
provisions of this section shall not apply;
(v) where machinery is likely to emit non-ionising radiation which may
cause harm to persons, in particular persons with active or non-active
implantable medical devices, information concerning the radiation
emitted for the operator and exposed persons.
1.7.4.3. Sales literature
Sales literature describing the machinery must not contradict the instructions as
regards health and safety aspects. Sales literature describing the performance
characteristics of machinery must contain the same information on emissions as is
contained in the instructions.
2. SUPPLEMENTARY
ESSENTIAL
HEALTH
AND
SAFETY
REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY
Foodstuffs machinery, machinery for cosmetics or pharmaceutical products,
handheld and, or hand-guided machinery, portable fixing and other impact
machinery, machinery for working wood and material with similar physical
characteristics and machinery for pesticide application must meet all the essential
health and safety requirements set out in this chapter (see General Principles,
paragraph 4).
FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS
OR PHARMACEUTICAL PRODUCTS
2.1.1. General
Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical
products must be designed and constructed in such a way as to avoid any risk of
infection, sickness or contagion.
MACHINERY
The following requirements must be observed
(a) materials in contact with, or intended to come into contact with,
foodstuffs or cosmetics or pharmaceutical products must satisfy the
conditions set down in those relevant regulations. The machinery must
be designed and constructed in such a way that these materials can be
cleaned before each use. Where this is not possible disposable parts
must be used;
(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical
products, other than surfaces of disposable parts, must
-
be smooth and have neither ridges nor crevices which could
harbour organic materials. The same applies to their joinings,
-
be designed and constructed in such a way as to reduce the
projections, edges and recesses of assemblies to a minimum,
-
be easily cleaned and disinfected, where necessary after removing
easily dismantled parts; the inside surfaces must have curves with
a radius sufficient to allow thorough cleaning;
(c) it must be possible for liquids, gases and aerosols deriving from
foodstuffs, cosmetics or pharmaceutical products as well as from
cleaning, disinfecting and rinsing fluids to be completely discharged
from the machinery (if possible, in a ‘cleaning’ position);
(d) machinery must be designed and constructed in such a way as to prevent
any substances or living creatures, in particular insects, from entering,
or any organic matter from accumulating in, areas that cannot be
cleaned;
(e) machinery must be designed and constructed in such a way that no
ancillary substances hazardous to health, including the lubricants used,
can come into contact with foodstuffs, cosmetics or pharmaceutical
products.
Where necessary, machinery must be designed and constructed in such a way that
continuing compliance with this requirement can be checked.
2.1.2. Instructions
The instructions for foodstuffs machinery and machinery for use with cosmetics or
pharmaceutical products must indicate recommended products and methods for
cleaning, disinfecting and rinsing, not only for easily accessible areas but also for
areas to which access is impossible or inadvisable.
PORTABLE HAND-HELD AND, OR HAND-GUIDED MACHINERY
2.2.1. General
Portable hand-held and, or hand-guided machinery must
depending on the type of machinery, have a supporting surface of
sufficient size and have a sufficient number of handles and supports of
an appropriate size, arranged in such a way as to ensure the stability of
the machinery under the intended operating conditions,
except where technically impossible, or where there is an independent
control device, in the case of handles which cannot be released in
complete safety, be fitted with manual start and stop control devices
arranged in such a way that the operator can operate them without
releasing the handles,
present no 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,
-
permit, where necessary, visual observation of the danger zone and of
the action of the tool with the material being processed.
The handles of portable machinery must be designed and constructed in such a
way as to make starting and stopping straightforward.
2.2.1.1. Instructions
The instructions must give the following information concerning vibrations
transmitted by portable handheld and hand-guided machinery
-
the vibration total value to which the hand-arm system is subjected, if it
exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s 2 , this must
be mentioned,
-
the uncertainty of measurement.
These values must be either those actually measured for the machinery in question
or those established on the basis of measurements taken for technically comparable
machinery which is representative of the machinery to be produced.
If harmonised standards are not applied, the vibration data must be measured
using the most appropriate measurement code for the machinery.
The operating conditions during measurement and the methods used for
measurement, or the reference of the harmonised standard applied, must be
specified.
2.2.2. Portable fixing and other impact machinery
2.2.2.1. General
Portable fixing and other impact machinery must be designed and constructed in
such a way that
-
energy is transmitted to the impacted element by the intermediary
component that does not leave the device,
-
an enabling device prevents impact unless the machinery is positioned
correctly with adequate pressure on the base material,
-
involuntary triggering is prevented; where necessary, an appropriate
sequence of actions on the enabling device and the control device must
be required to trigger an impact,
-
accidental triggering is prevented during handling or in case of shock,
-
loading and unloading operations can be carried out easily and safely.
Where necessary, it must be possible to fit the device with splinter guard(s) and
the appropriate guard(s) must be provided by the manufacturer of the machinery.
2.2.2.2. Instructions
The instructions must give the necessary information regarding
-
the accessories and interchangeable equipment that can be used with the
machinery,
-
the suitable fixing or other impacted elements to be used with the
machinery,
-
where appropriate, the suitable cartridges to be used.
2.3.
MACHINERY FOR WORKING WOOD AND MATERIAL WITH
MACHINERY
SIMILAR PHYSICAL CHARACTERISTICS
Machinery for working wood and materials with similar physical characteristics
must comply with the following requirements
(a) the machinery must be designed, constructed or equipped in such a way
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 workpieces or parts of them, it must be designed,
constructed, or equipped in such a way as to prevent such ejection, or, if
this is not possible, 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 designed and constructed in such a way as to eliminate or
reduce the risk of accidental injury.
2.4. MACHINERY FOR PESTICIDE APPLICATION
2.4.1. Definition
"Machinery for pesticide application" means machinery specifically intended for
the application of plant protection products within the meaning of Article 2(1) of
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21
October 2009 concerning the placing of plant protection products on the market ( * ).
2.4.2. General
The manufacturer of machinery for pesticide application or his authorised
representative must ensure that an assessment is carried out of the risks of
unintended exposure of the environment to pesticides, in accordance with the
process of risk assessment and risk reduction referred to in the General Principles,
paragraph 1.
Machinery for pesticide application must be designed and constructed taking into
account the results of the risk assessment referred to in the first paragraph so that the
machinery can be operated, adjusted and maintained without unintended exposure of
the environment to pesticides.
Leakage must be prevented at all times.
2.4.3. Controls and monitoring
It must be possible to easily and accurately control, monitor and immediately stop
the pesticide application from the operating positions.
2.4.4. Filling and emptying
The machinery must be designed and constructed to facilitate precise filling with
the necessary quantity of pesticide and to ensure easy and complete emptying, while
preventing spillage of pesticide and avoiding the contamination of the water source
during such operations.
2.4.5. Application of pesticides
*OJ L 309, 24.11.2009, p. 1.
2.4.5.1. Application rate
The machinery must be fitted with means of adjusting the application rate easily,
accurately and reliably.
2.4.5.2. Distribution, deposition and drift of pesticide
The machinery must be designed and constructed to ensure that pesticide is
deposited on target areas, to minimise losses to other areas and to prevent drift of
pesticide to the environment.
Where appropriate, an even distribution and homogeneous deposition must be
ensured.
2.4.5.3. Tests
In order to verify that the relevant parts of the machinery comply with the
requirements set out in sections 2.4.5.1 and 2.4.5.2 the manufacturer or his
authorised representative must, for each type of machinery concerned, perform
appropriate tests, or have such tests performed.
2.4.5.4. Losses during stoppage
The machinery must be designed and constructed to prevent losses while the
pesticide application function is stopped.
2.4.6. Maintenance
2.4.6.1. Cleaning
The machinery must be designed and constructed to allow its easy and thorough
cleaning without contamination of the environment.
2.4.6.2. Servicing
The machinery must be designed and constructed to facilitate the changing of
worn parts without contamination of the environment.
2.4.7. Inspections
It must be possible to easily connect the necessary measuring instruments to the
machinery to check the correct functioning of the machinery.
2.4.8. Marking of nozzles, strainers and filters
Nozzles, strainers and filters must be marked so that their type and size can be
clearly identified.
2.4.9. Indication of pesticide in use
Where appropriate, the machinery must be fitted with a specific mounting on
which the operator can place the name of the pesticide in use.
2.4.10. Instructions
The instructions must provide the following information
(a) precautions to be taken during mixing, loading, application, emptying,
cleaning, servicing and transport operations in order to avoid
contamination of the environment;
(b) detailed conditions of use for the different operating environments
envisaged, including the corresponding preparation and adjustments
required to ensure the deposition of pesticide on target areas while
minimising losses to other areas, to prevent drift to the environment
and, where appropriate, to ensure an even distribution and
homogeneous deposition of pesticide;
MACHINERY
(c) the range of types and sizes of nozzles, strainers and filters that can be
used with the machinery;
(d) the frequency of checks and the criteria and method for the replacement
of parts subject to wear that affect the correct functioning of the
machinery, such as nozzles, strainers and filters;
(e) specification of calibration, daily maintenance, winter preparation and
other checks necessary to ensure the correct functioning of the
machinery;
(f)
types of pesticides that may cause incorrect functioning of the
machinery;
(g) an indication that the operator should keep updated the name of the
pesticide in use on the specific mounting referred to in section 2.4.9;
(h) the connexion and use of any special equipment or accessories, and the
necessary precautions to be taken;
(i)
an indication that the machinery may be subject to national
requirements for regular inspection by designated bodies, as provided
for in Directive 2009/128/EC of the European Parliament and of the
Council of 21 October 2009 establishing a framework for Community
action to achieve the sustainable use of pesticides ( * );
(j)
the features of the machinery which must be inspected to ensure its
correct functioning;
(k) instructions for connecting the necessary measuring instruments.
3. SUPPLEMENTARY
ESSENTIAL
HEALTH
AND
SAFETY
MACHINERY
Machinery presenting hazards due to its mobility must meet all the essential health
and safety requirements described in this chapter (see General Principles, paragraph
GENERAL
3.1.1. Definitions
(a) ‘Machinery presenting hazards due to its mobility’ means
-
machinery the operation of which requires either mobility while
working, or continuous or semicontinuous movement between a
succession of fixed working locations, or
-
machinery which is operated without being moved, but which
may be equipped in such a way as to enable it to be moved more
easily from one place to another.
(b) ‘Driver’ means an operator responsible for the movement of a machine.
The driver may be transported by the machinery or may be on foot,
accompanying the machinery, or may guide the machinery by remote
control.
WORK POSITIONS
3.2.1. Driving position
Visibility from the driving position must be such that the driver can, in complete
*OJ L 309, 24.11.2009, p. 71.
safety for himself and the exposed persons, operate the machinery and its tools in
their foreseeable conditions of use. Where necessary, appropriate devices must be
provided to remedy hazards due to inadequate direct vision.
Machinery on which the driver is transported must be designed and constructed in
such a way that, from the driving positions, there is no risk to the driver from
inadvertent contact with the wheels and tracks.
The driving position of ride-on drivers must be designed and constructed in such a
way that a driver’s cab may be fitted, provided this does not increase the risk and
there is room for it. The cab must incorporate a place for the instructions needed for
the driver.
3.2.2. Seating
Where there is a risk that operators or other persons transported by the machinery
may be crushed between parts of the machinery and the ground should the machinery
roll or tip over, in particular for machinery equipped with a protective structure
referred to in paragraphs 3.4.3 or 3.4.4, their seats must be designed or equipped
with a restraint system so as to keep the persons in their seats, without restricting
movements necessary for operations or movements relative to the structure caused
by the suspension of the seats. Such restraint systems should not be fitted if they
increase the risk.
3.2.3. Positions for other persons
I f th e co n d i ti o n s o f u se pr ov i d e t h a t p e r so n s o t h er t h an t h e d r i v er m a y
occasionally or regularly be transported by the machinery or work on it, appropriate
positions must be provided which enable them to be transported or to work on it
without risk.
The second and third paragraphs of paragraph 3.2.1 also apply to the places
provided for persons other than the driver.
3.3.
CONTROL SYSTEMS
If necessary, steps must be taken to prevent unauthorised use of controls.
In the case of remote controls, each control unit must clearly identify the
machinery to be controlled from that unit.
The remote control system must be designed and constructed in such a way as to
affect only
-
the machinery in question,
-
the functions in question.
Remote controlled machinery must be designed and constructed in such a way that
it will respond only to signals from the intended control units.
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
actuated only by using control devices located elsewhere. These functions include,
in particular, those for which operators other than the driver are responsible or for
which the driver has to leave the driving position in order to control them safely.
Where there are pedals, they must be so designed, constructed and fitted as to
allow safe operation by the driver with the minimum risk of incorrect operation.
They must have a slip-resistant surface and be easy to clean.
Where their operation can lead to hazards, notably dangerous movements, the
MACHINERY
control devices, 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 in such a way as to reduce the force of sudden movements of the steering
wheel or the 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.
Paragraph 1.2.2(f), concerning acoustic and, or visual warning signals, applies
only in the case of reversing.
3.3.2. Starting/moving
All 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 is fitted with devices which exceed its
normal clearance zone (including stabilisers, jib, and other such-like devices), 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 does not give rise to other risks, movement of the machinery must
depend on safe positioning of the aforementioned parts.
It must not be possible for unintentional movement of the machinery to occur
while the engine is being started.
3.3.3. Travelling function
Without prejudice to 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, load, speed, ground
and gradient conditions allowed for.
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 needed to actuate the main device, an
emergency device with a fully independent and easily accessible control device 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 preceding paragraph, provided that it is purely mechanical.
Remote-controlled machinery must be equipped with devices for stopping
operation automatically and immediately and for preventing potentially dangerous
operation in the following situations
-
if the driver loses control,
-
if it receives a stop signal,
-
if a fault is detected in a safety-related part of the system,
-
if no validation signal is detected within a specified time.
Paragraph 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 device 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 in such
a way as to minimise the risks arising from inadvertent movement of the machine
towards the driver, in particular
-
crushing,
-
injury from rotating tools.
The speed of travel of the machinery 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 the tool when the reverse control is engaged, except where the
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
Machinery must be designed, constructed and where appropriate placed on its
mobile support in such a way as to ensure that, when moved, uncontrolled
oscillations of its centre of gravity do not affect its stability or exert excessive strain
on its structure.
3.4.2. Moving transmission parts
By way of exception to paragraph 1.3.8.1, in the case of engines, moveable guards
preventing access to the moving parts in the engine compartment need not have
interlocking 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, providing the latter is in a fully enclosed
cab with a lock to prevent unauthorised access.
3.4.3. Roll-over and tip-over
Where, in the case of self-propelled machinery with a ride-on driver, operator(s)
or other person(s), there is a risk of rolling or tipping over, the machinery must be
fitted with an appropriate protective structure, unless this increases the risk.
This structure must be such that in the event of rolling or tipping over it affords
the ride-on person(s) an adequate deflection-limiting volume.
In order to verify that the structure complies with the requirement laid down in the
second paragraph, the manufacturer or his authorised representative must, for each
type of structure concerned, perform appropriate tests or have such tests performed.
3.4.4. Falling objects
Where, in the case of self-propelled machinery with a ride-on driver, operator(s)
or other person(s), there is a risk due to falling objects or material, the machinery
must be designed and constructed in such a way as to take account of this risk and
fitted, if its size allows, with an appropriate protective structure.
This structure must be such that, in the event of falling objects or material, it
guarantees the ride-on person(s) an adequate deflection-limiting volume.
MACHINERY
In order to verify that the structure complies with the requirement laid down in the
second paragraph, the manufacturer or his authorised representative 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 control devices to assist
access.
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 in such a way as to ensure easy and
secure connection and disconnection and to prevent accidental disconnection during
use.
Insofar as the tow bar load so 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
Removable mechanical transmission devices linking self-propelled machinery (or
a tractor) to the first fixed bearing of recipient machinery must be designed and
constructed in such a way that any part that moves during operation is protected over
its whole length.
On the side of the self-propelled machinery (or tractor), the power take-off to
which the removable mechanical transmission device is attached must be protected
either by a guard fixed and linked to the self-propelled machinery (or tractor) or by
any other device offering equivalent protection.
It must be possible to open this guard for access to the removable transmission
device. Once it is in place, there must be enough room to prevent the drive shaft
damaging the guard when the machinery (or the tractor) is moving.
On the recipient 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 machinery. The removable mechanical transmission
device must be marked accordingly.
All recipient machinery, the operation of which requires a removable mechanical
transmission device to connect it to self-propelled machinery (or a tractor), must
have a system for attaching the removable mechanical transmission device so that,
when the machinery is uncoupled, the removable mechanical transmission device
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 removable mechanical transmission device. The guard
must cover the transmission 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.
If means of access to working positions are provided near to the removable
mechanical transmission device, they must be designed and constructed in such a
way that the shaft guards cannot be used as steps, unless designed and constructed
for that purpose.
3.5.
PROTECTION AGAINST OTHER HAZARDS
3.5.1. Batteries
The battery housing must be designed and constructed in such a way as to prevent
the electrolyte being ejected on to the operator in the event of rollover or tipover and
to avoid the accumulation of vapours in places occupied by operators.
Machinery must be designed and constructed in such a way 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, 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 hazardous substances
Paragraphs 1.5.13(b) and (c) do not apply where the main function of the
machinery is the spraying of products. However, the operator must be protected
against the risk of exposure to such hazardous emissions.
3.6.
INFORMATION AND INDICATIONS
3.6.1. Signs, signals and warnings
All machinery must have signs and, or instruction plates concerning use,
adjustment and maintenance, wherever necessary, so as to ensure the health and
safety of persons. They must be chosen, designed and constructed in such a way as
to be clearly visible and indelible.
Without prejudice to the provisions of road traffic regulations, machinery with a
ride-on driver must have the following equipment
-
an acoustic warning device to alert persons,
-
a system of light signals relevant to the intended conditions of use; the
latter requirement does not apply to machinery intended solely for
underground working and having no electrical power,
-
where necessary, there must be an appropriate connection between a
trailer and the machinery for the operation of signals.
Remote-controlled machinery which, under normal conditions of use, exposes
persons to the risk of impact or crushing must be fitted with appropriate means to
signal its movements or with means to protect persons against such risks. 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 area to the rear of the
machine is not directly visible to the driver.
Machinery must be constructed in such a way that the warning and signalling
devices cannot be disabled unintentionally. Where it 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 following must be shown legibly and indelibly on all machinery
MACHINERY
nominal power expressed in kilowatts (kW),
mass of the most usual configuration, in kilograms (kg);
and, where appropriate
maximum drawbar pull provided for at the coupling hook, in Newtons
(N),
maximum vertical load provided for on the coupling hook, in Newtons
(N).
3.6.3. Instructions
3.6.3.1. Vibrations
The instructions must give the following information concerning vibrations
transmitted by the machinery to the hand-arm system or to the whole body
the vibration total value to which the hand-arm system is subjected, if it
exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s 2 , this must
be mentioned,
the highest root mean square value of weighted acceleration to which
the whole body is subjected, if it exceeds 0,5 m/s 2 . Where this value
does not exceed 0,5 m/s 2 , this must be mentioned,
the uncertainty of measurement.
These values must be either those actually measured for the machinery in question
or those established on the basis of measurements taken for technically comparable
machinery which is representative of the machinery to be produced.
Where harmonised standards are not applied, the vibration must be measured
using the most appropriate measurement code for the machinery concerned.
The operating conditions during measurement and the measurement codes used
must be described.
3.6.3.2. Multiple uses
The instructions for machinery allowing several uses depending on the equipment
used and the instructions for the interchangeable equipment must contain the
information necessary for safe assembly and use of the basic machinery and the
interchangeable equipment that can be fitted.
4. SUPPLEMENTARY
ESSENTIAL
HEALTH
AND
SAFETY
REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS
Machinery presenting hazards due to lifting operations must meet all the relevant
essential health and safety requirements described in this chapter (see General
Principles, paragraph 4).
GENERAL
4.1.1. Definitions
(i)
‘Lifting operation’ means a movement of unit loads consisting of goods
and, or persons necessitating, at a given moment, a change of level.
(ii)
‘Guided load’ means a load where the total movement is made along
rigid or flexible guides whose position is determined by fixed points.
(iii)
‘Working coefficient’ means the arithmetic ratio between the load
guaranteed by the manufacturer or his authorised representative up to
which a component is able to hold it and the maximum working load
marked on the component.
(iv)
‘Test coefficient’ means the arithmetic ratio between the load used to
carry out the static or dynamic tests on lifting machinery or a lifting
accessory and the maximum working load marked on the lifting
machinery or lifting accessory.
(v)
‘Static test’ means the test during which lifting machinery or a 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 reinspected once the said load has been released to
ensure that no damage has occurred.
(vi)
‘Dynamic test’ means the test during which lifting machinery is
operated in all its possible configurations at the maximum working load
multiplied by the appropriate dynamic test coefficient with account
being taken of the dynamic behaviour of the lifting machinery in order
to check that it functions properly.
(vii)
‘Carrier’ means a part of the machinery on or in which persons and, or
goods are supported in order to be lifted.
4.1.2. Protection against mechanical hazards
4.1.2.1. Risks due to lack of stability
Machinery must be designed and constructed in such a way that the stability
required by paragraph 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
must use the appropriate verification methods.
4.1.2.2. Machinery running on guide rails and rail tracks
Machinery must be provided with devices which act on the guide rails or tracks to
prevent derailment.
If, despite such devices, there remains a risk of derailment or of failure of a rail or
of a running component, devices must be provided which prevent the equipment,
component or load from falling or the machinery from overturning.
4.1.2.3. Mechanical strength
Machinery, lifting accessories and their 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 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 in such a way
as to prevent failure from fatigue and wear, taking due account of their intended use.
The materials used must be chosen on the basis of the intended working
environments, with particular regard to corrosion, abrasion, impacts, extreme
temperatures, fatigue, brittleness and ageing.
Machinery and lifting accessories must be designed and constructed in such a way
as to withstand the overload in the static tests without permanent deformation or
patent defect. Strength calculations must take account of the value of the static test
coefficient chosen to guarantee an adequate level of safety. That coefficient has, as a
general rule, the following values
MACHINERY
(a) manually-operated machinery and lifting accessories: 1,5;
(b) other machinery: 1,25.
Machinery must be designed and constructed in such a way as 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. As a general rule, the tests will be performed at the nominal speeds provided for.
Should the control circuit of the machinery allow for a number of simultaneous
movements, the tests must be carried out under the least favourable conditions, as a
general rule by combining the movements concerned.
4.1.2.4. Pulleys, drums, wheels, ropes and chains
Pulleys, drums and wheels must have a diameter commensurate with the size of
the ropes or chains with which they can be fitted.
Drums and wheels must be designed, constructed and installed in such a way that
the ropes or chains with which they are equipped can be wound without coming off.
Ropes used directly for lifting or supporting the load must not include any splicing
other than at their ends. Splicings are, however, tolerated in installations which are
intended by design to be modified regularly according to needs of use.
Complete ropes and their endings must have a working coefficient chosen in such
a way as to guarantee an adequate level of safety. As a general rule, this coefficient
is equal to 5.
Lifting chains must have a working coefficient chosen in such a way as to
guarantee an adequate level of safety. As a general rule, this coefficient is equal to 4.
In order to verify that an adequate working coefficient has been attained, the
manufacturer or his authorized representative 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. Lifting accessories and their components
Lifting accessories and their components 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 wire-rope/rope-end combinations must be
chosen in such a way as to guarantee an adequate level of safety; this
coefficient is, as a general rule, equal to 5. 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 must be chosen in such a way as
to guarantee an adequate level of safety; this coefficient is, as a general
rule, equal to 4;
(c) the working coefficient for textile ropes or slings is dependent on the
material, method of manufacture, dimensions and use. This coefficient
must be chosen in such a way as to guarantee an adequate level of
safety; it is, as a general rule, equal to 7, 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 in such a way as to guarantee an adequate
level of safety; this coefficient is, as a general rule, equal to 4;
(e) the maximum working load of a multilegged sling is determined on the
basis of the working 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 must, for
each type of component referred to in sub-paragraphs (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 designed and constructed or fitted with devices in
such a way 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
machinery must be designed and constructed in such a way as to make it
possible to fit systems enabling these risks to be avoided.
(c) Machinery must be designed and constructed in such a way 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 designed and constructed in such a way that
inadvertent dropping of the loads is avoided.
4.1.2.7. Movements of loads during handling
The operating 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, equipment or other machinery which might be
manoeuvring at the same time and liable to constitute a hazard.
Machinery with guided loads must be designed and constructed in such a way as
to prevent persons from being injured by movement of the load, the carrier or the
counterweights, if any.
4.1.2.8. Machinery serving fixed landings
4.1.2.8.1. Movements of the carrier
The movement of the carrier of machinery serving fixed landings must be rigidly
guided to and at the landings. Scissor systems are also regarded as rigid guidance.
4.1.2.8.2. Access to the carrier
Where persons have access to the carrier, the machinery must be designed and
constructed in such a way as to ensure that the carrier remains stationary during
MACHINERY
access, in particular while it is being loaded or unloaded.
The machinery must be designed and constructed in such a way as to ensure that
the difference in level between the carrier and the landing being served does not
create a risk of tripping.
4.1.2.8.3. Risks due to contact with the moving carrier Where necessary in order
to fulfil the requirement expressed in the second paragraph of paragraph 4.1.2.7, the
travel zone must be rendered inaccessible during normal operation.
When, during inspection or maintenance, there is a risk that persons situated under
or above the carrier may be crushed between the carrier and any fixed parts,
sufficient free space must be provided either by means of physical refuges or by
means of mechanical devices blocking the movement of the carrier.
4.1.2.8.4. Risk due to the load falling off the carrier
Where there is a risk due to the load falling off the carrier, the machinery must be
designed and constructed in such a way as to prevent this risk.
4.1.2.8.5. Landings
Risks due to contact of persons at landings with the moving carrier or other
moving parts must be prevented.
Where there is a risk due to persons falling into the travel zone when the carrier is
not present at the landings, guards must be fitted in order to prevent this risk. Such
guards must not open in the direction of the travel zone. They must be fitted with an
interlocking device controlled by the position of the carrier that prevents
-
hazardous movements of the carrier until the guards are closed and
locked,
-
hazardous opening of a guard until the carrier has stopped at the
corresponding landing.
4.1.3. Fitness for purpose
When lifting machinery or lifting accessories are placed on the market or are first
put into service, the manufacturer or his authorised representative must ensure, by
taking appropriate measures or having them taken, that the machinery or the lifting
accessories which are ready for use - whether manually or power-operated - can
fulfil their specified functions safely.
The static and dynamic tests referred to in paragraph 4.1.2.3 must be performed on
all lifting machinery ready to be put into service.
Where the machinery cannot be assembled in the manufacturer’s premises or in
the premises of his authorised representative, the 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.
4.2.
REQUIREMENTS FOR MACHINERY WHOSE POWER SOURCE IS
OTHER THAN MANUAL EFFORT
4.2.1. Control of movements
Hold-to-run control devices must be used to control the movements of the
machinery or its equipment. 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 control devices authorising automatic stops at pre-selected positions
without the operator holding a hold-to-run control device.
4.2.2. 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 in the event
-
of overloading, either as a result of the maximum working load or the
maximum working moment due to the load being exceeded, or
-
of the overturning moment being exceeded.
4.2.3. Installations guided by ropes
Rope carriers, tractors or tractor carriers must be held by counter-weights or by a
device allowing permanent control of the tension.
4.3.
INFORMATION AND MARKINGS
4.3.1. Chains, ropes and webbing
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 and the
identifying reference of the relevant certificate.
The certificate mentioned above must show at least the following information
(a) the name and address of the manufacturer and, if appropriate, his
authorised representative;
(b) 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;
(c) the test method used;
(d) the maximum load to which the chain or rope should be subjected in
service. A range of values may be given on the basis of the intended
applications.
4.3.2. Lifting accessories
Lifting accessories must show the following particulars
-
identification of the material where this information is needed for
safe use,
-
the maximum working load.
In the case of lifting accessories on which marking is physically impossible, the
particulars referred to in the first paragraph must be displayed on a plate or other
equivalent 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 wear or jeopardise the strength of the accessory.
4.3.3. Lifting machinery
(a) The maximum working load must be prominently marked on the
machinery. This marking must be legible, indelible and in an un-coded
form.
(b) Where the maximum working load depends on the configuration of the
machinery, each operating position must be provided with a load plate
indicating, preferably in diagrammatic form or by means of tables, the
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working load permitted for each configuration.
(c) Machinery intended for lifting goods only, equipped with a carrier
which allows access to persons, 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.
INSTRUCTIONS
4.4.1. Lifting accessories
Each lifting accessory or each commercially indivisible batch of lifting
accessories must be accompanied by instructions setting out at least the following
particulars
(a) the intended use;
(b) the limits of use (particularly for lifting accessories such as magnetic or
vacuum pads which do not fully comply with paragraph 4.1.2.6(e));
(c) instructions for assembly, use and maintenance;
(d) the static test coefficient used.
4.4.2. Lifting machinery
Lifting machinery must be accompanied by instructions containing information
(a) the technical characteristics of the machinery, and in particular
-
the maximum working load and, where appropriate, a copy of the
load plate or load table described in the second paragraph
4.3.3(b),
-
the reactions at the supports or anchors and, where appropriate,
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 vision of the load
by the operator;
(d) where appropriate, a test report detailing the static and dynamic tests
carried out by or for the manufacturer or his authorised representative;
(e) for machinery which is not assembled on the premises of the
manufacturer in the form in which it is to be used, the necessary
instructions for performing the measures referred to in paragraph 4.1.3
before it is first put into service.
5. SUPPLEMENTARY
ESSENTIAL
HEALTH
AND
SAFETY
REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND
WORK
Machinery intended for underground work must meet all the essential health and
safety requirements described in this chapter (see General Principles, paragraph 4).
5.1.
RISKS DUE TO LACK OF STABILITY
Powered roof supports must be designed and constructed in such a way 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 persons.
5.3.
CONTROL DEVICES
The accelerator and brake controls for movement of machinery running on rails
must be hand-operated. However, enabling devices may be foot-operated.
The control devices of powered roof supports must be designed and positioned in
such a way that, during displacement operations, operators are sheltered by a support
in place. The control devices must be protected against any accidental release.
5.4.
STOPPING
Self-propelled machinery running on rails for use in underground work must be
equipped with an enabling device acting on the circuit controlling the movement of
the machinery such that movement is stopped if the driver is no longer in control of
the movement.
5.5.
FIRE
The second indent of paragraph 3.5.2 is mandatory in respect of machinery which
comprises highly flammable parts.
The braking system of machinery intended for use in underground workings must
be designed and constructed in such a way that it does not produce sparks or cause
fires.
Machinery with internal combustion engines for use in underground workings
must be fitted only with engines using fuel with a low vaporising pressure and which
exclude any spark of electrical origin.
5.6.
EXHAUST EMISSIONS
Exhaust emissions from internal combustion engines must not be discharged
upwards.
6. SUPPLEMENTARY
ESSENTIAL
HEALTH
AND
SAFETY
REQUIREMENTS FOR MACHINERY PRESENTING PARTICULAR HAZARDS
DUE TO THE LIFTING OF PERSONS
Machinery presenting hazards due to the lifting of persons must meet all the
relevant essential health and safety requirements described in this chapter (see
General Principles, paragraph 4).
6.1.
GENERAL
6.1.1. Mechanical strength
The carrier, including any trapdoors, must be designed and constructed in such a
way as to offer the space and strength corresponding to the maximum number of
persons permitted on the carrier and the maximum working load.
The working coefficients for components set out in paragraphs 4.1.2.4 and 4.1.2.5
are inadequate for machinery intended for the lifting of persons and must, as a
general rule, be doubled. Machinery intended for lifting persons or persons and
goods must be fitted with a suspension or supporting system for the carrier designed
and constructed in such a way as to ensure an adequate overall level of safety and to
prevent the risk of the carrier falling.
If ropes or chains are used to suspend the carrier, as a general rule, at least two
independent ropes or chains are required, each with its own anchorage.
MACHINERY
6.1.2. Loading control for machinery moved by power other than human strength
The requirements of paragraph 4.2.2 apply regardless of the maximum working
load and overturning moment, unless the manufacturer can demonstrate that there is
no risk of overloading or overturning.
6.2.
CONTROL DEVICES
Where safety requirements do not impose other solutions, the carrier must, as a
general rule, be designed and constructed in such a way that persons in the carrier
have means of controlling upward and downward movements and, if appropriate,
other movements of the carrier.
In operation, those control devices must override any other devices controlling the
same movement with the exception of emergency stop devices.
The control devices for these movements must be of the hold-to-run type except
where the carrier itself is completely enclosed.
6.3.
RISKS TO PERSONS IN OR ON THE CARRIER
6.3.1. Risks due to movements of the carrier
Machinery for lifting persons must be designed, constructed or equipped in such a
way that the acceleration or deceleration of the carrier does not engender risks for
persons.
6.3.2. Risk of persons falling from the carrier
The carrier must not tilt to an extent which creates a risk of the occupants falling,
including when the machinery and carrier are moving.
Where the carrier is designed as a work station, provision must be made to ensure
stability and to prevent hazardous movements.
If the measures referred to in paragraph 1.5.15 are not adequate, carriers must be
fitted with a sufficient number of suitable anchorage points for the number of
persons permitted on the carrier. The anchorage points must be strong enough for the
use of personal protective equipment against falls from a height.
Any trapdoor in floors or ceilings or side doors must be designed and constructed
in such a way as to prevent inadvertent opening and must open in a direction that
obviates any risk of falling, should they open unexpectedly.
6.3.3. Risk due to objects falling on the carrier
Where there is a risk of objects falling on the carrier and endangering persons, the
carrier must be equipped with a protective roof.
6.4.
MACHINERY SERVING FIXED LANDINGS
6.4.1. Risks to persons in or on the carrier
The carrier must be designed and constructed in such a way as to prevent risks due
to contact between persons and, or objects in or on the carrier with any fixed or
moving elements. Where necessary in order to fulfil this requirement, the carrier
itself must be completely enclosed with doors fitted with an interlocking device that
prevents hazardous movements of the carrier unless the doors are closed. The doors
must remain closed if the carrier stops between landings where there is a risk of
falling from the carrier.
The machinery must be designed, constructed and, where necessary, equipped
with devices in such a way as to prevent uncontrolled upward or downward
movement of the carrier. These devices must be able to stop the carrier at its
maximum working load and at the foreseeable maximum speed.
The stopping action must not cause deceleration harmful to the occupants,
whatever the load conditions.
6.4.2. Controls at landings
Controls, other than those for emergency use, at landings must not initiate
movements of the carrier when
the control devices in the carrier are being operated,
the carrier is not at a landing.
6.4.3. Access to the carrier
The guards at the landings and on the carrier must be designed and constructed in
su ch a wa y as t o e ns u r e sa f e t r a n sf e r to a n d f r o m t h e c ar r ie r, t a k i ng i n t o
consideration the foreseeable range of goods and persons to be lifted.
6.5. MARKINGS
The carrier must bear the information necessary to ensure safety including
the number of persons permitted on the carrier,
the maximum working load.
(1)
These regulations shall apply to the following
products
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f)
removable mechanical transmission devices;
(g) partly completed machinery.
(2) The following are excluded from the scope of these
regulations
(a) safety components intended to be used as spare parts
to replace identical components and supplied by the
manufacturer of the original machinery;
(b) specific equipment for use in fairgrounds and, or
amusement parks;
(c) machinery specially designed or put into service for
nuclear purposes which, in the event of failure, may
result in an emission of radioactivity;
(d) weapons, including firearms;
(e) the following means of transport
(i)
agricultural and forestry tractors for the risks
covered by the Type Approval of Agricultural or
Forestry Tractors Regulations, with the
exclusion of machinery mounted on these
vehicles,
MACHINERY
(ii) motor vehicles and their trailers covered by the
Motor
Vehicles
(EC
Type
Approval)
Regulations, with the exclusion of machinery
mounted on these vehicles,
(iii) vehicles covered by the Two or Three-Wheel
Motor
Vehicles
(EC
Type-Approval)
Regulations, with the exclusion of machinery
mounted on these vehicles,
(iv) motor vehicles exclusively intended for
competition, and
(v) means of transport by air, on water and on rail
networks with the exclusion of machinery
mounted on these means of transport;
(f)
seagoing vessels and mobile offshore units and
machinery installed on board such vessels and, or
units;
(g) machinery specially designed and constructed for
military or police purposes;
(h) machinery specially designed and constructed for
research purposes for temporary use in laboratories;
(i)
mine winding gear;
(j)
machinery intended to move performers during artistic
performances;
(k) electrical and electronic products falling within the
following areas, insofar as they are covered by the
Low Voltage Electrical Equipment Regulations
(i)
household appliances intended for domestic use,
(ii)
audio and video equipment,
(iii)
information technology equipment,
(iv)
ordinary office machinery,
(v)
low-voltage switchgear and control gear,
(vi)
electric motors;
(l)
the following
types
of
high-voltage
electrical
equipment
(i) switchgear and control gear,
(ii) transformers.
[Regulation 6(1)(e)]
Declarations
1. CONTENT
EC DECLARATION OF CONFORMITY OF THE MACHINERY
This declaration and translations thereof must be drawn up under the same
conditions as the instructions (see Schedule I, paragraph 1.7.4.1(a) and (b)), and
must be typewritten or else handwritten in capital letters.
This declaration relates exclusively to the machinery in the state in which it was
placed on the market, and excludes components which are added and, or operations
carried out subsequently by the final user.
The EC declaration of conformity must contain the following particulars
1. business name and full address of the manufacturer and, where
appropriate, his authorised representative;
2. name and address of the person authorised to compile the technical file,
who must be established in the Community;
3. description and identification of the machinery, including generic
denomination, function, model, type, serial number and commercial
name;
4. a sentence expressly declaring that the machinery fulfils all the relevant
provisions of these regulations and where appropriate, a similar
sentence declaring the conformity with other regulations and, or
relevant provisions with which the machinery complies. These
references must be those of the texts published in the Official Journal of
the European Union;
5. where appropriate, the name, address and identification number of the
MACHINERY
notified body which carried out the EC type-examination referred to in
Schedule IX and the number of the EC type-examination certificate;
6. where appropriate, the name, address and identification number of the
notified body which approved the full quality assurance system referred
to in Schedule X;
7. where appropriate, a reference to the harmonised standards used, as
referred to in regulation 8(2);
8. where appropriate, the reference to other technical standards and
specifications used;
9. the place and date of the declaration;
10. the identity and signature of the person empowered to draw up the
declaration on behalf of the manufacturer or his authorised
representative.
DECLARATION OF INCORPORATION OF PARTLY COMPLETED
MACHINERY
This declaration and translations thereof must be drawn up under the same
conditions as the instructions (see Schedule 1, paragraph 1.7.4.1(a) and (b)), and
must be typewritten or else handwritten in capital letters.
The declaration of incorporation must contain the following particulars
1. business name and full address of the manufacturer of the partly
completed machinery and, where appropriate, his authorised
representative;
2. name and address of the person authorised to compile the relevant
technical documentation, who must be established in the Community;
3. description and identification of the partly completed machinery
including generic denomination, function, model, type, serial number
and commercial name;
4. a sentence declaring which essential requirements of these regulations
are applied and fulfilled and that the relevant technical documentation
is compiled in accordance with Schedule VII, Part B, and, where
appropriate, a sentence declaring the conformity of the partly completed
machinery with other relevant regulations. These references must be
those of the texts published in the Official Journal of the European
Union;
5. an undertaking to transmit, in response to a reasoned request by the
national authorities, relevant information on the partly completed
machinery. This shall include the method of transmission and shall be
without prejudice to the intellectual property rights of the manufacturer
of the partly completed machinery;
6. a statement that the partly completed machinery must not be put into
service until the final machinery into which it is to be incorporated has
been declared in conformity with the provisions of these regulations,
where appropriate;
7. the place and date of the declaration;
8. the identity and signature of the person empowered to draw up the
declaration on behalf of the manufacturer or his authorised
representative.
2. CUSTODY
The manufacturer of machinery or his authorised representative shall keep the
original EC declaration of conformity for a period of at least 10 years from the last
date of manufacture of the machinery.
The manufacturer of partly completed machinery or his authorised representative
shall keep the original declaration of incorporation for a period of at least 10 years
from the last date of manufacture of the partly completed machinery.
For the purpose of these regulations, "machinery"
designates the products listed in regulation 2(1)(a) to (f).
For the purposes of these regulations, the following definitions
shall apply
"authorised representative" means any natural or legal person
established in the Community who has received a written mandate
from the manufacturer to perform on his behalf all or part of the
obligations and formalities connected with these regulations;
"chains, ropes and webbing" means chains, ropes and webbing
designed and constructed for lifting purposes as part of lifting
machinery or lifting accessories;
MACHINERY
"the Community" means the European Community;
"essential health and safety requirements" means mandatory
provisions relating to the design and construction of the products
subject to this Directive to ensure a high level of protection of the
health and safety of persons and, where appropriate, of domestic
animals and property and, where applicable, of the environment.
The essential health and safety requirements are set out in Schedule
I. Essential health and safety requirements for the protection of the
environment are applicable only to the machinery referred to in
section 2.4 of that Schedule;
"harmonized standard" means a non-binding technical
specification adopted by a standardisation body, namely the
European Committee for Standardisation (CEN), the European
Committee for Electrotechnical Standardisation (CENELEC) or the
European Telecommunications Standards Institute (ETSI), on the
basis of a remit issued by the Commission in accordance with the
procedures laid down in Directive 98/34/EC of the European
Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical
standards and regulations and of rules on Information Society
services;
"interchangeable equipment" means a device which, after the
putting into service of machinery or of a tractor, is assembled with
that machinery or tractor by the operator himself in order to change
its function or attribute a new function, in so far as this equipment
is not a tool;
"lifting accessory" means a component or equipment not
attached to the lifting machinery, allowing the load to be held,
which is placed between the machinery and the load or on the load
itself, or which is intended to constitute an integral part of the load
and which is independently placed on the market; slings and their
components are also regarded as lifting accessories;
"machinery" means
(a) an assembly, fitted with or intended to be fitted with a
drive system other than directly applied human or
animal effort, consisting of linked parts or
components, at least one of which moves, and which
are joined together for a specific application;
(b) an assembly referred to in paragraph (a), missing only
the components to connect it on site or to sources of
energy and motion;
(c) an assembly referred to in paragraphs (a) and (b),
ready to be installed and able to function as it stands
only if mounted on a means of transport, or installed in
a building or a structure;
(d) assemblies of machinery referred to in paragraphs (a),
(b) and (c) or partly completed machinery referred to
in definition "partly completed machinery" which, in
order to achieve the same end, are arranged and
controlled so that they function as an integral whole;
MACHINERY
(e) an assembly of linked parts or components, at least
one of which moves and which are joined together,
intended for lifting loads and whose only power source
is directly applied human effort;
"Market Surveillance Directorate" means the Market
Surveillance Directorate of the Malta Standards Authority as
described in the Establishment of Directorates of the Malta
Standards Authority Order;
"manufacturer" means any natural or legal person who designs
and, or manufactures machinery or partly completed machinery
covered by these regulations and is responsible for the conformity
of the machinery or the partly completed machinery with these
regulations with a view to its being placed on the market, under his
own name or trademark or for his own use. In the absence of a
manufacturer as defined above, any natural or legal person who
places on the market or puts into service machinery or partly
completed machinery covered by these regulations shall be
considered a manufacturer;
"partly completed machinery" means an assembly which is
almost machinery but which cannot in itself perform a specific
application. A drive system is partly completed machinery. Partly
completed machinery is only intended to be incorporated into or
asse mb le d w it h ot he r m achi ner y o r ot her par tl y com p let ed
machinery or equipment, thereby forming machinery to which
these regulations apply;
"placing on the market" means making available for the first time
in the Community machinery or partly completed machinery with a
view to distribution or use, whether for reward or free of charge;
"putting into service" means the first use, for its intended
purpose, in the Community, of machinery covered by these
regulations;
"Regulatory Affairs Directorate" means the Regulatory Affairs
Directorate of the Malta Standards Authority as described in the
Establishment of Directorates of the Malta Standards Authority
Order;
"removable mechanical transmission device" means a removable
component for transmitting power between self propelled
machinery or a tractor and another machine by joining them at the
first fixed bearing. When it is placed on the market with the guard
it shall be regarded as one product;
"safety component" means a component
(a) which serves to fulfill a safety function;
(b) which is independently placed on the market;
(c) the failure and, or malfunction of which endangers the
safety of persons, and
(d) which is not necessary in order for the machinery to
function, or for which normal components may be
substituted in order for the machinery to function.
An indicative list of safety components is set out in Schedule V.
MACHINERY
[Regulation 14(1) and (2)]
CE marking
The CE conformity marking shall consist of the initials ‘CE’ taking the following
form
If the CE marking is reduced or enlarged the proportions shown 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. The minimum dimension may
be waived for small-scale machinery.
The CE marking must be affixed in the immediate vicinity of the name of the
manufacturer or his authorised representative, using the same technique.
Where the full quality assurance procedure referred to in regulation 11(3)(c) and
12(4)(b) has been applied, the CE marking must be followed by the identification
number of the notified body.
Where, for machinery, the hazards referred to in Schedule I
are wholly or partly covered more specifically by other Community
legislation, these regulations shall not apply, or shall cease to
apply, to that machinery in respect of such hazards from the date of
implementation of those other Community laws.
[Regulation 11(2), (3) and (4)]
Categories of machinery to which one of the procedures referred to in regulation
11(3) and (4) must be applied
1. Circular saws (single- or multi-blade) for working with wood and material
with similar physical characteristics or for working with meat and material with
similar physical characteristics, of the following types
MACHINERY
1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed
or support with manual feed of the workpiece or with a demountable
power feed;
1.2. sawing machinery with fixed blade(s) during cutting, having a manually
operated reciprocating saw-bench or carriage;
1.3. sawing machinery with fixed blade(s) during cutting, having a built-in
mechanical feed device for the workpieces, with manual loading and, or
unloading;
1.4. sawing machinery with movable blade(s) during cutting, having
mechanical movement of the blade, with manual loading and, or
unloading.
2. Hand-fed surface planing machinery for woodworking.
3. Thicknessers for one-side dressing having a built-in mechanical feed device,
with manual loading and, or unloading for woodworking.
4. Band-saws with manual loading and, or unloading for working with wood
and material with similar physical characteristics or for working with meat and
material with similar physical characteristics, of the following types
4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or
reciprocating-movement bed or support for the workpiece;
4.2. sawing machinery with blade(s) assembled on a carriage with
reciprocating motion.
5. Combined machinery of the types referred to in paragraphs 1 to 4 and 7 for
working with wood and material with similar physical characteristics.
6. Hand-fed tenoning machinery with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and
material with similar physical characteristics.
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 machinery with manual loading
or unloading.
11. Injection or compression rubber-moulding machinery with manual loading
or unloading.
12. Machinery for underground working of the following types
12.1. locomotives and brake-vans;
12.2. hydraulic-powered roof supports.
13. Manually loaded trucks for the collection of household refuse incorporating
a compression mechanism.
14. Removable mechanical transmission devices including their guards.
15. Guards for removable mechanical transmission devices.
16. Vehicle servicing lifts.
17. Devices for the lifting of persons or of persons and goods involving a hazard
of falling from a vertical height of more than three metres.
18. Portable cartridge-operated fixing and other impact machinery.
19. Protective devices designed to detect the presence of persons.
(1) The Market Surveillance Directorate shall take all
appropriate measures to ensure that machinery may be placed on
the market and, or put into service only if it satisfies the relevant
provisions of this Directive and does not endanger the health and
safety of persons and, where appropriate, domestic animals and
property and, where applicable, the environment, when such
machinery is properly installed and maintained and used for its
intended purpose or under reasonably foreseeable conditions.
(2) The Market Surveillance Directorate shall take all
appropriate measures to ensure that partly completed machinery
can be placed on the market only if it satisfies the relevant
provisions of these regulations.
(3) The Market Surveillance Directorate shall monitor the
conformity of machinery and partly completed machinery with the
provisions set out in sub-regulations (1) and (2).
(4) The tasks, organisation and powers of the Market
Surveillance Directorate shall be defined and notified to the
Commission and other Member States.
(Regulation 3)
Indicative list of the safety components referred to in the definition
of ‘safety component’ in regulation 3
1. Guards for removable mechanical transmission devices.
2. Protective devices designed to detect the presence of persons.
3. Power-operated interlocking movable guards designed to be used as
safeguards in machinery referred to in Schedule IV, paragraphs 9, 10 and 11.
4. Logic units to ensure safety functions.
5. Valves with additional means for failure detection intended for the control of
dangerous movements on machinery.
6. Extraction systems for machinery emissions.
7. Guards and protective devices designed to protect persons against moving
parts involved in the process on the machinery.
8. Monitoring devices for loading and movement control in lifting machinery.
9. Restraint systems to keep persons on their seats.
10. Emergency stop devices.
11. Discharging systems to prevent the build-up of potentially dangerous
electrostatic charges.
12. Energy limiters and relief devices referred to in Schedule I, paragraphs
1.5.7, 3.4.7 and 4.1.2.6.
13. Systems and devices to reduce the emission of noise and vibrations.
14. Roll-over protective structures (ROPS).
15. Falling-object protective structures (FOPS).
16. Two-hand control devices.
17. Components for machinery designed for lifting and, or lowering persons
between different landings and included in the following list
(a) devices for locking landing doors;
(b) devices to prevent the load-carrying unit from falling or unchecked
upwards movement;
(c) overspeed limitation devices;
MACHINERY
(d) energy-accumulating shock absorbers,
-
non-linear, or
-
with damping of the return movement;
(e) energy-dissipating shock absorbers;
(f)
safety devices fitted to jacks of hydraulic power circuits where these are
used as devices to prevent falls;
(g) electric safety devices in the form of safety switches containing
electronic components.
(1) Before placing machinery on the market and, or putting
it into service, the manufacturer or his authorised representative
shall
(a) ensure that it satisfies the relevant essential health and
safety requirements set out in Schedule I;
(b) ensure that the technical file referred to in Schedule
VII, Part A is available;
(c) provide, in particular, the necessary information, such
as instructions;
(d) carry out the appropriate procedures for assessing
conformity in accordance with regulation 11;
(e) draw up the EC declaration of conformity in
accordance with Schedule II, Part 1, Section A and
ensure that it accompanies the machinery;
(f)
affix the CE marking in accordance with regulation 14.
(2) Before placing partly completed machinery on the market,
the manufacturer or his authorised representative shall ensure that
the procedure referred to in regulation 12 has been completed.
(3) For the purposes of the procedures referred to in regulation
11, the manufacturer or his authorised representative shall have, or
shall have access to the necessary means of ensuring that the
machinery satisfies the essential health and safety requirements set
out in Schedule I.
(4) Where machinery is also the subject of other Community
legislation relating to other aspects and providing for the affixing
MACHINERY
of the CE marking, the marking shall indicate that the machinery
al so co nf or ms to th e pr ov isio ns of th ose o th er Com m uni ty
legislation
Provided that, where one or more of those Community laws
allow the manufacturer or his authorised representative to choose,
during a transitional period, the system to be applied, the CE
marking shall indicate conformity only to the provisions of those
Community laws applied by the manufacturer or his authorised
representative. Particulars of the Community laws applied, as
published in the Official Journal of the European Union, shall be
given on the EC declaration of conformity.
[Regulation 12(1)(b)]
Assembly instructions for partly completed machinery
The assembly instructions for partly completed machinery must contain a
description of the conditions which must be met with a view to correct incorporation
in the final machinery, so as not to compromise safety and health.
The assembly instructions must be written in Maltese or in any other official
Community language acceptable to the manufacturer of the machinery in which the
partly completed machinery will be assembled, or to his authorised representative.
(1) The placing on the market and, or putting into service
in the Maltese territory of machinery which complies with these
regulations shall not be prohibited, restricted or impeded.
(2) The placing on the market of partly completed machinery in
the Maltese territory where the manufacturer or his authorised
representative makes a declaration of incorporation, referred to in
Schedule II, Part 1, Section B, stating that it is to be incorporated
into machinery or assembled with other partly completed
machinery to form machinery, shall not be prohibited, restricted or
impeded.
(3) At trade fairs, exhibitions, demonstrations, and such like,
the showing of machinery or partly completed machinery which
does not conform to these regulations shall not be prevented,
provided that a visible sign clearly indicates that it does not
conform and that it will not be made available until it has been
brought into conformity. Furthermore, during demonstrations of
such non-conforming machinery or partly completed machinery,
adequate safety measures shall be taken to ensure the protection of
persons.
[Regulations 6(1)(b) and 12(1)(a)]
A.
Technical file for machinery
This part describes the procedure for compiling a technical file. The technical file
must demonstrate that the machinery complies with the requirements of these
regulations . It must cover the design, manufacture and operation of the machinery to
the extent necessary for this assessment. The technical file must be compiled in
Maltese or in one or more official Community languages, except for the instructions
for the machinery, for which the special provisions of Schedule I, paragraph 1.7.4.1
apply.
1. The technical file shall comprise the following
(a) a construction file including
-
a general description of the machinery,
-
the overall drawing of the machinery and drawings of the control
circuits, as well as the pertinent descriptions and explanations
necessary for understanding the operation of the machinery,
-
full detailed drawings, accompanied by any calculation notes, test
results, certificates, and any other related material, required to
check the conformity of the machinery with the essential health
and safety requirements,
-
the documentation on risk assessment demonstrating the
procedure followed, including
(i) a list of the essential health and safety requirements which
apply to the machinery,
(ii) the description of the protective measures implemented to
eliminate identified hazards or to reduce risks and, when
appropriate, the indication of the residual risks associated
with the machinery,
-
the standards and other technical specifications used, indicating
the essential health and safety requirements covered by these
standards,
-
any technical report giving the results of the tests carried out
either by the manufacturer or by a body chosen by the
manufacturer or his authorised representative,
-
a copy of the instructions for the machinery,
-
where appropriate, the declaration of incorporation for included
partly completed machinery and the relevant assembly
instructions for such machinery,
-
where appropriate, copies of the EC declaration of conformity of
machinery or other products incorporated into the machinery,
-
a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented
to ensure that the machinery remains in conformity with the provisions
of these regulations.
The manufacturer must carry out necessary research and tests on components,
fittings or the completed machinery to determine whether by its design or
construction it is capable of being assembled and put into service safely.
The relevant reports and results shall be included in the technical file.
2. The technical file referred to in paragraph 1 must be made available to the
competent authorities of the Member States for at least 10 years following the date
of manufacture of the machinery or, in the case of series manufacture, of the last unit
produced.
The technical file does not have to be located in the territory of the Community,
nor does it have to be permanently available in material form. However, it must be
capable of being assembled and made available within a period of time
commensurate with its complexity by the person designated in the EC declaration of
conformity.
The technical file 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
essential health and safety requirements.
3. Failure to present the technical file in response to a duly reasoned request by
the competent national authorities may constitute sufficient grounds for doubting the
conformity of the machinery in question with the essential health and safety
requirements.
B.
Relevant technical documentation for partly completed machinery
This part describes the procedure for compiling relevant technical documentation.
The documentation must show which requirements of these regulations are applied
and fulfilled. It must cover the design, manufacture and operation of the partly
completed machinery to the extent necessary for the assessment of conformity with
the essential health and safety requirements applied. The documentation must be
MACHINERY
compiled in Maltese or in one or more official Community languages.
It shall comprise the following
(a) a construction file including
-
the overall drawing of the partly completed machinery and
drawings of the control circuits,
-
full detailed drawings, accompanied by any calculation notes, test
results, certificates, and other related material, required to check
the conformity of the partly completed machinery with the
applied essential health and safety requirements,
-
the risk assessment documentation showing the procedure
followed, including
(i) a list of the essential health and safety requirements
applied and fulfilled,
(ii) the description of the protective measures implemented to
eliminate identified hazards or to reduce risks and, where
appropriate, the indication of the residual risks,
(iii) the standards and other technical specifications used,
indicating the essential health and safety requirements
covered by these standards,
(iv) any technical report giving the results of the tests carried
out either by the manufacturer or by a body chosen by the
manufacturer or his authorised representative,
(v) a copy of the assembly instructions for the partly
completed machinery;
(b) for series manufacture, the internal measures that will be implemented
to ensure that the partly completed machinery remains in conformity
with the essential health and safety requirements applied.
The manufacturer must carry out necessary research and tests on components,
fittings or the partly completed machinery to determine whether by its design or
construction it is capable of being assembled and used safely. The relevant reports
and results shall be included in the technical file.
The relevant technical documentation must be available for at least 10 years
following the date of manufacture of the partly completed machinery or, in the case
of series manufacture, of the last unit produced, and on request presented to the
competent authorities of the Member States. It does not have to be located in the
territory of the Community, nor does it have to be permanently available in material
form. It must be capable of being assembled and presented to the relevant authority
by the person designated in the declaration for incorporation.
Failure to present the relevant technical documentation in response to a duly
reasoned request by the competent national authorities may constitute sufficient
grounds for doubting the conformity of the partly completed machinery with the
essential health and safety requirements applied and attested.
(1) Machinery bearing the CE marking and accompanied
by the EC declaration of conformity, the content of which is set out
in Schedule II, Part 1, Section A, shall be regarded as complying
with the provisions of these regulations.
(2) Machinery manufactured in conformity with a harmonized
standard, the references to which have been published in the
Official Journal of the European Union, shall be presumed to
comply with the essential health and safety requirements covered
by such a harmonised standard.
(3) The Malta Standards Authority shall take the appropriate
measures to enable the social partners to have an influence at
national level on the process of preparing and monitoring the
harmonized standards.
[Regulations 11(2), (3)(a) and (b), and (4)(a)]
Assessment of conformity with internal checks on the manufacture of machinery
1. This Schedule describes the procedure by which the manufacturer or his
authorised representative, who carries out the obligations laid down in paragraphs 2
and 3, ensures and declares that the machinery concerned satisfies the relevant
requirements of these regulations.
2. For each representative type of the series in question, the manufacturer or
his authorised representative shall draw up the technical file referred to in Schedule
VII, Part A.
3. The manufacturer must take all measures necessary in order that the
manufacturing process ensures compliance of the manufactured machinery with the
technical file referred to in Schedule VII, Part A, and with the requirements of these
regulations.
(1) Where the Regulatory Affairs Directorate considers
that a harmonised standard does not entirely satisfy the essential
health and safety requirements which it covers and which are set
out in Schedule I, the Regulatory Affairs Directorate shall bring the
matter before the committee set up by Directive 98/34/EC, setting
out the reasons therefor.
MACHINERY
(2) When the Regulatory Affairs Directorate considers that a
harmonised standard does not entirely satisfy the essential health
and safety requirements which it covers and which are set out in
Schedule I, the Regulatory Affairs Directorate may request the
Commission to take measures requiring Member States to prohibit
or restrict the placing on the market of machinery presenting the
same risk by virtue of its technical characteristics or to make such
machinery subject to special conditions.
[Regulation 11(3)(b) and (4)(a)]
EC type-examination
EC type-examination is the procedure whereby a notified body ascertains and
certifies that a representative model of machinery referred to in Schedule IV
(hereafter named the type) satisfies the provisions of these regulations.
1. The manufacturer or his authorised representative must, for each type, draw
up the technical file referred to in Schedule VII, Part A.
2. For each type, the application for an EC type-examination shall be
submitted by the manufacturer or his authorised representative to a notified body of
his choice.
The application shall include
-
the name and address of the manufacturer and, where appropriate, his
authorised representative,
-
a written declaration that the application has not been submitted to
another notified body,
-
the technical file.
Moreover, the applicant shall place at the disposal of the notified body a sample of
the type. The notified body may ask for further samples if the test programme so
requires.
3. The notified body shall
3.1. examine the technical file, check that the type was manufactured in
accordance with it and establish which elements have been designed in
accordance with the relevant provisions of the standards referred to in
regulation 8(2), and those elements whose design is not based on the
relevant provisions of those standards;
3.2. carry out or have carried out appropriate inspections, measurements and
tests to ascertain whether the solutions adopted satisfy the essential
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health and safety requirements of these regulations, where the standards
referred to in regulation 8(2) were not applied;
3.3. where harmonised standards referred to in regulation 8(2) were used,
carry out or have carried out appropriate inspections, measurements and
tests to verify that those standards were actually applied;
3.4. agree with the applicant as to the place where the check that the type
was manufactured in accordance with the examined technical file and
the necessary inspections, measurements and tests will be carried out.
4. If the type satisfies the provisions of these regulations, the notified body
shall issue the applicant with an EC type examination certificate. The certificate
shall include the name and address of the manufacturer and his authorized
representative, the data necessary for identifying the approved type, the conclusions
of the examination and the conditions to which its issue may be subject.
The manufacturer and the notified body shall retain a copy of this certificate, the
technical file and all relevant documents for a period of 15 years from the date of
issue of the certificate.
5. If the type does not satisfy the provisions of these regulations, the notified
body shall refuse to issue the applicant with an EC type-examination certificate,
giving detailed reasons for its refusal. It shall inform the applicant, the other notified
bodies and the Member State which notified it. An appeal procedure must be
available.
6. The applicant shall inform the notified body which retains the technical file
relating to the EC type-examination certificate of all modifications to the approved
type. The notified body shall examine these modifications and shall then either
confirm the validity of the existing EC type-examination certificate or issue a new
one if the modifications are liable to compromise conformity with the essential
health and safety requirements or the intended working conditions of the type.
7. The Commission, the Member States and the other notified bodies may, on
request, obtain a copy of the EC type-examination certificates. On reasoned request,
the Commission and the Member States may obtain a copy of the technical file and
the results of the examinations carried out by the notified body.
8. Files and correspondence referring to the EC type-examination procedures
shall be written in the official Community language(s) of the Member State where
the notified body is established or in any other official Community language
acceptable to the notified body.
9. Validity of the EC type-examination certificate
9.1. The notified body has the ongoing responsibility of ensuring that the EC
type-examination certificate remains valid. It shall inform the
manufacturer of any major changes which would have an implication on
the validity of the certificate. The notified body shall withdraw
certificates which are no longer valid.
9.2. The manufacturer of the machinery concerned has the ongoing
responsibility of ensuring that the said machinery meets the
corresponding state of the art.
9.3. The manufacturer shall request from the notified body the review of the
validity of the EC type-examination certificate every five years.
If the notified body finds that the certificate remains valid, taking into
account the state of the art, it shall renew the certificate for a further
five years.
The manufacturer and the notified body shall retain a copy of this
certificate, of the technical file and of all the relevant documents for a
period of 15 years from the date of issue of the certificate.
9.4. In the event that the validity of the EC-type examination certificate is
not renewed, the manufacturer shall cease the placing on the market of
the machinery concerned.
(1) Where it is ascertained that machinery covered by
these Regulation, bearing the CE marking, accompanied by the EC
declaration of conformity and used in accordance with its intended
purpose or under reasonably foreseeable conditions, is liable to
endanger the health or safety of persons or, where appropriate,
d o m e s t i c a n i m a l s o r p r o p e r t y o r, w h e r e a p p l i c a b l e , t h e
environment, it shall take all appropriate measures to withdraw
such machinery from the market, to prohibit the placing on the
market and or putting into service of such machinery or to restrict
the free movement thereof.
(2) The Regulatory Affairs Directorate shall immediately
inform the Commission and the other Member States 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 regulation 6(1)(a);
(b) incorrect application of the harmonized standards
referred to in regulation 8(2);
(c) shortcomings in the harmonized standards themselves
referred to in regulation 8(2).
(3) Where the measures referred to in sub-regulation (1) are
based on a shortcoming in the harmonised standards, the
Regulatory Affairs Directorate shall initiate the procedure referred
to in regulation 9.
(4) Where machinery does not conform and bears the CE
marking, the Market Surveillance Directorate shall take appropriate
a c t i o n a g a i n s t w h o m s o e v e r h a s a ff i x e d t h e m a r k i n g . T h e
Regulatory Affairs Directorate shall so inform the Commission.
[Regulation (3)(c) and (4)(b)]
Full quality assurance
This Schedule describes the conformity assessment of machinery referred to in
Schedule IV, manufactured using a full quality assurance system, and the procedure
whereby a notified body assesses and approves the quality system and monitors its
application.
1. The manufacturer must operate an approved quality system for design,
manufacture, final inspection and testing, as specified in paragraph 2, and shall be
subject to the surveillance referred to in paragraph 3.
2. Quality system
2.1. The manufacturer or his authorised representative shall lodge an application
for assessment of his quality system to a notified body of his choice.
The application shall contain
-
the name and address of the manufacturer and, where appropriate, his
authorised representative,
-
the places of design, manufacture, inspection, testing and storage of the
machinery,
-
the technical file described in Schedule VII, Part A, for one model of
each category of machinery referred to in Schedule IV which he intends
to manufacture,
-
the documentation on the quality system,
-
a written declaration that the application has not been submitted to
another notified body.
2.2. The quality system must ensure conformity of the machinery with the
provisions of these regulations. All the elements, requirements and provisions
adopted by the manufacturer must be documented in a systematic and orderly
manner, in the form of measures, procedures and written instructions. The
documentation on the quality system must permit a uniform interpretation of the
procedural and quality measures, such as quality programmes, plans, manuals and
records.
It must contain, in particular, an adequate description of
-
the quality objectives, the organisational structure, and the
responsibilities and powers of the management with regard to the design
and quality of the machinery,
-
the technical design specifications, including standards that will be
applied and, where the standards referred to in regulation 8(2) are not
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applied in full, the means that will be used to ensure that the essential
health and safety requirements of these regulations are fulfilled,
-
the design inspection and design verification techniques, processes and
systematic actions that will be used when designing machinery covered
by these regulations,
-
the corresponding manufacturing, quality control and quality assurance
techniques, processes and systematic actions that will be used,
-
the inspections and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out,
-
the quality records, such as inspection reports and test data, calibration
data, and reports on the qualifications of the personnel concerned,
-
the means of monitoring the achievement of the required design and
quality of the machinery, as well as the effective operation of the quality
system.
2.3. The notified body shall assess the quality system to determine whether it
satisfies the requirements of paragraph 2.2.
The elements of the quality system which conform to the relevant harmonised
standard shall be presumed to conform to the corresponding requirements referred to
in paragraph 2.2.
The team of auditors must have at least one member who is experienced in the
assessment of the technology of the machinery. The assessment procedure shall
include an inspection to be carried out at the manufacturer’s premises. During the
assessment, the team of auditors shall carry out a review of the technical files
referred to in paragraph 2.1, second paragraph, third indent to ensure their
compliance with the relevant health and safety requirements.
The manufacturer or his authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the examination and the reasoned
assessment decision. An appeal procedure must be available.
2.4. The manufacturer shall undertake to fulfil the obligations arising from the
quality system as approved and to ensure that it remains appropriate and effective.
2.4.1. The manufacturer or his authorised representative shall inform the notified
body which approved the quality system of any planned change to it.
2.4.2. The notified body shall evaluate the proposed changes and decide whether
the modified quality assurance system will continue to satisfy the requirements
referred to in paragraph 2.2, or whether a re-assessment is necessary.
2.4.3. It shall notify the manufacturer of its decision. The notification shall
contain the conclusions of the examination and the reasoned assessment decision.
3. Surveillance under the responsibility of the notified body
3.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
3.2. The manufacturer shall, for inspection purposes, allow the notified body
access to the places of design, manufacture, inspection, testing and storage, and shall
provide it with all necessary information, such as
-
the documentation concerning the quality system,
-
the quality records provided for in that part of the quality system
concerned with design, such as the results of analyses, calculations,
tests, and other related verifications,
-
the quality records provided for in that part of the quality system
concerned with manufacture, such as inspection reports and test data,
calibration data, reports on the qualifications of the personnel
concerned, and other related data.
3.3. The notified body shall conduct periodic audits to make sure that the
manufacturer is maintaining and applying the quality system; it shall provide the
manufacturer with an audit report.
The frequency of the periodic audits shall be such that a full reassessment is
carried out every three years.
3.4. Moreover, the notified body may pay the manufacturer unannounced visits.
The need for these additional visits and their frequency will be determined on the
basis of a visit monitoring system managed by the notified body. In particular, the
following factors will be taken into account in the visits monitoring system
-
the results of previous surveillance visits,
-
the need to monitor remedial measures,
-
where appropriate, special conditions attaching to approval of the
system,
-
significant modifications in the organisation of the manufacturing
process, measures or techniques.
On the occasion of such visits, the notified body may, if necessary, carry out tests
or have them carried out in order to check the proper functioning of the quality
system. It shall provide the manufacturer with a visit report and, if a test was carried
out, with a test report.
4. The manufacturer or his authorised representative shall keep available for
the national authorities, for a period of ten years from the last date of manufacture
-
the documentation referred to in paragraph 2.1,
-
the decisions and reports of the notified body referred to in paragraphs
2.4, 2.4.2, 2.4.3, 3.3 and 3.4.
(1) The manufacturer or his authorised representative
shall, in order to certify the conformity of machinery with the
provisions of these regulations, apply one of the procedures for
assessment of conformity described in sub-regulations (2), (3) and
(4).
(2) Where the machinery is not referred to in Schedule IV, the
manufacturer or his authorised representative shall apply the
procedure for assessment of conformity with internal checks on the
manufacture of machinery provided for in Schedule VIII.
(3) Where the machinery is referred to in Schedule IV and
manufactured in accordance with the harmonised standards referred
to in regulation 8(2), and provided that those standards cover all of
the relevant essential health and safety requirements, the
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manufacturer or his authorised representative shall apply one of the
following procedures
(a) the procedure for assessment of conformity with
internal checks on the manufacture of machinery,
provided for in Schedule VIII;
(b) the EC type-examination procedure provided for in
Schedule IX, and the internal checks on the
manufacture of machinery provided for in Schedule
VIII, paragraph 3;
(c) the full quality assurance procedure provided for in
Schedule X.
(4) Where the machinery is referred to in Schedule IV and has
n o t be en m an u f act ur ed in acco r d anc e wi t h th e h ar m on iz ed
standards referred to in regulation 8(2) or only partly in accordance
with such standards, or if the harmonised standards do not cover all
the relevant essential health and safety requirements or if no
harmonised standards exist for the machinery in question, the
manufacturer or his authorised representative shall apply one of the
following procedures
(a) the EC type-examination procedure provided for in
Schedule IX, and the internal checks on the
manufacture of machinery provided for in Schedule
VIII, paragraph 3;
(b) the full quality assurance procedure provided for in
Schedule X.
[Regulation 13(2), (3) and (6)(a)]
Minimum criteria to be taken into account for the notification of bodies
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
machines which they inspect, nor the authorised representative of any of these
p a r t i e s . T h ey sh a l l n o t b e c o m e i n v o l v e d , e i t h e r d i r e c t l y o r a s a u t h o r i s e d
representatives, in the design, construction, marketing or maintenance of the
machines. 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.
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3. For each category of machinery for which it is notified, the body must
possess personnel with technical knowledge and sufficient and appropriate
experience to perform a conformity assessment. It must have the means necessary to
complete the technical and administrative tasks connected with implementation of
the checks in an appropriate manner; it must also have access to the equipment
necessary for the exceptional checks.
4. The staff responsible for inspection shall have
-
sound technical and vocational 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 obtained in carrying out its tasks (except vis-à-vis the
competent administrative authorities of the State in which its activities are carried
out) under these regulations or any provision of national law giving effect to them.
8. Notified bodies shall participate in coordination activities. They shall also
take part directly or be represented in European standardisation, or ensure that they
know the situation in respect of relevant standards.
9. The Regulatory Affairs Directorate may take all necessary measures it
regards as necessary in order to ensure that, in the event of cessation of the activities
of a notified body, the files of its customers are sent to another body or are made
available to the Regulatory Affairs Directorate.
(1) The manufacturer of partly completed machinery or
his authorised representative shall, before placing it on the market,
ensure that
(a) the relevant technical documentation described in
Schedule VII, Part B, is prepared;
(b) assembly instructions described in Schedule VI are
prepared;
(c) a declaration of incorporation described in Schedule
II, Part 1, Section B has been drawn up.
(2) The assembly instructions and the declaration of
incorporation shall accompany the partly completed machinery
until it is incorporated into the final machinery and shall then form
part of the technical file for that machinery.
(1) The Regulatory Affairs Directorate shall notify the
Commission and the other Member States of the bodies which it
has appointed to carry out the assessment of conformity for placing
on the market referred to in regulation 11(3) and (4), together with
the specific conformity assessment procedures and categories of
machinery for which these bodies have been appointed and the
identification numbers assigned to them beforehand by the
Commission. The Regulatory Affairs Directorate shall notify the
Commission and other Member States of any subsequent
amendment.
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(2) The Regulatory Affairs Directorate shall ensure that the
notified bodies are monitored regularly to check that they comply
at all times with the criteria set out in Schedule XI. The notified
body shall provide all relevant information on request, including
budgetary documents, to enable the Regulatory Affairs Directorate
to ensure that the requirements of Schedule XI are met.
(3) The Regulatory Affairs Directorate shall apply the criteria
set out in Schedule XI in assessing the bodies to be notified and the
bodies already notified.
(4) Bodies meeting the assessment criteria laid down in the
relevant harmonised standards, the references of which shall be
published in the Official Journal of the European Union, shall be
presumed to fulfil the relevant criteria.
(5) If a notified body finds that relevant requirements of these
re gu la ti o ns ha ve n ot be en m et o r a re n o l on g er m et by th e
manufacturer or that an EC type-examination certificate or the
approval of a quality assurance system should not have been issued,
it shall, taking account of the principle of proportionality, suspend
or w ithdr aw th e cer tif icate or the appr oval issued or place
restrictions on it, giving detailed reasons, unless compliance with
such requirements is ensured by the implementation of appropriate
c o r r e c t i v e m e a s u r e s b y t h e m a n u f a c t u r e r. I n t h e e v e n t o f
suspension or withdrawal of the certificate or the approval or of
any restriction placed on it, or in cases where intervention by the
Regulatory Affairs Directorate may prove necessary, the notified
body shall inform the Market Surveillance Directorate. The
Regulatory Affairs Directorate shall inform the other Member
States and the Commission without delay. An appeal procedure
shall be available.
(6) The Regulatory Affaris Directorate shall immediately
withdraw its notification if it finds
(a) that the body no longer meets the criteria set out in
Schedule XI; or
(b) that the body
seriously
fails
to
fulfil
its
responsibilities.
The Regulatory Affairs Directorate shall immediately inform the
Commission and the other Member States accordingly.
(1) The CE conformity marking shall consist of the initials
"CE", as set out in Schedule III.
(2) The CE marking shall be affixed to machinery legibly,
visibly and indelibly in accordance with Schedule III.
(3) The affixing on machinery of markings, signs and
inscriptions 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, legibility and meaning of the CE marking is not thereby
impaired.
(1) The following marking shall be considered as not to
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conform
(a) the affixing of the CE marking pursuant to these
regulations on products not covered by these
regulations;
(b) the absence of the CE marking and, or the absence of
the EC declaration of conformity for machinery;
(c) the affixing on machinery of a marking, other than the
CE marking, which is prohibited under regulation
14(3).
(2) Where the Market Surveillance Directorate ascertains that
marking does not conform to the relevant provisions of these
regulations, the manufacturer or his authorised representative shall
be obliged to make the product conform and to put an end to the
infringement under conditions fixed by the Market Surveillance
Directorate.
(3) Where non-conformity persists, the Market Surveillance
Directorate shall 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 regulation 10.
(1) Without prejudice to existing national provisions and
practices in the area of confidentiality, the Market Surveillance
Directorate and the Regulatory Affairs Directorate shall treat as
confidential information obtained in the execution of their tasks.
More particularly business, professional and trade secrets shall be
treated as confidential, unless the divulging of such information is
necessary in order to protect the health and safety of persons.
(2) The provisions of sub-regulation (1) shall not affect the
obligations of the Regulatory Affairs Directorate and the notified
bodies with regard to mutual exchange of information and the
issuing of warnings.
(3) Any decisions taken by the Regulatory Affairs Directorate
in accordance with regulations 9(2) and 10 shall be published.
Appropriate measures shall be taken by the Regulatory
Affairs Directorate and the Market Surveillance Directorate to
cooperate with other Member States and with the Commission and
transmit to each other the information necessary to enable these
regulations to be applied uniformly.
Any measure taken pursuant to these regulations which
restricts the placing on the market and, or putting into service of
any machinery covered by these regulations shall state the exact
grounds on which it is based. Such a measure 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 Malta and of the time limits to which such remedies are
subject.
(1) Any violation of these regulations or provisions and
decisions issued in pursuance thereof shall be construed as
infringements pursuant to the Product Safety Act.
(2) The penalties applicable shall be those provided for in Part
IV of the Product Safety Act.
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Amended by
Power-operated interlocking movable guards designed to be used as
safeguards in machinery referred to in paragraphs 9, 10 and 11.
Logic units to ensure safety functions.
Roll-over protective structures (ROPS).
Falling-object protective structures (FOPS).