MT
Machinery Regulations, 2009
Table of Provisions (28)
Statutory Text (28 Articles)
L.N. 147 of 2009
PRODUCT SAFETY ACT
(CAP. 427)
Machinery Regulations, 2009
IN EXERCISE of the powers conferred by articles 38 to 40 of
the Product Safety Act (Cap. 427), the Minister of Finance, the
Economy and Investment, on the advice of the Malta Standards
Authority, has made the following regulations:-
(1) The title of these regulations is the Machinery Citation and
commencement.
Regulations, 2009.
(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) These regulations shall come into force on the 29th
December, 2009.
(4) Until 29th June 2011, the placing on the market and the Derogation.
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.
[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 has a general
scope and is 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 paragraph 1 of these General Principles.
1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
GENERAL REMARKS
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.
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),
-
take the necessary protective measures in relation
to risks that cannot be eliminated,
-
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.
(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,
-
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
-
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
-
be shaped in such a way that standard lifting gear can easily be
attached.
Where machinery or one of its component parts is to be moved by hand, it
must
-
either be easily moveable, or
-
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
-
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,
-
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.
Particular attention must be given to the following points
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the machinery must not start unexpectedly,
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the parameters of the machinery must not change in an
uncontrolled way, where such change may lead to hazardous situations,
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the machinery must not be prevented from stopping if the stop
command has already been given,
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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
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.
Control devices
(a)
Control devices must be
- clearly visible and identifiable, using pictograms
where appropriate,
- positioned in such a way as to be safely operated
without hesitation or loss of time and without ambiguity,
- designed in such a way that the movement of the
control device is consistent with its effect,
- located outside the danger zones, except where
necessary for certain control devices such as an
emergency stop or a teach pendant,
- positioned in such a way that their operation cannot
cause additional risk,
- designed or protected in such a way that the desired
effect, where a hazard is involved, can only be achieved
by a deliberate action,
- 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.
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
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
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.
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,
-
portable hand-held and, or hand-guided machinery.
The device must
-
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,
-
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
-
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.
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 situations.
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
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 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
-
when the workpiece comes into contact with the tool, the latter
must have attained its normal working condition,
-
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
-
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,
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.
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 DEVICES
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 tools.
Their fixing systems must remain attached to the guards or to the machinery
when the guards are removed.
Where possible, guards must be incapable of remaining in place without their
fixings.
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.
1.5.
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
prevented.
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 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 be taken.
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.
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.
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.
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.
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
MAINTENANCE
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 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.
The instructions accompanying the machinery must be either ‘Original
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.
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.
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;
(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,
hand-held and, or hand-guided machinery, portable fixing and other impact
machinery, machinery for working wood and material with similar physical
characteristics must meet all the essential health and safety requirements described
in this chapter (see General Principles, paragraph 4).
2.1.
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.
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.
2.2.
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/s 2 . 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 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.
3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY
REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY OF
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 4).
3.1.
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.
3.2.
WORK POSITIONS
3.2.1.
Driving position
Visibility from the driving position must be such that the driver can, in
complete safety for himself and the exposed persons, operate the machinery and its
tools in their 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
If the conditions of use provide that persons other than the driver may
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
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.
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
-
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/s 2 . 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.
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
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 re-
inspected 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
(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 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.
Lifting accessories
Lifting accessories must show the following particulars
identification of the material where this information is needed for
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.
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 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.
INSTRUCTIONS
Lifting accessories
Each lifting accessory or each commercially indivisible batch of lifting
accessories must be accompanied by instructions setting out at least the following
(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 on
(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.
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 such a way as to ensure safe transfer to and from the carrier, taking
into 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 Scope.
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,
(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 S.L. 427.34
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
A.
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 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.
B. 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" Definitions.
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;
"the Community" means the European Community;
"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;
(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 S.L. 419.03
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
assembled with other machinery or other partly completed 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 S.L. 419.03
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.
[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
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.
20. Power-operated interlocking movable guards designed to be used as
safeguards in machinery referred to in paragraphs 9, 10 and 11.
(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 these regulations and does not endanger the health and
safety of persons and, where appropriate, domestic animals or
property, when properly installed and maintained and used for its
intended purpose or under conditions which can reasonably be
foreseen.
(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;
(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
[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.
[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 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.
[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.
[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 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.
[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 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.
[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
parties. They shall not become involved, either directly or as authorised
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.
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.
(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 of
the CE marking, the marking shall indicate that the machinery also
conforms to the provisions of those other Community 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.
7. (1) The placing on the market and, or putting into Freedom of
service in the Maltese territory of machinery which complies with movement.
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.
8. (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.
9. (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.
(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.
10. (1) Where it is ascertained that machinery covered by
these regulations, bearing the CE marking, accompanied by the EC
declaration of conformity and used in accordance with its intended
purpose or under conditions which can reasonably be foreseen, is
liable to compromise the health and safety of persons and, where
appropriate, domestic animals or property, the Market Surveillance
Directorate 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 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
action against whomsoever has affixed the marking. The Regulatory
Affairs Directorate shall so inform the Commission.
11. (1) The manufacturer or his authorised representative Procedures for
shall, in order to certify the conformity of machinery with the assessing
conformity of
provisions of these regulations, apply one of the procedures for machinery.
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
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
not been manufactured in accordance with the harmonized 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.
12. (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.
13. (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.
(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
regulations have not been met or are no longer met by the
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
withdraw the certificate or the approval issued or place restrictions on
it, giving detailed reasons, unless compliance with such requirements
is ensured by the implementation of appropriate corrective measures
by the manufacturer. In the event of 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.
14. (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
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 Cooperation
Affairs Directorate and the Market Surveillance Directorate to between
Member States.
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 Legal remedies.
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 Infringements
decisions issued in pursuance thereof shall be construed as and penalties.
infringements pursuant to the Product Safety Act.
(2) The penalties applicable shall be those provided for in Part
IV of the Product Safety Act.
(1)
The Machinery Regulations, 2002 are hereby Revokes L.N.
369 of 2002.
revoked.
(2) Any reference to the Machinery Regulations, 2002 in any
other law shall be construed as a reference to these regulations.
Logic units to ensure safety functions.
Roll-over protective structures (ROPS).
Falling-object protective structures (FOPS).