Machinery Regulations, 2008

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,318, 7 ta’ Ottubru, 2008

L.N. 247 of 2008

PRODUCT SAFETY ACT

(CAP. 427)

Machinery Regulations, 2008

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act the Minister for 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, 2008.

(2) The regulations implement the requirements of Directive

2006#42#EC of the European Parliament and of the Council of 22 June

1998 on the approximation of the laws of the Member States relating to

machinery.

(3) The regulations shall come into force on the 29 th

December, 2009.

(4) Until 29 th June 2011, the placing on the market and the

putting into service of portable cartridge operated fixing and other impact

machinery which are in conformity with the national provisions of a

member state of the European Community shall be allowed.

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

— determine the limits of the machinery, which include the intended use

and any reasonably foreseeable misuse thereof,

— identify the hazards that can be generated by the machinery and the

associated hazardous situations,

— estimate the risks, taking into account the severity of the possible

injury or damage to health and the probability of its occurrence,

— evaluate the risks, with a view to determining whether risk reduction

is required, in accordance with the objective of this Directive,

— eliminate the hazards or reduce the risks associated with these hazards

by application of protective measures, in the order of priority established

in section 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

section 1.1.2 and the obligations concerning marking of machinery and

instructions referred to in sections 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 point 1 of these General

Principles.

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1. 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

— 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

— which experience has shown might occur

— 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.

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.

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.

Design of machinery to facilitate its handling

Machinery, or each component part thereof, must

— 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

— 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.

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

— allowing for the variability of the operator's physical dimensions,

strength and stamina,

— providing enough space for movements of the parts of the operator's

body,

— avoiding a machine-determined work rate,

— avoiding monitoring that requires lengthy concentration,

— adapting the man/machinery interface to the foreseeable

characteristics of the operators.

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 fulfill 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.

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.

CONTROL SYSTEMS

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,

— 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,

— reasonably foreseeable human error during operation does not lead to

hazardous 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, where such change may lead to hazardous situations,

— the machinery must not be prevented from stopping if the stop

command has already been given,

— no moving part of the machinery or piece held by the machinery must

fall or be ejected,

— automatic or manual stopping of the moving parts, whatever they may

be, must be unimpeded,

— the protective devices must remain fully effective or give a stop

command,

— the safety-related parts of the control system must apply in a coherent

way to the whole of an assembly of machinery and, or partly completed

machinery.

For cable-less control, an automatic stop must be activated when correct

control signals are not received, including loss of communication.

Control devices

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.

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.

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.

Machinery must be fitted with indicators as required for safe operation.

The operator must be able to read them from the control position.

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.

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.

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.

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.

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 cause,

— when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating

conditions may be effected by voluntary actuation of a device other than

the control device provided for the purpose, on condition that this does

not lead to a hazardous situation.

For machinery functioning in automatic mode, the starting of the

machinery, restarting after a stoppage, or a change in operating

conditions may be possible without intervention, provided this does not

lead to a hazardous situation.

Where machinery has several starting control devices and the operators

can therefore put each other in danger, additional devices must be fitted

to rule out such risks. If safety requires that starting and, or stopping must

be performed in a specific sequence, there must be devices which ensure

that these operations are performed in the correct order.

Stopping

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.

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.

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

— 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,

— 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.

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.

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 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.

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.

Risks due to falling or ejected objects

Precautions must be taken to prevent risks from falling or ejected objects.

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.

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.

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.

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.

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.

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 section 1.4.2.1, or

— interlocking movable guards as referred to in section 1.4.2.2.

Interlocking movable guards should be used where frequent access is

envisaged.

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 section 1.4.2.1, or

— interlocking movable guards as referred to in section 1.4.2.2, or

— protective devices as referred to in section 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 section 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.

Special requirements for guards

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.

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.

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.

Special requirements for protective devices

Protective devices must be designed and incorporated into the control

system in such a way that

— moving parts cannot start up while they are within the operator's

reach,

— persons cannot reach moving parts while the parts are moving, and

— the absence or failure of one of their components prevents starting or

stops the moving parts.

Protective devices must be adjustable only by means of an intentional

action.

RISKS DUE TO OTHER HAZARDS

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 Directive 73/23/EEC 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 this Directive.

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.

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.

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.

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.

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.

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 Directives.

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.

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.

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.

External radiation

Machinery must be designed and constructed in such a way that external

radiation does not interfere with its operation.

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

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.

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.

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 earth.

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 section 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.

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.

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, etc. In

this case, special steps must be taken to ensure operator safety.

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.

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.

INFORMATION

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 an

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.

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.

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 Directives concerning

colours and safety signals must be complied with.

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.

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 section 1.7.1.

Where a machine part must be handled during use with lifting equipment,

its mass must be indicated legibly, indelibly and unambiguously.

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 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 section 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 Directives lay down other requirements for

the measurement of sound pressure levels or sound power levels, those

Directives 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.

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.

SUPPLEMENTARY

ESSENTIAL

HEALTH

AND

SAFETY

2. 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,

point 4).

FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS

OR PHARMACEUTICAL PRODUCTS

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 the relevant Directives. 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.

Instructions

The instructions for foodstuffs machinery and machinery for use with

cosmetics or pharmaceutical products must indicate recommended

products and methods for cleaning, disinfecting and rinsing, not only for

easily accessible areas but also for areas to which access is impossible or

inadvisable.

PORTABLE HAND-HELD AND, OR HAND-GUIDED MACHINERY

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.

Instructions

The instructions must give the following information concerning

vibrations transmitted by portable handheld and hand-guided machinery

— the vibration total value to which the hand-arm system is subjected, if

it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, 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.

Portable fixing and other impact machinery

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.

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.

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.

SUPPLEMENTARY

ESSENTIAL

HEALTH

AND

SAFETY

3. 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, point 4).

GENERAL

Definitions

(a) ‘Machinery presenting hazards due to its mobility’ means

— machinery the operation of which requires either mobility while

working, or continuous or semicontinuous movement between a

succession of fixed working locations, or

— machinery which is operated without being moved, but which may be

equipped in such a way as to enable it to be moved more easily from one

place to another.

(b) ‘Driver’ means an operator responsible for the movement of a

machine. The driver may be transported by the machinery or may be on

foot, accompanying the machinery, or may guide the machinery by

remote control.

WORK POSITIONS

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.

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 section 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.

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 section 3.2.1 also apply to the places

provided for persons other than the driver.

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.

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.

The sixth paragraph of section 1.2.2, concerning acoustic and, or visual

warning signals, applies only in the case of reversing.

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 (e.g. stabilisers, jib, etc.), the driver

must be provided with the means of checking easily, before moving the

machinery, that such devices are in a particular position which allows

safe movement.

This also applies to all other parts which, to allow safe movement, have

to be in particular positions, locked if necessary.

Where it 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.

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 second 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.

Section 1.2.4 does not apply to the travelling function.

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.

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.

PROTECTION AGAINST MECHANICAL HAZARDS

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.

Moving transmission parts

By way of exception to section 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.

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.

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.

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.

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.

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.

PROTECTION AGAINST OTHER HAZARDS

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.

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.

Emissions of hazardous substances

The second and third paragraphs of section 1.5.13 do not apply where the

main function of the machinery is the spraying of products. However, the

operator must be protected against the risk of exposure to such hazardous

emissions.

INFORMATION AND INDICATIONS

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.

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).

Instructions

Vibrations

The instructions must give the following information concerning

vibrations transmitted by the machinery to the hand-arm system or to the

whole body

— the vibration total value to which the hand-arm system is subjected, if

it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, 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/s2. Where this value does

not exceed 0,5 m/s2, 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, point 4).

GENERAL

Definitions

(a) ‘Lifting operation’ means a movement of unit loads consisting of

goods and, or persons necessitating, at a given moment, a change of

level.

(b) ‘Guided load’ means a load where the total movement is made along

rigid or flexible guides whose position is determined by fixed points.

(c) ‘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.

(d) ‘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.

(e) ‘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.

(f) ‘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.

(g) ‘Carrier’ means a part of the machinery on or in which persons and,

or goods are supported in order to be lifted.

Protection against mechanical hazards

Risks due to lack of stability

Machinery must be designed and constructed in such a way that the

stability required by section 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.

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.

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.

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.

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 (a), (b), (c) and (d), perform the

appropriate tests or have such tests performed.

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.

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.

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 section 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.

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 section 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.

REQUIREMENTS FOR MACHINERY WHOSE POWER SOURCE IS

OTHER THAN MANUAL EFFORT

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.

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.

Installations guided by ropes

Rope carriers, tractors or tractor carriers must be held by counterweights

or by a device allowing permanent control of the tension.

INFORMATION AND MARKINGS

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 safe

use,

— the maximum working load.

In the case of lifting accessories on which marking is physically

impossible, the particulars referred to in the first paragraph must be

displayed on a plate or other equivalent means and securely affixed to the

accessory.

The particulars must be legible and located in a place where they are not

liable to disappear as a result of wear or jeopardise the strength of the

accessory.

Lifting machinery

The maximum working load must be prominently marked on the

machinery. This marking must be legible, indelible and in an un-coded

form.

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.

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 particulars

(a) the intended use;

(b) the limits of use (particularly for lifting accessories such as magnetic

or vacuum pads which do not fully comply with section 4.1.2.6(e));

(c) instructions for assembly, use and maintenance;

(d) the static test coefficient used.

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 of section 4.3.3,

— 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 section 4.1.3

before it is first put into service.

SUPPLEMENTARY

ESSENTIAL

HEALTH

AND

SAFETY

5. 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, point 4).

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.

MOVEMENT

Powered roof supports must allow for unhindered movement of persons.

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.

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.

FIRE

The second indent of section 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.

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, point 4).

GENERAL

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 sections 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.

Loading control for machinery moved by power other than human

strength

The requirements of section 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.

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.

RISKS TO PERSONS IN OR ON THE CARRIER

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.

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 section 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.

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.

MACHINERY SERVING FIXED LANDINGS

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.

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.

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.

MARKINGS

The carrier must bear the information necessary to ensure safety

including

— the number of persons permitted on the carrier,

— the maximum working load.

(1) These regulations shall apply to the following products> Derogation.

(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 Directive 2003#37#EC, with the exclusion of

machinery mounted on these vehicles,

(ii) motor vehicles and their trailers covered by Council

Directive 70#156#EEC of 6 February 1970 on the

approximation of the laws of the Member States relating to

the type-approval of motor vehicles and their trailers, with

the exclusion of machinery mounted on these vehicles,

(iii) vehicles covered by Directive 2002#24#EC of the

European Parliament and of the Council of 18 March 2002

relating to the type-approval of two or three-wheel motor

vehicles , 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 Council Directive

73#23#EEC of 19 February 1973 on the harmonization of the laws

of Member States relating to electrical equipment designed for

use within certain voltage limits>

(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) switch gear and control gear,

(ii) transformers.

(3) 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.

Declarations

1. CONTENT

EC DECLARATION OF CONFORMITY OF THE MACHINERY

This declaration and translations thereof must be drawn up under the same

conditions as the instructions (see Schedule I, section 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 this Directive and where appropriate, a similar sentence

declaring the conformity with other Directives 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 Article 7(2);

8. where appropriate, the reference to other technical standards and

specifications used;

9. the place and date of the declaration;

10. the identity and signature of the person empowered to draw up the

declaration on behalf of the manufacturer or his authorised representative.

DECLARATION OF INCORPORATION OF PARTLY COMPLETED

MACHINERY

This declaration and translations thereof must be drawn up under the same

conditions as the instructions (see Schedule 1, section 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 this Directive are

applied and fulfilled and that the relevant technical documentation is

compiled in accordance with part B of Schedule VII, and, where appropriate,

a sentence declaring the conformity of the partly completed machinery with

other relevant Directives. 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 this Directive, 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 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<

“harmonised 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 the first indent, missing

only the components to connect it on site or to sources of

energy and motion<

(c) an assembly referred to in the first and second

indents, 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 the first,

second and third indents or partly completed machinery

referred to in this definition 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<

“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 applies<

“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<

“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

hereof.

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 Article 12(3)(c) and

12(4)(b) has been applied, the CE marking must be followed by the

identification number of the notified body.

(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 7.

(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 6(1)

to (3) hereof.

(2) Before placing partly completed machinery on the

market, the manufacturer or his authorised representative shall ensure

that the procedure referred to in regulation 7(5) and (6) has been

completed.

(3) For the purposes of the procedures referred to in

regulation 7, 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.

(5) 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.

(6) The free movement, placing on the market or putting

into service in the Maltese territory of relevant machinery which satisfies

the provisions of these regulations shall not be impeded.

(7) The placing on the market, in the Maltese territory, of

partly completed machinery shall not be impeded, prohibited or restricted

provided that the manufacturer or his authorised representative makes

a declaration of incorporation produced by the 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.

(8) The display of machinery or partly completed machinery

at trade fairs, exhibitions, demonstrations, and such like, 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.

Categories of machinery to which one of the procedures referred to in

Article 12(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 points 1 to 4 and in point 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.

(1) Machinery bearing the CE marking and accompanied Presumption of

by the EC declaration of conformity, the content of which is set out in conformity.

Schedule II, Part 1, Section A, shall be regarded as complying with the

provisions of this regulation.

(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.

Indicative list of the safety components referred to in Article 2(c)

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 items 9, 10 and 11 of Schedule IV.

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 sections 1.5.7, 3.4.7 and

4.1.2.6 of Schedule I.

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) The CE conformity marking shall consist of the initials

“CE”, as set out in Schedule 3 of this regulation.

(2) The CE marking shall be affixed to machinery legibly,

visibly and indelibly in accordance with point 1.7.3 of Schedule 3 set

out in this regulation.

(3) The affixing of markings on the machinery which are

likely to deceive third parties as to the meaning and form of the CE

marking shall be prohibited. Any other marking may be affixed to the

machinery provided that the visibility and legibility of the CE marking

is not thereby reduced.

(4) A person who supplies relevant machinery which does

not bear the CE marking shall, at the request of the Director of Consumer

Affairs, or of an officer authorized by such Director, give any information

which he has, or which is available to him, concerning the date when

the relevant machinery was first supplied in the Community and explain,

so far as he is able< why the machinery does not bear that mark.

(5) Without prejudice to regulation 8>

(a) where it is established that the CE marking has been

affixed unduly, the manufacturer or his authorized representative

shall be obliged to make the product conform as regards the

provisions concerning the CE marking and to end the infringement

under the conditions imposed by the Director of Consumer Affairs<

(b) where non-conformity continues, the Director of

Consumer Affairs must take all appropriate measures to restrict or

prohibit the placing on the market of the product in question or to

ensure that it is withdrawn from the market in accordance with the

procedure laid down in regulation 8.

(6) For the purposes of these regulations, the CE marking

shall be regarded as properly affixed to relevant machinery if>

(a) the responsible person who affixes the CE marking to

the relevant machinery has issued an EC declaration of conformity

in respect thereof<

(b) the CE marking is affixed to the relevant machinery in

a distinct, visible, legible and indelible manner< and

(c) in the case of relevant machinery which is the subject of

regulations which transpose Community Legislation other than

these regulations, the requirements of those other regulations have

also been complied with in respect of the relevant machinery.

(7) No person shall affix the CE marking to any relevant

machinery unless that machinery>

(a) satisfies the relevant essential health and safety

requirements< and

(b) is safe.

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 an official Community language

acceptable to the manufacturer of the machinery in which the partly

completed machinery will be assembled, or to his authorised representative.

(1) The manufacturer or his authorised representative shall, Conformity

Assessment

in order to certify the conformity of machinery with the provisions of Procedures.

this regulation, apply one of the procedures for assessment of conformity

described in regulation 7(2), to (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 5(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, point 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 5(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, plus the internal checks on the manufacture of

machinery provided for in Schedule VIII, point 3<

(b) the full quality assurance procedure provided for in

Schedule X.

(5) 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.

(6) 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.

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

this Directive. 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 one or more official Community languages, except for the

instructions for the machinery, for which the special provisions of Schedule I,

section 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, etc., 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 this

Directive.

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 point 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 subassemblies 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.

Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical

documentation. The documentation must show which requirements of this

Directive 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 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, etc., required to check the conformity of the partly completed

machinery with the applied essential health and safety requirements,

— the risk assessment documentation showing the procedure followed,

including

(i) a list of the essential health and safety requirements applied and

fulfilled,

(ii) the description of the protective measures implemented to eliminate

identified hazards or to reduce risks and, where appropriate, the indication

of the residual risks,

(iii) the standards and other technical specifications used, indicating the

essential health and safety requirements covered by these standards,

(iv) any technical report giving the results of the tests carried out either by

the manufacturer or by a body chosen by the manufacturer or his authorised

representative,

(v) a copy of the assembly instructions for the partly completed machinery;

(b) for series manufacture, the internal measures that will be implemented to

ensure that the partly completed machinery remains in conformity with the

essential health and safety requirements applied.

The manufacturer must carry out necessary research and tests on components,

fittings or the partly completed machinery to determine whether by its design

or construction it is capable of being assembled and used safely. The relevant

reports and results shall be included in the technical file.

The relevant technical documentation must be available for at least 10 years

following the date of manufacture of the partly completed machinery or, in

the case of series manufacture, of the last unit produced, and on request

presented to the competent authorities of the Member States. It does not have

to be located in the territory of the Community, nor does it have to be

permanently available in material form. It must be capable of being

assembled and presented to the relevant authority by the person designated in

the declaration for incorporation.

Failure to present the relevant technical documentation in response to a duly

reasoned request by the competent national authorities may constitute

sufficient grounds for doubting the conformity of the partly completed

machinery with the essential health and safety requirements applied and

attested.

(1) Where it is ascertained that machinery 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, it shall

take all appropriate measures to withdraw such machinery from the

market, to prohibit the placing on the market and, or putting into service

of such machinery or to restrict free movement thereof.

(2) The Director of Consumer Affairs shall immediately

inform the Consumer and Industrial Goods Directorate of the Malta

Standards Authority 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 4(1)(a)<

(b) incorrect application of the standards referred to in

regulation 5(2)<

(c) shortcomings in the standards themselves referred to in

regulation 5(2).

(3) Where machinery which does not comply bears the CE

marking, the Director of Consumer Affairs shall take appropriate action

against whom so ever has affixed the marking or drawn up the

declaration and shall so inform the Consumer and Industrial Goods

Directorate of the Malta Standards Authority.

(4) Any decision taken pursuant to these regulations which

restricts the placing on the market and putting into service of machinery

or a safety component shall state the exact grounds on which it is based.

(5) Such a decision shall be notified as soon as possible to

the party concerned, who shall at the same time be informed of the

legal remedies available to him under the laws in force in Malta and of

the time limits to which such remedies are subject.

(6) The Consumer and Industrial Goods Directorate of the

Malta Standards Authority shall immediately inform the Commission

of any measures taken in pursuance of regulations 8(1) to (5).

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 points

2 and 3, ensures and declares that the machinery concerned satisfies the

relevant requirements of these regulations.

2. For each representative type of the series in question, the manufacturer or

his authorised representative shall draw up the technical file referred to in

Schedule VII, Part A.

3. The manufacturer must take all measures necessary in order that the

manufacturing process ensures compliance of the manufactured machinery

with the technical file referred to in Schedule VII, Part A, and with the

requirements of these regulations.

(1) Violations of this legal notice or provisions and decisions

issued in pursuance thereof are construed as infringements pursuant to

the Product Safety ActInfringements and Penalties

(2) The penalties applicable shall be those provided for in

Part IVof the Product Safety Act.

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 this Directive.

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 Article

7(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

Article 7(2) were not applied;

3.3. where harmonised standards referred to in Article 7(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 this Directive, 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 this Directive, the notified

body shall refuse to issue the applicant with an EC type-examination

certificate, giving detailed reasons for its refusal. It shall inform the applicant,

the other notified bodies and the Member State which notified it. An appeal

procedure must be available.

6. The applicant shall inform the notified body which retains the technical file

relating to the EC type-examination certificate of all modifications to the

approved type. The notified body shall examine these modifications and shall

then either confirm the validity of the existing EC type-examination

certificate or issue a new one if the modifications are liable to compromise

conformity with the essential health and safety requirements or the intended

working conditions of the type.

7. The Commission, the Member States and the other notified bodies may, on

request, obtain a copy of the EC type examination certificates. On reasoned

request, the Commission and the Member States may obtain a copy of the

technical file and the results of the examinations carried out by the notified

body.

8. Files and correspondence referring to the EC type-examination procedures

shall be written in the official Community language(s) of the Member State

where the notified body is established or in any other official Community

language acceptable to the notified body.

9. Validity of the EC type-examination certificate

9.1. The notified body has the ongoing responsibility of ensuring that the EC

type-examination certificate remains valid. It shall inform the manufacturer

of any major changes which would have an implication on the validity of the

certificate. The notified body shall withdraw certificates which are no longer

valid.

9.2. The manufacturer of the machinery concerned has the ongoing

responsibility of ensuring that the said machinery meets the corresponding

state of the art.

9.3. The manufacturer shall request from the notified body the review of the

validity of the EC type-examination certificate every five years.

If the notified body finds that the certificate remains valid, taking into

account the state of the art, it shall renew the certificate for a further five

years. The manufacturer and the notified body shall retain a copy of this

certificate, of the technical file and of all the relevant documents for a period

of 15 years from the date of issue of the certificate.

9.4. In the event that the validity of the EC-type examination certificate is not

renewed, the manufacturer shall cease the placing on the market of the

machinery concerned.

(1) The Machinery Regulations, 2002 are hereby revoked. Revokes L.N. 369

of 2002.

(2) Any reference to the Machinery Regulations, 2002 in

any other law shall be construed as a reference to these regulations.

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 point 2, and shall be

subject to the surveillance referred to in point 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 this Directive. 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 Article 7(2) are not applied in full, the

means that will be used to ensure that the essential health and safety

requirements of this Directive are fulfilled,

— the design inspection and design verification techniques, processes and

systematic actions that will be used when designing machinery covered by

this Directive,

— 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 point 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 point 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 point 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.

The manufacturer or his authorised representative shall inform the notified

body which approved the quality system of any planned change to it.

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 point 2.2, or whether a re-assessment is necessary.

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, etc.,

— 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, etc.

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 point 2.1,

— the decisions and reports of the notified body referred to in point 2.4, third

and fourth subparagraphs, and in points 3.3 and 3.4.

Injection or compression rubber-moulding machinery with manual

loading or unloading.

Minimum criteria to be taken into account by Member States 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 this Directive or any provision of national

law giving effect to it.

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. Member States may take all necessary measures they regard 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 Member State which has notified it.

Machinery for underground working of the following types

12.1. locomotives and brake-vans;

12.2. hydraulic-powered roof supports.

Manually loaded trucks for the collection of household refuse

incorporating a compression mechanism.

Removable mechanical transmission devices including their guards.

Guards for removable mechanical transmission devices.

Vehicle servicing lifts.

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.

Portable cartridge-operated fixing and other impact machinery.

Protective devices designed to detect the presence of persons.

Power-operated interlocking movable guards designed to be used as

safeguards in machinery referred to in points 9, 10 and 11.

Logic units to ensure safety functions.

Roll-over protective structures (ROPS).

Falling-object protective structures (FOPS).