EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 21.4.2021  
COM(2021) 202 final  
ANNEXES 1 to 11  
 
ANNEXES  
to the  
Proposal for a Regulation of the European Parliament and of the Council  
on machinery products  
{SEC(2021)  165 final}  - {SWD(2021)  82 final}  - {SWD(2021)  83 final}    
EN 1  EN ANNEX I  
HIGH -RISK MACHINERY PRODUCTS  
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) durin g 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 unloadin g.  
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 woo d 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 materi al 
with similar physical characteristics.  
8. Portable chainsaws for woodworking.  
9. Presses, including press -brakes, for the cold working of metals, with manual loading 
and/or unloading, whose movable working parts may have a travel exceeding 6 mm 
and a speed exceeding 30 mm/s.  
10. Injection or compression plastics -moulding machinery with manual loading or 
unloading.  
11. Injection or compression rubber -moulding machinery with manual loading or 
unloading.  
12. Machinery for underground working of the following types:  
12.1. locomotives and brake -vans;  
12.2. hydraulic -powered roof supports.   
EN 2  EN 13. Manually loaded trucks for the collection of household refuse incorporating a 
compression mechanism.  
14. Removable mechanical transmission devices including their guards.  
15. Guards for removable mechan ical transmission devices.  
16. Vehicle servicing lifts.  
17. Devices for the lifting of persons or of persons and goods involving a hazard of 
falling from a vertical height of more than three metres.  
18. Portable cartridge -operated fixing and other impact machinery.   
19. Protective devices designed to detect the presence of persons.  
20. Power -operated interlocking movable guards designed to be used as safeguards in 
machinery referred to in points 9, 10 and 11.  
21. Logic units to ensure safety functions.  
22. Roll-over protective s tructures (ROPS).  
23. Falling -object protective structures (FOPS).  
24. Software ensuring safety functions, including AI systems.  
25. Machinery embedding AI systems ensuring safety functions.  
   
EN 3  EN ANNEX II  
INDICATIVE LIST OF SAFETY COMPONENTS  
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 points 9, 10 and 11 of Annex I.  
4. Logic units to ensure safety functions.  
5. Valves with additional means for failure detection intended for the control of 
dangerous movements of machinery.  
6. Extraction systems for machinery emissions.  
7. Guards and protective devices designed to protect perso ns against moving parts 
involved in the process of the machinery.  
8. Monitoring devices for loading and movement control in lifting machinery.  
9. Restraint systems to keep persons in their seats.  
10. Emergency stop devices.  
11. Discharging systems to prevent the bui ld-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 
Annex III.  
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. The following components for machinery designed for lifting and/or lowering 
persons between different landings:  
(a) devices for locking landing doors;  
(b) devices to prevent the loa d-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 hydr aulic power circuits and used to prevent 
falls;  
(g) safety switches containing electronic components.  
18.         Software ensuring safety functions, including AI systems.   
EN 4  EN 19.  Filtration systems intended to be integrated into machinery cabins in order to protect 
operators or other persons against hazardous materials and substances, including 
pesticides, and filters for such filtration systems.  
  
EN 5  EN ANNEX III  
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATI NG TO THE 
DESIGN AND CONSTRUCTION OF MACHINERY PRODUCTS  
GENERAL PRINCIPLES  
1. The manufacturer of a machinery product or his or her authorised representative shall 
ensure that a risk assessment is carried out in order to determine the health and safety 
requirements, which apply to the machinery product. The machinery product shall then be 
designed and constructed to prevent and minimise all relevant risks, taking into account the 
results of the risk assessment.  
By the iterative process of risk assessment and risk reduction referred to in the first 
subparagraph, the manufacturer or his or her authorised representative shall:  
(a) determine the limits of the machinery product, which include the intended use and 
any rea sonably foreseeable misuse thereof;  
(b) determine the risks resulting from interactions between machinery in order to achieve 
the same end that are arranged and controlled so that they function as an integral 
whole, thus forming a machinery product as defined in Article 3, point (1), point (d);  
(c) identify the hazards that may be generated by the machinery product and the 
associated hazardous situations, including hazards that may be generated during the 
lifecycle of the machinery product that are foreseeable at the time of placing of the 
machinery product on the market as an intended evolution of its fully or partially 
evolving behaviour or logic as a result of the machinery product designed to operate 
with varying levels of autonomy. In this respect, where the m achinery product 
integrates an artificial intelligence system, the machinery risk assessment shall 
consider the risk assessment for that artificial intelligence system that has been 
carried out pursuant to the Regulation … of the European Parliament and of  the 
Council+  on a European approach for Artificial Intelligence+1; . 
(d) estimate the risks, taking into account the severity of the possible injury or damage to 
health and the probability of its occurrence;  
(e) evaluate the risks, with a view to determining whe ther risk reduction is required, in 
accordance with the objective of this Regulation;  
(f) 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 product in question when it is used under 
the conditions foreseen by the manufacturer or his or her authorised re presentative or in 
foreseeable abnormal situations. However, the principles of safety integration established in 
section 1.1.2 and the obligations concerning marking of machinery products and instructions 
referred to in sections 1.7.3 and 1.7.4 apply in al l cases.  
                                                 
1 + OJ: Please insert in the text the number of the Regulation contained in document … and insert the 
number, date, title and OJ reference of that Regulation in the footnote   
EN 6  EN 3. The essential health and safety requirements laid down in this Annex 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 product shall, as far  as possible, be designed and 
constructed with the purpose of approaching those objectives.  
4. This Annex is organised into six chapters. The first chapter is of general scope and 
applicable to all machinery products. The other chapters refer to certain so rts of more specific 
hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of 
meeting all the relevant essential requirements. When a machinery product is being designed, 
the requirements of the first chapter and the  requirements of one or more of the other chapters 
shall be taken into account, depending on the results of the risk assessment carried out in 
accordance with point 1 of these General Principles. Essential health and safety requirements 
for the protection of the environment are applicable only to the machinery product referred to 
in section 2.4.  
 
1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS  
1.1. GENERAL REMARKS  
1.1.1.  Definitions  
For the purpose of this Annex:  
(a) ‘hazard’ means a potential source of injury or damage to health;  
(b) ‘danger zone’ means any zone within and/or around a machinery product in which a 
person is subject to a risk to his or her health or safety;  
(c) ‘exposed person’ means any person wholly or part ially in a danger zone;  
(d) ‘operator’ means the person or persons installing, operating, adjusting, maintaining, 
cleaning, repairing or moving a machinery product;  
(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 a machinery product 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 a machinery product in accordance with the 
information provided in the instructions for use;  
(i) ‘reasonably foreseeable misuse’ means the use of a machinery product in a way not 
intended in the in structions for use, but which may result from readily predictable 
human behaviour.  
1.1.2.  Principles of safety integration  
(a) A machinery product shall be designed and constructed so that it is fit for its 
function, and can be operated, adjusted and maintained witho ut 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 protective 
measures shall be to eliminate any risk throughout the foreseeable lifetime of the 
machinery product including the phases of transport, assembly, dismantling, 
disabling and scrapping.   
EN 7  EN (b) In selecting the most appropriate methods, the manufacturer or his or her authorised 
representative shall apply the following principles, i n the order given:  
i.   eliminate or reduce risks as far as possible (inherently safe machinery product 
design and construction);  
ii. take the necessary protective measures in relation to risks that cannot be 
eliminated;  
iii.   inform users of the residual risks due t o 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 a machinery product and when drafting the 
instruction s, the manufacturer or his or her authorised representative shall envisage 
not only the intended use of the machinery product but also any reasonably 
foreseeable misuse thereof. The machinery product shall be designed and constructed 
in such a way as to pr event abnormal use if such use would engender a risk. Where 
appropriate, the instructions shall draw the user's attention to ways — which 
experience has shown might occur — in which the machinery product should not be 
used.  
(d) A machinery product shall be des igned 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) A machinery product shall be designed and constructed in such a way that it is 
possi ble for the user to test the safety functions, and the machinery product shall be 
supplied with all the special equipment and accessories, and where appropriate, with 
the description of specific functional test procedures, essential to enable it to be 
tested, adjusted, maintained and used safely.  
1.1.3.  Materials and products  
The materials used to construct a machinery product, or products used or created during its 
use, shall not endanger persons' safety or health. In particular, where fluids are used, 
machinery  products shall be designed and constructed to prevent risks due to filling, use, 
recovery or draining.  
1.1.4.  Lighting  
A machinery product shall 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.  
A machinery product shall 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 ef fects on moving parts due to the lighting.  
Internal parts requiring frequent inspection and adjustment, and maintenance areas shall be 
provided with appropriate lighting.  
1.1.5.  Design of a machinery product to facilitate its handling  
A machinery product or each component part thereof, shall:  
(a) be capable of being handled and transported safely;  
(b) be packaged or designed so that it can be stored safely and without damage.   
EN 8  EN During the transportation of the machinery product and/or its component parts, there shall be 
no possibility of sudden movements or of hazards due to instability as long as the machinery 
product and/or its component parts are handled in accordance with the instructions.  
Where the weight, size or shape of a machinery product or its various component pa rts 
prevents it or them from being moved by hand, the machinery product or each component part 
shall:  
(a) either be fitted with attachments for lifting gear, or  
(b) be designed so that it can be fitted with such attachments, or  
(c) be shaped in such a way that standar d lifting gear can easily be attached.  
Where a machinery product or one of its component parts is to be moved by hand, it shall 
either:  
(a) be easily moveable, or  
(b) be equipped for picking up and moving safely.  
Special arrangements shall be made for the handling  of tools and/or machinery product parts, 
which, even if lightweight, could be hazardous.  
1.1.6.  Ergonomics  
Under the intended conditions of use, the discomfort, fatigue and physical and psychological 
stress faced by the operator shall be reduced to the minimum p ossible, taking into account 
ergonomic principles such as:  
(a) allowing for the variability of the operator's physical dimensions, strength and 
stamina;  
(b) providing enough space for movements of the parts of the operator's body;  
(c) avoiding a machine -determined wor k rate;  
(d) avoiding monitoring that requires lengthy concentration;  
(e) adapting the human -machinery product interface to the foreseeable characteristics of 
the operators, including with respect to a machinery product with intended fully or 
partially evolving beh aviour or logic that is designed to operate with varying levels 
of autonomy;  
(f) adapting a machinery product with intended fully or partially evolving behaviour or 
logic that is designed to operate with varying levels of autonomy to respond to 
people adequate ly and appropriately (verbally through words and non -verbally 
through gestures, facial expressions or body movement) and to communicate its 
planned actions (what it is going to do and why) to operators in a comprehensible 
manner.  
1.1.7.  Operating positions  
The operating position shall 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 product is intended to be used in a hazardous environment presenting risks to 
the health and safety of the operator or if the machinery product itself gives rise to a 
hazardous environment, adequate means shall be provided to ensure that the operator has 
good working conditions and is protected against any foreseeable hazards.   
EN 9  EN Where appropriate, the operating p osition shall be fitted with an adequate cabin designed, 
constructed and/or equipped to fulfil the above requirements. The exit shall allow rapid 
evacuation. Moreover, when applicable, an emergency exit shall be provided in a direction 
which is different f rom the usual exit.  
1.1.8.  Seating  
Where appropriate and where the working conditions so permit, work stations constituting an 
integral part of the machinery product shall be designed for the installation of seats.  
If the operator is intended to sit during operat ion and the operating position is an integral part 
of the machinery product, the seat shall be provided with the machinery product.  
The operator's seat shall enable him to maintain a stable position. Furthermore, the seat and its 
distance from the control devices shall be capable of being adapted to the operator.  
If the machinery product is subject to vibrations, the seat shall be designed and constructed in 
such a way as to reduce the vibrations transmitted to the operator to the lowest level that is 
reaso nably possible. The seat mountings shall 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 shall be provided.  
1.1.9.  Protection against corruption  
The machinery product shall be designed and constructed so that the connection to it of 
another device, via any feature of the connected device itself or via any remote device that 
communicates with the machinery product does not lead to a hazardous situation .  
A hardware component for connection that is critical for the compliance of the machinery 
product with the relevant health and safety requirements shall be designed so that it is 
adequately protected against accidental or intentional corruption. The mach inery product shall 
collect evidence of a legitimate or illegitimate intervention in the hardware component.  
Software and data that are critical for the compliance of the machinery product with the 
relevant health and safety requirements shall be identifi ed as such and shall be adequately 
protected against accidental or intentional corruption.  
The machinery product shall identify the software installed on it that is necessary for it to 
operate safely, and shall be able to provide that information at all t imes in an easily accessible 
form.  
The machinery product shall collect evidence of a legitimate or illegitimate intervention in the 
software or a modification of the software installed on the machinery product or its 
configuration.  
1.2. CONTROL SYSTEMS  
1.2.1.  Safety  and reliability of control systems  
Control systems shall be designed and constructed in such a way as to prevent hazardous 
situations from arising.  
Control systems shall be designed and constructed in such a way that:  
(a) they can withstand, where appropriat e to the circumstances and the risks,  the 
intended operating stresses and intended and unintended external influences, 
including malicious attempts from third parties to create a hazardous situation;  
(b) a fault in the hardware or the logic of the control syst em shall not lead to hazardous 
situations;   
EN 10  EN (c) errors in the control system logic shall not lead to hazardous situations;  
(d) the safety functions cannot be changed beyond the limits defined by the 
manufacturer in the machinery product risk assessment. The establi shment of the 
limits of the safety functions shall be part of the risk assessment performed by the 
manufacturer, including any modifications to the settings or rules generated by the 
machinery product or by operators, covering also the learning phase, whic h cannot 
go beyond the limits addressed in the risk assessment;  
(e) reasonably foreseeable human errors during operation shall not lead to hazardous 
situations;  
(f) the tracing log of the data generated in relation to an intervention and of the versions 
of safety software uploaded after the machinery product has been placed on the 
market or put into service, is enabled for five years after such upload, exclusively to 
demonstrate the conformity of the machinery product with this Annex  further to a 
reasoned request from a competent national authority;  
(g) recording of data on the safety related decision -making process after the machinery 
product has been placed on the market or put into service, is enabled and that such 
data is retained for one year after its collection,  exclusively to demonstrate the 
conformity of the machinery product with this Annex  further to a reasoned request 
from a competent national authority.  
Control systems of machinery products with fully or partially evolving behaviour or logic that 
is designed to operate with varying levels of autonomy shall be designed and constructed in 
such a way that:  
(a) they shall not cause the machinery product to perfo rm actions beyond its defined task 
and movement space;  
(b) it shall be  possible at all times to correct the machinery product  in order to maintain 
its inherent safety.  
Particular attention shall be given to the following points:  
(a) the machinery product shall not start unexpectedly;  
(b) the parameters of the machinery product shall not change in an uncontrolled way, 
where such change may lead to hazardous situations;  
(c) modifications to the settings or rules, generated by the machinery product or by 
operators coverin g also the learning phase, shall be prevented, where such 
modifications may lead to hazardous situations;  
(d) the machinery product shall not be prevented from stopping if the stop command has 
already been given;  
(e) no moving part of the machinery product or piec e held by the machinery product 
shall fall or be ejected;  
(f) automatic or manual stopping of the moving parts, whatever they may be, shall be 
unimpeded;  
(g) the protective devices shall remain fully effective or give a stop command;  
(h) the safety -related parts of th e control system shall apply in a coherent way to the 
whole of an assembly of a machinery product.   
EN 11  EN For wireless control, a failure of the communication or connection or a faulty connection shall 
not lead to a hazardous situation.  
For autonomous mobile mac hinery products, the control system shall be designed to perform 
the safety functions by itself as set out in this section, even when actions are ordered by using 
a remote supervisory function.  
1.2.2.  Control devices  
Control devices shall be:  
(a) clearly visible and  identifiable, using pictograms where appropriate;  
(b) positioned in such a way as to be safely operated without hesitation or loss of time 
and without ambiguity;  
(c) designed in such a way that the movement of the control device is consistent with its 
effect;  
(d) located outside the danger zones, except where necessary for certain control devices 
such as an emergency stop or a teach pendant;  
(e) positioned in such a way that their operation cannot cause additional risk;  
(f) designed or protected in such a way that the desired  effect, where a hazard is 
involved, can only be achieved by a deliberate action;  
(g) made in such a way as to withstand foreseeable forces, paying particular attention to 
emergency stop devices liable to be subjected to considerable forces.  
Where a control de vice is designed and constructed to perform several different actions, 
namely, where there is no one -to-one correspondence, the action to be performed shall be 
clearly displayed and subject to confirmation, where necessary.  
Control devices shall be so arra nged that their layout, travel and resistance to operation are 
compatible with the action to be performed, taking account of ergonomic principles.  
Machinery products shall be fitted with indicators as required for safe operation. The operator 
shall be able  to read them from the control position.  
From each control position, the operator shall be able to ensure that no one is in the danger 
zones, or the control system shall 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 product starts, an acoustic 
and/or visual warning signal shall be given. The exposed persons shall have time to leave the 
danger zone or prevent the machinery startin g up.  
If necessary, means shall be provided to ensure that the machinery product 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 shall 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 the machinery product has two or more operating positions, each position shall be 
provided with all the required contr ol devices without the operators hindering or putting each 
other into a hazardous situation.  
1.2.3.  Starting   
EN 12  EN It shall be possible to start the machinery product only by voluntary actuation of a control 
device provided for the purpose.  
The same requirement applies : 
(a) when restarting the machinery product after a stoppage, whatever the cause;  
(b) when effecting a significant change in the operating conditions.  
However, the restarting of the machinery product 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 the machinery product functioning in automatic mode, the starting of the machinery 
product, 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 the machinery product has several starting control devices and the operators can 
therefore put each other in da nger, additional devices shall be fitted to rule out such risks. If 
safety requires that starting and/or stopping shall be performed in a specific sequence, there 
shall be devices that ensure that these operations are performed in the correct order.  
1.2.4.  Stoppi ng 
1.2.4.1.  Normal stop  
The machinery product shall be fitted with a control device whereby the machinery can be 
brought safely to a complete stop.  
Each workstation shall be fitted with a control device to stop some or all of the functions of 
the machinery product,  depending on the existing hazards, so that the machinery product is 
rendered safe.  
The machinery product's stop control shall have priority over the start controls.  
Once the machinery product or its hazardous functions have stopped, the energy supply to t he 
actuators concerned shall be cut off.  
1.2.4.2.  Operational stop  
Where, for operational reasons, a stop control that does not cut off the energy supply to the 
actuators is required, the stop condition shall be monitored and maintained.  
1.2.4.3.  Emergency stop  
The machinery product shall be fitted with one or more emergency stop devices to enable 
actual or impending danger to be averted.  
The following exceptions apply:  
(a) the machinery product 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;  
(b) portable hand -held and/or hand -guided machinery product.  
The device shall:  
(a) have clearly identifiable, clearly visible and quickly accessible control devices;  
(b) stop the hazardous process as quickly as possible, without creating additional risks;  
(c) where necessary, trigger or permit the triggering of certain safeguard movements.   
EN 13  EN Once active operation of the emergency stop device has ceased following a stop command, 
that command shall be sustained by engagement of the emergency stop device until that 
engagement is specifically overridden; it shall not be possible to engage the device without 
triggering a stop command; it shall be p ossible to disengage the device only by an appropriate 
operation, and disengaging the device shall not restart the machinery product but only permit 
restarting.  
The emergency stop function shall be available and operational at all times, regardless of the 
operating mode.  
Emergency stop devices shall be a backup to other safeguarding measures and not a substitute 
for them.  
1.2.4.4.  Assembly of machinery products  
In the case of a machinery product or parts of a machinery product designed to work together, 
the machine ry shall be designed and constructed in such a way that the stop controls, 
including the emergency stop devices, can stop not only the machinery product itself but also 
all related equipment, if its continued operation may be dangerous.  
1.2.5.  Selection of contro l or operating modes  
The control or operating mode selected shall override all other control or operating modes, 
with the exception of the emergency stop.  
If the machinery product has been designed and constructed to allow its use in several control 
or ope rating modes requiring different protective measures and/or work procedures, it shall be 
fitted with a mode selector, which can be locked in each position. Each position of the 
selector shall be clearly identifiable and shall correspond to a single operati ng or control 
mode.  
The selector may be replaced by another selection method, which restricts the use of certain 
functions of the machinery product to certain categories of operator.  
If, for certain operations, the machinery shall be able to operate with a  guard displaced or 
removed and/or a protective device disabled, the control or operating mode selector shall 
simultaneously:  
(a) disable all other control or operating modes;  
(b) permit operation of hazardous functions only by control devices requiring sustained 
action;  
(c) permit the operation of hazardous functions only in reduced risk conditions while 
preventing hazards from linked sequences;  
(d) prevent any operation of hazardous functions by voluntary or involuntary action on 
the machine product's sensors.  
If these f our conditions cannot be fulfilled simultaneously, the control or operating mode 
selector shall activate other protective measures designed and constructed to ensure a safe 
intervention zone.  
In addition, the operator shall be able to control the operation  of the parts he or she is working 
on from the adjustment point.   
EN 14  EN 1.2.6.  Failure of the power supply or communication network connection  
The interruption, the re -establishment after an interruption or the fluctuation in whatever 
manner of the power supply or comm unication network connection to the machinery product 
shall not lead to hazardous situations.  
Particular attention shall be given to the following:  
(a) the machinery product shall not start unexpectedly;  
(b) the parameters of the machinery shall not change in an u ncontrolled way when such 
change can lead to hazardous situations;  
(c) the machinery product shall not be prevented from stopping if the stop command has 
already been given;  
(d) no moving part of the machinery product or piece held by the machinery product 
shall f all or be ejected;  
(e) automatic or manual stopping of the moving parts, whatever they may be, shall be 
unimpeded;  
(f) the protective devices shall remain fully effective or give a stop command.  
 
1.3. PROTECTION AGAINST MECHANICAL RISKS  
1.3.1.  Risk of loss of stability  
The machinery product and its components and fittings shall be stable enough to avoid 
overturning, falling or uncontrolled movements during transportation, assembly, dismantling 
and any other action involving the machinery product.  
If the shape of the machiner y product itself or its intended installation does not offer sufficient 
stability, appropriate means of anchorage shall be incorporated and indicated in the 
instructions.  
1.3.2.  Risk of break -up during operation  
The various parts of machinery product and their li nkages shall be able to withstand the 
stresses to which they are subject when used.  
The durability of the materials used shall be adequate for the nature of the working 
environment foreseen by the manufacturer or his or her authorised representative, in p articular 
as regards the phenomena of fatigue, ageing, corrosion and abrasion.  
The instructions shall indicate the type and frequency of inspections and maintenance 
required for safety reasons. They shall, 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 shall be mounted, positioned and/or guarded in such a way that any fragments will 
be contained, preventing hazardous s ituations.  
Both rigid and flexible pipes carrying fluids, particularly those under high pressure, shall be 
able to withstand the foreseen internal and external stresses and shall be firmly attached 
and/or protected to ensure that no risk is posed by a rup ture.  
Where the material to be processed is fed to the tool automatically, the following conditions 
shall be fulfilled to avoid risks to persons:   
EN 15  EN (a) when the work piece comes into contact with the tool, the latter shall have attained 
its normal working cond ition;  
(b) when the tool starts and/or stops (intentionally or accidentally), the feed movement 
and the tool movement shall be coordinated.  
1.3.3.  Risks due to falling or ejected objects  
Precautions shall be taken to prevent risks from falling or ejected objects.  
1.3.4.  Risks due to surfaces, edges or angles  
Insofar as their purpose allows, accessible parts of the machinery shall have no sharp edges, 
no sharp angles and no rough surfaces likely to cause injury.  
1.3.5.  Risks related to a combined machinery product   
Where the mac hinery product is intended to carry out several different operations with manual 
removal of the piece between each operation (combined machinery product), it shall 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 shall be possible to start and stop separately any elements that are not 
protected.  
1.3.6.  Risks related to variations in operating conditions  
Where the machinery product perfo rms operations under different conditions of use, it shall 
be designed and constructed in such a way that selection and adjustment of these conditions 
can be carried out safely and reliably.  
1.3.7.  Risks related to moving parts and psychological stress  
The movin g parts of the machinery product shall be designed and constructed in such a way 
as to prevent risks of contact which could lead to accidents or shall, where risks persist, be 
fitted with guards or protective devices.  
All necessary steps shall be taken to  prevent accidental blockage of moving parts. In cases 
where, despite the precautions taken, a blockage is likely to occur, the necessary specific 
protective devices and tools shall, when appropriate, be provided to enable the equipment to 
be safely unbloc ked.  
The instructions and, where possible, a sign on the machinery product shall identify these 
specific protective devices and how they are to be used.  
The prevention of risks of contact leading to hazard situations and the psychological stress 
that may be caused by the interaction with the machine shall be adapted to:  
(a) human -machine coexistence  in a shared space without direct collaboration;  
(b) human -machine interaction.  
The machinery product with fully or partially evolving behaviour or logic  that is desi gned to 
operate with varying levels of autonomy shall be adapted to respond to people adequately and 
appropriately (verbally through words or nonverbally through gestures, facial expressions or 
body movement) and to communicate its planned actions (what it  is going to do and why) to 
operators in a comprehensible manner.  
1.3.8.  Choice of protection against risks arising from moving parts   
EN 16  EN Guards or protective devices designed to protect against risks arising from moving parts shall 
be selected on the basis of the ty pe of risk. The following guidelines shall be used to help to 
make the choice.  
1.3.8.1.  Moving transmission parts  
Guards designed to protect persons against the hazards generated by moving transmission 
parts shall be:  
(a) either fixed guards as referred to in section 1 .4.2.1, or  
(b) interlocking movable guards as referred to in section 1.4.2.2.  
Interlocking movable guards shall be used where frequent access is envisaged.  
1.3.8.2.  Moving parts involved in the process  
Guards or protective devices designed to protect persons against th e hazards generated by 
moving parts involved in the process shall be:  
(a) either fixed guards as referred to in section 1.4.2.1, or  
(b) interlocking movable guards as referred to in section 1.4.2.2, or  
(c) protective devices as referred to in section 1.4.3, or  
(d) a combi nation 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 shall be fitted with:  
(a) fixed guards or interlock ing movable guards preventing access to those sections of 
the parts that are not used in the work, and  
(b) adjustable guards as referred to in section 1.4.2.3 restricting access to those sections 
of the moving parts where access is necessary.  
1.3.9.  Risks of uncontro lled movements  
When a part of the machinery product has been stopped, any drift away from the stopping 
position, for whatever reason other than action on the control devices, shall be prevented or 
shall be such that it does not present a risk.  
1.4. REQUIRED CHA RACTERISTICS OF GUARDS AND PROTECTIVE DEVICES  
1.4.1.  General requirements  
Guards and protective devices shall:  
(a) be of robust construction;  
(b) be securely held in place;  
(c) not give rise to any additional hazard;  
(d) not be easy to by -pass or render non -operational;  
(e) be located at an adequate distance from the danger zone;  
(f) cause minimum obstruction to the view of the production process, and;  
(g) 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  
EN 17  EN 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 shall, where possible, protect against the ejection or falling of materials  or 
objects and against emissions generated by the machinery product.  
1.4.2.  Special requirements for guards  
1.4.2.1.  Fixed guards  
Fixed guards shall be fixed by systems that can be opened or removed only with tools.  
Their fixing systems shall remain attached to the guard s or to the machinery product when the 
guards are removed.  
Where possible, guards shall be incapable of remaining in place without their fixings.  
1.4.2.2.  Interlocking movable guards  
Interlocking movable guards shall:  
(a) as far as possible remain attached to the machi nery product when open;  
(b) be designed and constructed in such a way that they can be adjusted only by means 
of an intentional action.  
Interlocking movable guards shall be associated with an interlocking device that:  
(a) prevents the start of hazardous machinery product functions until they are closed and  
(b) 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 product functions has ceased, movable guards s hall be associated with a 
guard locking device in addition to an interlocking device that:  
(a) prevents the start of hazardous machinery product functions until the guard is closed 
and locked, and  
(b) keeps the guard closed and locked until the risk of injury from  the hazardous 
machinery product functions has ceased.  
Interlocking movable guards shall be designed in such a way that the absence or failure of one 
of their components prevents starting or stops the hazardous machinery product functions.  
1.4.2.3.  Adjustable guard s restricting access  
Adjustable guards restricting access to those areas of the moving parts strictly necessary for 
the work shall be:  
(a) adjustable manually or automatically, depending on the type of work involved; and  
(b) readily adjustable without the use of tools.  
1.4.3.  Special requirements for protective devices  
Protective devices shall be designed and incorporated into the control system in such a way 
that: 
(a) moving parts cannot start up while they are within the operator's reach;  
(b) persons cannot reach moving parts while the parts are moving, and  
(c) the absence or failure of one of their components prevents starting or stops the 
moving parts.   
EN 18  EN Protective devices shall be adjustable only by means of an intentional action.  
1.5. RISKS DUE TO OTHER CAUSES  
1.5.1.  Electricity supply  
Wher e a machinery product has an electricity supply, it shall 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 2014/35/EU shall apply to a machinery  product. 
However, the obligations concerning conformity assessment and the placing on the market 
and/or putting into service of a machinery product with regard to electrical risks are governed 
solely by this Regulation.  
1.5.2.  Static electricity  
A machinery prod uct shall be designed and constructed to prevent or limit the build -up of 
potentially dangerous electrostatic charges and/or be fitted with a discharging system.  
1.5.3.  Energy supply other than electricity  
Where a machinery product is powered by source of energy other than electricity, it shall be 
so designed, constructed and equipped as to avoid all potential risks associated with such 
sources of energy.  
1.5.4.  Errors of fitting  
Errors likely to be made when fitting or refitting certain parts, which could be a source of  risk, 
shall 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 shall 
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 shall give further information on these risks.  
Where a faulty connection can be the source of risk, incorrect connections shall be made 
impossible by design or, fail ing this, by information given on the elements to be connected 
and, where appropriate, on the means of connection.  
1.5.5.  Extreme temperatures  
Steps shall be taken to eliminate any risk of injury arising from contact with or proximity to 
machinery product parts o r materials at high or very low temperatures.  
The necessary steps shall also be taken to avoid or protect against the risk of hot or very cold 
material being ejected.  
1.5.6.  Fire 
A machinery product shall be designed and constructed in such a way as to avoid any risk of 
fire or overheating posed by the machinery product itself or by gases, liquids, dust, vapours or 
other substances produced or used by the machinery product.  
1.5.7.  Explosion  
A machinery product shall be designed and constructed in such a way as to avoid any risk of 
explosion posed by the machinery product itself or by gases, liquids, dust, vapours or other 
substances produced or used by the machinery product.  
A machinery product shall 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 Union 
harmonisation legislation.   
EN 19  EN 1.5.8.  Noise  
A machinery product shall 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 product.  
1.5.9.  Vibrations  
A machinery product shall be designed and constructed in such a way that risks resulting from 
vibrations produced by the machinery product are reduced to the lowest level, taking account 
of technical progress and the availability of means of reducing vibrat ion, in particular at 
source.  
The level of vibration emission may be assessed with reference to comparative emission data 
for similar machinery products.  
1.5.10.  Radiation  
Undesirable radiation emissions from the machinery product shall be eliminated or be reduced  
to levels that do not have adverse effects on persons.  
Any functional ionising radiation emissions shall be limited to the lowest level, which is 
sufficient for the proper functioning of the machinery product during setting, operation and 
cleaning. Where a risk exists, the necessary protective measures shall be taken.  
Any functional non -ionising radiation emissions during setting, operation and cleaning shall 
be limited to levels that do not have adverse effects on persons.  
1.5.11.  External radiation  
A machinery p roduct shall be designed and constructed in such a way that external radiation 
does not interfere with its operation.  
1.5.12.  Laser radiation  
Where laser equipment is used, the following shall be taken into account:  
(a) laser equipment on  a machinery product shall be  designed and constructed in such a 
way as to prevent any accidental radiation;  
(b) laser equipment on a machinery product shall be protected in such a way that 
effective radiation, radiation produced by reflection or diffusion and secondary 
radiation do not d amage health;  
(c) optical equipment for the observation or adjustment of laser equipment on a 
machinery product shall be such that no health risk is created by laser radiation.  
1.5.13.  Emissions of hazardous materials and substances  
A machinery product shall be design ed 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 risk cannot be eliminat ed, the machinery product shall be so equipped that hazardous 
materials and substances can be contained, captured, evacuated, precipitated by water 
spraying, filtered or treated by another equally effective method.   
EN 20  EN Where the process is not totally enclosed  during normal operation of the machinery product, 
the devices for containment or capture, filtration or separation and evacuation shall be situated 
in such a way as to have the maximum effect.  
1.5.14.  Risk of being trapped in a machine  
A machinery product shall b e designed, constructed or fitted with a means of preventing a 
person from being enclosed within it or, if that is impossible, with a means of summoning 
help.  
1.5.15.  Risk of slipping, tripping or falling  
Parts of the machinery product where persons are liable to move about or stand shall 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 shall be fitted with handholds that are fixed relative to the user 
and that enable  them to maintain their stability.  
1.5.16.  Lightning  
A machinery product in need of protection against the effects of lightning while being used 
shall be fitted with a system for conducting the resultant electrical charge to earth.  
1.6. MAINTENANCE  
1.6.1.  Machinery product  maintenance  
Adjustment and maintenance points shall be located outside danger zones. It shall be possible 
to carry out adjustment, maintenance, repair, cleaning and servicing operations while the 
machinery product is at a standstill.  
If one or more of the above conditions cannot be satisfied for technical reasons, measures 
shall 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 product, a 
connectin g device for mounting diagnostic fault -finding equipment shall be provided.  
Automated machinery components, which have to be changed frequently, shall be capable of 
being removed and replaced easily and safely. Access to the components shall enable these 
tasks to be carried out with the necessary technical means in accordance with a specified 
operating method.  
1.6.2.  Access to operating positions and servicing points  
Machinery shall be designed and constructed in such a way as to allow access in safety to all 
areas where intervention is necessary during operation, adjustment, maintenance and cleaning 
of the machinery.  
In the case of machinery into which persons shall enter for operation, adjustment, 
maintenance or cleaning,  the machinery accesses shall be dimensio ned and adapted for the 
use of rescue equipment in such a way that a timely rescue of the persons is guaranteed.  
1.6.3.  Isolation of energy sources  
A machinery product shall be fitted with means to isolate it from all energy sources. Such 
isolators shall be clea rly identified. They shall be capable of being locked if reconnection 
could endanger persons. Isolators shall also be capable of being locked where an operator is 
unable, from any of the points to which he or she has access, to check that the energy is sti ll 
cut off.   
EN 21  EN In the case of machinery products capable of being plugged into an electricity supply, removal 
of the plug is sufficient, if the operator can check from any of the points to which he or she 
has access that the plug remains removed.  
After the en ergy is cut off, it shall be possible to dissipate normally any energy remaining or 
stored in the circuits of the machinery product without risk to persons.  
As an exception to the requirement laid down in the previous paragraphs, certain circuits may 
remai n connected to their energy sources in order, for example, to hold parts, to protect 
information, to light interiors, etc. In this case, special steps shall be taken to ensure operator 
safety.  
1.6.4.  Operator intervention  
The machinery product shall be so designe d, constructed and equipped that the need for 
operator intervention is limited. If operator intervention cannot be avoided, it shall be possible 
to carry it out easily and safely.  
1.6.5.  Cleaning of internal parts  
The machinery shall 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 shall also be possible from the outside. If it is impossible to 
avoid entering the machiner y, it shall be designed and constructed in such a way as to allow 
cleaning to take place safely.  
1.7. INFORMATION  
1.7.1.  Information and warnings on the machinery product  
Information and warnings on the machinery product shall preferably be provided in the form 
of rea dily understandable symbols or pictograms.  
1.7.1.1.  Information and information devices  
The information needed to control a machinery product shall be provided in a form that is 
unambiguous and easily understood. It shall not be excessive to the extent of overload ing the 
operator.  
Visual display units or any other interactive means of communication between the operator 
and the machinery product shall be easily understood and easy to use.  
1.7.1.2.  Warning devices  
Where the health and safety of persons may be endangered by a fault in the operation of an 
unsupervised machinery product, the machinery product shall be equipped in such a way as to 
give an appropriate acoustic or light signal as a warning.  
Where a machinery product is equipped with warning devices, these shall be u nambiguous 
and easily perceived. The operator shall have facilities to check the operation of such warning 
devices at all times.  
The requirements of the specific Union legislation concerning colours and safety signals shall 
be complied with.  
1.7.2.  Warning of res idual risks  
Where risks remain despite the inherent safe design measures, safeguarding and 
complementary protective measures adopted, the necessary warnings, including warning 
devices, shall be provided.   
EN 22  EN 1.7.3.  Marking of a machinery product  
All machinery product s shall be marked visibly, legibly and indelibly with the following 
minimum particulars:  
(a) the business name and full address of the manufacturer and, where applicable, his or 
her authorised representative;  
(b) designation of the machinery product;  
(c) the CE marki ng; 
(d) designation of series or type;  
(e) serial number, if any;  
(f) 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 product when affixing the CE marking.  
Furthermor e, a machinery product designed and constructed for use in a potentially explosive 
atmosphere shall be marked accordingly.  
A machinery product shall 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 product part shall be handled during use with lifting equipment, its mass 
shall be indicated legibly, indelibly and unambiguously.  
1.7.4.  Instructions  
The instructions accompanying the machinery product s hall be either ‘Original instructions’ 
or a ‘Translation of the original instructions’, in which case the translation shall be 
accompanied by the original instructions.  
By way of exception, the maintenance instructions intended for use by specialised perso nnel 
mandated by the manufacturer or his or her authorised representative may be supplied in only 
one official language of the Union which the specialised personnel understand.  
The instructions may be provided in a digital format. However, upon purchaser’s  request at 
the time of the purchase of the machinery product, the instructions shall be provided in paper 
format free of charge.  
When the instructions are provided in digital format, the manufacturer shall:  
(a) mark on the machinery product and in an accompan ying paper how to access the 
digital instructions;  
(b) clearly describe which version of the instructions corresponds to the machinery 
product model;  
(c) be presented in a format that makes it is possible for the end user to download the 
instructions and save them  on an electronic device so that he or she can access them 
at all times, in particular during a breakdown of the machine. This requirement also 
applies to a machinery product where the instruction manual is embedded in the 
software of the machinery product . General principles for the drafting of instructions  
1.7.4.1.  General principles for the drafting of instructions   
EN 23  EN (a) The instructions shall be drafted in one or more official languages of the Union. The 
words ‘Original instructions’ shall appear on the language version(s) verified by the 
manufacturer or his or her authorised representative;  
(b) Where no ‘Original instructions’ exist in the official language or languages of the 
Member State where the machinery product is to be used, a translation into that/those 
langu age(s) shall be provided by the manufacturer or his or her authorised 
representative or by the person bringing the machinery product into the language 
area in question. The translations shall bear the words ‘Translation of the original 
instructions’;  
(c) The c ontents of the instructions shall cover not only the intended use of the 
machinery product but also take into account any reasonably foreseeable misuse 
thereof;  
(d) In the case of a machinery product intended for use by non -professional operators, 
the wording and layout of the instructions for use shall take into account the level of 
general education and acumen that can reasonably be expected from such operators.  
1.7.4.2.  Contents of the instructions  
1. Each instruction manual shall contain, where applicable, at least  the following information:  
(a) the business name and full address of the manufacturer and, where applicable, of his 
or her authorised representative;  
(b) the designation of the machinery product as marked on the machinery product itself, 
except for the serial num ber (see section 1.7.3);  
(c) the EU declaration of conformity, or a document setting out the contents of the EU 
declaration of conformity, showing the particulars of the machinery product, not 
necessarily including the serial number and the signature, or the i nternet address 
where the EU declaration of conformity can be accessed.  
(d) a general description of the machinery product;  
(e) the drawings, diagrams, descriptions and explanations necessary for the use, 
maintenance and repair of the machinery product and for che cking 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 product;  
(h) warnings concerning ways in which the machinery product shall 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 product is to be mounted;  
(j) instructions relating to in stallation and assembly for reducing noise or vibration;  
(k) instructions for the putting into service and use of the machinery product 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;   
EN 24  EN (n) the essential charac teristics of tools, which may be fitted to the machinery product;  
(o) the conditions in which the machinery product 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 product and of its various parts 
where these are regularly to be transported separately;  
(q) the operating method to be follo wed 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 b y the user and the preventive maintenance measures that should be observed 
taking account of the design and the use of the machinery product;   
(s) instructions designed to enable adjustment and maintenance to be carried out safely, 
including the protective mea sures 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:  
i. 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 
shall be indicated;  
ii. the peak C -weighted instantaneous sound pressure value at workstations, 
where this exceeds 63 Pa (130 dB in relation to 20 µPa);  
iii. the A -weighted sound power level emitted by the machinery product, 
where the A -weighted emission sound pressure level at workstations 
exceeds 80 dB(A).  
These values shall be either those actually measured for the machinery product in 
question or those establishe d on the basis of measurements taken for a technically 
comparable machinery product, which is representative of the machinery product to 
be produced.  
In the case of a very large machinery product, instead of the A -weighted sound 
power level, the A -weighted  emission sound pressure levels at specified positions 
around the machinery product may be indicated.  
Where the harmonised standards or technical specifications adopted by the 
Commission in accordance with Article 17(3) cannot be applied, sound levels shal l 
be measured using the most appropriate method for the machinery product. 
Whenever sound emission values are indicated, the uncertainties surrounding these 
values shall be specified. The operating conditions of the machinery product during 
measurement and  the measuring methods used shall be described.  
Where the workstation(s) are undefined or cannot be defined, A -weighted sound 
pressure levels shall be measured at a distance of 1 metre from the surface of the 
machinery product and at a height of 1, 6 metre s from the floor or access platform. 
The position and value of the maximum sound pressure shall be indicated.   
EN 25  EN With respect to noise reduction machinery products, the instructions shall specify, 
where appropriate, how to correctly assemble and install that  equipment (see also 
section 1.7.4.2(1), point (j)).  
Where specific Union legislation  lays down other requirements for the measurement 
of sound pressure levels or sound power levels, those legal acts shall be applied and 
the corresponding provisions of th is section shall not apply;  
(v) where a machinery product 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 t he operator and exposed 
persons;  
(w) where the machinery product design allows  emissions of hazardous substances from 
the machinery product, the characteristics of the capturing, filtration or discharge 
device if such device is not provided with the machinery product, and any of the 
following:  
i. the flow rate for the emission of hazardous materials and substances from 
the machinery product,  
ii. the concentration of hazardous materials or substances around the 
machinery product coming from the machinery product or fro m materials 
or substances used with the machinery product,  
iii. the effectiveness of the capturing or filtration device and the conditions to 
be observed to maintain its effectiveness over time.  
The values referred to in the first subparagraph shall either be a ctually measured for 
the machinery product in question or established based on measurements in respect 
of a technically comparable machinery product, which is representative of the state 
of the art.  
1.7.4.3.  Sales literature  
Sales literature describing the machiner y product shall not contradict the instructions as 
regards health and safety aspects. Sales literature describing the performance characteristics 
of machinery products shall contain the same information on emissions as is contained in the 
instructions.  
2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 
FOR CERTAIN CATEGORIES OF MACHINERY PRODUCTS  
Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand -held and/or 
hand -guided machinery, portable fixing and other impact machinery, m achinery for working 
wood and material with similar physical characteristics and machinery for pesticide 
application shall meet all the essential health and safety requirements described in this chapter 
(see General Principles, point 4).  
2.1. FOODSTUFFS MACHINE RY AND MACHINERY FOR COSMETICS OR 
PHARMACEUTICAL PRODUCTS  
2.1.1.  General  
Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products 
shall be designed and constructed in such a way as to avoid any risk of infection, sickness or 
contagi on. 
The following requirements shall be observed:   
EN 26  EN (a) materials in contact with, or intended to come into contact with, foodstuffs or 
cosmetics or pharmaceutical products shall satisfy the conditions set down in the 
relevant Union legal acts. The machinery sha ll be designed and constructed in such a 
way that these materials can be cleaned before each use. Where this is not possible, 
disposable parts shall be used;  
(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other 
than surfac es of disposable parts, shall:  
i. be smooth and have neither ridges nor crevices, which could harbour 
organic materials. The same applies to their joinings;  
ii. be designed and constructed in such a way as to reduce the projections, 
edges and recesses of assemblies to a minimum;  
iii. be easily cleaned and disinfected, where necessary after removing easily 
dismantled parts; the inside surfaces shall have curves with a radius 
sufficient to allow thorough cleaning;  
(c) it shall be possible for liquids, gases and aeros ols 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 shall 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 shall 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 
shall be designed and constructed in such a way that continuing compliance with this 
require ment can be checked.  
2.1.2.  Instructions  
The instructions for foodstuffs machinery and machinery for use with cosmetics or 
pharmaceutical products shall indicate recommended products and methods for cleaning, 
disinfecting and rinsing, not only for easily accessible areas but also for areas to which access 
is impossible or inadvisable.  
2.2. PORTABLE HAND -HELD AND/OR HAND -GUIDED MACHINERY  
2.2.1.  General  
Portable hand -held and/or hand -guided machinery shall:  
(a) depending on the type of machinery, have a supporting surface o f 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;  
(b) except where technically impossible, or where there i s 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;   
EN 27  EN (c) present no ri sks of accidental starting and/or continued operation after the operator 
has released the handles. Equivalent steps shall be taken if this requirement is not 
technically feasible;  
(d) permit, where necessary, visual observation of the danger zone and of the ac tion of 
the tool with the material being processed.  
(e) have a device or a connected exhaust system, with an extraction connection outlet or 
equivalent system to capture or reduce emissions of hazardous substances. This 
requirement does not apply where its app lication would result in the creation of a 
new risk, where the main function of the machinery is the spraying of hazardous 
substances and to emissions of internal combustion engines.  The handles of portable 
machinery shall be designed and constructed in s uch a way as to make starting and 
stopping straightforward.  
2.2.1.1.  Instructions  
The instructions shall give the following information concerning vibrations, expressed as 
acceleration (m/s2), and transmitted by portable handheld and hand -guided machinery:  
(a) the vib ration total value from continuous vibrations to which the hand -arm system is 
subjected;  
(b) the mean value of the peak amplitude of the acceleration from repeated shock 
vibrations, to which the hand -arm system is subjected;  
(c) the uncertainty of both measurement s. 
The values referred to in the first subparagraph shall either be those actually measured for the 
machinery in question or those established on the basis of measurements in respect of a 
technically comparable machinery product, which is representative of  the state of the art.  
If harmonised standards or technical specifications adopted by the Commission in accordance 
with Article 17(3) cannot be applied, the vibration data shall 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, shall be specified.  
2.2.2.  Portable fixing and other impact machinery  
2.2.2.1.  General  
Portable fixing and other impact machinery shall be designed and constructed in such a way 
that: 
(a) energy is transmitted to the impacted element by the intermediary component that 
does not leave the device;  
(b) an enabling device prevents impact unless the machinery is positioned correctly with 
adequate pressure on the base material;  
(c) involuntary triggering is prevented; where necessary, an appropriate sequence of 
actions on the enabling device and the control device shall be required to trigger an 
impact;  
(d) accidental triggering is prevented during handling or in ca se of shock;  
(e) loading and unloading operations can be carried out easily and safely.   
EN 28  EN Where necessary, it shall be possible to fit the device with splinter guard(s) and the 
appropriate guard(s) shall be provided by the manufacturer of the machinery.  
2.2.2.2.  Instruct ions 
The instructions shall give the necessary information regarding:  
(a) the accessories and interchangeable equipment that can be used with the machinery;  
(b) the suitable fixing or other impacted elements to be used with the machinery;  
(c) where appropriate, the su itable cartridges to be used.  
 
2.3. MACHINERY FOR WORKING WOOD AND MATERIAL WITH SIMILAR 
PHYSICAL CHARACTERISTICS  
Machinery for working wood and materials with similar physical characteristics shall comply 
with the following requirements:  
(a) the machinery shall 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 shall be sufficiently stable during the 
work and shall not impede the movement of th e piece;  
(b) where the machinery is likely to be used in conditions involving the risk of 
ejection of work pieces or parts of them, it shall be designed, constructed, or 
equipped in such a way as to prevent such ejection, or, if this is not possible, so 
that t he ejection does not engender risks for the operator and/or exposed 
persons;  
(c) the machinery shall 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 
shall be designed and constructed in such a way as to eliminate or reduce the 
risk of accidental injury.  
2.4. MACHINERY FOR PLANT PROTECTION PRODUCTS  APPLICATION  
2.4.1.  Definition  
‘Machinery for p lant protection products application’ means machinery specifically intended 
for the application of plant protection products within the meaning of Article 2, point (1), of 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council2.  
2.4.2.  Genera l  
The manufacturer of machinery for pesticide application or his or her authorised 
representative shall ensure that an assessment is carried out of the risks of unintended 
exposure of the environment to pesticides, in accordance with the process of risk a ssessment 
and risk reduction referred to in the General Principles, point 1.  
                                                 
2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L 30 9, 24.11.2009, p. 1).   
EN 29  EN Machinery for pesticide application shall be designed and constructed taking into account the 
results of the risk assessment referred to in the first subparagraph so that the mac hinery can be 
operated, adjusted and maintained without unintended exposure of the environment to 
pesticides.  
Leakage shall be prevented at all times.  
2.4.3.  Controls and monitoring  
It shall be possible to easily and accurately control, monitor and immediately stop the 
pesticide application from the operating positions.  
2.4.4.  Filling and emptying  
The machinery shall be designed and constructed to facilitate precise filling with the 
necess ary quantity of pesticide and to ensure easy and complete emptying, while preventing 
spillage of pesticide and avoiding the contamination of the water source during such 
operations.  
2.4.5.  Application of pesticides  
2.4.5.1.  Application rate  
The machinery shall be fitte d with means of adjusting the application rate easily, accurately 
and reliably.  
2.4.5.2.  Distribution, deposition and drift of pesticide  
The machinery shall be designed and constructed to ensure that pesticide is deposited on 
target areas, to minimise losses to o ther areas and to prevent drift of pesticide to the 
environment. Where appropriate, an even distribution and homogeneous deposition shall be 
ensured.  
2.4.5.3.  Tests  
In order to verify that the relevant parts of the machinery comply with the requirements set 
out i n sections 2.4.5.1 and 2.4.5.2 the manufacturer or his or her authorised representative 
shall, for each type of machinery concerned, perform appropriate tests, or have such tests 
performed.  
2.4.5.4.  Losses during stoppage  
The machinery shall be designed and const ructed to prevent losses while the pesticide 
application function is stopped.  
2.4.6.  Maintenance  
2.4.6.1.  Cleaning  
The machinery shall be designed and constructed to allow its easy and thorough cleaning 
without contamination of the environment.  
2.4.6.2.  Servicing  
The machiner y shall be designed and constructed to facilitate the changing of worn parts 
without contamination of the environment.  
2.4.7.  Inspections  
It shall be possible to easily connect the necessary measuring instruments to the machinery to 
check the correct functionin g of the machinery.  
2.4.8.  Marking of nozzles, strainers and filters   
EN 30  EN Nozzles, strainers and filters shall be marked so that their type and size can be clearly 
identified.  
2.4.9.  Indication of pesticide in use  
Where appropriate, the machinery shall be fitted with a s pecific mounting on which the 
operator can place the name of the pesticide in use.  
2.4.10.  Instructions  
The instructions shall provide the following information:  
(a) precautions to be taken during mixing, loading, application, emptying, cleaning, 
servicing and transport operations in order to avoid contamination of the 
environment;  
(b) detailed conditions of use for the different operating environments envisaged, 
includin g the corresponding preparation and adjustments required to ensure the 
deposition of pesticide on target areas while minimising losses to other areas, to 
prevent drift to the environment and, where appropriate, to ensure an even 
distribution and homogeneou s deposition of pesticide;  
(c) the range of types and sizes of nozzles, strainers and filters that can be used with the 
machinery;  
(d) the frequency of checks and the criteria and method for the replacement of parts 
subject to wear that affect the correct functi oning of the machinery, such as nozzles, 
strainers and filters;  
(e) specification of calibration, daily maintenance, winter preparation and other checks 
necessary to ensure the correct functioning of the machinery;  
(f) types of pesticides that may cause incorrec t functioning of the machinery;  
(g) an indication that the operator should keep updated the name of the pesticide in use 
on the specific mounting referred to in section 2.4.9;  
(h) the connexion and use of any special equipment or accessories, and the necessary 
precautions to be taken;  
(i) an indication that the machinery may be subject to national requirements for regular 
inspection by designated bodies, as provided for in Directive 2009/128/EC of the 
European Parliament and of the Council 3; 
(j) the features of the mac hinery, which shall be inspected to ensure its correct 
functioning;  
(k) instructions for connecting the necessary measuring instruments.  
                                                 
3 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing 
a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, 
p. 71).   
EN 31  EN 3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 
TO OFFSET RISKS DUE TO THE MOBILITY OF MACHINERY  
Machinery present ing risks due to its mobility shall meet all the essential health and safety 
requirements described in this chapter (see General Principles, point 4).  
3.1. GENERAL  
3.1.1.  Definitions  
(a) ‘Machinery presenting risks due to its mobility’ means  
i. machinery the operation of wh ich requires either mobility while working, 
or continuous or semi continuous movement between a succession of 
fixed working locations, or  
ii. machinery which is operated without being moved, but which may be 
equipped in such a way as to enable it to be moved m ore easily from one 
place to another.  
(b) ‘Driver’ means a person responsible for the movement of a machine, who may be 
transported by the machinery or may be on foot, accompanying the machinery, or 
may guide the machinery by remote control or may remotely supervise the 
autonomous mobile machinery  product regardless of the distance and the means of 
control communication.  
(c) ‘Autonomous mobile machinery’ means a mobile machinery that has an autonomous 
mode, in which all the essential safety functions of the mobile machinery are ensured 
in its travel a nd working operations area without permanent interaction of an 
operator.  
3.2. WORK POSITIONS  
3.2.1.  Driving position  
Visibility from the driving position shall be such that the driver can, in complete safety for 
himself or herself and the exposed persons operate the machinery and its tools in their 
foreseeable conditions of use. Where necessary, appropriate devices shall be provided to 
remedy risks due to inadequate direct vision.  
Machinery on which the driver is transported shall 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 shall be designed and constructed in such a way that a 
driver's cab may be fitted, provided t his does not increase the risk and there is room for it. The 
cab shall incorporate a place for the instructions needed for the driver.  
3.2.2.  Seating  
Where there is a risk that operators or other persons transported by the machinery may be 
crushed between parts o f the machinery and the surroundings 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, the machinery shall be designed or equipped with a restraint system so as to  
keep the persons in their seats or in the protective structure, without restricting movements 
necessary for operations or movements relative to the structure caused by the suspension of 
the seats. Such restraint systems or provision shall not be fitted if  they increase the risk.  
A visual or audible signal shall be provided at the driving position alerting the driver when the 
restraint system is not active.   
EN 32  EN 3.2.3.  Positions for other persons  
If the conditions of use provide that persons other than the driver may occasionally or 
regularly be transported by the machinery or work on it, appropriate positions shall be 
provided which enable them to be transported or to work on it without risk.  
The second and third subparagraphs of section 3.2.1 also apply to the places  provided for 
persons other than the driver.  
3.2.4.  Supervisory control function  
Autonomous mobile machinery products shall have a supervisory control function specific to 
the autonomous mode. This function shall allow the operator to remotely receive informatio n 
from the machine. The supervisory control function shall only allow actions to stop and to 
start remotely the machine. It shall be designed and constructed to allow those actions only 
when the driver can see directly or indirectly the machine's movement and working area and 
the protective devices are operational.  
The information the driver receives from the machine when the supervisory control function 
is active shall enable the driver to have a complete and accurate view of the operation, 
movement and s afe positioning of the machine in its travel and working area.  
This information shall alert the driver of the occurrence of unforeseen or dangerous situations 
present or impending, which require driver’s intervention.  
If the supervisory control function is not active, the machinery shall not be able to operate.  
3.3. CONTROL SYSTEMS  
If necessary, steps shall be taken to prevent unauthorised use of controls.  
In the case of remote controls, each control unit shall clearly identify the machinery to be 
controlled from that unit.  
The remote control system shall be designed and constructed in such a way as to affect only:  
(a) the machinery in question;  
(b) the functions in question.  
Remote controlled machinery shall be designed and constructed in such a way that it will 
respond only to signals from the intended control units.  
3.3.1.  Control devices  
The driver shall 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 contr ol 
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 shall be so designed, constructed and fitted as to allow safe 
operation by the driver with the minimum risk of incorrect operation. They shall 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 pre -set positions, shall return to the neutral position as soon as they are 
released by the operator.   
EN 33  EN In the case of wheeled machinery, the steering system shall be designed and constructed in 
such a wa y 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 shall 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.  
3.3.2.  Starting/moving  
All travel movements of self -propelled machinery with a ride -on driver shall be possible o nly 
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 shall be provided with the means of 
checking easily, before moving the ma chinery, 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, mov ement of the machinery shall depend on safe 
positioning of the aforementioned parts.  
It shall not be possible for unintentional movement of the machinery to occur while the engine 
is being started.  
The movement of an autonomous mobile machinery product sha ll take into account the risks 
related to the area where it is intended to move and work.  
3.3.3.  Travelling function  
Without prejudice to road traffic regulations, self -propelled machinery and its trailers shall 
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 shall 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 shall be provided for slowing down and 
stopping.  
Wher e safety so requires, a parking device shall be provided to render stationary machinery 
immobile. This device may be combined with one of the devices referred to in the second 
paragraph, if it is purely mechanical.  
Remote -controlled machinery shall be equi pped with devices for stopping operation 
automatically and immediately and for preventing potentially dangerous operation in the 
following situations:  
(a) if the driver loses control;  
(b) if it receives a stop signal;  
(c) if a fault is detected in a safety -related part of the system;  
(d) if no validation signal is detected within a specified time.  
Section 1.2.4 does not apply to the travelling function.   
EN 34  EN Autonomous mobile machinery products shall comply with any of the following conditions:  
(a) it shall move and operate in a n enclosed zone fitted with a peripheral protection 
system comprising guards or protective devices;  
(b) it shall be equipped with devices intended to detect any human, domestic animal or 
any other obstacle in its vicinity, where those obstacles could give ris e to a risk to 
health and safety of persons or of domestic animals or to safe operation of the 
machinery product.  
The movements of mobile machinery products connected with one or more trailers or towed 
equipment, including autonomous mobile machinery prod ucts, connected with one or more 
trailers or towed equipment, shall not give rise to risks for persons, domestic animals or any 
other obstacle in the danger zone of such machinery products and trailers or towed equipment.  
3.3.4.  Movement of pedestrian -controlled  machinery  
Movement of pedestrian -controlled self -propelled machinery shall be possible only through 
sustained action on the relevant control device by the driver. In particular, it shall not be 
possible for movement to occur while the engine is being star ted. The control systems for 
pedestrian -controlled machinery shall be designed in such a way as to minimise the risks 
arising from inadvertent movement of the machine towards the driver, in particular:  
(a) Crushing;  
(b) injury from rotating tools.  
The speed of travel of the machinery shall be compatible with the pace of a driver on foot.  
In the case of machinery on which a rotary tool may be fitted, it shall 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 shall be 
such that it does not endanger the driver.  
3.3.5.  Control circuit failure  
A failure in the power supply to the power -assisted steering, where fitted, shall not prevent 
machinery from being steered during the time required to stop it.  
For autonomous mobile machinery, a failure in the steering system shall not have an impact 
on the safety of the machinery.   
3.4. PROTECTION AGAINST MECHANICAL RISKS  
3.4.1.  Uncontrolled movements  
A ma chinery product shall 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 s tructure.  
3.4.2.  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 u se 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.   
EN 35  EN 3.4.3.  Roll-over and tip -over 
Where, in the case of self -propelled machinery with a ride -on driver, op erator(s) or other 
person(s), there is a risk of rolling or tipping over, the machinery shall be fitted with an 
appropriate protective structure, unless this increases the risk.  
This structure shall be such that in the event of rolling or tipping over it a ffords 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 or her authorised representative shall, for each type of 
structure concerned, perform appropriate tests or have such tests performed.  
3.4.4.  Falling objects  
Where, in the case of self -propelled machinery with a ride -on driver, operator(s) or other 
person(s), there is a risk due to falling objects or material, the machiner y shall 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 shall 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 or her authorised representative shall, for each type of 
structure concer ned, perform appropriate tests or have such tests performed.  
3.4.5.  Means of access  
Handholds and steps shall be designed, constructed and arranged in such a way that the 
operators use them instinctively and do not use the control devices to assist access.  
3.4.6.  Towing  devices  
All machinery used to tow or to be towed shall 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 shall be equipped with a support with 
a bearing surface suited to the load and the ground.  
3.4.7.  Transmission of power between self -propelled machinery (or tractor) and recipient 
machinery  
Removable mechanical transmission devices linking self -propelled machinery (or a tractor) to 
the first fixed bearing of recipient machinery shall 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 shall be protected either by a guard 
fixed and linked to the self -propelled machinery (or tractor) or by any othe r device offering 
equivalent protection.  
It shall be possible to open this guard for access to the removable transmission device. Once it 
is in place, there shall be enough room to prevent the drive shaft damaging the guard when the 
machinery (or the tract or) is moving.  
On the recipient machinery side, the input shaft shall be enclosed in a protective casing fixed 
to the machinery.   
EN 36  EN Torque limiters or freewheels may be fitted to universal joint transmissions only on the side 
adjoining the driven machinery. T he removable mechanical transmission device shall 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), shall 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 s hall be so designed, constructed and arranged that they cannot 
turn with the removable mechanical transmission device. The guard shall 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 shall be designed and constructed in such a way that the shaft 
guards can not be used as steps, unless designed and constructed for that purpose.  
3.5. PROTECTION AGAINST OTHER RISKS  
3.5.1.  Batteries  
The battery housing shall 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 tip over and to avoid the 
accumulation of vapours in places occupied by operators.  
A machinery product shall be designed and constructed in such a way that the battery can be 
disconnected with the aid of an easily accessible device pro vided for that purpose.  
The batteries with automatic charging for mobile machinery, including autonomous mobile 
machinery products, shall be designed to prevent hazards referred to in sections 1.3.8.2. and 
1.5.1., including the risks of contact or collusio n of the machine with a person or another 
machine when the machine moves autonomously to the charging station.  
3.5.2.  Fire 
Depending on the hazards anticipated by the manufacturer, machinery shall, where its size 
permits:  
(a) either allow easily accessible fire exti nguishers to be fitted, or  
(b) be provided with built -in extinguisher systems.  
3.5.3.  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 o perator shall be protected against the 
risk of exposure to such hazardous emissions.  
Ride -on mobile machinery having spraying of products as the main function shall be equipped 
with filtration cabs or equivalent safety measures.  
3.5.4.  Risk of contact with live overhead power lines  
Depending on the height of the machinery products, mobile machinery product shall, where 
relevant, be designed, constructed and equipped, so as to prevent the risk of contact with an 
energised overhead power line or the risk of creati ng an electric arc between any part of the 
machinery or an operator driving the machinery and an energised overhead power line.   
EN 37  EN When the risk of contact or electric arc with an energised overhead power line cannot be fully 
avoided, mobile machinery produc ts shall be designed, constructed and equipped in such a 
way that all hazards of an electrical nature are prevented or can be prevented in the event of 
contact or electrical arc with an energized power line.  
3.6. INFORMATION AND INDICATIONS  
3.6.1.  Signs, signals and w arnings  
All machinery products shall have signs and/or instruction plates concerning use, adjustment 
and maintenance, wherever necessary, so as to ensure the health and safety of persons. They 
shall be chosen, designed and constructed in such a way as to b e clearly visible and indelible.  
Without prejudice to the provisions of road traffic regulations, machinery product with a ride -
on driver shall have the following equipment:  
(a) an acoustic warning device to alert persons;  
(b) a system of light signals relevant to  the intended conditions of use; the latter 
requirement does not apply to machinery product intended solely for underground 
working and having no electrical power;  
(c) where necessary, there shall be an appropriate connection between a trailer and the 
machiner y product for the operation of signals.  
Remote -controlled machinery  which, under normal conditions of use, exposes persons to the 
risk of impact or crushing shall be fitted with appropriate means to signal its movements or 
with means to protect persons ag ainst such risks. The same applies to machinery product, 
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 sha ll be constructed in such a way that the warning and signalling devices cannot 
be disabled unintentionally. Where it is essential for safety, such devices shall be provided 
with the means to check that they are in good working order and their failure shall  be made 
apparent to the operator.  
Where the movement of machinery or its tools is particularly hazardous, signs on the 
machinery shall be provided to warn against approaching the machinery while it is working; 
the signs shall be legible at a sufficient di stance to ensure the safety of persons who have to be 
in the vicinity.  
3.6.2.  Marking  
The following shall be shown legibly and indelibly on all machinery products:  
(a) nominal power expressed in kilowatts (kW);  
(b) mass of the most usual configuration, in kilograms (kg);  
and, where appropriate:  
(a) maximum drawbar pull provided for at the coupling hook, in Newtons (N);  
(b) maximum vertical load provided for on the coupling hook, in Newtons (N).  
3.6.3.  Instructions   
EN 38  EN 3.6.3.1.  Vibrations  
The instructions shall give the following information concerni ng vibrations, expressed as 
acceleration (m/s2), transmitted by the machinery to the hand -arm system or to the whole 
body:  
(a) the vibration total value from continuous vibrations to which the hand -arm system is 
subjected;  
(b) the mean value of the peak amplitude of the acceleration from repeated shock 
vibrations, to which the hand -arm system is subjected;  
(c) 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 
shall be mentioned;  
(d) the uncertainty of measurements.   
These values shall 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 repr esentative of the machinery to be produced.  
Where harmonised standards or technical specifications adopted by the Commission in 
accordance with Article 17(3) cannot be applied, the vibration shall be measured using the 
most appropriate measurement code for  the machinery concerned.  
The operating conditions during measurement and the measurement codes used shall be 
described.  
3.6.3.2.  Multiple uses  
The instructions for a machinery product allowing several uses depending on the equipment 
used and the instructions for t he interchangeable equipment shall contain the information 
necessary for safe assembly and use of the basic machinery product and the interchangeable 
equipment that can be fitted.  
3.6.3.3.  Autonomous mobile machinery products   
The instructions for use of autonomous mobile machinery products shall specify the 
characteristics of its intended travel, working areas and danger zones.  
4. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 
TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS  
Machinery presenting hazards due to lifting operations shall meet all the relevant essential 
health and safety requirements described in this chapter (see General Principles, point 4).  
4.1. GENERAL  
4.1.1.  Definitions  
(a) ‘Lifting operation’ means a movement of unit loads c onsisting 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 or her authorised representative up to which a component is able 
to hold it and the maximum working load marked on the component;   
EN 39  EN (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 a ccessory 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.  
4.1.2.  Protection against mechanical risks  
4.1.2.1.  Risks due to lack of stability  
Machinery shall be designed a nd 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 ca rried out in accordance with the instruction handbook. To that end, the 
manufacturer or his or her authorised representative shall use the appropriate verification 
methods.  
4.1.2.2.  Machinery running on guide rails and rail tracks  
Machinery shall be provided with d evices, 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 shall be provided which prevent the equipment, component or 
load f rom falling or the machinery from overturning.  
4.1.2.3.  Mechanical strength  
Machinery, lifting accessories and their components shall be capable of withstanding the 
stresses to which they are subjected during their lifetime, 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 shall also be satisfied during tr ansport, assembly 
and dismantling.  
Machinery and lifting accessories shall 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 shall be chosen on the basis of t he intended working environments, with 
particular regard to corrosion, abrasion, impacts, extreme temperatures, fatigue, brittleness, 
radiation and ageing.   
EN 40  EN Machinery and lifting accessories shall be designed and constructed in such a way as to 
withstand th e overload in the static tests without permanent deformation or patent defect. 
Strength calculations shall 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, th e following 
values:  
(a) manually -operated machinery and lifting accessories: 1, 5;  
(b) other machinery: 1,25.  
Machinery shall be designed and constructed in such a way as to undergo, without failure, the 
dynamic tests carried out using the maximum working load mul tiplied 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 provi ded for. Should the control circuit of the machinery 
allow for a number of simultaneous movements, the tests shall be carried out under the least 
favourable conditions, as a general rule by combining the movements concerned.  
4.1.2.4.  Pulleys, drums, wheels, ropes and chains  
Pulleys, drums and wheels shall have a diameter commensurate with the size of the ropes or 
chains with which they can be fitted.  
Drums and wheels shall 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 shall not include any splicing other than 
at their ends. Splicings are, however, tolerated in installations, which are intended by design 
to be modified r egularly according to needs of use.  
Complete ropes and their endings shall 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 shall have a working c oefficient 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 or her authorised representat ive shall, for each type of chain and rope used directly for 
lifting the load and for the rope ends, perform the appropriate tests or have such tests 
performed.  
4.1.2.5.  Lifting accessories and their components  
Lifting accessories and their components shall be size d 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 combinatio ns shall 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 shall not comprise any splices or loops other than at their ends;  
(b) where chains with welded links are used, they shall be  of the short -link type. The 
working coefficient of chains shall 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, slings or webbing is depend ent on the 
material, method of manufacture, dimensions and use. This coefficient shall be 
chosen in such a way as to guarantee an adequate level of safety; it is, as a general  
EN 41  EN rule, equal to 7, provided the materials used are shown to be of very good quali ty 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, slings or webbings shall not inc lude 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 shall 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 sl inging configuration;  
(f) in order to verify that an adequate working coefficient has been attained, the 
manufacturer or his or her authorised representative shall, for each type of 
component referred to in (a), (b), (c) and (d), perform the appropriate tests or have 
such tests performed.  
4.1.2.6.  Control of movements  
Devices for controlling movements shall act in such a way that the machinery on which they 
are installed is kept safe.  
(a) Machinery shall 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 shall, where appropriate, be preceded by a warning.  
(b) Where several fixed or rail -mounted machine products can be manoeuvred 
simultaneously in the same place, with risks of collision, such machinery shall be 
designed and constructed in such a way as to make it possible to fit systems enabling 
these risks to be avoided.  
(c) Machinery shall 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 shall 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 shall be designed and constructed in such a way that inadvertent 
dropping of the loads is avoided.  
4.1.2.7.  Movements of loads during handling  
The ope rating position of machinery shall 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 shall be designed and constructed in such a way as to prevent 
persons from being injured by movement of the load, the carrier or the counterweights, if any.  
4.1.2.8.  Machinery serving fixed landing s 
4.1.2.8.1. Movements of the carrier   
EN 42  EN The movement of the carrier of machinery serving fixed landings shall 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 shall 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 shall 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 th e second paragraph of 
section 4.1.2.7, the travel zone shall 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 a ny fixed parts, sufficient free space shall 
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 loa d falling off the carrier, the machinery shall 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 shall 
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 shall be fitted in order to prevent this risk. Such guards shall not open 
in the direction of the travel zone. They shall be fitted with an interl ocking device controlled 
by the position of the carrier that prevents:  
(a) hazardous movements of the carrier until the guards are closed and locked;  
(b) hazardous opening of a guard until the carrier has stopped at the corresponding 
landing.  
4.1.3.  Fitness for purpose  
When lifting machinery or lifting accessories are placed on the market or are first put into 
service, the manufacturer or his or her authorised representative shall ensure, by taking 
appropriate measures or having them taken, that the machinery or the lifti ng 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 shall 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 or her authorised representative, the appropriate measures shall be taken at the place of 
use by the manufacturer, or by his or her authorised representative or by another subject on 
the manufacturers’ behalf . Otherwise, the measures may be taken either in the manufacturer's 
premises or at the place of use.   
EN 43  EN 4.2. REQUIREMENTS FOR MACHINERY PRODUCTS WHOSE POWER SOURCE 
IS OTHER THAN MANUAL EFFORT  
4.2.1.  Control of movements  
Hold-to-run control devices shall 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 de vices authorising 
automatic stops at pre -selected positions without the operator holding a hold -to-run control 
device.  
4.2.2.  Loading control  
Machinery with a maximum working load of not less than 1 000 kilograms or an overturning 
moment of not less than 40 000 N m shall be fitted with devices to warn the driver and prevent 
dangerous movements in the event:  
(a) of overloading, either as a result of the maximum working load or the maximum 
working moment due to the load being exceeded, or  
(b) of the overturning moment being exceeded.  
4.2.3.  Installations guided by ropes  
Rope carriers, tractors or tractor carriers shall be held by counterweights or by a device 
allowing permanent control of the tension.  
4.3. INFORMATION AND MARKINGS  
4.3.1.  Chains, ropes and webbing  
Each length of lifting chain, rope or webbing not forming part of an assembly shall bear a 
mark or, where this is not possible, a plate or irremovable ring bearing the name and address 
of the manufacturer or his or her authorised representative and the identifying reference of the 
relevant certificate.  
The certificate mentioned above shall show at least the following information:  
(a) the name and address of the manufacturer and, if appropriate, his or her authorised 
representative;  
(b) a description of the chain or rope, which includes:  
i. its nom inal size,  
ii. its construction,  
iii. the material from which it is made, and  
iv. 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.   
EN 44  EN 4.3.2.  Lifting accessories  
Lifting accessories shall show the following particulars:  
i. identification of the material where this information is needed for safe use;  
ii. the maximum working load.  
In the case of lifting ac cessories on which marking is physically impossible, the particulars 
referred to in the first paragraph shall be displayed on a plate or other equivalent means and 
securely affixed to the accessory.  
The particulars shall be legible and located in a place w here they are not liable to disappear as 
a result of wear or jeopardise the strength of the accessory.  
4.3.3.  Lifting machinery  
The maximum working load shall be prominently marked on the machinery. This marking 
shall be legible, indelible and in an un -coded form . 
Where the maximum working load depends on the configuration of the machinery, each 
operating position shall 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, shall bear a clear and indelible warning prohibiting the lifting of persons. This 
warning shall be visible at each place where access is possible.  
4.4. INSTRUC TIONS  
4.4.1.  Lifting accessories  
Each lifting accessory or each commercially indivisible batch of lifting accessories shall 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.  
4.4.2.  Lifting machinery  
Lifting machinery shall be accompanied by instructi ons containing information on:  
(a) the technical characteristics of the machinery, and in particular:  
i. 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,  
ii. the reactions at t he supports or anchors and, where appropriate, 
characteristics of the tracks,  
iii. 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, par ticularly to offset the lack of direct vision of the load by the 
operator;   
EN 45  EN (d) where appropriate, a test report detailing the static and dynamic tests carried out by 
or for the manufacturer or his or her authorised representative;  
(e) for machinery, which is not a ssembled 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.  
 
5. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREM ENTS 
FOR MACHINERY PRODUCTS INTENDED FOR UNDERGROUND WORK  
Machinery products intended for underground work shall meet all the essential health and 
safety requirements described in this chapter (see General Principles, point 4).  
5.1. RISKS DUE TO LACK OF STABILI TY 
Powered roof supports shall 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 shall be equipped with anchorages for the top  plates of the individual 
hydraulic props.  
5.2. MOVEMENT  
Powered roof supports shall allow for unhindered movement of persons.  
5.3. CONTROL DEVICES  
The accelerator and brake controls for movement of machinery running on rails shall be hand -
operated. However, enablin g devices may be foot -operated.  
The control devices of powered roof supports shall be designed and positioned in such a way 
that, during displacement operations, operators are sheltered by a support in place. The 
control devices shall be protected against any accidental release.  
5.4. STOPPING  
Self-propelled machinery running on rails for use in underground work shall be equipped with 
an enabling device acting on the circuit controlling the movement of the machinery such that 
movement is stopped if the driver is no longer in control of the movement.  
5.5. FIRE  
Section 3.5.2 (b) is mandatory in respect of machinery, which comprises highly flammable 
parts.  
The braking system of machinery intended for use in underground workings shall 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 shall be fitted 
only with engines using fuel with a low vaporising pressure and which exclude any spark of 
electrical origin.  
5.6. EXH AUST EMISSIONS  
Exhaust emissions from internal combustion engines shall not be discharged upwards.  
6. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 
FOR MACHINERY PRODUCTS PRESENTING PARTICULAR RISKS DUE TO 
THE LIFTING OF PERSONS   
EN 46  EN Machinery products presenting risks due to the lifting of persons shall meet all the relevant 
essential health and safety requirements described in this chapter (see General Principles, 
point 4).  
6.1. GENERAL  
6.1.1.  Mechanical strength  
The carrier, including any trapdoors, shall be desi gned 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 shall, as a general rule, be doubled. 
Machinery intended for lifting persons or persons and goods shall be fitted with a suspension 
or supporting system for the carrier designed and construct ed 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 ow n anchorage.  
6.1.2.  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.  
6.2. CONTROL DEVICES  
Where safety requirements do not impose other solutions, the carrier shall, as a general rule, 
be designed and constructed in such a way that persons in the carrier have means of 
controlling upward and downward movem ents and, if appropriate, other movements of the 
carrier.  
In operation, those control devices shall override any other devices controlling the same 
movement with the exception of emergency stop devices.  
The control devices for the movements referred to in the first paragraph shall be of the hold -
to-run type except where the carrier is completely enclosed. If there is no risk of persons or 
objects on the carrier colliding or falling and no other risks due to the upward and downward 
movements of the carrier, control devices authorising automatic stops at preselected positions 
may be used instead of hold -to-run type control devices  
6.3. RISKS TO PERSONS IN OR ON THE CARRIER  
6.3.1.  Risks due to movements of the carrier  
Machinery for lifting persons shall be designed, const ructed or equipped in such a way that 
the acceleration or deceleration of the carrier does not engender risks for persons.  
6.3.2.  Risk of persons falling from the carrier  
The carrier shall not tilt to an extent, which creates a risk of the occupants falling, incl uding 
when the machinery and carrier are moving.  
Where the carrier is designed as a workstation, provision shall be made to ensure stability and 
to prevent hazardous movements.  
If the measures referred to in section 1.5.15 are not adequate, carriers shall be fitted with a 
sufficient number of suitable anchorage points for the number of persons permitted on the  
EN 47  EN carrier. The anchorage points shall be strong enough for the use of personal protective 
equipment against falls from a height.  
Any trapdoor in floors or ceilings or side doors shall be designed and constructed in such a 
way as to prevent inadvertent opening and shall open in a direction that obviates any risk of 
falling, should they open unexpectedly.  
6.3.3.  Risk due to objects falling on the carrier  
Where there is a risk of objects falling on the carrier and endangering persons, the carrier shall 
be equipped with a protective roof.  
6.4. MACHINERY SERVING FIXED LANDINGS  
6.4.1.  Risks to persons in or on the carrier  
The carrier shall 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 shall be completely enclosed 
with doors fitted with  an interlocking device that prevents hazardous movements of the carrier 
unless the doors are closed. The doors shall remain closed if the carrier stops between 
landings where there is a risk of falling from the carrier.  
The machinery shall be designed, c onstructed and, where necessary, equipped with devices in 
such a way as to prevent uncontrolled upward or downward movement of the carrier. These 
devices shall be able to stop the carrier at its maximum working load and at the foreseeable 
maximum speed.  
The stopping action shall not cause deceleration harmful to the occupants, whatever the load 
conditions.  
6.4.2.  Controls at landings  
Controls, other than those for emergency use, at landings shall not initiate movements of the 
carrier when:  
(a) the control devices i n the carrier are being operated,  
(b) the carrier is not at a landing.  
6.4.3.  Access to the carrier  
The guards at the landings and on the carrier shall be designed and constructed in such a way 
as to ensure safe transfer to and from the carrier, taking into consid eration the foreseeable 
range of goods and persons to be lifted.  
6.5. MARKINGS  
The carrier shall bear the information necessary to ensure safety including:  
(a) the number of persons permitted on the carrier,  
(b) the maximum working load.   
EN 48  EN ANNEX IV  
 
A. TECHNICAL  DOCUMENTATION FOR MACHINERY PRODUCTS  
The technical documentation shall specify the means used by the manufacturer to ensure the 
conformity of the machinery product with the applicable essential health and safety 
requirements set out in Anne x III.  
The technical documentation shall include at least the following elements:  
(a) a complete description of the machinery product and of its intended use;  
(b) an assessment of the risks against which the machinery product is designed and 
constructed;   
(c) a list of the essential health and safety requirements that are applicable to the 
machinery product;  
(d) design and manufacturing drawings and schemes of the machinery product and of its 
components, sub -assemblies and circuits;  
(e) the descriptions and explanati ons necessary for the understanding of the drawings 
and schemes referred to in point (d) and of the operation of the machinery product;  
(f) the references of the harmonised standards or technical specifications adopted by the 
Commission in accordance with Article 17(3) that have been applied for the design 
and manufacture of the machinery. In the event of partial application of harmonised 
standards, the documentation shall specify the parts, which have been applied;  
(g) where harmonised standards have not been applied or have been only partially 
applied, descriptions of the other technical specifications that have been applied in 
order to satisfy the applicable essential health and safety requirements;  
(h) the results of the design calculations, inspections and examinations carried out to 
verify the conformity of the machinery with the applicable essential health and safety 
requirements;  
(i) reports on t he tests carried out to verify the conformity of the machinery with the 
applicable essential health and safety requirements;  
(j) a description of the means used by the manufacturer during the production of the 
machinery to ensure the conformity of the machine ry produced with the design 
specifications;  
(k) a copy of the manufacturer's instructions and the information set out in section 1.7.4 
of Annex III;  
(l) where appropriate, the declaration of incorporation for partly completed machinery 
set out in Annex V and the  relevant assembly instructions for such machinery;  
(m) for machinery products produced in series, the internal measures that will be 
implemented to ensure that the machinery product remains in conformity with this 
Regulation;  
(n) the source code or programmed lo gic of the safety related software to demonstrate 
the conformity of the machinery product with this Regulation further to a reasoned 
request from a competent national authority provided that is necessary in order for 
those authorities to be able to check c ompliance with the essential health and safety 
requirements set out in Annex III;    
EN 49  EN (o) for sensor -fed, remotely -driven, or autonomous machinery product, if the safety 
related operations are  controlled by sensor data, a description, where appropriate, of 
the general characteristics, capabilities and limitations of the system, data, 
development, testing and validation processes used, without prejudice to the 
requirements for artificial intelligence (AI) systems set out in the Regulation (EU) 
.../... of the Euro pean Parliament and of the Council+ on a European approach for 
Artificial Intelligence  if the safety related software includes an AI system;  
(p) the results of research and tests on components, fittings or the completed machinery 
carried out by the manufactur er to determine whether by its design or construction it 
is capable of being assembled and put into service safely.  
 
B. RELEVANT TECHNICAL DOCUMENTATION FOR PARTLY COMPLETED 
MACHINERY  
The technical documentation shall specify the means used by the manufa cturer to ensure the 
conformity of the partly completed machinery with the applicable essential health and safety 
requirements set out in Annex III.  
The technical documentation shall include at least the following elements:  
(a) a complete description of the partly completed machinery and of its intended use;  
(b) an assessment of the risks against  the partly completed machinery is designed and 
constructed; a list of the essential health and safety requirements that are applicable 
to the partly completed machiner y;  
(c) design and manufacturing drawings and schemes of the partly completed machinery 
and of its components, sub -assemblies and circuits;  
(d) the descriptions and explanations necessary for the understanding of the drawings 
and schemes referred to in point (d) and of the operation of the partly completed 
machinery;  
(e) the references of the harmonised standards referred to in Article 18 that have been 
applied for the design and manufacture of the partly completed machinery. In the 
event of partial application of ha rmonised standards, the documentation shall specify 
the parts, which have been applied;  
(f) where harmonised standards have not been applied or have been only partially 
applied, description of the other technical specifications that have been applied in 
order  to satisfy the applicable essential health and safety requirements;  
(g) the results of the design calculations, inspections and examinations carried out to 
verify the conformity of the partly completed machinery with the applicable essential 
health and safet y requirements;  
(h) reports on the tests carried out to verify the conformity of the partly completed 
machinery with the applicable essential health and safety requirements;  
(i) a description of the means used by the manufacturer during the production of the 
partly completed machinery to ensure the conformity of the partly completed 
machinery produced with the design specifications;  
                                                 
+  OJ: Please insert in  the text the number of the Regulation contained in document … and insert the 
number, date, title and OJ reference of that Regulation in the footnote.   
EN 50  EN (j) a copy of the assembly instructions for the par tly completed machinery set out in 
section 1.7.4 of Annex III;  
(k) for partly completed machinery products produced in series , the internal measures 
that will be implemented to ensure that the partly completed machinery product 
remains in conformity with the  essential health and safety requirements applied;   
(l) the source code or programmed logic of the safety related software upon a reasoned 
request from a competent national authority provided that is necessary in order for 
those authorities to be able to chec k compliance with the essential health and safety 
requirements set out in Annex III:  
(m) for sensor -fed, remotely -driven, or autonomous partly completed machinery, if the 
safety related operations are controlled by sensor data, a description, where 
appropriat e, of the general characteristics, capabilities and limitations of the system, 
data, development, testing and validation processes used, without prejudice to the 
requirements for artificial intelligence (AI) systems set out in the Regulation (EU) 
.../... o f the European Parliament and of the Council+ on a European approach for 
Artificial Intelligence  if the safety related software includes a AI system;  
(n) the results of research and tests on components, fittings or the completed machinery 
carried out by the m anufacturer to determine whether by its design or construction it 
is capable of being assembled and put into service safely.  
  
                                                 
+  OJ: Please insert in the text the number of the Regulation contained in document … . and insert the 
number, date, title and OJ reference of that Regulation in the footnote.   
EN 51  EN ANNEX V  
 
EU DECLARATION OF CONFORMITY OF MACHINERY PRODUCTS EXCEPT 
FOR PARTLY COMPLETED MACHINERY No… 4  
This declaration relate s exclusively to machinery products, except for partly completed 
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 unless there is a 
substanti al modification of the machinery product.  
1. The EU declaration of conformity shall contain the following particulars: Machinery 
product  (product, type, batch or serial number):  
2. Name and address of the manufacturer and, where applicable, his or her authori sed 
representative:  
3. The address where the machine product is permanently installed only for lifting 
machinery product installed in a building or a structure:  
4. This declaration of conformity is issued under the sole responsibility of the 
manufacturer:  
5. Obje ct of the declaration (identification of machinery product allowing traceability; 
where necessary for the identification of the machinery product, a colour image of 
sufficient clarity may be included):  
6. The object of the declaration described in point 4 is  in conformity with the relevant 
Union harmonisation legislation:  
7. References to the relevant harmonised standards used or technical specifications 
adopted by the Commission in accordance with Article 17(3), including the date of 
the standard, or references to the other technical specifications, including the date of 
the specification, in relation to which conformity is declared:  
8. Where applicable, the notified body … (name, number) … performed the EU type -
examination (Module B) and issued the EU ty pe-examination certificate … 
(reference to that certificate), followed by conformity to type based on internal 
production control (module C):  
9. Where applicable, the machinery product is subject to the conformity assessment 
procedure … (either internal prod uction control (Module A) or full quality assurance 
(module H) … under surveillance of the notified body … (name, number):  
10. Additional information:  
Signed for and on behalf of: …  
(place and date of issue):  
(name, function) (signature):  
 
 
                                                 
4 It is optional for the manufacturer to assign a number to the declaration of conformity.   
EN 52  EN  
EU DECLARATION OF INCORPORATION OF PARTLY COMPLETED 
MACHINERY No… 5 
 
The declaration of incorporation shall contain the following particulars:  
1. Partly Completed Machinery (product, type, batch or serial number):  
2. Name and address of the manufacturer and, w here applicable, his or her authorised 
representative:  
3. This declaration of incorporation is issued under the sole responsibility of the 
manufacturer:  
4. Object of the declaration (identification of partly completed machinery allowing 
traceability; where nec essary for the identification of the partly completed 
machinery, a colour image of sufficient clarity may be included):  
5. A sentence declaring which essential requirements of Regulation (EU) …/… … of 
the European Parliament and of the Council+6 are applied a nd fulfilled and that the 
relevant technical documentation was drawn -up in accordance with part B of Annex 
IV, and, where appropriate, a sentence declaring the conformity of the partly 
completed machinery with other relevant Union harmonisation legislation :  
6. References to the relevant harmonised standards used or technical specification 
adopted by the Commission in accordance with Article 17(3), including the date of 
the standard, or references to the other technical specifications, including the date of 
the specification, in relation to which conformity is declared:  
7. 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:  
8. A statement that the partly completed machinery shall not be put into service until 
the final machinery into which it is to be incorpo rated has been declared in 
conformity with this Regulation  where appropriate:  
9. Additional information:  
Signed for and on behalf of: …  
(place and date of issue):  
(name, function) (signature):
                                                 
5 It is optional to assign a number to the declaration of conformity.  
6 OJ: Please insert in  the text the number of the Regulation contained in document …and insert the 
number, date, title and OJ reference of that Regulation in the footnote   
EN 53  EN ANNEX VI  
INTERNAL PRODUCTION CONTROL  
(Mod ule A)  
1. Internal production control is the conformity assessment procedure whereby the 
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and 
declares on his or her sole responsibility that the machinery product satisfies the 
applicable requirements of this Regulation.  
2. Technical documentation  
The manufacturer shall draw up the technical documentation described in Annex IV.  
3. Manufacturing  
The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure compliance of the manufactured machinery product with the technical 
documentation referred to in point 2 and with the applicable requirements of this Regulation.  
4. CE marking and EU declaration of conformity  
4.1. The manufacturer shall affix the CE marking to each individual machinery product 
that satisfies the applicable requirements of this Regulation.  
4.2. The manufacturer shall draw up an EU declaration  of conformity for each machinery 
product model in accordance with Article 20 and keep it, together with the technical 
documentation, at the disposal of the national authorities for ten years after the 
machinery product has been placed on the market or put  into service. The EU 
declaration of conformity shall identify the machinery product for which it has been 
drawn up.  
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
5. Authorised representative  
The manufacturer's obligations set out in point 4 may be fulfilled by his or her authorised 
representative, on his or her behalf and under his or her responsibility, provided that they are 
specified in the mandate.   
EN 54  EN ANNEX VII  
EU TYPE -EXAM INATION  
(Module B)  
1. EU type -examination is the part of a conformity assessment procedure in which a 
notified body examines the technical design of a machinery product and verifies and 
attests that the technical design of the machinery product meets the appl icable 
requirements of this Regulation.  
2. EU type -examination shall be carried out by assessment of the adequacy of the 
technical design of the machinery product through examination of the technical 
documentation, plus examination of a specimen of the machinery product that is 
representative of th e production envisaged (production type).  
3. Application for EU type -examination  
The manufacturer shall lodge an application for EU type -examination with a single notified 
body of his or her choice.  
The application shall include:  
(a) the name and address of t he manufacturer and, if the application is lodged by 
an authorised representative, the name and address of that authorised 
representative;  
(b) a written declaration that the same application has not been lodged with any 
other notified body;  
(c) the technical doc umentation described in Annex IV;  
(d) the specimen(s) of the machinery product representative of the production 
envisaged. The notified body may request further specimens if needed for 
carrying out the test programme. For machinery products produced in series  
where each item is adapted to fit an individual user, specimens shall be 
provided that are representative of the range of different users, while for 
machinery products produced as a single unit to accommodate the special 
needs of an individual user, a bas ic model shall be provided.  
4. EU type -examination  
The notified body shall:  
(a) examine the technical documentation to assess the adequacy of the technical 
design of the machinery product. In conducting such an examination, Annex 
IV, second subparagraph, point  (j), need not be taken into account;  
(b) for machinery products produced in series where each item is adapted to fit an 
individual user, examine the description of the measures to assess their 
adequacy;  
(c) verify that the specimen(s) have been manufactured in conformity with the 
technical documentation, and identify the elements that have been designed in 
accordance with the applicable provisions of the relevant harmonised standards 
or technical specifications adopted by the Commission in accordance with  
EN 55  EN Articl e 17(3), as well as the elements that have been designed in accordance 
with other technical specifications;  
(d) carry out appropriate examinations and tests, or have them carried out, to check 
whether, where the manufacturer has chosen to apply the solutions in the 
relevant harmonised standards, those have been applied correctly;  
(e) carry out appropriate examinations and tests, or have them carried out, to check 
whether, where the solutions in the relevant harmonised standards or technical 
specifications adopted  by the Commission in accordance with Article 17(3) 
have not been applied, the solutions adopted by the manufacturer, including 
those in other technical specifications applied, meet the corresponding essential 
health and safety requirements and have been a pplied correctly.  
5. Evaluation report  
The notified body shall draw up an evaluation report that records the activities undertaken in 
accordance with point 4 and their outcomes. Without prejudice to its obligations vis -à-vis the 
notifying authorities, as men tioned in Article 32, the notified body shall release the content of 
that report, in full or in part, only with the agreement of the manufacturer.  
6. EU type -examination certificate  
6.1. Where the type meets the applicable essential health and safety requirement s, the 
notified body shall issue an EU type -examination certificate to the manufacturer.  
The period of validity of a newly issued certificate and, where appropriate, of a 
renewed certificate shall not exceed five years.  
6.2. The EU type -examination certificat e shall contain at least the following information:  
(a) the name and identification number of the notified body;  
(b) the name and address of the manufacturer and, if the application is lodged by 
an authorised representative, the name and address of that authoris ed 
representative;  
(c) an identification of the machinery product covered by the certificate (type 
number);  
(d) a statement that the machinery product type complies with the applicable 
essential health and safety requirements;  
(e) where harmonised standards or tech nical specifications adopted by the 
Commission in accordance with Article 17(3) have been fully or partially 
applied, the references of those standards or parts thereof;  
(f) where other technical specifications have been applied, the references of those 
techn ical specifications;  
(g) where applicable, the performance level(s) or protection class of the machinery 
product;  
(h) the date of issue, the date of expiry and, where appropriate, the date(s) of 
renewal;  
(i) any conditions attached to the issuing of the certificate . 
6.3. The EU type -examination certificate may have one or more annexes attached.   
EN 56  EN 6.4. Where the type does not satisfy the applicable essential health and safety 
requirements, the notified body shall refuse to issue an EU type -examination 
certificate and shall info rm the applicant accordingly, giving detailed reasons for its 
refusal.  
7. Review of the EU type -examination certificate  
7.1. The notified body shall keep itself apprised of any changes in the generally 
acknowledged state of the art, which indicate that the appro ved type may no longer 
comply with the applicable essential health and safety requirements, and shall 
determine whether such changes require further investigation. If so, the notified body 
shall inform the manufacturer accordingly.  
7.2. The manufacturer shall inform the notified body that holds the technical 
documentation relating to the EU type - examination certificate of all modifications to 
the approved type and of all modifications to the technical documentation that may 
affect the conformity of the machine ry product with the applicable essential health 
and safety requirements or the conditions for validity of that certificate. Such 
modifications shall require additional approval in the form of an addition to the 
original EU type -examination certificate.  
7.3. The manufacturer shall ensure that the machinery product continues to fulfil the 
applicable essential health and safety requirements in light of the state of the art.  
7.4. The manufacturer shall ask the notified body to review the EU type -examination 
certificate  either:  
(a) in the case of a modification to the approved type referred to in point 7.2;  
(b) in the case of a change in the state of the art referred to in point 7.3;  
(c) at the latest, before the date of expiry of the certificate.  
In order to allow the notified body to fulfil its tasks, the manufacturer shall submit 
his or her application at the earliest 12 months and at the latest 6 months prior to the 
expiry date of the EU type -examination certificate.  
7.5. The notified body shall exa mine the machinery product type and, where necessary in 
the light of the changes made, carry out the relevant tests to ensure that the approved 
type continues to fulfil the applicable essential health and safety requirements. If the 
notified body is satisf ied that the approved type continues to fulfil the applicable 
essential health and safety requirements, it shall renew the EU type -examination 
certificate. The notified body shall ensure that the review procedure is finalised 
before the expiry date of the EU type -examination certificate.  
7.6. Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a 
simplified review procedure shall apply. The manufacturer shall supply the notified 
body with the following:  
(a) His or her name and address a nd data identifying the EU type -examination 
certificate concerned;  
(b) confirmation that there has been no modification to the approved type as 
referred to in point 7.2, including materials, sub -components or sub -
assemblies, nor to the relevant harmonised sta ndards or technical specifications 
adopted by the Commission in accordance with Article 17(3) or other technical 
specifications applied;   
EN 57  EN (c) confirmation that there has been no change in the state of the art as referred to 
in point 7.3; and  
(d) where not already supplied, copies of current product drawings and 
photographs, product marking and information;  
Where the notified body has confirmed that no modification to the approved type 
referred to in point 7.2 and no change in the state of the art referred to in po int 7.3 has 
occurred, the simplified review procedure shall be applied and the examinations and 
tests referred to in point 7.5 shall not be carried out. In that case, the notified body 
shall renew the EU type -examination certificate.  
The costs associated with that renewal shall be proportionate to the administrative 
burden of the simplified procedure.  
If the notified body finds that a change in the state of the art referred to in point 7.3 
has occurred, the procedure set out in point 7.5 shall apply.  
7.7. If, following the review, the notified body concludes that the EU type -examination 
certificate is no longer valid, the body shall withdraw it and the manufacturer shall 
cease the placing on the market of the machinery product concerned.  
8. Each notified body shall inform its notifying authority concerning the EU type -
examination certificates and/or any additions thereto which it has issued or withdrawn, 
and shall, periodically or upon request, make available to its notifying authority the li st 
of such certificates and/or any additions thereto refused, suspended or otherwise 
restricted.  
Each notified body shall inform the other notified bodies concerning the EU type -
examination certificates and/or any additions thereto, which it has refused, withdrawn, 
suspended or otherwise restricted, and, upon request, concerning the EU type -
examination certificates and/or additions thereto which it has issued.  
The Commission, the Member States and the other notified bodies may, on request, 
obtain a copy o f the EU type -examination certificates and/or additions thereto. On 
request, the Commission and the Member States may obtain a copy of the technical 
documentation and the results of the examinations carried out by the notified body.  
The notified body shal l keep a copy of the EU type -examination certificate, its 
annexes and additions, as well as the technical file including the documentation 
submitted by the manufacturer, for a period of five years after the expiry of the 
validity of that certificate.  
9. The manufacturer shall keep a copy of the EU type -examination certificate, its 
annexes and additions, together with the technical documentation at the disposal of the 
national authorities, for 10 years after the machinery product has been placed on the 
market.   
10. The manufacturer's authorised representative may lodge the application referred to in 
point 3 and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are 
specified in the mandate.   
EN 58  EN ANNEX VIII  
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL 
(Module C)  
1. Conformity to type based on internal production control is the part of a conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points 2 and 3, and ensures and declares  under his or her sole responsibility that the 
machinery product concerned is in conformity with the type described in the EU 
type-examination certificate and satisfies the applicable requirements of this 
Regulation.  
2. Manufacturing  
The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure conformity of the manufactured machinery product with the type described 
in the EU type -examination certificate and with the applicable requireme nts of this 
Regulation.  
3. CE marking and EU declaration of conformity  
3.1. The manufacturer shall affix the CE marking to each individual machinery product 
that is in conformity with the type described in the EU type -examination certificate 
and satisfies the ap plicable requirements of this Regulation.  
3.2. The manufacturer shall draw up a written EU declaration of conformity for a 
machinery product model and keep it at the disposal of the national authorities for 10 
years after the machinery product has been placed on the market. The EU declaration 
of conformity shall identify the machinery product for which it has been drawn up.  
A copy of the EU declaration of conformity shall be made available to the relevant authorities 
upon request.  
4. Authorised representative  
The manufacturer's obligations set out in point 3 may be fulfilled by his or her authorised 
representative, on his or her behalf and under his or her responsibility, provided that they are 
specified in the mandate.   
EN 59  EN ANNEX IX  
CONFORMITY BA SED ON FULL QUALITY ASSURANCE  
(Module H)  
1. Conformity based on full quality assurance is the conformity assessment procedure 
whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and 
ensures and declares on his or her sole responsib ility that the machinery product 
concerned satisfy the requirements of this Regulation that apply to them.  
2. Manufacturing  
The manufacturer shall operate an approved quality system for design, manufacture and final 
product inspection and testing of the machi nery product concerned as specified in point 3 and 
shall be subject to surveillance as specified in point 4.  
3. Quality system  
3.1. The manufacturer shall lodge an application for assessment of his or her quality 
system with the notified body of his or her choice,  for the machinery product 
concerned.  
The application shall include:  
(a) the name and address of the manufacturer and, if the application is lodged by 
an authorised representative, the name and address of that authorised 
representative;  
(b) the technical documenta tion for one model of each category of products 
intended to be manufactured. The technical documentation shall, wherever 
applicable, contain at least the following elements:  
(i) a general description of the machinery product;  
(ii) conceptual design and man ufacturing drawings and schemes of 
components, sub -assemblies, circuits, etc.;  
(iii) descriptions and explanations necessary for the understanding of those 
drawings and schemes and the operation of the machinery product;  
(iv) a list of the harmonised stand ards or technical specifications adopted 
by the Commission in accordance with Article 17(3) and/or other 
relevant technical specifications the references of which have been 
published in the Official Journal of the European Union, applied in 
full or in part , and descriptions of the solutions adopted to meet the 
essential requirements of this Regulation where those harmonised 
standards have not been applied. In the event of partly applied 
harmonised standards, the technical documentation shall specify the 
parts which have been applied;  
(v) results of design calculations made, examinations carried out, etc.;  
(vi) test reports;  
(vii) the documentation concerning the quality system; and   
EN 60  EN (viii)  a written declaration that the same application has not been lodged 
with any other notified body.  
3.2. The quality system shall ensure compliance of the products with the requirements of 
this Regulation that apply to them.  
All the elements, requirements and provisions adopted by the manufacturer shall be 
documented in a systema tic and orderly manner in the form of written policies, procedures 
and instructions. That quality system documentation shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records.  
It shall, in particular, contain an adequ ate description of:  
(a) the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to design and product quality;  
(b) the technical design specifications, including standards, that will be applied 
and, where the relevant harmonised standards or technical specification 
adopted by the Commission in accordance with Article 17(3) and/or technical 
specifications will not be applied in full, the means that will be used to ensure 
that the essential requirements of th is Regulation that apply to the machinery 
product will be met;  
(c) the design control and design verification techniques, processes and systematic 
actions that will be used when designing the machinery product pertaining to 
the product category covered;  
(d) the co rresponding manufacturing, quality control and quality assurance 
techniques, processes and systematic actions that will be used;  
(e) the examinations and tests that will be carried out before, during and after 
manufacture and the frequency with which they will  be carried out;  
(f) the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned, etc.;  
(g) the means of monitoring the achievement of the required design and product 
quality and the effective operation of the quality system.  
3.3. The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2.  
It shall presume conformity with those requirements in respect of the elements of the quality 
system that comply with the corresponding specifications of the national standard that 
implements the relevant harmonised standard and/or technical specification.  
In addition to experience in quality management systems, the auditing team shall have at least 
one member experienced as an assessor in the relevant product field and product technology 
concerned, and with knowledge of the applicable requirements of this Regulation. The audit 
shall include an assessment visit to the manufacturer's premises. The audi ting team shall 
review the technical documentation referred to in point 3.1(b), point (ii), to verify the 
manufacturer's ability to identify the applicable requirements of this Regulation and to carry 
out the necessary examinations with a view to ensuring compliance of the machinery product 
with those requirements.  
The manufacturer or his or her authorised representative shall be notified of the decision.  
The notification shall contain the conclusions of the audit and the reasoned assessment 
decision.   
EN 61  EN 3.4. The m anufacturer shall undertake to fulfil the obligations arising out of the quality 
system as approved and to maintain it so that it remains adequate and efficient.  
3.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of  any intended change to the quality system.  
The notified body shall evaluate any proposed changes and decide whether the modified 
quality system will continue to satisfy the requirements referred to in point 3.2 or whether a 
reassessment is necessary.  
It shall notify the manufacturer of its decision. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision.  
4. Surveillance under the responsibility of the notified body  
4.1. The purpose of surveillance is to make sure tha t the manufacturer duly fulfils the 
obligations arising out of the approved quality system.  
4.2. The manufacturer shall, for assessment purposes, allow the notified body access to 
the design, manufacture, inspection, testing and storage sites, and shall provide  it 
with all necessary information, in particular:  
(a) the quality system documentation;  
(b) the quality records as provided for by the design part of the quality system, such 
as results of analyses, calculations, tests, etc.;  
(c) the quality records as provided for by the manufacturing part of the quality 
system, such as inspection reports and test data, calibration data, qualification 
reports on the personnel concerned, etc.  
4.3. The notified body shall carry out periodic audits to make sure that the manufacturer 
maintai ns and applies the quality system and shall provide the manufacturer with an 
audit report.  
4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During 
such visits, the notified body may, if necessary, carry out product tests, or ha ve 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 tests have been carried out, with a 
test report.  
5. Conformity marking and declaration of conformity  
5.1. The manufac turer shall affix the required conformity marking set out in  this 
Regulation, and, under the responsibility of the notified body referred to in point 3.1, 
the latter's identification number to each individual product that satisfies the 
applicable requirem ents of this Regulation.  
5.2. The manufacturer shall draw up a written declaration of conformity for each 
machinery product model and keep it at the disposal of the national authorities for 
ten years after the machinery product has been placed on the market. Th e declaration 
of conformity shall identify the product model for which it has been drawn up.  
A copy of the declaration of conformity shall be made available to the relevant authorities 
upon request.   
EN 62  EN 6. The manufacturer shall, for a period ending at least ten years after the machinery 
product has been placed on the market, keep at the disposal of the national 
authorities:  
(a) the technical documentation referred to in point 3.1;  
(b) the documentation concerning the quality system referred to in point 3.1;  
(c) the change re ferred to in point 3.5, as approved;  
(d) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 
4.4. 
7. Each notified body shall inform its notifying authorities of quality system approvals 
issued or withdrawn, and shall, periodically o r upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or 
otherwise restricted.  
Each notified body shall inform the other notified bodies of quality system approvals, which it 
has refused, suspen ded or withdrawn, and, upon request, of quality system approvals, which it 
has issued.  
8. Authorised representative  
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his or her 
authorised representative, on his or her beha lf and under his or her responsibility, provided 
that they are specified in the mandate.  
 
 
 
 
 
 
  
EN 63  EN  
 
ANNEX X  
ASSEMBLY INSTRUCTIONS FOR PARTLY COMPLETED MACHINERY  
The assembly instructions for partly completed machinery shall contain a description of the 
conditions, which are to be met to ensure that the partly completed machinery is correctly 
incorporated in the final machinery product, and that the final machinery  product does not 
compromise health and safety of persons and, where appropriate, domestic animals and 
property and, where applicable, the environment.  
The assembly instructions shall be written in an official language of the Union understandable 
to the m anufacturer of the machinery product in which the partly completed machinery is to 
be assembled, or to that manufacturer’s authorised representative.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
EN 64  EN ANNEX XI 
CORRELATION TABLE  
Directive 2006/42/EC  This Regulation  
Article 1  Article 2  
Article 2  Article 3  
Article 3  Article 8 and Article 9  
Article 4  -  
Article 5  Article 7  
Article 6  Article 4  
Article 7  Article 17 (1)  
Article 8 (1)  Article 45  
Article 8 (2)  - 
Article 9  - 
Article 10  Article 42 (3) 
Article 11  Article 41 to Article 44  
Article 12  Article 21  
Article 13  Article 22  
Article 14  Article 24 to Article 40  
Article 15  Article 23  
Article 16  Article 19  
Article 17  Article 20  
Article 18  Article 47  
Article 19  -  
   
EN 65  EN Directive 2006/42/EC  This Regulation  
Article 20  -  
Article 21  Article 51  
Article 21 a  Article 45  
Article 22  Article 46  
Article 23  Article 48  
Article 24  - 
Article 25  Article 49  
Article 26  - 
Article 27  - 
Article 28  Article 52  
Article 29  Article 52  
Annex I - General principles  Annex III - General principles  
Annex I, Section 1  Anne III, Section 1  
Annex I, Section 2  Annex III, Section 2  
Annex I, Section 3  Annex III, Section 3  
Annex I, Section 4  Annex III, Section 4  
Annex I, Section 5  Annex III, Section 5  
Annex I, Section 6  Annex III, Section 6  
Annex II, Parts A and B  Annex V  
Annex III  - 
Annex IV  Annex I  
Annex V  Annex II  
Annex VI  Annex X  
Annex VII, Parts A and B  Annex IV, Parts A and B  
   
EN 66  EN Directive 2006/42/EC  This Regulation  
Annex VIII  Annex VI  
Annex IX  Annex VII  
Annex X  Annex VIII  
Annex XI  Article 28