EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 27.3.2014  
COM(2014) 186 final 
ANNEXES 1 to 11 
  
ANNEXES 
to the 
Proposal for a 
 
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL 
on personal protective equipment 
{SWD(2014) 118 final} 
{SWD(2014) 119 final}   
EN 1   EN   
EN 2   EN ANNEX I  
Risk Categories of PPE 
Category I 
PPE intended to protect users against minimal risks. Category I includes exclusively PPE 
intended to protect users ag ainst the following risks: 
(a) superficial mechanical injury; 
(b) contact with water or cleani ng materials of weak action; 
(c) contact with hot surfaces not exceeding 50°C; 
(d) damage to the eyes due to exposure to sunlight (other than during observation 
of the sun); 
(e) atmospheric conditions that are not of an extreme nature. 
Category II 
Category II includes: 
(a) PPE intended to protect user s against risks other than those listed in Categories 
I and III; 
(b) made-to-measure PPE except where such PPE is intended to protect users 
against risks listed in Category I. 
Category III 
PPE intended to protect users against very se rious risks. Category I II includes exclusively 
PPE intended to protect users against the following risks: 
(a) inhalation of harmful substances; 
(b) aggressive chemicals; 
(c) ionising radiation; 
(d) high-temperature environments the effects of which are comparable to those of 
an air temperature of at least 100°C; 
(e) low-temperature environments the effects of which are comparable to those of 
an air temperature of -50°C or less; 
(f) falling from a height; 
(g) electric shock and live working; 
(h) drowning; 
(i) cuts by hand-held chain-saws; 
(j) high-pressure cutting; 
(k) bullet wounds or knife stabs; 
(l) harmful noise.  
EN 3   EN ANNEX II  
Essential health and safety requirements 
1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE 
PPE must provide adequate protection against the risks against which it is  intended to protect. 
1.1. Design principles 
1.1.1. Ergonomics PPE must be designed and manufactured so th at, in the foreseeable conditions of use for 
which it is intended, the user can perform the risk-related activity normally whilst enjoying appropriate protection of th e highest level possible. 
1.1.2. Levels and classes of protection 
1.1.2.1. Optimum level of protection 
The optimum level of protection to be taken in to account in the design  is that beyond which 
the constraints imposed by the wearing of the PPE would prevent its ef fective use during the 
period of exposure to the risk or th e normal performance of the activity. 
1.1.2.2. Classes of protection appropriate  to different levels of risk 
Where differing foreseeable conditions of use are su ch that several levels of the same risk can 
be distinguished, appropriate cla sses of protection must be taken into account in the design of 
the PPE. 
1.2. Innocuousness of PPE 
1.2.1. Absence of inherent risk s and other nuisance factors 
PPE must be designed and manufactured so as not to create risks or  other nuisance factors 
under foreseeable conditions of use. 
1.2.1.1. Suitable constituent materials 
The materials of which the PPE is made, including any of their possible decomposition 
products, must not adversely affect the health or safety of users. 
1.2.1.2. Satisfactory surface condition of all PP E parts in contact with the user 
Any part of the PPE that is in c ontact or is liable to come into contact with the user when the 
PPE is worn must be free of rough surfaces, sh arp edges, sharp points and the like which 
could cause excessive ir ritation or injuries. 
1.2.1.3. Maximum permissible user impediment 
PPE shall hinder as little as pos sible the actions to be carried out, the pos tures to be adopted 
and sensory perceptions; furthermore, use of the PPE must not engender actions which might 
endanger the user or other persons.  
EN 4   EN 1.3. Comfort and effectiveness 
1.3.1. Adaptation of PPE to user morphology PPE must be designed and manufactured to facil itate its correct positioning on the user and to 
remain in place for the foreseeable period of use,  bearing in mind ambient factors, the actions 
to be carried out and the postures to be adopte d. For this purpose, it must be possible to adapt 
the PPE to fit the morphology of the user by all appropriate means such as adequate adjustment and attachment systems or the provision of an ade quate range of sizes. 
1.3.2. Lightness and strength 
PPE must be as light as possible without prejudicing its strength and effectiveness. 
As well as the specific additional requirements wh ich they must satisfy in order to provide 
adequate protection against the risks for which they are inte nded, PPE must be capable of 
withstanding environmental factors in  the foreseeable conditions of use. 
1.3.3. Compatibility of types of PPE intended for simultaneous use 
If the same manufacturer places on the market  several models of PPE models of different 
types in order to ensure the simultaneous prot ection of adjacent parts of the body, they must 
be compatible. 
1.4. Manufacturer's instructions 
In addition to the name and address of the manu facturer or his authorized representative, or 
both, the instructions that must be drawn up by the manufacturer and supplied with the PPE 
when it is placed on the market must contain all relevant information on: 
(a) instructions for storage, use, cleaning, maintenance, servicin g and disinfection. 
Cleaning, maintenance or disi nfectant products recommended by 
manufacturers must have no adverse e ffect on the PPE or the user when 
applied in accordance with the relevant instructions; 
(b) performance as recorded during technical te sts to check the levels or classes of 
protection provided by the PPE; 
(c) accessories that may be used with the PPE and the characteristics of 
appropriate spare parts; 
(d) the classes of protection appropriate to  different levels of risk and the 
corresponding limits of use; 
(e) the date or period of obsolescence of the PPE or of certain of its components; 
(f) the type of packaging suitable for transport; 
(g) the significance of any markings (see 2.12); 
(h) where applicable, the references of other Union harmonisation legislation; 
(i) the name, address and identification number of the notified body or bodies 
involved in the conformity assessment of the PPE. 
These instructions, which must be precise and comprehensible, must be  provided at least in 
the official language(s) of the Member State of destination.  
EN 5   EN 2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE 
2.1. PPE incorporating adjustment systems 
If PPE incorporates adjustment systems, the latt er must be designed and manufactured so that, 
after adjustment, they do no become undone unint entionally in the foreseeable conditions of 
use. 
2.2. PPE enclosing the parts of the body to be protected 
As far as possible, PPE enclosing the parts of the body to be protected must be sufficiently 
ventilated to limit perspiration re sulting from use; otherwise, it must be equipped with means 
of absorbing perspiration. 
2.3. PPE for the face, eyes and respiratory system 
PPE for the face, eyes or respiratory system shall restrict the user's fiel d of vision and sight as 
little as possible. 
The screens for these types of PPE must have a de gree of optical neutrality  that is compatible 
with the degree of precision and the dur ation of the activit ies of the user. 
If necessary, they must be treated or provided with means to prevent misting up. 
Models of PPE intended for users requiring sight  correction must be compatible with the 
wearing of spectacles or contact lenses. 
2.4. PPE subject to ageing 
If it is known that the design performance of  new PPE may be significantly affected by 
ageing, the date of manufacture and/or, if possibl e, the date of obsolescence, must be indelibly 
and unambiguously marked on each item of PPE or each interchangeable component for PPE placed on the market and on their packaging. 
If the manufacturer is un able to give an undertaking with re gard to the useful life of the PPE, 
his instructions must provide all the information necessary to enable the purchaser or user to 
establish a reasonable obsolescence date, taking  into account the quality level of the model 
and the effective conditions of storage, use, cleaning, servicing and maintenance. 
Where appreciable and rapid deterioration in PPE performance is likely to be caused by 
ageing resulting from the periodic use of a cleaning process recommended by the manufacturer, the latter must, if possible, affix a marking to  each item of PPE placed on the 
market indicating the maximum number of cleani ng operations that may be carried out before 
the equipment needs to be inspected or discarded;  failing that, the manufact urer must give this 
information in his instructions. 
2.5. PPE which may be caught up during use 
Where the foreseeable conditions of  use include in par ticular the risk of the PPE being caught 
up by a moving object thereby creating a dange r for the user, the PPE must possess an 
appropriate resistance threshold above which a constituent part will break and eliminate the 
danger.  
EN 6   EN 2.6. PPE for use in potentially explosive atmospheres 
PPE intended for use in potentially explos ive atmospheres must be so designed and 
manufactured that it cannot be the source of an electr ic, electrostatic or impact-induced arc or 
spark likely to cause an e xplosive mixture to ignite. 
2.7. PPE intended for rapid intervention or to be put on or removed rapidly 
These types of PPE must be designed and ma nufactured to minimize the time required for 
putting on and removing the equipment. 
Where PPE comprises fixing systems enabling th e PPE to be maintained in the correct 
position on the user or removed, it must be possible to operate them quickly and easily. 
2.8. PPE for intervention in very dangerous situations 
The instructions supplied by th e manufacturer with PPE for in tervention in very dangerous 
situations must include, in particular, data in tended for competent, trained persons who are 
qualified to interpret them and ensu re their application by the user. 
They must also describe the procedure to be adopted in order to verify that PPE is correctly 
adjusted and functional when worn by the user. 
Where the PPE incorporates an alarm which is  activated in the absence of the level of 
protection normally provided, this must be desi gned and placed so that it can be perceived by 
the user in the foreseeable conditions of use. 
2.9. PPE incorporating components which ca n be adjusted or removed by the user 
Where PPE incorporates components which can be adjusted or removed by the user for 
replacement purposes, they must be designed a nd manufactured so that  they can be easily 
attached and removed without tools. 
2.10. PPE for connection to complementary equipment external to the PPE 
Where PPE incorporates a connexion syst em permitting its connection to other, 
complementary equipment, the means of attach ment must be designed and manufactured to 
enable it to be mounted onl y on appropriate equipment. 
2.11. PPE incorporating a fluid circulation system 
Where PPE incorporates a fluid ci rculation system, the latter mu st be chosen or designed and 
placed to permit adequate fluid renewal in the vi cinity of the entire part of the body to be 
protected, irrespective of the ac tions, postures or movements of the user under the foreseeable 
conditions of use. 
2.12. PPE bearing one or more identification markings or indicators directly or 
indirectly relating to health and safety 
The identification markings or indicators directly or indirectly relating to health and safety 
affixed to these types of PPE mu st, if possible,  take the form  of harmonized pictograms or 
ideograms. They must be perfectly visibl e and legible and remain so throughout the 
foreseeable useful life of the PPE. In addition, these markings must be complete, precise and  
EN 7   EN comprehensible so as to preven t any misinterpretation; in pa rticular, when such markings 
include words or sentences, the latter must be  written in the official language(s) of the 
Member State where the equipment is to be used. 
Where the PPE (or the interchangeable component fo r PPE) is too small to allow all or part of 
the necessary marking to be affixed, the rele vant information must be mentioned on the 
packaging and in the manufacturer's instructions.  
2.13. PPE capable of signalling the user's presence visually 
PPE intended for foreseeable conditions of use in  which the user's presence must be visibly 
and individually signalled must have one (or more) judiciously positioned means or devices 
for emitting direct or reflected visible radi ation of appropriate luminous intensity and 
photometric and colorimetric properties. 
2.14. Multi-risk PPE 
PPE intended to protect the user against seve ral potentially simulta neous risks must be 
designed and manufactured to satisfy, in part icular, the essential health and safety 
requirements specific to each of those risks. 
3. ADDITIONAL REQUIREMENTS SPECI FIC TO PARTICULAR RISKS 
3.1. Protection against mechanical impact 
3.1.1. Impact caused by falling or ejected objects and collisions of parts of the body with an 
obstacle 
PPE intended for this type of risk must be sufficiently shock-absorbent to prevent injury 
resulting, in particular, from the crushing or penetration of the protected part , at least up to an 
impact-energy level above which the excessive dimensions or mass of the means of shock-absorption would preclude effective use of th e PPE for the foreseeable period of wear. 
3.1.2. Falls 
3.1.2.1. Prevention of falls due to slipping 
The outsoles of protective foot wear intended to prevent s lipping must be designed and 
manufactured or equipped with additional means to ensure adequate grip by friction, studs or 
spikes, having regard to the nature  or state of th e ground surface. 
3.1.2.2. Prevention of falls from a height 
PPE intended to prevent falls from a height or  their effects must incorporate a body harness 
and a connexion system which can be connected to a reliable external anchorage point. It 
must be designed and manufactured so that, under the foreseeable conditions of use, the 
vertical drop of the user is minimized to pr event collision with obstacles while the braking 
force does not attain the threshold value at wh ich physical injury or the opening or breakage 
of any PPE component which might cause the us er to fall can be expected to occur. 
It must also ensure that, after braking, the user  is maintained in a correct position in which he 
may await help if necessary.  
EN 8   EN The manufacturer's instructions must specify, in  particular, all relevant information relating 
to: 
(a) the characteristics required for the reli able external anc horage point and the 
necessary minimum clearance below the user; 
(b) the proper way of putting on the body harness and of attaching the connexion 
system to the reliable anchorage point. 
3.1.3. Mechanical vibration 
PPE designed to prevent the effects of mechani cal vibrations must be capable of ensuring 
adequate attenuation of harmfu l vibration components for the part of the body at risk. 
3.2. Protection against static compre ssion of part of the body 
PPE designed to protect part of the body against static compressive  stress must be sufficiently 
capable of attenuating its effects to preven t serious injury or chronic complaints. 
3.3. Protection against mechanical injuries 
PPE constituent materials and other components designed to protect all or part of the body 
against superficial injuries, such as abrasion, perf oration, cuts or bites, must be so chosen or 
designed and incorporated as to ensure that th ese types of PPE provide sufficient resistance to 
abrasion, perforation and gashing (see also 3. 1) under the foreseeable conditions of use. 
3.4. Protection in the water 
3.4.1. Prevention of drowning 
PPE designed to prevent drowning must be capabl e of returning to the surface as quickly as 
possible, without danger to his health, a user  who may be exhausted or unconscious after 
falling into a liquid medium, and of keeping hi m afloat in a position which permits breathing 
while awaiting help. 
PPE may be wholly or partially inherently buo yant or may be inflated by gas which can be 
manually or automatically released, or orally. 
Under the foreseeable conditions of use: 
(a) PPE must, without prejudice to its satisfactory operation, be capable of 
withstanding the effects of impact  with the liquid medium and the 
environmental factors inherent in that medium; 
(b) inflatable PPE must be capable of inflating rapidly and fully. 
Where particular foreseeable conditions of use so require, certain t ypes of PPE must also 
satisfy one or more of the fo llowing additional requirements: 
(a) they must have all the inflation devices referred to in the second subparagraph, 
and/or a light or s ound-signalling device; 
(b) they must have a device for hitching and attaching the body so that the user 
may be lifted out of the liquid medium; 
(c) they must be suitable for prolonged use throughout the pe riod of activity 
exposing the user, possibly dressed, to the risk of falling into the liquid 
medium or requiring his immersion in it.  
EN 9   EN 3.4.2. Buoyancy aids 
Clothing which will ensure an effective degr ee of buoyancy, depending on its foreseeable use, 
which is safe when worn and which afford s positive support in wa ter. In foreseeable 
conditions of use, this PPE must not restrict th e user's freedom of movement but must enable 
him, in particular, to swim or take action to escape from danger or to rescue other persons.  
EN 10   EN 3.5. Protection against the ha rmful effects of noise 
PPE intended to prevent the harmful effects of no ise must be capable of attenuating the latter 
so that the exposure of the user does not under any circumstances exceed the limit values laid 
down by Directive 2003/10/EC of the Eur opean Parliament and of the Council1. 
Each item of PPE must bear labelling indicati ng the noise attenuation level provided by the 
PPE; should this not be possible, the labe lling must be fixed to the packaging. 
3.6. Protection against heat and/or fire 
PPE designed to protect all or part of the body against the effe cts of heat and/or fire must 
possess thermal insulation capacity and mechani cal strength appropriate to the foreseeable 
conditions of use. 
3.6.1. PPE constituent materi als and other components 
Constituent materials and other components in tended for protection against radiant and 
convective heat must possess an appropriate coe fficient of transmission of incident heat flux 
and be sufficiently incombustible to precl ude any risk of spontan eous ignition under the 
foreseeable conditions of use.  
Where the outside of these materials and compone nts must be reflective , its reflective power 
must be appropriate to the intensity of the h eat flux due to radiation in the infra-red range. 
Materials and other components of equipment intended for brief use in high-temperature 
environments and of PPE which may be splashed  by hot products such as large quantities of 
molten material must also possess sufficient thermal capacity to retain most of the stored heat until after the user has left the danger area and removed his PPE. 
PPE materials and other components which may be splashed by large amounts of hot products 
must also possess sufficient mechanical-impact absorbency (see 3.1). 
PPE materials and other components which may accidentally come into contact with flame 
and those used in the manufacture of fire-fi ghting equipment must also possess a degree of 
non-flammability corresponding to the risk class a ssociated with the foreseeable conditions of 
use. They must not melt when exposed to fl ames nor contribute to flame propagation. 
3.6.2. Complete PPE ready for use 
Under the foreseeable conditions of use: 
(a) the quantity of heat transmitted by PPE to the user must be sufficiently low to 
prevent the heat accumulated during wear in the part of the body at risk from 
attaining, under any circumstances, the pa in or health impairment threshold; 
(b) the PPE must if necessary prevent liqui d or steam penetration and must not 
cause burns resulting from contact betw een its protective integument and the 
user. 
                                                
 
1 Directive 2003/10/EC of the European Parliament and of the Council of 6 February 2003 on the 
minimum health and safety requirements regarding the exposure of workers to the risks arising from 
physical agents (noise) (OJ L 42, 15.2.2003, p. 38).  
EN 11   EN If PPE incorporates refrigeratio n devices for the absorption of  incident heat by means of 
liquid evaporation or solid sublimation, their desi gn must be such that any volatile substances 
released are discharged beyond the outer prot ective integument and not towards the user. 
If PPE incorporates a breathing device, the latter  must adequately fulfil the protective function 
assigned to it under the fore seeable conditions of use. 
The manufacturer's instructions accompanying PPE  intended for brief use in high-temperature 
environments must in particular provide all relevant data for the determination of the 
maximum permissible user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose. 
3.7. Protection against cold 
PPE designed to protect all or part of the body ag ainst the effects of cold must possess thermal 
insulating capacity and mechanical strength ap propriate to the foreseeable conditions of use 
for which it is intended. 
3.7.1. PPE constituent materi als and other components 
Constituent materials and other components suitabl e for protection against cold must possess 
a coefficient of transmission of incident ther mal flux as low as required under the foreseeable 
conditions of use. Flexible ma terials and other com ponents of PPE intended for use in a low-
temperature environment must retain the degr ee of flexibility requi red for the necessary 
gestures and postures. 
PPE materials and other components which may be splashed by large amounts of cold 
products must also possess sufficient m echanical-impact absorbency (see 3.1). 
3.7.2. Complete PPE ready for use 
Under the foreseeable conditions of use the following requirements apply: 
(a) the flux transmitted by PPE to the user must be sufficiently low to prevent the 
cold accumulated during wear at any point on the part of the body being 
protected, including the tips of fingers a nd toes in the case of hands or feet, 
from attaining, under any circumstances, the pain or health-impairment threshold; 
(b) PPE must as far as possible prevent the penetration of such liquids as rain 
water and must not cause injuries resu lting from contact between its cold 
protective integument and the user. 
If PPE incorporates a breathing device, this must adequately fulfil the protective function 
assigned to it under the fore seeable conditions of use. 
The manufacturer's instructions  accompanying PPE intended for brief use in low-temperature 
environments must provide all relevant da ta concerning the maximum permissible user 
exposure to the cold transmitted by the equipment.  
EN 12   EN 3.8. Protection against electric shock 
3.8.1. Insulating equipment PPE designed to protect all or part of the body ag ainst the effects of electric current must be 
sufficiently insulated against the voltages to which the user is likely to be e xposed under the 
most unfavourable foreseeable conditions. 
To this end, the constitu ent materials and other components of  these types of PPE must be so 
chosen or designed and incorporated as to en sure that the leakage current measured through 
the protective integument under test conditions at  voltages correlated with those likely to be 
encountered in situ is minimized and, at  all events, below a maximum conventional 
permissible value which correlates with the tolerance threshold. 
Together with their packaging, PPE types in tended exclusively for use during work or 
activities in electrical installations which are or may be under tension must bear markings 
indicating, in particular, thei r protection class or corresponding operating voltage, their serial 
number and their date of manuf acture; a space must also be provided outside the protective 
integument of such PPE for the subsequent inscri ption of the date of entry into service and 
those of the periodic  tests or inspections to be conducted. 
The manufacturer's instructions must indicate, in particular, the exclusive use for which these 
PPE types are intended and the nature and freque ncy of the dielectric tests to which they are 
to be subjected duri ng their useful life. 
3.8.2. Conductive equipment 
Conductive PPE intended for live working at high voltages shall be designed and 
manufactured to ensure that there is no di fference of potential betw een the user and the 
installations on which he is intervening. 
3.9. Radiation protection 
3.9.1. Non-ionizing radiation PPE designed to prevent acute or chronic eye-da mage from sources of non-ionizing radiation 
must be capable of absorbing or  reflecting the majority of the energy radiated in the harmful 
wavelengths without unduly affecting the transm ission of the innocuous part of the visible 
spectrum, the perception of contrasts and the abil ity to distinguish colours where required by 
the foreseeable conditions of use. 
To this end, protective glasses must be so de signed and manufactured as to possess, for each 
harmful wave length, a spectral transmission f actor such that the radiant-energy illumination 
density capable of r eaching the user's eye through the fi lter is minimized and, under no 
circumstances, exceeds the maximum permissible exposure value. 
Furthermore, the glasses must not deteriorate or lose their properti es as a result of the effects 
of radiation emitted under the foreseeable conditi ons of use and all marketed specimens must 
bear the protection-factor numb er corresponding to the spectra l distribution curve of their 
transmission factor. 
Glasses suitable for radiation sources of the sa me type must be classified in the ascending 
order of their protection fact ors and the manufacturer's inst ructions must indicate, in 
particular, how to select the appropriate PPE ta king into account the relevant conditions of use  
EN 13   EN such as the distance from the source and the spect ral distribution of the energy radiated at that 
distance 
The relevant protection factor number must be marked on all specimens of filtering glasses by 
the manufacturer. 
3.9.2. Ionizing radiation 
3.9.2.1. Protection against external  radioactive contamination 
PPE constituent materials and other components designed to protect all or part of the body 
against radioactive dust, gases, liquids or mixtures thereof must be so chosen or designed and 
incorporated as to ensure that this equipmen t effectively prevents the penetration of the 
contaminants under the foreseeable conditions of use. 
Depending on the nature or condition of these contaminants, the necessary leak-tightness can 
be provided by the impermeability of the pr otective integument and/or by any other 
appropriate means, such as ventilation and pr essurization systems designed to prevent the 
back-scattering of these contaminants. 
Any decontamination measures to which PPE is subject must not prejudice its possible re-use 
during the foreseeable useful life of these types of equipment. 
3.9.2.2. Protection against external irradiation 
PPE intended to provide complete user protection against external irradiation or, failing this, 
adequate attenuation thereof, must be designed to counter only weak electron (e. g. beta) or 
weak photon (e. g. X, gamma) radiation. 
The constituent materials and other components of  these types of PPE must be so chosen or 
designed and incorporated as to provide th e degree of user protection required by the 
foreseeable conditions of use without leading to an increase in exposure ti me as a result of the 
impedance of user gestures, posture or movement (see 1.3.2). 
PPE must bear a mark indicating the type and equivalent thickness of the constituent 
material(s) suitable for the foreseeable conditions of use. 
3.10. Protection against dangerous substances and infectious agents 
3.10.1. Respiratory protection PPE intended for the protection of  the respiratory system must make it possible to supply the 
user with breathable air when exposed to a po lluted atmosphere and/or  an atmosphere having 
an inadequate oxygen concentration. 
The breathable air supplied to th e user by the PPE must be obtai ned by appropriate means, for 
example after filtration of the polluted air through the prot ective equipment or by supply from 
an external unpolluted source. 
The constituent materials and other components of these types of PPE must be chosen or 
designed and incorporated to ensure appropriate  user respiration and respiratory hygiene for 
the period of wear concerned under th e foreseeable conditions of use. 
The leak-tightness of the facepiece and the pressu re drop on inspiration a nd, in the case of the 
filtering devices, purification capacity must keep contaminant penetration from a polluted atmosphere low enough not to be prejudicial to the health or h ygiene of the user.  
EN 14   EN The PPE must bear the manufacturer's identification mark and details of the specific 
characteristics of the equipment which, in conj unction with the instructions, enable a trained 
and qualified user to employ the PPE correctly. 
In the case of filtering equipment, the manufactur er's instructions must also, indicate the time 
limit for the storage of new filters kept in their original packaging. 
3.10.2. Protection against cuta neous and ocular contact 
PPE intended to prevent the surface contact of all or part of the body with dangerous 
substances and infective agents must be capab le of preventing the penetration or permeation 
of such substances and ag ents through the protective in tegument under the foreseeable 
conditions of use for which the PPE is intended. 
To this end, the constituent materials and othe r components of these types of PPE must be 
chosen or designed and incorporated to ensure, as far as possible, complete leak-tightness, 
which will allow where necessary prolonged daily use or, failing this, limited leak-tightness 
necessitating a restriction of the period of wear. 
Where, by virtue of their nature and the fores eeable conditions of their use, certain dangerous 
substances or infectious agents possess high penetrative power which limits the duration of 
the protection provided by the PPE in question, the latter must be subjected to standard tests 
with a view to their classification on the basis of their performance. PPE  which is considered 
to be in conformity with the test specificati ons must bear a marking indicating, in particular, 
the names or, failing this, the codes of the subs tances used in the tests and the corresponding 
standard period of protection. The manufacturer's instructions must  also contain, in particular, 
an explanation of the codes (if necessary), a de tailed description of the standard tests and all 
appropriate information for the determination of the maximum permissi ble period of wear 
under the different foreseeable conditions of use. 
3.11. Diving equipment 
The breathing equipment must make it possible to  supply the user with a breathable gaseous 
mixture, under foreseeable conditions of use and taking account in particular of the maximum 
depth of immersion. 
Where the foreseeable conditions of use so requ ire, the diving equipment must comprise the 
following: 
(a) a suit which protects the user  against cold (see 3.7); 
(b) an alarm designed to give the user prompt  warning of an approaching failure in 
the supply of breathable gaseous mixture (see 2.8); 
(c) a life-saving device enab ling the user to return to the surface.  
EN 15   EN ANNEX III  
Technical documentation for PPE 
The technical documentation shall specify the m eans used by the manufacturer to ensure the 
conformity of the PPE with the applicable esse ntial health and safety requirements referred to 
in Article 5 and set out in Annex II. 
The technical documentation shall include  at least the following elements: 
1. a complete description of the PPE and of its intended use; 
2. an assessment of the risk(s) against which the PPE is intended to protect; 
3. a list of the essential health and safety re quirements that are applicable to the PPE; 
4. design and manufacturing draw ings and schemes of the PPE and of its components, 
sub-assemblies, and circuits; 
5. the descriptions and explanations necessa ry for the understanding of the drawings 
and schemes referred to in point 4 and of the operation of the PPE; 
6. the reference(s) of the harmonised standard(s ) referred to in Article  14 that have been 
applied for the design and manufacture of th e PPE; in the event of partial application 
of harmonised standards, the documentation shall specify the part s which have been 
applied; 
7. where harmonised standards have not b een applied or only partially applied, 
descriptions of the other technical specifica tions that have been applied in order to 
satisfy the applicable essential health and safety requirements; 
8. the results of the design calculations, in spections and examinations carried out to 
verify the conformity of the PPE with th e applicable essential health and safety 
requirements; 
9. reports on the tests carried out to verify the conformity of the PPE with the 
applicable essential health and safety requirements and, wh ere appropriate, to 
establish the relevant  protection class; 
10. a description of the means used by the manufacturer during the production of the 
PPE to ensure the conformity of the PPE  produced with the de sign specifications; 
11. a copy of the manufacturer's instructions referred to in point 1.4 of Annex II; 
12. for made-to-measure PPE, all the necessary instructions of the designer of the basic 
model for manufacturing made-to-measure PPE on the basis of the approved basic 
model.  
EN 16   EN ANNEX IV  
Internal production control 
(Module A) 
1. Internal production control is the conf ormity assessment procedure whereby the 
manufacturer fulfils the obligations laid  down in points 2, 3 and 4, and ensures and 
declares on his sole responsibility that th e PPE concerned satisfies the applicable 
essential health and safety requirements refe rred to in Article 5 and set out in Annex 
II. 
2. Technical documentation 
The manufacturer shall establish the techni cal documentation described in Annex III. 
The documentation shall make it possible to assess the conformity of the PPE to the 
applicable requirements, and shall include an adequate analysis and assessment of 
the risk(s). The technical documentation sh all specify the applicable requirements 
and cover, as far as relevant for th e assessment, the design, manufacture and 
operation of the PPE. 
3. Manufacturing 
The manufacturer shall take all measures n ecessary so that the manufacturing process 
and its monitoring ensure compliance of the manufactured PPE with the technical documentation referred to in point 2 and w ith the applicable essential health and 
safety requirements. 
4. CE marking and EU decl aration of conformity 
4.1. The manufacturer shall affix the CE marking to each individual PPE that satisfies the 
applicable essential health  and safety requirements. 
4.2. The manufacturer shall draw up a written EU declaration of conformity for a PPE 
model and keep it together with the techni cal documentation at the disposal of the 
national authorities for 10 year s after the PPE has been placed on the market. The EU 
declaration of conformity shall identify  the PPE for which it has been drawn up. 
A copy of the EU declaration of conform ity or a simplified EU declaration of 
conformity shall accompany every PPE. 
5. Authorised representative 
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised 
representative, on his behalf  and under his responsibility,  provided that they are 
specified in the mandate.  
EN 17   EN ANNEX V  
EU type-examination 
(Module B) 
1. EU type-examination is the part of a c onformity assessment procedure in which a 
notified body examines the tech nical design of PPE and veri fies and attests that the 
technical design of the PPE meets  the applicable essential health and safety 
requirements referred to in Arti cle 5 and set out in Annex II. 
2. EU type-examination shall be carried out  with the examination of a specimen, 
representative of the pro duction envisaged, of the complete PPE (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 choice. 
The application shall include: (a) the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address as well; 
(b) a written declaration that the same a pplication has not been lodged with any 
other notified body; 
(c) the technical documentation described in Annex III. The documentation shall 
make it possible to assess the conformity of the PPE to the applicable requirements, and shall include an ade quate analysis and assessment of the 
risk(s). The technical documentation sha ll specify the applicable requirements 
and cover, as far as relevant for the assessment, the design, manufacture and 
operation of the PPE; 
(d) the specimen(s) of the PPE representa tive of the production envisaged. The 
notified body may request further specimens  if needed for ca rrying out the test 
programme. For individually adapted PPE , specimens shall be provided that 
are representative of the range of different users; 
(e) for individually adapted PPE, a descripti on of the measures to be taken by the 
manufacturer during the f itting and production process to ensure that each item 
of PPE complies with the approved type and with the applicable essential health and safety requirements. 
4. EU type-examination 
The notified body shall: (a) examine the technical documentation to assess the adequacy of the technical 
design of the PPE; 
(b) for individually adapted PPE, examine the description of the measures referred 
to in point 3 to assess their adequacy; 
(c) for made-to-measure PPE, examine the inst ructions of the designer of the basic 
model for manufacturing made-to-meas ure PPE on the basis of the approved 
basic model to assess their adequacy; 
(d) verify that the specimen(s) have been manufactured in conformity with the 
technical documentation, and identify the elements which have been designed  
EN 18   EN in accordance with the applicable pr ovisions of the relevant harmonised 
standards as well as the elements which have been designed in accordance with other technical specifications; 
(e) carry out appropriate examina tions and tests, or have them carried out, to check 
whether, where the manufacturer has c hosen to apply the solutions in the 
relevant harmonised standards, th ese have been applied correctly; 
(f) carry out appropriate examina tions and tests, or have them carried out, to check 
whether, where the solutions in the re levant harmonised standards have not 
been applied, the solutions adopted by the manufacturer, including those in 
other technical specificati ons applied, meet the corre sponding essential health 
and safety requirements and have been applied correctly. 
5. Evaluation report 
The notified body shall draw up an evalua tion report that reco rds the activities 
undertaken in accordance with point 4 and their outcomes. Without prejudice to its 
obligations vis-à vis the notifying authorities, the not ified body shall release the 
content of that report, in fu ll or in part, only with the agreement of the manufacturer. 
6. EU type-examination certificate 
6.1. Where the type meets the applicable essent ial health and safety requirements, the 
notified body shall issue an EU type-exa mination certificate to the manufacturer. 
6.2. That certificate shall contain at least the following information: 
(a) the name and identification number of the notified body; 
(b) the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address; 
(c) identification of the PPE covered by the certificate (type, model, 
manufacturer’s reference); 
(d) a statement that the PPE complies with the applicable essential health and 
safety requirements referred to in Article 5 and set out in Annex II; 
(e) where harmonised standards have been fully  or partially applied, the references 
of those standards or parts thereof; 
(f) where other technical specifications ha ve been applied, their references; 
(g) where applicable, the performance leve l(s) or protection class of the PPE; 
(h) for made-to-measure PPE, the range of permissible variations of relevant 
parameters for made-to-measure PPE based on the approved basic model; 
(i) the date of issue and, where appr opriate, the date (s) of renewal; 
(j) the date of expiry (a maximum of five y ears after the date of issue or the date 
of the last renewal); 
(k) any conditions attached to the issue of the certificate; 
(l) for category III PPE, a statement that the certificate shall only be used in 
conjunction with one of the conformity assessment procedures referred to in 
Article 18. 
6.3. The EU type-examination certificate may have one or more annexes attached.  
EN 19   EN 6.4. For made-to-measure PPE, if the pers on to whom the EU type-examination 
certificate was issued is not the manuf acturer of the made-to-measure PPE: 
(a) the manufacturer of the made-to-measure PPE shall have the written 
authorisation of the certificate hol der to use that certificate; 
(b) the certificate holder shall provide th e manufacturer of the made-to-measure 
PPE with the instructions referre d to in point 12 of Annex III. 
6.5. Where the type does not satisfy the appl icable essential health and safety 
requirements, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving deta iled reasons for its 
refusal. 
7. Review of the EU type-examination certificate 
7.1. The notified body shall keep itself appris ed of any changes in the generally 
acknowledged state of the art which indica te that the approved type may no longer 
comply with the applicable essential he alth and safety requirements, and shall 
determine whether such changes require furt her investigation. If  so, the notified body 
shall inform the manufacturer accordingly. 
7.2. The manufacturer shall inform the no tified body that hold s the technical 
documentation relating to the EU type-examina tion certificate of all modifications to 
the approved type that may affect the conf ormity of the PPE with the applicable 
essential health and safety  requirements or the conditio ns 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 PPE c ontinues 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: 
(a) in case of a modification to th e PPE referred to in point 7.2; 
(b) in 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. 
7.5. The notified body shall examine the PPE and ca rry out any tests necessary to ensure 
that the PPE continues to fulfil the applicable essential health and safety requirements. In that case, it shall rene w the EU type-examination certificate. 
7.6. If, following the review, the notified body concludes that the EU type-examination 
certificate is no longer valid, the body shal l withdraw it and th e manufacturer shall 
cease the placing on the market of the PPE concerned. 
8. The notified body shall inform  its notifying authority concerning the EU type-
examination certificates and/or any add itions thereto which it has issued or 
withdrawn, and shall, periodi cally or upon request, make available to its notifying 
authority the list of such certificates and/ or any additions thereto refused, suspended 
or otherwise restricted. 
The notified body shall inform the other notified bodies concerning the EU type-
examination certificates and/or any addi tions thereto which it has refused,  
EN 20   EN withdrawn, suspended or otherwise rest ricted, and, upon request , concerning such 
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 of the EU type-examination ce rtificates and/or additions thereto. On a 
reasoned request, the Commission and the Me mber States may obtain a copy of the 
technical documentation and the results of the examinations carried out by the 
notified body. 
The notified body shall keep a copy of th e EU type-examination certificate, its 
annexes and additions, as well as the technical file including the documentation 
submitted by the manufacturer, until 5 years after the expiry of the validity of that 
certificate. 
9. The manufacturer shall keep a copy of th e EU type-examination certificate, its 
annexes and additions together with the t echnical documentation at the disposal of 
the national authorities for 10 years afte r the PPE has been placed on the market. 
10. The manufacturer's authorised representativ e may lodge the application referred to in 
point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.  
EN 21   EN ANNEX VI  
Conformity to type based on internal production control 
(Module C) 
1. Conformity to type based on internal producti on control is the part of a conformity 
assessment procedure whereby the manufactur er fulfils the obligations laid down in 
points 2 and 3, and ensures and declares unde r his sole responsib ility that the PPE 
concerned is in conformity with the t ype described in the EU type-examination 
certificate and satisfies the applicable es sential health and safety requirements 
referred to in Article 5 and set out in Annex II. 
2. Manufacturing 
The manufacturer shall take all measures n ecessary so that the manufacturing process 
and its monitoring ensure conformity of  the manufactured PPE with the type 
described in the EU type-examination certifi cate and with the applicable essential 
health and safety requirements. 
For made-to-measure PPE the manufacturer shal l take all measures necessary so that 
the manufacturing process and its monitoring ensure conformity of the manufactured 
made-to-measure PPE with the basic model described in the EU type-examination certificate and with the app licable essential health and safety requirements. 
3. CE marking and EU decl aration of conformity 
3.1. The manufacturer shall affi x the CE marking to each individual PPE that is in 
conformity with the type described in the EU type-e xamination certificate and 
satisfies the applicable essential health and safety requirements. 
3.2. The manufacturer shall draw up a written EU declaration of conformity for a PPE 
model and keep it at the disposal of the na tional authorities for 10 years after the PPE 
has been placed on the market. The EU decl aration of conformity shall identify the 
PPE for which it has been drawn up. 
A copy of the EU declaration of conform ity or a simplified EU declaration of 
conformity shall accompany every PPE. 
4. Authorised representative 
The manufacturer's obligations set out in point 3 may be fulfilled by his authorised 
representative, on his behalf  and under his responsibility,  provided that they are 
specified in the mandate.  
EN 22   EN ANNEX VII  
Conformity to type based on product verification 
(Module F) 
1. Conformity to type based on product veri fication is the part of a conformity 
assessment procedure whereby the manufactur er fulfils the obligations laid down in 
points 2, 3, 5.2 and 6, and ensures and declar es on his sole responsibility that the 
PPE, which has been subject to the provision s of point 4, is in conformity with the 
type described in the EU type-examination certificate and satisfies the applicable essential health and safety requirements refe rred to in Article 5 and set out in Annex 
II. 
2. Manufacturing 
The manufacturer shall take all measures n ecessary so that the manufacturing process 
and its monitoring ensure the homogeneity  of production and conformity of the 
manufactured PPE with the type describe d in the EU type-examination certificate 
and with the applicable essential health and safety requirements. 
3. Application for product verification 
Before placing PPE on the market, the manuf acturer shall lodge an application for 
product verification with a singl e notified body of his choice. 
The application shall include the following: (a) the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address; 
(b) a written declaration that the same a pplication has not been lodged with any 
other notified body;  
(c) the identification of  the PPE concerned. 
Where the chosen body is not the body that has carried out the EU type-examination, 
the application shall also include the following: 
(a) the technical documentation described in Annex III;  
(b) a copy of the EU type-examination certificate. 
4. Verification of conformity 
4.1. The notified body shall carry out appropriate ex aminations and tests in order to check 
the homogeneity of production and the conf ormity of the PPE with the type 
described in the EU type-examination certifi cate and with the applicable essential 
health and safety requirements. 
4.2. The examinations and tests shall be carri ed out at least once a year, at random 
intervals determined by the notified body. The first examina tions and tests shall be 
carried out no more than one year after the date of issu e of the EU type-examination 
certificate. 
4.3. An adequate random sample of the manufactured PPE shall be selected by the 
notified body at a place agreed between th e body and the manufacturer. All items of 
PPE of the sample shall be examined and appropriate tests set out in the relevant 
harmonised standard(s) and/or equivalent tests set out in  other relevant technical 
specifications shall be carried out in order to verify the conformity of the PPE with  
EN 23   EN the type described in the EU type-examination certificat e and with the applicable 
essential health and safety requirements. 
4.4. Where the notified body referred to in point 3 is not the body that issued the relevant 
EU type-examination certificate, it shall c ontact that body in the event of difficulties 
in connection with the assessment of  the conformity of the sample. 
4.5. If the examination and testing reveal that  the production is not homogeneous or that 
the PPE does not comply with the type described in the EU type-examination 
certificate or with the applicab le essential health and safety requirements, the notified 
body shall take measures appropriate to the fault(s) recorded and inform the 
notifying authority thereof. 
5. Test report 
5.1. The notified body shall provide the manufac turer with a test report, and shall 
authorise the manufacturer to affix the notified body's identificat ion number to each 
individual PPE that is in conformity with the type described in the EU type-
examination certificate and satisfies the applicable essential health and safety requirements. 
5.2. The manufacturer shall keep th e test report at th e disposal of the national authorities 
for 10 years after the PPE has been placed on the market. 
6. CE marking and EU decl aration of conformity 
6.1. The manufacturer shall affix the CE mark ing, and, with the authorisation of the 
notified body referred to in point 3, the latter's identification number to each individual PPE that is in conformity with the type described in the EU type-
examination certificate and satisfy the applicable essential health and safety requirements. 
6.2. The manufacturer shall draw up a written EU  declaration of conformity for each PPE 
model and keep it at the disposal of the na tional authorities for 10 years after the PPE 
has been placed on the market. The EU decl aration of conformity shall identify the 
PPE model for which it has been drawn up. 
A copy of the EU declaration of conform ity or a simplified EU declaration of 
conformity shall accompany every PPE. 
7. If the notified body referred to in point 3 agrees, the manufacturer may affix the 
notified body's identification number to th e PPE during the manufacturing process.  
EN 24   EN 8. Authorised representative 
The manufacturer's obligations may be fulfilled by his authorised representative, on 
his behalf and under his res ponsibility, provided that th ey are specified in the 
mandate. An authorised representative ma y not fulfil the manufacturer's obligations 
set out in point 2.  
EN 25   EN ANNEX VIII  
Conformity to type based on quality assurance of the production process 
(Module D) 
1. Conformity to type based on quality assura nce of the production process is the part 
of a conformity assessment procedur e whereby the manufacturer fulfils the 
obligations laid down in points 2, 5 and 6, and ensures and declares on his sole 
responsibility that the PPE con cerned is in conformity with  the type described in the 
EU type-examination certificate and satisfies the applicable essential health and safety requirements referred to in Article 5 and set out in Annex II. 
2. Manufacturing 
The manufacturer shall operate an appr oved quality system for production, final 
product inspection and testing of the PPE con cerned 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 assessme nt of his quality system 
with a single notifie d body of his choice. 
The application shall include: (a) the name and address of the manufacture r and, if the application is lodged by 
the authorised representative, his name and address; 
(b) a written declaration that the same a pplication has not been lodged with any 
other notified body; 
(c) the identification of the PPE concerned;  
(d) the documentation concerning the quality system. 
Where the chosen body is not the body that has carried out the EU type-examination, 
the application shall also include the following: 
(a) the technical documentation of the PPE described in Annex III;  
(b) a copy of the EU type-examination certificate. 
3.2. The quality system shall ensure that the PPE is in conformity with the type described 
in the EU type-examination certificate and fulfils the applicable essential health and safety requirements. 
All the elements, requirements and provision s adopted by the manufacturer shall be 
documented in a systematic and orderly ma nner in the form of written policies, 
procedures and instructions. The quali ty system documentation shall permit a 
consistent interpretation of the quality programmes, plans, manuals and records.  
EN 26   EN It shall, in particular, contai n an adequate description of: 
(a) the quality objectives and the organisa tional structure, responsibilities and 
powers of the management with  regard to product quality; 
(b) the corresponding manufacturing, quali ty control and quality assurance 
techniques, processes and systematic actions that will be used; 
(c) the examinations and tests that will be  carried out before, during and after 
manufacture, and the frequency with which they will be carried out; 
(d) the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the pe rsonnel concerned, etc., and 
(e) the means of monitoring the achieveme nt of the required product quality and 
the effective operation of the quality system. 
3.3. The notified body shall assess th e quality system to determ ine whether it satisfies the 
requirements referred to in point 3.2. 
It shall presume conformity w ith those requirements in respect of the elements of the 
quality system that comply with the co rresponding specifications of the relevant 
harmonised standards. 
In addition to experience in quality mana gement systems, the auditing team shall 
have at least one member with experien ce of evaluation in the field of PPE and 
technology concerned, and know ledge of the appli cable essential health and safety 
requirements. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical docume ntation of the PPE 
referred to in point 3.1 to ve rify the manufacturer's ability  to identify the applicable 
essential health and safety requirements a nd to carry out the necessary examinations 
with a view to ensuring conformity of the PPE with those requirements. 
The result of that assessment shall be notified to the manufacturer. The notification 
shall contain the conclusions of the a udit and the reasoned assessment decision. 
3.4. The manufacturer shall undertak e 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 evalua te any proposed changes and decide whether the 
modified quality system will continue to sa tisfy the requirements referred to in point 
3.2 or whether a reassessment is necessary. 
It shall notify the manufacturer of its de cision. The notification shall contain the 
conclusions of the examination a nd the reasoned assessment decision. 
3.6. The notified body shall authorise the ma nufacturer to affix the notified body's 
identification number to each individual PPE that is in conformity with the type 
described in the EU type-examination certifi cate and satisfy the applicable essential 
health and safety requirements. 
4. Surveillance under the respons ibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system.  
EN 27   EN 4.2. The manufacturer shall, fo r assessment purposes, allow the notified body access to 
the manufacture, inspection, te sting and storage sites and shall provide it with all 
necessary information, in particular: 
(a) the quality system documentation; 
(b) the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned. 
4.3. The notified body shall carry out periodic audits , at least once a year, to make sure 
that the manufacturer maintains and applies the quality system and shall provide the 
manufacturer with an audit report. 
4.4. In addition, the notified body may pay unexpect ed visits to the manufacturer. During 
such visits the notified body may, if necessary, carry out examinations or tests of the 
PPE, or have them carried out, in order to verify that the quality system is 
functioning correctly. The notified body shall provide the manufact urer with a visit 
report and, if tests have been car ried out, with a test report. 
5. CE marking and EU decl aration of conformity 
5.1. The manufacturer shall affix the CE mark ing, and, with the authorisation of the 
notified body referred to in point 3.1, the latter's identifica tion number to each 
individual PPE that is in conformity with the type described in the EU type-
examination certificate and satisfy the applicable essential health and safety requirements. 
5.2. The manufacturer shall draw up a written EU  declaration of conformity for each PPE 
model and keep it at the di sposal of the national authorities for 10 years after the 
product has been placed on the market. The EU declaration of conformity shall 
identify the PPE model for which it has been drawn up. 
A copy of the EU declaration of conform ity or a simplified EU declaration of 
conformity shall accompany every PPE. 
6. The manufacturer shall, for a period ending 10 years afte r the PPE has been placed 
on the market, keep at the disposal of the national authorities: 
(a) the documentation referred to in point 3.1; 
(b) the information related to the change referred to in point 3.5, as approved; 
(c) the decisions and reports of the notif ied body referred to in points 3.5, 4.3 and 
4.4. 
7. The notified body shall inform its notifying authority of quality system approvals 
issued or withdrawn, and shall, periodical ly or upon request, make available to its 
notifying authority the list of  such quality system approvals refused, suspended or 
otherwise restricted. 
The notified body shall inform the other notif ied bodies of qualit y system approvals 
which it has refused, suspended, withdr awn or otherwise restricted, and, upon 
request, of such quality system approvals which it has issued. 
8. If the notified body referred to in point 3.1 agrees, the manufacturer may affix the 
notified body’s identificati on number to the PPE during the manufacturing process. 
9. Authorised representative  
EN 28   EN The manufacturer's obligations set out in  points 3.1, 3.5, 5 and 6 may be fulfilled by 
his authorised representative, on his behalf  and under his responsibility, provided that 
they are specified in the mandate.  
EN 29   EN ANNEX IX  
EU declaration of conformity 
1. PPE (product, batch, type  or serial number): 
2. Name and address of the manufacturer or  his authorised representative [The 
authorised representative must also gi ve the business name and address of the 
manufacturer]: 
3. This declaration of confor mity is issued under the sole responsib ility of the 
manufacturer: 
4. Object of the declaration (identification of PPE allowing traceability; it may, where 
necessary for the identification of the PPE , include a colour image of sufficient 
clarity): 
5. The object of the declaration described in poi nt 4 is in conformity with the relevant 
Union harmonisation legislation: 
6. References to the relevant harmonised standa rds, including the date of the standard, 
or references to the other technical sp ecifications, including the date of the 
specification, in relation to which conformity is declared: 
7. Where applicable, the notified body ... (nam e, number)… performed the EU type-
examination (Module B) and issued th e EU type-examination certificate … 
(reference to that certificate). 
8. Where applicable, the PPE is subject to the conformity assessment procedure … 
(either (Conformity to type based on product verification (Module F)) or 
(Conformity to type based on quality assu rance of the production process (Module 
D)) … under surveillance of the notified body ... (name, number). 
9. Additional Information: 
Signed for and on behalf of:  
(place and date of issue):  (name, function) (signature):  
EN 30   EN ANNEX X  
Simplified EU declaration of conformity 
The simplified EU declaration of confor mity shall be provided as follows: 
 
Hereby, [Name of manufacturer] declares that  the PPE type [designation of type of 
PPE] is in compliance with the PPE Regulation (EU) No [XXXX/YYYY] . 
  
EN 31   EN ANNEX XI  
Correlation table 
CORRELATION TABLE  
Directive 89/686/EEC This Regulation 
  
Article 1(1) Articles 1 and 2(1) 
Article 1(2) and (3) Article 3(1) 
Article 1(4) Article 2(2) and (3) 
Article 2(1) Article 4 
Article 2(2) Article 6 
Article 2(3) Article 7(2) 
Article 3 Article 5 
Article 4(1) Article 7(1) 
Article 4(2) ___ 
Article 5(1), (4), (5), (6) ___ 
Article 5(2) Article 14 
Article 6 Article 38 
Article 7 ___ 
Article 8(1) Article 8( 2) first subparagraph 
Article 8(2) – (4) Articles 17 and 18 and Annex I 
Article 9 Articles 19, 23(1), 24, and 29(1) 
Article 10 Annex V 
Article 11(A) Annex VII 
Article 11(B) Annex VIII 
Article 12(1) Article 15 
Articles 12(2) and 13 Article 16 
Article 14 ___  
EN 32   EN Article 15 ___ 
Article 16 ___ 
Annex I Article 2(2) 
Annex II Annex II 
Annex III Annex III 
Annex IV Article 16 
Annex V Article 23(2) – (11) 
Annex VI Annex IX