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    • Abstract: PPE GUIDELINESGUIDELINES ON THE APPLICATION OF COUNCIL DIRECTIVE 89/686/EEC OF21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THEMEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENTVersion26 August 2009

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PPE GUIDELINES
GUIDELINES ON THE APPLICATION OF COUNCIL DIRECTIVE 89/686/EEC OF
21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE
MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
Version
26 August 2009
NOTES
1. These guidelines are intended to be a manual for all parties directly or indirectly affected
by Directive 89/686/EEC1, commonly referred to as PPE (“Personal Protective
Equipment) directive. Readers’ attention is drawn to the fact that this guide is intended
only to facilitate the application of Directive 89/686/EEC and it is the relevant national
transposition of the text of the directive which is legally binding. However, this
document does represent a reference for ensuring consistent application of the directive
by all stakeholders. The guidelines are intended to help ensure the free movement of PPE
in the Community territory2 by consensus amongst Member States’ government experts
and other parties concerned.
2. These guidelines have been prepared by the relevant services of the Directorate General -
Enterprise and Industry of the European Commission in collaboration with Member
States, European industry, European standardisation and Notified Bodies.
3. The European Commission will undertake to maintain this guide. It is our goal to ensure
that the information provided is both timely and accurate. If errors are brought to our
attention, we will try to correct them. However the Commission accepts no responsibility
or liability whatsoever with regard to the information in this guide.
This information is:
• of a general nature only and is not intended to address the specific circumstances of any
particular individual or entity;
• not necessarily comprehensive, complete, accurate or up to date;
• sometimes refers to external information over which the Commission services have no
control and for which the Commission assumes no responsibility;
• not professional or legal advice.
4. All references to the CE marking and EC declaration of conformity in this Guide relate
only to Directive 89/686/EEC. To place PPE on the market in the Community territory
all other relevant legislation must be applied.
5. Further guidance, especially concerning specific type of products, can be found on the
Commissions website:
http://ec.europa.eu/enterprise/mechan_equipment/ppe/index.htm
1
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States
relating to personal protective equipment as amended by Directive 93/68/EEC, Directive 93/95/EEC and
Directive 96/58/EC.
2
According to the agreement related to the European Economic Area (EEA) (Council and Commission
Decision 94/1/EC of 13 December 1993 (OJEC n° L 1 of 3 January 1994, p. 1) the territories of
Liechtenstein, Iceland and Norway have to be considered, for the implementation of Directive 89/686/EEC,
in the same right as of the Community territory. When this term, Community territory, is used in this guide,
the same applies to the EEA territory. Likewise, solely in respect of this Directive, the responsibilities of the
“Member States” can also be taken for the national authorities of these three territories.
2
INTRODUCTION
The objective of these guidelines is to clarify certain matters and procedures referred to in
directive 89/686/EEC concerning Personal Protective Equipment (PPE). It provides a cross
reference from the legal text of the directive to explanations by EU sectoral experts. The
guidelines should be used in conjunction with the directive and with the European
Commission’s ”Guide to the implementation of directives based on New Approach and
Global Approach (Blue Guide)”.
These guidelines are not only for the use of Member States’ competent authorities, but also by
the main economic operators concerned, such as manufacturers, their trade associations,
bodies in charge of the preparation of standards as well as those entrusted with the conformity
assessment procedures.
First and foremost, this document must ensure that, when correctly applied, the directive leads
to the removal of obstacles and difficulties related to the free circulation (free movement) of
goods within the European Community (see footnote 2). It should be noted that the statements
in these guidelines refer only to the application of Directive 89/686/EEC unless otherwise
indicated. All parties concerned should be aware of other requirements, which may also apply
(see Article 5 (6)(a).
The PPE directive is a “New Approach” directive laying down Basic Health and Safety
Requirements (BHSR) and leaving it to standards, primarily European harmonised standards,
to give technical expression of the relevant requirements contained in the directive.
Directive 89/686/EEC is a total harmonisation directive, i.e. its provisions replace existing
divergent national and European legislation which cover the same subjects as stipulated by
directive 89/686/EEC.
“Use” Directives
The reader will want to be aware that where PPE is intended for use in a place of work,
national and Community legislation intended to ensure the safety of employees will usually
apply. Whereas “New Approach” Directives set the highest possible requirements given their
overall objectives and hence do not allow for additional national provisions within scope,
“Use” Directives (89/391/EEC3, 89/656/EEC4) set minimum requirements. In effect this
means that national authorities, following the agreement of other Member States by means of
the notification procedure under Directive 98/34/EC, can put in place further requirements
relating to “use” and selection so long as these do not constitute a barrier to trade.
3
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in
the safety and health of workers at work
4
Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the
use by workers of personal protective equipment at the workplace (third individual directive within the
meaning of Article 16 (1) of Directive 89/391/EEC)
3
Table of contents
PPE GUIDELINES............................................................................................ 1
INTRODUCTION ............................................................................................. 3
Definitions ......................................................................................................................... 5
1.1 CHAPTER 1 SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT. 6
1.1.1 Article 1.......................................................................................................... 6
1.1.2 Article 2.......................................................................................................... 8
1.1.3 Article 3........................................................................................................ 10
1.1.4 Article 4........................................................................................................ 10
1.1.5 Article 5........................................................................................................ 11
1.1.6 Article 6........................................................................................................ 15
1.1.7 Article 7........................................................................................................ 16
1.2 CHAPTER II - CERTIFICATION PROCEDURES .............................................. 18
1.2.1 Article 8........................................................................................................ 18
1.2.2 Article 9........................................................................................................ 24
1.2.3 Article 10...................................................................................................... 25
1.2.4 Article 11...................................................................................................... 30
1.2.5 Article 12...................................................................................................... 37
1.3 CHAPTER III - CE MARKING ............................................................................ 37
1.3.1 Article 13...................................................................................................... 37
1.4 CHAPTER IV ....................................................................................................... 38
1.4.1 Article 14...................................................................................................... 38
1.4.2 Article 15...................................................................................................... 39
1.4.3 Article 16...................................................................................................... 39
1.4.4 Article 17...................................................................................................... 39
1.5 ANNEX I .............................................................................................................. 41
1.6 ANNEX II............................................................................................................. 42
1.7 ANNEX III............................................................................................................ 80
1.8 ANNEX IV ........................................................................................................... 81
1.9 ANNEX V............................................................................................................. 82
1.10 ANNEX VI ........................................................................................................... 84
1.11 APPENDIX GUIDE FOR THE CATEGORISATION OF PERSONAL
PROTECTIVE EQUIPMENT (PPE)................................................................................ 86
4
Definitions
In general terms, the following definitions are considered acceptable.
Placing on the market – the first making available on the Community market of an
individual product with a view to distribution and/or use, whether in return of payment or free
of charge.
Putting into service – takes place at the moment of the first use within the Community by the
end user.
Manufacturer – the natural or legal person, who:
• designs and/or manufactures a product covered by the Directive, or who has a PPE
designed and/or manufactured with view to its placing on the market or for his own
professional or private use, under his own name or trademark; or who:
• places a PPE on the market and/or puts it into service, under his own name or
trademark.
The manufacturer bears responsibility for:
- undertaking an analysis to conclude if his product is subject to the PPE Directive and
which requirements apply;
- design and construction of the PPE in accordance with the Basic Health and Safety
Requirements (BHSR) laid down in the Directive;
- following the procedures for the assessment of the conformity of the product with the
BHSR laid down in the Directive;
- providing marking and instructions for safe use, maintenance etc.
The manufacturer has sole and ultimate responsibility for the conformity of the PPE to this
and other applicable directives. He is required to have a knowledge about the design and
construction of the product to be able to declare such conformity in respect of all applicable
provisions and requirements of the relevant directives.
Authorised representative – Any natural or legal person established within the Community
who has received a mandate from the manufacturer to act on his behalf for specified tasks
with regard to the latter’s responsibilities under the Directive. The mandate should be written
and should specify which obligations of the manufacturer can be conferred upon the
authorised representative.
5
1.1 CHAPTER 1 SCOPE, PLACING ON THE MARKET AND FREE
MOVEMENT
1.1.1 Article 1
1. This Directive applies to personal protective equipment, hereinafter referred to as PPE' .
It lays down the conditions governing its placing on the market and free movement within the
Community and the basic safety requirements which PPE must satisfy in order to ensure the
health protection and safety of users.
The PPE Directive applies to PPE intended for use in domestic, leisure and sports activities,
as well as for professional use.
The objectives of the PPE Directive are:
• to provide the BHSRs which the PPE must satisfy to preserve the health and ensure
the safety of intended users;
• to ensure free movement of PPE within the Community.
The Directive applies to each individual PPE which is intended to be placed and/or put into
service on the Community market for the first time. Consequently, the Directive applies to
new PPE manufactured in the Member States, and to new and used PPE imported from
outside of the Community.
The provisions of the Directive does not apply to the PPE intended to be placed on the
market in a country outside the Community, or imported into the Community for re-export to
a country outside.
2. For the purposes of this Directive, PPE shall mean any device or appliance designed to be
worn or held by an individual for protection against one or more health and safety hazards.
This definition has proved readily understandable to equipment manufacturers and users alike,
although some borderline cases still raise questions. Every term in the definition is important:
− PPE is “worn” in the sense that clothing, glasses, hearing protectors or fall arrest
harnesses are worn. Indeed much PPE is clothing, be it garments, headgear, gloves or
footwear. Other PPE is to be “held” in the hand, such as screens to protect the eyes and
face during welding. The protection provided by PPE thus depends on an action by the
person exposed to the hazard: the donning or holding of the equipment.
Portable equipment which is neither worn nor held during use is not considered as PPE.
So, for example, insulating mats or stools used by electricians for live working, or
protective screens placed in the work stations are not regarded as PPE.
− PPE is worn or held “by an individual”. This is what distinguishes personal equipment
from collective protective equipment. Significantly, the terms of the definition of PPE
place it within the broad field of the protection of persons. The field of PPE is not limited
to equipment used by employees or workers in general, but extends to areas unconnected
with work, such as sports and leisure activities. Sunglasses, cycling or riding helmets,
gardening gloves, shin-guards for footballers, harnesses for mountaineering, are all PPE.
6
− PPE is used “for protection” of the individual. Generally the equipment forms a shield
between part of the body and the hazard for the protection of the individual against any
type of risk: a shield of leather against rough surfaces which may graze the skin on hands,
a shield of filtering glass against radiation which may injure the eyes, a shield of lead
against X-rays which can damage body cells, and so on. This role of PPE as a shield is
underlined by the pictograms chosen by PPE standards to symbolise protection against
different hazards: a symbol representing the hazard is shown within a shield.
On the other hand, equipment warning against risks, but which do not have a protective
function, such as stand alone alarm devices e.g., gas detectors or oxygen depletion
detectors, are not classed as PPE. However if these devices are integrated in the PPE then
they are to be considered as integral part of the PPE. (Please see also BHSR 2.8 3rd
paragraph and BHSR 3.11.2 b)
− PPE protects against “one or more hazards”. Risk is generally defined as the conjunction
of two elements: a hazard, which is a phenomenon which may cause harm, and the
probability of a person being exposed to that hazard. Since PPE is designed to protect
against hazard, its function is to prevent the occurrence of harm to the exposed person.
Consequently, when several risks exist simultaneously, the PPE has to protect against all
the risks, not just against one of them.
This is what differentiates PPE from equipment used after harm has occurred, such as
rescue or first-aid equipment, which also tends to be used by third parties. Equipment used
by a rescuer is not classed as PPE, unless used to protect the rescuer himself, for example,
respiratory protective devices used by firemen when retrieving people from smoke-filled
buildings.
The hazards involved are those which may harm the equipment user. Equipment used to
protect people other than the wearer, such as masks used to protect hospital patients, are
not PPE. Nevertheless all equipment worn by health care personnel to protect themselves
are PPE. Similarly equipment for protecting goods, such as gloves worn to protect
foodstuffs or electronic components are not PPE.
PPE shall also cover:
( a) a unit constituted by several devices or appliances which have been integrally combined
by the manufacturer for the protection of an individual against one or more potentially
simultaneous risks;
For example, a helmet coupled with a visor and/or hearing protection.
( b) a protective device or appliance combined, separably or inseparably, with personal non-
protective equipment worn or held by an individual for the execution of a specific activity;
Some examples of this type of device are protectors against impacts included in motorcycle
clothing or knee protectors included in trousers used for performing work whilst kneeling.
( c) interchangeable PPE components which are essential to its satisfactory functioning and
used exclusively for such equipment.
There are many items which fall into this category, including filters for respiratory protective
devices and screens for eye protectors.
7
3. Any system placed on the market in conjunction with PPE for its connection to another
external, additional device shall be regarded as an integral part of that equipment even if the
system is not intended to be worn or held permanently by the user for the entire period of risk
exposure.
An air line linking respiratory equipment to a compressor is such an example.
4. This Directive does not apply to:
• PPE covered by another directive designed to achieve the same objectives as this
Directive with regard to placing on the market, free movement of goods and safety;
Marine Equipment Directive 96/98/CE5 as amended by Directive 2002/75/EC and Directive
2009/26/EC relating to marine equipment states that PPE (listed in Annexes A1 and A2), if
designed exclusively for use on board sea-going vessels, are excluded from the PPE directive
and will be covered only by the Directive on marine equipment. The following equipment, if
used as permanent equipment on board is excluded from the PPE Directive:
- life jackets;
- immersion suits;
- combinations of immersion suits with life jackets;
- breathing apparatus for firemen.
(Please note that the exhaustive list can be found in Annex A of Directive 96/98/EC as
amended by Directive 2002/75/EC)
Directive 96/98/EC applies to equipment for use on board any new European Union ship,
wherever the ship is situated at the time of construction, and to equipment placed on board
existing EU ships, whether such equipment is being placed for the first time or is replacing
used equipment already on board.
• the PPE classes specified in the list of excluded products in Annex I, independently of
the reason for exclusion mentioned in the first indent.
See Annex I for an exhaustive list of products specifically excluded from the scope of the PPE
Directive.
1.1.2 Article 2
1. Member States shall take all appropriate measures to ensure that the PPE referred to in
Article 1 may be placed on the market and brought into service only if it preserves the health
and ensures the safety of users without prejudice to the health or safety of other individuals,
domestic animals or goods, when properly maintained and used for its intended purpose.
Article 2 defines market surveillance as an obligation for Member States.
5
Directive 96/98/EC of December 20, 1996 relating to the marine equipment (OJ n° L 46 of February 17, 1997,
p. 25).
8
The purpose of market surveillance is to ensure that the provisions of applicable directives are
complied with across the Community. Article 2(1) obliges Member States to apply the
Directive correctly6 and to monitor its application. Market surveillance is also important for
the interest of economic operators, as it helps to eliminate unfair competition.
The national authorities conducting market surveillance have an obligation to take all
appropriate measures to ensure that products, which do not comply with the provisions of the
PPE Directive, are removed from the market.
Article 2 obliges Member States to take “all appropriate measures” with regard to PPE if it
does not preserve the health and ensure the safety of users, irrespective of whether or not it
complies with the Directive. These measures are implemented under the principle of
“subsidiarity”, that is, it is for the Member States themselves to decide the most appropriate
action but such action needs to be both dissuasive and proportionate. Those foreseen in
national legislation range from the issue of a compliance notice to (potential) gaol sentences
and very high financial penalties.
On the application of any such measure restricting the free movement of a PPE the Member
States must notify the action to the Commission services according to Article 7.
2. This Directive shall be without prejudice to the right of Member States to lay down in
conformity with the Treaty any requirements which they consider necessary to ensure user
protection, provided that this does not give rise to modifications to PPE which could result in
its non-conformity with the provisions of this Directive.
Member States retain the right to lay down additional national provisions regarding the use of
PPE which is intended to ensure the protection of workers or other intended users.
Directives 89/391/EEC and 89/656/EEC lay down minimum requirements for the health and
safety of users under Article 137 of the EC Treaty. Member States are allowed to adopt or
retain more stringent provisions, so long as they are compatible with the Treaty.
However, such measures must neither lead to the modification of a PPE designed and
manufactured in accordance with the provisions of the applicable directives, nor influence the
conditions for its placing on the Community market. This is evidently the case with the PPE
Directive, which is a total harmonisation Directive under Article 95 of the Treaty.
National regulations (e.g. national exposure values) can lead to different rules for selection
and use of PPE.
The PPE Directive does not lay down obligations for users. However, it must be remembered
that according to directives based on Article 137 of the EC Treaty, employers have
obligations as regards the use of work equipment at the workplace. An employer is considered
to be any natural or legal person who has an employment relationship with a worker (that is
any person employed by an employer), and has responsibility for the undertaking or
establishment.
6
See http://ec.europa.eu/enterprise/mechan_equipment/ppe/transpos.htm for references of national measures
transposing directive 89/686/EEC.
9
3. Member States shall not prevent the presentation at trade fairs, exhibitions and the like of
PPE which is not in conformity with the provisions of this Directive, provided that an
appropriate notice is displayed drawing attention to this fact and the prohibition on its
acquisition and/or use for any purpose whatsoever until it has been brought into conformity
by the manufacturer or his representative established in the Community.
Paragraph 3 concerns the showing at exhibitions of products which do not comply with the
Directive. The display of PPE at a trade or retail show does not constitute “placing on the
market”. However, if PPE is not in full conformity with the provisions of the Directive, this
fact must be clearly advertised next to the PPE being exhibited.
1.1.3 Article 3
The PPE referred to in Article 1 must satisfy the basic health and safety requirements laid
down in Annex II.
Article 3 sets out the obligation of the manufacturer to design and produce PPE which
satisfies the requirements at Annex II. The manufacturer must ensure that the BHSRs remain
fulfilled during the lifetime of the PPE.
The Directive uses the term “Basic Health and Safety Requirements” (BHSRs) which are the
same as “Essential Health and Safety Requirements” which is the wording more typical used
for other so-called “New Approach” directives.
Only PPE complying with these BHSRs may be placed on the Community market and/or put
into service. The manufacturer must provide information about the measures he has taken in
order to ensure the conformity of the PPE to the BHSRs in his technical documentation which
is further referred to in Article 8 and described in detail at Annex III.
BHSRs only deal with product characteristics aimed at ensuring the health and safety of
intended users. They do not cover either environmental or social aspects.
These requirements are designed to ensure the optimal level of protection. They:
• arise from certain hazards associated with the product (for example physical and
mechanical resistance, flammability, chemical, electrical or biological properties,
hygiene, radioactivity,);
• refer to the product and/or its performance (for example provisions regarding
materials, design, construction, manufacturing process, instructions drawn up by the
manufacturer);
• lay down the principal protection objective(s) (for example by means of an illustrative
list).
Or a combination of these three aspects.
1.1.4 Article 4
10
1. Member States may not prohibit, restrict or hinder the placing on the market of PPE or PPE
components which comply with the provisions of this Directive and which bear the CE
marking attesting their conformity to all the provisions of this Directive, including the
certification procedures in Chapter II.
Article 4(1) seeks to ensure the free movement of PPE and PPE components7 in the
Community.
The CE marking is a declaration that all relevant conformity assessment procedures have been
complied with and is a declaration to the national market surveillance authorities that this is
the case.
2. Member States shall not prohibit, restrict or impede the placing on the market of PPE
components which do not bear the CE marking and which are intended to be incorporated in
PPE, provided that they are not essential to its satisfactory functioning.
Paragraph 2 authorises the free movement of PPE components, which, whilst they do not bear
the CE marking, are meant to be built-into the PPE provided that they do not impact on the
safe functioning of the PPE. Some examples of such components are:
• hygiene pads for earmuffs /ear-defenders;
• sweat band for safety helmets,
1.1.5 Article 5
1. Member States shall regard as in conformity with the basic requirements referred to in
Article 3 the PPE referred to in Article 8 (3) bearing the CE marking with respect to which the
manufacturer is able to produce, on demand, the declaration of conformity referred to in
Article 12.
Simple design PPE (Article 8 (3)) is regarded in conformity with the BHSRs if the CE
marking is affixed and the manufacturer is able to present an EC declaration of conformity.
The model for this EC declaration of conformity is at Annex VI to the Directive.
The PPE Directive does not foresee that the EC declaration of conformity is either attached to
or needs to accompany the product itself. However, it is generally understood that this has to
be presented on the demand of a market surveillance authority in a reasonable period of time
in relation to the nature of the suspected non-compliance.
2. Member States shall presume that the PPE referred to in Article 8 (2) satisfies the basic
requirements referred to in Article 3 if it bears the CE marking with respect to which the
manufacturer is able to produce, on demand, not only the declaration referred to in Article 12
but also the certificate issued by the body of which notification has been given8 in accordance
with Article 9 attesting to their conformity to the relevant national standards, transposing the
harmonized standards, assessed at the EC type examination level in accordance with the first
indent of Article 10 ( 4) ( a) and ( b) .
7
Interchangeable components defined at Article 1(2)(c) which are essential to the safe functioning of the PPE
8
Also referred to as an “Approved”, “Notified”, or “Inspection” Body in the text of the Directive.
11
Where a manufacturer has not applied or has only partly applied the harmonized standards or
where there are no such standards the certificate issued by the body of which notification has
been given must state the conformity to the basic requirements in accordance with the second
indent of Article 10 ( 4) ( a) and ( b) .
The application of European harmonised standards is voluntary, as is the case with all “New
Approach” Directives. However, the application of a national standard that transposes a
European harmonised standard, whose reference has been published, confers a presumption of
conformity with the BHSRs of the PPE Directive that is covered by the standard.
European harmonised standards are European standards, which are adopted by European
Standardisation Organisations (in this case CEN and CENELEC) prepared in accordance with
the General Guidelines agreed between the Commission and the European standards
organisations, and follow a mandate issued by the Commission after consultation with the
Member States. The references of these are required to be published in all official EU
languages in the OJEU9 in order to provide for a presumption of conformity.
For PPE category II and III when the European harmonised standard(s) applied do(es) not
cover all BHSRs the EC-type examination certificate issued by the Notified Body must state
compliance to the BHSRs directly. If this is the case for “Simple” PPE, the manufacturer must
be able to demonstrate the way the conformity is assured.
Article 5, paragraph 3 of the directive was deleted by the Directive 93/95/EEC.
4. The Commission shall publish the references of the harmonized standards in the Official
Journal of the European Communities.
Member States shall publish the references of the national standards transposing the
harmonized standards.
As noted above, European harmonised standards giving technical expression to the BHSRs at
Annex II of Directive 89/686/EEC are developed by the following European standardisation
bodies:
– European Committee for Standardisation (CEN)
– European Committee for Electrotechnical Standardisation (CENELEC)
Detailed information on the EU policy regarding (European harmonised) standards is
available at:
http://ec.europa.eu/enterprise/standards_policy/index_en.htm
The list of European harmonised standards in the OJEU is regularly updated and is available
at the following European Commission Internet address:
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/ppe.html
Information on standards is also available at the CENELEC and CEN web sites:
9
The Official Journal of the European Communities (OJEC) was replaced by the Official Journal of the
European Union (OJEU) following the entering into force of the Treaty of Nice.
12
http://www.cen.eu
http://www.cenelec.org
A list of the national standardisation organizations is provided at:
CEN - http://www.cen.eu/cenorm/members/national+members/index.asp
CENELEC -
http://www.cenelec.org/Cenelec/About+CENELEC/Our+organization/CENELEC+Members/
Default.htm
5. Member States shall ensure that by 30 June 1991 appropriate steps are taken to enable both
sides of industry to have an influence at national level on the process of formulating the
harmonized standards and keeping them under review.
This paragraph seeks to ensure that all stakeholders including employers, workers and
consumers are represented in the standardisation process.
6. ( a) Where the PPE is subject to other Directives concerning other aspects and which also
provide for the affixing of the CE marking, the latter shall indicate that the PPE is also
presumed to conform to the provisions of the other Directives.
Directives sometimes cover a wide range of products, phenomena and/or hazards.
As a result several directives may have to be taken into consideration for PPE, since the
placing on the market and putting into service can only take place when the product complies
with the provisions of all legislation applicable to it.
By the affixing of the CE marking and the declaration of conformity the manufacturer or his
authorised representative declares that the PPE is in conformity with all the provisions which
are applicable to them.
Manufacturers of PPE may need to consider the following Directives10:
- Pressure Equipment Directive 97/23/EC - applies to a limited range of equipment for
holding gasses under pressure, for example breathing devices.
- Electromagnetic Compatibility directive 2004/108/EC - the EMC directive must also be
applied to ensure that PPE with electrical/electronic devices does not cause
electromagnetic disturbance and that its normal operation is not affected by such
disturbances;
- Radiocommunications and Telecommunications Terminal Equipment (RTTE)
directive 1999/5/EC. The RTTE directive must also be applied to ensure that PPE
incorporating such device(s) is safe and does not disturb radio services or other
equipment. The RTTE directive also covers EMC and safety aspects of such equipment.
- Nickel Directive 94/27/EC as amended by Directive 2004/96/EC- restricting the release
of nickel for those parts in direct and prolonged contact with the skin of the wearer;
10
Please note that this list of examples is not exhaustive.
13
- General Product Safety Directive11 2001/95/EC - requires that producers only place on
the market safe products destined for the consumer and entrusts Member States with the
obligation to ensure that both producers and distributors comply with their obligations.
For more information see Guidance Document on the Relationship between the General
Product Safety Directive (GPSD) and certain sectoral Directives with Provisions on
Product Safety;
There are also a number of products which, whilst they may appear to fall within the
scope of the PPE Directive, are dealt with by other directives because of their
“specificity”, as follows:
- Toys directive 88/378/EEC
Equipment designed to be worn by children to protect them against one or more risks
falls within the scope of the PPE Directive e.g. bicycle or ski helmets, ski goggles etc.
However, imitations of PPE (such as imitations of firemen's helmets, doctor's protective
clothing) fall under the Toys Directive. Where there may be doubt as to the real intended
use of such a product, it has been agreed with the Member States that such products
should be supplied with a warning to the effect that they are toys and not PPE. Care does
need to be taken by the manufacturer if it appears that imitation PPE might be reasonably
assumed to protect against hazards. In such cases the manufacturer may not be able to
derogate from his liability even with such a warning.
Without prejudice to the above on 5 November 2008 the PPE WG further clarified the
borderline between the two directives by agreeing distinguishing three categories of
products:
a) Toys which imitate PPEs and which remain toys
They are only acceptable if it is clear that no protection at all can be expected from them.
For example: a fireman’s or motorcyclist’s helmet in a fancy dress outfit can constitute a
toy.
b) PPEs sold with toys
Insofar as each product has its specific destination (respectively protection function and
game function), each element falls within the scope of the regulations connected with its
destination and which is specific to it.
c) Products for children, even decorated in an infantile manner, which have a protection
function and remain PPEs
These products only have a single destination: protection. They remain PPEs.
It is the case, for example, of a child’s cycle helmet. Even decorated with naïve motifs, it
remains a PPE because protection is awaited from it, irrespective of its appearance.
Please note that the new Toys Directive (2009/48/EC) will replace Directive 88/378/EEC
as of from 20 July 2011;
- Medical Devices Directive (MDD) 93/42/EEC.
The MDD applies to devices, other than medicines, used in health care. It aims at
protecting the health and safety of patients, users of medical devices and other exposed
persons. In order to decide whether the PPE Directive or the Medical Devices Directive
should apply, the principal intended purpose of the device must be considered. For
example, a mask to be used by a surgeon is a medical device as it protects the patient. On
the other hand equipment worn by healthcare personnel to protect themselves against
infectious agents falls under the PPE Directive. Furthermore a recent modification t


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