GUIDE PPE - Cyprus Organization for the Promotion of Quality

EuropeAid /114385/D/SV/CY 

Assessment and administration capacity building 

for the harmonisation with the New Approach directives 

GUIDE 

to the implementation of 

DIRECTIVE 

89/686/EEC 

on 

PPE 

Personal Protective Equipment

Guide on PPE Directive 


This Guide was printed with funds of the EuropeAid /114385/D/SV/CY project: 

“Assessment and administration capacity building for the harmonisation with the New Approach directives” 

The views expressed in this publication do not necessarily reflect the views of the European Commission, 

or the Ministry of Commerce, Industry and Tourism or the Ministry of Labour and Social Insurance. 

© Republic of Cyprus, Nicosia, May 2004



INTRODUCTION 

This guide has been prepared in order to assist all parties involved in the application of Directive 

89/686/EEC on Personal Protective Equipment (PPE). The legally binding text is the directive itself and its 

implementation into the national legislation. Further guidance has been given by the Working Group of 

Committee 98/37/EC in relation to the Personal Protective Equipment (PPE) Directive 89/686/EEC. 

Any matter concerning the implementation or the practical application may be submitted to a Standing 

Committee. The committee is constituted by representatives of Member States, who are, for the most part, 

civil servants from Ministries of Labour or Industry, and presided by a representative of the European 

Commission. 

Representatives of other parties with an interest in the field of PPE are present with observer status. 

These include, in particular, manufacturers of PPE represented by European Safety Federation (ESF) and 

Federation of the European Sporting goods Industry (FESI), consumers represented by ANEC, the Trade 

Unions represented by TUTB, the Notified Bodies, represented by the Horizontal Co-ordination, and the 

standardization organizations, represented by CEN. 

When a problem arising from interpretation or practical application of the directive is raised with the 

Standing Committee, the Commission submits a proposed solution which is discussed by the Committee, 

and expresses its opinion, by a vote if need be. Each Member State may register its point of view. The 

Commission is required to take the utmost account of the opinion of the Standing Committee. 

Since the directive came into force, the Standing Committee and the Commission have developed a 

certain number of aids to interpreting and using the directive. These include a guide to the categorisation 

of PPE (in other words to the application of the different conformity evaluation procedures to different 

kinds of PPE), and a list of “Questions and Answers” to problems posed by the application of the directive. 

These documents do not have legally binding force, but they are useful tools for harmonising 

interpretation of the directive. 

In addition, the Standing Committee discusses and approves the Recommendation for Use sheets edited 

by the Horizontal Co-ordination of Notified Bodies, which provide a guide for the application of the 

evaluation procedures by these bodies. 

This document focuses specially on issues relevant to PPE. The documents and recommendations of the 

Standing Committee and the co-ordination of the Notified Bodies are taken into account. General 

guidelines on the implementation of directives based on the New Approach and the Global Approach are 

given by the Commission (so called The Blue Guide). This guide can be found at: 

http://www.europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm 

PPE DIRECTIVE 89/686/EEC 

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member 

States relating to personal protective equipment has been amended three times. 

Amended by Council Directive 93/68/EEC; CE-marking 

Amended by Council Directive 93/95/EEC; transitional period extended to 30 June 1995 and helmets and 

visors intended for users of two- or three-wheeled motor vehicles were excluded from the scope.



Amended by European Parliament and Council Directive 96/58/EC: The requirement to add last two digits 

of the year in which the CE marking was affixed was deleted. 

The directive will be amended and the latest working paper can be found at: 

http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/index.htm 

The obligations created by the PPE Directive concern principally manufacturers of PPE. Other agents, 

such as importers of PPE from third countries, wholesalers or distributors of PPE, may act as authorised 

representatives of PPE or take the responsibility themselves for the placing of PPE on the market, but in 

that case they assume all the duties of the manufacturer. 

Before production of a given model of PPE, the manufacturer must identify which of the Essential Health 

and Safety Requirements (EHSRs), detailed in Annex II of the directive, are applicable to the PPE 

concerned. The PPE must be designed in such a way as to satisfy the relevant requirements. 

The manufacturer is free to choose the technical means of satisfying the requirements. He may choose to 

apply a harmonised standard, which both helps to identify the relevant requirements and provides a guide 

to the choice of technical solutions. 

The manufacturer must then constitute the technical documentation, showing how the EHSRs have been 

satisfied. He must be able to produce relevant extracts of this documentation on request of the competent 

authorities. 

Before placing production of the model of PPE on the market, the manufacturer submits the model to the 

appropriate conformity evaluation procedure, which differs according to the risk covered by the equipment. 

He may then affix the CE marking to the product and draw up the EC conformity declaration. 

This declaration is an undertaking by the manufacturer as to the conformity of each item of PPE actually 

placed on the market. It must be stressed that even when the conformity evaluation procedure involves 

third-party examination of the model by a NB, the manufacturer remains entirely responsible for the 

conformity of the PPE actually produced and placed on the market. 

SCOPE, PLACING ON THE MARKET 

SCOPE OF THE DIRECTIVE 

The directive applies to PPE, which is defined as follows: 

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. 

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. (Such 

as, for example an industrial safety helmet with hearing protectors and powered filtering device); 

(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; (such as for example 

industrial safety helmet equipped with a lamp)



(c) interchangeable PPE components which are essential to its satisfactory functioning and used 

exclusively for such equipment. (Such as, for example components of fall arresting systems or 

replaceable filters for respiratory protective equipment) 

The term "worn" must be understood in the sense of wearing clothes, a helmet, a mask, glasses, shoes, 

etc. The term "held" must be understood as the action of holding the PPE with one’s hand(s) (such as a 

hand-held protective screen used by welders to protect the face and eyes, for example). The PPE 

Directive applies to all PPE for sport, domestic and leisure activities as well as for occupational use. 

The Directive does not apply to PPEs covered by another directive designed to achieve the same 

objectives as PPE Directive with regard to placing on the market, free movement of goods and safety and 

to PPE listed in Annex I of the Directive: 

• PPE for the armed forces or the maintenance of law and order; 

• PPE for self-defence; 

• PPE for private use against adverse atmospheric conditions, damp and water and heat; 

• PPE for the protection or rescue of persons on vessels or aircraft, not worn all the time; 

• Motorcycle helmets and visors. 

The guidance, how to apply the directive can be found at: 

http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/guide.htm 

MANUFACTURER, PLACING ON THE MARKET AND BRINGING INTO SERVICE 

The PPE Directive aims at ensuring that PPE preserve the health and safety of users when they are 

placed on the market and brought into service. Placing on the market corresponds to when the PPE is first 

made available, in return for payment or free of charge, by the manufacturer or his authorised 

representative in view of its distribution and/or its use in the EEA. Bringing into service includes all 

operations, which are necessary before the PPE is used by the end user. In practice, most PPE are 

placed on the market in a state where they are ready for use. Recommendations how custom made (PPE 

modified according to the characteristics of one specified user) PPE shall be placed on the market are 

given by the Standing Committee. The manufacturer is defined as follows; 

• any legal or natural person who takes responsibility for designing and manufacturing a PPE with a 

view to placing it on Community Market under his own name 

• any legal or natural person who assembles, packs, processes or re-label ready made products 

with a view to their being placed on Community Market under his own name 

• any legal or natural person who changes the intended use of product in such a way that different 

essential requirements will become applicable 

• any legal or natural person who customises, modifies or rebuilds a PPE



CONFORMITY ASSESSMENT PROCEDURES 

THE THREE CATEGORIES OF PPE 

In the Directive PPE is specifies in three different groups, according to the different conformity 

assessment procedures. Normally these groups are called categories. The categories correspond to 

different levels of the risk against which the PPE is designed to protect. 

Category Level of risk Conformity assessment 

procedures 

I 

PPE models of simple design where the designer 

assumes the user can himself assess the level of 

protection provided against the minimal risks 

concerned the effects of which can be safely 

identified by the user in good time. 

EC declaration of conformity only. 

II 

All PPE, other than those in category I or in 

category III. 

EC type-examination and 

EC declaration of conformity. 

III 

PPE of complex design intended to protect against 

mortal danger or against dangers that may 

seriously and irreversibly harm the health, the 

immediate effects of which the designer assumes 

the user cannot identify in sufficient time. 

EC type-examination and either - 

EC quality control system for the 

final product, or -Quality control 

system for the production, and 

EC declaration of conformity. 

Category I includes exclusively PPE intended to protect the wearer against: 

• mechanical action whose effects are superficial; 

• cleaning materials of weak action and easily reversible effects; 

• risks encountered in the handling of hot components which do not expose the user to a 

temperature exceeding 50 o C or to dangerous impacts; 

• atmospheric agents of a neither exceptional nor extreme nature; 

• minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot 

cause irreversible lesions; 

• sunlight (sunglasses). 

Category III includes exclusively: 

• filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, 

toxic or radiotoxic gases;



• respiratory protection devices providing full insulation from the atmosphere, including those for 

use in diving; 

Category I Category II Category III 

Assemble technical documentation 

EC type-examination by a notified body 

'EC' quality 

control 

system for 

the final 

product 

System for 

ensuring EC 

quality of 

production 

by means of 

monitoring 

Draw up a declaration of conformity 

Affix CE marking Affix CE marking Affix CE marking 

1234



• PPE providing only limited protection against chemical attack or against ionising radiation; 

• emergency equipment for use in high-temperature environments, the effects of which are 

comparable to those of an air temperature of 100 °C or more and which may or may not be 

characterised by the presence of infrared radiation, flames or the projection of large amounts of 

molten material; 

• emergency equipment for use in low-temperature environments the effects of which are 

comparable to those of an air temperature of - 50 °C or less; 

• PPE to protect against falls from a height; 

• PPE against electrical risks and dangerous voltages or used as insulation in high-tension work. 

All other PPE belong to category II. Thus no list of Category II PPE is given in the directive. The 

Commission has published a Guide to categorize PPE, which will be updated in the light of experience of 

application of the directive. 

http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/categorizationguide.pdf 

TECHNICAL DOCUMENTATION 

Before placing a PPE model on the market, the manufacturer must assemble a technical documentation 

the content of which is set out in Annex III of the directive. The documentation must comprise all relevant 

data on the means used by the manufacturer to ensure that a PPE complies with the EHSRs applicable. 

For category II and III PPE, the documentation must comprise in particular: 

1. The manufacturer’s technical file consisting of: 

• overall and detailed plans of the PPE accompanied, when appropriate, by calculation notes and 

the results of prototype tests in so far as necessary for the verification of compliance with the 

EHSRs; 

• an exhaustive list of the EHSRs and of the harmonized standards or other technical specifications 

taken into account in the design of the model; 

2. A description of the control and test facilities to be used in the manufacturer's plant to check compliance 

of production PPE with the harmonized standards or other technical specifications and to maintain quality 

level; 

3. A copy of the information supplied with the equipment shall be supplied to the notified body with the 

technical file.



NOTIFIED BODIES 

For most types of PPE, with the exception of a limited list of PPE to cover minimal risks, the directive 

requires third party conformity evaluation prior to placing on the market. Some types of PPE for very 

serious risks are also submitted to evaluation of the conformity of production. Member States are 

responsible for designating the bodies able to carry out these evaluation procedures, and for notifying the 

bodies thus approved to the European Commission. Annex V of the directive lays down the minimal 

criteria, which such a body must meet: 

• availability of the necessary personnel and equipment; 

• competence and integrity of personnel; 

• independence from parties with a vested interest in the manufacture and sale of PPE; 

• maintenance of professional secrecy; 

• subscription to civil liability insurance. 

Bodies complying with the requirements of the appropriate standards of the EN ISO 17000 / EN 45000 

series are presumed to comply with these minimum criteria. It is recommended that the testing 

laboratories should have accreditation according to the standard EN ISO 17025 Most Member States 

designate bodies, which have been accredited by the national accreditation system, according to one or 

other of these standards. 

A body must be notified for one or more specific procedures: EC type-examination according to Article 10 

of the directive, or one of the EC quality control systems according to Article 11. 

Member States are free to take into account further criteria, such as the particular experience of the body 

in the field of the PPE concerned, participation of the body in the work of co-ordination between Notified 

Bodies, or participation in standardization work. 

The notifying authority is also responsible for checking periodically that the bodies that they have notified 

remain in compliance with the criteria. National authorities are free to choose the most effective and 

appropriate means of carrying out these checks. Regular reporting on activity to the notifying authority 

seems indispensable. Some Member States delegate entirely the task of checking Notified Bodies to their 

national accreditation bodies. In other cases, the public authorities themselves carry out regular audits of 

the bodies they have notified. In several Member States a combination of the two approaches is used. 

The list of Notified bodies is given in: 

http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/nb.htm 

As NB fulfil tasks delegated to them by public authorities, they have a duty to take part in Co-ordination 

activities organised by the Commission. Objectives of the Co-ordination of Notified Bodies are as follows: 

• to share experience on practical application of the conformity assessment procedures, with the 

aim of reaching common understanding of the requirements of the directive; 

• to identify points of difficulty and propose agreed solutions on the basis of consensus; 

• to raise matters of interpretation of the directive with the Commission and Member States and 

seek guidance;



• to discuss working documents submitted by the Commission and Member States and express the 

views of Notified Bodies on the issues raised. 

The European Co-ordination of Notified Bodies for PPE has two basic structures: The Horizontal 

Committee of Notified Bodies for PPE deals with questions of general interest and Vertical Groups of NB 

for PPE are dealing with questions specific to certain PPE types The following Vertical Groups are in 

operation: 

VG 1 

VG 2 

VG 3 

VG 4 

VG 5 

VG 6 

VG 8 

VG 9 

VG 10 

VG 11 

Head protection 

Respiratory protection 

Eye and face protection 

Hearing protection 

Protective clothing, hand and arm protection 

Protection against knife cut 

Lifejackets 

Motorcycle rider's protective clothing and protectors for sports 

Foot and leg protection 

Protection against falls from a height 

In addition, an ad hoc Group of the Horizontal Group deals with questions arising from the quality control 

procedures defined by Articles 11 A and B of the directive. 

An important tool of the Co-ordination of Notified Bodies in the field of PPE is the drafting of Technical coordination 

sheets. If a NB, a Vertical group or the Horizontal Committee has a question of technical or 

horizontal nature, they can draft a Proposal for Enquiry. This proposal contains a short description of the 

problem and a proposed solution. 

If the question only concerns one Vertical Group, this group can approve the proposed solution and turn it 

into a Recommendation for Use, which is a recommendation for all the Notified Bodies, active in this field 

aiming at reaching uniform treatment of the manufacturers throughout the Community. Most of the 

recommendations of a vertical nature concern questions arising during the testing and certification 

process: either no harmonized standards are available, or the harmonized standards are not sufficient or 

standards for test procedures are not precise enough. Recommendations for Use are thus in principle only 

temporary solution of problems arising from the use of standards. The aim must be to improve the 

standards during the revision. 

If the question is of a horizontal nature or concerns interpretation of the directive, the Proposal for Enquiry 

is first dealt with by the Advisory Panel, then transferred to the Horizontal Committee, where a decision is 

taken, either to reject the proposal, or to pass on the enquiry to the Commission for discussion by the 

Standing Committee. All Recommendations for Use of a horizontal nature are given to the Commission 

for information, and those dealing with the interpretation of the PPE Directive, are submitted for approval



to the Standing Committee. If the Recommendation for Use is of a general, horizontal nature, all Notified 

Bodies are informed. If the Recommendation for Use is only of relevance for a certain area of PPE, only 

those Notified Bodies who are active in this field will be informed. 

EC TYPE-EXAMINATION 

Prior to the (series) production of category II or III PPE, the manufacturer or his authorised representative 

established in the Community shall submit a model for EC type-examination. EC type-examination is the 

procedure whereby a NB establishes and certifies that the PPE model in question satisfies the relevant 

provisions of the PPE Directive. Application for EC type-examination shall be made by the manufacturer 

or his authorised representative to a single approved inspection body in respect of the model in question. 

The application shall comprise: 

• The name and address of the manufacturer or his authorised representative and of the PPE 

production plant in question; 

• The manufacturer's technical file; 

• The information supplied by the manufacturer. 

It shall be accompanied by the appropriate number of specimens of the model to be approved. The 

number of samples needed determined by the NB, but indication is normally given in the relevant 

harmonized standard. 

The application of harmonized standards that give a presumption of conformity remains voluntary. If the 

manufacturer has designed the product according to a harmonized standard, the NB shall conduct the EC 

type-examination first examining the manufacturer's technical file to establish its suitability with respect to 

the harmonized standards. 

If a manufacturer has not applied, or has only partly applied, the harmonized standards, or when there are 

no such standards, the NB must check the suitability of the technical specifications used by the 

manufacturer with respect to the EHSRs. If the manufacturer partly applies a harmonized standard or if 

the relevant harmonized standard does not cover all the EHSRs applicable to the product, the 

presumption of conformity exists only with regard to the EHSRs covered by the standard. 

The NB shall make the necessary tests to verify that PPE has been produced in accordance with the 

manufacturer's technical file and can be used in complete safety for its intended purpose in foreseeable 

conditions of use. Most PPE is tested according to the methods described in the harmonized standards. 

EC TYPE-EXAMINATION CERTIFICATE 

If the model satisfies the relevant requirements, the NB shall draw up an EC type-examination certificate. 

This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its 

issue and incorporate the descriptions and drawings necessary for the identification of the approved 

model. 

If the PPE does not fulfil, the requirements of the directive, the NB shall refuse to issue an EC typeexamination 

certificate. In this case, the NB shall inform the other Notified Bodies. However in practice the 

testing is usually discontinued when negative results are found, and the manufacturer has the possibility 

to make changes to the design of the PPE.



The NB shall withdraw the certificate if, for example, during the controls according to Article 11 the NB 

notices that the PPE is not in conformity with the type described in the EC type-approval certificate. In 

such a case the NB shall inform the Member State which shall then inform the other Member States and 

the Commission, setting out the reasons for the decision. 

EC QUALITY CONTROL SYSTEM FOR THE FINAL PRODUCT 

For category III products the manufacturer shall either take the necessary steps to control the quality of 

the final product (Article 11A) or he must have a quality-control system for the production (Article 11B). 

The manufacturer shall plan procedures to ensure that the manufacturing process, including the final 

inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the 

type described in the EC type-approval certificate and with the relevant EHSRs of the directive. 

The manufacturer selects a NB to carry out the necessary checks of the products. Those checks are 

carried out at random, normally at intervals of less than one year. Some Recommendation for Use sheets 

produced by the Co-ordination of Notified Bodies describe which tests are relevant for the checking of the 

products. The NB gives the manufacturer a test report. The manufacturer must be able to present this 

report on request. The NB must try to find out the reasons if the checks reveal that the product does not 

fulfil the requirements or is not such as described in the technical file. It shall also inform the Member 

State in such cases. 

SYSTEM FOR ENSURING EC QUALITY OF PRODUCTION BY MEANS OF MONITORING 

The manufacturer must make an application to the NB for the approval of his quality-control system. The 

application shall include: 

• all the information relating to the category of PPE concerned, including, when appropriate, 

documentation relating to the approved model; 

• documentation on the quality-control system; 

• the undertaking to maintain the obligations arising from the quality-control system and to maintain 

its adequacy and efficiency. 

The directive requires that under this system, each model of PPE shall be examined and the appropriate 

tests specifically relating to the certification of PPE category III shall be carried out to check their 

conformity to the relevant EHSRs of the directive. The documentation on the quality-control system shall 

in particular include an adequate description of: 

• the quality objectives, the organization chart, the responsibilities of executives and their powers in 

respect of product quality; 

• the checks and tests which must be carried out after manufacture; 

• the means to be employed to check the efficient operation of the quality-control system. 

The NB shall then assess the quality-control system to determine whether it satisfies the requirements. A 

quality-control system satisfying the relevant harmonized standard is deemed to be in compliance with 

these requirements. The PPE Directive does not refer any particular EN ISO 9000 standard when giving 

requirements to the quality control system for the production of PPE. The guidance given by the 

Commission is that a system fulfilling the requirements given by EN ISO 9002 is deemed to fulfil the



requirements of the directive. The requirements given in EN ISO 9003 shall be completed with some 

additional requirements. This guidance is not amended after the publication of the new EN ISO 

9001:2000. The European foreword of the standard gives some guidance and there is also a 

Recommendation for Use sheet (Sheet number 119), describing, which clauses of the standard EN ISO 

9001:2000 are relevant. 

http://www.europa.eu.int/comm/enterprise/mechan_equipment/ppe/clarificationsheets/ 

tablecontents.pdf 

The NB carries out audits to evaluate the quality-control system and to make sure that the manufacturer is 

maintaining and applying the approved quality control. 

THE EC DECLARATION OF CONFORMITY 

The manufacturer or his authorised representative must draw up and sign an EC declaration of conformity 

for each model of PPE whatever its category. In this declaration the manufacturer certifies that the PPE 

placed on the market is in conformity with the provisions of the PPE Directive. The declaration also 

contains reference to the harmonized standards applied, to the EC type-examination certificate and to the 

NB responsible for the 11 A or B procedure, as appropriate. A model of this declaration is given in Annex 

VI of the directive. 

CE MARKING 

The CE marking shall be affixed to each item of PPE placed on the market and on its packaging. If 

marking on the PPE is impossible (for instance, because it is too small) the marking may be on the 

packaging only. The marking must be visible, legible and indelible throughout the foreseeable useful life 

of the PPE. Other marks, which could be confused with the CE marking, may not be affixed to PPE. 

CE marking is evidence that the product conforms to all the relevant EHSRs and that the product has 

been subject to the appropriate conformity assessment procedure. The form of CE marking is given in 

Annex IV of the directive (which has been amended twice, by Directive 93/68/EEC [10] and Directive 

96/58/EC). [13] It must have a minimum height of 5 mm except for very small PPE. 

For category I equipment the CE marking is the letters CE in the given form. The same goes for category 

II products, which can be identified as Category II products from the information notice supplied by the 

manufacturer, which must include the name and address of the NB having made the EC typeexamination. 

For category III products, the CE marking includes the identification number of the NB 

responsible for the Article 11 A or 11 B procedure.



ESSENTIAL HEALTH AND SAFETY REQUIREMENTS (EHSRS) 

GENERAL 

The basic health and safety requirements are normally called as Essential Health and Safety 

Requirements. The EHRSs are set out in annex II of the Directive 89/686/EEC. Annex II is divided into 

three sections 

• General requirements applicable to all PPE; 

• Additional requirements common to several classes or types of PPE; 

• Additional requirements specific to particular risks. 

GENERAL REQUIREMENTS 

The basic principle laid down by Annex II is that PPE should provide the highest level of protection 

possible. The optimum level of protection to be taken into account in the design is that beyond which the 

constraints imposed by the wearing of the PPE would prevent its effective use during the period of 

exposure to the risk or normal performance of the activity. 

The first section of Annex II also includes requirements concerning levels of risk, the innocuousness of 

PPE, comfort and efficiency and the information to be supplied by the manufacturer. 

ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE 

The second section of Annex II includes requirements for PPE: 

• incorporating adjustment systems; 

• for the face, eyes and respiratory tracts; 

• subject to ageing; 

• which may be caught up during use; 

• for use in explosive atmospheres; 

• for emergencies, requiring rapid donning or removal; 

• for use in very dangerous situations; 

• incorporating components which can be adjusted or removed by the user; 

• for connection to another, external complementary device; 

• incorporating a fluid circulation system; 

• bearing identification or recognition marks; 

• for signalling the user's presence visually; 

• and multi-risk PPE.



ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS 

The third section of Annex II includes requirements relevant to PPE designed to protect against: 

• mechanical impact, falls due to slipping, falls from a height and vibration; 

• compression, abrasion, perforation, cuts and bites; 

• drowning; 

• noise, heat and fire, and cold; 

• electric shock, non-ionising and ionising radiation; 

• dangerous substances and infectious agents: respiratory protection and cutaneaous and ocular 

contact; 

• risks incurred during diving.



HARMONISED STANDARDS 

GENERAL 

Harmonized standards are European standards: 

• prepared in accordance with the General Guidelines agreed between the European Commission 

and CEN / CENELEC; 

• mandated by the Commission; 

• adopted in accordance with CEN/CENELEC rules, officially presented to the Commission 

following their adoption. 

Harmonized standards provide a presumption of conformity with EHSRs if they are published at the 

national level in at least one Member State and their references are published in the OJEC. 

There are seven specific PPE standardisation Technical Committees in CEN 

TC number Field Subgroups Secretariat 

CEN / TC 79 Respiratory protective devices 9 SC DIN (Germany) 

CEN / TC 85 Eye-protective equipment 9 WG AFNOR (France) 

CEN / TC 158 Head protection 11 WG BSI (U-K) 

CEN / TC 159 Hearing protectors 3 WG SIS (Sweden) 

CEN / TC 160 

Protection against falls from a height and work 

restraint systems 

5 WG DIN (Germany) 

CEN / TC 161 Foot and leg protectors 4 WG BSI (U-K) 

CEN / TC 162 

Protective clothing including hand and arm 

protection and lifejackets 

12 WG DIN (Germany) 

OTHER TCS DEALING WITH PPE ARE: 

TC number Field Secretariat 

CEN/TC 122/JWG 9 Ergonomics of PPE DS (Denmark) 

CEN/TC 136 WG 5,6,7 

Sports-Playground and other recreational 

equipment 

DIN (Germany) 

CENELEC/TC 78 Equipment and tools for live working UTE (France)



CEN/TC 211 Acoustics DS (Denmark) 

CEN/TC 231/WG 3 Vibrations DIN (Germany) 

More than 300 harmonised standards are already published and many of those are under revision. Lists of 

PPE harmonised standards have been published by the OJEC under the following references: 

Commission communication in relation to personal protective equipment - OJ C 203 of 28.8.2003. The list 

of the harmonised standards can be found also at: 

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/ppe.html 

INTERNATIONAL STANDARDISATION 

In order to avoid the barriers to international trade, it has been accepted to give preference to the 

international standardisation. Some ISO technical committees (like ISO TC 94/SC13, ISO TC 94/SC 14 

and ISO TC 94/SC 15) are already drafting new standards. 

CYPRUS STANDARDS BODY 

Further information on standards and guidance information can be obtained from the Standards Body of 

Cyprus: 

CYS 

Cyprus Organisation for the Promotion of Quality 

At the Ministry of Commerce, Industry and Tourism 

13-15, Andreas Araouzos Street 

1421 Nicosia 

RELATION WITH OTHER DIRECTIVES 

GENERAL 

If different aspects of a product are dealt with by more than one directive, it may only be placed on the 

market and/or put into service when it complies with the requirements and the conformity assessment 

procedures of all the directives applicable to it. 

THE MEDICAL DEVICES DIRECTIVE (93/42/EEC) 

This directive applies to devices, other than medicines, used in health care. It aims at protecting the 

health and safety of patients and users of medical devices, and other exposed persons. The directive 

states in Article 1.6 that it is not applicable to PPE. The decision as to which directive is applicable 

depends on the principal use of the device. Thus surgical masks used principally to protect the patient are



under the medical devices directive. However equipment worn by health care personnel to protect 

themselves against infectious agents is under the PPE Directive. 

Corrective spectacles are medical devices, but protective spectacles with corrective lenses are under PPE 

Directive because their main aim is to protect the eyes of the wearer. (The additional optical correction 

increases the comfort and usability of the PPE because the worker does not have to wear simultaneously 

corrective lenses). 

Some PPE are adapted to the individual user's needs, such as orthopaedic shoes or individually moulded 

earplugs. In these cases the PPE Directive is applicable. 

THE MARINE EQUIPMENT DIRECTIVE (96/98/EC) 

This Directive covers equipment used on board sea-going ships. The Directive does not prescribe CE 

marking, as it establishes a special conformity marking (a Steering Wheel); however the principles are 

identical to those concerning CE marking. Rather than essential requirements, equipment covered by the 

directive must meet the applicable requirements of the international conventions, the relevant resolutions 

and circulars of the IMO, and the relevant international testing standards. 

The PPE used on board and listed in this directive, shall fulfil the requirements of marine directive only. 

For the PPE the directive requires EC type-examination and production quality assurance (module D), or 

product quality assurance (module E) or product verification (module F). 

Annex A1 of the Directive contains a list of equipment for which detailed testing standards already exist in 

international regulations. In this list, lifejackets, immersion suits and thermal protective aids are 

mentioned. In Annex 2 of the directive, there is a list stating equipment for which no international test 

standards exist. This list includes firemen's breathing apparatus. These annexes will be amended 

periodically and relevant references to EN ISO standards will be added. The testing for CE marking or 

Steering Wheel marking will be similar, so equipment concerned will be marked under one or the other 

directive, depending on its intended use. 

THE TOYS DIRECTIVE (88/378/EEC) 

This directive covers safety of products designed for play for children under 14. 

Equipment designed to be worn by children (such as bicycle or ski helmets, ski goggles etc.) to protect 

them against a risk comes under the PPE Directive. 

However children also play with imitations of adult PPE (such as imitations of firemen's helmets, nurse's 

protective clothing etc). Such imitated PPE for children comes under the Toys Directive and according to 

the Annex of this directive manufacturers of such toys must supply a warning to avoid any confusion with 

real PPE. 

THE MACHINERY DIRECTIVE (98/37/EC) 

This directive applies to machinery, and is based on the principle of integration of measures by design to 

ensure the safety of users. In the design of control devices, constraints due to the necessary or 

foreseeable use of personal protection equipment (such as footwear, gloves, etc.) must be taken into 

account.



According to the directive, the manufacturer of the machine shall inform users of the residual risks due to 

any shortcomings of the protection measures adopted, indicate whether any particular training is required 

and specify any need to provide personal protective equipment. 

THE GENERAL PRODUCT SAFETY DIRECTIVE (2001/95/EC) 

The General Product Safety Directive is aimed at ensuring that consumer products placed on the EU 

market are safe. The objectives of the Directive are both to protect consumer health and safety and to 

ensure the proper functioning of the internal market. The Directive applies to products intended for or 

likely to be used by consumers. It obliges producers to place only “safe” products on the market. When 

the manufacturer is not based in the EU, this obligation applies to his representative in the EU or, in the 

absence of a representative, to the importer. 

The GPSD is intended to ensure a high level of product safety throughout the EU for consumer products 

not covered by sector legislation, but also to complete and complement the provisions of such sector 

legislation for the risks, the producer obligations and the authorities’ powers and tasks not covered in it. 

The Directive provides a generic definition of safe product. Products in conformity with the specific rules 

(like PPE directive) applicable in the Member State in which they are in circulation are deemed to meet 

the definition of safe product. In the absence of specific national rules, the safety of a product shall be 

assessed having regard to European standards, Community technical specifications, national standards of 

the country in which the product is in circulation, codes of good practice, the state of the art and 

expectations of consumers. 

In addition to the basic requirement to place only safe products on the market, producers must inform 

consumers of the risks associated with the products they supply. They must take measures to be informed 

of risks posed by the products which they supply and take the appropriate measures to prevent such risks. 

Finally, they must be able to trace dangerous products. 

The PPE Directive does not contain any system for rapid exchange of information between market 

surveillance authorities in emergency situations. Therefore, the provisions concerning the procedure for 

rapid exchange of information on dangers and the subsequent action at Community level are applicable to 

PPE for consumer use. 

DIRECTIVE CONCERNING THE MINIMUM HEALTH AND SAFETY REQUIREMENTS FOR 

THE USE OF PERSONAL PROTECTIVE EQUIPMENT BY WORKERS AT WORKPLACE 

(89/656/EEC) 

On the basis of the Article 16 of the Framework Directive (89/391/EEC), directive concerning the minimum 

health and safety requirements for the use of personal protective equipment by workers at workplace has 

been given. The general principle of the directive is that PPE shall be used when the risks cannot be 

avoided or sufficiently limited by technical means, by collective protective measures, or by methods of 

work organization. 

The assessment of the needs to use PPE has three phases: 

• an analysis and assessment of risks which cannot be avoided by other means; 

• based on this risk assessment, the characteristics of the PPE needed must be defined;



• the PPE must then be selected among CE marked PPE, taking the special needs of the workplace 

and worker into account. 

This assessment must be reviewed, if any changes occur. 

The employer must ensure, that the PPE: 

• complies with the requirements of the PPE Design Directive 89/686/CEE; 

• is appropriate for the risks involved, without itself leading to any increased risks; 

• corresponds to existing conditions at the workplace; 

• is selected taking ergonomic requirements and the worker’s state of health into account; 

• fits the wearer correctly after any necessary adjustment; 

• is compatible with other items of PPE worn simultaneously; 

• is in principle for personal use; 

• is provided free of charge; 

• is kept in good working order by means of necessary maintenance. 

Also the conditions of use shall be determined. These include the determination of the length of the use 

period, taking into account the seriousness of the risk, frequency of exposure, the characteristics of the 

workstation of each worker and the performance of the PPE. The employer shall inform the workers of 

the risks and arrange the necessary training. 

THE PRODUCT LIABILITY DIRECTIVE (85/374/EEC) 

This Directive deals with liability for any product manufactured or imported into the Community, which 

causes damage to individuals or property. It thus may apply to damage caused by defective PPE. The 

objective of the PPE Directive is to prevent, as far as possible, the placing on the market and putting into 

service of unsafe PPE. The Product Liability Directive is a further incitement to the manufacturer to design 

and make safe products, in light of the costs incurred through liability for defective products. Thus the PPE 

Directive and the Product Liability Directive may be seen as complementary. 

OTHER DIRECTIVES 

Other directive, which may be applicable to PPE, is ATEX directive concerning equipment intended to be 

used in potentially explosive atmospheres. Some equipment, like e.g. powered respiratory protective 

equipment, shall be assessed also against requirements of the ATEX directive. 

Some PPE may contain pressure vessels. Those are covered by Directive 87/404/EEC, as amended.



MARKET SURVEILLANCE 

The PPE Directive defines the responsibility of Member States for market surveillance in very general 

terms: 

“Member States shall take all appropriate measures to ensure that PPE ... may be placed on 

the market and brought into service only if it preserves the health and ensures the safety of 

users ... when properly maintained and used for its intended purpose.” (Article 2.1. of the 

directive). 

Member States must allow free circulation to PPE placed on the market in compliance with the 

requirements of the directive. But the presumption of compliance accorded to “CE” marked products is 

not absolute: it is subordinated to the duty to protect the health and safety of users. 

“ If a Member State discovers that PPE bearing CE marking and used in accordance with its 

intended purpose could compromise the safety of individuals, domestic animals or property, it shall 

take all necessary measures to remove that equipment from the market and prohibit the marketing 

or free movement thereof (Article 7.1. of the directive). 

The responsibility of Member States to thus ensure that only safe products are placed on the market 

implies the obligation to organise and carry out effective surveillance of the market. The main aim of this 

surveillance is to ensure that the EHSRs of the directive are satisfied by the PPE effectively placed on the 

market. 

In the case of PPE certified by the manufacturer himself, market surveillance is necessary to ensure that 

this simple procedure is not seen as an open door for noncompliant products. 

In the case of the majority of PPE, for which the model has been approved by a third party before 

production is placed on the market, market surveillance involves checking that the products effectively 

placed on the market are in conformity with the provisions of the PPE directive. It may also bring to light 

cases where conformity evaluation has not been properly carried out by the NB. 

For PPE submitted to the procedures described in Article 11 of the directive, involving approval of the 

manufacturers’ quality-control system or periodic controls of production, market surveillance may be 

considered less vital. But experience shows, even in this case, that checks are useful to ensure that the 

procedures are being properly applied. 

Market surveillance is thus an essential tool for effective enforcement of the provisions of the directive. It 

is to be considered vital to the credibility of CE marking, and more generally, to creating confidence in the 

single market. 

WHO IS RESPONSIBLE FOR MARKET SURVEILLANCE? 

Market surveillance must be carried out with a guaranty of impartiality and objectivity, which implies 

overall responsibility by the public authorities of Member States. In particular, surveillance of PPE already



placed on the market is not the job of the Notified Bodies responsible for evaluation of PPE models before 

they are placed on the market. 

However the public authorities do not always have the necessary expertise or equipment needed to carry 

out the very specific tests required to check the conformity of PPE with EHSRs. The public authorities may 

thus call on competent bodies, including the Notified Bodies, to provide this expertise, while remaining 

sole judge of the conclusions to be drawn and the action to be taken. 

Member States must designate the authorities responsible for enforcement, including market surveillance 

of PPE. They may be national, regional or local authorities, provided the whole national territory is 

covered. Market surveillance may also be shared between several authorities; indeed this may be 

necessary to cover both PPE for professional and private use for which distribution channels are often 

different. 

The authorities concerned may include the consumer protection services, labour inspection, and customs 

authorities. When Member States designate several authorities for market surveillance it is necessary to 

organise co-ordination of their activity. It is also useful to select a single co-ordinating authority, which may 

be the correspondent for the authorities of other Member States. 

These authorities must have the necessary powers and be attributed sufficient resources to be able to 

carry out effective market surveillance activity. These include the power to visit manufacturers’ distributors’ 

or users’ premises, to take or purchase samples for examination or for testing, and to require all 

necessary information. 

Market surveillance activity can take several forms. Schematically, it is possible to distinguish formal 

checks from checks on substantial, technical compliance with EHSRs. 

CHECKS ON MARKING AND DOCUMENTATION 

The directive provides the authorities responsible for market surveillance with a number of tools for 

checking compliance with the conformity evaluation procedures. 

Absence of CE marking is a clear indication that the requirements of the directive have not been taken 

into account. 

The manufacturers’ EC declaration of conformity must be produced on demand. This document enables 

market surveillance authorities to know which evaluation procedure has been followed, the notified body 

or bodies concerned, and the harmonized standard or standards used. 

The information contained in the EC declaration of conformity can be compared with the manufacturers’ 

instructions for use (which must accompany the PPE), to check that the evaluation procedure followed 

corresponds to the risks against which the PPE is designed to protect. 

The information contained in the EC declaration of conformity also enables the authorities to contact the 

Notified Bodies concerned in order to obtain a copy of the EC type-examination certificate, of the 

manufacturers’ technical file and of the test reports. 

Finally, the authorities may require the manufacturer to produce relevant extracts of the technical 

documentation in support of the EC conformity declaration. 

In many cases, examination of the marking and documentation may be considered a sufficient indication 

of the conformity of the PPE. However, in case of doubt as to the conformity of PPE with the EHSRs or



with the performance levels claimed by the manufacturer, it is generally not possible to reach a conclusion 

simply by visual examination. Checking technical conformity of PPE requires carrying out laboratory tests. 

CHECKING COMPLIANCE WITH ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 

The tests necessary to check compliance with EHSRs are often destructive, and may require several 

samples of the PPE concerned. So this aspect of market surveillance involves either the taking or the 

purchase of the required number of samples (depending on the surveillance authorities’ powers). Tests 

may be carried out within the authorities own facilities when these are available, or else entrusted to 

competent laboratories. 

In general, when the type of PPE concerned is covered by harmonized standards, the appropriate tests 

are those described in the relevant standard. If no harmonized standard exists, or if the manufacturer has 

applied other criteria for conformity evaluation, it may be necessary to determine appropriate tests. In 

many cases, it may be considered unnecessary to carry out all the tests laid down by the harmonized 

standard. Time and money may be saved by limiting the checks to test with particular importance for the 

safety of users, or sufficient to determine the level of protection afforded by the PPE. 

In many cases the laboratories most competent and best equipped to carry out the tests are the 

laboratories of Notified Bodies, but it must be clear that in this case the body is not acting as a NB but as a 

test-house on behalf of the market surveillance authorities. 

When the market surveillance authorities receive the test reports, manufacturers should whenever 

possible be informed of the results and asked to present their observations, before action is decided. 

Exceptions may be justified, if action is considered urgent to protect the safety of users. 

Experience shows that in most cases, when market surveillance checks reveal anomalies, corrective 

measures are agreed by the manufacturer. These corrective measures may include completion of the 

conformity evaluation procedure, modifications concerning the product and the instructions for use, or 

improvement of the arrangements for quality control of the production. When surveillance reveals 

substantial problems concerning either the PPE itself or the information supplied to users, manufacturers 

may be asked to withdraw products from the market and/or inform their customers. 

In the case of noncompliant PPE, after taking into account the observations presented by manufacturers, 

and in light of the seriousness of the non-compliance, the market surveillance authorities have to 

determine the appropriate course of action. Several possibilities are open. 

IF ADEQUATE CORRECTIVE MEASURES ARE AGREED BY THE MANUFACTURER 

When the manufacturer and the authorities agree on corrective measures, and these are considered 

sufficient to protect the health and safety of users provided sufficient assurance is given that these 

measures will effectively be carried out, the market surveillance authorities may consider the file to be 

closed. In the majority of cases this outcome is doubtful. 

This situation raises a problem, since technical harmonization introduced by the directive has created a 

single market enabling PPE to move freely across national borders, but the market surveillance authority 

is competent only for the national market. If a problem has reached a satisfactory solution in one Member 

State, an unscrupulous manufacturer may be tempted to sell off noncompliant stock in other Member 

States where the problem may not be detected.



To deal with this eventuality, and ensure an equivalent level of protection throughout the community, it is 

clearly necessary for Member States to develop mutual information about their market surveillance 

activity. In particular, this enables each Member State to verify that corrective measures agreed in another 

Member State have been applied elsewhere. 

Exchange of information between market surveillance authorities is also useful to increase the efficiency 

of market surveillance. If one authority, for instance, has surveyed one type of PPE and found a generally 

satisfactory situation, another Member State may consider that work in this field has little interest. On the 

other hand if a Member State clearly identifies a problem area, this may alert others and enable them to 

concentrate their surveillance activity where it is most needed. Exchanges of experience also enable the 

spread of good practice and effective techniques for surveillance. Finally, good contacts between 

surveillance authorities facilitate the solving of problems in files, which have implications for several 

Member States. 

As things stand, no formal procedure for administrative co-operation is laid down in the directive. 

However, Member States are required, under Article 5 of the Treaty of Rome to co-operate in order to fulfil 

their obligations. Improving this co-operation is thus a priority task for the Standing Committee set up to 

deal with problems of application of the directive, and it may indeed require improvement of the directive 

itself. 

IF CE MARKED PPE IS POSSIBLE TO ENDANGER THE HEALTH OR SAFETY OF USERS 

In the first instance, placing on the market PPE that is not in conformity with the EHSRs is an 

infringement, which may incur penalties under national law. However this is not sufficient to protect users. 

If the manufacturer does not take corrective measures voluntarily, or if these are considered insufficient to 

protect users, the Member State must take the necessary measures to have the PPE withdrawn from the 

market, and to restrict or prohibit its being placed on the market. Article 7 of the directive lays down a 

procedure to be followed in such a case, known as the safeguard procedure or safeguard clause. 

THE SAFEGUARD PROCEDURE FOR UNSAFE PPE 

The Member State informs the Commission indicating the reasons for the measures taken. In particular, it 

must be indicated whether the nonconformity of the PPE concerned is due to failure to comply with the 

EHSRs, to unsatisfactory application of harmonized standards, or to shortcomings in the harmonized 

standards themselves. 

The Commission then consults the parties concerned. After enquiry, which may involve recourse to 

expert opinion if technical questions are at stake, the Commission decides whether or not the action taken 

by the Member State is justified. If the action is justified, the other Member States are informed so that 

appropriate action may be taken to prevent circulation of the dangerous product throughout the 

Community. If the Commission judges that the action of the Member State is not justified, the Member 

State and the manufacturer are informed accordingly. 

If it is confirmed that the nonconformity of the PPE results from shortcomings in a harmonized standard 

the Commission uses the procedure laid down in the “safeguard clause” for standards.



THE SAFEGUARD PROCEDURE FOR UNSATISFACTORY HARMONIZED STANDARDS 

If either the Commission or a Member State considers that a harmonized standard does not satisfy the 

EHSRs of the directive, they must refer the matter to the Committee set up under the Directive 98/34/EC 

amended by Directive 98/48/EC, which deals with standards and technical regulations. In light of the 

opinion of this Committee, the Commission decides whether it is necessary to withdraw the reference of 

the standard concerned from the OJEC. 

FURTHER INFORMATION 

STANDARDS 

CYS 

Cyprus Organisation for the Promotion of Quality 

at the 

Ministry of Commerce, Industry and Tourism 

13-15, Andreas Araouzou Street 

1421 Nicosia 

Further information and links to all relevant European websites are available at 

www.cys.mcit.gov.cy 

under the button named: 

NEW APPROACH



CYPRUS COMPETENT AUTHORITY 

In Cyprus, the Ministry of Labour and Social Insurance, through the Department of Labour Inspection, is 

the competent authority and responsible for enforcement of the PPE related Regulations. Further details 

on enforcement and penalties are available at the following Cyprus Contact point: 

Department of Labour Inspection 

Ministry of Labour and Social Insurance 

Contact: 

Tasoula Kyprianidou - Leontidou 

Labour Inspection Officer 

Tel. 22 40 56 53 

Fax 22 66 37 88 

e-mail: tkyprianidou@dli.mlsi.gov.cy 

CYPRUS LEGISLATION 

General requirements and stipulation are layed down in the Cyprus Framework Law N. 30(I)/2002 

(published 5.4.2002) as amended by Law N. 29(I)/2003 (published 28.3.2003). 

The Framework Law represents the legal basis for the Cyprus Regulations addressing respective 

Directives. 

The Cyprus Regulation addressing the PPE directive is the Essential Requirements (Personal Protective 

Equipment) Regulations of 2003, P.I. 315/2003 (published 18.4.2003).

GUIDE PPE - Cyprus Organization for the Promotion of Quality

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