CELEX: 51988PC0157
Language: en
Date: 1988-04-14
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to personal protective equipment (presented by the Commission)

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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                   COM(88 ) 157 final - SYN
                ©Brussels, 14 April 198
                             HT
                                                   Brussels , 14 Apri I 1988
                 W t>
                            Proposai for a
                          COUNCIL DIRECTIVE
 on the approximation of the laws of the Member States relating to
                    personal protective equipment
                    (presented by the Commission )
 ---pagebreak---                                                                                2
                                    MEMORANDUM
Directive on personal orotective eauipment and the 1992 horizon
The level of protection enjoyed by users of personal protective equipment
( PPE ) has always been a matter of concern to the public authorities of the
Member States who have adopted a number of regulations and standards in this
field .    The technical specifications involved have given rise to numerous
technical barriers to trade , which make the free movement of many types of PPE
within the Community difficult if not impossible .
Trade in PPE accounts for a considerable turnover and , since the adoption of
the Council Resolution of 7 May 1985 on a new approach to technical
harmonization and standardization , the Commission has been of the opinion that
this vast sector should be covered by one of the first Directives based on
that approach .   The Commission 's position is supported by the representatives
of the Member States and the parties concerned .
This proposal for a Directive applies to a wide range of PPE for professional
or private use .
The only PPE excluded is that covered by existing future special Directives
relating to the free movement and safety of such products , PPE intendend for
use by the armed forces or in the maintenance of law and order , PPE for
private use in bad weather and PPE for self-defence .
The guidelines laid down under the new approach state that Directives should
no longer contain highly detailed design and manufacturing provisions but
should merely define the basic safety requirements that are considered
necessary and adequate to ensure user safety and , as a result , to facilitate
the free movement of goods in the Community .
Adherence to the new approach proved to be a particularly difficult task in
the case in point since it involved the execution of a detailed study and
necessitated numerous discussions with all the parties concerned , namely the
Member States , the manufacturers , the inspection bodies and professional and
worker 's organizations .
With a view to ensuring the satisfactory application of the Directive , the
European Committee for Standardization ( CEN ) must be given the important task
of drafting - from the technical standpoint - all the basic safety
requirements specified as objectives byf the Directive , the aim being to
provide manufacturers and the Member States with the means of minimizing
misinterpretation with regard both to the design and manufacture of PPE and
its inspection .
 ---pagebreak---                                                                                  3
                                            1
                                 EXPLANATORY MEMORANDUM
I.   PRINCIPAL OBSERVATIONS CONCERNING TO THE PROPOSAL FOR A DIRECTIVE
     1.  Purpose of the Directive
         This proposal for a Directive has been drawn up pursuant to the Council
         resolution of 7 May 1985 on a new approach to technical harmonization
                         1
         and standards .      It forms part of the work programme defined in the
         White Paper which is intended to lead to the completion of the internal
         market before the end of 1992 .
         The sector covered by this proposal , personal protective equipment ( PPE )
         comprises PPE for both professional and private use .
                                                          ■>
         The field in question is thus vast and of major economic importance for
         the Community .
         The primary objective of the Directive is the harmonization of national
         provisions relating to the design and manufacture of PPE with a view to
         ensuring its free movement within the Community .        This objective is
         associated with a requirement , namely the need to attain the maximum
         possible degree of protection .       In the pursuit of this goal , this
         proposal complements Directive .               which , among other things ,
         deals with the choice and the use of PPE at the workplace .
   OJ No C 136 , 4.6.1985 , p. 1 .
   COM 88 ( 53 )
 ---pagebreak---                                                                                i
                                   - 2 -
    The scope of the sector covered , the number of products concerned , the
    comprehensive and systematic nature of the safety philosophy underlying
    the basic requirements specified and the impact it will have on the
   progress of European standardization are all factors which make this a
   particularly important proposal for the completion of the internal
   market in these products .
2. Conformity with the Treaty
   As is clear from section 1 above , this proposal is intended to afford as
   high a level of protection as possible and is therefore in conformity
   with Article 100A ( 3 ) of the Treaty .
   The Proposal does not call for any special provisions of the kind
   referred to in Article 8c of the Treaty .
3. Scope
   This proposal for a Directive covers an extremely broad range of PPE for
   both professional and private use .
   Apart from certain PPE which are expressly excluded ,      the scope of the
   proposal has been restricted in order to take account of the existence
   of other directives regulating the design and manufacture of certain
   PPE .   It is , however , difficult to avoid the presence , at the limit of
   its field of application , of a grey area including hybrid personal
   equipment essential to the performance of certain activities - work , for
   example - that nevertheless fulfill an indissociable safety function to
   which the relevant basic requirements of this proposal apply ; certain
   PPE must also provide '’personal-protection " pursuant to the basic
   requirements of the proposal and , at the same time , preclude the
   contamination of other persons , animals or property , a function not
   covered by those requirements .     The Commission is of the opinion that
   these two shortcomings should be remedied at the stage of European
   standardization when the necessary specification should be exhaustively
   covered .
 ---pagebreak---                                                                              Г
                                   - 3 -
4. Basic requirements
   The basic requirements correspond to a number of criteria and are
   designed to Lead to Community legislation based on the concept of
   ultimate personal protection ensuring user safety throughout the period
   of use against risks that have not been removed by priority public
   safety measures .
   The principle whose application caused most difficulty concerns the
   drafting of requirements capable of covering all PPE from the simplest
   to the most complicated whilst ensuring as far as possible the
   applicability of the basic requirements in the absence of standards .
   The solution adopted involves the division of the basic requirements
   into three associated groups , namely :
   - general requirements applicable to all PPE , irrespective of the risk
     in question or the part of the body to be protected ;
   - additional requirements common to several types of PPE ,    irrespective
     of the risks in question ;
                                                     ■>
   - additional requi rements , spécifie to particular risks .
5. The role of standardization
   The role of European standardization is to codify in a free and
   non-binding manner the state of the art as regards the means to be
   deployed to satisfy the obligations arising from the basic requirements .
   Since , under the new approach . Member States will be expected to presume
   that products manufactured in accordance with European standards comply
   with the basic safety requirements , those standards can , constitute an
   extremely important limitation of liability for any manufacturer in the
   event of a dispute .   This limitation of liability is imperative in the
   case of PPE because of the degree of safety to which users are entitled .
 ---pagebreak---                                                4
       6.  Certification procedures
           Council Directive 85 / 374 / EEC of 25 July 1985 on the approximation of the
            laws , regulations and administrative provisions of the Member States
           concerning liability for defective products will enter into force on
           30 July 1988.^ On the basis of tiis new Community legislation, the
           proposed PPE Directive provides for three certification procedures
           corresponding to the degree of risk in question ; an EEC type-examination
           certificate must be issued by an approved inspection body prior to the
           manufacture of most PPE ,        although a " less stringent " procedure is
           permitted in the case of equipment providing protection against minimal
           risks ( associated with housework , dressmaking and gardening ) and a "more
           stringent " approach is required for a limited range of equipment of
           complex design providing protection against immediate danger involving
           potentially lethal acute effects ,         with the basic procedure being
           supplemented by an EEC verification certificate issued by the approved
           inspection body in respect of the series manufactured .
II .   SPECIAL CONSIDERATIONS
       1.  Economie and social impact
           Before initiating work on its proposal ,        the Commission conducted a
           survey in order to examine the national regulations and standards in
           force in this vast sector .       The results of this enquiry confirmed the
           existence of considerable differences between the Member States ,       with
           regard both to the technical specifications laid down in standards and
           other rules of the art relating to the design of PPE and to the
           administrative procedures governing examination , testing , inspection and
           authorization at the time of marketing .
           These technical and administrative differences are a source of trade
           barriers between most of the Member States .
 2
     0J L 210 , 7.8.1985 , p. 29 .
 ---pagebreak---                                                                                Ί
                                   - 5
   It is obviously extremely difficult to evaluate the economic impact of
   these barriers and to calculate their cost .      This difficulty is further
   aggravated by the fact that the sector contains a large number of small
   and medium-sized businesses ,    and even craft businesses which are very
   often forced by trade barriers to concentrate on their national or local
   markets .    Although difficult to prove , the costs incured as a result of
   " non-harmonization " are   certainly very considerable .      There are no
   Community statistics concerning the number of accidents or illnesses
   which can be ascribed to the unsuitable design or faulty manufacture of
   PPE ; the rare factual data available at national level nevertheless
   reveal that the number of serious , and even fatal , accidents primarily
   due to the use of faulty PPE is not negligible .
   The application of the principles adopted in drafting the Directive and ,
   in particular , the basic requirements , namely PPE design aimed at
   precluding risks without creating discomfort or nuisance factors for the
   user   should   lead to  a  substantial  reduction   in the  number of   such
   accidents   or   illnesses with   all  the  beneficial   human  and economic
   consequences which this can be expected to entail .
2. Consultation of the parties concerned
   From the start of preparatory work , the Commission sought to involve all
   the parties concerned , namely representatives of governments , trade
   unions , industrial federations , inspection bodies and the European
   standardization organizations CEN and CENELEC .              Furthermore , a
   delegation from the ad hoc PPE Working Party of the Advisory Committee
   on Safety , Hygiene and Health Protection at Work participated in the
   above-mentioned preparatory activities .         The Committee itself was
   consulted and delivered a very favourable opinion .
   The Commission will ensure that all the parties concerned , including the
   relevant labour organizations , are involved in the standardization and
   administrative activities provided for by this proposal for a Directive .
 ---pagebreak--- 3.  Transitional period
    In order to fulfill their intended role of unifying the markets , it must
   be possible to accompany the Directives based on the new approach with
   standards corresponding to the essential requirements of the Directive .
   In the field in question , however , given the broad scope of the
   Directive , and the great number of standards to be harmonized , there
   will probably be a fairly lengthy period during which , on the one hand ,
   not all the necessary European standards will be available and , on the
   other , it may well not always be possible to offset this lack by
   reference to national standards covering all or part of the relevant
   basic requirements , and to control them at Community level .
   Under these circumstances , it must be anticipated that on the one hand ,
   for certain P.P.E. , the status quo as regards conformity to existing
   national standards will have to be maintained on a transitory basis ,
   during the period leading to the deadline set for the creation of the
   internal market , and , on the other , that manufacturers or the approved
   inspection bodies will have to provide respectively a declaration or
   certificate attesting the direct conformity of PPE with         the basic
   requirements of the Directive , in the absence of European standards
   containing detailed technical specifications which will enable an
   objective and uniform interpretation of these requirements to the made
   in the Member States .
   The Commission considers that the lack of uniformity inherent in such a
   situation , which national governments and industries will find difficult
   to accept , will produce a powerful stimulus towards rapid progress in
   European PPE standardization and a clear commitment to this goal on the
   part of the industries concerned , since it is in their interest that
   such harmonization should provide a recognized method of establishing
   conformity to the basic requirements without delay .
   Pending the complete attainment of this objective , the Commission must
   seek to ensure through the effective application of the procedures
   provided for by the safeguards clause , th3t recourse to that clause does
 ---pagebreak---                                                                            3
                               - 7 -
not become too frequent .       This could be achieved by establishing
efficient cooperation between the Commission ,    the national inspection
bodies and all the parties concerned .   Examination of specific cases of
recourse should make it possible to adopt common attitudes to the
problem of evaluating the technical solutions evolved in response to the
basic requirements of the Directive and , as a result , to take preventive
measures against the proliferation of subsequent recourse .
Such cooperation between the Commission and the inspection bodies of the
Member States already exists ; it has proved successful in the context of
application of several Directives and should be applicalbe on the basis
of informal and pragmatic arrangements ,       without compromising the
exclusive powers conferred by the Treaty on the Commission as the
guardian of Community law .
 ---pagebreak---                                                                               )o
                                 Proposai for a
                               CGUNCIL DIRECTIVE
       on the approximation of the Uws of the Member States relating
                       to personal protective equipment
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community, and in
particular Article 100 A thereof .
Having regard to the proposal from the Commission ,
In cooperation with the European Parliament ,
Having regard to the Opinion of the Economic and Social Committee ,
Whereas it is necessary to adopt measures with the aim of progressively
establishing the internal market over a period expiring on 31 December 1992 ;
whereas the internal market comprises an area without . internal frontiers in
which the free movement of goods , persons , services and capital is guaranteed;
Whereas , in recent years , several Member States have introduced regulations and
standards covering numerous items of personal protective equiorrent with a view ,
in particular , to safeguarding public health , improving safety at work and
ensuring user protection ;
Whereas these regulations and standards frequently contain extremely detailed
requirements relating to the design , manufacture , quality level , testing and
certification of personal protective equipment with a view to the protection of
individuals against injury and illness ;
Whereas , in particular , the requirements relating to safety at work make the use
of personal protective equipment compulsory ; whereas many requirements oblige
employers to make appropriate personal protective equipment available to their
 ---pagebreak---                                                                               n
staff in the event of the absence or inadequacy of ( priority ) public protection
measures ;
Whereas national provisions relating to personal protective equipment may differ
significantly from one Member State to another and may thus constitute a barrier
to trade with direct consequences for the creation and operation of the common
market ;
Whereas it is necessary to harmonize these different national provisions in
order to ensure the free movement of these products , without in any way reducing
the valid levels of protection already required in the Member States, and to
provide for any necessary increase therein ;
Whereas the provisions governing the design and manufacture of personal protec¬
tive equipment laid down in this Directive which are fundamental , in particular ,
to attempts to ensure a safer working environment are without prejudice to
provisions relating to the use of such 'equipment and the organization of the health
and safety of workers at the workplace ;
Whereas this Directive defines only the basic requirements to be satisfied by
personal protective equipment ; whereas , in order to facilitate proof of
conformity with those basic requirements , it is 'essential that harmonized
European standards be available relating , in particular , to the design and
manufacture of , and the specifications and test methods applicable to , personal
protective equipment , since compliance therewith confers on these products a
presumption of conformity with the above-mentioned basic requirements ; whereas
such harmonized European standards are drawn up by private bodies and must
retain the status of non-mandatory texts ; whereas , to this end , the European
Committee for Standardization ( CEN ) and the European Committee for Electro¬
technical Standardization ( CENELEC ) are the competent bodies which have been
authorized to adopt harmonized standards in accordance with the general guide¬
lines governing cooperation between the Commission and those two institutions
ratified on 13 November 1984 ; whereas , for the purposes of this Directive , a
harmonized standard is a text containing technical specifications (a European
standard or a harmonization document ) which has been adopted by one or both of
the above-mentioned bodies at the instigation of the Commission in accordance
 ---pagebreak---                                                                                 \t
                                          - 3 -
 with the provisions of Council Directive 83/ 189/ EEC of 28 March 1983 laying down
 a procedure for the provision of information in the field of technical standards
 and regulations      and pursuant to the above-mentioned general guidelines ;
 Whereas , pending the adoption of harmonized standards within the meaning of this
 Directive , which will be very numerous because of the broad
 scope of application and the preparation of which within the deadline set for
 the creation of the internal market will involve a great deal of work , it would
be advisable to maintain, on a transitional basis and subject to the requirements
of the Treaty , the status quo as regards conformity with existing national
standards for personal protective equipment not covered by a harmonized standard
at the date of adoption of this Directive ;
Whereas ,   given the general and horizontal nature of the role played by the
standing Committee set up pursuant to Article 5 of Directive 83/ 189/ EEC in the
implementation of the Community standardization policy and, more particularly,
its part in the preparation of standardization applications and the operation of
the existing European standardization agreements , this standing
Committee is especially suited to the task of assisting the Commission in
monitoring the conformity of harmonized standards throughout the Community ;
Whereas steps should be taken to ensure adequate consultation of the two sides
of industry and , in particular , the workers' organizations in the context of the
standardizations and administrative activities associated with this Directive ;
Whereas compliance with these technical requirements must be monitored in order
to ensure adequate user and third-party protection ; whereas existing monitoring
procedures may differ appreciably from one Member State to another ; whereas , in
order to avoid numerous checks which merely impede the free movement of personal
protective equipment , provision should be made for the mutual recognition of
inspections conducted by the Member States ; whereas , in order to facilitate such
recognition , it is necessary , in particular , to lay down harmonized Community
procedures and to harmonize the criteria to be taken into account in selecting
the bodies responsible for examination , monitoring and verification ;
HAS ADOPTED THIS DIRECTIVE :
1)
    OJ No L 109 , 2 6.4.1983 , p.8
 ---pagebreak---                                                                                '3
                                           - 4 -
                    CHAPTER I : SCCPE , MARKETING AND FREE BOVEWENT
                                        Article 1
1. This Directive applies to personal protective equipment , hereinafter
    referred to as PPE .
    It lays down the conditions governing its marketing and free movement
   within the Community and the basic safety requirements which PPE must
   satisfy in order to ensure the safety and health protection of users .
2.  For the purposes of this Directive , " PPE" means any device or appliance
   designed to be worn or held by an individual for protection against one or
   more safety and health hazards .
    " PPE " also covers :
   ( 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 ;
   ( b ) a protective device or appliance combined , separably or inseparably ,
          with personal non-protecti ve equipment worn or held by an individual for
          the execution of a specific activity ;
   ( c ) interchangeable PPE components which are essential to its satisfactory
          functioning .
3.  Any system marketed in conjunction with PPE for its connection to an external
   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 .
4.  This Directive does not apply to :
   - PPE covered by another Community Directive designed to achieve the same
       objectives as this Directive with regard to marketing , free movement of
       goods and safety .
 ---pagebreak---                                                                              14
                                       - 5 -
    - The PPE classes and types specified in the list of excluded products in
      Annex I , independently of the above-mentioned reason for exclusion .
                                       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 protects 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 .
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 .
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 - including tests involving individuals - until it has been
    brought into conformity by the manufacturer or his representative
    established in the Community .
                                       Article 3
1 . The PPE referred to in Article 1 shall satisfy the basic safety requirements
    set out in Annex II .
2 . The PPE mentioned in Article 8(2 ) shall conform :
        - either to relevant national standards ,         transposing harmonized
          standards , the titles and reference numbers of which have been
          published in the official Journal of the European Communities,
 ---pagebreak---                                                                                 ΙΓ
                                       - 6 -
       - or to other technical specifications ,      provided that these give the
         PPE   a    . level of protection equivalent to that defined in the basic
         safety requirements , to be assessed by an approved inspection body
         referred to in Article 9 , in accordance with the procedure laid down
         in Article 10 ( 3 ) .
3. The    PPE    referred to in Article 8 ( 2 ), for which harmonized standards are
   not available , may continue , on a transitional basis until 31 December 1992 at
   the latest , to be subject to national provisions already in force on the
   date of adoption of this Directive , provided that any such provisions are
   compatible with the requirements of the Treaty .
                                       Article 4
1. Member States shall not prohibit , restrict or hinder the marketing       of PPE
   or PPE components which satisfy the provisions of this Directive and which
   bear the " EC " mark .
2. Member States shall not prohibit , restrict or impede the marketing of PPE
   components , which do not bear the " EC " mark , and which are intended to be
   incorporated in PPE , provided that they are not essential to its satis¬
   factory functioning .
                                       Article 5
   Member States shall presume that PPE              satisfies the basic safety
   requirements referred to in Article 3 if it bears the " EC " mark , declaring
   its conformity :
       - with relevant national standards , transposing harmonized standards ,
         the titles and reference numbers of which have been published in the
         official Journal of the European Communities . The Member States shall
         publish the appropriate references of these national standards .
       - or with other technical specifications providing a level of protection
         eauivalent to that defined in the basic safety requirements of this
         Directive .
 ---pagebreak---                                                                                 ις
                                        - 7 -
                                        Article 6
   If a Member State or the Commission considers that the harmonized standards
   referred to in Article 5 do not , or no longer , completely satisfy the
   relevant basic requirements referred to in Article 3 , the Commission or the
   Member State concerned shall refer the matter to the Standing Committee
   created pursuant to Directive 83 / 189 / EEC , hereinafter referred to as " the
   Committee ", setting out its reasons . The Committee shall deliver an opinion
   without delay .
   In the light of that opinion ,    the Commission shall inform the Member States
   whether the reference to the standards in question need or need not be
   withdrawn from the publications referred to in Article 5 .
                                        Article 7
1. If a Member State discovers that PPE bearing the " EC " mark and used in
   accordance with its intended purpose       could compromise the safety of indi ¬
   viduals , 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 .
   The Member State concerned shall immediately inform the Commission of such
   action ,    indicating the reasons for its decision and , in particular, stating
   whether non-conformity is due to :
   ( a ) failure to comply with the basic requirements referred to in Article 3;
   ( b ) the unsatisfactory application of the standards referred to in Article 5 ;
   ( c ) a gap in the standards referred to in Article 5 .
2. The Commission shall initiate discussions with the parties concerned as soon
   as possible . If , a _ ter such consultation , the Commission decides that the
   action taken was justified , it shall immediately inform the Member State
   concerned and all the other Member States to this effect .         If the action
   referred to in paragraph 1 was taken as a result of a gap in the standards ,
   the Commission shall refer the matter to the Committee within two months if
   the Member State concerned intends to adhere to its decision and shall
    initiate the procedures referred to in Article 6 .
 ---pagebreak---                                                                                 />
                                         - 8 -
3. If PPE which is not in conformity with the relevant requirements bears the
   " EC " mark , the Member State concerned shall take the appropriate measures
   with regard to those responsible for affixing the mark and shall inform the
   Commission and the other Member States accordingly .
4. The Commission shall ensure that the Member States are kept informed of the
   progress and results of the procedure provided for in this Article .
                           CHAPTER II : CERTIFICATION PROCEDURES
                                         ARTICLE 8
1. Before placing a PPE model on the market , the manufacturer or his authorized
   representative established in the Community shall assemble the documentation
   referred to in Annex III , Section I , so that this can , if necessary , be
   submitted to the competent authorities .
2. Prior to the series        production of   PPE other   than that referred to in
   paragraph     3 , ‘ the manufacturer  or  his   authorized  representative
   established in the Community shall submit a model for " EC " type-examination
   in accordance with Article 10 .
3. " EC " type-examination shall not be required in the case of PPE models of
   simple design where the user can himself assess the level of protection
   provided against the minimal risks concerned which can be safely identifed
   in good time owing to the gradual nature of their effects .
   This category includes PPE models intended for use in domestic , dressmaking
   and gardening activities and models providing protection against solar
   radiation , bad weather and dirt .
   Prior to marketing , series-manufactured PPE shall be subject to :
   ( a ) the MEC " verification procedure referred to in Article 11 in the case of
         PPE of complex design intended to protect the user against mortal danger ,
         the immediate effects of which cannot be identified in sufficient time .
         This category includes :
 ---pagebreak---                                                                                 15
                                         - 9 -
         - emergency equipment for use in atmospheres rendered unbreathable by
           oxygen deficiency and ( or ) serious contamination due to highly toxic
           or radiotoxic substances , which can harmfully affect other parts of
           the body in addition to the respiratory tract ;
         - emergency equipment for use in high-temperature environments in which
           the atmospheric temperature is liable to exceed 10CPC and which may or
           may not be characterized by the presence of flames or the projection of
           large amounts of molten material ;
         - emergency equipment for use in low-temperature environments in which
           the atmospheric temperature is liable to be below - 50°C .
   ( b ) the " EC " declaration of conformity referred to in Article 12 for all PPE
         not falling within the category referred to in ( a ).
                                           Article 9
1. Each Member State shall inform the Commission and the other Member States of
   the approved bodies responsible for the execution of the certification
   procedures referred to in Article 8 .           For information purposes , the
   Commission shall publish in the Official Journal of the European Communities
   and keep up to date a list giving the names of these bodies and the
   distinguishing numbers it has assigned to them .
2. Annex III , Section II sets out the minimum criteria to be observed by the
   Member States in approving the above-mentioned bodies .
3. A Member State shall withdraw its approval from such a body if                it
   establishes that the latter no longer satisfies the criteria referred to      in
   Annex III ,     Section II . It shall inform the Commission and the other Member
   States of its action forthwith .
 ---pagebreak---                                       " EC " TYPE-EXAMINATION
                                             Article 10
" EC " type-examination is the procedure whereby the approved inspection body
establishes and certifies that the PPE model in question satisfies the relevant
provisions of this Directive .
1.    Application for " EC " type-examination shall be made by the manufacturer or
      his authorized representative to a single approved inspection body in
       respect of the model in question .         The authorized representative shall be
      established in the Community .
2.    The application shall comprise :
      - the name and address of the manufacturer or his authorized representative
           and of the PPE production plant in question ;
      - the manufacturer 's file referred to in Annex III , Section I.
       It shall be accompanied by the appropriate number of specimens of the model
      to be approved .
                                                                 *
3.    The approved inspection body shall conduct the " EC " type-examination in
      accordance with the undermentioned procedures :
      ( a ) It shall examine the manufacturer 's technical          file to establish its
             suitability ;  in    the    case of technical specifications ,     other than
             those of the harmonised standards , referred to in Article 3 ( 2 ),        it
             shall satisfy itself as to thei r . sui tabi li ty compared to the basic
             safety requirements .
      ( b ) In examining the model , the inspection body :
             - shall verify that it has been produced in accorcance with the manu¬
               facturer 's technical file and can be used in complete safety for its
               intended purpose ;
 ---pagebreak---                                                                               to
                                           - 11 -
         - shall conduct the necessary examinations and tests to establish the
            conformity of the model with the relevant standards or technical
            specifications and ( or ) basic requirements .
4.  If the model satisfies the relevant provisions , the inspection body shall
    draw up an " EC” type-examination certificate and shall notify the applicant
    to this effect .   This certificate shall reproduce the fi-dings of the exami ¬
    nation , indicate any conditions attaching to its issue and incorporate the
    descriptions and drawings necessary for the identification of the approved
    model .
    The Commission , the other approved inspection bodies and the other Member
    States may obtain a copy of the certificate and , in response to a reasoned
    request , a copy of the manufacturer 's technical file and the reports of the
    examinations and tests ronHv.teH
5 . Any      inspection body which refuses to issue ^n " E (- r tyot -examination
    certificate shall inform the other approved inspection bioi.ts of this fact
    An inspection body withdrawing an " EC " type-examination Lcrtiiiiate snail
    inform the Member State which approved it , to this effect . That Member State
    shall then inform the other Member States and the Commission, setting out the
    reasons for the decision .
                                      " EC " VERIFICATION
                                            Article 11
1 . " EC" verification is a procedure for checking and certifying the conformity
    of production PPE with the approved model . It shall be conducted by the
    inspection body which drew up the " EC " type-examination certificate pursuant
    to the undermentioned provisions .
2 . The verification procedure shall be conducted periodically with reference to
    PPE batches submitted by the manufacturer or his authorized representative
    established in the Community . Batches shall be accompanied by the
    "EC" type-examination certificate referred to in Article 10 .
 ---pagebreak---                                                                                    г\
                                            - 12 -
3.     In examining a batch ,   the inspection body shall establish that the PPE in
      question has been manufactured and checked in accordance with the manu¬
      facturer 's file and shall perform the appropriate tests on the batch speci ¬
      mens ; it shall issue an " EC " verification certificate .
                               " EC " DECLARATION OF CONFORMITY
                                            Article 12
The " EC " declaration of conformity is the procedure whereby the manufacturer who
has satisfied the provisions of Article 8(4 ) ( b ) :
( 1 ) draws up a declaration certifying that the PPE model specimens placed on the
      market are in conformity with the basic requirements of this Directive with
      a view , where necessary , to its submission to the competent authorities ;
( 2 ) affixes the " EC " mark of conformity provided for by Article 13 to each PPE
      model specimen .
                                           CHAPTER III
                                            " EC " Mark
                                           Article 13
1.    The " EC " mark consists of the letters " EC " followed by the last two figures of the
      year in which the mark was affixed together , in the event of the involvement
      of an approved inspection body , with the distinguishing number referred to
      in Article 9(1 ).
      The two models of the " EC " mark to be used respectively in the event of the
      intervention or non-intervention of an approved inspection body are shown in
      Annex IV .
2.    The " EC " mark shall be affixed to PPE and its packaging so as to be visible ,
      legible and indelible throughout the foreseeable "useful life " of that PPE .
3.    Marks or inscriptions which could be confused with the " EC " mark shall not
      be affixed to PPE .
 ---pagebreak---                                                                             2Z
                                       - 13 -
                               CHAPTER IV : FINAL PROVISIONS
                                         Article 14
         Any decision taken by a Member State in implementation of this Directive
         shall be accompanied by a detailed explanation of the grounds on which
         it is based . The interested party shall be notified of the decision
         without delay and informed of the possibilities for appeal under the
         legislation in force in the Member State concerned and of the deadlines
         for lodging such appeals .
                                         Article 15
1 . By 31 December 1989 Member States shall adopt and publish the laws ,
    regulations and administrative provisions necessary to comply with this
    Directive .
    They shall apply . those provisions from 1 July 1990 .
2.  Member States shall communicate to the Commission the texts of the provi ¬
    sions of national law which they adopt in the field governed by this
    Di rective .
                                       Article 16
    This Directive is addressed to the Member States .
 ---pagebreak---                                                                  ANNEX I
                  EXHAUSTIVE LIST OF PPE CLASSES OR TYPES
                      NOT COVERED BY THIS DIRECTIVE™
1.   PPE designed and manufactured for use by the armed forces or in
     the maintenance of Law and order .
2.   PPE for self-private use in bad weather .
3.   PPE for self-defence .
1)
   Independent ly of the reason for exclusion referred to in Article 1 .
 ---pagebreak---                                                                                 V
                                                                            ANNEX II
                                PROPOSAL FOR A DIRECTIVE
                       RELATING TO PERSONAL PROTECTIVE EQUIPMENT
              BASIC REQUIREMENTS IN RESPECT OF THE DESIGN AND MANUFACTURE
                        OF PERSONAL PROTECTIVE EQUIPMENT ( PPE )
1.    GENERAL REQUIREMENTS
1.1 .   Design principles
1.1.1 .    Ergonomics
           PPE must be so designed that in the conditions of use for which it is
           intended and for the foreseeable period of wear the user can perform the
           risk-related activity in question efficiently and without undue
           discomfort whilst enjoying the level of protection appropriate to the
           risks concerned .
1.1.2 .    Levels of protection
           Whenever appropriate , PPE must be produced in different classes so as to
           provide several levels of protection .
1.2 .   Innocuousness of PPE
1.2.1 .    Absence of risks and other " inherent " nuisance factors
           PPE must be so designed and manufactured as to preclude risks and other
           nuisance factors both under normal conditions of use and under the
           abnormal conditions which can reasonably be expected to occur .
1.2 . 1.1 . Suitable constituent materials
 ---pagebreak---                                                                                   2$
                                             2
              PPE constituent materials must    be so chosen and    incorporated that
              neither they nor any of their decomposition products adversely affect
              user hygiene or health .
1.2 . 1.2 .   Satisfactory surface condition of all PPE parts in contact with the
              user
              Any PPE part in contact ,   or in potential contact with the user when
              such equipment is worn must be free of roughness , sharp edges ,
              projections and the like which could cause excessive irritation or
              injuries .
1.2 . 1.3 .   Minimum uses impediment
              Any impediment caused by PPE to movements to be made , postures to be
              adopted and sensory perception must be minimized . Nor must PPE cause
              the user to perform dangerous movements .
1.3 .   Comfort and efficiency
1.3.1 .     Adaptation of PPE to user morphology
            PPE must be so designed and manufactured as to facilitate correct
            positioning on the user and to remain in place for the foreseeable
            period of use , bearing in mind ambient factors , movements to be made and
            postures to be adopted .     For this purpose , it must be possible to
            optimize PPE adaptation to user morphology by all appropriate means ,
            such as adequate adjustment and attachment systems or the provision of
            an adequate size range .
1.3.2 .     Lightness and design strength
            Design strength and efficiency must be appropriate to the levels of risk
            in question , the conditions of use and the foreseeable "useful life " of
            the PPE concerned .
            PPE must be as light as possible without unduly prejudicing design
            strength and efficiency .
 ---pagebreak---                                                                                    26
                                          - 3 -
           Apart from the specific additional requirements which they must satisfy
           in order to provide adequate protection against the risks in question
           ( see Point 3 ), PPE must be capable of withstanding the effects of such
           normal ambient phenomena as the physical stresses ( abrasions , impact ,
           vibrations , etc .) and chemical attack ( from solvents , oil , hydocarbons ,
           detergents , etc .) to which they may be subject during transport or use ,
           and climatic conditions and their seasonal variations .
1.3.3 .    Compatibility   of   different  classes or   types  of   PPE   designed  for
           simultaneous use
           If a manufacturer markets several PPE models of different classes or
           types in order to ensure the simultaneous protection of adjacent parts
           of the body against combined risks , the composite equipment thus
           constituted must comply with all the basic requirements applicable to
           each class or type .
1.4 .   Information supplied by the manufacturer
        In addition to the name and address of the manufacturer or his authorized
        representative established in the Community ,      the notes drawn up by the
        former and supplied when PPE is marketed must contain all relevant
        information on :
        1 . storage, use , cleaning, maintenance, servicing and disinfection^;
        2 . performance as recorded during laboratory conformity tests designed to
             establish the level of protection ( or degree of attenuation ) provided
             by the PPE in question ;
        3 . suitable PPE accessories and the characteristics of appropriate spare
             parts ;
        4 . the limits beyond which the use of PPE is inappropriate ;
    Cleaning , maintenance or disinfectant products recommended by manufacturers
    must have no adverse effect on PPE or users when applied in accordance with
    the relevant instructions
 ---pagebreak---                                                                                    lï
                                            - 4 -
        5 . the obsolescence deadline or period of obsolescence of PPE or certain
            of its components ;
        6 . the type of packaging suitable for storage or transport ;
        7 . the significance of any markings ( see 2.12 )
        These notes , which must be precise and comprehensible , must be provided at
        least in the official language(s ) of the Member State of destination .
2.    ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE
2.1 .   PPE incorporating adjustment systems
        If PPE incorporates adjustment systems , the latter must be so designed and
        manufactured as to remain correctly adjusted under the conditions of use
        for which that PPE is marketed .
2.2 .   PPE " enclosing 1* the parts of the body to be protected
        As far as possible ,    PPE " enclosing " the parts of the body to be protected
        must be sufficiently ventilated to prevent user perspiration ; if this is
        not possible , it must be equipped with devices which absorb perspiration .
2.3 .   PPE for the face , eyes and respiratory tracts
        Any restriction of the user 's field of vision by PPE for the face ,       eyes
        and respiratory tract must be minimized .
        The degree of optical neutrality of the vision systems of these PPE
        classes must be compatible with the type of relatively meticulous and / or
        prolonged activities for which the equipment is marketed .
        If necessary , they must be treated or provided with ventilation facilities
        designed to prevent moisture formation or to remove moisture .
 ---pagebreak---                                                                                Zi
                                         - 5 -
Ï.U.  PPE subject to ageing
      If it is known that the design performances of new PPE may be
      significantly affected by ageing, the date of manufacture or , if possible ,
      the date of obsolescence , must be indelibly inscribed on every PPE item or
      interchangeable component marketed in such a way as to preclude any
      misinterpretation this information must also be indelibly inscribed on the
      packaging .
      If a manufacturer is unable to give an undertaking with regard to the
      " useful life " of PPE , his notes must provide all the information necessary
      to enable the purchaser or user to establish a reasonable obsolescence
      date , bearing in mind the quality level of the model and the effective
      conditions of storage , use , cleaning , servicing and maintenance .
      Where appreciable and rapid deterioration in PPE performance is likely to
      be caused by ageing resulting from the periodic use of a cleaning process
      recommended by the manufacturer , the latter must if possible , affix a mark
      to each item of PPE placed on the market indicating the maximum number of
      cleaning operations that may be carried out before the equipment needs to
      be inspected or discarded ; failing that , the manufacturer must give this
      information in his notes .
2.5 . PPE Cor PPE components ) which may be accidently snagged,    jammed or caught
      up .
      These PPE classes ( or components ),     which may be accidentally snagged ,
      jammed or caught up in external objects ,    such as moving machine parts , or
      obstacles when the user changes position ,       must possess an appropriate
      tensile-strength threshold above which a constituent part is designed to
      break so as to protect the user against physical injury .
2.6 . PPE   for use in explosive atmospheres
      The constituent materials ( and , where relevant , the electric circuits ) of
      such PPE must be so chosen or designed and incorporated as to preclude the
      production , under normal conditions of use, of an electric arc or spark
      capable of attaining the level required to ignite an explosive mixture as
      a result of mechanical impact , friction , ( the opening or closing of the
      electric circuit ), or accidental contact of the PPE with energized
      conductors or exposed conductive parts , or the generation of electrostatic
      charges .
 ---pagebreak---                                          - 6 -
 2.7 . PPE intended for emergency use or rapid removal
       These PPE classes must be so designed and manufactured as to minimize the
       time required for attachment and ( or ) removal .
       Any integral systems permitting correct positioning on ,    or removal from ,
       the user must be susceptible of rapid and easy operation .
 2.8 . PPE for use in " criticai " situations
       The information notes supplied by the manufacturer together with PPE for
       use in the " critical " situations referred to in Article 8(A ) must include ,
       in particular , data reserved for the exlcusive use of competent trained
       individuals who are qualified to interpret them and ensure their
       application by the user ..
       They must also describe the procedure to be adopted in order to verify
       that PPE is correctly adjusted and functional when worn by the user .
       If PPE incorporates an alarm which is activated in the absence of the
       level of protection normally provided , this must be so designed and
       accommodated as to be perceived by the user in the conditions of use for
       which the PPE is marketed .
 2.9 . PPE incorporating components which can be adjusted or removed by the user
       Any PPE components which can be adjusted or removed by the user for the
       purDose of replacement ,     must be so designed and manufactured as to
       facilitate manual adjustment , attachment and removal .
2.10 . PPE for connection to an external device
       If PPE incorporates a system permitting connection to an external device ,
       the attachment mechanism must be so designed and manufactured as to
       preclude its mounting on inappropriate equipment .
 ---pagebreak---                                                                                io
                                          - 7 -
2.11 .   PPE i ncorporat ing a fluid circulation system
       If PPE incorporates a fluid circulation system , the latter must be so
       chosen , or designed , and incorporated as to permit adequate fluid renewal
       in the vicinity of the entire part of the body to be protected ,
       irrespective of user gestures , posture or movement under the conditions of
       use for which the PPE is marketed .
2.12 . PPE bearing one or more identification or recognition marks
       The identification or recognition marks affixed to these types of PPE must
       remain perfectly legible throughout the foreseeable "useful life " of this
       PPE . In addition , these marks must be complete , precise and comprehensible
       so as to prevent any misinterpretation ; in particular , when such marks
       incoporate words or sentences , the latter must appear in the official
       language(s ) of the Member State of destination .
       If PPE ( or a PPE component )     is too small to allow all or part of the
       necessary marking to be affixed , this fact must be mentioned on          the
       packing and in the manufacturer 's notes .
2.13 . PPE in the form of clothing capable of signalling the user 's presence
       PPE in the- form of clothing intended for foreseeable conditions of use in
       which the user 's presence must be visibly and individually signalled must
       have one ( or more ) external part(s ) that are reflective by nature or have
       a reflective coating .         Each reflecting element must be carefully
       positioned on the PPE so as to reflect back any incident radiation in the
       direction of its emission source with a suitable coefficient of luminous
       intensity and appropriate photometric and colorimetric properties .
2.14 . " Multi-risk " PPE
       All PPE designed to protect the user against several potentially
       simultaneous risks must be so designed and manufactured as to satisfy , in
       particular , the basic requirements specific to each of those risks ( see
       3 ).
 ---pagebreak---                                                                                         31
                                               - 8 -
3.    ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS
3.1 .     Protection against mechanical inpact
3.1.1 .       Impact caused by falling or projecting objects and collision of parts of
              the body with an obstacle
              Suitable PPE for this type of risk must be sufficently shock-absorbent
              to prevent injury resulting ,       in particular ,  from the crushing or
              penetration of the protected part , at least up to an impact-energy level
              above which the excessive dimensions and ( or ) mass of the absorbing
              device would preclude effective use of the PPE for the foreseeable
              period of wear .
3.1.2 .       Falls
3 . 1.2.1 .     Prevention of falls due to slipping
                The outsoles   of   footwear   designed  to prevent    slipping  on  loose ,
                irregular or smooth ground or floors made slippery by foreign bodies
                must be so designed , manufactured or equipped with added elements as
                to possess for example , an adequate " tread " and ( or ) at the same time ,
                provide a sufficient contact surface insuring’ sati sfactory adhesion by
                grip and friction
3 . 1.2 . 2 .   Prevention of falls from a height
                PPE designed to prevent      falls from a height or their effects must
                incorporate a body harness and an attachment system which can be
                connected to a reliable anchorage point by means of an appropriate
                device .  It must be so designed and manufactured that , even under the
                most unfavourable conditions of use - heavily-built person or person
                carrying a considerable weight situated at the maximum possible height
                in relation to the PPE anchorage point at the moment of losing
                balance -, the vertical drop is minimized so as to preclude collision
                                 1)
                with obstacles ,    and the braking force nevertheless does not attain
                the threshold value at which physical injury or the tearing or rupture
                of any PPE component can be expected to occur .
^ This vertical drop must always be less than the necessary minimum "headroom"
    indicated in the manufacturer 's notes .
 ---pagebreak---                                                                                    21
                                            - 9 -
3 . 1-2 . 3 . Prevention of drowning
              Under the foreseeable conditions of use for which it is marketed , PPE
              designed to prevent drowning must be capable of returning to the
              surface as quickly as possible a user who may be exhausted or
              unconscious after accidentally falling into a liquid medium, and of
              keeping him afloat in a waiting position which permits respiration .
              For this purpose , these PPE classes must be capable of withstanding ,
              without prejudice to their functional capacity , the energy level
              resulting from impact with the liquid medium , which depends on the
              height of fall .
              Such PPE must inflate automatically , rapidly and completely on impact .
              PPE constituent materials and other components must be water-tight and
              incorporated in such a way that "buoyancy " derives , in particular ,
              from a system of upward hydrostatic forces , the centres of thrust of
              which are at the user 's thorax and nape of the neck .
              If ,   after impact with the liquid medium ,        the user is in the
              " face-down , head-immersed " position , the system of forces must impart
              a rotary motion to the body so as to bring it to the " face-up "
              position .
              The "buoyancy" provided by PPE must be such that ,         in the waiting
              position ,    the  orifices   of   the  user 's  respiratory  tracts  are
              sufficiently above the surface of the liquid medium , due account being
              taken , in particular , of foreseeable fluctuations in the latter .
              In addition , this PPE must be so designed and manufactured that it
              can , if necessary , be worn by a ful ly-dressed person for as long as
              the risk of drowning exists .
 ---pagebreak---                                                                                      зз
                                           - 10 -
3.1.3 .   Mechanical vibration
          PPE designed to prevent osteoarticular and angioneurotic disorders
          resulting from mechanical vibrations must be capable of ensuring
          adequate attenuation of the most harmful vibration components for the
          part of the body at risk ,      without dangerously amplifying the vibration
          components emitted at other frequencies or in other frequency bands .
          Under no   circumstances must      the effective value of the accelerations
          transmitted to the user by those vibrations exceed the            limit values
          recommended in the light of the maximum foreseeable daily exposure of
          the part of the body at risk .
3.2 .   Protection against ( static ) compression of part of the body
        PPE designed to protect part of the body against ( static ) compressive
        stress must be sufficiently capable of attenuating its effects to prevent
        serious injury or chronic complaints up to compressive-force level above
        which the dimensions of the shock-absorbing device would preclude
        effective use during the necessary period of wear .
3.3 .   Protection   against   superficial     injury  caused by   machinery   ( abrasion ,
        perforation , cuts , bites )
        PPE constituent materials and other components designed to protect all or
        part of the body against superficial injury caused by machinery , such as
        abrasion , perforation cuts , or bites must be so chosen or designed and
        incorporated   as   to  ensure   that    these PPE  classes  provide sufficient
        resistance to abrasion ,     perforation and gashing ( see also 3.1 .) under the
        conditions of use for which they are marketed .
3.4 .   Protection against the harmful effects of noise
        PPE designed to prevent the harmful effects of noise must be capable of
        attenuating the latter to such an extent that the equivalent sound levels
        perceived by the user do not under any circumstances exceed the daily
        limit values laid down for the protection of workers by the Council
        Directive of 12 May 1986 .
 ---pagebreak---         The noise attenuation class of the PPE must be appropriate to the
        " typical " noise for which it is marketed .
        All PPE and (or , failing this ) its packaging must bear labelling
        indicating the A-weighted overall attenuation level of the "typical " noise
        and the value of the comfort index provided by the P°!I .                 The
        package-insert notes must contain , in particular , tne graph of noise
        attenuation in relation to octave band :;.
3.5 .   Protection against heat and ( or ) fire
        PPE designed to protect all or part of the body against the effects of
        heat and ( or ) fire must possess thermal insulation capacity and mechanical
        strength appropriate to the conditions of use for which it is ma*:ctteo .
        In designing these PPE classes ,    the manufacturer must take account of a.l
        parameters of relevance to the evaluation of the heat flow transmitted
        through PPE by atmospheric radiation and convection or by concuctior
        resulting from contact with elements at high temperature such ws          die
        ground , partitions or hot objects and the projection of hot prooucts -
        incandescent particles , molten materials , etc . - nr transmitted by ci^ert
        contact with flame .
3.5.1 .    PPE constituted materials and othe r ccmoonents
           Constituent   materials  and  other   components suitable   for protection
           against radiant and convective heat must possess the lowest possible
           coefficient of transmission of incident heat flux and fce sufficient .)
           incombustible^ to preclude any risk of soontaneous ignition under the
           foreseeable conditions of use . The reflective power of the outside of
           these materials and components in the infrared range must increase in
           line with the intensity of the heat flux due to radiation .
           Materials and other components of equipment intended for brief use in
           high-temperature environments and of PPE which may be splashed by hot
           products such as large quantities of molten material , must also possess
           sufficient thermal capacity to retain most of the stored heat        until
           after the user has left the danger area and removed his PPE .
 ---pagebreak---          PPE materials and other components which may be splashed by large
         amounts of hot products must also possess sufficient mechanical-impact
         absorbency ( see 3.1 .).
         PPE materials and other components which may accidentally        come into
         contact with flame and those used in the manufacture of f i re-f ignting
         equipment must also possess a degree of non-flammability^ corresponding
         to the   risk  class associated with the foreseeable conditions of use .
         They must    not  melt   when exposed to flames nor contribute to flame
        propagation .
3.5.2 .  Complété PPE ready for use
        Under the foreseeable conditions of use :
        1)   the    quantity of heat transmitted by PPE to the user must be
            sufficiently low to prevent the heat accumulated during wear in the
            part of the body at risk from attaining , under any circumstances , the
            pain or health impairment threshold ;
        2 ) PPE must prevent liquid or steam pénétration and must         not cause
            burns resulting from pinpoint contact between its            protective
            integument and the user .
        If PPE incorporates refrigeration devices for the absorption of incident
        heat by means of liquid evaporation or solid sublimation , their design
        must be such that any volatile substances released are discharged beyond
        the outer protective integument and not towards the user .
        If PPE incorporates a breathing device , the latter must adequately
        fulfil the protective function assigned to it under the foreseeable
        conditions of use .
  Measured on an inflammability test bench with reference to the Oxygen Index
  Limit ( ILO ) or the minimum oxygen concentration of an oxygen-nitrogen mixture
  required to maintain flame combustion of a material .
 ---pagebreak---                                                                                       Si
                                            - 13 -
          The manufacturer 's notes accompanying each PPE model intended for brief
          use in high-temperature environments must provide all relevant data for
          the determination of the maximum permissible user exposure to the heat
          transmitted by the equipment when used in accordance with its intended
          purpose .
3.6 .   Protection against cold
        PPE designed to protect all or part of the body against the effects of
        cold must possess thermal insulating capacity and mechanical strength
        appropriate to the foreseeable conditions of use for which it is marketed .
        In designing these PPE classes , the manufacturer must take account of all
        parameters of relevance to the evaluation of the cold transmitted through
        PPE , in particular by atmospheric convection or by conduction resulting
        from contact with elements at an unsuitably low temperature such as the
        ground , partitions or cold objects or the splashing of cold products .
3.6.1 .   PPE constituent materials and other components
          Constituent     materials   and  other   components    suitable   for  protection
          against      cold   must   possess   the    lowest    possible   coefficient   of
          transmission of      incident cold     flux .   Flexible   materials  ( and other
          components ) of PPE intended for use in low-temperature environment must ,
          under     the   foreseeable   conditions   of   use ,    retain  the  degree   of
          flexibility required for the necessary gestures and postures .
          PPE materials and other components which may be splashed by large
          amounts of cold products must also possess sufficient mechanical-impact
          absorbency ( see 3.1 ).
3.6.2 .   Complété PPE ready for use
          Under the foreseeable conditions of use :
           ( 1 ) the flux transmitted by PPE to the user must be sufficiently low to
                 prevent the cold accumulated during wear at any point on the part of
                 the body being protected ( including the tips of fingers and toes in
                 the case of hands or feet ) from attaining ,     under any circumstances ,
                 the pain or health-impairment threshold ;
 ---pagebreak---                                                                               3?
                                        - 14 -
         ( 2 ) PPE must prevent the penetration of such liquids as rain water and
               must not cause injuries resulting from pinpoint contact between its
               cold protective integument and the user .
         If PPE incorporates a breathing device , this must adequately fulfil the
         protective function assigned to it under the foreseeable conditions of
         use .
         The manufacturer 's notes accompanying each PPE model intended for brief
         use in low-temperature environments must provide all relevant data
         concerning the maximum permissible user exposure to the cold transmitted
         by the equipment .
3.'7 . Protection against electric shock
       PPE designed to protect all or part of the body against the effects of
       electric current must be sufficiently insulated against the voltages to
       which the user is likely to be exposed under the most unfavourable
       foreseeable conditions .
       To this end ,   the constituent materials and other components of these PPE
       classes must be so chosen or designed and incorporated as to ensure that
       the leakage current measured through the protective integument under test
       conditions, at voltages correlated with those likely to be encountered in
       situ is minimized and , at all events , below a maximum conventional
       permissible value which correlates with the tolerance threshold .
       Together with their packaging , PPE types intended exclusively for use
       during work or activities in electrical installations which are or may be
       under tension must bear markings indicating ,         in particular , their
       protection class and Cor ) corresponding operating voltage , their serial
       number and their date of manufacture ; a space must also be provided
       outside the protective integument of such PPE for the subsequent
       inscription of the date of entry into service and those of the periodic
       tests or inspections to be conducted .        The manufacturer 's notes must
       indicate ,   in particular , the exclusive use for which these PPE types are
       intended and the nature and frequency of the dielectric tests to which
       they are to be subjected during their "useful life ".
 ---pagebreak---                                                                                 i a9
                                         - 15 -
3.8 .   Radiation protection
3.8.1 .   Non-ionizing radiation
          PPE designed to prevent acute or chronic eye-damage from sources of
          non-ionizing radiation must be capable of absorbing or reflecting the
          majority of the energy radiated in the harmful wavelengths without
          unduly affecting the transmission of the innocuous part of the visible
          spectrum , the perception of contrasts and the ability to distinguish
          colours where required by the foreseeable conditions of use .
          To this end ,  protective glasses must be so designed and manufactured as
          to possess ,  for each harmful wave , a spectral transmission factor such
          that the radiant-energy illumination density capable of reaching the
          user 's eye through the filter is minimized and , under no circumstances ,
          exceeds the maximum permissible exposure value .
          Furthermore ,   the glasses must not deteriorate or lose their properties
          as a   result of the effects of radiation emitted under the foreseeable
          conditions of use and all marketed specimens must bear the protection -
          factor number corresponding to the spectral distribution curve of their
          transmission factor .
          Glasses suitable for radiation sources of the same type must be
          classified in the ascending order of their protection factors and the
          manufacturer 's notes must indicate , in particular , the transmission
          curves which make it possible to select the most appropriate PPE bearing
          in mind such inherent factors of the effective      conditions of use as
          distance to source and the spectral distribution of the energy radiated
          at that distance .
          All protective glasses must bear the relevant protection-factor number .
 ---pagebreak--- 3.8.2 .   Ionizing radiation
                                                                            1)
          1.   Protection against external radioactive contamination
               PPE constituent materials and other components designed to protect
               all or part of the body against radioactive dust , gases , liquids or
               mixtures thereof must be so chosen or designed and incorporated as
               to ensure that this equipment effectively prevents the penetration
               of the contaminants which it is designed to exclude .
               Depending on the nature or condition of these contaminants , the
               necessary leak-tightness can be provided by the impermeability of
               the protective " integument " and ( or ) by any other appropriate means ,
               such as ventilation and pressuri sat ion systems designed to prevent
               the back-scattering of these contaminants .
               Any decontamination        measures   to  which   PPE  is subject  must  not
               prejudice its re-use during         the foreseeable "useful life " of these
               classes of equipment .
          2.   Limited protection against external irradiation
                                                               *
               PPE intended to provide complete user protection against external
               irradiation or , failing this , adequate attenuation thereof , must be
               designed to counter only weak electron ( e.g. beta ) or weak photon
               ( s.g . X , gamma ) radiation .
          The constitutent        materials and other components of these PPE classes
          must be so chosen or designed and incorporated as to provide the maximum
          possible degree of user protection without leading to an increase in
          exposure time as a result of the impedance of user gestures ,          posture or
          movement    ( see 1.3 . 2 .).
          PPE must      bear a       mark    indicating   the type   and thickness  of the
          constituent material(s ) suitable for         the conditions of use for which it
          is marketed .
1 )
    See 3.9.1 . for protection against contamination of the respiratory tracts .
 ---pagebreak---                                                                              40
                                        17 •
3.9 . Protection against dangerous substances and infective agents
3.9.1 . Protection against inhalation ( respiratory protection )
        PPE intended for the protection of the respiratory tract must make it
        possible to supply the user with breathable air when the latter is
        exposed to a polluted atmosohere and ( or ) an atmosphere having
        inadequate oxygen concentration .
        The breathable air supplied to the user by the PPE is obtained after
        filtration of the polluted air through the protective device or
        appliance or by a piped supply from an unpolluted source .
        The constituent materials and other components of these PPE classes must
        be so chosen or designed and incorporated as to ensure appropriate user
        respiration and respiratory hygiene for the period of wear concerned
        under the foreseeable conditions of use for which the PPE is marketed .
        The leak-tightness of the facepiece and the pressure drop on inspiration
        and , in the case of the filtering devices , purification capacity must be
        such as to minimize contaminant penetration from a polluted atmosphere ,
        without resulting under the least favourable conditions in an
        overshooting of the maximum permissible concentration values or an
        oxygen concentration of less than the minimum required by the user .
        The PPE must bear the manufacturer’s identification mark and details of
        the specific characteristics of that type of equipment which ,          in
        conjunction with the instructions for use ,     wilt enable a trained and
        qualified user to employ the PPE correctly .
        The manufacturer’s notes must also indicate the deadline for filter
        storage .
3.9.2 . D rotection against eoidermal or ocular contact
        PPE intended to prevent the surface contact of alt or part of the body
        with dangerous substances and infective agents must be capable of
         p-eventing the penetration or diffusion of such substances through the
        protective envelope under the conditions of use for which the PPE is
        marketed .
 ---pagebreak---                                                                             Ml
                              - 18 -
To this end , the constituent materials and other components of these PPE
classes must be so chosen , or designed , and incorporated as to ensure ,
as far as possible , complete leak-tightness , which will allow where
necessary prolonged daily use or ,   failing this ,  limited leak-tightness
necessitating a restriction of the period of wear .
Where , by virtue of their nature and the foreseeable conditions of their
use ,   certain dangerous substances or infective agents possess high
penetrative power which limits the duration of the protecton provided by
the PPE in question , the latter must be subjected to standard tests with
a view to their classification on the basis of efficiency . PPE which is
considered to be in conformity with the test specifications must bear
a mark indicating ,  in particular , the names or , failing this , the codes
of the substances used in      the tests and    the corresponding standard
period of protection .    The manufacturer 's notes must also contain , in
particular , an explanation    of the codes   ( if necessary ), a detailed
description of the standard    tests and all   appropriate information for
the determination of the maximum permissible period of wear under the
different foreseeable conditions of use .
 ---pagebreak---                                                                           HL
                                                ANNEX III
              Certification of PPE conformity with the basic
                      requirements of this Directive
Technical documentation supplied by the manufacturer
The documentation referred to in Article 8(1 ) must comprise :
1.  the manufacturer 's technical file consisting of :
    a)  overall and detailed plans accompanied , where necessary, by calcula¬
        tion notes and the results of prototype tests conducted prior to
        manufacture ;
    b)  an exhaustive list indicating the basic requirements of this Direc ¬
        tive , and harmonized standards or other technical specifications
        referred to in Article 5 , taken into account in the design and
        manufacture of the PPE ; in the case of technical specifications ,
        other than those of the harmonized standards , the manufacturer 's
        technical file must include in particular all the data required to
        enable the approved inspection body referred to in Article 9 ( 1 ) to
        establish the conformity of the P.P.E.          to the basic safety
        requirements referred to in Article 3 of this directive .
    c)  a list of all the test facilities used to verify maintenance of the
        minimum permissible quality level of the starting materials,
        semi-finished products and finished products used in the production
        of the PPE in question ;
2.  a detailed description of the control and test facilities used in the
    manufacturer 's plant , for the periodic batch checking or systematic
    specimen checking of complete PPE ready for use with regard to :
    a ) - its conformity to the harmonized or other technical specifications
        standards referred to in Article 5 ;
 ---pagebreak---                                                                                 Hl
                                         - 2 -
         b)  - maintenance    of  the    minimum  permissible    quality    level  of
                series-production PPE .
     3.  any reports drawn up by a competent body establishing the conformity of
         the prototype with the harmonized standards            or  other   technical
         specifications referred to in Article 5 ;
     4.  a copy of the information notes referred to in Annex II , 1.4 .
II . HINIWUH CRITERIA TO BE TAKEN INTO ACCOUNT BY THE WEBBER STATES IN APPOINTING
     INSPECTION BODIES
     1.  The inspection body ,   its director and the staff responsible for the
         execution of the verification procedures must be neither the designer ,
         manufacturer   or  supoliers   of   the PPE   tested   nor  the   authorized
         representative of one of those individuals . They must not      be involved ,
         either directly or as representatives , in the design ,         manufacture ,
         marketing or maintenance of this PPE .    This provision does   not preclude
         the possiblity of an exchange of technical information          between the
         manufacturer and the inspection body concerned .     v
     2.  The inspection body and the staff responsible for examinations must
         carry out the verification procedures with the greatest professional
         integrity and maximum technical competence ; they must be free from all
         pressures and incentives , particularly financial , which could influence
         their judgment or the results of their examinations , especially where
         these emanate from individuals or groups of individuals with an interest
         in the test results .
     3.  The inspection body must employ the necessary staff and possess the
         necessary resources for the satisfactory accomplishment of the technical
         and administrative tasks which form part of the verification procedures ;
         it must also have access to any equipment required for exceptional
         examinations .
     4.  The staff responsible for inspection must be :
         - technically and professionally well-qualified
 ---pagebreak---                                                                           V*
                                  - 3 -
   - sufficiently familiar with the requirements relating to the tests they
     carry out and sufficiently experienced in the execution of those
     tests ;
   - capable of completing the certificates ,     records and reports which
     constitute the material evidence of the test conducted .
5. The independence of the inspection staff must be guaranteed .         The
   remuneration of each official must be determined neither by the number
   of tests conducted nor by the results obtained .
6. The inspection body must take out third-party insurance unless its
   liability is covered by the State under national law or the tests are
   not directly conducted by the Member State concerned .
7. The staff of the inspection body must observe professional secrecy as
   regards everything learned in the performance of their duties ( except in
   relation to the competent authorities of the State in which those duties
   are performed ) in the context of the application of this Directive or of
   any provisions of national law implementing this Directive .
 ---pagebreak---                                                                                        чг
                                           ANNEX IV
                                       MODEL " EC " MARKS
A.    Model for use in ”EC   " EC " type-examination or " EC " verification procedures
      ( See Articles 10 and 11 )
                                                                      ( 2)
                                                                   For example
                                                                                         37®
r.    M.'del fcr use in the " EC " declaration of conformity procedure
      ( '•re Article * 2 ) not involving " EC " type-examination .
                                                                    ( 2)
                                                                      For example
                                                                                    im
 (1)    Distinguishing number of approved inspection body ( see Article 13 )
 ( 2)   Last two figures of the year in which the mark was affixed ( see Article 13 )
         ’he vertical dimension of the different components of the " EC " mark must be
         pe-cept - b L > the same , namely not less iSan 2 mm on the PPE and r.ot less than
         5 mm cn its packaging .                                                             I
 ---pagebreak---                                                                                  V6
                               FINANCIAL MEMORANDUM
            concerning the proposal for a Council Directive on the
             approximation of the laws of the Member States relating
                         to personal protective equipment
1. Introduction
   The proposal for a Directive on PPE defines the basic safety requirements
   which such products must satisfy .      Article 3 of the proposal provides for
   general reference to European standards as a matter of priority or ,
   pending their adoption , to national standards .             PPE manufactured in
   accordance with these standards is presumed to satisfy the relevant safety
   requirements of the Directive .
   The Commission intends to contribute to the strengthing of European
   standardization by assigning CEN and / or CENELEC the task of preparing the
   necessary harmonized standards in the PPE sector in accordance with the
   general guidelines governing cooperation between the Commission , CEN and
   CENELEC approved on 13 November 1984 .         This work will be carried out in
   the    context  of  commissions  to   CEN   and / or CENELEC ,  pursuant  to   the
   framework agreements signed on 10 October 1985 which provide the financial
   support from the Commission .       The latter will also endeavour to ensure
   adequate participation by the trade unions in this context .
   The above-mentioned activities , which will last for some considerable
   time , must be brought within the general framework of the long-term
   management of the Directive .
   The figures quoted can provide no more than a rough estimate since the
   planning of European standardization is still in progress .
2. Budget lines affected
   Article 775                               : Community projects concerning      the
                                               internal market
   Item 7750                                 : Harmonization of labour laws
        ;                                      multiannual activities     designed
                                               to stregthen the     European
                                               standardization     organizations
   Article 648                               : Community measures in the field of
           health
   Item 6482                                 : Health protection ,   hygiene and
                                               safety at work
 ---pagebreak---                                                                                     'O.
                                                                                     • 7
3.  Legal basis
    3.1 harmonization
        Council Resolution     of 7 f^y 1985 on a r ?w approach to technical
                        and standards
    3.2 Directive to be adopted by the Council on he approximation of the
        laws of the Member States relating to the d sign and manufacture of
        PPE .
    3.3 Commission communication concerning its progr irn.ie      in the   field of
        safety , hygiene and health at work ..
4.  Proposed classification
    Non-compulsory expenditure .
5.  Description and justification of the activities
    5.1 Objectives
        The proposed activities should contribute , in p<i -t i cular , to the
        preparation of harmonized standards covering * ne basic safety
        requirements of the PPE Directive which will greatly facilitate the
        implementation of the Directive .      Harmonized standards will also help
        to improve the competitiveness of European industry Lnd the safety of
        machinery for users .
    5.2 Parties concerned
        Pursuant to the provisions of the Council Resolution of 7 May 1985 ,
        standardization activities are the responsibility not of the
        Commission but of the European standardization organizations .           The
        Commission communication referred to in point 3.3 provides for trade
        union participation in this context .
                                                        «
6.  Type of expenditure and method of calculation
    6.1 Expenditure in respect of Commissions issued under the framework
        agreement of 10 October 1985 between the Commission and 'EN / CENELEC
        and support for professional and trade-union organizations .
    6.2 Calculation
        The amount of finance for standardization services will be determined
        in the case of each order voucher on the basis of the work ass gned to
        the contractors .
        It    comprises   the expenditure  borne   by  the  central  units   of  the
        European standardization bodies in implementing the standardization
        programmes assigned to them and a contribution to the expenses if the
        committees and technical working parties concerned with the execution
        of these programmes .     It also covers the private expenses of experts
        responsible for specific activities in this context .
        These expenses are calculated with reference to the " man / month” unit ,
        which is currently worth 5 000 ECU .
1)
   OJ No 136 , 6.4.1985 .
 ---pagebreak---                                                                               HS
        Trade-union participation will be financed on the basis of the number
        of European standards in preparation and the scale of the activities
        involved .
        The preparation of harmonized standards will certainly continue beyond
        the first five years .
7. Financial impact of the activity on operating appropriations
   7.1 Schedule of commitment and payment appropriations :
        ( Item 7750 )
                                 CAs ( ECU )             PAs ( ECU )
            1988                 1.000.000                  500.000
            1989                 1.000.000                1.000.000
            1990                 2.000.000                1.000.000
            1991                 1.000.000                1.000.Ü00
            1992                    -                     1.500 . 000
                                 5.000.000                5.000.000
        ( Item 6482 )
                                 CAs ( ECU )            PAs ( ECU )
            1988                   300.000                  300.000
            1989                   300.000                  300.000
            1990                   300.000                  300·. 000
            1991                   300.000                  300.000
            1992                   300.000                  300.000
                                 1.500.000                1.500.000
   7.2 Community share of financing
        Since , in principle , those involved in standardization activities bear
        their own expenses , the Community 's contribution to the financing of
        the work should not exceed 50 X of the total expenditure .
        It should ,   however , be pointed out that the Community 's contribution
        will be reduced if the EFTA countries decide to participate in these
        standardization activities .
        The    Community 's  contribution    to the  financing     of trade-union
        participation should cover most of the expenditure incurred .
8. Observations
   None .
 ---pagebreak---                                                                                 VS
9. Financial      im pact  of   the    activity   on  staff    and administrative
   approori at i ons
   9.1 Staff required to work exclusively on this projet .
       This projet also covers management activities relating to the
       " Machinery " Directive ,      which will require substantial full-time
       participation by the relevant Commission departments ( DG III and DG
       V) .
       From 1988 , the work in question will require :
       - the    full-time participation of one A and two B and one C grade
          officials from DG III ;
       - the full-time participation of one A and one 8 grade official from
          DG V.
   9.2 and 9.3 Staff and administrative appropriations
                  The necessary appropriations are estimated at :
                  - 240 000 ECU / year in the case of DG III ;
                  - 180 000 ECU / year in the case of DG V.
 ---pagebreak---                 IMPACT ON COMPETITIVENESS AND EMPLOYMENT
Principle grounds for introducing the measure
The manufacture of personal protective equipment ( PPE ) is a mainstay of
the Community economy .
Nevertheless , the legislation governing PPE in the different Member
States is characterized by considerable divergence as regards both
safety and certification . Furthermore , de facto mandatory technical
specifications and standards which are , in principle , voluntary but
whose observance is in practice a prior condition to marketing are
often incompatible in the different Community countries .           These
differences impede intra-Community trade by creating technical barriers
to the free movement of P.P.E. between the Member States , thereby
preventing the completion of the internal market .
This proposal     for a   Directive  is designed  to ensure   that P.P.E.
certified as satisfying the basic safety requirements which it lays
down can be placed on the market without restriction and provides the
maximum level of protection corresponding to those requirements .
Furthermore , it provides assurance to consumers and to producers from
numerous S.M.E.       that the products considered meet the stated
requirements , while taking account of the economic interests of the
manufactuers .
In this connection , it should also be pointed out that PPE which is in
conformity with harmonized standards is considered to satisfy the basic
requi rements .
 ---pagebreak---                                                                                   SI
                                       - 2 -
 II . Characteristics of the firms concerned .    In particular :
      Are many small and medium-sized enterprises affected ?
      There are a large number of such enterprises in the PPE manufacturing
      sector .
      Are there regional concentrations :
      -  eligible for regional aid from the Member States ?
         No
      -  eligible for support under ERDF ?
         No .
III . Direct obligations on firms
      All the PPE covered by this Directive must satisty its provisions , from
      the date of its entry into force .        All items of PPE or PPE units
      manufacturers must bear the " EC " mark .       For example ,     it will be
      necessary to modify a number of existing models          in order     to take
      account of this underlying philosophy namely greater design safety .
      The deadline for implementing this Directive is linked to the progress
      made at harmonising standards at European level .        This represents a
      transition period which is surely acceptable for the manuf actuers .
 IV . Obligations  which   may  be  imposed    indirectly   on    firms   by   local
      authorities
      The directive will be applied in each Member State on the basis of the
      transposition of its provisions into national law .       Regional or local
      authorities may  impose additional   requirements only if these do not
      adversely affect the conformity of PPE with the basic requirements .
 ---pagebreak---                                                                                   SL
                                               - 3 -
  V.    Are there are any special measures applicable to small and medium-sized
        f i r.-ns ?
        No .
 VI .   What is the likely effect
        - on the competitiveness of undertakings ?
            The powerful      incentive given    by the  directive to   industry and
            commerce as regards the preparation of harmonized standards and
            production in accordance both with those standards and with the
            requirements of purchasers or users in this sector should ultimately
            lead to an overall reduction in the production and marketing costs
            incurred by manufacturers , importers and retailers , notwithstanding
            the expenditive arising from the implementation of third-party
            inspection procedures .      It will no longer be possible to impede the
            free movement of this PPE on the internal market .
        - on employment ?
            The     above-mentioned  reduction the   production and marketing costs
            should result in a general improvement in the competitiveness of
            European PPE firms , with a consequent beneficial effect on the labour
            market .
VII .   Have emoloyers' and workers' representatives been consulted?
        Yes
      -     Ooinion of emoloyers' and workers' representatives
            The two sides of industry , reoresented in particulara by Orgalime for
            manufacturers in the mechanical engineering industry and the European
            Trace Union Confederation ( ETUC ) for the trades unions , played an
            active part in the activities of the group of exoerts which was
            directly involved in the preparation of this proposal for a
            directive .
 ---pagebreak---                                                                          *3 .
A delegation from the ad hoc PPE Working Grouo of the Advisory Committee
on Safety , Hygiene and Health Protection at Work also participated in
the activities of the above-mentioned expert group ;   the Committee was
consulted and delivered a very favourable opinion .