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

N o C 141/14                              Official Journal of the European Communities                                         30. 5. 88
                                                                ANNEX 11
                      MINIMUM REQUIREMENTS FOR WORKPLACES REFERRED T O IN ARTICLE 6
           The requirements set out in this Annex only apply where the workplace is subject to the risk in question.
            1. Buildings containing workplaces shall be structurally sound and possess a stability appropriate to the nature
               of their use.
           2. Escape routes and emergency exits shall follow the shortest possible route to the outside or a safe area. In the
               event of danger, it shall be possible to evacuate all workplaces quickly and safely; there shall be an adequate
               number of escape routes and emergency exits.
           3. Emergency exit doors shall be easy to open and shall open outwards; sliding or rotating doors shall not be
               permitted.
               Escape routes and emergency exits shall be marked in accordance with the national regulations
               implementing Directive 77/756/EEC. They shall be permanently marked at appropriate points.
               Workplaces shall be equipped with suitable first-aid and fire-fighting equipment. The location of this
               equipment shall be adequately marked at appropriate points.
           4. If the workplaces contain hazardous areas, due to the nature of the work, or involve the risk of workers
               falling or of falling objects, these workplaces shall be equipped, as far as possible, with devices preventing
               workers from entering such areas.
           5. Rooms in which workers would be exposed to particular risks if the artificial lighting were to fail, and all
               emergency exits and traffic routes, shall have emergency lighting which provides sufficient illumination.
           6. Swing doors shall be transparent or have see-through panels.
           7. Workplaces shall be organized in such a way that pedestrians and vehicles can circulate without danger.
            8. Workplaces shall be organized in such a way that workers have separate rooms in the vicinity of their
               workstations equipped with an adequate number of toilets and washbasins (cubicles).
            9. Appropriate measures for the protection of non-smokers shall be taken in staff rest rooms.
               Proposal for a Council Directive on the approximation of the laws of the Member States
                                              relating to personal protective equipment
                                                           COM(88)      157 final
                               (Submitted    by the Commission        to the Council on 14 April 1988)
                                                             (88/C 141/03)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  Having regard to the opinion of the Economic and Social
                                                                          Committee,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100A                        In cooperation with the European Parliament,
thereof,
                                                                          Whereas it is necessary to adopt measures with the aim of
Having regard to the proposal from the Commission,                        progressively establishing the internal market over a period
 ---pagebreak---  30. 5. 88                              Official Journal of the European Communities                              No C 141/15
 expiring on 31 December 1992; whereas the internal                with the general guidelines governing cooperation between
 market comprises an area without internal frontiers in            the Commission and those two institutions ratified on 13
 which the free movement of goods, persons, services and           November 1984; whereas, for the purposes of this
 capital is guaranteed;                                            Directive, a harmonized standard is a text containing
                                                                   technical specifications (a European standard or a
                                                                   harmonization document) which has been adopted by one
Whereas, in recent years, several Member States have               or both of the above-mentioned bodies at the instigation of
introduced regulations and standards covering numerous             the Commission in accordance with the provisions of
items of personal protective equipment with a view, in             Council Directive 83/189/EEC of 28 March 1983 laying
particular, to safeguarding public health, improving safety        down a procedure for the provision of information in the
 at work and ensuring user protection;                             field of technical standards and regulations (*) and
                                                                   pursuant to the above-mentioned general guidelines;
Whereas these regulations and standards frequently
contain extremely detailed requirements relating to the
design, manufacture, quality level, testing and certification      Whereas, pending the adoption of harmonized standards
of personal protective equipment with a view to the                within the meaning of this Directive, which will be very
protection of individuals against injury and illness;              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
Whereas, in particular, the requirements relating to safety        work, it would be advisable to maintain, on a transitional
at work make the use of personal protective equipment              basis and subject to the requirements of the Treaty, the
compulsory; whereas many requirements oblige employers             status quo as regards conformity with existing national
to make appropriate personal protective equipment                  standards for personal protective equipment not covered
available to their staff in the event of the absence or            by a harmonized standard at the date of adoption of this
inadequacy of (priority) public protection measures;               Directive;
Whereas national provisions relating to personal protective
equipment may differ significantly from one Member State           Whereas, given the general and horizontal nature of the
to another and may thus constitute a barrier to trade with         role played by the standing Committee set up pursuant to
direct consequences for the creation and operation of the          Article 5 of Directive 83/189/EEC in the implementation of
common market;                                                     the Community standardization policy and, more par-
                                                                   ticularly, its part in the preparation of standardization
                                                                   applications and the operation of the existing European
Whereas it is necessary to harmonize these different
                                                                   standardization agreements, this standing Committee is
national provisions in order to ensure the free movement of
                                                                  especially suited to the task of assisting the Commission in
these products, without in any way reducing the valid levels
                                                                   monitoring the conformity of harmonized standards
of protection already required in the Member States, and to
                                                                  throughout the Community;
provide for any necessary increase therein;
Whereas the provisions governing the design and manufac-          Whereas steps should be taken to ensure adequate
ture of personal protective equipment laid down in this           consultation of the two sides of industry and, in particular,
Directive which are fundamental, in particular, to attempts       the workers' organizations in the context of the standardiz-
to ensure a safer working environment are without                 ations and administrative activities associated with this
prejudice to provisions relating to the use of such               Directive;
equipment and the organization of the health and safety of
workers at the workplace;
                                                                  Whereas compliance with these technical requirements
Whereas this Directive defines only the basic requirements        must be monitored in order to ensure adequate user and
to be satisfied by personal protective equipment; whereas,        third-party protection; whereas existing monitoring
in order to facilitate proof of conformity with those basic       procedures may differ appreciably from one Member State
requirements, it is essential that harmonized European            to another; whereas, in order to avoid numerous checks
standards be available relating, in particular, to the design     which merely impede the free movement of personal
and manufacture of, and the specifications and test               protective equipment, provision should be made for the
methods applicable to, personal protective equipment,             mutual recognition of inspections conducted by the
since compliance therewith confers on these products a            Member States; whereas, in order to facilitate such
presumption of conformity with the above-mentioned                recognition, it is necessary, in particular, to lay down
basic requirements; whereas such harmonized European              harmonized Community procedures and to harmonize the
standards are drawn up by private bodies and must retain          criteria to be taken into account in selecting the bodies
the status of non-mandatory texts; whereas, to this end, the      responsible for examination, monitoring and verification,
European Committee for Standardization (CEN) and the
European Committee for Electrotechnical Standardization
(Cenelec) are the competent bodies which have been
authorized to adopt harmonized standards in accordance            (!) OJ No L 109, 26. 4. 1983, p. 8.
 ---pagebreak--- N o C 141/16                             Official Journal of the European Communities                                  30. 5. 88
HAS ADOPTED THIS DIRECTIVE:                                         the health or safety of other individuals, domestic animals
                                                                    or goods, when properly maintained and used for its
                                                                    intended purpose.
                         CHAPTER I
                                                                    2. This Directive shall be without prejudice to the right of
                                                                    Member States to lay down — in conformity with the
            Scope, marketing and free movement                      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-
                           Article 1                                conformity with the provisions of this Directive.
1. This Directive applies to personal protective equip-             3. Member States shall not prevent the presentation at
ment, hereinafter referred to as 'PPE'.                             trade fairs, exhibitions and the like of PPE which is not in
                                                                    conformity with the provisions of this Directive, provided
It lays down the conditions governing its marketing and             that an appropriate notice is displayed drawing attention to
free movement within the Community and the basic safety             this fact and the prohibition on its acquisition and (or) use
requirements which PPE must satisfy in order to ensure the          for any purpose — including tests involving individuals —
safety and health protection of users.                              until it has been brought into conformity by the
                                                                    manufacturer or his representative established in the
2. For the purposes of this Directive, PPE means any                Community.
device or appliance designed to be worn or held by an
individual for protection against one or more safety and
health hazards.
                                                                                                Article 3
PPE also covers:
                                                                     1. The PPE referred to in Article 1 shall satisfy the basic
(a) a unit constituted by several devices or appliances which       safety requirements set out in Annex II.
    have been integrally combined by the manufacturer for
    the protection of an individual against one or more
    potentially simultaneous risks;                                 2.    The PPE mentioned in Article 8(2) shall conform:
(b) a protective device or appliance combined, separably or         — either to relevant national standards, transposing
    inseparably, with personal non-protective equipment                  harmonized standards, the titles and reference numbers
    worn or held by an individual for the execution of a                 of which have been published in the Official Journal of
    specific activity;                                                   the European     Communities,
(c) interchangeable PPE components which are essential to           — or to other technical specifications, provided that these
    its satisfactory functioning.                                        give the PPE a level of protection equivalent to that
                                                                         defined in the basic safety requirements, to be assessed
3. Any system marketed in conjunction with PPE for its                   by an approved inspection body referred to in Article 9,
connection to an external device shall be regarded as an                 in accordance with the procedure laid down in Article
integral part of that equipment even if the system is not                10(3).
intended to be worn or held permanently by the user for the
entire period of risk exposure.
                                                                     3. The PPE referred to in Article 8(2), for which
4.    This Directive does not apply to:                              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
— PPE covered by another Community Directive designed
                                                                     date of adoption of this Directive, provided that any such
    to achieve the same objectives as this Directive with
                                                                     provisions are compatible with the requirements of the
    regard to marketing, free movement of goods and
                                                                     Treaty.
    safety,
— the PPE classes and types specified in the list of excluded
    products in Annex I, independently of the above-                                            Article 4
     mentioned reason for exclusion.
                                                                     1. Member States shall not prohibit, restrict or hinder the
                           Article 2                                 marketing of PPE or PPE components which satisfy the
                                                                     provisions of this Directive and which bear the ' E C mark.
 1. Member States shall take all appropriate measures to
 ensure that the PPE referred to in Article 1 may be placed on       2. Member States shall not prohibit, restrict or impede
 the market and brought into service only if it protects the         the marketing of PPE components, which do not bear the
 health and ensures the safety of users without prejudice to         ' E C mark, and which are intended to be incorporated in
 ---pagebreak--- 30. 5. 88                               Official Journal of the European Communities                                 No C 141/17
PPE, provided that they are not essential to its satisfactory      concerned and all the other Member States to this effect. If
functioning.                                                       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
                           Article 5                               State concerned intends to adhere to its decision and shall
                                                                   initiate the procedures referred to in Article 6.
Member States shall presume that PPE satisfies the basic
safety requirements referred to in Article 3 if it bears the       3. If PPE which is not in conformity with the relevant
' E C mark, declaring its conformity:                              requirements bears the ' E C mark, the Member State
                                                                   concerned shall take the appropriate measures with regard
— with relevant national standards, transposing harmo-             to those responsible for affixing the mark and shall inform
     nized standards, the titles and reference numbers of          the Commission and the other Member States accordingly.
     which have been published in the Official Journal of the
     European Communities. The Member States shall                 4. The Commission shall ensure that the Member States
     publish the appropriate references of these national          are kept informed of the progress and results of the
     standards,                                                    procedure provided for in this Article.
— or with other technical specifications providing a level
     of protection equivalent to that defined in the basic
     safety requirements of this Directive.
                                                                                              CHAPTER II
                           Article 6
                                                                                       Certification procedures
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                                     Article 8
referred to in Article 3, the Commission or the Member
State concerned shall refer the matter to the Standing             1. Before placing a PPE model on the market, the
Committee created pursuant to Directive 83/189/EEC,                manufacturer or his authorized representative established
hereinafter referred to as 'the Committee', setting out its        in the Community shall assemble the documentation
reasons. The Committee shall deliver an opinion without            referred to in Annex III (I), so that this can, if necessary, be
delay.                                                             submitted to the competent authorities.
In the light of that opinion, the Commission shall inform
                                                                   2. Prior to the series production of PPE other than that
the Member States whether the reference to the standards
                                                                   referred to in paragraph 3, the manufacturer or his
in question need or need not be withdrawn from the
                                                                   authorized representative established in the Community
publications referred to in Article 5.
                                                                   shall submit a model for ' E C type-examination in
                                                                   accordance with Article 10.
                           Article 7
                                                                   3. ' E C type-examination shall not be required in the case
1. If a Member State discovers that PPE bearing the ' E C          of PPE models of simple design where the user can himself
mark and used in accordance with its intended purpose              assess the level of protection provided against the minimal
could compromise the safety of individuals, domestic               risks concerned which can be safely identified in good time
animals or property, it shall take all necessary measures to       owing to the gradual nature of their effects.
remove that equipment from the market and prohibit the
marketing or free movement thereof.                                This category includes PPE models intended for use in
                                                                   domestic, dressmaking and gardening activities and models
The Member State concerned shall immediately inform the            providing protection against solar radiation, bad weather
Commission of such action, indicating the reasons for its          and dirt.
decision and, in particular, stating whether non-conformity
is due to:                                                         Prior to marketing, series-manufactured PPE shall be
                                                                   subject t o :
(a) failure to comply with the basic requirements referred
     to in Article 3 ;
                                                                   (a) the ' E C verification procedure referred to in Article 11
                                                                       in the case of PPE of complex design intended to protect
(b) the unsatisfactory application of the standards referred
                                                                       the user against mortal danger, the immediate effects of
     to in Article 5;
                                                                       which cannot be identified in sufficient time. This
(c) a gap in the standards referred to in Article 5.                   category includes:
2. The Commission shall initiate discussions with the                  — emergency equipment for use in atmospheres
parties concerned as soon as possible. If, after such                      rendered unbreathable by oxygen deficiency and (or)
consultation, the Commission decides that the action taken                 serious contamination due to highly toxic or
was justified, it shall immediately inform the Member State                radiotoxic substances, which can harmfully affect
 ---pagebreak--- No C 141/18                              Official Journal of the European Communities                                       30. 5. 88
        other parts of the body in addition to the respiratory           (a) It shall examine the manufacturer's technical file to
        tract,                                                           establish its suitability; in the case of technical
                                                                         specifications, other than those of the harmonized
    — emergency equipment for use in high-temperature                    standards, referred to in Article 3(2), it shall satisfy itself
        environments in which the atmospheric temperature                as to their suitability compared to the basic safety
        is liable to exceed 100 °C and which may or may not              requirements.
        be characterized by the presence of flames or the
        projection of large amounts of molten material,
                                                                         (b) In examining the model, the inspection body:
    — emergency equipment for use in low-temperature
        environments in which the atmospheric temperature                — shall verify that it has been produced in accordance
        is liable to be below -50 °C.                                        with the manufacturer's technical file and can be
                                                                             used in complete safety for its intended purpose,
(b) the ' E C declaration of conformity referred to in Article
    12 for all PPE not falling within the category referred to
    in (a).                                                              — shall conduct the necessary examinations and tests
                                                                             to establish the conformity of the model with the
                                                                             relevant standards or technical specifications and
                              Article 9                                      (or) basic requirements.
1. Each Member State shall inform the Commission and
                                                                    4. If the model satisfies the relevant provisions, the
the other Member States of the approved bodies re-
                                                                    inspection body shall draw up an ' E C type-examination
sponsible for the execution of the certification procedures
                                                                    certificate and shall notify the applicant to this effect. This
referred to in Article 8. For information purposes, the
                                                                    certificate shall reproduce the findings of the examination,
Commission shall publish in the Official Journal of the
                                                                    indicate any conditions attaching to its issue and in-
European Communities and keep up to date a list giving the
                                                                    corporate the descriptions and drawings necessary for the
names of these bodies and the distinguishing numbers it has
                                                                    identification of the approved model.
assigned to them.
2. Annex III (II) sets out the minimum criteria to be               The Commission, the other approved inspection bodies
observed by the Member States in approving the above-               and the other Member States may obtain a copy of the
mentioned bodies.                                                   certificate and, in response to a reasoned request, a copy of
                                                                    the manufacturer's technical file and the reports of the
3. A Member State shall withdraw its approval from such             examinations and tests conducted.
a body if it establishes that the latter no longer satisfies the
criteria referred to in Annex III (II). It shall inform the
                                                                    5. Any inspection body which refuses to issue an ' E C
Commission and the other Member States of its action
                                                                    type-examination certificate shall inform the other ap-
forthwith.
                                                                    proved inspection bodies of this fact. An inspection body
                                                                    withdrawing an ' E C type-examination certificate shall
                      ' E C type-examination
                                                                    inform the Member State which approved it, to this effect.
                                                                    That Member State shall then inform the other Member
                             Article 10                             States and the Commission, setting out the reasons for the
                                                                    decision.
' E C type-examination is the procedure whereby the
approved inspection body establishes and certifies that the
                                                                                            ' E C verification
PPE model in question satisfies the relevant provisions of
this Directive.
 1. Application for ' E C type-examination shall be made by                                      Article 11
     the manufacturer or his authorized representative to a
     single approved inspection body in respect of the model
     in question. The authorized representative shall be             1. ' E C verification is a procedure for checking and
     established in the Community.                                  certifying the conformity of production PPE with the
                                                                    approved model. It shall be conducted by the inspection
2. The application shall comprise:                                  body which drew up the ' E C type-examination certificate
     — the name and address of the manufacturer or his              pursuant to the under-mentioned provisions.
         authorized representative and of the PPE production
         plant in question,                                          2. The verification procedure shall be conducted periodi-
                                                                     cally with reference to PPE batches submitted by the
     — the manufacturer's file referred to in Annex III (I).         manufacturer or his authorized representative established
                                                                     in the Community. Batches shall be accompanied by the
 It shall be accompanied by the appropriate number of                ' E C type-examination certificate referred to in Article 10.
 specimens of the model to be approved.
 3. The approved inspection body shall conduct the ' E C             3. In examining a batch, the inspection body shall
     type-examination in accordance with the under-                  establish that the PPE in question has been manufactured
     mentioned procedures:                                           and checked in accordance with the manufacturer's file and
 ---pagebreak--- 30. 5. 88                                 Official Journal of the European Communities                                 No C 141/19
shall perform the appropriate tests on the batch specimens;              2. The ' E C mark shall be affixed to PPE and its
it shall issue an ' E C verification certificate.                        packaging so as to be visible, legible and indelible
                                                                         throughout the foreseeable 'useful life' of that PPE.
                ' E C declaration of conformity
                                                                         3. Marks of inscriptions which could be confused with
                                                                         the ' E C mark shall not be affixed to PPE.
                           Article 12
The ' E C declaration of conformity is the procedure
whereby the manufacturer who has satisfied the provisions                                         CHAPTER IV
of Article 8(4)(b):
                                                                                                Final provisions
1. draws up a declaration certifying that the PPE model
    specimens placed on the market are in conformity with                                          Article 14
    the basic requirements of this Directive with a view,
    where necessary, to its submission to the competent                  Any decision taken by a Member State in implementation
    authorities;                                                         of this Directive shall be accompanied by a detailed
                                                                         explanation of the grounds on which it is based. The
2. affixes the ' E C mark of conformity provided for by                  interested party shall be notified of the decision without
    Article 13 to each PPE model specimen.                               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.
                          CHAPTER III
                                                                                                   Article 15
                           ' E C mark
                                                                         1. By 31 December 1989 Member States shall adopt and
                                                                         publish the laws, regulations and administrative provisions
                           Article 13                                    necessary to comply with this Directive.
1. The ' E C mark consists of the letters ' E C followed by              They shall apply those provisions from 1 July 1990.
the last two figures of the year in which the mark was
affixed together, in the event of the involvement of an                  2. Member States shall communicate to the Commission
approved inspection body, with the distinguishing number                 the texts of the provisions of national law which they adopt
referred to in Article 9(1).                                             in the field governed by this Directive.
The two models of the ' E C mark to be used respectively in                                        Article 16
the event of the intervention or non-intervention of an
approved inspection body are shown in Annex IV.                          This Directive is addressed to the Member States.
                                                                ANNEX I
                     EXHAUSTIVE LIST OF PPE CLASSES OR TYPES N O T 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.
               (!) Independently of the reason for exclusion referred to in Article 1.
 ---pagebreak--- No C 141/20                                    Official Journal of the European Communities                                      30. 5. 88
                                                                         ANNEX U
                  PROPOSAL FOR A DIRECTIVE RELATING T O 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
                        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.     S a t i s f a c t o r y surface c o n d i t i o n of all PPE p a r t s in c o n t a c t w i t h 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.     M i n i m u m uses i m p e d i m e n t
                        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
 ---pagebreak--- 30. 5. 88                                Official Journal of the European Communities                                        No C 141/21
                          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
             c
                          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.
                          Apart from the specific additional requirements which they must satisfy in order to provide
                          adequate protection against the risks in question (see 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, hydrocarbons, 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 0 ) ;
                          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;
                          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 C O M M O N T O 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.
          (J) 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--- No C 141/22                  Official Journal of the European Communities                                            30. 5. 88
          2.2. PPE 'enclosing' the parts of the body to be protected
               As far as possible, PPE 'enclosing' the parts of the body to be protected must be sufficiently
               ventilated to 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.
          2.4. 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 (or 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.
          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 'critical' situations
               The information notes supplied by the manufacturer together with PPE for use in the 'critical'
               situations referred to in Article 8(4) must include, in particular, data reserved for the exclusive
 ---pagebreak--- 30. 5. 88                      Official Journal of the European Communities                                       No C 141/23
                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 purpose 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.
          2.11. PPE incorporating 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 incorporate 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--- No C 141/24                                    Official Journal of the European Communities                                     30. 5. 88
          3.              ADDITIONAL REQUIREMENTS SPECIFIC T O PARTICULAR RISKS
          3.1.            Protection against mechanical impact
          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 sufficiently shock-absorbent to prevent injury resulting,
                          in particular, from the crushing or penetration of the protected part, at least up to an impact-
                          energy level above which the excessive dimensions 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.        P r e v e n t i o n of falls due to s l i p p i n g
                          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 ensuring satisfactory adhesion by grip and friction.
          3.1.2.2.        P r e v e n t i o n of falls from a h e i g h t
                          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 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.
           3.1.2.3.        P r e v e n t i o n of d r o w n i n g
                           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.
            (!) This vertical drop must always be less than the necessary minimum 'headroom' indicated in the
                manufacturer's notes.
 ---pagebreak--- 30. 5. 88                      Official Journal of the European Communities                                           No C 141/25
                 In addition, this PPE must be so designed and manufactured that it can, if necessary, be worn by a
                 fully-dressed person for as long as the risk of drowning exists.
          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.
                 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 PPE.
                 The package-insert notes must contain, in particular, the graph of noise attenuation in relation to
                 octave bands.
          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 marketed.
                 In designing these PPE classes, the manufacturer must take account of all parameters of relevance
                 to the evaluation of the heat flow transmitted through PPE by atmospheric radiation and
                 convection or by conduction resulting from contact with elements at high temperature such as
                 the ground, partitions or hot objects and the projection of hot products — incandescent particles,
                 molten materials, etc. — or transmitted by direct contact with flame.
          3.5.1. PPE consituent materials and other       components
                 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
 ---pagebreak--- No C 141/26                             Official Journal of the European Communities                                           30. 5. 88
                         and be sufficiently incombustible (x) to preclude any risk of spontaneous 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.
                         PPE materials and other components which may be splashed by large amounts of hot products
                         must also possess sufficient mechanical-impact absorbency (see 3.1).
                         PPE materials and other components which may accidentally come into contact with flame and
                         those used in the manufacture of fire-fighting equipment must also possess a degree of non-
                         flammability (J) 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.        Complete 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 penetration 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.
                         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
            (!) 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--- 30. 5. 88                        Official Journal of the European Communities                                       No C 141/27
                  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.  Complete 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;
                 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 (or) 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'.
          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.
 ---pagebreak--- No C 141/28                             Official Journal of the European Communities                                           30. 5. 88
                          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.
          3.8.2.          Ionizing   radiation
                           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 pressurization 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 (e. g. X, gamma) radiation.
                           The constituent 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.
           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 atmosphere 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
            (*) See 3.9.1 for protection against contamination of the respiratory tracts.
 ---pagebreak--- 30. 5. 88                      Official Journal of the European Communities                                         No C 141/29
                 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
            i    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, will
                 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. Protection against epidermal or ocular contact
                 PPE intended to prevent the surface contact of all or part of the body with dangerous substances
                 and infective agents must be capable of preventing the penetration or diffusion of such
                 substances through the protective envelope under the conditions of use for which the PPE is
                 marketed.
                 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
                 protection provided by the PPE in question, the latter must be subjected to standard tests with a
                 view to their classification on the basis of 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--- No C 141/30                                Official Journal of the European Communities                                         30. 5. 88
                                                                  ANNEX III
                 CERTIFICATION OF PPE CONFORMITY WITH THE BASIC REQUIREMENTS OF THIS
                                                                  DIRECTIVE
                          I. 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 calculation notes and the results of
                   prototype tests conducted prior to manufacture;
              (b) an exhaustive list indicating the basic requirements of this Directive, 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 PPE 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;
              (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. MINIMUM CRITERIA T O BE TAKEN INTO ACCOUNT BY THE MEMBER 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 suppliers 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 possibility of an
              exchange of technical information between the manufacturer and the inspection body concerned.
          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,
              — 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.
 ---pagebreak--- 30. 5. 88                             Official Journal of the European Communities                                          No C 141/31
          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
            t 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--- No C 141/32                                Official Journal of the European Communities                                         30. 5. 88
                                                                ANNEX     IV
                                                         MODEL ' E C MARKS
                  A. MODEL FOR USE IN ' E C TYPE-EXAMINATION OR ' E C VERIFICATION PROCEDURES
                                                          (see Articles 10 and 11)
                                                                                                              for example (2)
            B. MODEL FOR USE IN THE ' E C DECLARATION OF CONFORMITY PROCEDURE N O T INVOLVING
                                               ' E C TYPE-EXAMINATION (see Article 12)
                                                                                                    for example( 2 )
The vertical dimension of the different components of the ' E C mark must be perceptibly the same, namely not less than 2 mm on the PPE and
not less than 5 mm on its packaging.
(') 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).