Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment
Date: 1989-12-21
Institutions: Council of the European Union
Subjects: Community certification, EC conformity marking, approximation of laws, harmonisation of standards, market approval, product quality, protective equipment, safety standard













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31989L0686

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment  


Official Journal L 399 , 30/12/1989 P. 0018 - 0038 Finnish special edition: Chapter 13 Volume 19 P. 0129  Swedish special edition: Chapter 13 Volume 19 P. 0129  





COUNCIL DIRECTIVEof 21  December 1989on the approximation of the laws of the Member States relating to personal protective  equipment(89/686/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), 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 thefree movement of goods, persons, services and capital is  guaranteed; Whereas various Member States have, over recent years, adopted provisions covering numerous items  of personal protective equipment with a view in particular to safeguarding public health, improving  safety at work and ensuring user protection; Whereas these national provisions are often very detailed as regards the 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 national provisions 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 staff in the absence or inadequacy of priority  public protection measures; Whereas national provisions relating to personal protective equipment differ significantly from one  Member State to another; whereas they 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 theseOJ N° C 304, 4. 12. 1989, p. 29. 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 protective 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 abovementioned 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 Electrotechnical  Standardization (Cenelec) are the competent bodies which have been authorized to adopt harmonized  standards in accordance with the general guidelines 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 abovementioned bodies at  the instigation of the Commission in accordance with 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 (4), as amended by Directive 88/182/EEC (5), and pursuant to the abovementioned general  guidelines; Whereas, pending the adoption of harmonized standards, 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 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 compliance with these technical requirementsmust be monitored in order to ensure adequate  userand 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; Whereas the legislative framework should be improvedso that both sides of industry will make an  effectiveand appropriate contribution to the process of standardization, HAS ADOPTED THIS DIRECTIVE: CHAPTER ISCOPE, PLACING ON THE MARKET AND FREEMOVEMENTArticle 11.  This  Directive applies to personal protective equipment, hereinafter referred to as 'PPE'. It lays down the conditions governing its placing on the market and free movement within the  Community and the basic safety requirements which PPE must satisfy in order to ensure the health  protection and safety of users. 2.  For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn  or held by an individual for protection against one or more health and safety hazards. PPE shall also cover: (a)  a unit constituted by several devices or appliances which have been integrally combined by the  manufacturer for the protection of an individual against one or more potentially simultaneous  risks; (b)  a protective device or appliance combined, separably or inseparably, with personal  non-protective equipmentworn or held by an individual for the execution of a specific activity; (c)  interchangeable PPE components which are essential to its satisfactory functioning and used  exclusively for such equipment. 3.  Any system placed on the market in conjunction with PPE for its connection to another external,  additional device shall be regarded as an integral part of that equipment even if the system is not  intended to be worn or held permanently by the user for the entire period of risk exposure. 4.  This Directive does not apply to: - PPE covered by another directive designed to achieve the same objectives as this Directive with  regard to placing on the market, free movement of goods and safety, - the PPE classes specified in the list of excluded products in Annex I, independently of the  reason for exclusion mentioned in the first indent. Article 21.  Member States shall take all appropriate measures to ensure that the PPE referred to  in Article 1 may be placed on the market and brought into service only if it preserves the health  and ensures the safety of users without prejudice to the health or safety of other individuals,  domestic animals or goods, when properly maintained and used for its intended purpose. 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 whatsoever until it has been brought into conformity by the manufacturer or his  representative established in the Community. Article 3The PPE referred to in Article 1 must satisfy the basic health and safety requirements  laid down in Annex II. Article 41.  Member States shall not prohibit, restrict or hinder the placing on the market of  PPE or PPE components whichsatisfy the provisions of this Directive and which bear the EC mark. 2.  Member States shall not prohibit, restrict or impede the placing on the market 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 satisfactory functioning. Article 51.  Member States shall regard as in conformity with the basic requirements referred to  in Article 3 the PPE referred to in Article 8 (3) bearing the EC mark with respect to which the  manufacturer is able to produce, on demand, the declaration of conformity referred to in Article  12. 2.  Member States shall presume that the PPE referred to in Article 8 (2) satisfies the basic  requirements referred to in Article 3 if it bears the EC mark with respect to which the  manufacturer is able to produce, on demand, not only the declaration referred to in Article 12 but  also the certificate issued by the body of which notification has been given in accordance with  Article 9 attesting to their conformity to the relevant national standards, transposing the  harmonized standards, assessed at the EC type examination levelin accordance with the first indent  of Article 10 (4) (a)and (b). Where a manufacturer has not applied or has only partly applied the harmonized standards or where  there are no such standards the certificate issued by the body of which notification has been given  must state the conformity to the basic requirements in accordance with the second indent of Article  10 (4) (a) and (b). 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  arrangements already in force on the date of adoption of this Directive, provided that such  arrangements are compatible with the provisions of the Treaty. 4.  The Commission shall publish the references of the harmonized standards in the Official Journal  of the European Communities. Member States shall publish the references of the national standards transposing the harmonized  standards. 5.  Member States shall ensure that by 30 June 1991 appropriate steps are taken to enable both  sides of industry to have an influence at national level on the process of formulating the  harmonized standards and keeping them under review. Article 61.  Should a Member State or the Commission consider that the harmonized standards  referred to in Article 5 do notcompletely satisfy the relevant basic requirements referred to in  Article 3, the Commission or the Member State concerned shall refer the matter to the committee  created pursuant to Directive 83/189/EEC (1), setting out its reasons. The committee shall deliver  an opinion without delay. In the light of the committee's opinion, the Commission shall notify Member States of whether or  not it is necessary to withdraw the standards concerned from publications made pursuant to Article  5. 2.  The Standing Committee set up by Article 6 (2) of Directive 89/392/EEC (2) may be apprised, in  accordance with the procedure described below, of any matter to which the implementation and  practical application of this Directive give rise. The representative of the Commission shall submit to the committee a draft of the measures to be  taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman  may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right  to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the committee. It shall  inform the committee of the manner in which its opinion has been taken into account. Article 71.  If a Member State discovers that PPE bearing the EC mark and used in accordance with  its intended purpose could compromise the safety of individuals, domestic animals or property, it  shall take all necessary measures to remove that equipment from the market and prohibit the  marketing or free movement thereof. 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 shortcoming in the standards referred to in Article 5. 2.  The Commission shall initiate discussions with the parties concerned as soon as possible. If,  after such consultation, the Commission decides that the action takenwas justified, it shall  immediately inform the Member State concerned and all the other Member States to that effect. If,  after such consultation, the Commission decides that the action taken was not justified, it shall  immediately inform the Member State concerned and the manufacturer or his authorized representative  established in the Community to that effect. If the decision referred to in paragraph 1 is in  response to a shortcoming in the standards, the Commission shall refer the matter to the Committee  referred to inArticle 6 (1) if the Member State concerned intends to adhere to its decision and  shall initiate the procedure referred to in Article 6 (2). 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 IICERTIFICATION PROCEDURESArticle 81.  Before placing a PPE model on the market, the  manufacturer or his authorized representative established in the Community shall assemble the  technical documentation referred to in Annex III so that this can, if necessary, be submitted to  the competent authorities. 2.  Prior to the series production of PPE other than those referred to in paragraph 3, the  manufacturer or his authorized representative established in the Community shall submit a model for  EC type-examination as referred to in Article 10. 3.  EC type-examination shall not be required in the case of PPE models of simple design where the  designer assumes the user can himself assess the level of protection provided against the minimal  risks concerned the effects of which, when they are gradual, can be safely identified by the user  in good time. This category shall cover exclusively PPE intended to protect the wearer against: - mechanical action whose effects are superficial (gardening gloves, thimbles, etc.), - cleaning materials of weak action and easily reversible effects (gloves affording protection  against diluted detergent solutions, etc.), - risks encountered in the handling of hot components which do not expose the user to a temperature  exceeding 50 gC or to dangerous impacts (gloves, aprons for professional use, etc.), - atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing,  footwear, etc.), - minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot  cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.), - sunlight (sunglasses). 4.  Production of PPE shall be subject: (a)  according to the manufacturer's choice, to one of the two procedures referred to in Article 11  in the case of PPE of complex design intended to protect against mortal danger or against dangers  that may seriously and irreversibly harm the health, the immediate effects of which the designer  assumes the user cannot identify in sufficient time. This category shall cover exclusively: - filtering respiratory devices for protection against solid and liquid aerosols or irritant,  dangerous, toxic or radiotoxic gases, - respiratory protection devices providing full insulation from the atmosphere, including those for  use in diving, - PPE providing only limited protection against chemical attack or against ionizing radiation, - emergency equipment for use in high-temperature environments the effects of which are comparable  to those of an air temperature of 100 gC or more and which may or may not be characterized by the  presence of infra-red radiation, flames or the projection of large amounts of molten material, - emergency equipment for use in low-temperature environments the effects of which are comparable  to those of an air temperature of  50 gC or less, - PPE to protect against falls from a height, - PPE against electrical risks and dangerous voltages or that used as insulation in high-tension  work, - motor cycle helmets and visors; (b)  the EC declaration of conformity referred to inArticle 12 for all PPE. Article 91.  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.  Member States shall apply the criteria laid down in Annex V in assessing the bodies to be  indicated in such notification. Bodies meeting the assessment criteria laid down in the relevant  harmonized standards shall be presumed to fulfil those criteria. 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 V. It shall inform the Commission and the  other Member States of its action forthwith. EC TYPE-EXAMINATIONArticle 101.  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. 2.  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. 3.  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 technical file referred to inAnnex III. It shall be accompanied by the appropriate number of specimens of the model to be approved. 4.  The inspection body of which notification has been given shall conduct the EC type-examination  in accordance with the undermentioned procedures: (a)  Examination of the manufacturer's technical file- It shall examine the manufacturer's  technical file to establish its suitability with respect to the harmonized standards referred to in  Article 5. - Where a manufacturer has not applied, or has only partly applied, the harmonized standards or  where there are no such standards, the body of which notification has been given must check the  suitability of the technical specifications used by the manufacturer with respect to the basic  requirements before examining the manufacturer's technical file to establish its suitability with  respect to these technical specifications. (b)  Examination of the model- When examining the model, the inspection body shall verify that it  has been produced in accordance with the manufacturer's technical file and can be used in complete  safety for its intended purpose. - It shall conduct the necessary examinations and tests to establish the conformity of the model  with the harmonized standards. - Where a manufacturer has not applied or has only partly applied the harmonized standards or where  there are no such standards the body of which notification has been given shall conduct the  necessary examinations and tests to establish the conformity of the model with the technical  specifications used by the manufacturer, subject to their being suitable with respect to these  basic requirements. 5.  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 findings of the examination, indicate any conditions attaching to its issue and  incorporate the descriptions and drawings necessary for the identification of the approved model. 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 conducted. The file shall be held at the disposal of the competent authorities for 10 years following the  placing of the PPE on the market. 6.  Any inspection body which refuses to issue an EC type-examination certificate shall inform the  other approved inspection bodies of this fact. An inspection body withdrawing an EC  type-examination certificate shall 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. CHECKING OF PPE MANUFACTUREDArticle 11A.  'EC' quality control system for the final product1.   A manufacturer shall take all steps necessary to ensure that the manufacturing process, including  the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of  PPE with the type described in the EC type-approval certificate and with the relevant basic  requirements of this Directive. 2.  A body of which notification has been given, chosen by a manufacturer, shall carry out the  necessary checks. Those checks shall be carried out at random, normally at intervals of at least  one year. 3.  An adequate sample of PPE taken by the body of which notification has been given shall be  examined and appropriate tests defined in the harmonized standards or necessary to show conformity  to the basic requirements of this Directive shall be carried out to check the conformity of PPE. 4.  Where a body is not the body that issued the relevant EC type-approval certificate it shall  contact the body of which notification has been given in the event of difficulties in connection  with the assessment of the conformity of samples. 5.  The body of which notification has been given shall provide the manufacturer with a test  report. If the report concludes that production is not homogeneous or that the PPE examined do not  conform to the type described in the ECtype-approval certificate or the relevant basic  requirements, the body shall take measures appropriate to the nature of the fault or faults  recorded and inform the Member State which gave notification thereof accordingly. 6.  The manufacturer must be able to present, on request, the report of the body of which  notification has been given. B.  System for ensuring EC quality of production by means of monitoring1.  The system(a)  Under  this procedure the manufacturer submits an application for the approval of his quality-control  system to a body of which notification has been given, of his choice. That application shall include: - all the information relating to the category of PPE concerned, including, where appropriate,  documentation relating to the model approved, - documentation on the quality-control system, - the undertaking to maintain the obligations arising from the quality-control system and to  maintain its adequacy and efficiency. (b)  Under the quality-control system, each PPE shall be examined and the appropriate tests  referred to in Section A paragraph 3 shall be carried out to check their conformity to the relevant  basic requirements of this Directive. The documentation on the quality-control system shall in particular include an adequate description  of: - the quality objectives, the organization chart, the responsibilities of executives and their  powers in respect of product quality, - the checks and tests which must be carried out after manufacture, - the means to be employed to check the efficient operation of the quality-control system. (c)  The body shall assess the quality-control system to determine whether it satisfies the  provisions referred to in paragraph 1 (b). It shall assume that quality-control systems applying  the relevant harmonized standard satisfy those provisions. The body carrying out audits shall make all necessary objective evaluations of the components of  the quality-control system and shall check in particular whether the system ensures conformity of  PPE manufactured with the approved model. The decision shall be communicated to the manufacturer. It shall include the conclusions of the  check and the reasoned assessment decision. (d)  The manufacturer shall inform the body which approved the quality-control system of any plan  to alter the quality-control system. The body shall examine the proposed changes and decide whether the altered quality-control system  satisfies the relevant provisions. It shall communicate its decision to the manufacturer. The  communication shall include the conclusions of the check and the reasoned assessment decision. 2.  Supervision(a)  The purpose of supervision is to ensure that a manufacturer correctly fulfils  the obligations arising from the approved quality-control system. (b)  The manufacturer shall authorize the body to have access, for purposes of inspection, to PPE  inspection, testing and storage sites and shall provide the body with all requisite information, in  particular: - documentation on the quality-control system, - technical documentation, - quality control manuals. (c)  The body shall periodically carry out audits to ensure that the manufacturer is maintaining  and applying the approved quality-control system and shall provide the manufacturer with a copy of  the audit report. (d)  In addition, the body may make unannounced visits to the manufacturer. In the course of such  visits the body shall provide the manufacturer with a report of the visit and, if appropriate, with  an audit report. (e)  The manufacturer must be able to present, on request, the report of the body of which  notification has been given. EC DECLARATION OF PRODUCTION CONFORMITYArticle 12The EC declaration of conformity is the  procedure whereby the manufacturer: 1.  draws up a declaration using the form laid down in Annex VI certifying that the PPE placed on  the market are in conformity with the provisions of this Directive with a view to its submission to  the competent authorities; 2.  affixes the EC mark of conformity provided for by Article 13 to each PPE. CHAPTER IIIEC MARKArticle 131.  The EC mark consists of the letters 'CE' followed by the last  two figures of the year in which the mark was affixedand, in the event of the involvement of a  notified body having carried out an EC examination of the type referred to in Article 10, its  distinguishing number shall be added. The form of the mark to be used is shown in Annex IV. 2.  The EC mark shall be affixed to each production 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 may not be affixed to PPE. CHAPTER IVFINAL PROVISIONSArticle 14Any decision taken in implementation of this Directive and  leading to restrictions on the marketing of PPE 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 15The Commission shall take the necessary steps to ensure that data concerning all the  relevant decisions in connection with the management of this Directive are made available. Article 161.  By 31 December 1991, Member States shall adopt and publish the laws, regulations  and administrative provisions necessary to comply with this Directive. They shall forthwith inform  the Commission thereof. They shall apply those provisions from 1 July 1992. 2.  Member States shall communicate to the Commission the texts of the provisions of national law  which they adopt in the field governed by this Directive. Article 17This Directive is addressed to the Member States. Done at Brussels, 21 December 1989. For the CouncilThe PresidentE. CRESSON(1) OJ N° C 141, 30. 5. 1988, p. 14. (2) OJ N° C 12, 16. 1. 1989, p. 109, (3) OJ N° C 337, 31. 12. 1988, p. 37. (4) OJ N° L 109, 26. 4. 1983, p. 8. (5) OJ N° L 81, 26. 3. 1988, p. 75. (1) OJ N° L 109, 26. 4. 1983, p. 8. (2) OJ N° L 183, 29. 6. 1989, p. 9. ANNEX I EXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THIS DIRECTIVE 1.  PPE designed  and manufactured specifically for use by the armed forces or in the maintenance of law and order  (helmets, shields, etc.). 2.  PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.). 3.  PPE designed and manufactured for private use against: - adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.), - damp and water (dish-washing gloves, etc.), - heat (gloves etc.). 4.  PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the  time.ANNEX II BASIC HEALTH AND SAFETY REQUIREMENTS 1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPEPPE must provide adequate protection against all risks  encountered. 1.1. Design principles1.1.1. ErgonomicsPPE must be so designed and manufactured that in the foreseeable conditions of use for  which it is intended the user can perform the risk-related activity normally whilst enjoying  appropriate protection of the highest prossible level. 1.1.2. Levels and classes of protection1.1.2.1. Highest level of protection possibleThe optimum level of protection to be taken into account in  the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its  effective use during the period of exposure to the risk or normal performance of the activity. 1.1.2.2. Classes of protection appropriate to different levels of riskWhere differing foreseeable  conditions of use are such that several levels of the same risk can be distinguished, appropriate  classes of protection must be taken into account in the design of the PPE. 1.2. Innocuousness of PPE1.2.1. Absence of risks and other 'inherent' nuisance factorsPPE must be so designed and manufactured as  to preclude risks and other nuisance factors under foreseeable conditions of use. 1.2.1.1. Suitable constituent materialsPPE materials and parts, including any of their decomposition  products, must not adversely affect user hygiene or health. 1.2.1.1. Satisfactory surface condition of all PPE parts in contact with the userAny 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. Maximum permissible user impedimentAny inpediment caused by PPE to movements to be made, postures  to be adopted and sensory perception must be minimized; nor must PPE cause movements which endanger  the user or other persons. 1.3. Comfort and efficiency1.3.1. Adaptation of PPE to user morphologyPPE 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 strengthPPE must be as light as possible without 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 ambient phenomena inherent under the foreseeable conditions of use. 1.3.3. Compatibility of different classes or types of PPE designed for simultaneous useIf the same  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, these must be  compatible. 1.4. Information supplied by the manufacturerIn addition to the name and address of the manufacturer  and/or his authorized representative established in the Community, the notes that must be drawn up  by the former and supplied when PPE is placed on the market must contain all relevant information  on: (a)  storage, use, cleaning, maintenance, servicing and disinfection. 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; (b)performance as recorded during technical tests to check the levels or classes of protection  provided by the PPE in question; (c)suitable PPE accessories and the characteristics of appropriate spare parts; (d)the classes of protection appropriate to different levels of risk and the corresponding limits  of use; (e)the obsolescence deadline or period of obsolescence of PPE or certain of its components; (f)the type of packaging suitable for transport; (g)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 PPE2.1. PPE incorporating adjustment systemsIf PPE incorporates adjustment systems, the latter must be so  designed and manufactured as not to become incorrectly adjusted without the user's knowledge under  the foreseeable conditions of use. 2.2. PPE 'enclosing' the parts of the body to be protectedAs far as possible, PPE 'enclosing' the parts  of the body to be protected must be sufficiently ventilated to limit perspiration resulting from  use; if this is not the case, it must if possible be equipped with devices which absorb  perspiration. 2.3. PPE for the face, eyes and respiratory tractsAny restriction of the user's field of vision or  sight by PPE for the face, eyes or 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 of the user. If necessary, they must be treated or provided with facilities to prevent moisture formation. PPE models intended for users requiring sight correction must be compatible with the wearing of  spectacles or contact lenses. 2.4. PPE subject to ageingIf it is known that the design performances of new PPE may be significantly  affected by ageing, the date of manufacture and/or, if possible, the date of obsolescence, must be  indelibly inscribed on every PPE item or interchangeable component placed on the market 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 which may be caught up during useWhere the foreseeable conditions of use include in particular  the risk of the PPE being caught up by a moving object thereby creating a danger for the user, the  PPE must possess an appropriate resistance threshold above which a constituent part will break and  eliminate the danger. 2.6. PPE for use in explosive atmospheresPPE intended for use in explosive atmospheres must be so  designed and manufactured that it cannot be the source of an electric, electrostatic or  impact-induced arc or spark likely to cause an explosive mixture to ignite. 2.7. PPE intended for emergency use or rapid installation and/or removalThese 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 very dangerous situationsThe information notes supplied by the manufacturer  together with PPE for use in the very dangerous situations referred to in Article 8 (4) (a) must  include, in particular, data intended for the exclusive 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 userAny 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 adjustment, attachment and removal without tools. 2.10. PPE for connection to another, external complementary deviceIf PPE incorporates a system  permitting connection to another, complementary, device, the attachment mechanism must be so  designed and manufactured as to enable it to be mounted only on appropriate equipment. 2.11. PPE incorporating a fluid circulation systemIf 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 foreseeable conditions of use. 2.12. PPE bearing one or more identification or recognition marks directly or indirectly relating to  health and safetyThe identification or recognition marks directly or indirectly relating to health  and safety affixed to these types or classes of PPE must preferably take the form of harmonized  pictograms or ideograms and must remain perfectly legible throughout the foreseeable useful life of  the 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 where the equipment is to be used. If PPE (or a PPE component) is too small to allow all or part of the necessary marking to be  affixed, the relevant information 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 visuallyPPE 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) judiciously positioned means of or devices for  emitting direct or reflected visible radiation of appropriate luminous intensity and photometric  and colorimetric properties. 2.14. 'Multi-risk' PPEAll 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). 3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS3.1. Protection against mechanical impact3.1.1. Impact caused by falling or projecting objects and collision of parts of the body with an  obstacleSuitable 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 or mass of the absorbing device would  preclude effective use of the PPE for the foreseeable period of wear. 3.1.2. Falls3.1.2.1. Prevention of falls due to slippingThe outsoles for footwear designed to prevent slipping must be  so designed, manufactured or equipped with added elements as to ensure satisfactory adhesion by  grip and friction having regard to the nature or state of the surface. 3.1.2.2. Prevention of falls from a heightPPE 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. It must be designed so that under the foreseeable conditions of use the vertical drop of the  user is minimized to prevent collision with obstacles and the braking force does not, however,  attain the threshold value at which physical injury or the tearing or rupture of any PPE component  which might cause the user to fall can be expected to occur. It must also ensure that after braking the user is maintained in a correct position in which he may  await help if necessary. The manufacturer's notes must specify in particular all relevant information relating to: - the characteristics required for the reliable anchorage point and the necessary minimum clearance  below the user, - the proper way of putting on the body harness and of connecting the attachment system to the  reliable anchorage point. 3.1.3. Mechanical vibrationPPE designed to prevent the effects of mechanical vibrations must be capable  of ensuring adequate attenuation of harmful vibration components for the part of the body at risk. 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 bodyPPE 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. 3.3. Protection against physical injury (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 foreseeable conditions of use. 3.4. Prevention of drowning (lifejackets, armbands and lifesaving suits)PPE designed to prevent  drowning must be capable of returning to the surface as quickly as possible, without danger to his  health, a user who may be exhausted or unconscious after falling into a liquid medium, and of  keeping him afloat in a position which permits breathing while awaiting help. PPE may be wholly or partially inherently buoyant or may be inflated either by gas which can be  manually or automatically released or orally. Under the foreseeable conditions of use: - PPE must, without prejudice to its satisfactory operation, be capable of withstanding the effects  of impact with the liquid medium and the environmental factors inherent in that medium, - inflatable PPE must be capable of inflating rapidly and fully. Where particular foreseeable conditions of use so require, certain types of PPE must also satisfy  one or more of the following additional requirements: - it must have all the inflation devices referred to in the second subparagraph, and/or a light or  sound-signalling device, - it must have a device for hitching and attaching the body so that the user may be lifted out of  the liquid medium, - it must be suitable for prolonged use throughout the period of activity exposing the user,  possibly dressed, to the risk of falling into the liquid medium or requiring his immersion in it. 3.4.1. Buoyancy aidsClothing which will ensure an effective degree of buoyancy, depending on its  foreseeable use, which is safe when worn and which affords positive support in water. In  foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must  enable him, in particular, to swim or take action to escape from danger or rescue other persons. 3.5. Protection against the harmful effects of noisePPE 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 by  Council Directive 86/188/EEC of 12 May 1986 on the protection of workers from the risks related to  exposure to noise at work (;). All PPE must bear labelling indicating the noise attenuation level and the value of the comfort  index provided by the PPE; should this not be possible, the labelling must be fixed to the  packaging. 3.6. Protection against heat and/or firePPE 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 foreseeable conditions of use. 3.6.1. PPE constituent materials and other componentsConstituent materials and other components suitable  for protection against radiant and convective heat must possess an appropriate coefficient of  transmission of incident heat flux and be sufficiently incombustible to preclude any risk of  spontaneous ignition under the foreseeable conditions of use. Where the outside of these materials and components must be reflective, its reflective power must  be appropriate to the intensity of the heat flux due to radiation in the infra-red range. Materials and other components of equipment intended for brief use in high-temperature environments  and of PPE which may be splashed by hot products such as large quantities of molten material must  also possess sufficient thermal capacity to retain most of the stored heat until after the user has  left the danger area and removed his PPE. PPE materials and other components which may be splashed by large amounts of hot products must also  possess sufficient mechanical-impact absorbency (see 3.1). PPE materials and other components which may accidentally come into contact with flame and those  used in the manufacture of fire-fighting 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. 3.6.2. Complete PPE ready for useUnder 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 if necessary prevent liquid or steam penetration and must not cause burns resulting  from 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 in particular provide all relevant data for the determination of the maximum  permissible user exposure to the heat transmitted by the equipment when used in accordance with its  intended purpose. 3.7. Protection against coldPPE 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. (;) OJ N° L 137, 24. 5. 1986, p. 28. 3.7.1. PPE constituent materials and other componentsConstituent materials and other components suitable  for protection against cold must possess a coefficient of transmission of incident thermal flux as  low as required under the foreseeable conditions of use. Flexible materials and other components of  PPE intended for use in a low-temperature environment must 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). 3.7.2. Complete PPE ready for useUnder 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 as far as possible prevent the penetration of such liquids as rain water and must not  cause injuries resulting from contact between its cold protective integument and the user. If PPE incorporates a breathing device, this must adequately fulfil the protective function  assigned to it under the 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. 3.8. Protection against electric shockPPE 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 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. 3.9. Radiation protection3.9.1. Non-ionizing radiationPPE 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 conditons 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. The relevant protection-factor number must be marked on all specimens of filtering glasses by the  manufacturer. 3.9.2. Ionizing radiation3.9.2.1. Protection against external radioactive contaminationPPE 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 under the foreseeable conditions of use. Depending on the nature or condition of these contaminants, the necessary leak-tightness can be  provided by the impermeability of the 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 possible re-use during  the foreseeable useful life of these classes of equipment. 3.9.2.2. Limited protection against external irradiationPPE 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 degree of user protection required by the foreseeable conditions  of use 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 foreseeable conditions of use. 3.10. Protection against dangerous substances and infective agents3.10.1. Respiratory protectionPPE 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 must be obtained by appropriate means, for  example 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. 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 keep contaminant penetration from a  polluted atmosphere low enough not to be prejudicial to the health or hygiene of 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 in the case of filtering devices, indicate the deadline for the  storage of filters as new and kept in their original packaging. 3.10.2. Protection against cutaneous and ocular contactPPE 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 integument under the  foreseeable conditions of use for which the PPE is placed on the market. 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 effeciency. 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. 3.11. Safety devices for diving equipment1.  Breathing equipmentThe breathing equipment must make it  possible to supply the user with a breathable gaseous mixture, under foreseeable conditions of use  and taking account in particular of the maximum depth of immersion. 2.  Where the foreseeable conditions of use so require, the equipment must comprise: (a)  a suit which protects the user against the pressure resulting from the depth of immersion(see  3.2) and/or against cold (see 3.7); (b)an alarm designed to give the user prompt warning of an approaching failure in the supply of  breathable gaseous mixture (see 2.8); (c)a life-saving suit enabling the user to return to the surface (see 3.4.1).ANNEX III TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER The documentation  referred to in Article 8 (1) must comprise all relevant data on the means used by the manufacturer  to ensure that a PPE complies with the basic requirements relating to it. In the case of PPE models referred to in Article 8 (2), the documentation must comprise in  particular: 1.  the manufacturer's technical file consisting of: (a)  overall and detailed plans of the PPE accompanied, where appropriate, by calculation notes and  the results of prototype tests in so far as necessary for the verification of compliance with the  basic requirements; (b)  an exhaustive list of the basic safety requirements and of the harmonized standards or other  technical specifications referred to in Articles 3 and 5, taken into account in the design of the  model; 2.  a description of the control and test facilities to be used in the manufacturer's plant to  check compliance of production PPE with the harmonized standards or other technical specifications  and to maintain quality level; 3.  a copy of the information notice referred to in Annex II, 1.4. ANNEX IV   EC MARK OF CONFORMITY The EC mark of conformity consists of the symbol shown  below. (¹)(²)The vertical dimensions of the different components of the EC mark must be perceptibly the  same and not less than 5 mm. (¹) As provided in Article 13 (1) the mark may also include the distinguishing number of the  approved inspection body referred to in Article 9 (1). (²) Year in which the mark was affixed. ANNEX V CONDITIONS TO BE FULFILLED BY THE BODIES OF WHICH NOTIFICATION HAS BEEN GIVEN  (Article 9 (2))The bodies designated by the Member States must fulfil the following minimum  conditions: 1.  availability of personnel and of the necessary means and equipment; 2.  technical competence and professional integrity of personnel; 3.  independence, in carrying out the tests, preparing the reports, issuing the certificates and  performing the surveillance provided for in the Directive, of staff and technical personnel in  relation to all circles, groups or persons directly or indirectly concerned with PPE; 4.  maintenance of professional secrecy by personnel; 5.  subscription of a civil liability insurance unless that liability is covered by the State under  national law. Fulfilment of the conditions under 1 and 2 shall be verified at intervals by the competent  authorities of the Member States. ANNEX VI MODEL EC DECLARATION OF CONFORMITY The manufacturer or his authorized  representative established in the Community (¹): . . . declares that the new PPE described hereafter (¹). . . . . is in conformity with the provisions of Council Directive 89/686/EEC and, where such is the case,  with the national standard transposing harmonized standard N° ............ (for the PPE referred to  in Article 8 (3))is identical to the PPE which is the subject of EC certificate of conformity N°  ............ issued by (³) (%) . . . is subject to the procedure set out in Article 11 point A or point B (%) of Directive 89/686/EEC  under the supervision of the notified body (³) . . . Done at ............................................, on . . Signature (¹)(¹) Business name and full address; authorized representatives must also give the  business name and address of the manufacturer. (²) Description of the PPE (make, type, serial number, etc.). (³) Name and address of the approved body. (%) Delete whichever is inapplicable. (¹) Name and position of the person empowered to sign on behalf of the manufacturer or his  authorized representative.