CELEX: 51989FC0686
Language: en
Date: 2007-02-16
Title: Proposal for a Directive …/…/EC of the European Parliament and of the Council of […] relating to personal protective equipment (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        COM(2008)

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                                    relating to personal protective equipment

                                                                (Codified version)

                                                              EXPLANATORY MEMORANDUM

1.    In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make  it
       clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the  specific  rights
       it gives him.

       This aim cannot be achieved so long as numerous provisions that have  been  amended  several  times,  often  quite  substantially,  remain
       scattered, so that they must be sought partly in the original instrument and partly in later amending ones.  Considerable  research  work,
       comparing many different instruments, is thus needed to identify the current rules.

       For this reason a codification of rules that have frequently been amended  is  also  essential  if  Community  law  is  to  be  clear  and
       transparent.

2.    On 1 April 1987 the Commission therefore decided[1] to instruct its staff that all legislative acts should be codified after no  more  than
       ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the
       texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

3.    The Conclusions of the Presidency of the Edinburgh  European  Council  (December 1992)  confirmed  this[2],  stressing  the  importance  of
       codification as it offers certainty as to the law applicable to a given matter at a given time.

       Codification must be undertaken in full compliance with the normal Community legislative procedure.

       Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council  and  the
       Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-
       track adoption of codification instruments.

4.    The purpose of this proposal is to undertake a codification of Council Directive 89/686/EEC of 21 December 1989  on  the  approximation  of
       the laws of the Member States relating to personal protective equipment[3]. The new Directive will supersede the various acts incorporated
       in it[4]; this proposal fully preserves the content of the acts being codified and hence does no more than bring them together  with  only
       such formal amendments as are required by the codification exercise itself.

5.    The codification proposal was drawn up on the basis of a preliminary consolidation, in all official languages, of Directive 89/686/EEC  and
       the instruments amending it, carried out by the Office for Official Publications  of  the  European  Communities,  by  means  of  a  data-
       processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table
       contained in Annex VIII to the codified Directive.

                                            ê 89/686/EEC (adapted)

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                                    relating to personal protective equipment

                                                            (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article  95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee[5],

Acting in accordance with the procedure laid down in Article 251 of the Treaty[6],

Whereas:

                                            ê

   1) Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member  States  relating  to  personal  protective
      equipment[7] has been substantially amended several times[8]. In the interests of clarity and rationality  the  said  Directive  should  be
      codified.

                                            ê 89/686/EEC Recitals 5 and 6 and 93/95/EEC Recital 4 (adapted)

   2) It is necessary Ö to adopt harmonized standards Õ Ö relating to personal protective equipment Õ in order to ensure  the  free  movement  of
      these products Ö and to facilitate their placing on the market Õ, without in any way  reducing  the  valid  levels  of  protection  already
      required in the Member States, and to provide for any necessary increase therein.

                                            ê 89/686/EEC Recital 7 (adapted)

   3) 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 Ö should be Õ without prejudice to provisions relating to  the  use  of  such
      equipment and the organisation of the health and safety of workers at the workplace.

                                            ê 89/686/EEC Recital 8 (adapted)

   4) This Directive Ö should Õ only Ö define Õ the basic requirements to be satisfied by personal protective equipment. In order  to  facilitate
      proof of conformity with those basic requirements, it is essential that harmonized standards be available Ö at Community level Õ  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. Such standards
      Ö harmonised at Community level Õ are drawn up by private bodies and Ö should Õ retain the status of non-mandatory texts. To this end,  the
      European Committee for Standardization (CEN) the European  Committee  for  Electrotechnical  Standardization  (Cenelec)  and  the  European
      Telecommunications Standards Institute (ETSI) are the competent bodies  which  have  been  authorized  to  adopt  harmonized  standards  in
      accordance with the general guidelines governing cooperation between the Commission, the European Free Trade Association (EFTA)  and  those
      Ö three bodies signed Õ on 28 March 2003[9].

                                            ê 89/686/EEC Recital 10

(5)   Given the general and horizontal nature of the role played by the Standing Committee set up pursuant to Article 5 of Directive 98/34/EC  of
      the European Parliament and of the Council of 22 June 1998 laying down a procedure for  the  provision  of  information  in  the  field  of
      technical standards and regulations and of rules on  Information  Society  services[10]  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.

                                            ê 93/68/EEC Recitals 1, 2 and 3 (adapted)

(6)   Ö The Council has adopted a series of Directives designed to  remove  technical  barriers  to  trade  in  accordance  with  the  principles
      established in its Resolution of 7 May 1985 on a new approach to technical  harmonization  and  standards[11];  each  of  these  Directives
      provides for the affixing of the 'CE' marking. The Commission, in its communication of 15 June 1989 on a global approach  to  certification
      and testing[12], proposed that common rules be drawn up concerning a 'CE' conformity marking with a single  design.  The  Council,  in  its
      Resolution of 21 December 1989 on a global approach to conformity assessment[13], approved  as  a  guiding  principle  the  adoption  of  a
      consistent approach such as this with regard to the use of the 'CE' marking. Õ The two basic elements of the new approach which  Ö should Õ
      be applied are the essential requirements and the conformity assessment procedures.

                                            ê 89/686/EEC Recital 11 (adapted)

(7)   Compliance with these technical requirements Ö should Õ be monitored in order to ensure adequate user and third-party protection.  Existing
      monitoring procedures may differ appreciably from one Member State to another. 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. 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.

                                            ê 89/686/EEC Recital 12

(8)   The legislative framework should be improved so that both sides of industry will make an effective  and  appropriate  contribution  to  the
      process of standardization.

                                            ê

(9)   The measures necessary for the implementation of this Directive should be adopted in accordance with Council  Decision  1999/468/EC  of  28
      June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[14].

(10)  This Directive should be without prejudice to the obligations of the Member States  relating  to  the  time-limits  for  transposition  and
      application into national law of the Directives set out in Annex VII, Part B,

                                            ê 89/686/EEC

HAVE ADOPTED THIS DIRECTIVE:

                                                                    CHAPTER I

                                            ê 89/686/EEC (adapted)

                                         SCOPE, Ö DEFINITIONS, Õ PLACING ON THE MARKET AND FREE MOVEMENT

                                            ê 89/686/EEC

                                                                    Article 1

1. This Directive applies to personal protective equipment, hereinafter referred to as ‘PPE’.

It lays down the conditions governing its placing on the market and free movement within the Community and the basic  safety  requirements  which
PPE must satisfy in order to ensure the health protection and safety of users.

                                            ê 89/686/EEC Article 2(2)

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.

                                            ê 89/686/EEC Article 1(4)

3. This Directive does not apply to:

(a)   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;

                                            ê 89/686/EEC Article 1(4) (adapted)

(b)   the PPE classes specified in the list of excluded Ö classes Õ in Annex I, independently of the reason  for  exclusion  mentioned  in  point
       (a).

                                            ê 89/686/EEC Article 1(2) and (3)

                                                                    Article 2

1. 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 equipment worn or held by  an  individual
       for the execution of a specific activity;

(c)   interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

2. 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.

                                            ê 89/686/EEC Recital 8, last sentence (adapted)

3. For the purposes of this Directive, a harmonized standard is a technical specifications (a European  standard  or  a  harmonization  document)
adopted by Ö the European Committee for Standardization (CEN), the European Committee  for  Electrotechnical  Standardization  (Cenelec)  or  the
European Telecommunications Standards Institute (ETSI) or by two or three of those bodies upon a remit from Õ the Commission in  accordance  with
Directive 98/34/EC and pursuant to the general guidelines Ö for cooperation between the Commission, the European Free  Trade  Association  (EFTA)
and those three bodies signed on 28 March 2003 Õ.

                                            ê 89/686/EEC

                                                                    Article 3

1. Member States shall take all appropriate measures to ensure that the PPE referred to in Article 1 may be placed  on  the  market  and  brought
into service only if it preserves the health and ensures the safety of users without prejudice to the health  or  safety  of  other  individuals,
domestic animals or goods, when properly maintained and used for its intended purpose.

2. 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 4

The PPE must satisfy the basic health and safety requirements laid down in Annex II.

                                                                    Article 5

                                            ê 93/68/EEC Art. 7 pt. 2 (adapted)

1. Member States may not prohibit, restrict or hinder the placing on the market of PPE or PPE components which  comply  with  the  provisions  of
this Directive, including the certification procedures in Chapter II.

                                            ê 89/686/EEC (adapted)
                                            è1 93/68/EEC Art. 7 pt.

2. Member States shall not prohibit, restrict or Ö hinder Õ the placing on the market of PPE components which do not bear  the  è1 CE  marking ç,
and which are intended to be incorporated in PPE, provided that they are not essential to its satisfactory functioning.

                                                                    Article 6

1. Member States shall regard as in conformity with the basic requirements Ö laid down in Annex  II Õ  the  PPE  referred  to  in  Article  10(3)
bearing the è1 CE marking ç with respect to which the manufacturer is able to produce, on demand, the declaration of conformity  referred  to  in
Article 16.

2. Member States shall presume that the PPE referred to in Article 10(2) satisfies the basic requirements Ö laid down in Annex II  Õ if it  bears
the è1 CE marking ç with respect to which the manufacturer is able to produce, on demand, not only the declaration referred to in Article 16  but
also the certificate issued by the body of which notification has been given in accordance with Article 11  attesting  their  conformity  to  the
relevant national standards, transposing the harmonized standards, assessed at the EC  type  examination  level  in  accordance  with  the  first
subparagraph of Article 12(5) and the first subparagraph of Article 12 (6).

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 Ö notified Õ body must state the conformity to the basic requirements in accordance with the second subparagraph  of  Article 12(5)
and the third subparagraph of Article 12(6).

                                            ê 89/686/EEC

3. The Commission shall publish the references of the harmonized standards in the Official Journal of the European Union.

Member States shall publish the references of the national standards transposing the harmonized standards.

4. 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.

                                            ê 93/68/EEC Art. 7 pt. 3

5. Where the PPE is subject to other Directives concerning other aspects and which also provide for the affixing of the CE  marking,  the  latter
shall indicate that the PPE is also presumed to conform to the provisions of the other Directives.

However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to  apply,  the
CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this  case,  particulars  of  the
Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions  required
by the Directives and accompanying such PPE.

                                            ê 89/686/EEC (adapted)

                                                                    Article 7

Should a Member State or the Commission consider that the harmonized standards referred to in Article 6 do not completely  satisfy  the  relevant
basic requirements Ö laid down Õ in Annex II , the Commission or the Member State concerned shall refer  the  matter  to  the  committee  created
pursuant to Ö Article 5 of Õ Directive 98/34/EC, setting out its reasons.

                                            ê 89/686/EEC

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 6(3).

                                            ê 1882/2003 Art. 1 and Annex I pt. 1

                                                                    Article 8

1. The Commission shall be assisted by the Standing Committee, set up by Article 6(2) of Directive 98/37/EC of the  European  Parliament  and  of
the Council[15], hereinafter referred to as ‘the Committee’.

It may be appraised, in accordance with the procedure referred to in paragraph 2, of  any  matter  to  which  the  implementation  and  practical
application of this Directive give rise.

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article  8
thereof.

3. The Committee shall adopt its rules of procedure.

                                            ê 89/686/EEC
                                            è1 93/68/EEC Art. 7 pt. 1

                                                                    Article 9

1. If a Member State discovers that PPE bearing the è1 CE marking çand 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:

                                            ê 89/686/EEC (adapted)

(a)   failure to comply with the basic requirements Ö laid down Õ in Annex II;

(b)   the unsatisfactory application of the Ö harmonised Õ standards referred to in Article 6;

(c)   a shortcoming in the Ö harmonised Õ standards referred to in Article 6.

                                            ê 89/686/EEC

2. The Commission shall initiate discussions with the parties concerned as soon as possible. If, after such consultation, the Commission  decides
that the action taken was justified, it shall immediately inform the Member State concerned and all the other Member States to 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.

                                            ê 89/686/EEC (adapted)
                                            è1 93/68/EEC Art. 7 pt. 1

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 Ö created pursuant to Article 5 of Directive 98/34/EC Õ if the Member State concerned intends to  adhere  to  its  decision  and  shall
initiate the procedure referred to in Article 8(2).

3. If PPE which is not in conformity with the relevant requirements bears  the  è1 CE marking ç,  the  Member  State  concerned  shall  take  the
appropriate measures with regard to those responsible for affixing the mark  and  shall  inform  the  Commission  and  the  other  Member  States
accordingly.

4. The Commission shall ensure that the Member States are kept informed of the progress and  results  of  the  procedure  provided  for  in  this
Article.

                                                                    CHAPTER II

                                                                  CERTIFICATION

                                                                    Section 1

                                                             CERTIFICATION PROCEDURES

                                                                    Article 10

1. 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 12.

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:

(a)   mechanical action whose effects are superficial (gardening gloves, thimbles, etc.);

(b)   cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.);

(c)   risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to  dangerous  impacts
       (gloves, aprons for professional use, etc.);

(d)   atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.);

(e)   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.);

(f)   sunlight (sunglasses).

4. 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, production of PPE  shall,  according
to the manufacturer's choice, be subject to one of the two procedures referred to in Articles 13 and 14.

This category shall cover exclusively:

(a)   filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic gases;

(b)   respiratory protection devices providing full insulation from the atmosphere, including those for use in diving;

(c)   PPE providing only limited protection against chemical attack or against ionizing radiation;

(d)   emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature  of  100 °C
       or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection  of  large  amounts  of
       molten material;

(e)   emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air  temperature  of  -50 °C
       or less;

(f)   PPE to protect against falls from a height;

(g)   PPE against electrical risks and dangerous voltages or that used as insulation in high-tension work.

                                            ê 89/686/EEC (adapted)

5. Ö Production of all PPE shall be subject to Õ the EC declaration of conformity referred to in Article 16 for all PPE.

                                            ê 89/686/EEC

                                                                    Article 11

                                            ê 93/68/EEC Art. 7 pt. 4

1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed  to  carry  out  the  procedures
referred to in Article 10 together with the specific tasks which these bodies have been appointed to carry out  and  the  identification  numbers
assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Union a list of the notified bodies and  their  identification  numbers  and
the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

                                            ê 89/686/EEC

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.

                                                                    Section 2

                                                               EC TYPE-EXAMINATION

                                                                    Article 12

1. 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:

(a)   the name and address of the manufacturer or his authorized representative and of the PPE production plant in question;

(b)   the manufacturer's technical file referred to in Annex III.

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

                                            ê 89/686/EEC (adapted)

4. The Ö notified Õ body shall conduct the EC type-examination in accordance with Ö paragraphs 5 and 6 Õ.

5. Ö In the context of Õ examination of the manufacturer's technical file, Ö the  notified  body Õ  shall  examine  the  file  to  establish  its
suitability with respect to the harmonized standards referred to in Article 6.

Where a manufacturer has not applied, or has only  partly  applied,  the  harmonized  standards  or  where  there  are  no  such  standards,  the
Ö notified Õ body 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.

6. Ö In the context of Õ examination of 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.

                                            ê 89/686/EEC

It shall conduct the necessary examinations and tests to establish the conformity of the model with the harmonized standards.

                                            ê 89/686/EEC (adapted)

Where a manufacturer has not applied or has only partly applied the harmonized standards or where there are no such  standards  the  Ö notified Õ
body 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.

                                            ê 89/686/EEC

7. 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.

8. 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.

                                                                    Section 3

                                                           CHECKING OF PPE MANUFACTURED

                                                                    Article 13

                                            ê 89/686/EEC (adapted)

1. Ö In order to carry out an Õ ‘EC’ quality control system for the final product 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 Ö notified Õ body, 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 Ö notified Õ body 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 Ö notified Õ  body  in  the  event  of
difficulties in connection with the assessment of the conformity of samples.

5. The Ö notified Õ body 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 EC type-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 Ö notified Õ body.

                                                                    Article 14

1. Ö In order to ensure EC quality of production, Õ the manufacturer Ö shall Õ submits an application for the  approval  of  his  quality-control
system to a Ö notified Õ body of his choice.

                                            ê 89/686/EEC (adapted)

That application shall include:

(a)   all the information relating to the category of PPE concerned, including, where appropriate, documentation relating to the model approved;

(b)   documentation on the quality-control system;

(c)   the undertaking to maintain the obligations arising from the quality-control system and to maintain its adequacy and efficiency.

2. Under the quality-control system, each PPE shall be examined and the appropriate tests referred to in Article 13(3) shall be  carried  out  to
check their conformity to the relevant basic requirements of this Directive.

3. The documentation on the quality-control system shall in particular include an adequate description of:

(a)   the quality objectives, the organization chart, the responsibilities of executives and their powers in respect of product quality;

(b)   the checks and tests which must be carried out after manufacture;

(c)   the means to be employed to check the efficient operation of the quality-control system.

4. The body shall assess the quality-control system to determine whether it satisfies the provisions referred to in paragraph 2. 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.

5. 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.

                                            ê 89/686/EEC (adapted)

                                                                    Article 15

1. The purpose of supervision is to ensure that a manufacturer correctly fulfils  the  obligations  arising  from  the  approved  quality-control
system.

                                            ê 89/686/EEC

2. 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:

(a)   documentation on the quality-control system;

(b)   technical documentation;

(c)   quality control manuals.

3. 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.

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.

                                            ê 89/686/EEC (adapted)

4. The manufacturer must be able to present, on request, the report of the Ö notified Õ body.

                                            ê 89/686/EEC

                                                                   CHAPTER III

                                                     EC DECLARATION OF PRODUCTION CONFORMITY

                                                                    Article 16

                                            ê 93/68/EEC Art. 7 pt. 5

The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established within the Community:

                                            ê 89/686/EEC
                                            è1 93/68/EEC Art. 7 pt. 1

(a)   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;

(b)   affixes the è1 CE conformity marking ç provided for by Article 17 to each PPE.

                                            ê 89/686/EEC

                                                                    CHAPTER IV

                                            ê 93/68/EEC Art. 7 pt. 1 (adapted)

                                                            CE Ö CONFORMITY Õ MARKING

                                            ê 93/68/EEC Art. 7 pt. 6

                                                                    Article 17

1. The CE conformity marking shall consist of the initials ‘CE’ in the form shown in the specimen in Annex IV.

In the event of the involvement of a notified body in the production control phase as indicated in Articles 13, 14  and  15,  its  identification
number shall be added.

2. The CE marking must be affixed to each piece of manufactured PPE so as to be visible, legible and indelible throughout the  expected  life  of
the PPE. However, if this is not possible in view of the characteristics of the product, the CE marking may be affixed to the packaging.

3. The affixing of markings on the PPE which are likely to deceive third parties as  to  the  meaning  and  form  of  the  CE  marking  shall  be
prohibited. Any other marking may be affixed to the PPE or its packaging provided that the visibility and legibility of the  CE  marking  is  not
thereby reduced.

4. Without prejudice to Article 9, where a Member State establishes that the CE  marking  has  been  affixed  unduly,  the  manufacturer  or  his
authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning  the
CE marking and to end the infringement under the conditions imposed by the Member State.

Where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing  on  the  market  of  the
product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 9.

                                            ê 89/686/EEC

                                                                    CHAPTER V

                                                                 FINAL PROVISIONS

                                                                    Article 18

Any 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 19

The 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.

                                            ê 93/95/EEC Art. 1 pt. 3 (adapted)

                                                                    Article 20

Member States shall communicate to the Commission the texts of the Ö main Õ provisions of national law which they adopt in the field governed  by
this Directive.

                                            ê

                                                                    Article 21

Directive 89/686/EEC, as amended by the acts listed in Annex VII, Part A, is repealed, without prejudice to the obligations of the Member  States
relating to the time-limits for transposition and application into national law of the Directives set out in Annex VII, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read  in  accordance  with  the  correlation
table in Annex VIII.

                                                                    Article 22

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

                                            ê 89/686/EEC

                                                                    Article 23

This Directive is addressed to the Member States.

                                            ê

Done at Brussels, […]

For the European Parliament  For the Council
The President    The President
[…]   […]

                                            ê 89/686/EEC

                                                                     ANNEX I

                                           EXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THIS DIRECTIVE

                                            ê 89/686/EEC (adapted)

                                                       Ö (Referred to in Article 1(3)(b)) Õ

                                            ê 89/686/EEC

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.

                                            ê 93/95/EEC Art. 1 pt. 4

5.    Helmets and visors intended for users of two- or three-wheeled motor vehicles.

                                                              ______________________

                                            ê 89/686/EEC

                                                                     ANNEX II

                                                       BASIC HEALTH AND SAFETY REQUIREMENTS

                                            ê 89/686/EEC (adapted)

                                                          Ö (Referred to in Article 4) Õ

                                            ê 89/686/EEC

1.    GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

      PPE must provide adequate protection against all risks encountered.

1.1.  Design principles

1.1.1.      Ergonomics

      PPE 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 possible level.

1.1.2.      Levels and classes of protection

1.1.2.1.    Highest level of protection possible

      The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing  of  the
       PPE would prevent its effective use during the period of exposure to the risk or normal performance of the activity.

1.1.2.2.    Classes of protection appropriate to different levels of risk

      Where 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 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 under foreseeable conditions of use.

1.2.1.1.    Suitable constituent materials

      PPE materials and parts, including any of their decomposition products, must not adversely affect user hygiene or health.

1.2.1.2.    Satisfactory surface condition of all PPE parts in contact with the user

      Any PPE part in contact or in potential contact with the user when such  equipment  is  worn  must  be  free  of  roughness,  sharp  edges,
       projections and the like which could cause excessive irritation or injuries.

1.2.1.3.    Maximum permissible user impediment

      Any impediment caused by PPE to movements to be made, postures to be adopted and sensory perception must be minimized; nor must  PPE  cause
       movements which endanger the user or other persons.

1.3.  Comfort and efficiency

1.3.1.      Adaptation of PPE to user morphology

      PPE must be so designed and manufactured as to facilitate correct positioning on the user and  to  remain  in  place  for  the  foreseeable
       period of use, bearing in mind ambient factors, movements to be made and postures to be adopted. For this purpose, it must be possible  to
       optimize PPE adaptation to user morphology by all appropriate means, such as adequate adjustment and attachment systems or  the  provision
       of an adequate size range.

1.3.2.      Lightness and design strength

      PPE 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 point 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 use

      If 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 manufacturer

      In 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 point 2.12).

                                            ê 93/68/EEC Art. 7 pt. 7

       (h)  where appropriate, the references of the Directives applied in accordance with the second subparagraph of Article 6(5);

       (i)  the name, address and identification number of the notified body involved in the design stage of the PPE.

                                            ê 89/686/EEC

      These notes, which must be precise and comprehensible, must be provided at least in  the  official  language(s)  of  the  Member  State  of
       destination.

2.    ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE

2.1.  PPE incorporating adjustment systems

      If PPE incorporates adjustment systems, the latter must be so designed and manufactured as 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 protected

      As 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 tracts

      Any 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 ageing

      If 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 use

      Where 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 atmospheres

      PPE 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 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 very dangerous situations

      The information notes supplied by the manufacturer together with PPE for use in the very dangerous situations  referred  to  in  the  first
       subparagraph of Article 10(4) 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 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 adjustment, attachment and removal without tools.

2.10. PPE for connection to another, external complementary device

      If 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 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
       foreseeable conditions of use.

2.12. PPE bearing one or more identification or recognition marks directly or indirectly relating to health and safety

      The 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 visually

      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) 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’ 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 point 3).

3.    ADDITIONAL REQUIREMENTS SPECIFIC TO 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 or  mass  of  the  absorbing
       device would preclude effective use of the PPE for the foreseeable period of wear.

3.1.2.      Falls

3.1.2.1.    Prevention of falls due to slipping

      The outsoles 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 height

      PPE designed to prevent falls from a height or their effects must incorporate a  body  harness  and  an  attachment  system  which  can  be
       connected to a reliable anchorage point. 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 vibration

      PPE 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 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.

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 point 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 aids

      Clothing 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 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  by  Directive  2003/10/EC  of  the
       European Parliament and of the Council[16].

      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 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 foreseeable conditions of use.

3.6.1.      PPE constituent materials and other components

      Constituent 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 point 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 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 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 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.

3.7.1.      PPE constituent materials and other components

      Constituent 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 point 3.1).

3.7.2.      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 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 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.

3.9.  Radiation protection

3.9.1.      Non-ionizing radiation

      PPE designed to prevent acute or chronic eye-damage from sources of non-ionizing radiation must be capable of absorbing or  reflecting  the
       majority of the energy radiated in the harmful wavelengths without unduly affecting the transmission of the innocuous part of the  visible
       spectrum, the perception of contrasts and the ability to distinguish colours where required by the foreseeable conditions of use.

      To this end, protective glasses must be so designed and manufactured as to possess, for each harmful wave, a spectral  transmission  factor
       such that the radiant-energy illumination density capable of reaching the user's eye  through  the  filter  is  minimized  and,  under  no
       circumstances, exceeds the maximum permissible exposure value.

      Furthermore, the glasses must not deteriorate or lose their properties  as  a  result  of  the  effects  of  radiation  emitted  under  the
       foreseeable conditions of use and all marketed specimens must bear the protection-factor number corresponding to the spectral distribution
       curve of their transmission factor.

      Glasses suitable for radiation sources of the same type must be classified in the ascending order  of  their  protection  factors  and  the
       manufacturer's notes must indicate, in particular, the transmission curves which make it possible  to  select  the  most  appropriate  PPE
       bearing in mind such inherent factors of the effective conditions of use as distance to source and the spectral distribution of the energy
       radiated at that distance.

      The relevant protection-factor number must be marked on all specimens of filtering glasses by the manufacturer.

3.9.2.      Ionizing radiation

3.9.2.1.    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 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 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
       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 point 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 agents

3.10.1.     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 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 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 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 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.

3.11. Safety devices for diving equipment

       1.   Breathing equipment

            The 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 point 3.2) and/or  against  cold
                (see point 3.7);

           (b)   an alarm designed to give the user prompt warning of an approaching failure in the supply of breathable  gaseous  mixture  (see
                point 2.8);

           (c)   a life-saving suit enabling the user to return to the surface (see point 3.4.1).

                                                             ________________________

                                            ê 89/686/EEC

                                                                    ANNEX III

                                               TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER

                                            ê 89/686/EEC (adapted)

                                                        Ö (Referred to in Article 10(1)) Õ

                                            ê 89/686/EEC

The documentation referred to in Article 10(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 10(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;

                                            ê 89/686/EEC (adapted)

       (b)  an exhaustive list of the basic Öhealth and Õ safety requirements and of the harmonized standards or other  technical  specifications
           referred to in Articles 4 and 6, taken into account in the design of the model;

                                            ê 89/686/EEC

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, point 1.4.

                                                           ___________________________

                                            ê 93/68/EEC Art. 7 pt. 8

                                                                     ANNEX IV

                                                      CE CONFORMITY MARKING AND INFORMATION

                                            ê 93/68/EEC Art. 7 pt.8 (adapted)

                                                         Ö (Referred to in Article 17) Õ

                                            ê 93/68/EEC Art. 7 pt.8

The CE conformity marking shall consist of the initials ‘CE’ taking the following form:

                                                                      [pic]

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be  less  than  5  mm.  This  minimum
dimension may be waived for small-scale PPE.

                                                               ___________________

                                            ê 89/686/EEC

                                                                     ANNEX V

                                            ê 89/686/EEC (adapted)

                                              CONDITIONS TO BE FULFILLED BY THE Ö NOTIFIED Õ BODIES

                                            ê 89/686/EEC

                                                          (Referred to in Article 11(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
       this 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 points 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([17]):

.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
..................................................................................................

declares that the new PPE described hereafter([18]):

.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
..................................

is in conformity with the provisions of the Directive .../.../EC of the European Parliament and of the Council and, where such is the case, with
the national standard transposing harmonized standard No ......... (for the PPE referred to in Article 10(2))

.is identical to the PPE which is the subject of EC certificate of conformity No ........ issued by([19])([20])

.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................

is subject to the procedure set out in Article 13 or Article 144 of Directive .../.../EC of the European Parliament and of the Council under the
supervision of the notified body(3)
.................................................................................................................................................
.................................................................................................................................................
.................................................................................................................................................
.................

.

Done at ..................................., on ..................................................

.

                                                                                                    .............................................
                                                                                                                                  Signature([21])

.

                                                                 _______________

                                            é

                                                                    ANNEX VII

                                                                      Part A

                                            Repealed Directive with list of its successive amendments
                                                           (referred to in Article 21)

|Council Directive 89/686/EEC                                       |                                                                   |
|(OJ L 399, 30.12.1989, p. 18)                                      |                                                                   |
|Council Directive 93/68/EEC                                         |Article 7 only                                               |
|(OJ L 220, 30.8.1993, p. 1)                                         |                                                             |
|Council Directive 93/95/EEC                                         |                                                             |
|(OJ L 276, 9.11.1993, p. 11)                                        |                                                             |
|Directive 96/58/EC of the European Parliament and of the Council    |                                                             |
|(OJ L 236, 18.9.1996, p. 44)                                        |                                                             |
|Regulation (EC) No 1882/2003 of the European Parliament and of the  |Article 1 and Annex I, pt. 1 only                            |
|Council                                                             |                                                             |
|(OJ L 284, 31.10.2003, p. 1)                                        |                                                             |

                                                                      Part B

                                     List of time-limits for transposition into national law and application
                                                           (referred to in Article 21)

|Directive                                   |Time-limit for transposition                |Date of application                         |
|89/686/EEC                                  |30.12.1991                                  |1.7.1992[22]                                |
|93/68/EEC                                   |30.6.1994                                   |1.1.1995[23]                                |
|93/95/EEC                                   |29.1.1994                                   |_                                           |
|96/58/EC                                    |31.12.1996                                  |1.1.1997                                    |

                                                                _________________

                                                                    ANNEX VIII

                                                                Correlation table

|Directive 89/686/EEC                                               |This Directive                                                     |
|Recital 8 last sentence                                            |Article 2(3)                                                       |
|Article 1(1)                                                       |Article 1(1)                                                       |
|Article 1(2)                                                       |Article 2(1)                                                       |
|Article 1(3)                                                       |Article 2(2)                                                       |
|Article 1(4) introductory wording                                  |Article 1(3) introductory wording                                  |
|Article 1(4) first and second indents                              |Article 1(3)(a) and (b)                                            |
|Article 2(1)                                                       |Article 3(1)                                                       |
|Article 2(2)                                                       |Article 1(2)                                                       |
|Article 2(3)                                                       |Article 3(2)                                                       |
|Article 3                                                          |Article 4                                                          |
|Article 4                                                          |Article 5                                                          |
|Article 5(1) and (2)                                               |Article 6(1) and (2)                                               |
|Article 5(4)                                                       |Article 6(3)                                                       |
|Article 5(5)                                                       |Article 6(4)                                                       |
|Article 5(6)(a)                                                    |Article 6(5) first subparagraph                                    |
|Article 5(6)(b)                                                    |Article 6(5) second subparagraph                                   |
|Article 6(1) first subparagraph, first sentence                    |Article 7 first paragraph                                          |
|Article 6(1) first subparagraph, final sentence                    |Article 7 second paragraph                                         |
|Article 6(1) second subparagraph                                   |Article 7 third paragraph                                          |
|Article 6(2) first and second subparagraphs                        |Article 8(1)                                                       |
|Article 6(2) third subparagraph                                    |Article 8(2)                                                       |
|Article 6(2) fourth subparagraph                                   |Article 8(3)                                                       |
|Article 7 paragraph 1                                              |Article 9 (1)                                                      |
|Article 7(2) first, second and third sentence                      |Article 9(2)first subparagraph                                     |
|Article 7(2) fourth sentence                                       |Article 9(2)second subparagraph                                    |
|Article 7(3) and (4)                                               |Article 9(3) and (4)                                               |
|Article 8(1) and (2)                                               |Article 10(1) and (2)                                              |
|Article 8(3) first subparagraph                                    |Article 10(3) first subparagraph                                   |
|Article 8(3) second subparagraph, introductory sentence            |Article 10(3) second subparagraph, introductory sentence           |
|Article 8(3) second subparagraph, first to sixth indents           |Article 10(3) second subparagraph, points (a) to (f)               |
|Article 8(4) introductory wording and 8(4)(a) first sentence       |Article 10(4) first subparagraph                                   |
|Article 8(4)(a) final sentence                                     |Article 10(4) second subparagraph, introductory wording            |
|Article 8(4)(a) first to seventh indents                           |Article 10(4) second subparagraph, points (a) to (g)               |
|Article 8(4)(b)                                                    |Article 10(5)                                                      |
|Article 9                                                          |Article 11                                                         |
|Article 10(1) and (2)                                              |Article 12(1) and (2)                                              |
|Article 10(3) first subparagraph introductory wording              |Article 12(3) first subparagraph introductory wording              |
|Article 10(3) first subparagraph first and second indents          |Article 12(3) first subparagraph (a) and (b)                       |
|Article 10(3second subparagraph                                    |Article 12(3) second subparagraph                                  |
|Article 10(4) introductory wording                                 |Article 12(4)                                                      |
|Article 10(4)(a) introductory wording, first indent                |Article 12(5) first subparagraph                                   |
|Article 10(4)(a) second indent                                     |Article 12(5) second subparagraph                                  |
|Article 10(4)(b) introductory wording, first indent                |Article 12(6) first subparagraph                                   |
|Article 10(4)(b) second indent                                     |Article 12(6) second subparagraph                                  |
|Article 10(4)(b) third indent                                      |Article 12(6) third subparagraph                                   |
|Article 10(5)                                                      |Article 12(7)                                                      |
|Article 10(6)                                                      |Article 12(8)                                                      |
|Article 11 A (1) to (6)                                            |Article 13(1) to (6)                                               |
|Article 11 B(1)(a) first subparagraph                              |Article 14(1) first subparagraph                                   |
|Article 11 B(1)(a) second subparagraph, introductory wording       |Article 14(1) second subparagraph, introductory wording            |
|Article 11 B(1)(a) second subparagraph, first, second and third    |Article 14(1) second subparagraph, points (a), (b) and (c)         |
|indents                                                            |                                                                   |
|Article 11 B(1)(b) first subparagraph                              |Article 14(2)                                                      |
|Article 11 B(1)(b) second subparagraph, introductory wording       |Article 14(3) introductory wording                                 |
|Article 11 B(1)(b) second subparagraph, first, second and third    |Article 14(3)(a), (b) and (c)                                      |
|indents                                                            |                                                                   |
|Article 11 B(1)(c)                                                 |Article 14(4)                                                      |
|Article 11 B(1)(d)                                                 |Article 14(5)                                                      |
|Article 11 B(2)(a)                                                 |Article 15(1)                                                      |
|Article 11 B(2)(b) introductory wording                            |Article 15(2) introductory wording                                 |
|Article 11 B(2)(b) first, second and third indents                 |Article 15(2)(a), (b) and (c)                                      |
|Article 11 B(2)(c)                                                 |Article 15(3) first subparagraph                                   |
|Article 11 B(2)(d)                                                 |Article 15(3) second subparagraph                                  |
|Article 11 B(2)(e)                                                 |Article 15(4)                                                      |
|Article 12 introductory wording                                    |Article 16 introductory wording                                    |
|Article 12 points 1 and 2                                          |Article 16 points (a) and (b)                                      |
|Article 13(1) first sentence                                       |Article 17(1) first subparagraph                                   |
|Article 13(1) second sentence                                      |Article 17(1) second subparagraph                                  |
|Article 13(2)                                                      |Article 17(2)                                                      |
|Article 13(3)                                                      |Article 17(3)                                                      |
|Article 13(4) introductory wording and 13(4)(a)                    |Article 17(4) first subparagraph                                   |
|Article 13(4)(b)                                                   |Article 17(4) second subparagraph                                  |
|Article 14                                                         |Article 18                                                         |
|Article 15                                                         |Article 19                                                         |
|Article 16(1)                                                      |_                                                                  |
|Article 16(2)                                                      |_                                                                  |
|Article 16(3)                                                      |Article 20                                                         |
|_                                                                  |Article 21                                                         |
|_                                                                  |Article 22                                                         |
|Article 17                                                         |Article 23                                                         |
|Annexes I – VI                                                     |Annexes I – VI                                                     |
|_                                                                  |Annex VII                                                          |
|_                                                                  |Annex VIII                                                         |

                                                            _________________________

                                                             -----------------------
[1]   COM(87) 868 PV.
[2]   See Annex 3 to Part A of the Conclusions.
[3]   Carried out pursuant to the Communication from the Commission to the European Parliament and the  Council  –  Codification  of  the  Acquis
      communautaire, COM(2001) 645 final.
[4]   See Annex VII, Part A of this proposal.
[5]   OJ C [...], [...], p. [...].
[6]   OJ C [...], [...], p. [...].
[7]   OJ L 399, 30.12.1989, p. 18. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ  L
      284, 31.10.2003, p. 1).
[8]   See Annex VII, Part A.
[9]   OJ C 91, 16.4.2003, p. 7
[10]  OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).
[11]  OJ C 136, 4.6.1985, p. 1
[12]  OJ C 231, 8.9.1989, p. 3 and OJ C 267, 19.10.1989, p. 3
[13]  OJ C 10, 16.1.1990, p. 1
[14]  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
[15]  OJ L 207, 23.7.1998, p. 1.
[16]  OJ L 42, 15.2.2003, p. 38.
[17]  Business name and full address, authorized representatives must also give the business name and address of the manufacturer,
[18]  Description of the PPE (make, type, serial number, etc.).
[19]  Name and address of the approved body,
[20]  Delete whichever is inapplicable,
[21]  Name and fonction of the person empowered to sign on behalf of the manufacturer or his authorized representative.
[22]  According to Article 16(2) of Directive 89/686/EEC, "Member States shall allow, for the period until 30  June  1995,  the  placing  on  the
      market and putting into service on PPE in conformity with the national regulations in force in their territory on 30 June 1992".
[23]  According to Article 14(2) of Directive 93/68/EEC, "until 1 January 1997 Member States shall allow  the  placing  on  the  market  and  the
      bringing into service of products which comply with the marking arrangements in force before 1 January 1995".