The Personal Protective Equipment (EC Directive) Regulations 1992

1. Introductory Text

2. 1. Citation and commencement

3. 2. Interpretation

4. 3. Scope, Placing on the Market and Free Movement

5. 4. Certification and Monitoring Procedures

6. Signature

7. 1. SCHEDULE

      COUNCIL DIRECTIVE

      1. of 21 December 1989

      2. on the approximation of the laws of the Member States...

      3. (89/686/EEC)

      4. The Council of the European Communities,

      5. Having regard to the Treaty establishing the European Economic Community,...

      6. Having regard to the proposal from the Commission,

      7. In co-operation with the European Parliament

      8. Having regard to the opinion of the Economic and Social...

      9. Whereas it is necessary to adopt measures with the aim...

      10. Whereas various Member States have, over recent years, adopted provisions...

      11. Whereas these national provisions are often very detailed as regards...

      12. Whereas, in particular, the national provisions relating to safety at...

      13. Whereas national provisions relating to personal protective equipment differ significantly...

      14. Whereas it is necessary to harmonize these different national provisions...

      15. Whereas the provisions governing the design and manufacture of personal...

      16. Whereas this Directive defines only the basic requirements to be...

      17. Whereas, pending the adoption of harmonized standards, which will be...

      18. Whereas, given the general and horizontal nature of the role...

      19. Whereas compliance with these technical requirements must be monitored in...

      20. Whereas the legislative framework should be improved so that both...

      21. HAS ADOPTED THIS DIRECTIVE:

      22. CHAPTER I SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

          1. Article 1

             1. 1. This Directive applies to personal protective equipment, hereinafter referred to...

             2. 2. For the purposes of this Directive, PPE shall mean any...

             3. 3. Any system placed on the market in conjunction with PPE...

             4. 4. This Directive does not apply to: PPE covered by another...

          2. Article 2

             1. 1. Member States shall take all appropriate measures to ensure that...

             2. 2. This Directive shall be without prejudice to the right of...

             3. 3. Member States shall not prevent the presentation at trade fairs,...

          3. Article 3

             1. The PPE referred to in Article 1 must satisfy the...

          4. Article 4

             1. 1. Member States shall not prohibit, restrict or hinder the placing...

             2. 2. Member States shall not prohibit, restrict or impede the placing...

          5. Article 5

             1. 1. Member States shall regard as in conformity with the basic...

             2. 2. Member States shall presume that the PPE referred to in...

             3. 3. The PPE referred to in Article 8(2) for which harmonized...

             4. 4. The Commission shall publish the references of the harmonized standards...

             5. 5. Member States shall ensure that by 30 June 1991 appropriate...

          6. Article 6

             1. 1. Should a Member State or the Commission consider that the...

             2. 2. The Standing Committee set up by Article 6(2) of Directive...

          7. Article 7

             1. 1. If a Member State discovers that PPE bearing the EC...

             2. 2. The Commission shall initiate discussions with the parties concerned as...

             3. 3. If PPE which is not in conformity with the relevant...

             4. 4. The Commission shall ensure that the Member States are kept...

      23. CHAPTER II CERTIFICATION PROCEDURES

          1. Article 8

             1. 1. Before placing a PPE model on the market, the manufacturer...

             2. 2. Prior to the series production of PPE other than those...

             3. 3. EC type-examination shall not be required in the case of...

             4. 4. Production of PPE shall be subject: (a) according to the...

          2. Article 9

             1. 1. Each Member State shall inform the Commission and the other...

             2. 2. Member States shall apply the criteria laid down in Annex...

             3. 3. A Member State shall withdraw its approval from such a...

      24. EC TYPE-EXAMINATION

          1. Article 10

             1. 1. EC type-examination is the procedure whereby the approved inspection body...

             2. 2. Application for EC type-examination shall be made by the manufacturer...

             3. 3. The application shall comprise: the name and address of the...

             4. 4. The inspection body of which notification has been given shall...

             5. 5. If the model satisfies the relevant provisions, the inspection body shall draw up an EC type-examination certificate and shall notify the applicant to this effect. This certificate shall reproduce the findings of the examination, indicate any conditions attaching to its issue and incorporate the descriptions and drawings necessary for the identification of the approved model.

             6. 6. Any inspection body which refuses to issue an EC type-examination...

      25. CHECKING OF PPE MANUFACTURED

          1. Article 11

             1. A. ‘EC’ quality control system for the final product

             2. 1. A manufacturer shall take all steps necessary to ensure that...

             3. 2. A body of which notification has been given, chosen by a manufacturer, shall carry out the necessary checks. Those checks shall be carried out at random, normally at intervals of at least one year.

             4. 3. An adequate sample of PPE taken by the body of which notification has been given shall be examined and appropriate tests defined in the harmonized standards or necessary to show conformity to the basic requirements of this Directive shall be carried out to check the conformity of PPE.

             5. 4. Where a body is not the body that issued the relevant EC type-approval certificate it shall contact the body of which notification has been given in the event of difficulties in connection with the assessment of the conformity of samples.

             6. 5. The body of which notification has been given shall provide...

             7. 6. The manufacturer must be able to present, on request, the...

             8. B. System for ensuring EC quality of production by means of monitoring

             9. 1. The system (a) Under this procedure the manufacturer submits an...

             10. 2. Supervision (a) The purpose of supervision is to ensure that...

      26. EC DECLARATON OF PRODUCTION CONFORMITY

          1. Article 12

             1. The EC declaration of conformity is the procedure whereby the...

             2. 1. draws up a declaration using the form laid down in...

             3. 2. affixes the EC mark of conformity provided for by Article...

      27. CHAPTER III EC MARK

          1. Article 13

             1. 1. The EC mark consists of the letters ‘CE’ followed by...

             2. 2. The EC mark shall be affixed to each production PPE...

             3. 3. Marks or inscriptions which could be confused with the EC...

      28. CHAPTER IV FINAL PROVISIONS

          1. Article 14

             1. Any decision taken in implementation of this Directive and leading...

          2. Article 15

             1. The Commission shall take the necessary steps to ensure that...

          3. Article 16

             1. 1. By 31 December 1991, Member States shall adopt and publish...

             2. 2. Member States shall communicate to the Commission the texts of...

          4. Article 17

             1. This Directive is addressed to the Member States.

             2. Done at Brussels, 21 December 1989.

             3. For the Council The President

             4. E. CRESSON

   2. ANNEX I

      EXHAUSTIVE LIST OF PPE CLASSES NOT COVERED BY THIS DIRECTIVE

      1. 1. PPE designed and manufactured specifically for use by the armed...

      2. 2. PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).

      3. 3. PPE designed and manufactured for private use against: adverse atmospheric...

      4. 4. PPE intended for the protection or rescue of persons on...

   3. ANNEX II

      BASIC HEALTH AND SAFETY REQUIREMENTS

      1. 1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

      2. 1.1. Design principles

      3. 1.1.1. Ergonomics

      4. 1.1.2. Levels and classes of protection

      5. 1.1.2.1. Highest level of protection possible

      6. 1.1.2.2. Classes of protection appropriate to different levels of risk

      7. 1.2. Innocuousness of PPE

      8. 1.2.1. Absence of risks and other ‘inherent’ nuisance factors

      9. 1.2.1.1. Suitable constituent materials

      10. 1.2.1.1. Satisfactory surface condition of all PPE parts in contact with the user

      11. 1.2.1.3. Maximum permissible user impediment

      12. 1.3. Comfort and efficiency

      13. 1.3.1. Adapation of PPE to user morphology

      14. 1.3.2. Lightness and strength

      15. 1.3.3. Compatibility of different classes or types of PPE designed for simultaneous use

      16. 1.4. Information supplied by the manufacturer

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

      18. 2.1. PPE incorporating adjustment systems

      19. 2.2. PPE ‘enclosing’ the parts of the body to be protected

      20. 2.3. PPE for the face, eyes and respiratory tracts

      21. 2.4. PPE subject to ageing

      22. 2.5. PPE which may be caught up during use

      23. 2.6. PPE for use in explosive atmospheres

      24. 2.7. PPE intended for emergency use or rapid installation and/or removal

      25. 2.8. PPE for use in very dangerous situations

      26. 2.9. PPE incorporating components which can be adjusted or removed by the user

      27. 2.10. PPE for connection to another, external complementary device

      28. 2.11. PPE incorporating a fluid circulation system

      29. 2.12. PPE bearing one or more identification or recognition marks directly or indirectly relating to health and safety

      30. 2.13. PPE in the form of clothing capable of signalling the user’s presence visually

      31. 2.14. ‘Multi-risk’ PPE

      32. 3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS

      33. 3.1. Protection against mechanical impact

      34. 3.1.1. Impact caused by falling or projecting objects and collision of parts of the body with an obstacle

      35. 3.1.2. Falls

      36. 3.1.2.1. Prevention of falls due to slipping

      37. 3.1.2.2. Prevention of falls from a height

      38. 3.1.3. Mechanical vibration

      39. 3.2. Protection against (static) compression of part of the body

      40. 3.3. Protection against physical injury (abrasion, perforation, cuts, bites)

      41. 3.4. Prevention of drowning (lifejackets, armbands and lifesaving suits)

      42. 3.4.1. Buoyancy aids

      43. 3.5. Protection against the harmful effects of noise

      44. 3.6. Protection against heat and/or fire

      45. 3.6.1. PPE constituent materials and other components

      46. 3.6.2. Complete PPE ready for use

      47. 1. the quantity of heat transmitted by PPE to the user...

      48. 2. PPE must if necessary prevent liquid or steam penetration and...

      49. 3.7. Protection against cold

      50. 3.7.1. PPE constituent materials and other components

      51. 3.7.2. Complete PPE ready for use

      52. 1. the flux transmitted by PPE to the user must be...

      53. 2. PPE must as far as possible prevent the penetration of...

      54. 3.8. Protection against electric shock

      55. 3.9. Radiation protection

      56. 3.9.1. Non-ionizing radiation

      57. 3.9.2. Ionizing radiation

      58. 3.9.2.1. Protection against external radioactive contamination

      59. 3.9.2.2. Limited protection against external irradiation

      60. 3.10. Protection against dangerous substances and infective agents

      61. 3.10.1. Respiratory protection

      62. 3.10.2. Protection against cutaneous and ocular contact

      63. 3.11. Safety devices for diving equipment

      64. 1. Breathing equipment The breathing equipment must make it possible to...

      65. 2. Where the foreseeable conditions of use so require, the equipment...

   4. ANNEX III

      TECHNICAL DOCUMENTATION SUPPLIED BY THE MANUFACTURER

      1. The documentation referred to in Article 8(1) must comprise all...

      2. In the case of PPE models referred to in Article...

   5. ANNEX IV

      EC MARK OF CONFORMITY

      1. The EC mark of conformity consists of the symbol shown...

      3. The vertical dimensions of the different components of the EC...

   6. ANNEX V

      CONDITIONS TO BY FULFILLED BY THE BODIES OF WHICH NOTIFICATION HAS BEEN GIVEN

      1. (Article 9(2))

         1. The bodies designated by the Member States must fulfil the...

         2. 1. availability of personnel and of the necessary means and equipment;...

         3. 2. technical competence and professional integrity of personnel;

         4. 3. independence, in carrying out the tests, preparing the reports, issuing...

         5. 4. maintenance of professional secrecy by personnel;

         6. 5. subscription of a civil liability insurance unless that liability is...

   7. ANNEX VI

      MODEL EC DECLARATION OF CONFORMITY

8. Explanatory Note