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Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Subject matter

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Making available on the market

    5. Article 5.Essential health and safety requirements

    6. Article 6.Provisions concerning the use of PPE

    7. Article 7.Making available, putting into service and exhibition at trade fairs, etc

    8. Article 7A.Designated standard

  3. CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 8.Obligations of manufacturers

    2. Article 9.Authorised representatives

    3. Article 10.Obligations of importers

    4. Article 11.Obligations of distributors

    5. Article 12.Cases in which obligations of manufacturers apply to importers and distributors

    6. Article 13.Identification of economic operators

  4. CHAPTER III CONFORMITY OF THE PPE

    1. Article 14.Presumption of conformity of PPE

    2. Article 15.... Declaration of conformity

    3. Article 16.General principles of the UK marking

    4. Article 17.Rules and conditions for affixing the UK marking

  5. CHAPTER IV CONFORMITY ASSESSMENT

    1. Article 18.Risk categories of PPE

    2. Article 19.Conformity assessment procedures

  6. CHAPTER V APPROVAL OF CONFORMITY ASSESSMENT BODIES

    1. Article 20.Approved bodies

    2. Article 21.Approval of conformity assessment bodies

    3. Article 22.UK national accreditation body

    4. Article 23.Monitoring obligations

    5. Article 24.Approved body requirements

    6. Article 25.Presumption of conformity of approved bodies

    7. Article 26.Subsidiaries of, and subcontracting by approved bodies

    8. Article 27.Application for notification

    9. Article 28.Notification procedure

    10. Article 29.Identification numbers and register of approved bodies

    11. Article 30.Restriction, suspension or withdrawal of approval

    12. Article 31.Challenge of the competence of notified bodies

    13. Article 32.Operational obligations of approved bodies

    14. Article 33.Appeal against decisions of approved bodies

    15. Article 34.Information obligation on approved bodies

    16. Article 35.Exchange of experience

    17. Article 36.Coordination of notified bodies

  7. CHAPTER VI MARKET SURVEILLANCE AND CONTROL OF PPE ENTERING THE UNITED KINGDOM MARKET

    1. Article 37.Market surveillance and control of PPE entering the United Kingdom market

    2. Article 38.Procedure ... for dealing with PPE presenting a risk

    3. Article 39.Union safeguard procedure

    4. Article 40.Compliant PPE which presents a risk

    5. Article 41.Formal non-compliance

  8. CHAPTER VII DELEGATED AND IMPLEMENTING ACTS

    1. Article 42.Regulation making powers

    2. Article 43.Exercise of the delegation

    3. Article 44.Committee procedure

  9. CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS

    1. Article 45.Penalties

    2. Article 46.Repeal

    3. Article 47.Transitional provision in relation to EU exit

    4. Article 48.Entry into force and application

  10. Signature

    1. ANNEX I

      RISK CATEGORIES OF PPE

      1. This Annex lays down the categories of risk against which...

      2. Category I

      3. Category II

      4. Category III

    2. ANNEX II

      ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

      1. PRELIMINARY REMARKS

        1. 1. The essential health and safety requirements laid down in this...

        2. 2. Obligations related to essential health and safety requirements apply only...

        3. 3. The essential health and safety requirements are to be interpreted...

        4. 4. The manufacturer shall carry out a risk assessment in order...

        5. 5. When designing and manufacturing the PPE, and when drafting the...

      2. 1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

        1. 1.1. Design principles

          1. 1.1.1. Ergonomics

          2. 1.1.2. Levels and classes of protection

            1. 1.1.2.1. Optimum level of protection

            2. 1.1.2.2. Classes of protection appropriate to different levels of risk

        2. 1.2. Innocuousness of PPE

          1. 1.2.1. Absence of inherent risks and other nuisance factors

            1. 1.2.1.1. Suitable constituent materials

            2. 1.2.1.2. Satisfactory surface condition of all PPE parts in contact with...

            3. 1.2.1.3. Maximum permissible user impediment

        3. 1.3. Comfort and effectiveness

          1. 1.3.1. Adaptation of PPE to user morphology

          2. 1.3.2. Lightness and strength

          3. 1.3.3. Compatibility of different types of PPE intended for simultaneous use...

          4. 1.3.4. Protective clothing containing removable protectors

        4. 1.4. Manufacturer's instructions and information

      3. 2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE

        1. 2.1. PPE incorporating adjustment systems

        2. 2.2. PPE enclosing the parts of the body to be protected...

        3. 2.3. PPE for the face, eyes and respiratory system

        4. 2.4. PPE subject to ageing

        5. 2.5. PPE which may be caught up during use

        6. 2.6. PPE for use in potentially explosive atmospheres

        7. 2.7. PPE intended for rapid intervention or to be put on...

        8. 2.8. PPE for intervention in very dangerous situations

        9. 2.9. PPE incorporating components which can be adjusted or removed by...

        10. 2.10. PPE for connection to complementary equipment external to the PPE...

        11. 2.11. PPE incorporating a fluid circulation system

        12. 2.12. PPE bearing one or more identification markings or indicators directly...

        13. 2.13. PPE capable of signalling the user's presence visually

        14. 2.14. Multi-risk PPE

      4. 3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS

        1. 3.1. Protection against mechanical impact

          1. 3.1.1. Impact caused by falling or ejected objects and collisions of...

          2. 3.1.2. Falls

            1. 3.1.2.1. Prevention of falls due to slipping

            2. 3.1.2.2. Prevention of falls from a height

          3. 3.1.3. Mechanical vibration

        2. 3.2. Protection against static compression of a part of the body...

        3. 3.3. Protection against mechanical injuries

        4. 3.4. Protection in liquids

          1. 3.4.1. Prevention of drowning

          2. 3.4.2. Buoyancy aids

        5. 3.5. Protection against the harmful effects of noise

        6. 3.6. Protection against heat and/or fire

          1. 3.6.1. PPE constituent materials and other components

          2. 3.6.2. Complete PPE ready for use

        7. 3.7. Protection against cold

          1. 3.7.1. PPE constituent materials and other components

          2. 3.7.2. Complete PPE ready for use

        8. 3.8. Protection against electric shock

          1. 3.8.1. Insulating equipment

          2. 3.8.2. Conductive equipment

        9. 3.9. Radiation protection

          1. 3.9.1. Non-ionising radiation

          2. 3.9.2. Ionising radiation

            1. 3.9.2.1. Protection against external radioactive contamination

            2. 3.9.2.2. Protection against external irradiation

        10. 3.10. Protection against substances and mixtures which are hazardous to health...

          1. 3.10.1. Respiratory protection

          2. 3.10.2. Protection against cutaneous and ocular contact

        11. 3.11. Diving equipment

    3. ANNEX III

      TECHNICAL DOCUMENTATION FOR PPE

      1. The technical documentation shall specify the means used by the...

      2. The technical documentation shall include at least the following elements:...

      3. a complete description of the PPE and of its intended...

    4. ANNEX IV

      1. INTERNAL PRODUCTION CONTROL (Module A)

        1. 1. Internal production control is the conformity assessment procedure whereby the...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. UK marking and ... declaration of conformity

          1. 4.1. The manufacturer shall affix the UK marking to each individual...

          2. 4.2. The manufacturer shall draw up a written ... declaration of...

        5. 5. Authorised representative

    5. ANNEX V

      1. ... TYPE-EXAMINATION (Module B)

        1. 1. ... Type-examination is the part of a conformity assessment procedure...

        2. 2. ... type-examination shall be carried out by assessment of the...

        3. 3. Application for ... type-examination

        4. 4. ... Type-examination

        5. 5. Evaluation report

        6. 6. ... Type-examination certificate

          1. 6.1. Where the type meets the applicable essential health and safety...

          2. 6.2. The ... type-examination certificate shall contain at least the following...

          3. 6.3. The ... type-examination certificate may have one or more annexes...

          4. 6.4. Where the type does not satisfy the applicable essential health...

        7. 7. Review of the ... type-examination certificate

          1. 7.1. The approved body shall keep itself apprised of any changes...

          2. 7.2. The manufacturer shall inform the approved body that holds the...

          3. 7.3. The manufacturer shall ensure that the PPE continues to fulfil...

          4. 7.4. The manufacturer shall ask the approved body to review the...

          5. 7.5. The approved body shall examine the PPE type and, where...

          6. 7.6. Where the conditions referred to in points (a) and (b) of point 7.4...

          7. 7.7. If, following the review, the approved body concludes that the...

        8. 8. Each approved body shall inform the Secretary of State concerning...

        9. 9. The manufacturer shall keep a copy of the ... type-examination...

        10. 10. The manufacturer's authorised representative may lodge the application referred to...

    6. ANNEX VI

      1. CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (Module C)

        1. 1. Conformity to type based on internal production control is the...

        2. 2. Manufacturing

        3. 3. UK marking and ... declaration of conformity

          1. 3.1. The manufacturer shall affix the UK marking to each individual...

          2. 3.2. The manufacturer shall draw up a written ... declaration of...

        4. 4. Authorised representative

    7. ANNEX VII

      1. CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (Module C2)

        1. 1. Conformity to type based on internal production control plus supervised...

        2. 2. Manufacturing

        3. 3. Application for supervised product checks at random intervals

        4. 4. Product checks

          1. 4.1. The approved body shall carry out product checks in order...

          2. 4.2. The product checks shall be carried out at least once...

          3. 4.3. An adequate statistical sample of the manufactured PPE shall be...

          4. 4.4. Where the approved body referred to in point 3 is not...

          5. 4.5. The acceptance sampling procedure to be applied is intended to...

          6. 4.6. If the examination and testing reveal that the production is...

        5. 5. Test report

          1. 5.1. The approved body shall provide the manufacturer with a test...

          2. 5.2. The manufacturer shall keep the test report at the disposal...

          3. 5.3. The manufacturer shall, under the responsibility of the approved body,...

        6. 6. UK marking and ... declaration of conformity

          1. 6.1. The manufacturer shall affix the UK marking and, under the...

          2. 6.2. The manufacturer shall draw up a written ... declaration of...

        7. 7. Authorised representative

    8. ANNEX VIII

      1. CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (Module D)

        1. 1. Conformity to type based on quality assurance of the production...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of his...

          2. 3.2. The quality system shall ensure that the PPE is in...

          3. 3.3. The approved body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the approved body that has approved...

          6. 3.6. The approved body shall authorise the manufacturer to affix the...

        4. 4. Surveillance under the responsibility of the approved body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the approved body...

          3. 4.3. The approved body shall carry out periodic audits, at least...

          4. 4.4. In addition, the approved body may pay unexpected visits to...

        5. 5. UK marking and ... declaration of conformity

          1. 5.1. The manufacturer shall affix the UK marking and, under the...

          2. 5.2. The manufacturer shall draw up a written ... declaration of...

        6. 6. The manufacturer shall, for 10 years after the PPE has been...

        7. 7. The approved body shall inform the Secretary of State of...

        8. 8. Authorised representative

    9. ANNEX IX

      ... DECLARATION OF CONFORMITY No …

      1. 1. PPE (product, type, batch or serial number):

      2. 2. Name and address of the manufacturer and, where applicable, his...

      3. 3. This declaration of conformity is issued under the sole responsibility...

      4. 4. Object of the declaration (identification of PPE allowing traceability; where...

      5. 5. The object of the declaration described in point 4 is...

      6. 6. References to the relevant designated standards used, including the date...

      7. 7. Where applicable, the approved body … (name, number) … performed...

      8. 8. Where applicable, the PPE is subject to the conformity assessment...

      9. 9. Additional information:

      10. Signed for and on behalf of: …

      11. (place and date of issue):

      12. (name, function) (signature):

    10. ANNEX X

      CORRELATION TABLE

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