xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"

  1. Introductory Text

  2. CHAPTER 1 GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

    3. Article 3.Making available on the market and putting into service

    4. Article 4.Essential health and safety requirements

    5. Article 5.Free movement

  3. CHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 6.Obligations of manufacturers

    2. Article 7.Authorised representatives

    3. Article 8.Obligations of importers

    4. Article 9.Obligations of distributors

    5. Article 10.Cases in which obligations of manufacturers apply to importers and distributors

    6. Article 11.Identification of economic operators

  4. CHAPTER 3 CONFORMITY OF THE PRODUCT

    1. Article 12.Presumption of conformity of products

    2. Article 13.Conformity assessment procedures

    3. Article 14.EU declaration of conformity

    4. Article 15.General principles of the CE marking

    5. Article 16.Rules and conditions for affixing the CE marking and other markings

  5. CHAPTER 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

    1. Article 17.Notification

    2. Article 18.Notifying authorities

    3. Article 19.Requirements relating to notifying authorities

    4. Article 20.Information obligation on notifying authorities

    5. Article 21.Requirements relating to notified bodies

    6. Article 22.Presumption of conformity of notified bodies

    7. Article 23.Subsidiaries of and subcontracting by notified bodies

    8. Article 24.Application for notification

    9. Article 25.Notification procedure

    10. Article 26.Identification numbers and lists of notified bodies

    11. Article 27.Changes to notifications

    12. Article 28.Challenge of the competence of notified bodies

    13. Article 29.Operational obligations of notified bodies

    14. Article 30.Appeal against decisions of notified bodies

    15. Article 31.Information obligation on notified bodies

    16. Article 32.Exchange of experience

    17. Article 33.Coordination of notified bodies

  6. CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

    1. Article 34.Union market surveillance and control of products entering the Union market

    2. Article 35.Procedure for dealing with products presenting a risk at national level

    3. Article 36.Union safeguard procedure

    4. Article 37.Compliant products which present a risk

    5. Article 38.Formal non-compliance

  7. CHAPTER 6 COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS

    1. Article 39.Committee procedure

    2. Article 40.Penalties

    3. Article 41.Transitional provisions

    4. Article 42.Transposition

    5. Article 43.Repeal

    6. Article 44.Entry into force and application

    7. Article 45.Addressees

  8. Signature

    1. ANNEX I

      CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES

      1. 1. Equipment-group I

        1. (a) Equipment category M 1 comprises equipment designed and, where necessary,...

        2. (b) Equipment category M 2 comprises equipment designed to be capable...

      2. 2. Equipment-group II

        1. (a) Equipment category 1 comprises equipment designed to be capable of...

        2. (b) Equipment category 2 comprises equipment designed to be capable of...

        3. (c) Equipment category 3 comprises equipment designed to be capable of...

    2. ANNEX II

      ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES

      1. Preliminary observations

        1. A. Technological knowledge, which can change rapidly, must be taken into...

        2. B. For the devices referred to in point (b) of Article...

      2. 1. Common requirements for Equipment and protective systems

        1. 1.0. General requirements

          1. 1.0.1. Principles of integrated explosion safety

          2. 1.0.2. Equipment and protective systems must be designed and manufactured after...

          3. 1.0.3. Special checking and maintenance conditions

          4. 1.0.4. Surrounding area conditions

          5. 1.0.5. Marking

          6. 1.0.6. Instructions

        2. 1.1. Selection of materials

          1. 1.1.1. The materials used for the construction of equipment and protective...

          2. 1.1.2. Within the limits of the operating conditions laid down by...

          3. 1.1.3. Materials must be so selected that predictable changes in their...

        3. 1.2. Design and construction

          1. 1.2.1. Equipment and protective systems must be designed and constructed with...

          2. 1.2.2. Components to be incorporated into or used as replacements in...

          3. 1.2.3. Enclosed structures and prevention of leaks

          4. 1.2.4. Dust deposits

          5. 1.2.5. Additional means of protection

          6. 1.2.6. Safe opening

          7. 1.2.7. Protection against other hazards

          8. 1.2.8. Overloading of equipment

          9. 1.2.9. Flameproof enclosure systems

        4. 1.3. Potential ignition sources

          1. 1.3.1. Hazards arising from different ignition sources

          2. 1.3.2. Hazards arising from static electricity

          3. 1.3.3. Hazards arising from stray electric and leakage currents

          4. 1.3.4. Hazards arising from overheating

          5. 1.3.5. Hazards arising from pressure compensation operations

        5. 1.4. Hazards arising from external effects

          1. 1.4.1. Equipment and protective systems must be so designed and constructed...

          2. 1.4.2. Equipment parts used must be appropriate to the intended mechanical...

        6. 1.5. Requirements in respect of safety-related devices

          1. 1.5.1. Safety devices must function independently of any measurement and/or control...

          2. 1.5.2. In the event of a safety device failure, equipment and/or...

          3. 1.5.3. Emergency stop controls of safety devices must, as far as...

          4. 1.5.4. Control and display units

          5. 1.5.5. Requirements in respect of devices with a measuring function for...

          6. 1.5.6. Where necessary, it must be possible to check the reading...

          7. 1.5.7. The design of devices with a measuring function must incorporate...

          8. 1.5.8. Risks arising from software

        7. 1.6. Integration of safety requirements relating to the system

          1. 1.6.1. Manual override must be possible in order to shut down...

          2. 1.6.2. When the emergency shutdown system is actuated, accumulated energy must...

          3. 1.6.3. Hazards arising from power failure

          4. 1.6.4. Hazards arising from connections

          5. 1.6.5. Placing of warning devices as parts of equipment

      3. 2. Supplementary requirements in respect of equipment

        1. 2.0. Requirements applicable to equipment in equipment-group I

          1. 2.0.1. Requirements applicable to equipment category M 1 of equipment-group I...

            1. 2.0.1.1. Equipment must be so designed and constructed that sources of...

            2. 2.0.1.2. Where necessary, equipment must be so constructed that no dust...

            3. 2.0.1.3. The surface temperatures of equipment parts must be kept clearly...

            4. 2.0.1.4. Equipment must be so designed that the opening of equipment...

          2. 2.0.2. Requirements applicable to equipment category M 2 of equipment-group I...

            1. 2.0.2.1. Equipment must be equipped with means of protection ensuring that...

            2. 2.0.2.2. Equipment must be so designed that the opening of equipment...

            3. 2.0.2.3. The requirements regarding explosion hazards arising from dust applicable to...

        2. 2.1. Requirements applicable to equipment category 1 of equipment-group II

          1. 2.1.1. Explosive atmospheres caused by gases, vapours or mists

            1. 2.1.1.1. Equipment must be so designed and constructed that sources of...

            2. 2.1.1.2. For equipment with surfaces which may heat up, measures must...

            3. 2.1.1.3. Equipment must be so designed that the opening of equipment...

          2. 2.1.2. Explosive atmospheres caused by air/dust mixtures

            1. 2.1.2.1. Equipment must be so designed and constructed that ignition of...

            2. 2.1.2.2. Where necessary, equipment must be so designed that dust can...

            3. 2.1.2.3. The surface temperatures of equipment parts must be kept well...

            4. 2.1.2.4. With regard to the safe opening of equipment parts, requirement...

        3. 2.2. Requirements applicable to equipment category 2 of equipment-group II

          1. 2.2.1. Explosive atmospheres caused by gases, vapours or mists

            1. 2.2.1.1. Equipment must be so designed and constructed as to prevent...

            2. 2.2.1.2. Equipment parts must be so designed and constructed that their...

            3. 2.2.1.3. Equipment must be so designed that the opening of equipment...

          2. 2.2.2. Explosive atmospheres caused by air/dust mixtures

            1. 2.2.2.1. Equipment must be designed and constructed so that ignition of...

            2. 2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

            3. 2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies.

            4. 2.2.2.4. With regard to the safe opening of equipment parts, requirement...

        4. 2.3. Requirements applicable to equipment category 3 of equipment-group II

          1. 2.3.1. Explosive atmospheres caused by gases, vapours or mists

            1. 2.3.1.1. Equipment must be so designed and constructed as to prevent...

            2. 2.3.1.2. Surface temperatures must not exceed the stated maximum surface temperatures...

          2. 2.3.2. Explosive atmospheres caused by air/dust mixtures

            1. 2.3.2.1. Equipment must be so designed and constructed that air/dust mixtures...

            2. 2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

            3. 2.3.2.3. Equipment, including cable entries and connecting pieces, must be so...

      4. 3. Supplementary requirements in respect of protective systems

        1. 3.0. General requirements

          1. 3.0.1. Protective systems must be dimensioned in such a way as...

          2. 3.0.2. Protective systems must be designed and capable of being positioned...

          3. 3.0.3. In the event of a power failure, protective systems must...

          4. 3.0.4. Protective systems must not fail due to outside interference.

        2. 3.1. Planning and design

          1. 3.1.1. Characteristics of materials

          2. 3.1.2. Protective systems designed to resist or contain explosions must be...

          3. 3.1.3. Accessories connected to protective systems must be capable of withstanding...

          4. 3.1.4. The reactions caused by pressure in peripheral equipment and connected...

          5. 3.1.5. Pressure-relief systems

          6. 3.1.6. Explosion suppression systems

          7. 3.1.7. Explosion decoupling systems

          8. 3.1.8. Protective systems must be capable of being integrated into a...

    3. ANNEX III

      1. MODULE B: EU-TYPE EXAMINATION

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

        2. 2. EU-type examination shall be carried out with the examination of...

        3. 3. The manufacturer shall lodge an application for EU-type examination with...

        4. 4. The notified body shall:

        5. 5. The notified body shall draw up an evaluation report that...

        6. 6. Where the type meets the requirements of this Directive that...

        7. 7. The notified body shall keep itself apprised of any changes...

        8. 8. Each notified body shall inform its notifying authority concerning the...

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

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

    4. ANNEX IV

      MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

      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 products are in...

        3. 3.3. The notified 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 notified body that has approved...

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

        3. 4.3. The notified body shall carry out periodic audits to make...

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

      5. 5. CE marking, EU declaration of conformity and attestation of conformity...

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

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

        3. 5.3. The manufacturer shall draw up a written attestation of conformity...

      6. 6. The manufacturer shall, for a period ending 10 years after...

      7. 7. Each notified body shall inform its notifying authority of quality...

      8. 8. Authorised representative

    5. ANNEX V

      1. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

        1. 1. Conformity to type based on product verification is the part...

        2. 2. Manufacturing

        3. 3. Verification

        4. 4. Verification of conformity by examination and testing of every product...

          1. 4.1. All products shall be individually examined and appropriate tests set...

          2. 4.2. The notified body shall issue a certificate of conformity in...

        5. 5. CE marking, EU declaration of conformity and attestation of conformity...

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

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

          3. 5.3. The manufacturer shall draw up a written attestation of conformity...

        6. 6. If the notified body agrees and under its responsibility, the...

        7. 7. Authorised representative

    6. ANNEX VI

      1. MODULE C1: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED...

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

        2. 2. Manufacturing

        3. 3. Product checks

        4. 4. CE marking, EU declaration of conformity and attestation of conformity...

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

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

          3. 4.3. The manufacturer shall draw up a written attestation of conformity...

        5. 5. Authorised representative

    7. ANNEX VII

      1. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

        1. 1. Conformity to type based on product quality assurance is that...

        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 compliance of the products with...

          3. 3.3. The notified 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 notified body that has approved...

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

          3. 4.3. The notified body shall carry out periodic audits to make...

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

        5. 5. CE marking, EU declaration of conformity and attestation of conformity...

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

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

          3. 5.3. The manufacturer shall draw up a written attestation of conformity...

        6. 6. The manufacturer shall, for a period ending 10 years after...

        7. 7. Each notified body shall inform its notifying authority of quality...

        8. 8. Authorised representative

    8. ANNEX VIII

      1. MODULE A: INTERNAL PRODUCTION CONTROL

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

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. CE marking, EU declaration of conformity and attestation of conformity...

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

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

          3. 4.3. The manufacturer shall draw up a written attestation of conformity...

        5. 5. Authorised representative

    9. ANNEX IX

      1. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

        1. 1. Conformity based on unit verification is the conformity assessment procedure...

        2. 2. Technical documentation

          1. 2.1. The manufacturer shall establish the technical documentation and make it...

          2. 2.2. The manufacturer shall keep the technical documentation at the disposal...

        3. 3. Manufacturing

        4. 4. Verification

        5. 5. CE marking, EU declaration of conformity and attestation of conformity...

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

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

          3. 5.3. The manufacturer shall draw up a written attestation of conformity...

        6. 6. Authorised representative

    10. ANNEX X

      EU DECLARATION OF CONFORMITY (No XXXX)

      1. 1. Product model/product (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 product allowing traceability; it...

      5. 5. The object of the declaration described above is in conformity...

      6. 6. References to the relevant harmonised standards used or references to...

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

      8. 8. Additional information:

    11. ANNEX XI

      1. PART A

      2. PART B

    12. ANNEX XII

  10. ATTACHMENTS

    1. STATEMENT OF THE EUROPEAN PARLIAMENT