The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

1. Introductory Text

2. PART 1 Preliminary

   1. 1. Citation, commencement and extent

   2. 2. Interpretation

   3. 2A. Designated standard

   4. 3. Scope

   5. 4. Exceptions for trade fairs, exhibitions and demonstrations

3. PART 2 Obligations of economic operators

   1. Chapter 1 Manufacturers

      1. 5. Design and manufacture in accordance with essential health and safety requirements

      2. 6. Technical documentation and conformity assessment

      3. 7. Declaration of conformity and UK marking

      4. 8. Retention of technical documentation and ... declaration of conformity

      5. 9. Compliance procedures for series production

      6. 10. Monitoring

      7. 11. Labelling and packaging of products

      8. 12. Labelling and packaging of products, other than components

      9. 13. Information identifying manufacturer

      10. 14. Provision of instructions and safety information

      11. 15. Duty to take action in respect of a product placed on the market which is considered not to be in conformity

      12. 16. Provision of information and cooperation

      13. 17. Authorised representatives

   2. Chapter 2 Importers

      1. 18. Prohibition on placing on the market products which are not in conformity

      2. 19. Requirements which must be satisfied before an importer places a product on the market

      3. 20. Prohibition on placing on the market products considered not to be in conformity with the essential health and safety requirements

      4. 21. Information identifying importer

      5. 22. Provision of Instructions and safety information

      6. 23. Storage and transport

      7. 24. Monitoring

      8. 25. Duty to take action in respect of a product placed on the market which is considered not to be in conformity

      9. 26. Provision of information and cooperation

      10. 27. Retention of technical documentation and ... declaration of conformity

   3. Chapter 3 Distributors

      1. 28. Duty to act with due care

      2. 29. Requirements which must be satisfied before a distributor makes a product available on the market

      3. 30. Storage and transport

      4. 31. Prohibition on making available on the market where product not considered to be in conformity with safety objectives

      5. 32. Duty to take action in respect of products made available on the market which are not in conformity

      6. 33. Provision of information and cooperation

   4. Chapter 4 Importers and distributors

      1. 34. Cases in which obligations of manufacturers apply to importers and distributors

   5. Chapter 5 All economic operators

      1. 35. Identification of economic operators

      2. 36. Prohibition on improper use of UK marking

      3. 36A. Obligations which are met by complying with obligations in the ATEX Directive

      4. 36B. Conformity assessment procedure obligation which is met by complying with the ATEX Directive

      5. 36C. Further Use of UK marking

      6. 36D. Qualifying Northern Ireland Goods

      7. 37. Translation of declaration of conformity

4. PART 3 Conformity assessment

   1. 38. Presumption of conformity

   2. 39. Conformity assessment procedures

   3. 40. ... Declaration of conformity

   4. 41. UK Marking

5. PART 4 Approval of Conformity Assessment Bodies

   1. 42. Approved bodies

   2. 43. Approval of conformity assessment bodies

   3. 44. Presumption of conformity of approved bodies

   4. 45. Monitoring

   5. 46. Restriction, suspension or withdrawal of approval

   6. 47. Operational matters in relation to approved bodies

   7. 48. Subsidiaries and contractors

   8. 49. Register of approved bodies

   9. 50. UK national accreditation body

6. PART 5 Market surveillance and enforcement

   1. 51. Designation of market surveillance authority

   2. 52. Enforcement

   3. 53. Enforcement powers

   4. 54. Exercise of enforcement powers

   5. 55. Evaluation of a product presenting a risk

   6. 56. Enforcement action in respect of products which are not in conformity and which present a risk

   7. 57. EU safeguard procedure

   8. 58. Enforcement action in respect of products which are in conformity, but present a risk

   9. 59. Enforcement action in respect of formal non-compliance

   10. 60. Restrictive measures

   11. 61. Offences

   12. 62. Penalties

   13. 63. Defence of due diligence

   14. 64. Liability of persons other than principal offender

   15. 65. Time limit for prosecution of offences

   16. 66. Service of documents

   17. 67. Recovery of expenses of enforcement

   18. 68. Action by the market surveillance authority

   19. 69. Appeals against notices

   20. 70. Appropriate court for appeals against notices

7. PART 6 Miscellaneous

   1. 71. Review

   2. 72. Transitional provisions

   3. 72A. Transitional provision in relation to EU Exit

   4. 73. Revocations and savings

   5. 74. Consequential Amendments

8. Signature

9. 1. SCHEDULE 1

      Essential Health and Safety Requirements

      1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES (Annex II of the ATEX Directive)

         1. 1. Preliminary observations

      2. COMMON REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS

         1. General requirements

            1. 2. Principles of integrated explosion safety

            2. 3. Special checking and maintenance conditions

            3. 4. Surrounding area conditions

            4. 5. Marking

            5. 6. Instructions

            6. 7. Selection of materials

            7. 8. Design and construction

            8. 9. Enclosed structures and prevention of leaks

            9. 10. Dust deposits

            10. 11. Additional means of protection

            11. 12. Safe opening

            12. 13. Protection against other hazards

            13. 14. Overloading of equipment

            14. 15. Flameproof enclosure systems

      3. POTENTIAL IGNITION SOURCES

         1. 16. Hazards arising from different ignition sources

         2. 17. Hazards arising from static electricity

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

         4. 19. Hazards arising from overheating

         5. 20. Hazards arising from pressure compensation operations

         6. 21. Hazards arising from external effects

         7. 22. Requirements in respect of safety-related devices

         8. 23. Control and display units

         9. 24. Requirements in respect of devices with a measuring function for explosion protection

         10. 25. Risks arising from software

         11. 26. Integration of safety requirements relating to the system

         12. 27. Hazards arising from power failure

         13. 28. Hazards arising from connections

         14. 29. Placing of warning devices as parts of equipment

      4. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF EQUIPMENT

         1. Requirements applicable to equipment in equipment - group I

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

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

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

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

            2. 33. Explosive atmospheres caused by air and dust mixtures

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

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

            2. 35. Explosive atmospheres caused by air and dust mixtures

         4. Requirements applicable to equipment category 3 of equipment – groupII

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

            2. 37. Explosive atmospheres caused by air and dust mixtures

         5. Supplementary requirements in respect of protective systems

            1. 38. General requirements

         6. Planning and design

            1. 39. Characteristics of materials

            2. 40. Pressure-relief systems

            3. 41. Explosion suppression systems

            4. 42. Explosion decoupling systems

            5. 43. Protective systems must be capable of being integrated into a...

   2. SCHEDULE 1A

      Criteria determining the classification of equipment-groups into categories (Annex I to the ATEX Directive)

      1. 1. Equipment group I (a) Equipment category M 1 comprises equipment...

      2. 2. Equipment-group II (a) Equipment category 1 comprises equipment designed to...

   3. SCHEDULE 2

      Approved body requirements

      1. 1. (1) A conformity assessment body must have legal personality and...

      2. 2. A conformity assessment body must be a third party body...

      3. 3. A body belonging to a business association or professional federation...

      4. 4. (1) A conformity assessment body, its top level management and...

      5. 5. A conformity assessment body, its top level management and the...

      6. 6. A conformity assessment body, its top level management and the...

      7. 7. A conformity assessment body must ensure that the activities of...

      8. 8. A conformity assessment body and its personnel must carry out...

      9. 9. A conformity assessment body must be capable of carrying out...

      10. 10. A conformity assessment body must have —

      11. 11. A conformity assessment body must have the means necessary to...

      12. 12. The personnel responsible for carrying out conformity assessment activities must...

      13. 13. A conformity assessment body must be able to demonstrate the...

      14. 14. The remuneration of the top level management and the personnel...

      15. 15. A conformity assessment body must have, and must satisfy the...

      16. 16. A conformity assessment body must ensure that its personnel observe...

      17. 17. Paragraph 16 does not prevent the personnel from providing information...

      18. 18. A conformity assessment body must participate in, or ensure that...

   4. SCHEDULE 3

      Operational obligations of approved bodies

      1. 1. An approved body must carry out conformity assessments in accordance...

      2. 2. An approved body must carry out conformity assessments in a...

      3. 3. An approved body must perform its activities taking due account...

      4. 4. An approved body must respect the degree of rigour and...

      5. 5. Where an approved body finds that essential health and safety...

      6. 6. Where, in the course of the monitoring of conformity following...

      7. 7. Where the approved body has required a manufacturer to take...

      8. 8. Paragraph 9 applies where an approved body is minded to—...

      9. 9. Where this paragraph applies, the approved body must—

      10. 10. An approved body must inform the Secretary of State of—...

      11. 11. An approved body must make provision in its contracts with...

      12. 12. An approved body must provide other bodies approved under these...

      13. 13. An approved body must participate in the work of any...

      14. 14. An approved body must— (a) acknowledge receipt of the technical...

   5. SCHEDULE 3A

      Conformity Assessment Procedures (Annexes III to IX of the ATEX Directive)

      1. PART 1

         1. 1. TYPE EXAMINATION

         2. 2. Type examination shall be carried out with the examination of...

         3. 3. The manufacturer shall lodge an application for Type examination with...

         4. 4. The approved body shall:

         5. 4.1. examine the technical documentation, verify that the specimen(s) have been...

         6. 4.2. carry out appropriate examinations and tests, or have them carried...

         7. 4.3. carry out appropriate examinations and tests, or have them carried...

         8. 4.4. agree with the manufacturer on a location where the examinations...

         9. 5. The approved body shall draw up an evaluation report that...

         10. 6. Where the type meets the requirements of these Regulations that...

         11. 7. The approved body shall keep itself apprised of any changes...

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

         13. 9. The manufacturer shall keep a copy of the Type examination...

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

      2. PART 2 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

         4. 3.1. The manufacturer shall lodge an application for assessment of his...

         5. 3.2. The quality system shall ensure that the products are in...

         6. 3.3. The approved body shall assess the quality system to determine...

         7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

         8. 3.5. The manufacturer shall keep the approved body that has approved...

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

         10. 4.1. The purpose of surveillance is to make sure that the...

         11. 4.2. The manufacturer shall, for assessment purposes, allow the approved body...

         12. 4.3. The approved body shall carry out periodic audits to make...

         13. 4.4. In addition, the approved body may pay unexpected visits to...

         14. 5. UK marking, declaration of conformity and attestation of conformity

         15. 5.1. The manufacturer shall affix the UK marking and, under the...

         16. 5.2. The manufacturer shall draw up a written declaration of conformity...

         17. 5.3. The manufacturer shall draw up a written attestation of conformity...

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

         19. 7. Each approved body shall inform the Secretary of State of...

         20. 8. Authorised representative

      3. PART 3 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

         5. 4.1. All products shall be individually examined, and appropriate tests set...

         6. 4.2. The approved body shall issue a certificate of conformity in...

         7. 5. UK marking, declaration of conformity and attestation of conformity

         8. 5.1. The manufacturer shall affix the UK marking and, under the...

         9. 5.2. The manufacturer shall draw up a written declaration of conformity...

         10. 5.3. The manufacturer shall draw up a written attestation of conformity...

         11. 6. If the approved body agrees and under its responsibility, the...

         12. 7. Authorised representative

      4. PART 4 CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING

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

         2. 2. Manufacturing

         3. 3. Product checks

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

         5. 4.1. The manufacturer shall affix the UK marking to each individual...

         6. 4.2. The manufacturer shall draw up a written declaration of conformity...

         7. 4.3. The manufacturer shall draw up a written attestation of conformity...

         8. 5. Authorised representative

      5. PART 5 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

         4. 3.1. The manufacturer shall lodge an application for assessment of his...

         5. 3.2. The quality system shall ensure compliance of the products with...

         6. 3.3. The approved body shall assess the quality system to determine...

         7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

         8. 3.5. The manufacturer shall keep the approved body that has approved...

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

         10. 4.1. The purpose of surveillance is to make sure that the...

         11. 4.2. The manufacturer shall, for assessment purposes, allow the approved body...

         12. 4.3. The approved body shall carry out periodic audits to make...

         13. 4.4. In addition, the approved body may pay unexpected visits to...

         14. 5. UK marking, declaration of conformity and attestation of conformity

         15. 5.1. The manufacturer shall affix the UK marking and, under the...

         16. 5.2. The manufacturer shall draw up a written declaration of conformity...

         17. 5.3. The manufacturer shall draw up a written attestation of conformity...

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

         19. 7. Each approved body shall inform the Secretary of State of...

         20. 8. Authorised representative

      6. PART 6 INTERNAL PRODUCTION CONTROL

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

         2. 2. Technical documentation

         3. 3. Manufacturing

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

         5. 4.1. The manufacturer shall affix the UK marking to each individual...

         6. 4.2. The manufacturer shall draw up a written declaration of conformity...

         7. 4.3. The manufacturer shall draw up a written attestation of conformity...

         8. 5. Authorised representative

      7. PART 7 CONFORMITY BASED ON UNIT VERIFICATION

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

         2. 2. Technical documentation

         3. 2.1. The manufacturer shall establish the technical documentation and make it...

         4. 2.2. The manufacturer shall keep the technical documentation at the disposal...

         5. 3. Manufacturing

         6. 4. Verification

         7. 5. UK marking, declaration of conformity and attestation of conformity

         8. 5.1. The manufacturer shall affix the UK marking and, under the...

         9. 5.2. The manufacturer shall draw up a written declaration of conformity...

         10. 5.3. The manufacturer shall draw up a written attestation of conformity...

         11. 6. Authorised representative

   6. SCHEDULE 4

      Enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act

      1. 1. Enforcement powers under the 1974

      2. 2. Modifications to the 1974 Act

   7. SCHEDULE 5

      Compliance, withdrawal and recall notices

      1. 1. Compliance notice

      2. 2. Withdrawal notice

      3. 3. Recall notice

      4. 4. Interpretation

   8. SCHEDULE 6

      EU Declaration of Conformity (No. XXXX)

      1. 1. Product model/product (product, type, batch or serial number):

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

      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 designated standards used or references to...

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

      8. 8. Additional information: Signed for and on behalf of: (place and...

10. Explanatory Note