PART 1Preliminary

Citation, commencement and extent_I1

1.—(1) These Regulations may be cited as the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 and come into force on 8th December 2016 (“the commencement date”).

(2) These Regulations extend to England, Wales and Scotland.

Interpretation_I2

2.—(1) In these Regulations—

the “1974 Act” means the Health and Safety at Work etc Act 1974(4);

^F1the “1994 Directive” means of the European Parliament and of the Council on the approximation of the laws of the member States concerning Directive 94/9/ECequipment and protective systems intended for use in potentially explosive atmospheres(5) ...;

“the 1996 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996(6);

[^F2“approved body” has the meaning given to it in regulation 42;^F2]

^F3...

“ATEX Directive” means of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to Directive 2014/34/EUequipment and protective systems intended for use in potentially explosive atmospheres (recast)(7);

^F4“attestation of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7(3) (... declaration of conformity and [^F5UK^F5] Marking);

“authorised representative” means a person appointed in accordance with regulation 17(1);

^F6...

^F7...

“component” means any item essential to the safe functioning of equipment and protective systems but with no autonomous function;

“conformity assessment” means the process demonstrating whether the essential health and safety requirements relating to a product have been fulfilled;

[^F8“conformity assessment activities” means any activities connected with conformity assessment including calibration, testing, certification and inspection;^F8]

“conformity assessment body” means a person that performs conformity assessment activities, including calibration, testing, certification and inspection;

[^F9“conformity assessment procedure” means a procedure referred to in regulation 39 (conformity assessment procedures);^F9]

[^F9“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7(1)(a) (declaration of conformity and UK marking);^F9]

[^F9“designated standard” has the meaning given to it in regulation 2A;^F9]

“distributor” means any person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

“economic operator” means a manufacturer, authorised representative, importer or distributor;

“equipment” means machines, apparatus, fixed or mobile devices, control components and their instrumentation and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy or the processing of material or both and which are capable of causing an explosion through their own potential sources of ignition;

[^F10“equipment category” means the classification of equipment, within each equipment group, specified in Schedule 1A to these Regulations;^F10]

“equipment-group I” means equipment intended for use in underground parts of mines, and in those parts of surface installations of such mines, liable to be endangered by firedamp or combustible dust or both, comprising equipment categories M 1 and M 2 [^F11as set out in Schedule 1A to these Regulations^F11] ;

“equipment-group II” means equipment intended for use in other places liable to be endangered by explosive atmospheres, comprising equipment categories 1, 2 and 3 [^F12as set out in Schedule 1A to these Regulations^F12] ;

“essential health and safety requirements” means the requirements set out in Schedule 1 (essential health and safety requirements);

^F13...

^F14...

“explosive atmosphere” means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture;

^F15...

[^F16“importer” means a person who—

“intended use” means the use of a product prescribed by the manufacturer by assigning the equipment to a particular equipment-group and category or by providing all the information which is required for the safe functioning of a protective system, device or component;

“make available on the market” means any supply of a product for distribution, consumption or use on the [^F17market of Great Britain^F17] in the course of a commercial activity, whether in return for payment or free of charge, and related expressions are to be construed accordingly;

“manufacturer” means a person who—

“market surveillance authority” has the meaning set out in regulation 51 (designation of market surveillance authority);

^F18...

^F19...

^F20...

“place on the market” means make a product available on the [^F21market of Great Britain^F21] for the first time, and related expressions are to be construed accordingly;

“potentially explosive atmosphere” means an atmosphere which could become explosive due to local and operational conditions;

“protective systems” means devices other than components of equipment which are intended to halt incipient explosions immediately or to limit the effective range of an explosion or both, and which are separately made available on the market for use as autonomous systems;

^F22“putting into service” means the first use of a product by an end-user ..., for the purposes for which it was intended, and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93(8);

“recall” means taking any measure aimed at achieving the return of a product that has already been made available to the end-user and related expressions must be construed accordingly;

“relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 39 (conformity assessment procedures);

“relevant economic operator” means, in relation to a product, an economic operator with obligations in respect of that product under Part 2;

“technical documentation” has the meaning given in regulation 6 (technical documentation and conformity assessment);

“technical specification” means a document that prescribes technical requirements to be fulfilled by a product;

[^F23“UK marking” means the marking in the form set out in Annex 2 of RAMS;^F23]

[^F23“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;^F23]

“withdraw” when used in relation to a product, means taking any measure aimed at preventing a product in the supply chain from being made available on the market and related expressions must be construed accordingly.

[^F24(1A)Schedule 1A reproduces the provisions of Annex I to the ATEX Directive with amendments to correct deficiencies in [^F25assimilated^F25] law.

(1B)A reference to a provision of Schedule 1A is a reference to the equivalent provisions of Annex I to the ATEX Directive as set out in Schedule 1A.

(1C)Schedule 3A reproduces the provisions of Annexes III to IX to the ATEX Directive with amendments to correct deficiencies in [^F26assimilated^F26] law.

(1D)A reference to any provision of Schedule 3A is a reference to the equivalent provisions of Annex III to IX of the ATEX Directive.^F24]

(2) In these Regulations, a reference to a product being “in conformity with Part 2” means that—

(a)the product is in conformity with the essential health and safety requirements; and

(b)each relevant economic operator has complied with the obligations imposed on them under Part 2 which must be satisfied at or before the time at which they make the product available on the market.

^F27(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) In regulations 10(1) and 24(1) (monitoring) and Schedule 1 (essential health and safety requirements), “risk” means a risk which could arise from lawful and readily predictable human behaviour.

(5) In the other provisions of these Regulations, “risk” means a risk—

(a)which could arise from lawful and readily predictable human behaviour, and

(b)which may result in harm to any of the following interests—

(i)health and safety of persons, in particular workers,

(ii)domestic animals, or

(iii)property.

^F28(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F29Designated standard

2A.—(1)Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body[^F30or an international standardising body^F30], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2)For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a product, service or system, including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii)the requirements applicable to the product, service or system as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b)production methods and processes relating to the product, where these have an effect on the characteristics of the product, service or system.

(3)For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[^F31(3A)In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).^F31]

(4)When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5)Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [^F32such^F32]technical specifications adopted by the other recognised standardisation bodies[^F33or by international standardising bodies as the Secretary of State considers to be relevant.^F33]

(6)The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7)Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8)The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(9)Regulations made under paragraph (8) are to be made by statutory instrument.

(10)A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.^F29]

Scope_I3

3.—(1) These Regulations apply to products which—

(a)fall within the meaning of “product” in paragraph (2); and

(b)are not excluded by paragraph (3).

(2) A “product” means—

(a)equipment and protective systems intended for use in potentially explosive atmospheres;

(b)safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion;

(c)components intended to be incorporated into equipment and protective systems referred to in sub-paragraph (a).

(3) The following products are excluded from the definition in paragraph (2)—

(a)medical devices intended for use in a medical environment;

(b)equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances;

(c)equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas;

(d)personal protective equipment covered by Council on the approximation of the laws of the member States relating to personal protective Directive 89/686/EECequipment(9);

(e)seagoing vessels and mobile offshore units together with equipment on board such vessels or units;

(f)means of transport (other than vehicles intended for use in a potentially explosive atmosphere), including vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks and means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water;

[^F34(g)products connected with the production of trade in arms, munitions and war material;^F34]

(h)products which have been placed on the market before the commencement date.

Exceptions for trade fairs, exhibitions and demonstrations_I4

4. The provisions of Part 2 (and of Part 5, so far as applying in relation to obligations under Part 2) do not apply to the showing of a product which is not in conformity with Part 2, at a trade fair, exhibition or demonstration, provided that a visible sign clearly indicates that—

(a)the product is not in conformity with Part 2, and

(b)the product is not available for sale until brought into conformity with Part 2.

PART 2Obligations of economic operators

Chapter 1Manufacturers

Design and manufacture in accordance with essential health and safety requirements_I5

5. Before placing a product on the market or using a product for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential health and safety requirements.

Technical documentation and conformity assessment_I6

6. Before placing a product on the market or using it for their own purposes, a manufacturer must—

(a)carry out the relevant conformity assessment procedure or have a relevant conformity assessment procedure carried out; and

[^F35(b)draw up the technical documentation referred to—

(i)for a product in respect of which the conformity assessment procedure in regulation 39(1)(a) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;

(ii)for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;

(iii)for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in paragraph 2 of Part 6 of Schedule 3A to these Regulations;

(iv)for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in paragraph 2 of Part 7 of Schedule 3A to these Regulations.^F35]

[^F36Declaration^F36] of conformity and [^F37UK^F37] marking_I7

7.—(1) Save for where a product is a component, where the conformity of a product with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—

(a)^F38draw up a declaration of conformity in accordance with regulation 40 (... declaration of conformity), and

(b)affix the [^F39UK^F39] Marking in accordance with regulation 41 ( [^F39UK^F39] Marking).

^F40(2) The manufacturer must keep the ... declaration of conformity up-to-date.

(3) Where the conformity of a component with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the component on the market, draw up a written attestation of conformity in accordance with regulation 39(3) (conformity assessment procedures).

^F41(4) Subject to paragraph (5), before placing a product on the market, the manufacturer must ensure that each product is accompanied by a copy of the ... declaration of conformity or attestation of conformity as appropriate.

^F42(5) Where a large number of products are delivered to a single user, the batch or consignment may be accompanied by a single copy of the ... declaration or attestation of conformity as appropriate.

[^F43(6)Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.^F43]

^F44Retention of technical documentation and ... declaration of conformity_I8

^F458. A manufacturer must keep the technical documentation and the ... declaration of conformity (or where applicable, the attestation of conformity) drawn up in respect of a product for a period of 10 years beginning on the day on which the product is placed on the market.

Compliance procedures for series production_I9

9.—(1) A manufacturer of a product which is manufactured by series production must ensure that, before placing a product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any change in the product design or characteristics, and

(b)^F47any change in a [^F46designated^F46] standard or in another technical specification by reference to which the ... declaration of conformity or attestation of conformity was drawn up.

Monitoring_I10

10.—(1) When appropriate, with regard to the risks to the health and safety of end-users presented by a product, a manufacturer must—

(a)carry out sample testing of a product manufactured by the manufacturer made available on the market,

(b)investigate complaints that a product manufactured by the manufacturer is not in conformity with Part 2, and

(c)keep distributors informed of any actions carried out under sub-paragraphs (a) and (b).

(2) A manufacturer must keep a register of—

(a)complaints that a product is not in conformity with Part 2,

(b)products which are found not to be in conformity with Part 2, and

(c)product recalls.

(3) A manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Labelling and packaging of products_I11

11.—(1) Before placing a product on the market, a manufacturer must ensure that it bears a type, batch or serial number or other element allowing its identification.

(2) If the size or nature of the product does not provide sufficient space for the labelling requirements in paragraph (1), the manufacturer must ensure that the information is provided on the packaging or in a document accompanying the product.

Labelling and packaging of products, other than components_I12

12. Save for where a product is a component, before placing a product on the market a manufacturer must ensure that it—

(a)bears the specific marking of explosion protection as referred to at paragraph 5(1)(f) of Schedule 1, and

(b)where applicable, bears the other markings and information referred to at paragraph 5 of Schedule 1.

Information identifying manufacturer_I13

13.—(1) Before placing a product on the market, a manufacturer must indicate on the product—

(a)the name, registered trade name or registered trade mark of the manufacturer, and

(b)a postal address at which the manufacturer can be contacted.

(2) Where it is not possible to indicate the information specified in paragraph (1) on the product, the manufacturer must indicate that information—

(a)on the product packaging, or

(b)in a document accompanying the product.

[^F48(3)The information specified in paragraph (1) must be in a language which can be easily understood by end users and the market surveillance authority.^F48]

[^F49Provision of instructions and safety information

14.When placing a product on the market, a manufacturer must ensure that a product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.^F49]

Duty to take action in respect of a product placed on the market which is considered not to be in conformity_I14

15.—(1) A manufacturer who considers, or has reason to believe, that a product which the manufacturer has placed on the market is not in conformity with Part 2, must immediately take the corrective measures necessary to—

(a)bring the product into conformity,

(b)withdraw the product, or

(c)recall the product.

^F50(2) Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority... of the risk, giving details of—

(a)the respect in which the product is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Provision of information and cooperation_I15

16.—(1) A manufacturer must, further to a reasoned request from the market surveillance authority, and within such period as the market surveillance authority may specify, provide the authority with the information and documentation necessary to demonstrate that the product is in conformity with Part 2—

(a)in paper or electronic form, and

(b)in a language which can be easily understood by the market surveillance authority.

(2) A manufacturer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—

(a)evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);

(b)eliminate the risks posed by a product which the manufacturer has placed on the market.

Authorised representatives_I16

17.—(1) A manufacturer may, by written mandate, appoint a person established in the [^F51United Kingdom^F51] as their authorised representative to perform specified tasks on the manufacturer’s behalf.

(2) A manufacturer who has appointed an authorised representative to perform, on the manufacturer’s behalf, a task under these Regulations remains responsible for the proper performance of that task.

(3) The obligations laid down in regulation 5 (design and manufacture in accordance with essential health and safety requirements) and regulation 6(b) (technical documentation and conformity assessment) must not form part of an authorised representative’s mandate.

(4) The mandate must allow the authorised representative to do at least the following in relation to a product covered by the mandate—

(a)^F52perform the manufacturer’s obligations under regulation 8 (retention of technical documentation and ... declaration of conformity), and

(b)perform the manufacturer’s obligations under regulation 16 (provision of information and cooperation).

(5) An authorised representative must comply with all duties imposed on the manufacturer in relation to each obligation under these Regulations that the authorised representative is appointed by the mandate to perform and, accordingly as far as those duties are concerned, as well as the penalties for failure to comply with those duties, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.

Chapter 2Importers

Prohibition on placing on the market products which are not in conformity_I17

18. An importer must not place a product on the market unless it is in conformity with the essential health and safety requirements.

Requirements which must be satisfied before an importer places a product on the market_I18

19.—(1) Before placing a product on the market, an importer must ensure that—

(a)a relevant conformity assessment procedure has been carried out by the manufacturer,

(b)the manufacturer has drawn up the technical documentation,

(c)the product—

(i)bears the [^F53UK^F53] marking where applicable,

(ii)^F54is accompanied by the ... declaration of conformity or the attestation of conformity as appropriate, and

(iii)is accompanied by the required documents, and

(d)the manufacturer has complied with the requirements set out in regulation 11 (labelling and packaging of products), regulation 12 (labelling and packaging of products, other than components) and regulation 13 (information identifying manufacturer).

(2) In paragraph (1)(c)(iii), “required documents” means any documents that are required to be provided with a product pursuant to—

(a)regulation 11(2) (labelling and packaging of products);

(b)regulation 13(2)(b) (information identifying manufacturer);

(c)regulation [^F5514 (provision of instructions and safety information)^F55] .

Prohibition on placing on the market products considered not to be in conformity with the essential health and safety requirements_I19

20.—(1) Where an importer considers, or has reason to believe, that a product is not in conformity with the essential health and safety requirements, the importer must not place the product on the market.

(2) Where the product presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Information identifying importer_{cross-notesI20}

21.—(1) Before placing a product on the market, an importer must indicate on the product—

(a)the name, registered trade name or registered trade mark of the importer, and

(b)a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and [^F56the market surveillance authority^F56] .

[^F57(3)Paragraph (1) does not apply where—

(a)either—

(i)it is not possible to set out the information referred to in paragraph (1) on the product, or

(ii)the importer has imported the product from an EEA state or Switzerland and places it on the market within the period of [^F58seven years^F58] beginning with IP completion day, and

(b)before placing the product on the market, the importer sets out the information referred to in paragraph (1)—

(i)on the packaging; or

(ii)in a document accompanying the product.^F57]

[^F59Provision of Instructions and safety information

22.When placing a product on the market, an importer must ensure that the product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.^F59]

Storage and transport_I21

23. Each importer must ensure that, whilst a product is under that importer’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential health and safety requirements.

Monitoring_I22

24.—(1) When deemed appropriate, with regard to the risks to the health and safety of end-users presented by a product, an importer must—

(a)carry out sample testing of a product made available by the importer on the market,

(b)investigate complaints that a product placed on the market by the importer is not in conformity with Part 2, and

(c)keep distributors informed of actions carried out under sub-paragraphs (a) and (b).

(2) An importer must keep a register of—

(a)complaints that a product is not in conformity with Part 2,

(b)products which are found not to be in conformity with Part 2, and

(c)product recalls.

(3) An importer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Duty to take action in respect of a product placed on the market which is considered not to be in conformity_I23

25.—(1) An importer who considers, or has reason to believe, that a product which the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring the product into conformity,

(b)withdraw the product, or

(c)recall the product.

^F60(2) Where the product presents a risk, the importer must immediately inform the market surveillance authority... of the risk, giving details of—

(a)the respect in which the product is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Provision of information and cooperation_I24

26.—(1) An importer must, further to a reasoned request from the market surveillance authority and within such period as the market surveillance authority may specify, provide the authority with the information and documentation necessary to demonstrate that the product is in conformity with Part 2—

(a)in paper or electronic form, and

(b)in a language which can be easily understood by the market surveillance authority.

(2) An importer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—

(a)evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);

(b)eliminate the risks posed by the product which the importer has placed on the market.

^F61Retention of technical documentation and ... declaration of conformity_I25

27. An importer must, for a period of ten years beginning on the day on which the product was placed on the market, keep and, upon request, make available to the market surveillance authority—

(a)^F62a copy of the ... declaration of conformity or, where applicable, the attestation of conformity, and

(b)the technical documentation.

Chapter 3Distributors

Duty to act with due care_I26

28. When making a product available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Requirements which must be satisfied before a distributor makes a product available on the market_I27

29.—(1) Before making a product available on the market, the distributor must verify that—

(a)the product—

(i)bears a [^F63UK^F63] marking where applicable;

(ii)^F64is accompanied by the ... declaration of conformity or the attestation of conformity;

(iii)is accompanied by the required documents;

[^F65(iv)is accompanied by instructions and safety information that are clear, legible and in easily understandable English;^F65]

(b)the manufacturer has complied with the requirements set out in regulation 11 (labelling and packaging of products), regulation 12 (labelling and packaging of products, other than components) and regulation 13 (information identifying manufacturer);

(c)the importer has complied with the requirements set out in regulation 21 (information identifying importer).

(2) In paragraph (1)(a)(iii), “required documents” means the documents that the manufacturer or importer is required to provide with the product pursuant to—

(a)regulation 11(2) (labelling and packaging of products);

(b)regulation 13(2)(b) (information identifying manufacturer);

(c)regulation 21(3)(b) (information identifying importer).

Storage and transport_I28

30. Each distributor must ensure that, whilst a product is under that distributor’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential health and safety requirements.

Prohibition on making available on the market where product not considered to be in conformity with safety objectives_I29

31.—(1) Where a distributor considers, or has reason to believe, that a product is not in conformity with the essential health and safety requirements, the distributor must not make the product available on the market.

(2) Where the product presents a risk, the distributor must inform the following persons of the risk—

(a)the manufacturer or the importer, and

(b)the market surveillance authority.

Duty to take action in respect of products made available on the market which are not in conformity_I30

32.—(1) A distributor who considers, or has reason to believe, that a product which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—

(a)bring that product into conformity,

(b)withdraw the product, or

(c)recall the product.

^F66(2) Where the product presents a risk, the distributor must immediately inform the market surveillance authority... of that risk, giving details of—

(a)the respect in which the product is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Provision of information and cooperation_I31

33.—(1) A distributor must, further to a reasoned request from the market surveillance authority and within such period as the authority may specify, provide the authority with the information and documentation, in paper or electronic form, necessary to demonstrate that the product is in conformity with Part 2.

(2) A distributor must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—

(a)evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);

(b)eliminate the risks posed by a product which the distributor has made available on the market.

Chapter 4Importers and distributors

Cases in which obligations of manufacturers apply to importers and distributors_I32

34. An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of these Regulations and is subject to the obligations of the manufacturer under this Part, where A—

(a)places a product on the market under A’s own name or trademark; or

(b)modifies a product already placed on the market in such a way that it may affect whether the product is in conformity with Part 2.

Chapter 5All economic operators

Identification of economic operators_I33

35.—(1) An economic operator (“E”) who receives a request from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority—

(a)any economic operator who has supplied E with a product, and

(b)any economic operator to whom E has supplied a product.

(2) The relevant period is—

(a)for information under paragraph (1)(a), a period of 10 years beginning on the day on which E was supplied with the product;

(b)for information under paragraph (1)(b), a period of 10 years beginning on the day on which E supplied the product.

Prohibition on improper use of [^F67UK^F67] marking_I34

36.—(1) An economic operator must not affix the [^F68UK^F68] marking to a product unless—

(a)that economic operator is the manufacturer, and

(b)the conformity of the product with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix to a product a marking (other than the [^F68UK^F68] marking) which purports to attest that the product is in conformity with the essential health and safety requirements.

(3) An economic operator must not affix to a product a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [^F68UK^F68] marking.

(4) An economic operator must not affix to a product any other marking if the visibility, legibility and meaning of the [^F68UK^F68] marking would be impaired as a result.

[^F69Obligations which are met by complying with obligations in the ATEX Directive

36A.—(1)In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the ATEX Directive;

(b)“CE marking” has the meaning given to it in Article 2(26); and

(c)“harmonised standard” has the meaning given to in in Article 2(18).

(2)^F70... Paragraph (3) applies where, before placing the product on the market, the manufacturer—

(a)ensures that the product has been designed and manufactured in accordance with the [^F71essential health and safety requirements^F71] set out in Annex II;

(b)ensures that the relevant conformity assessment procedures that apply to that product in accordance with Article 13(1) and (2) have been carried out;

(c)draws up the technical documentation referred to in Annexes III to IX;

(d)ensures that the records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e)affixes a CE marking and the inscriptions in accordance with Articles 15 and 16(1) to (4);

(f)draws up an EU declaration of conformity, in accordance with Article 14; and

(g)ensures that the declaration of conformity is prepared in or translated into English.

(3)Where this paragraph applies—

(a)the requirements of regulations 5, 6, 7(1), (3) and 7(6) are to be treated as being satisfied;

(b)regulations 2(a), 7(6), 8, 9(2), 17(4), 36 and 59 apply subject to the modifications in paragraph (10);

(c)Part 3 does not apply; and

(d)regulation 57 does not apply.

(4)^F72... Paragraph (5) applies where, before placing a product on the market, the importer ensures that—

(a)the relevant conformity assessment procedure referred to in Article 13 has been carried out;

(b)the manufacturer has drawn up the technical documents relevant to the conformity assessment procedure followed; and

(c)the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II.

(5)Where this paragraph applies—

(a)the requirements of regulation 19(1)(a) to (c) are to be treated as being satisfied; and

(b)regulations 2(a),18, 23 and 27 apply subject to the modifications in paragraph (10).

^F73(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F74(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8)Paragraph (9) applies where, before making a product available on the market, a distributor ensures that the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II.

(9)Where this paragraph applies—

(a)regulation 29(1)(a)(i) is to be treated as being satisfied; and

(b)regulations 2(a), 30 and 31(1) apply subject to the modifications in paragraph (10).

(10)The modifications referred to in subparagraphs (3)(b), (5)(b) and (9)(b) are that—

(a)any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b)any reference to “UK marking” is to be read as reference to the CE marking;

(c)any reference to “[^F71essential health and safety requirements^F71]” is to be read as a reference to the [^F71essential health and safety requirements^F71] referred to in Annex II;

(d)any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 13;

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Annexes III to IX.

Conformity assessment procedure obligation which is met by complying with the ATEX Directive

36B.—(1)In this regulation any reference to an Article or Annex is a reference to an Article or an Annex of the ATEX Directive;

(2)Paragraph (3) applies where, prior to the manufacture of a product, the manufacturer ensures that the conformity assessment procedure that applies to that product in accordance with Annex III as referred to in Article 13(1)(a) and (b) has been carried out.

(3)Where this paragraph applies—

(a)any requirement to follow the Type-examination set out in Part 1 of Schedule 3A in regulation 39 is to be treated as being satisfied;

(b)any reference to “relevant conformity assessment procedure” in regulations 6(a), 7(1), 19(a), 36(1)(b), 40(c) and 41(3) is to be read as including the conformity assessment procedure set out in Annex III as referred to in Article 13(1)(a) and (b); and

(c)any reference to “technical documentation” in regulations 6(b), 8, 19(b) and 27(b) is to be read as including the technical documentation relating to the design of the product referred to in Annex III.

[^F75Further Use of UK marking

36C.—(1)In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the ATEX Directive;

(b)“harmonised standard” has the meaning given to it in Article 2(18).

(2)Paragraph (3) applies where, before placing a product on the market, the manufacturer— 

(a)ensures that the product has been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II;

(b)ensures that the relevant conformity assessment procedures that apply to the product in accordance with Article 13(1) and (2) have been carried out;

(c)draws up the technical documentation referred to in Annexes III to IX; and

(d)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.

(3)Where this paragraph applies—

(a)regulations 5 and 6 are to be treated as being satisfied;

(b)except for regulations 40 and 41(1) to (2) and (5) to (6), Part 3 does not apply;

(c)regulations 2(2)(a), 7 to 9, 18, 19(1)(a) and (b), 20, 23, 27, 30, 31, 36 and 59 apply subject to the modifications in paragraph (4);

(d)regulations 40 and 41(6) and Schedule 6 apply subject to the modifications in paragraphs (4) and (5).

(4)The modifications referred to in paragraph (3)(c) and (d) are that—

(a)any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements set out in Annex II;

(b)any reference to “designated standard” is to be read as a reference to a harmonised standard;

(c)any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to that product in accordance with Article 13;

(d)any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annexes III to IX.

(5)The modifications referred to in paragraph (3)(d) are that—

(a)in regulation 40, the reference to “Schedule 3A to these Regulations” is to be read as a reference to Annexes III to IX;

(b)regulation 41(5) is to be read as if the words beginning with “and, where” and ending with “body” were omitted;

(c)in Schedule 6—

(i)in paragraph 5 the reference to “statutory requirements” is to be read as including the ATEX Directive;

(ii)in paragraph 7 the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 13.^F75]

Qualifying Northern Ireland Goods

36D.—(1)In this regulation—

“the 2017 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017;

“CE marking” has the meaning given to it in regulation 2(1) of the 2017 Regulations;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1) of the 2017 Regulations;

“technical documentation” has the meaning given to it in regulation 2(1) of the 2017 Regulations.

(2)Where paragraph (3) applies, a product is to be treated as being in conformity with Part 2.

(3)This paragraph applies where—

(a)a product—

(i)is in conformity with Part 2, within the meaning of regulation 2(2) of the 2017 Regulations; and

(ii)is qualifying Northern Ireland goods; and

(b)an importer has complied with the obligations set out in paragraph (4).

(4)The obligations referred to in paragraph (3)(b) are that, before placing the product on the market, the importer—

(a)complies with regulation 21;

(b)ensures that—

(i)the relevant conformity assessment procedure has been carried out in relation to the product;

(ii)the manufacturer has drawn up the technical documentation; and

(iii)the product bears the CE marking.^F69]

Translation of declaration of conformity

^F7637. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3Conformity assessment

Presumption of conformity_I35

^F7838.—(1) A product which is in conformity with a [^F77designated^F77] standard (or part of such a standard) ... is presumed to be in conformity with the essential health and safety requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Conformity assessment procedures_I36

39.—(1) For the assessment of conformity of equipment, and where necessary those devices referred to at regulation 3(2)(b), the manufacturer must follow one of the following procedures—

[^F79(a)for equipment-groups I and II, equipment-categories M1 and 1, the manufacturer must follow either—

(i)the Type-examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in—

(aa)Part 2 of Schedule 3A, or

(bb)Part 3 of Schedule 3A; or

(ii)the conformity based on unit verification referred to in Part 7 of Schedule 3A;^F79]

[^F80(b)for equipment-groups I and II, equipment-categories M2 and 2, the manufacturer must follow—

(i)for internal combustion engines and electrical equipment in these groups and categories the Type examination set out in Part 1 of Schedule 3A, in conjunction with either the procedure set out in either Part 4 or Part 5 of Schedule 3A;

(ii)for other equipment in these groups and categories the procedures set out in Part 6 of Schedule 3A;^F80]

[^F81(c)for equipment group II, equipment-category 3, the procedure relating to internal production control referred to in Part 6 of Schedule 3A;^F81]

[^F82(d)for equipment-groups I and II, instead of the procedures referred to in paragraphs (1)(a), (b) and (c), the manufacturer may follow conformity based on unit verification referred to in Part 7 of Schedule 3A.^F82]

(2) The procedure referred to in paragraph (1)(a) or (d) must be used for the conformity assessment of protective systems.

(3) For the assessment of conformity of components, the manufacturer must—

(a)follow the procedures referred to in paragraph (1), with the exception of—

(i)affixing the [^F83UK^F83] marking;

(ii)^F84drawing up of the ... declaration of conformity;

(b)issue a written attestation of conformity which must—

(i)confirm conformity of the component with Part 2 of these Regulations,

(ii)state the characteristics of the component, and

(iii)explain how the component must be incorporated into equipment or protective systems to comply with the essential health and safety requirements.

(4) In respect of the safety aspects referred to in paragraph 13 of Schedule 1, instead of the conformity assessment procedures referred to in paragraphs (1) and (2), the manufacturer may follow the procedure referred to in [^F85Part 6 of Schedule 3A^F85] .

^F86(5) Where the procedures referred to in paragraphs (1), (2) and (4) have not been applied, the market surveillance authority, may authorise the placing on the market and the putting into service, of a product other than a component, ... where—

(a)the market surveillance authority is in receipt of a duly justified request, requesting the placing on the market and the putting into service of a product, other than a component, and

(b)the use of that product is in the interests of protection.

(6) The manufacturer must ensure that the documents and correspondence relating to the conformity assessment procedures referred to in paragraphs (1) to (4) are in [^F87English^F87] .

^F88... Declaration of conformity_I37

^F8940. The ... declaration of conformity for a product must—

(a)state that the fulfilment of the essential health and safety requirements have been demonstrated in respect of the product;

(b)have the model structure set out in Schedule 6;

(c)contain the elements specified in [^F90Schedule 3A to these Regulations^F90] for the relevant conformity assessment procedure followed in respect of the product.

[^F91UK^F91] Marking_I38

41.[^F92—(1)The UK marking must be affixed visibly, legibly and indelibly—

(a)to the product;

(b)to its data plate; or

(c)where paragraph (1A) applies, to—

(i)a label affixed to the product; or

(ii)a document accompanying the product.^F92]

[^F93(1A)For a period of [^F94seven years^F94] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the product; or

(b)a document accompanying the product.^F93]

(2) Where [^F95paragraph (1A) does not apply and^F95] it is not possible or warranted, on account of the nature of the product, to affix the [^F96UK^F96] marking in accordance with [^F97paragraph (1)(a) or (b)^F97] , the [^F96UK^F96] marking must be affixed to—

(a)the packaging, and

(b)the accompanying documents.

(3) The [^F96UK^F96] marking must be followed by the identification number of the [^F98approved body^F98] which carried out the relevant conformity assessment procedure for the product, where that body is involved in the production control phase.

(4) The identification number of the [^F98approved body^F98] must be affixed—

(a)by the [^F98approved body^F98] itself, or

(b)under the instructions of the [^F98approved body^F98] , by the manufacturer or the authorised representative.

(5) The [^F96UK^F96] marking and, where applicable, the identification number of the [^F98approved body^F98] must be followed by—

(a)the specific marking of explosion protection as referred to in paragraph 5(1)(f) of Schedule 1,

(b)the symbols of the equipment-group and category, and

(c)where applicable, the other markings and information referred to in paragraph 5 of Schedule 1.

(6) Products designed for a particular explosive atmosphere must be marked accordingly.

[^F99PART 4Approval of Conformity Assessment Bodies

Approved bodies

42.—(1)An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 43 (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State has taken no action under regulation 48(1) or (2) as it had effect immediately before IP completion day to restrict, suspend or withdraw the body's status as a notified body.

(2)Paragraph (1) has effect subject to regulation 46 (restriction, suspension or withdrawal of approval).

(3)In this Part—

“notified body” means a body—

“approved body requirements” means the requirements set out in Schedule 2.

Approval of conformity assessment bodies

43.—(1)The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2)A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3)The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii)the category of products in respect of which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate, or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(4)The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5)For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6)When deciding whether to approve a conformity assessment body that applies for approval, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7)For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

Presumption of conformity of approved bodies

44.—(1)Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or part of that standard).

(2)The presumption in paragraph (1) is rebuttable.

Monitoring

45.The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet the approved body requirements;

(b)meets any conditions set—

(i)in accordance with regulation 43(6)(b), or

(ii)in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 43(6)(b) as it applied immediately before IP completion day; and

(c)carries out its functions in accordance with these Regulations.

Restriction, suspension or withdrawal of approval

46.—(1)Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 45(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 42 (approved bodies).

(2)Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 45(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 42.

(3)In deciding what action is required under paragraph (1) or (2) the Secretary of State must have regard to the seriousness of the non-compliance.

(4)Before taking action under paragraph (1) or (2) the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

(5)Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a)transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State, or

(b)keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created.

(6)The activities undertaken by an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.

Operational matters in relation to approved bodies

47.—(1)Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures—

(a)in respect of which the body's approval was given under regulation 43, or

(b)in respect of which the body's notification as a notified body was made.

(2)Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 3.

(3)An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body—

(a)to issue a Type examination certificate referred to in Part 1 of Schedule 3B;

(b)to affix, or cause to be affixed, the body's identification number pursuant to regulation 41 (UK marking).

Subsidiaries and contractors

48.—(1)An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meet the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meet those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2)The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3)Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documents concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

(4)In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006;

Register of approved bodies

49.—(1)The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body notification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2)The register referred to in paragraph (1) must be made publicly available.

UK national accreditation body

50.The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements;

(b)monitoring approved bodies in accordance with regulation 45; and

(c)compiling and maintaining the register of approved bodies, in accordance with regulation 49.^F99]

PART 5Market surveillance and enforcement

Designation of market surveillance authority_I39

51.—(1) Save where paragraph (2) applies, the market surveillance authority in Great Britain for a product is the Health and Safety Executive.

(2) The market surveillance authority in Great Britain for a product is the Office for Nuclear Regulation, in so far as these Regulations apply to—

(a)any person who places on the market or supplies a product intended exclusively or primarily for use on a GB nuclear site;

(b)any person who puts into service a product on a relevant nuclear site.

(3) In paragraph (2), “relevant nuclear site” means a site which is—

(a)a GB nuclear site;

(b)an authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998);

(c)a new nuclear build site (within the meaning given in regulation 2A of the Health and Safety (Enforcing Authority) Regulations 1998).

(4) In paragraphs (2) and (3), “GB nuclear site” means a nuclear site in Great Britain (within the meaning given in section 68 of the Energy Act 2013(10)).

Enforcement_I40

52.—(1) The market surveillance authority must enforce these Regulations and RAMS in its application to a product.

(2) In Scotland, only the Lord Advocate may prosecute an offence under these Regulations.

Enforcement powers_I41

53.—(1)Schedule 4 (enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act) is to have effect.

(2) In addition to the powers available to the market surveillance authority under paragraph (1), the authority may use the powers set out in Schedule 5 (compliance, withdrawal and recall notices).

Exercise of enforcement powers_I42

54. When enforcing these Regulations, the market surveillance authority must exercise its powers in a manner which is consistent with—

(a)regulation 55 (evaluation of a product presenting a risk);

(b)regulation 56 (enforcement action in respect of products which are not in conformity and which present a risk);

^F100(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)regulation 58 (enforcement action in respect of products which are in conformity, but present a risk);

(e)regulation 59 (enforcement action in respect of formal non-compliance);

(f)regulation 60 (restrictive measures).

Evaluation of a product presenting a risk_I43

55. Where the market surveillance authority has sufficient reason to believe that a product presents a risk, the market surveillance authority must carry out an evaluation in relation to the product covering the relevant requirements of Part 2.

Enforcement action in respect of products which are not in conformity and which present a risk_I44

56.—(1) Where, in the course of the evaluation referred to in regulation 55, the market surveillance authority finds that the product is not in conformity with Part 2, it must, without delay, require a relevant economic operator to—

(a)take appropriate corrective action to bring the product into conformity with those requirements within a prescribed period,

(b)withdraw the product within a prescribed period, or

(c)recall the product within a prescribed period.

(2) The market surveillance authority must inform the [^F101approved^F101] body which carried out the conformity assessment procedure in respect of the product of—

(a)the respect in which the product is not in conformity with Part 2, and

(b)the actions which the market surveillance authority is requiring the relevant economic operator to take.

(3) Where the market surveillance authority considers that the lack of conformity referred to in paragraph (1) is not restricted to Great Britain, it must notify the Secretary of State of—

(a)the results of the evaluation, and

(b)the actions which it has required the economic operator to take.

(4) Where the Secretary of State receives a notice under paragraph (3), or otherwise considers that the lack of conformity referred to in paragraph (1) is not restricted to Great Britain, the Secretary of State must inform the [^F102Health and Safety Executive for Northern Ireland^F102] of—

(a)the results of the evaluation, and

(b)the actions which the market surveillance authority has required the economic operator to take.

(5) Where the relevant economic operator does not take adequate corrective action within the prescribed period, the market surveillance authority must take appropriate measures to—

(a)prohibit or restrict the product being made available on the market in Great Britain,

(b)withdraw the product from the market in Great Britain, or

(c)recall the product.

(6) Where the market surveillance authority takes measures under paragraph (5), it must notify the Secretary of State of those measures without delay.

(7) Where the Secretary of State receives a notice under paragraph (6), the Secretary of State must notify the [^F103Health and Safety Executive for Northern Ireland^F103] of those measures without delay.

(8) The notices in paragraphs (6) and (7) must include details about the product and, in particular—

(a)the data necessary for the identification of the product which is not in conformity with Part 2;

(b)the origin of the product;

(c)the nature of the lack of conformity alleged and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the relevant economic operator;

(f)whether the lack of conformity is due to either of the following—

(i)failure of the product to meet requirements relating to a risk;

(ii)shortcomings in the [^F104designated^F104] standards referred to in regulation 38 (presumption of conformity) conferring a presumption of conformity.

(9) In this regulation, “prescribed period” means a period which is—

(a)prescribed by the market surveillance authority;

(b)reasonable and commensurate with the nature of the risk presented by the product.

EU safeguard procedure

^F10557. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enforcement action in respect of products which are in conformity, but present a risk_I45

58.—(1) Where, having carried out an evaluation under regulation 55, the market surveillance authority finds that although a product is in conformity with Part 2, it presents a risk, the market surveillance authority must require a relevant economic operator to take appropriate measures to—

(a)ensure that the product concerned, when placed on the market, no longer presents a risk,

(b)withdraw the product within a prescribed period, or

(c)recall the product within a prescribed period.

(2) Where the market surveillance authority takes measures under paragraph (1), it must notify the Secretary of State immediately.

(3) Where the Secretary of State receives a notice under paragraph (2), the Secretary of State must notify [^F106the Health and Safety Executive for Northern Ireland^F106] immediately.

(4) The notices referred to in paragraphs (2) and (3) must include details about the product and, in particular—

(a)the data necessary for the identification of the product concerned;

(b)the origin and the supply chain of the product;

(c)the nature of the risk involved;

(d)the nature and duration of the measures taken by the market surveillance authority.

(5) In this regulation, “prescribed period” means a period which is—

(a)prescribed by the market surveillance authority;

(b)reasonable and commensurate with the nature of the risk presented by the product.

Enforcement action in respect of formal non-compliance_I46

59.—(1) Where the market surveillance authority makes one of the following findings relating to a product, it must require a relevant economic operator to remedy the non-compliance concerned within a specified period—

(a)the [^F107UK^F107] marking—

(i)where required, has not been affixed;

(ii)has been affixed otherwise than in accordance with regulations 36 (prohibition on improper use of [^F107UK^F107] marking) and 41 ( [^F107UK^F107] marking);

(b)where [^F108an approved^F108] body is involved in the production control phase for the product, the identification number of the notified body—

(i)has not been affixed;

(ii)has been affixed otherwise than in accordance with regulation 41;

(c)^F109the ... declaration of conformity or the attestation of conformity as appropriate—

(i)does not accompany the product;

(ii)^F109,F109has been drawn up otherwise than in accordance with regulations 7 (... declaration of conformity and [^F110UK^F110] marking) and 40 (... declaration of conformity);

(d)the technical documentation is either not available or not complete;

(e)the following product information has not been affixed or has been affixed otherwise than in accordance with paragraph 5 of Schedule 1—

(i)specific marking of explosion protection in accordance with paragraph 5(1)(f) of Schedule 1;

(ii)the symbols of the equipment-group and category in accordance with paragraph 5(1)(g) of Schedule 1;

(iii)where applicable, the other markings and information required by paragraph 5(1) of Schedule 1;

(f)the following information that is required to be included in the labelling of the product is absent, false or incomplete—

(i)the information specified in regulation 13 (information identifying manufacturer)

(ii)the information specified in regulation 21 (information identifying importer);

(g)any other administrative requirement imposed on the manufacturer or importer under Part 2 has not been fulfilled.

(2) The market surveillance authority must not take any enforcement action against the relevant economic operator under these Regulations in respect of the non-compliance concerned until the period referred to in paragraph (1) has elapsed.

(3) Where the non-compliance referred to in paragraph (1) persists, the market surveillance authority must take appropriate measures to—

(a)restrict or prohibit the product being made available on the market,

(b)ensure that the product is withdrawn, or

(c)ensure that the product is recalled.

(4) This regulation does not apply where a product presents a risk.

Restrictive measures_I47

60. When enforcing these Regulations, the market surveillance authority must comply with the requirements of Article 21 of RAMS (as amended from time to time) in relation to any measure to—

(a)prohibit or restrict a product being made available on the market,

(b)withdraw a product, or

(c)recall a product.

Offences_I48

61.—(1) It is an offence for a person to contravene or fail to comply with any requirement of regulations 5 to 15, 16(2), 18 to 25, 26(2), 27 to 32, 33(2), 35 or 36.

(2) It is an offence for any person to contravene or fail to comply with any requirement of a withdrawal or recall notice served on that person by the market surveillance authority under these Regulations.

Penalties_I49

62. A person guilty of an offence under regulation 61 is liable—

(a)on summary conviction—

(i)in England and Wales, to a fine or imprisonment for a term not exceeding 3 months or to both;

(ii)in Scotland, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding 3 months, or to both;

(b)on conviction on indictment, to a fine or imprisonment for a term not exceeding 2 years or to both.

Defence of due diligence_I50

63.—(1) Subject to paragraphs (2) and (4), in proceedings for an offence under regulation 61, it is a defence for a person (“P”) to show that P took all reasonable steps and exercised all due diligence to avoid committing the offence.

(2) P may not rely on a defence under paragraph (1) which involves a third party allegation unless P has—

(a)served a notice in accordance with paragraph (3), or

(b)obtained the leave of the court.

(3) The notice must—

(a)give any information in P’s possession which identifies or assists in identifying the person who—

(i)committed the act or default, or

(ii)supplied the information on which P relied;

(b)be served on the person bringing the proceedings not less than 7 clear days before—

(i)in England and Wales, the hearing of the proceedings;

(ii)in Scotland, the trial diet.

(4) P may not rely on a defence under paragraph (1) which involves an allegation that the commission of the offence was due to reliance on information supplied by another person unless it was reasonable for P to have relied upon the information, having regard in particular to—

(a)the steps that P took, and those which might reasonably have been taken, for the purpose of verifying the information, and

(b)whether P had any reason to disbelieve the information.

(5) In this regulation, “third party allegation” means an allegation that the commission of the offence was due—

(a)to the act or default of another person; or

(b)to reliance on information supplied by another person.

Liability of persons other than principal offender_I51

64.—(1) Where the commission of an offence by one person (“A”) under regulation 61 is due to anything which another person (“B”) did or failed to do in the course of business, B is guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against A.

(2) Where a body corporate commits an offence, a relevant person is also guilty of the offence where the body corporate’s offence was committed—

(a)with the consent or connivance of the relevant person, or

(b)as a result of the negligence of the relevant person.

(3) In paragraph (2), “relevant person” means any of the following—

(a)a director, manager, secretary or other similar officer of the body corporate;

(b)in relation to a body corporate managed by its members, a member of that body corporate performing managerial functions;

(c)in relation to a Scottish partnership, a partner;

(d)a person purporting to act as a person described in sub-paragraphs (a), (b) or (c).

Time limit for prosecution of offences_I52

65.—(1) Subject to paragraph (3), in England and Wales, information relating to an offence under regulation 61 that is triable by a magistrates’ court may be so tried if it is laid within 12 months after the date on which evidence which is sufficient in the opinion of the prosecutor to justify the proceedings comes to the knowledge of the prosecutor.

(2) Subject to paragraph (3), in Scotland—

(a)summary proceedings for an offence under regulation 61 may be commenced before the end of 12 months after the date on which evidence which is sufficient in the Lord Advocate’s opinion to justify the proceedings came to the Lord Advocate’s knowledge;

(b)section 136(3) of the Criminal Procedure (Scotland) Act 1995 (time limit for certain offences) applies for the purpose of this paragraph as it applies for the purpose of that section.

(3) No proceedings may be brought more than 3 years after the commission of the offence.

(4) For the purposes of this regulation a certificate of the prosecutor (or in Scotland, the Lord Advocate) as to the date on which the evidence referred to paragraphs (1) and (2) came to light, is conclusive evidence.

(5) This regulation has effect subject to paragraphs 1(n) and 2(o) of Schedule 4 (enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act).

Service of documents_I53

66.—(1) Any document required or authorised by these Regulations to be served on a person may be served by—

(a)delivering it to that person in person,

(b)leaving it at that person’s proper address, or

(c)sending it by post or electronic means to that person’s proper address.

(2) In the case of a body corporate, a document may be served on a director of that body.

(3) In the case of a partnership, a document may be served on a partner or a person having control or management of the partnership business.

(4) For the purposes of this regulation, “proper address” means—

(a)in the case of a body corporate or its director—

(i)the registered or principal office of that body;

(ii)the email address of the secretary or clerk of that body;

(b)in the case of a partnership, a partner or person having control or management of the partnership business—

(i)the principal office of the partnership;

(ii)the email address of a partner or person having that control or management;

(c)in any other case, a person’s last known address, which includes an email address.

(5) If a person to be served with a document has specified an address in the United Kingdom (other than that person’s proper address) at which that person or someone on that person’s behalf will accept service, that address must also be treated as that person’s proper address.

(6) In this regulation, “partnership” includes a Scottish partnership.

Recovery of expenses of enforcement_I54

67.—(1) This regulation applies where a person commits an offence under regulation 61.

(2) The court may (in addition to any other order it may make as to costs or expenses) order the person to reimburse the market surveillance authority for any expenditure which the market surveillance authority has incurred in investigating the offence.

Action by the market surveillance authority_I55

68.—(1) The market surveillance authority may itself take action which an economic operator could have been required to take by a notice served under these Regulations where the conditions for serving such a notice are met and either—

(a)the market surveillance authority has been unable to identify any economic operator on whom to serve such a notice, or

(b)the economic operator on whom such a notice has been served has failed to comply with it.

(2) If the market surveillance authority has taken action as a result of the condition in paragraph (1)(b) being met, the authority may recover from the economic operator, as a civil debt, any costs or expenses reasonably incurred by the market surveillance authority in taking the action.

(3) A civil debt recoverable under paragraph (2) may be recovered summarily in England and Wales by way of a complaint pursuant to section 58 of the Magistrates’ Courts Act 1980(11).

Appeals against notices_I56

69.—(1) An application for an order to vary or set aside the terms of a notice served under these Regulations may be made—

(a)by the economic operator on whom the notice has been served;

(b)in the case of a notice other than a recallnotice, by a person having an interest in the product in respect of which the notice has been served.

(2) An application must be made before the end of the period of 21 days beginning with the day on which the notice was served.

(3) The appropriate court may only make an order setting aside a notice served under these Regulations if satisfied—

(a)that the product to which the notice relates is in conformity with Part 2 and does not present a risk;, or

(b)that the market surveillance authority failed to comply with regulation 54 (exercise of enforcement powers) when serving the notice.

(4) On an application to vary the terms of a notice served under these Regulations, the appropriate court may vary the terms of the notice as it considers appropriate.

(5) In this regulation—

(a)the “appropriate court” is to be determined in accordance with regulation 70 (appropriate court for appeals against notices);

(b)“notice” means any of the following—

(i)a notice to warn served in accordance with Schedule 4 (enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act);

(ii)a suspension notice served in accordance with Schedule 4 ;

(iii)a compliance notice served in accordance with Schedule 5 (compliance, withdrawal and recall notices);

(iv)a withdrawal notice served in accordance with Schedule 5;

(v)a recallnotice served in accordance with Schedule 5.

Appropriate court for appeals against notices_I57

70.—(1) In England and Wales, the appropriate court for the purposes of regulation 69 is—

(a)the court in which proceedings have been brought in relation to the product for an offence under regulation 61 (offences),

(b)an employment tribunal seized of appeal proceedings against a notice which relates to the product and which has been served under or by virtue of paragraph 1 of Schedule 4 (Enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act), or

(c)in any other case, a magistrates’ court.

(2) In Scotland, the appropriate court for the purposes of regulation 69 is—

(a)the sheriff of a sheriffdom in which the person making the appeal resides or has a registered or principal office, or

(b)an employment tribunal seized of appeal proceedings against a notice which relates to the product and which has been served under or by virtue of paragraph 1 of Schedule 4 (Enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act).

(3) A person aggrieved by an order made by a magistrates’ court in England and Wales pursuant to an application under regulation 69, or by a decision of such a court not to make such an order, may appeal against that order or decision in England and Wales, to the Crown Court.

PART 6Miscellaneous

Review_I58

71.—(1) The Secretary of State must from time to time—

(a)carry out a review of these Regulations,

(b)set out the conclusions of the review in a report, and

(c)publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in other Member States.

(3) The report must, in particular—

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations,

(b)assess the extent to which those objectives are achieved, and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved by a system that imposes less regulation.

(4) The first report under this regulation must be published no later than 5 years after the commencement date.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding 5 years.

Transitional provisions_I59

72.—(1) A certificate issued, or approval granted, by a notified body under Schedule 6 to the 1996 Regulations, or any enactment of another Member State which implemented the 1994 Directive, is to be treated as a certificate issued or approval granted under the ATEX Directive.

^F111(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F112Transitional provision in relation to EU Exit

72A.—(1)In this regulation—

(2)Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 25 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

(3)Paragraph (2) does not apply to—

(a)any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or

(b)any obligation to take action outside of the market in respect of that product.

^F113(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F113(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F113(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .^F112]

Revocations and savings_I60

73.—(1) Subject to paragraph (3) [^F114and (3A)^F114] , the 1996 Regulations, the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (Amendment) Regulations 2001(12) and the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (Amendment) Regulations 2005(13) are revoked.

(2)The Electrical Equipment for Explosive Atmospheres (Certification) (Amendment) Regulations 1999(14) are revoked.

[^F115(3)Subject to the modifications made in paragraph (3A), the Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to a product placed on the market before the commencement date.^F115]

[^F116(3A)The modifications in the 1996 Regulations referred to in paragraph (3) are as follows—

(i)any reference to “the Community” shall be read as including the United Kingdom;

(ii)any reference to “member State” shall be read as including the United Kingdom;

(iii)any reference to “notified body” shall be read as “approved body” as defined in the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016.^F116]

Consequential Amendments_I61

74.—(1) In paragraph 1 of Schedule 3 to the Dangerous Substances and Explosive Atmospheres Regulations 2002(15) for “the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996” substitute “the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016”.

(2) In relation to a product placed on the market before the commencement date, the amendments in paragraph (1) do not apply.

Regulation 2(1)

SCHEDULE 1Essential Health and Safety Requirements

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)

Preliminary observations_I62

1.—(1) Technological knowledge which can change rapidly, must be taken into account as far as possible and be utilised immediately.

(2) For the devices referred to in regulation 3(2)(b), the essential health and safety requirements must apply only in so far as they are necessary for the safe and reliable functioning and operation of those devices with respect to the risks of explosion.

COMMON REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS

General requirements

Principles of integrated explosion safety_I63

2.—(1)Equipment and protective systems intended for use in potentially explosive atmospheres must be designed from the point of view of integrated explosion safety.

(2) In this connection, the manufacturer must take measures—

(a)above all, if possible, to prevent the formation of explosive atmospheres which may be produced or released by equipment and by protective systems themselves;

(b)to prevent the ignition of explosive atmospheres, taking into account the nature of every electrical and non-electrical source of ignition;

(c)should an explosion nevertheless occur which could directly or indirectly endanger persons and, as the case may be, domestic animals or property, to halt the explosion immediately or to limit the range of explosion flames and explosion pressures to a sufficient level of safety, or both.

(3)Equipment and protective systems must be designed and manufactured after due analysis of possible operating faults in order as far as possible to preclude dangerous situations.

(4) Any misuse which can reasonably be anticipated must be taken into account.

Special checking and maintenance conditions_I64

3.Equipment and protective systems subject to special checking and maintenance conditions must be designed and constructed with such conditions in mind.

Surrounding area conditions_I65

4.Equipment and protective systems must be so designed and constructed as to be capable of coping with actual or foreseeable surrounding area conditions.

Marking_I66

5.—(1) All equipment and protective systems must be marked legibly and indelibly with the following minimum particulars—

(a)name, registered trade name or registered trade mark, and address of the manufacturer;

(b)[^F117UK marking^F117] ;

(c)designation of series or type;

(d)batch or serial number, if any;

(e)year of construction;

(f)the specific marking of explosion protection followed by the symbol of the followed by the symbol of the equipment-group and category;

(g)for equipment-group II,

(i)the letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists); or

(ii)the letter ‘D’ (concerning explosive atmospheres caused by dust); or

(iii)both the letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists) and the letter ‘D’ (concerning explosive atmospheres caused by dust).

(2) Furthermore, where necessary, they must also be marked with all information essential to their safe use.

Instructions_I67

6.—(1) All equipment and protective systems must be accompanied by instructions, including at least the following particulars—

(a)a recapitulation of the information with which the equipment or protective system is marked, except for the batch or serial number (see paragraphs 5(1) and (2)), together with any appropriate additional information to facilitate maintenance (e.g. address of the repairer, etc.);

(b)instructions for safe—

(i)putting into service;

(ii)use;

(iii)assembling and dismantling;

(iv)maintenance (servicing and emergency repair);

(v)installation;

(vi)adjustment;

(c)where necessary, an indication of the danger areas in front of pressure-relief devices;

(d)where necessary, training instructions;

(e)details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category or a protective system can be used safely in the intended area under the expected operating conditions;

(f)electrical and pressure parameters, maximum surface temperatures and other limit values;

(g)where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur;

(h)where necessary, the essential characteristics of tools which may be fitted to the equipment or protective system.

(2) The instructions must contain the drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, where appropriate, repair of the equipment or protective system, together with all useful instructions, in particular with regard to safety.

(3) Literature describing the equipment or protective system must not contradict the instructions with regard to safety aspects.

Selection of materials_I68

7.—(1) The materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account foreseeable operational stresses.

(2) Within the limits of the operating conditions laid down by the manufacturer, it must not be possible for a reaction to take place between the materials used and the constituents of the potentially explosive atmosphere which could impair explosion protection.

(3) Materials must be so selected that predictable changes in their characteristics and their compatibility in combination with other materials will not lead to a reduction in the protection afforded; in particular, due account must be taken of the material’s corrosion and wear resistance, electrical conductivity, mechanical strength, ageing resistance and the effects of temperature variations.

Design and construction_I69

8.—(1)Equipment and protective systems must be designed and constructed with due regard to technological knowledge of explosion protection so that they can be safely operated throughout their foreseeable lifetime.

(2)Components to be incorporated into or used as replacements in equipment and protective systems must be so designed and constructed that they function safely for their intended purpose of explosion protection when they are installed in accordance with the manufacturer’s instructions.

Enclosed structures and prevention of leaks_I70

9.—(1)Equipment which may release flammable gases or dusts must, wherever possible, employ enclosed structures only.

(2) If equipment contains openings or non-tight joints, these must, as far as possible, be designed in such a way that releases of gases or dusts cannot give rise to explosive atmospheres outside the equipment.

(3) Points where materials are introduced or drawn off must, as far as possible, be designed and equipped so as to limit releases of flammable materials during filling or draining.

Dust deposits_I71

10.—(1)Equipment and protective systems which are intended to be used in areas exposed to dust must be so designed that deposit dust on their surfaces is not ignited.

(2) In general, dust deposits must be limited where possible. Equipment and protective systems must be easily cleanable.

(3) The surface temperatures of equipment parts must be kept well below the glow temperature of the deposit dust.

(4) The thickness of deposit dust must be taken into consideration and, if appropriate, means must be taken to limit the temperature in order to prevent a heat build up.

Additional means of protection_I72

11.—(1)Equipment and protective systems which may be exposed to certain types of external stresses must be equipped, where necessary, with additional means of protection.

(2)Equipment must withstand relevant stresses, without adverse effect on explosion protection.

Safe opening_I73

12. If equipment and protective systems are in a housing or a locked container forming part of the explosion protection itself, it must be possible to open such housing or container only with a special tool or by means of appropriate protection measures.

Protection against other hazards_I74

13.—(1)Equipment and protective systems must be so designed and manufactured as to—

(a)avoid physical injury or other harm which might be caused by direct or indirect contact;

(b)assure that surface temperatures of accessible parts or radiation which would cause a danger, are not produced;

(c)eliminate non-electrical dangers which are revealed by experience;

(d)assure that foreseeable conditions of overload do not give rise to dangerous situations.

(2) Where, for equipment and protective systems, the risks referred to in paragraph (1) are wholly or partly covered by [^F118any other enactment^F118] , these Regulations do not apply or cease to apply in the case of such equipment and protective systems and of such risks upon application of that specific [^F119enactment^F119] .

Overloading of equipment_I75

14. Dangerous overloading of equipment must be prevented at the design stage by means of integrated measurement, regulation and control devices, such as over-current cut-off switches, temperature limiters, differential pressure switches, flowmeters, time-lag relays, overspeed monitors or similar types of monitoring devices, or both overspeed monitors and similar types of monitoring devices.

Flameproof enclosure systems_I76

15. If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must be taken to ensure that the enclosure withstands the pressure developed during an internal explosion of an explosive mixture and prevents the transmission of the explosion to the explosive atmosphere surrounding the enclosure.

POTENTIAL IGNITION SOURCES

Hazards arising from different ignition sources_I77

16. Potential ignition sources such as sparks, flames, electric arcs, high surface temperatures, acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not occur.

Hazards arising from static electricity_I78

17. Electrostatic charges capable of resulting in dangerous discharges must be prevented by means of appropriate measures.

Hazards arising from stray electric and leakage currents_I79

18. Stray electric and leakage currents in conductive equipment parts which could result in, for example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of provoking an ignition must be prevented.

Hazards arising from overheating_I80

19. Overheating caused by friction or impacts occurring, for example, between materials and parts in contact with each other while rotating or through the intrusion of foreign bodies must, as far as possible, be prevented at the design stage.

Hazards arising from pressure compensation operations_I81

20.Equipment and protective systems must be so designed or fitted with integrated measuring, control and regulation devices that pressure compensations arising from them do not generate shock waves or compressions which may cause ignition.

Hazards arising from external effects_I82

21.—(1)Equipment and protective systems must be so designed and constructed as to be capable of performing their intended function in full safety, even in changing environmental conditions and in the presence of extraneous voltages, humidity, vibrations, contamination and other external effects, taking into account the limits of the operating conditions established by the manufacturer.

(2)Equipment parts used must be appropriate to the intended mechanical and thermal stresses and capable of withstanding attack by existing or foreseeable aggressive substances.

Requirements in respect of safety-related devices_I83

22.—(1) Safety devices must function independently of any measurement or control devices, or both measurement and control devices required for operation.

(2) As far as possible, failure of a safety device must be detected sufficiently rapidly by appropriate technical means to prevent dangerous situations from occurring.

(3) The fail-safe principle is to be applied in general.

(4) Safety-related switching must in general directly actuate the relevant control devices without intermediate software command.

(5) In the event of a safety device failure, equipment or protective systems or both must wherever possible, be secured.

(6) Emergency stop controls of safety devices must, as far as possible, be fitted with restart lockouts. A new start command may take effect on normal operation only after the restart lockouts have been intentionally reset.

Control and display units_I84

23. Where control and display units are used, they must be designed in accordance with ergonomic principles in order to achieve the highest possible level of operating safety with regard to the risk of explosion.

Requirements in respect of devices with a measuring function for explosion protection_I85

24.—(1) In so far as they relate to equipment used in explosive atmospheres, devices with a measuring function must be designed and constructed so that they can cope with foreseeable operating requirements and special conditions of use.

(2) Where necessary, it must be possible to check the reading accuracy and serviceability of devices with a measuring function.

(3) The design of devices with a measuring function must incorporate a safety factor which ensures that the alarm threshold lies far enough outside the explosion or ignition limits of the atmospheres to be registered, or both the explosion and ignition limits, taking into account, in particular, the operating conditions of the installation and possible aberrations in the measuring system.

Risks arising from software_I86

25. In the design of software-controlled equipment, protective systems and safety devices, special account must be taken of the risks arising from faults in the programme.

Integration of safety requirements relating to the system_I87

26.—(1) Manual override must be possible in order to shut down the equipment and protective systems incorporated within automatic processes which deviate from the intended operating conditions, provided that this does not compromise safety.

(2) When the emergency shutdown system is actuated, accumulated energy must be dispersed as quickly and as safely as possible or isolated so that it no longer constitutes a hazard.

(3) Sub-paragraph (2) does not apply to electrochemically-stored energy.

Hazards arising from power failure_I88

27. Where equipment and protective systems can give rise to a spread of additional risks in the event of a power failure, it must be possible to maintain them in a safe state of operation independently of the rest of the installation.

Hazards arising from connections_I89

28.—(1)Equipment and protective systems must be fitted with suitable cable and conduit entries.

(2) When equipment and protective systems are intended for use in combination with other equipment and protective systems, the interface must be safe.

Placing of warning devices as parts of equipment_I90

29. Where equipment or protective systems are fitted with detection or alarm devices for monitoring the occurrence of explosive atmospheres, the necessary instructions must be provided to enable them to be provided at the appropriate places.

SUPPLEMENTARY REQUIREMENTS IN RESPECT OF EQUIPMENT

Requirements applicable to equipment in equipment - group I

Requirements applicable to equipment in category M 1 of equipment-group I_I91

30.—(1)Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.

(2)Equipment must be equipped with means of protection such that—

(a)either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection; or

(b)the requisite level of protection is ensured in the event of two faults occurring independently of each other.

(3) Where necessary, equipment must be equipped with additional special means of protection.

(4)Equipment must remain functional with an explosive atmosphere present.

(5) Where necessary, equipment must be so constructed that no dust can penetrate it.

(6) The surface temperatures of equipment parts must be kept clearly below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.

(7)Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

(8) If necessary, equipment must be fitted with appropriate additional interlocking systems.

Requirements applicable to equipment in category M 2 of equipment-group I_I92

31.—(1)Equipment must be equipped with means of protection ensuring that sources of ignition do not become active during normal operation, even under more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

(2) The equipment must be de-energised in the event of an explosive atmosphere.

(3)Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

(4) The requirements regarding explosion hazards arising from dust applicable to equipment category M 1 must be applied.

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

Explosive atmospheres caused by gases, vapours or mists_I93

32.—(1)Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.

(2) It must be equipped with means of protection such that—

(a)either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection; or

(b)the requisite level of protection is ensured in the event of two faults occurring independently of each other.

(3) For equipment with surfaces which may heat up, measures must be taken to ensure that the stated maximum surface temperatures are not exceeded even in the most unfavourable circumstances.

(4) Temperature rises caused by heat build-ups and chemical reactions must also be taken into account.

(5)Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

(6) If necessary, equipment must be fitted with appropriate additional interlocking systems.

Explosive atmospheres caused by air and dust mixtures_I94

33.—(1)Equipment must be so designed and constructed that ignition of air and dust mixtures does not occur even in the event of rare incidents relating to equipment.

(2) It must be equipped with means of protection such that—

(a)either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection; or

(b)the requisite level of protection is ensured in the event of two faults occurring independently of each other.

(3) Where necessary, equipment must be so designed that dust can enter or escape from the equipment only at specifically designated points.

(4) The requirement in sub-paragraph (3) must also be met by cable entries and connecting pieces.

(5) The surface temperatures of equipment parts must be kept well below the ignition temperature of the foreseeable air and dust mixtures in order to prevent the ignition of suspended dust.

(6) With regard to the safe opening of equipment parts, sub-paragraph 32(5) applies.

Requirements applicable to equipment category 2 of equipment - group II

Explosive atmospheres caused by gases, vapours or mists_I95

34.—(1)Equipment must be so designed and constructed as to prevent ignition sources arising, even in the event of frequently occurring disturbances or equipment operating faults, which normally have to be taken into account.

(2)Equipment parts must be so designed and constructed that their stated surface temperatures are not exceeded, even in the case of risks arising from abnormal situations anticipated by the manufacturer.

(3)Equipment must be so designed that the opening of equipment parts which might be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.

Explosive atmospheres caused by air and dust mixtures_I96

35.—(1)Equipment must be designed and constructed so that ignition of air and dust mixtures is prevented, even in the event of frequently occurring disturbances or equipment operating faults which normally have to be taken into account.

(2) With regard to surface temperatures, sub-paragraph 33(5) applies.

(3) With regard to protection against dust, sub-paragraph 33(3) applies.

(4) With regard to the safe opening of equipment parts, sub-paragraph 34(3) applies.

Requirements applicable to equipment category 3 of equipment – groupII

Explosive atmospheres caused by gases, vapours or mists_I97

36.—(1)Equipment must be so designed and constructed as to prevent foreseeable ignition sources which can occur during normal operation.

(2) Surface temperatures must not exceed the stated maximum surface temperatures under intended operating conditions. Higher temperatures in exceptional circumstances may be allowed only if the manufacturer adopts special additional protective measures.

Explosive atmospheres caused by air and dust mixtures_I98

37.—(1)Equipment must be so designed and constructed that air and dust mixtures cannot be ignited by foreseeable ignition sources likely to exist during normal operation.

(2) With regard to surface temperatures, sub-paragraph 33(5) applies.

(3)Equipment, including cable entries and connecting pieces, must be so constructed that, taking into account the size of its particles, dust can neither develop explosive mixtures with air nor form dangerous accumulations inside the equipment.

Supplementary requirements in respect of protective systems

General requirements_I99

38.—(1)Protective systems must be dimensioned in such a way as to reduce the effects of an explosion to a sufficient level of safety.

(2)Protective systems must be designed and capable of being positioned in such a way that explosions are prevented from spreading through dangerous chain reactions or flashover and incipient explosions do not become detonations.

(3) In the event of a power failure, protective systems must retain their capacity to function for a period sufficient to avoid a dangerous situation.

(4)Protective systems must not fail due to outside interference.

Planning and design

Characteristics of materials_I100

39.—(1) With regard to the characteristics of materials, the maximum pressure and temperature to be taken into consideration at the planning stage are the expected pressure during an explosion occurring under extreme operating conditions and the anticipated heating effect of the flame.

(2)Protective systems designed to resist or contain explosions must be capable of withstanding the shock wave produced without losing system integrity.

(3) Accessories connected to protective systems must be capable of withstanding the expected maximum explosion pressure without losing their capacity to function.

(4) The reactions caused by pressure in peripheral equipment and connected pipe-work must be taken into consideration in the planning and design of protective systems.

Pressure-relief systems_I101

40. If it is likely that stresses on protective systems will exceed their structural strength, provision must be made in the design for suitable pressure-relief devices which do not endanger persons in the vicinity.

Explosion suppression systems_I102

41. Explosion suppression systems must be so planned and designed that they react to an incipient explosion at the earliest possible stage in the event of an incident and counteract it to best effect, with due regard to the maximum rate of pressure increase and the maximum explosion pressure.

Explosion decoupling systems_I103,I104

42. Decoupling systems intended to disconnect specific equipment as swiftly as possible in the event of incipient explosions by means of appropriate devices must be planned and designed so as to remain proof against the transmission of internal ignition and to retain their mechanical strength under operating conditions.

43.Protective systems must be capable of being integrated into a circuit with a suitable alarm threshold so that, if necessary, there is cessation of product feed and output and shutdown of equipment parts which can no longer function safely.

Regulation 2

[^F120SCHEDULE 1ACriteria determining the classification of equipment-groups into categories (Annex I to the ATEX Directive)

1.Equipment group I

(a)Equipment category M 1 comprises equipment designed and, where necessary, equipped with additional special means of protection to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust.

Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present, and is characterised by means of protection such that:

• — either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

• — or the requisite level of protection is assured in the event of two faults occurring independently of each other.

• Equipment in this category must comply with the supplementary requirements referred to in paragraph 30 of Schedule 1.

(b)Equipment category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines likely to be endangered by firedamp and/or combustible dust.

This equipment is intended to be de-energised in the event of an explosive atmosphere.

The means of protection relating to equipment in this category assure the requisite level of protection during normal operation and also in the case of more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.

Equipment in this category must comply with the supplementary requirements referred to in paragraph 31 of Schedule 1.

2.Equipment-group II

(a)Equipment category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently.

Equipment in this category must ensure the requisite level of protection, even in the event of rare incidents relating to equipment, and is characterised by means of protection such that:

• — either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,

• — or the requisite level of protection is assured in the event of two faults occurring independently of each other.

• Equipment in this category must comply with the supplementary requirements referred to in paragraphs 32 and 33 of Schedule 1.

(b)Equipment category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and of ensuring a high level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally.

The means of protection relating to equipment in this category ensure the requisite level of protection, even in the event of frequently occurring disturbances or equipment faults which normally have to be taken into account.

Equipment in this category must comply with the supplementary requirements referred to in paragraphs 34 and 35 of Schedule 1.

(c)Equipment category 3 comprises equipment designed to be capable of functioning in conformity with the operating parameters established by the manufacturer and ensuring a normal level of protection.

Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only.

Equipment in this category ensures the requisite level of protection during normal operation.

Equipment in this category must comply with the supplementary requirements referred to in paragraphs 36 and 37 of Schedule 1.^F120]

Regulation 2(1)

SCHEDULE 2[^F121Approved^F121] body requirements_{I105,I106,I107,I108,I109,I110,I111,I112,I113,I114,I115,I116,I117,I118,I119,I120,I121}

[^F1221.—(1)A conformity assessment body must have legal personality and must be established in—

(a)the United Kingdom; or

(b)the territory of a party to the CPTPP.

(2)In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.^F122]

2. A conformity assessment body must be a third party body independent of the organisation or the product it assesses.

3. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses is to be a conformity assessment body for the purposes of [^F123regulation 43 (approval of conformity assessment bodies)^F123] provided that such body can demonstrate—

(a)its independence from such business association or professional federation; and

(b)the absence of any conflict of interest.

4.—(1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products, nor the representative of any of those parties.

(2) Sub-paragraph (1) does not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.

5. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of the products, or represent the parties engaged in those activities.

6. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not engage in activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are [^F124approved^F124] (including consultancy services).

7. A conformity assessment body must ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

8. A conformity assessment body and its personnel must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons who have an interest in the results of those activities.

9. A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been, or is to be, [^F125approved^F125] , whether those activities are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

10. A conformity assessment body must have —

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment activities are to be carried out, ensuring the transparency of and the ability to reproduce those procedures, and have appropriate policies and procedures in place that distinguish between tasks it carries out as [^F126an approved^F126] body and other activities;

(c)procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the process.

11. A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to the necessary equipment or facilities to enable it to perform those activities.

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

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [^F127approved^F127] ;

(b)satisfactory knowledge of the requirements of the assessments which the personnel carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential health and safety requirements, of the applicable [^F128designated standards^F128] and of these Regulations;

(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

13. A conformity assessment body must be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities.

14. The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities must not depend on the number of assessments carried out or on the results of those assessments.

15. A conformity assessment body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities.

16. A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations and that proprietary rights are protected.

17. Paragraph 16 does not prevent the personnel from providing information to the Secretary of State or the market surveillance authority pursuant to these Regulations or under any enactment.

18. A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any [^F129approved^F129] body coordination group established [^F130by the Secretary of State^F130] and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

[^F132Regulation 47^F132]

SCHEDULE 3Operational obligations of [^F131approved^F131] bodies_{I122,I123,I124,I125,I126,I127,I128,I129,I130,I131,I132,I133,I134,I135}

1.[^F133An approved^F133] body must carry out conformity assessments in accordance with the relevant conformity assessment procedures.

2.[^F133An approved^F133] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.

3.[^F133An approved^F133] body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

4.[^F133An approved^F133] body must respect the degree of rigour and the level of protection required to ensure that the product is in conformity with the requirements of these Regulations.

5. Where [^F133an approved^F133] body finds that essential health and safety requirements or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it must require the manufacturer to take appropriate corrective measures and must not issue a certificate of conformity or grant an approval.

6. Where, in the course of the monitoring of conformity following the issue of a certificate or grant of an approval, [^F133an approved^F133] body finds that a product is no longer in conformity with the essential health and safety requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the certificate of conformity or approval (if necessary).

7. Where the [^F134approved^F134] body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the [^F134approved^F134] body must restrict, suspend or withdraw any certificate of conformity or approval.

8. Paragraph 9 applies where [^F133an approved^F133] body is minded to—

(a)refuse to issue a certificate of conformity or grant an approval;

(b)restrict, suspend or withdraw a certificate of conformity or approval.

9. Where this paragraph applies, the [^F135approved^F135] body must—

(a)give the person applying for the certificate or approval, or the person to whom the certificate or approval was given, a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect;

(b)give the person applying for the certificate or approval, or the person to whom the certificate or approval was given, an opportunity to make representations within a reasonable period from the date of the notice; and

(c)take account of any such representations before taking its decision.

10.[^F133An approved^F133] body must inform the Secretary of State of—

(a)any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval;

(b)any circumstances affecting the scope of, or conditions for, notification under [^F136regulation 43 (approval of conformity assessment bodies)^F136] ;

(c)any request for information which it has received from the market surveillance authority regarding conformity assessment activities; and

(d)on request, any conformity assessment activities performed within the scope of its [^F137approval under regulation 43^F137] and any other activity performed, including cross-border activities and subcontracting.

11.[^F133An approved^F133] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—

(a)to refuse to issue a certificate of conformity or grant an approval; or

(b)to restrict, suspend or withdraw a certificate of conformity or approval.

12.[^F133An approved^F133] body must provide other [^F138bodies approved under these Regulations^F138] carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

13.[^F133An approved^F133] body must participate in the work of any [^F139approved body coordination group established by the Secretary of State^F139] , directly or by means of its designated representatives.

14.[^F133An approved^F133] body must—

(a)acknowledge receipt of the technical documentation provided by the manufacturer in accordance with regulation 39(1)(b)(ii)(bb) (conformity assessment procedures) as soon as possible; and

(b)retain the technical documentation referred to in sub-paragraph (a).

Regulations 2, 6, 39 and 40

[^F140SCHEDULE 3AConformity Assessment Procedures (Annexes III to IX of the ATEX Directive)

PART 1

TYPE EXAMINATION

1.Type examination is the part of a conformity assessment procedure in which an approved body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of these Regulations that apply to it.

2.Type examination shall be carried out with the examination of a specimen, representative of the production envisaged, of the complete product (production type).

3.The manufacturer shall lodge an application for Type examination with a single approved body of his choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)a written declaration that the same application has not been lodged with any other approved body,

(c)the technical documentation. The technical documentation shall make it possible to assess the product's conformity with the applicable requirements of these Regulations and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(i)a general description of the product,

(ii)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(iii)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(iv)a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied,

(v)results of design calculations made, examinations carried out, etc., and

(vi)test reports,

(d)the specimens representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme.

4.The approved body shall:

4.1.examine the technical documentation, verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.2.carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards, these have been applied correctly;

4.3.carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential health and safety requirements of these Regulations;

4.4.agree with the manufacturer on a location where the examinations and tests will be carried out.

5.The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.Where the type meets the requirements of these Regulations that apply to the product concerned, the approved body shall issue a Type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The Type examination certificate may have one or more annexes attached.

The Type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a Type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

The manufacturer shall inform the approved body that holds the technical documentation relating to the Type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of these Regulations or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original Type examination certificate.

8.Each approved body shall inform the Secretary of State concerning the Type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies concerning the Type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

The Health and Safety Executive for Northern Ireland may, on request, obtain a copy of the Type examination certificates and/or additions thereto. On request, The Health and Safety Executive for Northern Ireland may obtain a copy of the technical documentation and the results of the examinations carried out by the approved body. The approved body shall keep a copy of the Type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

9.The manufacturer shall keep a copy of the Type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.

10.The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 7 and 9, provided that they are specified in the mandate.

PART 2CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1.Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2.The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality system

3.1.The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)a written declaration that the same application has not been lodged with any other approved body,

(c)all relevant information for the product category envisaged,

(d)the documentation concerning the quality system,

(e)the technical documentation of the approved type and a copy of the Type examination certificate.

3.2.The quality system shall ensure that the products are in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

(c)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

(d)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e) to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a)the quality system documentation,

(b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking, declaration of conformity and attestation of conformity

5.1.The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

5.2.The manufacturer shall draw up a written declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product, other than a component.

5.3.The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a)the documentation referred to in paragraph 3.1,

(b)the information relating to the change referred to in paragraph 3.5, as approved,

(c)the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4.

7.Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

Authorised representative

8.The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 3CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

1.Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the Type examination certificate and with the requirements of these Regulations that apply to them.

Verification

3.An approved body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations.

The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out by examination and testing of every product as specified in paragraph 4.

Verification of conformity by examination and testing of every product

4.1.All products shall be individually examined, and appropriate tests set out in the relevant designated standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations.

In the absence of such a designated standard, the approved body concerned shall decide on the appropriate tests to be carried out.

4.2.The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.

UK marking, declaration of conformity and attestation of conformity

5.1.The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual product other than a component that is in conformity with the approved type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

5.2.The manufacturer shall draw up a written declaration of conformity for each product model other than a component and keep it at the disposal of the national authorities, for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product other than a component.

5.3.The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the products other than components.

6.If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the products during the manufacturing process.

Authorised representative

7.The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in paragraph 2.

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

1.Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the Type examination certificate and with the requirements of these Regulations that apply to them.

Product checks

3.For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the Type examination certificate and with the corresponding requirements of these Regulations. The tests shall be carried out under the responsibility of an approved body, chosen by the manufacturer.

The manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process.

UK marking, declaration of conformity and attestation of conformity

4.1.The manufacturer shall affix the UK marking to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

4.2.The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product, other than a component.

4.3.The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

Authorised representative

5.The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 5CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

1.Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2.The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality System

3.1.The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the products concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well

(b)a written declaration that the same application has not been lodged with any other approved body,

(c)all relevant information for the product category envisaged,

(d)the documentation concerning the quality system, and

(e)the technical documentation of the approved type and a copy of the Type examination certificate.

3.2.The quality system shall ensure compliance of the products with the type described in the Type examination certificate and with the applicable requirements of these Regulations.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

(b)the examinations and tests that will be carried out after manufacture,

(c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

(d)the means of monitoring the effective operation of the quality system.

3.3.The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in paragraph 3.1(e) in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

(a)the quality system documentation,

(b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking, declaration of conformity and attestation of conformity

5.1.The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations.

5.2.The manufacturer shall draw up a written declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product other than a component.

5.3.The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

6.The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

(a)the documentation referred to in paragraph 3.1,

(b)the information relating to the change referred to in paragraph 3.5, as approved,

(c)the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4.

7.Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Each approved body shall inform the other approved bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

Authorised representative

8.The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 6INTERNAL PRODUCTION CONTROL

1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2.The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements and shall include an adequate analysis and assessment of the risk(s).

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)a general description of the product,

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied,

(e)results of design calculations made, examinations carried out, etc., and

(f)test reports.

Manufacturing

3.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations that apply to them.

UK marking, declaration of conformity and attestation of conformity

4.1.The manufacturer shall affix the UK marking to each individual product other than a component that satisfies the applicable requirements of these Regulations.

4.2.The manufacturer shall draw up a written declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The declaration of conformity shall identify such product model for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product other than a component.

4.3.The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

Authorised representative

5.The manufacturer's obligations set out in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

PART 7CONFORMITY BASED ON UNIT VERIFICATION

1.Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 5, and ensures and declares on his sole responsibility that the product concerned, which has been subject to the provisions of paragraph 4, is in conformity with the requirements of these Regulations that apply to it.

Technical documentation

2.1.The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 4. The documentation shall make it possible to assess the product's conformity with the relevant requirements and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements:

(a)a general description of the product,

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(d)a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of these Regulations, including a list of other relevant technical specifications applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied,

(e)results of design calculations made, examinations carried out, etc., and

(f)test reports.

2.2.The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.

Manufacturing

3.The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of these Regulations.

Verification

4.An approved body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant designated standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of these Regulations, or have them carried out. In the absence of such a designated standard the approved body concerned shall decide on the appropriate tests to be carried out.

The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.

UK marking, declaration of conformity and attestation of conformity

5.1.The manufacturer shall affix the UK marking and, under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each product other than a component that satisfies the applicable requirements of these Regulations.

5.2.The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product, other than a component has been placed on the market. The declaration of conformity shall identify such product for which it has been drawn up.

A copy of the declaration of conformity shall accompany every product, other than a component.

5.3.The manufacturer shall draw up a written attestation of conformity and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

Authorised representative

6.The manufacturer's obligations set out in paragraphs 2.2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.^F140]

Regulation 53(1)

SCHEDULE 4Enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act

Enforcement powers under the 1974_I136

1. For the purposes of enforcing these Regulations, the following sections of the 1974 Act apply subject to the modifications in paragraph 2—

(a)section 19 (appointment of inspectors);

(b)section 20 (powers of inspectors);

(c)section 21 (improvement notices);

(d)section 22 (prohibition notices);

(e)section 23 (provisions supplementary to ss 21 and 22);

(f)section 24 (appeal against improvement or prohibition notice);

(g)section 25 (power to deal with cause of imminent danger);

(h)section 25A (power of customs officer to detain articles and substances);

(i)section 26 (power of enforcing authorities to indemnify inspectors);

(j)section 27 (obtaining of information by the Executive, enforcing authorities etc);

(k)section 27A (information communicated by Commissioners for Revenue and Customs);

(l)section 28 (restrictions on disclosure of information);

(m)section 33 (offences);

(n)section 34 (extension of time for bringing summary proceedings);

(o)section 35 (venue);

(p)section 39 (prosecution by inspectors);

(q)section 41 (evidence); and

(r)section 42 (power of court to order cause of offence to be remedied or, in certain cases, forfeiture).

Modifications to the 1974 Act_I137

2. The sections of the 1974 Act referred to in paragraph 1 are to apply as if—

(a)references to “relevant statutory provisions” were references to—

(i)the provisions of the 1974 Act set out in paragraph 1, as modified by this paragraph; and

(ii)these Regulations;

(b)references to “risk” were references to risk within the meaning of regulation 2(5) of these Regulations;

(c)in section 19—

(i)in subsection (1), for “Every enforcing authority” there were substituted “the Health and Safety Executive and the Office for Nuclear Regulation”;

(ii)in subsection (1), “within its field of responsibility” were omitted;

(iii)in subsection (2), paragraph (b) were omitted;

(iv)in subsection (3), for “enforcing authority which appointed him” there were substituted “Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(d)in section 20—

(i)in subsection (1), “within the field of responsibility of the enforcing authority which appointed him” were omitted;

(ii)in subsection (2)(c)(i), for “his (the inspector’s) enforcing authority” there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(iii)in subsection 2(h), for “him to have caused or to be likely to cause danger to health or safety”, there were substituted “contravene the relevant statutory provisions or present a risk”; and

(iv)subsection (3) were omitted;

(e)in section 21—

(i)before paragraph (a), there were inserted—

“(za)is making available on the market a product which presents a risk;”;

(ii)after “specifying the”, there were inserted “risk, or”; and

(iii)after “requiring that person to”, there were inserted “address the risk or”;

(f)for section 22(2) there were substituted—

“(2)An inspector may serve a notice (in this Part referred to as “a prohibition notice”) on a person if, as regards any activities to which this section applies, the inspector is of the opinion that, as carried on or likely to be carried on by or under the control of the person in question, the activities involve or, as the case may be, will involve—

(a)a risk; or

(b)a contravention of a relevant statutory provision.”;

(g)in section 23, subsections (3), (4) and (6) were omitted;

(h)in section 25A(1)—

(i)for “an enforcing authority or inspector”, there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(ii)for the “authority”, there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(i)for the title to section 26, there were substituted “Power to indemnify its inspectors”;

(j)in section 26, for each of the following references there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”—

(i)“the enforcing authority which appointed him”;

(ii)“that authority”; and

(iii)“the authority”;

(k)in section 27—

(i)for “Executive”, on each occasion that it appears, there were substituted “Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(ii)in subsection (1), paragraph (b) were omitted; and

(iii)in subsection (1), “or, as the case may be, to the enforcing authority in question” were omitted;

(l)for section 27A(2) there were substituted—

“(2)This subsection applies to the Health and Safety Executive, the Office for Nuclear Regulation and to an inspector”;

(m)in section 28—

(i)for “Executive”, on each occasion that it appears, there were substituted “Health and Safety Executive”;

(ii)in subsection (1)(a), “, other than the Officer for Nuclear Regulation (or an inspector appointed by it),” were omitted;

(iii)in subsection (1)(a), “, by virtue of section 43A(6) below” were omitted;

(iv)in subsection (3)(a), “or an enforcing authority” were omitted;

(v)in subsection (4), “or an enforcing authority” were omitted;

(vi)in subsection (4), “(including, in the case of an enforcing authority, any inspector appointed by it)” were omitted;

(vii)in subsection (5)(a), “or the purposes of the enforcing authority in question in connection with the relevant statutory provisions” were omitted;

(viii)in subsection (7), “14(4)(a) or” were omitted;

(ix)in subsection (7), for paragraph (b), there were substituted—

“(b)for the purposes of any legal proceedings or for the purposes of a report of any such proceedings;”; and

(x)subsection (9B) were omitted;

(n)in section 33—

(i)in subsection (1), the paragraphs (a) to (i) and (k) to (m) were omitted;

(ii)for subsection (2), there were substituted—

“(2)A person guilty of an offence under this section is liable—

(a)on summary conviction—

(i)in England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both;

(ii)in Scotland, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding three months, or to both;

(b)on conviction on indictment to a fine or imprisonment for a term not exceeding two years, or to both.”; and

(iii)section 33(3) were omitted;

(o)in section 34—

(i)in subsection (1), paragraphs (a) and (b) were omitted;

(ii)in subsection (1), for the words from “and it appears” to the end, there were substituted “and it appears from the investigation or, in a case falling within paragraph (d), from the proceedings at the inquiry, that any of the relevant statutory provisions was contravened at a time which is material in relation to the subject-matter of the investigation or inquiry, summary proceedings against any person liable to be proceeded against in respect of the contravention may be commenced at any time within three months of the conclusion of the investigation or inquiry.”; and

(iii)subsections (3) to (6) were omitted;

(p)in section 35, for “any enforcing authority”, there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”;

(q)in section 39(1), for “enforcing authority which appointed him” there were substituted “the Health and Safety Executive or the Office for Nuclear Regulation as the case may be”; and

(r)in section 42, subsections (3A), (4) and (5) were omitted.

Regulation 53(2)

SCHEDULE 5Compliance, withdrawal and recall notices

Compliance notice_I138

1.—(1) The market surveillance authority may serve a compliance notice on a relevant economic operator in respect of a product if the authority has reasonable grounds for believing that there is non-compliance.

(2) A compliance notice must—

(a)require the relevant economic operator on which it is served to—

(i)end the non-compliance within such period as may be specified in the notice; or

(ii)provide evidence, within such period as may be specified in the notice, demonstrating to the satisfaction of the market surveillance authority that the non-compliance has not in fact occurred; and

(b)warn the economic operator that, if the non-compliance persists or if satisfactory evidence has not been produced under sub-paragraph (a) within the period specified in the notice, further action may be taken in respect of the product or any product of the same type made available on the market by the relevant economic operator.

(3) A compliance notice may include directions as to the measures to be taken by the economic operator to secure compliance, including different ways of securing compliance.

(4) Subject to sub-paragraph (5), the market surveillance authority may revoke or vary a compliance notice by serving a notification on the economic operator.

(5) The market surveillance authority may not vary a compliance notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

Withdrawal notice_I139

2.—(1) The market surveillance authority may serve a withdrawal notice on a relevant economic operator in respect of a product if the authority has reasonable grounds for believing that—

(a)the product has been made available on the market; and

(b)there is non-compliance.

(2) A withdrawal notice must prohibit the relevant economic operator from making the product available on the market without the consent of the market surveillance authority.

(3) A withdrawal notice may require the relevant economic operator to take action to alert end-users to any risk presented by the product.

(4) A withdrawal notice may require the relevant economic operator to keep the market surveillance authority informed of the whereabouts of any product referred to in the notice.

(5) A consent given by the market surveillance authority pursuant to a withdrawal notice, may impose such conditions on the making available on the market as the market surveillance authority considers appropriate.

(6) Subject to sub-paragraph (7), the market surveillance authority may revoke or vary a withdrawal notice by serving a notification on the economic operator.

(7) The market surveillance authority may not vary a withdrawal notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(8) A withdrawal notice has effect throughout Great Britain.

Recall notice_I140

3.—(1) The market surveillance authority may serve a recall notice on a relevant economic operator in respect of a product if the authority has reasonable grounds for believing that—

(a)the product has been made available to end-users; and

(b)there is non-compliance.

(2) A recall notice must require the relevant economic operator to use reasonable endeavours to organise the return of the product from end-users to the relevant economic operator or another person specified in the notice.

(3) A recall notice may—

(a)require the recall to be effected in accordance with a code of practice;

(b)require the relevant economic operator to—

(i)contact end-users in order to inform them of the recall, to the extent that it is practicable to do so;

(ii)publish a notice in such form and such manner as is likely to bring to the attention of end-users any risk the product poses and the fact of the recall; or

(iii)make arrangements for the collection or return of the product from end-users or its disposal; or

(c)impose such additional requirements on the relevant economic operator as are reasonable and practicable with a view to achieving the return of the product.

(4) In determining what requirements to include in a recall notice, the market surveillance authority must take into consideration the need to encourage distributors and end-users to contribute to its implementation.

(5) A recall notice may only be issued by the market surveillance authority where—

(a)other action which it may require under these Regulations would not suffice to address the non-compliance;

(b)the action being undertaken by the relevant economic operator is unsatisfactory or insufficient to address the non-compliance;

(c)the market surveillance authority has given not less than 10 days’ notice to the relevant economic operator of its intention to serve such a notice; and

(d)the market surveillance authority has taken account of any advice obtained under sub-paragraph (6).

(6) A relevant economic operator which has received notice from the market surveillance authority of an intention to serve a recall notice may at any time prior to the service of the recall notice require the authority to seek the advice of such person as the Institute determines on the questions of—

(a)whether there is non-compliance; and

(b)whether the issue of a recall notice would be proportionate.

(7) Sub-paragraphs (5)(b), (c) and (d) do not apply in the case of a product presenting a serious risk requiring, in the view of the market surveillance authority, urgent action.

(8) Where a relevant economic operator requires the market surveillance authority to seek advice under sub-paragraph (6), that relevant economic operator is to be responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute to advise the market surveillance authority.

(9) In this paragraph, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

(10) A recall notice served by the market surveillance authority may require the relevant economic operator to keep the authority informed of the whereabouts of a product to which the recall notice relates, so far as the relevant economic operator is able to do so.

(11) Subject to sub-paragraph (12), the market surveillance authority may revoke or vary a recall notice by serving a notification on the economic operator.

(12) The market surveillance authority may not vary a recall notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(13) A recall notice has effect throughout Great Britain.

Interpretation_I141

4. In this Schedule, “non-compliance” means that the product—

(a)presents a risk; or

(b)is not in conformity with Part 2 or RAMS in its application to a product.

Regulation 40(b)

SCHEDULE 6^F141... Declaration of Conformity (No. XXXX)_{I142,I143,I144,I145,I146,I147,I148,I149}

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

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

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

4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):

5. The object of the declaration described above is in conformity with the relevant [^F142statutory requirements^F142] :

6. References to the relevant [^F143designated^F143] standards used or references to the other technical specifications in relation to which conformity is declared:

7. Where applicable, the [^F144approved^F144] body (name, number) performed (description of intervention) and issued the certificate:

8. Additional information:

• Signed for and on behalf of:

• (place and date of issue):

• (name, function) (signature):