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

Type Statutory-Instrument

Publication 2016-11-15

Last updated 2025-02-27

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 15th November 2016

Laid before Parliament: 16th November 2016

Coming into force: 8th December 2016

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A[^f00003] of Schedule 2 to, the European Communities Act 1972:

PART 1 — Preliminary

Citation, commencement and extent

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

2

(1) In these Regulations—

the “1974 Act” means the Health and Safety at Work etc Act 1974[^f00004];

the “1994 Directive” means Directive 94/9/EC of the European Parliament and of the Council on the approximation of the laws of the member States concerning equipment and protective systems intended for use in potentially explosive atmospheres[^f00005] ...;

“the 1996 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996[^f00006];

“approved body” has the meaning given to it in regulation 42;

“ATEX Directive” means Directive 2014/34/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)[^f00007];

“attestation of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7(3) (... declaration of conformity and UK Marking);

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

“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;

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

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

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

“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);

“designated standard” has the meaning given to it in regulation 2A;

“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;

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

“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 as set out in Schedule 1A to these Regulations;

“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 as set out in Schedule 1A to these Regulations;

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

“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;

“importer” means a person who— is established in the United Kingdom and places a product from a country outside of the United Kingdom on the market; oris established in Northern Ireland and places a product on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

“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 market of Great Britain 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—manufactures a product, or has a product designed or manufactured, andmarkets that product—under that person’s name or trade mark, oruses such product for that person’s own purposes;

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

“place on the market” means make a product available on the market of Great Britain 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;

“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[^f00009];

“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;

“UK marking” means the marking in the form set out in Annex 2 of RAMS;

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

“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.

(1A) Schedule 1A reproduces the provisions of Annex I to the ATEX Directive with amendments to correct deficiencies in assimilated 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 assimilated 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.

(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.

(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.

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope

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;

(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 Directive 89/686/EEC on the approximation of the laws of the member States relating to personal protective equipment[^f00010];

(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;

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

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

Exceptions for trade fairs, exhibitions and demonstrations

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 2 — Obligations of economic operators

Chapter 1 — Manufacturers

Design and manufacture in accordance with essential health and safety requirements

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

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

(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.

EU declaration of conformity and CE marking

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

(b) affix the UK Marking in accordance with regulation 41 ( UK Marking).

(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).

(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.

(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.

(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.

Retention of technical documentation and ... declaration of conformity

8

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

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) any change in a designated standard or in another technical specification by reference to which the ... declaration of conformity or attestation of conformity was drawn up.

Monitoring

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

(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

(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

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

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

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.

(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.

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.

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

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

(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

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

17

(1) A manufacturer may, by written mandate, appoint a person established in the United Kingdom 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) perform 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 2 — Importers

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

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

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,

(i) bears the UK marking where applicable,

(ii) is 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);

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

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

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 the market surveillance authority.

(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 seven years 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.

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.

Storage and transport

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

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

(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

(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

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

(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

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.

Retention of technical documentation and ... declaration of conformity

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

(b) the technical documentation.

Chapter 3 — Distributors

Duty to act with due care

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

29

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

(a) the product—

(i) bears a UK marking where applicable;

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

(iii) is accompanied by the required documents;

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

(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);

(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);

Storage and transport

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

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

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

(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

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 4 — Importers and distributors

Cases in which obligations of manufacturers apply to importers and distributors

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 5 — All economic operators

Identification of economic operators

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 CE marking

36

(1) An economic operator must not affix the UK 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 UK 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 UK marking.

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

Translation of declaration of conformity

37

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3 — Conformity assessment

Presumption of conformity

38

(1) A product which is in conformity with a designated 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

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—

(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;

(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;

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

(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.

(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 UK marking;

(ii) drawing 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 Part 6 of Schedule 3A.

(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 English.

EU declaration of conformity

40

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 Schedule 3A to these Regulations for the relevant conformity assessment procedure followed in respect of the product.

CE Marking

41

(1) The UK marking must be affixed visibly, legibly and indelibly—

(a) to the product;

(b) to its data plate; or

(i) a label affixed to the product; or

(ii) a document accompanying the product.

(1A) For a period of seven years 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.

(2) Where paragraph (1A) does not apply and it is not possible or warranted, on account of the nature of the product, to affix the UK marking in accordance with paragraph (1)(a) or (b), the UK marking must be affixed to—

(a) the packaging, and

(b) the accompanying documents.

(3) The UK marking must be followed by the identification number of the approved body 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 approved body must be affixed—

(a) by the approved body itself, or

(b) under the instructions of the approved body, by the manufacturer or the authorised representative.

(5) The UK marking and, where applicable, the identification number of the approved body 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

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

PART 4 — Approval of Conformity Assessment Bodies

Notified 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—which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union, in accordance with Article 17 of the ATEX Directive; andin respect of which no objections had been raised as referred to in regulation 42(1)(b) as it had effect immediately before IP completion day.

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

Presumption of conformity of notified 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.

Notification

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.

Contents of Notification

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

Monitoring

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

(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.

United Kingdom Accreditation Service

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).

Changes to notifications

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;

Operational obligations of notified 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.

Subsidiaries and contractors

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

PART 5 — Market surveillance and enforcement

Designation of market surveillance authority

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[^f00011]).

Enforcement

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

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

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);

(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

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

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

(2) The market surveillance authority must inform the approved 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 Health and Safety Executive for Northern Ireland 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

(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 Health and Safety Executive for Northern Ireland 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;

(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 designated 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

57

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

(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 the Health and Safety Executive for Northern Ireland 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;

(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

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 UK marking—

(i) where required, has not been affixed;

(ii) has been affixed otherwise than in accordance with regulations 36 (prohibition on improper use of UK marking) and 41 (UK marking);

(b) where an approved 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;

(i) does not accompany the product;

(ii) has been drawn up otherwise than in accordance with regulations 7 (... declaration of conformity and UK 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

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

Restrictive measures

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

Offences

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

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

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

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;

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

Time limit for prosecution of offences

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

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

(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;

(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

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

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.

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