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

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;

• (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 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,