The Pressure Equipment (Safety) Regulations 2016

• Citation: S.I. 2016/1105
• Sections: 335

Section 1 Citation and commencement

These Regulations may be cited as the Pressure Equipment (Safety) Regulations 2016 and come into force on 8th December 2016 (“ the commencement date ”).

Section 2 Interpretation

(1) In these Regulations—

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

“ the 1978 Order ” means the Health and Safety at Work (Northern Ireland) Order 1978 ;

“ the 1987 Act ” means the Consumer Protection Act 1987 ;

“ the 1999 Regulations ” means the Pressure Equipment Regulations 1999 ;

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“ applicant ” means any person making an application for a conformity assessment procedure to be carried out by a approved body;

“ assembly ” means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole;

“ authorised representative ” means a person established within the United Kingdom appointed in accordance with regulation 19(1) (manufacturer’s authorised representative);

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“ conformity assessment ” means the process demonstrating whether the essential requirements relating to pressure equipment or assemblies have been fulfilled;

“conformity assessment activities” means any activities involved in conformity assessment, including calibration, testing, certification and inspection;

“conformity assessment body” means a person that performs conformity assessment activities;

“ conformity assessment procedure ” means a procedure for conformity assessment set out in Schedule 1A;

“ conformity assessment procedure ” means a procedure for conformity assessment set out in Annex III to the Directive (as amended from time to time);

“ the CPTPP ” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024;

“ declaration of conformity ” means a declaration of conformity drawn up in accordance with regulation 48 (declaration of conformity);

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

“ the Directive ” means Directive 2014/68/EU of the European Parliament and of the Council of 15th May 2014 on the harmonisation of the laws of the member States relating to the making available on the market of pressure equipment (recast) ...;

“ designating authority ” means the Secretary of State;

“ distributor ” means any person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or an assembly available on the market;

“ district council ” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972 ;

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

“ enforcing authority ” means any person enforcing these Regulations under regulation 67 (enforcement);

“ essential safety requirements ” means the requirements set out in Schedule 2;

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“ fluids ” means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension of solids;

“ fluid in Group 1 ” has the meaning set out in paragraph 3(1) of Schedule 3;

“ fluid in Group 2 ” has the meaning set out in paragraph 3(2) of Schedule 3;

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“ importer ” means a person who—

is established in the United Kingdom and places pressure equipment or an assembly from a country outside of the United Kingdom on the market; or

is established in Northern Ireland and places pressure equipment or an assembly 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;

“ make available on the market ” means the supply of pressure equipment or an assembly 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 pressure equipment or an assembly, or has such equipment or assembly designed or manufactured; and either—

markets that pressure equipment under that person's name or trade mark; or

uses it for his own purposes;

“ market surveillance authority ” has the meaning set out in regulation 66 (designation of market surveillance authority);

“ maximum allowable pressure PS ” means the maximum pressure for which the equipment is designed, as specified by the manufacturer, and defined at a location specified by the manufacturer, being either the connection of protective and/or limiting devices, or the top of equipment or, if not appropriate, any point specified;

“ maximum/minimum allowable temperature TS ” means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer;

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“ nominal size (DN) ” means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number;

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“ permanent joints ” means joints which cannot be disconnected except by destructive methods;

“ piping ” means piping components intended for the transport of fluids, when connected together for integration into a pressure system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air are to be considered as piping;

“ place on the market ” means make pressure equipment or an assembly available on the market of Great Britain for the first time, and related expressions are to be construed accordingly;

“ pressure ” means pressure relative to atmospheric pressure, i.e. gauge pressure; and as a consequence, vacuum is designated by a negative value;

“ pressure accessories ” means devices with an operational function and having pressure-bearing housings;

“ pressure equipment ” means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts such as flanges, nozzles, couplings, supports and lifting lugs;

“ putting into service ” means the first use of pressure equipment or an assembly by its user, and related expressions are to be construed accordingly;

“ RAMS ” means Regulation ( EC ) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation ( EEC ) No 339/93 ;

“ recall ” means the taking of any measure aimed at achieving the return of pressure equipment or an assembly that has already been made available to the end-user and related expressions are to be construed accordingly;

“recognised third party organisation” except in Schedule 2 (essential safety requirements), is a body within the meaning set out in regulation 52;

“ relevant conformity assessment procedure ” means a conformity assessment procedure appropriate for the classification of the pressure equipment, as set out in regulation 42;

“ relevant economic operator ” means, in relation to pressure equipment or an assembly, an economic operator who has obligations in respect of that pressure equipment or assembly under these Regulations;

“ safety accessories ” means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices;

“ technical documentation ” has the meaning set out in regulation 10(2) (technical documentation and conformity assessment);

“ technical specification ” means a document that prescribes technical requirements to be fulfilled by pressure equipment or an assembly;

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

“user inspectorate” is a body within the meaning set out in regulation 53 (User inspectorates);

“ user inspectorate requirements ” means the requirements set out in Schedule 5;

“ vessel ” means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber;

“ volume (V) ” means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts;

“ weights and measures authority ” means a local weights and measures authority within the meaning of section 69 of the Weights and Measures Act 1985 ;

“withdrawal”, when used in relation to pressure equipment or an assembly, means the taking of any measure aimed at preventing pressure equipment or an assembly in the supply chain from being made available on the market, and related expressions must be construed accordingly.

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

(a) pressure equipment is in conformity with the essential safety requirements; and

(b) each relevant economic operator has complied, or is complying, with the obligations imposed on them under Part 2 of these Regulations which must be satisfied at or before the time at which they made the pressure equipment or assembly available on the market.

(3) In regulations 16 and 26, “ risk ” means a risk which could arise from lawful and readily predictable human behaviour.

(4) In the other provisions of these Regulations (except Schedule 2), “ 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) the health and safety of persons;

(ii) domestic animals; or

(iii) property.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) In these Regulations, the definition of a manufacturer does not include a private person who manufactures pressure equipment or an assembly on an occasional basis for their own use in a non-commercial context.

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Section 2A Designated standard

(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 or an international standardising body , 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, including—

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

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

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

(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).

(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).

(4) When considering whether the publication 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 such technical specifications adopted by the other standardisation organisations or by international standardising bodies as the Secretary of State considers to be relevant .

(6) The Secretary of State may remove from publication the reference to a standard that 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) In this regulation, a reference to a “ product ” is a reference to a product to which these Regulations apply.

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

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

(11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Section 3 Pressure equipment and assemblies

(1) Subject to paragraph (2) and regulation 4, these Regulations apply to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

(2) These Regulations apply to pressure equipment and assemblies placed on the market on or after the commencement date.

Section 4 Excluded pressure equipment and assemblies

(1) These Regulations do not apply to the items listed in Schedule 1.

(2) These Regulations do not apply to the assembly of pressure equipment on the site of and under the responsibility of a user who is not the manufacturer.

Section 5 Exception for trade fairs, exhibitions and demonstrations

Nothing in these Regulations prevents the showing and use of pressure equipment and assemblies, which is not in conformity with Part 2, at a trade fair, exhibition or demonstration for the marketing of pressure equipment, provided that a visible sign clearly indicates—

(a) that the pressure equipment or assembly is not in conformity with Part 2; and

(b) that the pressure equipment or assembly must not be made available on the market or put into service until brought into conformity.

Section 6 Pressure equipment and assemblies subject to essential safety requirements

The following pressure equipment must satisfy the essential safety requirements set out in Schedule 2—

(a) vessels, except those referred to in subparagraph (b), for—

(i) gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) within the following limits—

(aa) for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar∙L, or with a pressure PS greater than 200 bar;

(bb) for fluids in Group 2, with a volume greater than 1 L and a product of PS and V greater than 50 bar∙L or with a pressure PS greater than 1000 bar, and all portable extinguishers and bottles for breathing apparatus;

(ii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) within the following limits—

(aa) for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar∙L, or with a pressure PS greater than 500 bar;

(bb) for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10 000 bar∙L, or with a pressure PS greater than 1000 bar;

(b) fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than 110°C having a volume greater than 2 L, and all pressure cookers;

(c) piping intended for—

(i) gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) within the following limits—

(aa) for fluids in Group 1 with a DN greater than 25;

(bb) for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1000 bar;

(ii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) within the following limits—

(aa) for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2000 bar;

(bb) for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5000 bar;

(d) safety and pressure accessories intended for equipment covered by (a) to (c) above including where such equipment is incorporated into an assembly.

Section 7

(1) The following assemblies which include at least one item of pressure equipment covered by regulation 6 must satisfy the essential safety requirements set out in Schedule 2—

(a) assemblies intended for generating steam or superheated water at a temperature higher than 110 °C comprising at least one item of fired or otherwise heated pressure equipment presenting a risk of overheating;

(b) assemblies other than those referred to in subparagraph (a), if the manufacturer intends them to be made available on the market and put into service as assemblies.

(2) By way of derogation from subparagraph (1)(a) above, assemblies intended for generating warm water at temperatures not greater than 110°C which are manually fed with solid fuels and have a PS∙V greater than 50 bar∙L must comply with only those essential safety requirements referred to in paragraphs 14, 15, 30, 33(2)(a) and 33(2)(d) of Schedule 2.

Section 8 Requirement for pressure equipment and assemblies to comply with sound engineering practice

(1) This regulation applies to pressure equipment and assemblies to which these Regulations apply and which are below or equal to the limits set out in regulations 6(a) to (c) or regulation 7, as applicable.

(2) Pressure equipment and assemblies to which this regulation applies must be—

(a) designed and manufactured in accordance with sound engineering practice in order to ensure safe use; and

(b) accompanied by adequate instructions for use.

(3) Pressure equipment and assemblies to which this regulation applies must not bear the UK marking referred to in regulation 49 unless required to do so by other applicable UK legislation.

(4) In this regulation, “ safe ” means that the pressure equipment or assembly, when properly installed and maintained and used for its intended purpose, is not liable to endanger the health or safety of persons and, where applicable, domestic animals or property.

Section 8A Power to reclassify pressure equipment and assemblies

(1) Where the condition in paragraph (2) is met, the Secretary of State may by regulations make provision that pressure equipment or assemblies referred to in regulation 8 are to satisfy the essential requirements in Schedule 2.

(2) The condition referred to in paragraph (1) is that the Secretary of State considers that the provision is required to mitigate the effects of very serious safety concerns.

(3) Regulations made under paragraph (1)—

(a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and

(b) include power—

(i) to make different provision for different cases; and

(ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

Section 9 Design and manufacture in accordance with essential safety requirements

(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements.

(2) Before placing pressure equipment or an assembly referred to in regulation 8 on the market or using it for their own purposes, a manufacturer must ensure that it complies with regulation 8(2).

Section 10 Technical documentation and conformity assessment

(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market or using it for their own purposes, a manufacturer must—

(a) classify it using the categories set out in Schedule 3 (classification of pressure equipment), according to an ascending level of hazard;

(b) determine the conformity assessment procedures to apply to the pressure equipment or assembly in accordance with regulation 41 (conformity assessment procedure);

(c) carry out the relevant conformity assessment procedure in respect of that pressure equipment or assembly, or have such a procedure carried out; and

(d) draw up the relevant technical documentation referred to in the conformity assessment module followed in accordance with regulation 41.

(2) For the purposes of paragraph (1)(d), the relevant technical documentation is the following with reference to the modules set out in Schedule 1A to these Regulations —

(a) where Module A is followed, the technical documentation is the technical documentation referred to in point 2 under Module A (Internal production control);

(b) where Module A2 is followed, the technical documentation is the technical documentation referred to in point 2 under Module A2 (Internal production control plus supervised pressure equipment checks at random intervals);

(c) where Module B (production type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B ( Type examination – production type);

(d) where Module B (design type) is followed, the technical documentation is the technical documentation referred to in point 3 under Module B ( Type examination – design type);

(e) where Module G is followed, the technical documentation is the technical documentation referred to in point 2 under Module G (Conformity based on unit verification);

(f) where Module H is followed, the technical documentation is the technical documentation referred to in point 3 under Module H (Conformity based on full quality assurance);

(g) where Module H1 is followed, the technical documentation is the technical documentation referred to in point 3 under Module H1 (Conformity based on full quality assurance plus design examination).

Section 11 Declaration of conformity and UK marking

(1) Where the conformity of pressure equipment or an assembly referred to in regulation 6 or 7 with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the pressure equipment or assembly on the market—

(a) draw up a declaration of conformity in accordance with regulation 48 ( ... declaration of conformity);

(b) affix the UK marking in accordance with regulation 49 (CE marking); and

(c) where applicable, ensure that the identification number of the approved body is affixed in accordance with regulation 49.

(2) The requirement in paragraph (1)(b) does not apply in cases where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) The manufacturer must keep the ... declaration of conformity up-to-date.

(4) Where pressure equipment or an assembly 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.

Section 12 Duty to keep technical documentation and ... declaration of conformity

A manufacturer must keep the technical documentation and the ... declaration of conformity drawn up in respect of pressure equipment or an assembly and make them available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the pressure equipment or assembly is placed on the market.

Section 13 Labelling of pressure equipment and assemblies

(1) Before placing pressure equipment or an assembly on the market, a manufacturer must—

(a) ensure that it bears a type, batch or serial number or other element allowing its identification; and

(b) ensure that it is marked with—

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

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

(2) Where it is not possible for information specified in paragraph (1)(a) and (b) to be indicated on the pressure equipment or assembly, the manufacturer must ensure that the information is indicated on its packaging or in a document accompanying the pressure equipment or assembly.

(3) The details set out in paragraph (1)(b) must be clear, legible and in easily understandable English.

Section 14 Instructions and safety information

(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, a manufacturer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English .

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, a manufacturer must ensure that it is accompanied by adequate instructions for use that are clear, legible and in easily understandable English .

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(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 15 Compliance procedures for series production

(1) A manufacturer of pressure equipment or assemblies which are manufactured by series production must ensure that procedures are in place to ensure that any pressure equipment or assemblies so manufactured will be in conformity with Part 2.

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

(a) any change in pressure equipment or assembly design or characteristics; and

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

Section 16 Monitoring

(1) When appropriate, with regard to the risks to the health and safety of consumers and other users presented by pressure equipment or assemblies, the manufacturer must—

(a) carry out sample testing of pressure equipment or assemblies made available on the market;

(b) investigate complaints that pressure equipment or assemblies are not in conformity with Part 2;

(c) keep a register of—

(i) complaints that pressure equipment or assemblies are not in conformity with Part 2;

(ii) pressure equipment or assemblies which are found not to be in conformity with Part 2; and

(iii) pressure equipment or assemblies recalls; and

(d) keep distributors informed of any monitoring carried out under this regulation.

(2) The 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.

Section 17 Duty to take action in respect of pressure equipment or assemblies placed on the market which are considered not to be in conformity

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

(a) bring the pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.

(2) Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authority ... of the risk, giving details of—

(a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 18 Provision of information and cooperation

(1) Further to a request from an enforcing authority, and within such period as the authority may specify, a manufacturer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a) may only be made during the period of 10 years beginning on the day the pressure equipment or assembly was placed on the market; and

(b) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a) may be provided electronically; and

(b) must be in a language which can be easily understood by the enforcing authority.

(4) A manufacturer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a) evaluate pressure equipment or an assembly in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b) eliminate the risks posed by pressure equipment or an assembly which the manufacturer has placed on the market.

Section 19 Manufacturer's authorised representatives

(1) A manufacturer may, by written mandate, appoint a person as their authorised representative to perform specified tasks on the manufacturer's behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to pressure equipment or assemblies covered by the mandate—

(a) perform the manufacturer's obligations under regulation 12 (duty to keep technical documentation and ... declaration of conformity); and

(b) perform the manufacturer's obligations under regulation 18 (provision of information and cooperation).

(3) The obligations laid down in regulation 9 (design and manufacture in accordance with the essential safety requirements) and regulation 10(1)(b) (technical documentation and conformity assessment) must not form part of an authorised representative's mandate.

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

(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer's behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.

Section 20 Prohibition on placing on the market pressure equipment or assemblies which are not in conformity

An importer must not place pressure equipment or an assembly on the market unless it is in conformity with Part 2.

Section 21 Requirements which must be satisfied before an importer places pressure equipment or assemblies on the market

(1) Before placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that—

(a) the relevant conformity assessment procedure has been carried out;

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

(c) the pressure equipment or assembly—

(i) bears the UK marking; and

(ii) is accompanied by the required documents; and

(d) the manufacturer has complied with the requirements of regulation 13 (labelling).

(2) The requirement in paragraph (1)(c)(i) does not apply in cases where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) Before placing pressure equipment or an assembly referred to in regulation 8 on the market, an importer must ensure that—

(a) the manufacturer has drawn up the technical documentation;

(b) the pressure equipment or assembly is accompanied by adequate instructions for use and any required documents; and

(c) the manufacturer has complied with the requirements of regulation 13 (labelling).

(4) In paragraphs (1)(c)(ii) and (3)(b), “ required documents ” means any documents that the manufacturer is required to provide with pressure equipment or an assembly pursuant to regulation 13(2) (labelling) and 14 (instructions and safety information).

Section 22 Prohibition on placing on the market pressure equipment or assemblies considered not to be in conformity with the essential safety requirements

(1) Where an importer considers, or has reason to believe, that pressure equipment or an assembly referred to in Regulation 6 or 7 is not in conformity with the essential safety requirements, the importer must not place the pressure equipment or assembly on the market.

(2) Where pressure equipment or an assembly presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Section 23 Information identifying importer

(1) Before placing pressure equipment or an assembly on the market, an importer must indicate on the pressure equipment or assembly—

(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 consumers and other 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 pressure equipment or assembly, or

(ii) the importer has imported the pressure equipment or assembly 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 pressure equipment or assembly on the market, the importer sets out the information referred to in paragraph (1) on the packaging of the pressure equipment or assembly or in a document accompanying the pressure equipment or assembly.

Section 24 Instructions and safety information

(1) When placing pressure equipment or an assembly referred to in regulation 6 or 7 on the market, an importer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English .

(2) The instructions and safety information referred to in paragraph (1) must include the information listed in paragraphs 29 and 30 of Schedule 2.

(3) When placing pressure equipment or an assembly covered by regulation 8 on the market, an importer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English .

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Section 25 Storage and transport

Where an importer has responsibility for pressure equipment or an assembly referred to in Regulation 6 or 7, the importer must ensure that the conditions under which the pressure equipment or assembly is stored or transported do not jeopardise its conformity with the essential safety requirements.

Section 26 Monitoring

(1) Where appropriate, having regard to the risks to the health and safety of consumers and other users presented by the pressure equipment or assemblies, the importer must—

(a) carry out sample testing of pressure equipment and assemblies made available on the market by the importer;

(b) investigate complaints of pressure equipment and assemblies made available on the market by the importer which are not in conformity with Part 2;

(c) keep a register of—

(i) complaints that pressure equipment or assemblies are not in conformity with Part 2;

(ii) pressure equipment or assemblies which are found not to be in conformity with Part 2; and

(iii) pressure equipment or assemblies recalls; and

(d) keep distributors informed of any monitoring carried out under this regulation.

(2) The 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.

Section 27 Duty to take action in respect of pressure equipment or assemblies placed on the market considered not to be in conformity

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

(a) bring that pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the importer must immediately inform the market surveillance authority and the competent national authorities ... of the risk, giving details of—

(a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 28 Retention of technical documentation and ... declaration of conformity

An importer must, for a period of 10 years beginning on the day on which pressure equipment or an assembly is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to the pressure equipment or assembly—

(a) a copy of the ... declaration of conformity; and

(b) the technical documentation.

Section 29 Provision of information and cooperation

(1) Following a request from an enforcing authority, and within such period as the authority may specify, an importer must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a) may only be made during the period of 10 years beginning on the day the importer places the pressure equipment or assembly on the market; and

(b) must be accompanied by the reasons for making the request.

(3) The information and documentation referred to in paragraph (1)—

(a) may be provided electronically; and

(b) must be clear, legible and in easily understandable English .

(4) An importer must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a) evaluate pressure equipment or assemblies in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b) eliminate the risks posed by pressure equipment or assemblies which the importer has placed on the market.

Section 30 Duty to act with due care

When making pressure equipment or an assembly available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Section 31 Requirements which must be satisfied before a distributor makes pressure equipment or assemblies available on the market)

(1) Before making pressure equipment or an assembly referred to in regulation 6 or 7 available on the market, the distributor must verify that—

(a) the pressure equipment or assembly—

(i) bears the UK marking;

(ii) is accompanied by the required documents;

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

(b) the manufacturer has complied with the requirements of regulation 13 (labelling of pressure equipment and assemblies); and

(c) the importer has complied with the requirements of regulation 23 (information identifying importer).

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

(a) regulation 13 (labelling of pressure equipment and assemblies);

(b) regulation 23 (information identifying importer);

(c) regulation 14 or 24 (instructions and safety information); and

(d) regulation 49 ( UK marking).

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 32 Storage and transport

Where a distributor has responsibility for pressure equipment or an assembly referred to in Regulation 6 or 7, the distributor must ensure that the conditions under which the pressure equipment or assembly is stored or transported do not jeopardise its conformity with the essential safety requirements.

Section 33 Prohibition on making available on the market where pressure equipment or assemblies are not considered to be in conformity with essential safety requirements

(1) Where a distributor considers, or has reason to believe, that pressure equipment or an assembly referred to in Regulation 6 or 7 is not in conformity with the essential safety requirements, the distributor must not make the pressure equipment or assembly available on the market until it has been brought into conformity.

(2) Where the pressure equipment or assembly 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.

Section 34 Duty to take action in respect of pressure equipment made available on the market which are not in conformity

(1) A distributor who considers, or has reason to believe, that pressure equipment or assemblies 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 pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.

(2) Where the pressure equipment or assembly presents a risk, the distributor must immediately inform the market surveillance authority, and the competent national authorities ..., of that risk, giving details of—

(a) the respect in which pressure equipment is considered not to be in conformity with Part 2; and

(b) any corrective measures taken.

Section 35 Provision of information and cooperation

(1) Following a request from an enforcing authority, and within such period as the authority may specify, a distributor must provide the authority with all the information and documentation necessary to demonstrate that pressure equipment or an assembly is in conformity with Part 2.

(2) The information referred to in paragraph (1)—

(a) may be provided electronically; and

(b) must be clear, legible and in easily understandable English .

(3) A distributor must, at the request of the enforcing authority, cooperate with that authority on any action taken to—

(a) evaluate pressure equipment in accordance with regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); or

(b) eliminate the risks posed by pressure equipment or assemblies which the distributor has made available on the market.

Section 36 Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor (“A”) 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 pressure equipment or an assembly on the market under A's own name or trademark; or

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

Section 37 Translation of ... declaration of conformity

(1) Before making pressure equipment or an assembly available on the market, an economic operator must ensure that the ... declaration of conformity is in English .

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 38 Identification of economic operators

(1) An economic operator (“E”) who receives a request in relation to pressure equipment or an assembly from the market surveillance authority before the end of the relevant period must, within such period as that authority may specify, identify to the authority—

(a) any other economic operator who has supplied E with the pressure equipment or assembly; and

(b) any other economic operator to whom E has supplied the pressure equipment or assembly.

(2) The relevant period is—

(a) for information under paragraph (1)(a), 10 years beginning on the day on which E was supplied with the pressure equipment or assembly; and

(b) for information under paragraph (1)(b), 10 years beginning on the day on which E supplied the pressure equipment or assembly.

Section 39 Prohibition on improper use of UK marking

(1) An economic operator must not affix the UK marking to pressure equipment or an assembly unless—

(a) that economic operator is the manufacturer of the pressure equipment or assembly; and

(b) the conformity of the pressure equipment or assembly with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix the UK marking to pressure equipment or an assembly where—

(a) the conformity assessment procedure followed in accordance with regulation 41 is either module A2, C2, F or G; and

(b) the conformity assessment procedure has been carried out by a user inspectorate.

(3) An economic operator must not affix to pressure equipment or an assembly a marking which—

(a) is not the UK marking; but

(b) purports to attest that the pressure equipment or assembly is in conformity with the essential safety requirements.

(4) An economic operator must not affix to pressure equipment or an assembly a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the UK marking.

(5) An economic operator must not affix to pressure equipment or an assembly any other marking if the visibility, legibility and meaning of the UK marking would be impaired as a result.

Section 39A Obligations which are met by complying with the obligations in the Directive

(1) In this regulation—

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

(b) “ CE marking ” has the meaning given to it in Article 2(31); and

(c) “ pressure equipment and assemblies ” means the pressure equipment and assemblies referred to in Article 4(1) and (2).

(2) Paragraph (3) applies where, before placing pressure equipment or an assembly on the market, the manufacturer—

(a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures referred to in Article 14 have been carried out;

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

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

(e) affixes a CE marking and the identification number of the notified body (where that body is involved in the product control phase) in accordance with Articles 18 and 19(1) to (4);

(f) draws up an EU declaration of conformity, in accordance with Article 17; and

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

(3) Where this paragraph applies—

(a) the requirements of regulations 9(1), 10 and 11(1) are to be treated as being satisfied;

(b) regulations 2(2)(a), 11(3), 12, 15(2), 19(2) and 39 apply subject to the modifications in paragraph (8); and

(c) Part 3 does not apply;

(d) regulation 74 does not apply.

(4) Paragraph (5) applies where, before placing pressure equipment or an assembly on the market, the importer ensures that—

(a) the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c) the pressure equipment or assembly bears the CE marking and any notified body identification number.

(5) Where this paragraph applies—

(a) the requirements of regulation 21(1)(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making pressure equipment or an assembly available on the market, a distributor ensures that the pressure equipment or assembly bears the CE marking.

(7) Where this paragraph applies—

(a) regulation 31(1)(a)(i) is to be treated as being satisfied; and

(b) regulations 2(2)(a) and 33(1) apply subject to the modifications in paragraph (8).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(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 a reference to the CE marking;

(c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(24); and

(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 14.

Section 39B Conformity assessment procedure obligation which is met by complying with the Directive.

(1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive.

(2) Paragraph (3) applies where, prior to the manufacture of pressure equipment or an assembly, the manufacturer ensures that the conformity assessment procedure that applies to that pressure equipment or assembly in accordance with Article 14(2), referred to as Module B and set out in Annex III, has been carried out.

(3) Where this paragraph applies—

(a) the requirement in regulation 42 to follow the conformity assessment procedure referred to in that regulation as Module B is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 10(1)(c), 11(1), 21(1)(a), 39(1)(b) and 48(b) is to be read as including the conformity assessment procedure referred to in Article 14(2), referred to as Module B and set out in Annex III; and

(c) any reference to “technical documentation” in regulations 10(1)(d), 21(1)(b) and 28(b) is to be read as including the technical documentation relating to the design of the pressure equipment or assembly referred to as Module B as set out in Annex III.

Section 39C Further use of the UK marking

(1) In this regulation—

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

(b) “ pressure equipment or assembly ” means the pressure equipment or assembly referred to in Article 4(1) and (2);

(c) “ harmonised standard ” has the meaning given in Article 2(24).

(2) Paragraph (3) applies where, before placing pressure equipment or assembly on the market, the manufacturer—

(a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures that apply to that pressure equipment or assembly referred to in Article 14 have been carried out;

(c) draws up the technical documentation referred to in Annex III; 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 9(1) and 10 are to be treated as being satisfied;

(b) except for regulations 48 and 49(1) to (5), Part 3 does not apply;

(c) regulations 2(2)(a), 12, 15, 21(1)(a) and (b), 22, 25, 31, 32, 33 and 39 apply subject to the modifications in paragraph (4);

(d) regulations 11, 14, 24, 48 and 49(2) and Schedule 11 are 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 safety requirements” is to be read as a reference to the essential safety requirements set out in Annex I;

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

(c) any reference to “conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure referred to in Article 14;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III;

(e) any reference to “pressure equipment or an assembly referred to in regulation 6 or 7” is to be read as a reference to pressure equipment or assembly referred to in Article 4(1) or (2).

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

(a) in regulation 11—

(i) paragraph (1) is to be read as if sub-paragraph (c) were omitted;

(ii) in paragraph (4) the reference to “enactment” is to be read as including the Directive;

(b) in regulations 14 and 24 any reference to paragraphs 29 and 30 of Schedule 2 is to be read as a reference to paragraphs 3.3 and 3.4 of Annex I;

(c) in regulation 48 the reference to “Schedule 1A to these Regulations” is to be read as a reference to Annex III;

(d) in regulation 49(2)—

(i) the reference to “regulation 42” is to be read as a reference to Article 14;

(ii) the reference to “user inspectorate” is to be read as a reference to any body designated in accordance with Article 16;

(e) in Schedule 11—

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

(ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IV.

Section 39D Qualifying Northern Ireland Goods

(1) Where paragraph (2) applies any pressure equipment or assembly is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a) any pressure equipment or assembly—

(i) is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii) is qualifying Northern Ireland goods; and

(b) an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the pressure equipment or assembly on the market, the importer—

(a) complies with regulation 23;

(b) ensures that—

(i) the relevant conformity assessment procedure has been carried out in accordance with Part 3, as that Part applies in Northern Ireland;

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

(iii) the pressure equipment or assembly bears the CE marking.

(4) In this regulation—

“ CE marking ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

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

“ technical documentation ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Section 40 Presumption of conformity

(1) Pressure equipment or an assembly which is in conformity with a designated standard (or part of such a standard) ... is to be presumed to be in conformity with the essential safety requirements covered by that standard (or that part of that standard).

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Section 41 Conformity assessment procedures

For the assessment of conformity of pressure equipment falling within regulation 6, the manufacturer must determine the applicable category in accordance with the procedure set out in Schedule 3.

Section 42

(1) The manufacturer must follow one of the following conformity assessment procedures referred to in Schedule 1A to these Regulations according to the category in which the equipment is classified—

(a) Category I: Module A;

(b) Category II : Module A2; or, at the choice of the manufacturer, Module D1; or Module E1;

(c) Category III: Modules B (design type) + D; or, at the choice of the manufacturer, Modules B (design type) + F; or Modules B (production type) + E; or Modules B (production type) + C2; or Module H;

(d) Category IV : Modules B (production type) + D; or, at the choice of the manufacturer, Modules B (production type) + F; or Module G; or Module H1.

(2) The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.

Section 42A Power to amend applicable module

(1) Where in order to mitigate the effects of very serious safety concerns the Secretary of State considers that an item or family of pressure equipment are to be subject to different categories of modules, the Secretary of State may by regulations make such provision.

(2) Regulations made under paragraph (1)—

(a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and

(b) include power—

(i) to make different provision for different cases; and

(ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

Section 43

(1) The approved body or user inspectorate must, when performing unexpected visits in the framework of quality assurance procedures for pressure equipment in categories III and IV in regulation 6(a)(i), 6(a)(ii)(aa) or 6(b), take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in paragraph 25 of Schedule 2.

(2) The manufacturer must inform the approved body or user inspectorate of the intended schedule of production.

(3) The approved body or user inspectorate must carry out at least two visits during the first year of manufacturing.

(4) The approved body or user inspectorate must determine the frequency of subsequent visits on the basis of the criteria set out in point 4.4. of modules D, E and H and point 5.4 of module H1 in Schedule 1A to these Regulations .