Consumer Protection PART 1 Preliminary Citation and commencement 1 These Regulations may be cited as the Pressure Equipment (Safety) Regulations 2016 and come into force on 8th December 2016 (“ the commencement date ”). Interpretation 2 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 ; ... ... “ 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); ... ... “ 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; ... ... “ 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; ... “ 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; ... “ 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; ... ... ... “ 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. 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Designated standard 2A 1 Subject to paragraphs (6) and (7), in these Regulations a “ designated standard ” means a technical specification which is— a adopted by a recognised standardisation body 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. Pressure equipment and assemblies 3 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. Excluded pressure equipment and assemblies 4 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. Exception for trade fairs, exhibitions and demonstrations 5 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. Pressure equipment and assemblies subject to essential safety requirements 6 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. 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. Requirement for pressure equipment and assemblies to comply with sound engineering practice 8 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. Power to reclassify pressure equipment and assemblies 8A 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. PART 2 Obligations of economic operators Manufacturers Design and manufacture in accordance with essential safety requirements 9 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). Technical documentation and conformity assessment 10 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). Declaration of conformity and UK marking 11 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. Duty to keep technical documentation and ... declaration of conformity 12 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. Labelling of pressure equipment and assemblies 13 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. Instructions and safety information 14 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 . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compliance procedures for series production 15 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. Monitoring 16 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. Duty to take action in respect of pressure equipment or assemblies placed on the market which are considered not to be in conformity 17 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. Provision of information and cooperation 18 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. Manufacturer's authorised representatives 19 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. Importers Prohibition on placing on the market pressure equipment or assemblies which are not in conformity 20 An importer must not place pressure equipment or an assembly on the market unless it is in conformity with Part 2. Requirements which must be satisfied before an importer places pressure equipment or assemblies on the market 21 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). Prohibition on placing on the market pressure equipment or assemblies considered not to be in conformity with the essential safety requirements 22 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. Information identifying importer 23 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. Instructions and safety information 24 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 . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Storage and transport 25 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. Monitoring 26 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. Duty to take action in respect of pressure equipment or assemblies placed on the market considered not to be in conformity 27 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. Retention of technical documentation and ... declaration of conformity 28 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. Provision of information and cooperation 29 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. Distributors Duty to act with due care 30 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. Requirements which must be satisfied before a distributor makes pressure equipment or assemblies available on the market) 31 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Storage and transport 32 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. Prohibition on making available on the market where pressure equipment or assemblies are not considered to be in conformity with essential safety requirements 33 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. Duty to take action in respect of pressure equipment made available on the market which are not in conformity 34 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. Provision of information and cooperation 35 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. All economic operators Cases in which obligations of manufacturers apply to importers and distributors 36 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. Translation of ... declaration of conformity 37 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Identification of economic operators 38 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. Prohibition on improper use of UK marking 39 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. Obligations which are met by complying with the obligations in the Directive 39A 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. Conformity assessment procedure obligation which is met by complying with the Directive. 39B 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. Further use of the UK marking 39C 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. Qualifying Northern Ireland Goods 39D 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. PART 3 Conformity assessment Presumption of conformity 40 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. Conformity assessment procedures 41 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. 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. Power to amend applicable module 42A 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. 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 . 44 In the case of one-off production of vessels and pressure equipment in category III referred to in regulation 6(b) under the module H procedure, the approved body or user inspectorate must perform or have performed the final assessment, as referred to in paragraph 25 of Schedule 2, for each unit. 45 For the assessment of conformity of assemblies referred to in regulation 7, the manufacturer must apply a global conformity assessment procedure comprising— a the assessment (the procedure for which is to be determined by the category of each item) of each item of pressure equipment making up the assembly and referred to in regulation 6 which has not been previously subjected to a conformity assessment procedure and to a separate UK marking; b the assessment of the integration of the components of the assembly as referred to in paragraphs 7, 12 and 13 of Schedule 2 which must be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories; and c the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in paragraph 14 and 28 of Schedule 2 which must be conducted against the highest category applicable to individual items of equipment included in the assembly. 46 Regulations 41 to 45 do not apply to pressure equipment items and assemblies which are made available on the market or put into service solely in the interests of experimentation. 47 The records and correspondence relating to conformity assessment must be clear, legible and in easily understandable English. ... Declaration of conformity 48 The ... declaration of conformity in respect of pressure equipment or an assembly must— a state that the fulfilment of the essential safety requirements has been demonstrated in respect of pressure equipment; b contain the elements specified in Schedule 1A to these Regulations for the relevant conformity assessment procedure followed in respect of the pressure equipment or assembly; and c have the model structure set out in Schedule 11. UK marking 49 1 Before placing on the market, the UK marking must be affixed visibly, legibly and indelibly to the following: a any item of pressure equipment referred to in regulation 6 or its dataplate; and b any assembly referred to in regulation 7 or its data plate; or c where paragraph (1A) applies— i a label affixed to the pressure equipment or assembly; or ii to a document accompanying the pressure equipment or assembly. 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 pressure equipment or assembly; or b to a document accompanying the pressure equipment or assembly. 2 The requirement in paragraph (1) does not apply in cases where— a the conformity assessment procedure followed in accordance with regulation 42 is either module A2, C2, F or G; and b the conformity assessment procedure has been carried out by a user inspectorate. 3 Where paragraph (1A) does not apply and it is not possible or warranted, on account of the nature of the equipment or assembly, to affix the UK marking in accordance with paragraph (1), the UK marking must be affixed to— a the packaging; and b the accompanying documents. 4 At the time the UK marking is affixed, the item or assembly referred to in subparagraph (1)(a) or (b) must be— a complete; or b in a state permitting final assessment as described in paragraph 25 (Final assessment) of Schedule 2. 5 Individual items of pressure equipment already bearing the UK marking when incorporated into an assembly must continue to bear that marking, but the UK marking need not be affixed to each additional item of pressure equipment making up an assembly. 6 The UK marking must be followed by the identification number of the approved body which carried out the relevant conformity assessment procedure for the pressure equipment or assembly, where that body is involved in the production control phase. 7 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 his authorised representative. 8 The UK marking and, where applicable, the identification number of the approved body may be followed by any other mark indicating a special risk or use. UK(NI) indication 49A 1 Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the pressure equipment or assembly, in accordance with this regulation. 2 The UK(NI) indication must be affixed— a visibly, legibly and indelibly; and b before pressure equipment or an assembly is placed on the market in Northern Ireland. 3 The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 49. 4 The UK(NI) indication must be affixed by— a the manufacturer; or b the manufacturer's authorised representative. 5 When placing pressure equipment or an assembly on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation. Register of notified bodies established in the United Kingdom 49B 1 The Secretary of State must ensure that— a each notified body established in the United Kingdom is assigned an identification number; and b there is a register of— i notified bodies established in the United Kingdom; ii their notified body identification number; iii the activities for which they have been notified; iv any restrictions on those activities. 2 The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available. 3 The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b). European approval for materials 50 1 For the purpose of this regulation, an issuing body is a body which has been notified under regulation 55 (notification) specifically in relation to the activity of issuing European approval for materials. 2 European approval for materials must be issued, at the request of one or more manufacturers of materials or equipment, by an issuing body. 3 The issuing body must determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the conformity of the types of material with the corresponding requirements of these Regulations. 4 In the case of materials recognised as being safe to use before 29 November 1999, the issuing body must take account of the existing data when certifying such conformity. 5 Prior to issuing a European approval for materials, the issuing body must inform the other relevant states and the Commission by sending them the appropriate information. 6 Where, within three months of being informed by the issuing body, a relevant state or the Commission provides comments with reasons, the issuing body must take those comments into account before issuing the European approval for materials. 7 A copy of the European approval for materials must be sent to the relevant states , the bodies notified under regulation 55 and the Commission. 8 The issuing body must withdraw its approval if it finds that it should not have been issued or that the type of materials is covered by a harmonised standard. 9 If an issuing body withdraws approval for materials under paragraph 8, it must immediately inform the other relevant states and the bodies notified under regulation 55 of that withdrawal. PART 4 Notification of conformity assessment bodies Approval of Conformity Assessment Bodies Approved bodies 51 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 54 (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 62(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body. 2 Paragraph (1) has effect subject to regulation 60 (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 as a notified body, in accordance with Article 20 of the Directive; and in respect of which no objections had been raised, as referred to in regulation 51(1)(b), as it had effect immediately before IP completion day; “ approved body requirements ” means the requirements set out in Schedule 4; “ product ” means pressure equipment or assemblies; “ accreditation certificate ” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. Recognised third party organisations 52 1 A recognised third party organisation is a conformity assessment body which— a has been approved by the Secretary of State to be a recognised third party organisation, under regulation 54 (approval of conformity assessment bodies); or b immediately before IP completion day— i was a conformity assessment body which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union as a recognised third party organisation, in accordance with Article 20 of the Directive; ii in respect of which no objections had been raised, as referred to in regulation 52(1)(b), as it had effect immediately before IP completion day; and iii in respect of which the Secretary of State had taken no action under regulation 62(1) or (2), as they had effect immediately before IP completion day to suspend or withdraw the body's status as a recognised third party organisation. 2 Paragraph (1) has effect subject to regulation 60 (restriction, suspension or withdrawal of approval). User inspectorates 53 1 A user inspectorate is a conformity assessment body which— a has been approved as a user inspectorate by the Secretary of State under regulation 54 (approval of conformity assessment bodies); or b immediately before IP completion day— i was a conformity assessment body which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union as a user inspectorate, in accordance with Article 20 of the Directive; ii in respect of which no objections had been raised, as referred to in regulation 53(1)(b), as it had effect immediately before IP completion day; and iii in respect of which the Secretary of State had taken no action under regulation 62(1) or (2), as they had effect immediately before IP completion day, to suspend or withdraw the body's status as a recognised third party organisation. 2 Paragraph (1) has effect subject to regulation 61 (restriction, suspension or withdrawal of approval (user inspectorates)). Approval of conformity assessment bodies 54 1 The Secretary of State may approve only those conformity assessment bodies which— a qualify for approval as an approved body in accordance with regulation 55; b qualify for approval as a recognised third party organisation in accordance with regulation 56; or c qualify for approval as a user inspectorate in accordance with regulation 57. 2 When deciding whether to approve a conformity assessment body that qualifies 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. Approval of approved bodies 55 1 A conformity assessment body qualifies for approval as an approved body if the first and second conditions below are met. 2 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. 3 The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. 4 For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. Approval of recognised third party organisations 56 1 A conformity assessment body qualifies for approval as a recognised third party organisation if the conditions in paragraphs (2), (3) and (4) are met. 2 The first condition is that the conformity assessment body has applied to the Secretary of State to become a recognised third party organisation 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. 3 The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. 4 The third condition is that the conformity assessment body must carry out approvals of only those activities referred to in paragraphs 21 and 22 of Schedule 2 (permanent joining and non-destructive tests). 5 For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. Approval of user inspectorates 57 1 A conformity assessment body qualifies for approval as a user inspectorate if the conditions in paragraphs (2) to (7) are met. 2 The conformity assessment body must apply to the Secretary of State to become a user inspectorate and that application must be 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 user inspectorate requirements. 3 The Secretary of State must be satisfied that the conformity assessment body meets the user inspectorate requirements. 4 The conformity assessment procedures which a user inspectorate may carry out are modules A2, C2, F and G, set out in Part 2, Part 4, Part 9 and Part 10 of Schedule 1A respectively. 5 The group of which the user inspectorate is part must apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of products. 6 The user inspectorate must act exclusively for the group of which it is part. 7 Where the conformity of a product has been assessed by a user inspectorate, that product may only be used in establishments operated by the group of which the user inspectorate is part. 8 For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the user inspectorate requirements. Presumption of conformity of conformity assessment bodies 58 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 or the user inspectorate requirements (as the case may be) covered by that standard (or part of that standard). 2 The presumption in paragraph (1) is rebuttable. Monitoring 59 The Secretary of State must monitor each approved body, recognised third party organisation and user inspectorate with a view to verifying that the body— a continues to meet the approved body requirements or user inspectorate requirements, as applicable; b meets any conditions set— i in accordance with regulation 54(2)(b), or ii in the case of— aa an approved body which was a notified body immediately before IP completion day; bb a recognised third party organisation falling within regulation 52(1)(b); or cc a user inspectorate falling within regulations 53(1)(b); in accordance with regulation 55(2)(b) as it applied immediately before IP completion day; and c carries out its functions in accordance with these Regulations. Restriction, suspension or withdrawal of approval (approved bodies and recognised third party organisations) 60 1 Where the Secretary of State determines that an approved body or a recognised third party organisation— 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 59(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body or a recognised third party organisation under regulation 51 or 52 (as the case may be). 2 Where the Secretary of State determines that an approved body or a recognised third party organisation no longer meets a condition referred to in regulation 59(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body or a recognised third party organisation under regulation 51 or 52 (as the case may be). 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 or recognised third party organisation of the proposed action and the reasons for it; b give the approved body or recognised third party organisation an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and c consider any such representations made by the approved body or recognised third party organisation. 5 Where the Secretary of State has taken action in respect of an approved body or recognised third party organisation under paragraph (1) or (2), or where an approved body or recognised third party organisation has ceased its activity, the approved body or recognised third party organisation must, at the request of the Secretary of State— a transfer its files relating to the activities it has undertaken as an approved body or recognised third party organisation to another approved body or recognised third party organisation or to the Secretary of State, or b keep its files relating to the activities it has undertaken as an approved body or recognised third party organisation 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. Restriction, suspension or withdrawal of approval (user inspectorates) 61 1 Where the Secretary of State determines that a user inspectorate— a no longer meets a user inspectorate requirement, or b is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 59(b), the Secretary of State must restrict, suspend or withdraw the body's status as a user inspectorate under regulation 53. 2 Where the Secretary of State determines that a user inspectorate no longer meets a condition referred to in regulation 59(b), the Secretary of State may restrict, suspend or withdraw the body's status as a user inspectorate under regulation 53. 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 user inspectorate of the proposed action and the reasons for it; b give the user inspectorate an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and c consider any such representations made by the user inspectorate. 5 Where the Secretary of State has taken action in respect of a user inspectorate under paragraph (1) or (2), or where a user inspectorate has ceased its activity, the user inspectorate must at the request of the Secretary of State— a transfer its files relating to the activities it has undertaken as a user inspectorate to an approved body, a recognised third party organisation or to the Secretary of State, or b keep its files relating to the activities it has undertaken as a user inspectorate available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created. Operational matters in relation to approved bodies, recognised third party organisations and user inspectorates 62 1 Subject to the terms of its appointment, an approved body, recognised third party organisation or user inspectorate must carry out the conformity assessment activities and procedures— a in respect of which the body's approval was given under regulation 55, 56 or 57 (as the case may be); or b in respect of which the body's notification to the European Commission was made as a notified body, a recognised third party organisation or a user inspectorate (as the case may be). 2 Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6. 3 An approved conformity assessment 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 Schedule 1A, or b to affix, or cause to be affixed, the body's identification number pursuant to regulation 49 (UK marking), where applicable. Subsidiaries and contractors 63 1 An approved body, recognised third party organisation or user inspectorate may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— a the body, organisation or inspectorate is satisfied that the subcontractor or subsidiary meets the approved body requirements or user inspectorate requirements, as applicable; b the body, organisation or inspectorate 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, recognised third party organisation or user inspectorate 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, recognised third party organisation or user inspectorate subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the body, organisation or inspectorate must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documents concerning— a the assessment of the qualifications of the subcontractor or the subsidiary; and b the conformity assessment activity carried out by the subcontractor or subsidiary. 4 In this regulation “ subsidiary ” has the meaning given to it in section 1159 of the Companies Act 2006. Register of approved bodies 64 1 The Secretary of State must— a assign— i an approved body identification number to each approved body; ii a recognised third party organisation identification number to each third party organisation; iii a user inspectorate identification number to each user inspectorate; and b compile and maintain a register of— i approved bodies, recognised third party organisations and user inspectorates; ii their identification 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. United Kingdom Accreditation Service 65 The Secretary of State may authorise the United Kingdom Accreditation Service 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 or user inspectorate requirements (as applicable); b monitoring approved bodies, recognised third party organisations and user inspectorates in accordance with regulation 59; and c compiling and maintaining the register of approved bodies, recognised third party organisations and user inspectorates, in accordance with regulation 64. PART 5 Market surveillance and enforcement Designation of market surveillance authority 66 1 The market surveillance authority is— a in the case of pressure equipment and assemblies for use in the workplace— i subject to paragraph (2), in Great Britain, the Health and Safety Executive ; and ii in Northern Ireland, the Health and Safety Executive for Northern Ireland ; b in the case of pressure equipment and assemblies for private use or consumption— i in Great Britain, within its area, a weights and measures authority; and ii in Northern Ireland, within its area, a district council. 2 In so far as these Regulations apply to pressure equipment or assemblies intended exclusively or primarily for use on relevant nuclear sites, the market surveillance authority is the Office for Nuclear Regulation. 3 In paragraph (2), “ relevant nuclear site ” means a site which is— a a GB nuclear site (within the meaning given in section 68 of the Energy Act 2013 ); b an authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998 ); or c a new nuclear build site (within the meaning given in regulation 2A of those Regulations). Enforcement 67 1 Subject to paragraph (2), these Regulations and RAMS (in its application to pressure equipment or assemblies) must be enforced by the market surveillance authority. 2 The Secretary of State, or a person appointed by the Secretary of State to act on behalf of the Secretary of State, may enforce these Regulations and RAMS (in its application to pressure equipment or assemblies). 3 Before taking enforcement action under paragraph (2), an enforcing authority which is not the market surveillance authority must notify the market surveillance authority of the proposed action. 4 In Scotland, only the Lord Advocate may commence proceedings for an offence under these Regulations. Enforcement powers 68 1 Schedule 7 (enforcement powers of weights and measures authorities, district councils and the Secretary of State under the 1987 Act) has effect where the enforcing authority is— a a weights and measures authority; b a district council; or c the Secretary of State. 2 Schedule 8 (enforcement powers of the Health and Safety Executive and the Office for Nuclear Regulation under the 1974 Act) has effect where the enforcing authority is the Health and Safety Executive or the Office for Nuclear Regulation. 3 Schedule 9 (Enforcement Powers of the Health and Safety Executive for Northern Ireland under the 1978 Order) has effect where the enforcing authority is the Health and Safety Executive for Northern Ireland. 4 In addition to the powers available to an enforcement authority by virtue of, as appropriate, paragraph (1), (2) or (3), the authority may use the powers in Schedule 10 (compliance, withdrawal and recall notices) . 5 This regulation does not prevent an enforcing authority from taking action in respect of pressure equipment or assemblies under the General Product Safety Regulations 2005 . Exercise of enforcement powers 69 When enforcing these Regulations or RAMS (in its application to pressure equipment or assemblies) the enforcing authority must exercise its powers in a manner which is consistent with— a regulation 70 (evaluation of pressure equipment or assemblies presenting a risk); b regulation 71 (enforcement action in respect of pressure equipment or assemblies which are not in conformity and which present a risk); c regulation 72 ( EU safeguard procedure); d regulation 73 (pressure equipment or assemblies which are in conformity, but present a risk); e regulation 74 (enforcement action in cases of formal non-compliance); f regulation 75 (restrictive measures). Evaluation of pressure equipment or assemblies presenting a risk 70 1 Where the market surveillance authority has sufficient reason to believe that pressure equipment or an assembly presents a risk, the market surveillance authority must carry out an evaluation to determine whether that pressure equipment or assembly is in conformity with the requirements of Part 2 applying in respect of that equipment or assembly. 2 Where an enforcing authority other than the market surveillance authority has sufficient reason to believe that pressure equipment or an assembly presents a risk, that enforcing authority may carry out an evaluation to determine whether that pressure equipment or assembly is in conformity with the requirements of Part 2 applying in respect of that equipment or assembly. Enforcement action in respect of pressure equipment or assemblies which are not in conformity and which present a risk 71 1 Where, in the course of an evaluation referred to in regulation 70, an enforcing authority finds that pressure equipment or an assembly is not in conformity with Part 2, it must, without delay, require a relevant economic operator to— a take all appropriate corrective action to bring the pressure equipment or assembly into conformity with those requirements within a prescribed period; b withdraw the pressure equipment or assembly within a prescribed period; or c recall the pressure equipment or assembly within a prescribed period. 2 The enforcing authority must inform the approved body which carried out the conformity assessment procedure in respect of the pressure equipment or assembly of— a the respect in which the pressure equipment or assembly is not in conformity with Part 2; and b the action which the enforcing authority has required the relevant economic operator to take. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Where the relevant economic operator does not take adequate corrective action within the prescribed period referred to in paragraph (1), the enforcing authority must take all appropriate measures to— a prohibit or restrict the pressure equipment or assembly being made available on the market in the United Kingdom; b withdraw the pressure equipment or assembly from the United Kingdom market; or c recall the pressure equipment or assembly. 6 Where the enforcing authority is not the Secretary of State and it takes measures under paragraph (5), it must notify the Secretary of State of those measures without delay. 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 The notice in paragraph (6) must include all available details about the pressure equipment or assembly and, in particular— a the data necessary for the identification of the pressure equipment or assembly; b the origin of the pressure equipment or assembly; c the nature of the lack of conformity alleged and the risk involved; d the nature and duration of the measures taken; e the arguments put forward by the relevant economic operator; and f whether the lack of conformity is due to either of the following— i failure of the pressure equipment or assembly to meet relevant requirements relating to a risk; ii shortcomings in a designated standard referred to in regulation 40 conferring a presumption of conformity. 9 In this regulation, “ prescribed period ” means a period which is— a prescribed by the enforcing authority; and b reasonable and commensurate with the nature of the risk presented by the pressure equipment or assembly. EU safeguard procedure 72 1 Where another relevant state has initiated the procedure under Article 40 of the Directive (as amended from time to time), each enforcing authority (other than the Secretary of State) must, without delay, inform the Secretary of State of— a any measures taken by the enforcing authority in respect of the pressure equipment or assembly which is the subject of the procedure; b any additional information which the enforcing authority has at its disposal relating to the lack of conformity of the pressure equipment or assembly. 2 Where another relevant state has initiated the procedure under Article 40 of the Directive (as amended from time to time), the Secretary of State must, without delay, inform the European Commission and the other relevant states of— a any measures taken in Northern Ireland by an enforcing authority in respect of the pressure equipment or assembly which is the subject of the procedure; b any additional information which an enforcing authority has at its disposal relating to the lack of conformity of the pressure equipment or assembly; ... c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Where a measure taken by another relevant state in respect of pressure equipment or an assembly is considered justified by the European Commission under Article 40(7) of the Directive (as amended from time to time), the market surveillance authority must ensure that appropriate measures, such as withdrawal, are taken in Northern Ireland in respect of the pressure equipment or assembly without delay. 4 Where a measure taken by another relevant state in respect of pressure equipment or an assembly is considered justified by the European Commission under Article 41(1) of the Directive (as amended from time to time), the market surveillance authority must take the necessary measures to ensure that the pressure equipment or assembly is withdrawn from the market in Northern Ireland . 5 Where the market surveillance authority has taken action under paragraph (3) or (4), it must notify the Secretary of State. 6 Where the Secretary of State receives a notice under paragraph (5), the Secretary of State must inform the European Commission of the action taken in respect of Northern Ireland . 7 If a measure taken by an enforcing authority pursuant to regulation 71 is considered unjustified by the European Commission under Article 41(1) of the Directive (as amended from time to time), the enforcing authority must withdraw that measure in respect of Northern Ireland . Pressure equipment or assemblies which are in conformity, but present a risk 73 1 Where, having carried out an evaluation under regulation 70, an enforcing authority finds that although pressure equipment is in conformity with Part 2, it presents a risk, the enforcing authority must require a relevant economic operator to take all appropriate measures to— a ensure that the pressure equipment or assembly, when placed on the market, no longer presents a risk; b withdraw the pressure equipment or assembly within a prescribed period; c recall the pressure equipment or assembly within a prescribed period. 2 Where an enforcing authority is not the Secretary of State and it takes measures under paragraph (1), it must notify the Secretary of State immediately. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The notice referred to in paragraph (2) must include all available details about the pressure equipment or assembly and, in particular— a the data necessary for the identification of the pressure equipment or assembly; b the origin and the supply chain of the pressure equipment or assembly; c the nature of the risk involved; and d the nature and duration of the measures taken by the enforcing authority. 5 In this regulation, “ prescribed period ” means a period which is— a prescribed by the enforcing authority; and b reasonable and commensurate with the nature of the risk presented by the pressure equipment or assembly. Enforcement action in cases of formal non-compliance 74 1 Where an enforcing authority makes one of the following findings in relation to pressure equipment or an assembly, it must require a relevant economic operator to remedy the non-compliance within a specified period— a the UK marking— i has not been affixed; or ii has been affixed otherwise than in accordance with regulations 39 (Prohibition on improper use of UK marking) and 49 ( UK marking); b where an approved body is involved in the production control phase for the pressure equipment or assembly, the identification number of the approved body— i has not been affixed; or ii has been affixed otherwise than in accordance with regulation 49; c the ... declaration of conformity— i has not been drawn up; ii has been drawn up otherwise than in accordance with regulations 11 ( ... declaration of conformity and UK marking) and 48 ( ... declaration of conformity); d the technical documentation is either not available or not complete; e the following information is absent, false or incomplete— i the information specified in regulation 13 (labelling of pressure equipment and assemblies); or ii the information specified in regulation 14 (instructions and safety information); f any other administrative requirement imposed on the manufacturer or importer under Part 2 has not been fulfilled. 2 Until the specified period has elapsed, the enforcing authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the relevant economic operator in respect of the non-compliance concerned. 3 Where the non-compliance referred to in paragraph (1) persists, the enforcing authority must take appropriate measures to— a restrict or prohibit the pressure equipment or assembly being made available on the market; b ensure that the pressure equipment or assembly is withdrawn; or c ensure that the pressure equipment or assembly is recalled. 4 Nothing in this regulation is to prevent an enforcing authority from taking action under regulation 71 (enforcement action in respect of pressure equipment or assemblies which are not in conformity and which present a risk) ... or 73 (pressure equipment or assemblies which are in conformity but present a risk). Restrictive measures 75 When enforcing these Regulations, an enforcing 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 pressure equipment or an assembly being made available on the market; b withdraw pressure equipment or an assembly; or c recall pressure equipment or an assembly. Offences 76 1 It is an offence for a person to contravene or fail to comply with any requirement of regulations 9 to 17, 18(4), 20 to 28, 29(4), 30 to 34, 35(3), 38 or 39. 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 an enforcing authority under these Regulations. Penalties 77 1 A person guilty of an offence under regulation 76 (other than an offence arising from a contravention of or failure to comply with a requirement of regulation 12 or regulation 28) is liable— a on summary conviction— i in England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both; ii in Scotland, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding three months, or to both; iii in Northern Ireland, to a fine not exceeding the statutory maximum or imprisonment for a term not exceeding three months, or to both; b on conviction on indictment, to a fine or imprisonment for a term not exceeding two years or to both. 2 A person guilty of an offence arising from a contravention of or failure to comply with a requirement of regulation 12 or regulation 28 is liable on summary conviction— a in England and Wales, to a fine or imprisonment for a term not exceeding three months, or to both; b in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding three months, or to both. Defence of due diligence 78 1 In proceedings for an offence under regulation 76, 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 seven clear days before— i in England, Wales and Northern Ireland, 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— a to the steps that P took, and those which might reasonably have been taken, for the purpose of verifying the information; and b to 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 79 1 Where the commission of an offence under regulation 76 (offences) is due to anything which another person did or failed to do in the course of business, that other person is guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against the first person. 2 Where a body corporate commits an offence, a relevant person is also guilty of the offence where the offence was committed by the body corporate— 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— a a director, manager, secretary or other similar officer of the body corporate; b in relation to a body corporate managed by its members, a member of that body corporate performing managerial functions; c in relation to a Scottish partnership, a partner; or d a person purporting to act as a person described in sub-paragraphs (a), (b) or (c). Time limit for prosecution of offences 80 1 In England and Wales an information relating to an offence under regulation 76 that is triable by a magistrates' court may be so tried if it is laid within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify the proceedings comes to the knowledge of the prosecutor. 2 In Scotland— a summary proceedings for an offence under regulation 76 may be commenced before the end of 12 months after the date on which evidence sufficient in the Lord Advocate's opinion to justify the proceedings came to the Lord Advocate's knowledge; and 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 In Northern Ireland, summary proceedings for an offence under regulation 76 may be instituted within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify proceedings comes to the knowledge of the prosecutor. 4 No proceedings may be brought more than three years after the commission of the offence. 5 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 paragraph (1), (2) or (3) came to light, is conclusive evidence. 6 This regulation has effect subject to paragraph (1)(n) of Schedule 8 and paragraph (1)(n) of Schedule 9. Service of documents 81 1 Any document required or authorised by these Regulations to be served on a person may be served by— a delivering it to that person in person; b leaving it at that person's proper address; or c sending it by post or electronic means to that person's proper address. 2 In the case of a body corporate, a document may be served on a director of that body. 3 In the case of a partnership, a document may be served on a partner or a person having control or management of the partnership business. 4 For the purposes of this regulation, “ proper address ” means— a in the case of a body corporate or its director— i the registered or principal office of that body; or 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; or ii the email address of a partner or person having that control or management; c in any other case, a person's last known address, which may be an email address. 5 If a person to be served with a document has specified an address in the United Kingdom (other than that person's proper address) at which that person or someone on that person's behalf will accept service, that address must also be treated as that person's proper address. 6 In this regulation, “ partnership ” includes a Scottish partnership. Recovery of expenses of enforcement 82 1 This regulation applies where a person commits an offence under regulation 76. 2 The court may (in addition to any other order it may make as to costs or expenses) order the person to reimburse the enforcing authority for any expenditure which the enforcing authority has incurred in investigating the offence. Action by enforcing authority 83 1 An enforcing authority may itself take action which an economic operator could have been required to take by a notice served under regulation 68 (enforcement powers) where the conditions for serving such a notice are met and either— a the enforcing 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 enforcing authority has taken action under paragraph (1) following the failure of an economic operator to comply with a notice, the authority may recover from that person as a civil debt any costs or expenses reasonably incurred by the enforcing authority in taking the action. 3 A civil debt recoverable under paragraph (2) may be recovered summarily— a in England and Wales by way of a complaint pursuant to section 58 of the Magistrates' Courts Act 1980 ; b in Northern Ireland in proceedings under article 62 of the Magistrates' Courts (Northern Ireland) Order 1981 . Appeals against notices 84 1 An application for an order to vary or set aside the terms of a notice served under regulation 68 may be made— a by the economic operator on whom the notice has been served; and b in the case of a notice other than a recall notice, by a person having an interest in the pressure equipment or assembly in respect of which the notice has been served. 2 An application must be made before the end of the period of 21 days beginning with the day on which the notice was served. 3 The appropriate court may only make an order setting aside a notice served under regulation 68 (enforcement powers) if satisfied— a that the pressure equipment or assembly to which the notice relates is in conformity with Part 2; or b that the enforcing authority failed to comply with regulation 69 (exercise of enforcement powers) when serving the notice. 4 On an application to vary the terms of a notice served under regulation 68, the appropriate court may vary the terms of the notice as it considers appropriate. 5 In this regulation— a the “appropriate court” is to be determined in accordance with regulation 85 (appropriate court for appeals against notices); and b “ notice ” means any of the following— i a prohibition notice served in accordance with Schedule 7; ii a notice to warn served in accordance with Schedule 7; iii a suspension notice served in accordance with Schedule 7; iv a compliance notice served in accordance with Schedule 10; v a withdrawal notice served in accordance with Schedule 10; or vi a recall notice served in accordance with Schedule 10. Appropriate court for appeals against notices 85 1 In England and Wales or Northern Ireland, the appropriate court for the purposes of regulation 84 is— a the court in which proceedings have been brought in relation to the pressure equipment or assembly for an offence under regulation 76 (offences); b an employment tribunal seized of appeal proceedings against a notice which relates to pressure equipment and which has been served under or by virtue of paragraph 1 of Schedule 8 (enforcement powers of the Health and Safety Executive under the 1974 Act); or c an industrial tribunal seized of appeal proceedings against a notice which relates to pressure equipment and which has been served under or by virtue of paragraph 1 of Schedule 9 (enforcement powers of the Health and Safety Executive for Northern Ireland under the 1978 Order); or d in any other case, a magistrates' court. 2 In Scotland, the appropriate court for the purposes of regulation 84 is— a the sheriff court within whose sheriffdom the appellant resides or, as the case may be, has a registered or principal office; or b an employment tribunal seized of appeal proceedings against a notice which relates to pressure equipment and which has been served under or by virtue of paragraph 1 of Schedule 8. 3 A person aggrieved by an order made by a magistrates' court in England and Wales or Northern Ireland pursuant to an application under regulation 84, or by a decision of such a court not to make such an order, may appeal against that order or decision— a in England and Wales, to the Crown Court; b in Northern Ireland, to the county court. Compensation 86 1 When an enforcing authority other than the Health and Safety Executive, the Health and Safety Executive for Northern Ireland or the Office for Nuclear Regulation serves a relevant notice in respect of pressure equipment or an assembly, that authority is liable to pay compensation to a person having an interest in the equipment or assembly for any loss or damage suffered by reason of the notice if both of the conditions in paragraph (2) are met. 2 The conditions are that— a the pressure equipment or assembly in respect of which the relevant notice was served neither— i presents a risk; nor ii contravenes any requirement of these Regulations; and b the relevant notice was not served because of neglect or default by a relevant economic operator. 3 In this regulation, “ relevant notice ” means a suspension, withdrawal or recall notice as referred to in regulation 84(5)(b). PART 6 Miscellaneous Review 87 1 The Secretary of State must from time to time— a carry out a review of these Regulations; b set out the conclusions of the review in a report; and c publish the report. 2 In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in other member States. 3 The report must, in particular— a set out the objectives intended to be achieved by the regulatory system established by these Regulations; b assess the extent to which those objectives are achieved; and c assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved by a system that imposes less regulation. 4 The first report under this regulation must be published before the end of the period of five years beginning on the commencement date. 5 Reports under this regulation are afterwards to be published at intervals not exceeding five years. Transitional provisions 88 1 Nothing in these Regulations prevents the making available on the market or putting into service of pressure equipment or assemblies which— a were placed on the market before the commencement date; and b are in conformity with the 1999 Regulations. 2 Nothing in these Regulations prevents the putting into service of pressure equipment and assemblies which— a were placed on the market before 30th May 2002; and b comply with any provisions with which they would have been required to comply in order for them to be placed on the market in the United Kingdom on 28th November 1999. Transitional provision in relation to EU Exit 88A 1 In this regulation— “ pre-exit period ” means the period beginning with the commencement date and ending immediately before IP completion day; “ product ” means pressure equipment or an assembly required, under regulation 6 or 7, to satisfy the essential safety requirements set out in Schedule 2 to which these Regulations apply on or after IP completion day. 2 Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 24 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product. 3 Paragraph (2) does not apply to— a any obligation of any enforcing authority to inform the European Commission or the member States of any matter; or b any obligation to take action outside of the United Kingdom in respect of that product. 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 For the purposes of these Regulations, a certificate issued, or approval granted, by a notified body, recognised third party organisation or user inspectorate under the 1999 Regulations, or any enactment of another member State which implemented Directive 97/23/EC , is to be treated as a certificate issued or approval granted under Annex II to the Directive (as amended from time to time). Revocations, amendments and savings 90 — 1 Subject to paragraph (2) and (2A) , the 1999 Regulations are revoked. 2 Subject to the modifications made in paragraph (2A), the Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to pressure equipment or assemblies placed on the market before the commencement date. 2A The modifications referred to in paragraph (2) are that in the 1999 Regulations— a references to “the Community” shall be read as including the United Kingdom; b references to a “member State” shall be read as including the United Kingdom; and c in Schedule 8 (enforcement), in paragraph 6, omit “with a view to this information being passed by him to the Commission”. 3 Accordingly, despite its repeal by paragraph 12(a) of Schedule 12, the entry in paragraph 10 of Schedule 5 to the Consumer Rights Act 2015 relating to the 1999 Regulations is to continue to have effect in relation to pressure equipment or assemblies placed on the market before the commencement date. 91 Schedule 12 (Consequential amendments and revocations) has effect. Margot James Parliamentary Under Secretary of State Minister for Small Business, Consumers and Corporate Responsibility Department for Business, Energy and Industrial Strategy