The Simple Pressure Vessels (Safety) Regulations 2016

• Citation: S.I. 2016/1092
• Sections: 177

Section 1 Citation and commencement

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

Section 2 Interpretation

(1) In these Regulations, “ vessel ” means a simple pressure vessel manufactured in series with the following characteristics—

(a) the vessel is welded, intended to be subjected to an internal gauge pressure greater than 0.5 bar and to contain air or nitrogen, and is not intended to be fired;

(b) the parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys;

(c) the vessel is made of either of the following elements—

(i) a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part;

(ii) two dished ends revolving around the same axis;

(d) the maximum working pressure of the vessel does not exceed 30 bar and the product of PS x V does not exceed 10,000 bar.L; and

(e) the minimum working temperature of the vessel is no lower than -50°C and the maximum working temperature is not higher than—

(i) 300°C where the vessel is constructed of steel; and

(ii) 100°C where the vessel is constructed of aluminium or aluminium alloy vessels.

(2) A vessel is manufactured in series if more than one vessel of the same type is manufactured during a given period by a continuous manufacturing process, in accordance with a common design and using the same manufacturing processes.

(3) The categories of vessels relevant for the purposes of these Regulations are—

(a) “category A vessel”, meaning a vessel of which the product of PS x V exceeds 50 bar.L, this category being subdivided into—

(i) “category A.1 vessel”, meaning a vessel of which the product of PS x V exceeds 3,000 bar.L;

(ii) “category A.2 vessel”, meaning a vessel of which the product of PS x V is more than 200 bar.L but not more than 3,000 bar.L;

(iii) “category A.3 vessel” meaning a vessel of which the product of PS x V is more than 50 bar.L but not more than 200 bar.L; and

(b) “category B vessel” meaning a vessel of which the product of PS x V is 50 bar.L or less.

(4) In these Regulations—

“ the 1991 Regulations ” means the Simple Pressure Vessels (Safety) Regulations 1991 ;

“ 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 ;

“ approved body ” has the meaning given to it in regulation 45 (approved bodies);

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“ authorised representative ” means a person established in the United Kingdom appointed in accordance with regulation 15;

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

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

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

“ conformity assessment procedure ” means a procedure referred to in regulations 40 (conformity assessment procedures prior to manufacture) and 41(conformity assessment procedures prior to placing a vessel on the market);

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

“ the Directive ” means Directive 2014/29/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels ...;

“ distributor ” means any person in the supply chain, other than the manufacturer or the importer, who makes a vessel 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 authorised representative, an importer or a distributor;

“ enforcing authority ” means any person enforcing these Regulations under regulation 55 (enforcement);

“ essential safety requirements ” means the requirements set out in Schedule 1;

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“ the HSE ” means the Health and Safety Executive established under section 10 of the 1974 Act;

“ the HSE NI ” means the Health and Safety Executive for Northern Ireland established under Article 12 of the 1978 Order;

“ importer ” means a person who—

is established in the United Kingdom and places a vessel from a country outside of the United Kingdom on the market; or

is established in Northern Ireland and places a vessel 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;

“ inscriptions ” means the following information in respect of a vessel—

the maximum working pressure (PS);

the maximum working temperature (T max );

the minimum working temperature (T min ); and

the capacity (V);

“ instructions and safety information ” means the following information in respect of a vessel—

its intended use; and

the maintenance and installation requirements for vessel safety;

“ make available on the market ” means any supply of a vessel for distribution 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 must be construed accordingly;

“ manufacturer ” means a person who—

manufactures a vessel or has a vessel designed or manufactured; and

markets that vessel under that person's name or trademark;

“ market surveillance authority ” has the meaning set out in regulation 54 (designation of market surveillance authority);

“maximum working pressure” or “ PS ” means the maximum gauge pressure (in Bar) which may be exerted under a vessel's normal conditions of use;

“maximum working temperature” or “ T max ” means the highest stabilised temperature (in °C) which the wall of the vessel may attain under normal conditions of use;

“minimum working temperature or “ T min ” means the lowest stabilised temperature which the wall of the vessel may attain under normal conditions of use;

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“ place on the market ” means the first making available of a vessel on the market of Great Britain , and related expressions must be construed accordingly;

“ place on the market ” means the first making available of a vessel on the EU market, and related expressions must be construed accordingly;

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

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

“ relevant economic operator ” means, in relation to a vessel, an economic operator who has obligations in respect of that vessel under Part 2 of these Regulations;

“ supply ” is to be read in accordance with section 46 of the 1987 Act, and includes offering or agreeing to supply, and exposing or possessing for supply, and “supplied” and “supplier” have the corresponding meanings;

“ technical documentation ” means the documentation referred to in paragraph 2(2)(c) of Part 1 of Schedule 2;

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

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

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

“ V ” means capacity of the vessel in litres;

“ weights and measures authority ” means a local weights and measures authority as defined in section 69 of the Weights and Measures Act 1985 ;

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

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

(a) the vessel complies with the essential safety requirements; and

(b) is a vessel in respect of which each relevant economic operator has complied, or is complying, with the obligations imposed on them under Part 2 of these Regulations.

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(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 2A Designated standard

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

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

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

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

(a) the characteristics required of a product, including—

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

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

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

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies 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 which has been published in accordance with paragraph (1)(b).

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

(8) In this regulation, a reference to a “ product ” is a reference to a vessel to which these Regulations apply.

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

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

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

Section 3 Application

(1) Subject to paragraph 2, these Regulations apply to a vessel placed on the market on or after the commencement date.

(2) These Regulations do not apply to—

(a) a vessel specifically designed for nuclear use, failure of which may cause an emission of radioactivity;

(b) a vessel specifically intended for installation in or the propulsion of ships and aircraft; and

(c) fire extinguishers.

(3) In paragraph (2), “ ship ” has the meaning given by section 313 of the Merchant Shipping Act 1995 .

Section 4 Design and manufacture in accordance with essential safety requirements and sound engineering practice

(1) Before placing a category A vessel on the market, a manufacturer must ensure that the vessel has been designed and manufactured in accordance with the essential safety requirements.

(2) Before placing a category B vessel on the market, a manufacturer must ensure that the vessel has been designed and manufactured in accordance with sound engineering practice .

Section 5 Technical documentation and conformity assessment for category A vessels

Before placing a category A vessel on the market, a manufacturer must–

(a) draw up the technical documentation in respect of that vessel; and

(b) carry out a relevant conformity assessment procedure in respect of the vessel or have such a procedure carried out.

Section 6 Declaration of conformity, UK marking and inscriptions for category A vessels

(1) Where the conformity of a category A vessel with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, before placing that vessel on the market, a manufacturer must—

(a) draw up a declaration of conformity in accordance with regulation 43 ...; and

(b) affix the information set out in paragraph (1B) to—

(i) the vessel;

(ii) its data plate; or

(iii) where paragraph (1A) applies—

(aa) to a label affixed to the vessel; or

(bb) in a document accompanying the vessel;

(1A) This paragraph applies to a vessel that is placed on the market within a period of seven years beginning with IP completion day.

(1B) The information referred to in paragraph (1)(b) is—

(a) the UK marking;

(b) the last two digits of the year in which the UK marking is affixed;

(c) the inscriptions.

(2) Where a data plate is used, it must be so designed that it cannot be reused and must include a vacant space to enable other information to be provided.

(3) The information referred to in paragraph (1)(b) must be visible, legible and indelible.

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

(5) Where a category A vessel is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

Section 7 Inscriptions for category B vessels

(1) Before placing a category B vessel on the market, a manufacturer must affix the following to the vessel or to its data plate—

(a) the inscriptions; and

(b) the information referred to in regulation 11(1).

(2) Where a data plate is used, it must be so designed that it cannot be reused and must include a vacant space to enable other information to be provided.

(3) The inscriptions and information referred to in paragraph (1) must be visible, legible and indelible.

Section 8 Retention by manufacturer of technical documentation and ... declaration of conformity

A manufacturer must keep the technical documentation and the ... declaration of conformity drawn up in respect of a category A vessel and make it available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the vessel was placed on the market.

Section 9 Compliance procedures for series production

(1) A manufacturer must ensure, before placing a vessel on the market, that procedures are in place to ensure that series production remains in conformity with Part 2.

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

(a) any change in vessel design or characteristics; and

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

Section 10 Monitoring of vessels made available on the market

(1) When appropriate, having regard to the risks to the health and safety of end-users presented by a vessel, a manufacturer must—

(a) carry out sample testing of vessels manufactured by it made available on the market;

(b) investigate complaints that vessels manufactured by it are not in conformity with Part 2;

(c) keep a register of—

(i) complaints that vessels are not in conformity with Part 2;

(ii) vessels which are found not to be in conformity with Part 2; and

(iii) vessel recalls; and

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

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

Section 11 Labelling of vessels

(1) Before placing a vessel on the market, a manufacturer must ensure that the following appear on the vessel or its data plate—

(a) a type and serial or batch identification allowing its identification; and

(b) the following information—

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

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

(2) The information referred to in paragraph (1) must be clear, understandable and intelligible.

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Section 12 Provision of instructions and safety information

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

Section 13 Duty of manufacturer to take action in respect of vessels placed on the market which are considered not to be in conformity

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

(a) bring the vessel into conformity;

(b) withdraw the vessel; or

(c) recall the vessel.

(2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, a manufacturer must immediately inform the market surveillance authority of the risk, ... giving details, in particular, of—

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

(b) any corrective measures taken.

Section 14 Provision of information and cooperation

(1) Following a request from the 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 a vessel 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 vessel was placed on the market; and

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

(3) The information 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 a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk); or

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

Section 15 Appointment by manufacturer of authorised representative

(1) Subject to regulation 16, a manufacturer may, by written mandate, appoint a person established in the United Kingdom as their authorised representative to perform specified tasks on the manufacturer's behalf.

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

Section 16 Obligations of authorised representative

(1) The obligations laid down in regulation 4 (design and manufacture in accordance with essential safety requirements and sound engineering practice) and in of regulation 5(a) (technical documentation and conformity assessment for category A vessels) must not form part of an authorised representative's mandate.

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

(a) perform the manufacturer's obligations under regulation 8 (retention by manufacturer of technical documentation and ... declaration of conformity); and

(b) perform the manufacturer's obligations under regulation 14 (provision of information and cooperation).

(3) 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 mandate to perform and accordingly as far as those duties are concerned, as well as the penalties for failure to comply with those duties, a reference in these Regulations (except in regulation 15) to the manufacturer is to be taken as including a reference to the authorised representative.

Section 17 Prohibition on placing on the market vessels which are not in conformity

An importer must not place a vessel on the market unless it is in conformity with Part 2.

Section 18 Requirements which must be satisfied before an importer places a category A vessel on the market

Before placing a category A vessel 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 UK marking and the inscriptions have been affixed in accordance with regulation 6(1)(b) to (d);

(d) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels).

Section 19 Prohibition on an importer placing on the market a category A vessel considered not to be in conformity with the essential safety requirements

(1) Where an importer considers or has reason to believe that a category A vessel is not in conformity with the essential safety requirements, the importer must not place the vessel on the market.

(2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, the importer must inform the manufacturer and the market surveillance authority of that risk.

Section 20 Requirements which must be satisfied before an importer places a category B vessel on the marke t

Before placing a category B vessel on the market, an importer must ensure that—

(a) it has been designed and manufactured in accordance with sound engineering practice ;

(b) it bears the inscriptions; and

(c) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels).

Section 21 Information identifying importer

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

(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.

(1A) 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 vessel, or

(ii) the importer has imported the vessel 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 vessel on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the vessel.

(2) The contact details referred to in paragraph (1) must be in a language which can be easily understood by end-users and the enforcing authority .

Section 22 Instructions and safety information

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

Section 23 Transport and storage conditions

Where an importer has responsibility for a category A vessel, the importer must ensure that the conditions under which the vessel is stored or transported do not jeopardise its conformity with the essential safety requirements.

Section 24 Monitoring by importer of vessels made available on the market

(1) When appropriate, having regard to the risks to the health and safety of end-users presented by a vessel, an importer must—

(a) carry out sample testing of vessels made available by the importer on the market;

(b) investigate complaints that vessels made available on the market by the importer are not in conformity with Part 2;

(c) keep a register of—

(i) complaints that vessels are not in conformity with Part 2;

(ii) vessels which are found not to be in conformity with Part 2; and

(iii) vessel recalls; and

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

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

Section 25 Duty of importer to take action in respect of vessels placed on the market which are considered not to be in conformity

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

(a) bring the vessel into conformity;

(b) withdraw the vessel; or

(c) recall the vessel.

(2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, an importer must immediately inform the market surveillance authority of the risk, ... giving details, in particular, of—

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

(b) any corrective measures taken.

Section 26 Retention by importer of technical documentation and ... declaration of conformity

An importer must, for a period of 10 years beginning on the day on which a category A vessel was placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to the vessel—

(a) a copy of the ... declaration of conformity (as referred to in regulation 43); and

(b) the technical documentation.

Section 27 Provision of information and cooperation

(1) Following a request from an enforcing authority, and within such period as the authority may specify, an importer must provide the authority with all the information and documentation necessary to demonstrate that a vessel 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 that the importer places the vessel on the market; and

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

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

(a) evaluate a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk); or

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

Section 28 Duty to act with due care

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

Section 29 Requirements which must be satisfied before a distributor makes available on the market a category A vessel

Before making a category A vessel available on the market, a distributor must ensure that—

(a) the vessel—

(i) bears the UK marking and the inscriptions; and

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

(b) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels); and

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

Section 30 Prohibition on a distributor making available on the market a category A vessel not considered to be in conformity with essential safety requirements

(1) Where a distributor considers or has reason to believe that a category A vessel is not in conformity with the essential safety requirements, the distributor must not make the vessel available on the market until it has been brought into conformity.

(2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, the distributor must inform the following of that risk–

(a) the importer (if there is one);

(b) the manufacturer (if there is no importer); and

(c) the market surveillance authority.

Section 31 Requirements which must be satisfied before a distributor makes a category B vessel available on the market

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

(a) the vessel—

(i) bears the inscriptions;

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

(b) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels); and

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

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

Section 32 Storage and transport conditions

Where a distributor has responsibility for a Category A vessel, the distributor must ensure that the conditions under which it is stored or transported do not jeopardise its conformity with the essential safety requirements.

Section 33 Duty for distributor to take action in respect of vessels made available on the market which are not in conformity

(1) A distributor who considers or has reason to believe that a vessel 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 the vessel into conformity;

(b) withdraw the vessel; or

(c) recall the vessel.

(2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, a distributor must immediately inform the market surveillance authority of the risk ..., giving details, in particular, of—

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

(b) any corrective measures taken.

Section 34 Provision of information and cooperation

(1) Following a request from an enforcing authority, and within such period as the authority may specify, a distributor must provide the authority with all the information and documentation necessary to demonstrate that a vessel 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 on which the vessel was made available on the market; and

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

(3) The information referred to in paragraph (1)–

(a) may be provided electronically; and

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

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

(a) evaluate a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk);

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

Section 35 Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor (“A”) is to be considered a manufacturer for the purposes of these Regulations, and is subject to the obligations of the manufacturer under this Part, where A—

(a) places a vessel on the market under A's own name or trademark; or

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

Section 36 Translation of EU declaration of conformity

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Section 37 Identification of economic operators

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

(a) any other economic operator who has supplied E with the vessel; and

(b) any other economic operator to whom E has supplied the vessel.

(2) The relevant period is—

(a) in the case of paragraph (1)(a), the period of 10 years beginning on the day on which E was supplied with the vessel; and

(b) in the case of paragraph 1(b), the period of 10 years beginning on the day on which E supplied the vessel.

Section 38 Prohibition on improper use of UK marking

(1) An economic operator must not affix the UK marking to a Category A vessel unless—

(a) that economic operator is the manufacturer of the vessel; and

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

(2) An economic operator must not affix a marking to a vessel which is not the UK marking but which purports to attest that the vessel satisfies the essential safety requirements.

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

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

Section 38A Obligations which are met by complying with obligations in the Directive

(1) In this regulation—

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

(b) “ CE marking ” has the meaning given to it in Article 2(17);

(c) “ harmonised standard ” has the meaning given to it in Article 2(9).

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer—

(a) ensures that the vessel has been designed and 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 vessel in accordance with Article 13(1) and (2) have been carried out;

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

(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 inscriptions, in accordance with Articles 15 and 16(1) to (4);

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

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

(3) Where this paragraph applies—

(a) the requirements of regulations 4(1), 5, 6(1) to (3) and (5) are to be treated as being satisfied;

(b) regulations 2(5)(a), 6(4), 8, 9(2), 16(2) and 38 apply subject to the modifications in paragraph (10);

(c) Part 3 does not apply; and

(d) regulation 62 does not apply.

(4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a category A vessel on the market, the importer ensures that—

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

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

(c) the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III.

(5) Where this paragraph applies—

(a) the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and

(b) regulations 2(5)(a), 19(1), 23 and 26 apply subject to the modifications in paragraph (10).

(6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12.

(7) Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out—

(a) the conformity assessment procedure set out in Article 13(1)(b); and

(b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2).

(8) Paragraph (9) applies where, before making a category A vessel available on the market, a distributor ensures that the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III.

(9) Where this paragraph applies—

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

(b) regulations 2(5)(a), 30(1) and 32 apply subject to the modifications in paragraph (10).

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

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

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

(e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the vessel in accordance with Article 13(1) and (2);

(f) any reference to “ technical documentation ” is a reference to the technical documentation referred to in Annex II.

Section 38B Conformity assessment procedure obligation which is met by complying with the Directive

(1) In this regulation—

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

(b) “ harmonised standard ” has the meaning given to it in Article 2(9).

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, prior to the manufacture of a category A vessel, the manufacturer ensures that the conformity assessment procedure that applies to that vessel in accordance with Article 13(1) has been carried out.

(3) Where this paragraph applies—

(a) regulation 40 is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 5(b), 6(1), 18(a), 38(b) and 43(c) is to be read as including the conformity assessment procedure referred to in Article 13(1); and

(c) any reference to “technical documentation” in regulations 5(a), 8, 18(b) and 26(b) is to be read as including the technical documentation relating to the design of the vessel referred to in Annex II.

(4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12.

(5) Where paragraph (4) applies, paragraph (2) is to be treated as requiring the manufacturer to have carried out the conformity assessment procedure set out in Article 13(1)(b).

Section 38C Further use of the UK marking

(1) In this regulation—

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

(b) “ harmonised standard ” has the meaning given to it in Article 2(9).

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer—

(a) ensures that the vessel has been designed and 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 vessel in accordance with Article 13(1) and (2) have been carried out;

(c) draws up the technical documentation referred to in Annex II; 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) the requirements of regulations 4(1) and 5 are to be treated as being satisfied;

(b) except for regulation 43, Part 3 does not apply;

(c) regulations 2(5)(a), 6, 8, 9(2), 16(2), 18(a) and (b), 19(1), 23, 26, 30, 32, 38(1) and 62 apply subject to the modifications in paragraph (6);

(d) regulation 43 and Schedule 3 apply subject to the modifications in paragraphs (6) and (7).

(4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12.

(5) Where paragraph (4) applies, paragraph (2)(b) is to be treated as requiring the manufacturer to have carried out—

(a) the conformity assessment procedure set out in Article 13(1)(b); and

(b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2).

(6) 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 referred to in Annex I;

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

(c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to the vessel in accordance with Article 13(1) and (2);

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

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

(a) in regulation 43, the reference to Schedule 2 is to be read as a reference to Annex II;

(b) in Schedule 3—

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

(ii) in paragraph 7 the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 13(1) or 13(2).

Section 38D Qualifying Northern Ireland Goods

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

(2) This paragraph applies where—

(a) a vessel—

(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 vessel on the market, the importer—

(a) complies with regulation 21;

(b) ensures that—

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

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

(iii) the vessel 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 ” means the documentation referred to in paragraph 2(2)(c) of Part 1 of Schedule 2 to these Regulations, as that Schedule applies in Northern Ireland.

Section 39 Presumption of conformity of category A vessels

(1) A category A vessel which is in conformity with a designated standard (or part of such a standard) ... , is presumed to be in conformity with the essential safety requirements covered by that standard (or that part of that standard).

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

Section 40 Conformity assessment procedures prior to manufacture

(1) Prior to the manufacture of a category A vessel, a Type examination (Module B), as described in paragraph 1 of Schedule 2, must be carried out in respect of the technical design of the vessel.

(2) Where a vessel is to be manufactured in accordance with a designated standard (or part of such standard) referred to in regulation 39, (presumption of conformity of category A vessels) the manufacturer must choose one of the following forms of examination—

(a) an examination of the technical documentation and supporting evidence in respect of the vessel without an examination of a specimen vessel (Module B – design type); or

(b) an examination of the technical documentation and supporting evidence in respect of the vessel, with an examination of a prototype, representative of the production envisaged, of the complete vessel (Module B – production type).

(3) Where a vessel is not to be manufactured, or is to be manufactured only partly, in accordance with a designated standard (or part of such standard) referred to in regulation 39, the examination must be an examination of the type referred to in paragraph (2)(b).

(4) Paragraphs 2 to 9 of Schedule 2 make provision in respect of a Type examination (Module B) and related matters.

Section 41 Conformity assessment procedures prior to placing a vessel on the market

(1) Before placing a category A.1 vessel on the market, the vessel must be subjected to conformity to type based on internal production control plus supervised testing (Module C1) as described in paragraph 10 of Schedule 2.

(2) Before placing a category A.2 vessel on the market, that vessel must be subjected to either–

(a) the procedure referred to in paragraph (1) (Module C1), or

(b) conformity to type based on internal production control plus supervised vessel checks at random intervals (Module C2) as described in paragraph 14 of Schedule 2.

(3) Before placing a category A.3 vessel on the market, that vessel must be subjected to either–

(a) the procedure referred to in paragraph (1) (Module C1), or

(b) conformity to type based on internal production control (Module C) as described in paragraph 18 of Schedule 2.

(4) Paragraphs 11 to 13 of Schedule 2 make provision in respect of conformity to type based on internal production control plus supervised testing (Module C1) and related matters.

(5) Paragraphs 15 to 17 of Schedule 2 make provision in respect of conformity to type based on internal production control plus supervised vessel checks at random intervals (Module C2) and related matters.

(6) Paragraphs 19 and 20 of Schedule 2 make provision in respect of conformity to type based on internal production control (Module C) and related matters.

Section 42 Records and correspondence language requirements

The records and correspondence relating to the conformity assessment procedures referred to in regulations 40 (conformity assessment procedures prior to manufacture) and 41 (conformity assessment procedures prior to placing a vessel on the market) must be in English or in a language acceptable to the approved body .

Section 43 Declaration of conformity

The ... declaration of conformity in respect of a category A vessel must—

(a) state that the fulfilment of the essential safety requirements has been demonstrated in respect of the vessel;

(b) have the model structure set out in Schedule 3; and

(c) contain the elements specified in Schedule 2 for the relevant conformity assessment procedure followed in respect of the vessel.

Section 44 Identification number

(1) The UK marking must be followed by the identification number of the approved body involved in the relevant conformity assessment procedure pursuant to regulation 41.

(2) The identification number of the approved body must be affixed—

(a) by the approved body; or

(b) where instructed to do so by the approved body, by the manufacturer or the manufacturer's authorised representative.

Section 44A UK(NI) indication

(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 vessel, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before a vessel 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 6.

(4) The UK(NI) indication must be affixed by—

(a) the manufacturer; or

(b) the manufacturer's authorised representative.

(5) When placing a vessel on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.