PART 1

Citation and commencement

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

Interpretation _E1

2. —(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—

^F4 “ the 1991 Regulations ” means the Simple Pressure Vessels (Safety) Regulations 1991 ;

^F5 “ 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;

^F6,F7 “ the 1987 Act ” means the Consumer Protection Act 1987 ;

[^F8 “ approved body ” has the meaning given to it in regulation 45 (approved bodies); ^F8]

^F9 ...

^F10 ...

“ authorised representative ” means a person established in the [^F11 United Kingdom ^F11] appointed in accordance with regulation 15;

^F12 ...

^F13 ...

“ 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);

[^F14 “ designated standard ” has the meaning given to it in regulation 2A; ^F14]

^F15,F16 “ 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;

^F17 “ 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;

^F18 ...

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

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

[^F19 “ importer ” means a person who—

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

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

“ make available on the market ” means any supply of a vessel for distribution or use on the [^F20 market of Great Britain ^F20] 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—

“ 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;

^F21 ...

^F22 ...

^F23 ...

^F24 ...

“ place on the market ” means the first making available of a vessel on the [^F25 market of Great Britain ^F25] , 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;

^F26 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;

[^F27 “ UK marking ” means the marking in the form set out in Annex 2 of RAMS; ^F27]

[^F27 “ UK national accreditation body ” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS; ^F27]

“ V ” means capacity of the vessel in litres;

^F28 “ 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.

^F29 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F29 (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interpretation _E88

2. —(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—

^F190 “ the 1991 Regulations ” means the Simple Pressure Vessels (Safety) Regulations 1991 ;

^F191 “ 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;

^F192,F193 “ the 1987 Act ” means the Consumer Protection Act 1987 ;

“ accreditation ” has the meaning set out in Article 2(10) of RAMS (as amended from time to time);

“ accreditation certificate ” means a certificate, issued by the United Kingdom Accreditation Service or a national accreditation body in another [^F194relevant state^F194] , attesting that a conformity assessment body meets the notified body requirements;

“ authorised representative ” means a person established in [^F195 a relevant state^F195] appointed in accordance with regulation 15;

“ CE marking ” means a marking in the form set out in Annex II of RAMS (as amended from time–to-time);

“ competent national authority ” means an authority of a [^F196relevant state^F196] responsible for enforcing the law of that state which implements the Directive;

“ 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);

^F197 “ 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;

^F198 “ 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;

^F199 “ harmonised standard ” has the meaning given by Article 2(1)(c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC , 94/25/EC , 95/16/EC , 97/23/EC , 98/34/EC , 2004/22/EC , 2007/23/EC , 2009/23/EC and 2009/105/EC of the European Parliament and of the Council, and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (as amended from time to time);

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

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

“ importer ” means a person who—

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

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

“ make available on the market ” means any supply of a vessel for distribution or use on the [^F202 relevant ^F202] market 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—

“ 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;

“ national accreditation body ” has the meaning set out in Article 2(11) of RAMS (as amended from time to time);

^F203 ...

“ notified body requirements ” means the requirements set out in Part 1 of Schedule 4;

“ Official Journal ” means the Official Journal of the European Union;

“ place on the market ” means the first making available of a vessel on the [^F204 relevant ^F204] market, and related expressions must be construed accordingly;

^F205 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;

[^F206 “relevant market” means—

[^F206 “relevant state” means—

“ 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;

[^F207 “ UK(NI) indication ” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020; ^F207]

“ V ” means capacity of the vessel in litres;

^F208 “ 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.

^F209 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F210 (7) In these Regulations (except Part 4 (notification of conformity assessment bodies) and Schedule 4 (notified bodies), “notified body” means—

(a) a notified body within the meaning set out in regulation 45 (notified bodies), or

(b) a notified body under the laws of any other [^F211relevant state^F211] which implements the Directive . ^F210]

[^F30 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[^F31 or an international standardising body^F31] , 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).

[^F32 (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). ^F32]

(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 [^F33 such ^F33]technical specifications adopted by the other recognised standardisation bodies[^F34 or by international standardising bodies as the Secretary of State considers to be relevant. ^F34]

(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. ^F30]

Application

3. —(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.

^F35 (3) In paragraph (2), “ ship ” has the meaning given by section 313 of the Merchant Shipping Act 1995 .

PART 2 Obligations of economic operators

Manufacturers

Design and manufacture in accordance with essential safety requirements and sound engineering practice _E2

4. —(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 [^F36 sound engineering practice ^F36] .

Design and manufacture in accordance with essential safety requirements and sound engineering practice _E89

4. —(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 the sound engineering practice of a [^F212relevant state^F212] .

Technical documentation and conformity assessment for category A vessels

5. 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.

[^F37 Declaration ^F37] of conformity, [^F38 UK ^F38] marking and inscriptions for category A vessels _E3

6. —(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) ^F40 draw up [^F39 a ^F39] declaration of conformity in accordance with regulation 43 ...; and

[^F41 (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; ^F41]

[^F42 (1A) This paragraph applies to a vessel that is placed on the market within a period of [^F43 seven years ^F43] 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. ^F42]

(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.

^F44 (4) The manufacturer must keep the ... declaration of conformity up-to-date.

[^F45 (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. ^F45]

EU declaration of conformity, CE marking and inscriptions for category A vessels _E90

6. —(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 an EU declaration of conformity in accordance with regulation 43 (EU declaration of conformity); and

(b) affix to the vessel, or to its data plate, the CE marking, the last two digits of the year in which the CE marking is affixed, the inscriptions and the information referred to in regulation 11(1)(labelling).

(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 EU declaration of conformity up-to-date.

(5) Where a category A vessel is subject to more than one EU instrument requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity, which—

(a) identifies the EU instruments; and

(b) includes references to the publication of those EU instruments in the Official Journal.

Inscriptions for category B vessels

7. —(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.

^F46 Retention by manufacturer of technical documentation and ... declaration of conformity _E4

^F478. 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.

Retention by manufacturer of technical documentation and EU declaration of conformity _E91

8. A manufacturer must keep the technical documentation and the EU 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.

Compliance procedures for series production _E5

9. —(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) ^F49 any change in a [^F48 designated ^F48] standard or in another technical specification by reference to which the ... declaration of conformity was drawn up.

Compliance procedures for series production _E92

9. —(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 harmonised chnical specification by reference to which the EU declaration of conformity was drawn up.

Monitoring of vessels made available on the market

10. —(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) vesselrecalls; 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.

Labelling of vessels _E6

11. —(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.

^F50 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Labelling of vessels _E93

11. —(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.

(3) The contact details referred to in paragraph (1)(b) must be in a language which can be easily understood by end-users and the competent national authority in the [^F213relevant state^F213] in which it is to be made available.

[^F51 Provision of instructions and safety information _E7

12. 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. ^F51]

Provision of instructions and safety information _E94

12. —(1) When placing a vessel on the market, a manufacturer must ensure that a vessel is accompanied by the instructions and safety information in a language which can be easily understood by end-users in the [^F214relevant state^F214] in which it is to be made available on the market.

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

(3) Where the [^F215relevant state^F215] referred to in paragraph (1) is [^F216 Northern Ireland ^F216] , the language referred to in that paragraph must be English.

Duty of manufacturer to take action in respect of vessels placed on the market which are considered not to be in conformity _E8

13. —(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.

^F52 (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.

Duty of manufacturer to take action in respect of vessels placed on the market which are considered not to be in conformity _E95

13. —(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, and the competent national authorities of any other [^F217relevant state^F217] in which the manufacturer made the vessel available on the market, 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.

Provision of information and cooperation

14. —(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.

Appointment by manufacturer of authorised representative _E9

15. —(1) Subject to regulation 16, a manufacturer may, by written mandate, appoint a person [^F53 established in the United Kingdom ^F53] 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.

Appointment by manufacturer of authorised representative _E96

15. —(1) Subject to regulation 16, a manufacturer may, by written mandate, appoint a person 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.

Obligations of authorised representative _E10

16. —(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) ^F54 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.

Obligations of authorised representative _E97

16. —(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 EU 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.

Importers

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

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

Requirements which must be satisfied before an importer places a category A vessel on the market _E11

18. 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;

[^F55 (c) the UK marking and the inscriptions have been affixed in accordance with regulation 6(1)(b) to (d); ^F55]

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

Requirements which must be satisfied before an importer places a category A vessel on the market _E98

18. 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 vessel bears the CE marking and the inscriptions; and;

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

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

19. —(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.

Requirements which must be satisfied before an importer places a category B vessel on the marke t _E12

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

(a) it has been designed and manufactured in accordance with [^F56 sound engineering practice ^F56] ;

(b) it bears the inscriptions; and

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

Requirements which must be satisfied before an importer places a category B vessel on the market _E99

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

(a) it has been designed and manufactured in accordance with the sound engineering practice in a [^F218relevant state^F218] ;

(b) it bears the inscriptions; and

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

Information identifying importer _{cross-notesE13}

^F5721. —(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.

[^F58 (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 [^F59 seven years ^F59] 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. ^F58]

(2) The contact details referred to in paragraph (1) must be in a language which can be easily understood by end-users and the [^F60enforcing authority^F60] .

Information identifying importer _{cross-notesE100}

21. —(1) Before placing a vessel on the market, an importer must indicate on the vessel or, where that is not possible, in a document accompanying 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.

(2) The contact details referred to in paragraph (1) must be in a language which can be easily understood by end-users and the competent national authority in the [^F219relevant state^F219] in which it is to be made available to such end-users.

[^F61 Instructions and safety information _E14

22. 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. ^F61]

Instructions and safety information _E101

22. —(1) When placing a vessel on the market, an importer must ensure that the vessel is accompanied by the instructions and safety information in a language which can be easily understood by end-users in the [^F220relevant state^F220] in which it is to be made available.

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

(3) Where the [^F221relevant state^F221] referred to in paragraph (1) is [^F222 Northern Ireland ^F222] , the language referred to in that paragraph must be English.

Transport and storage conditions

23. 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.

Monitoring by importer of vessels made available on the market

24. —(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) vesselrecalls; 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 of importer to take action in respect of vessels placed on the market which are considered not to be in conformity _E15

25. —(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.

^F62 (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.

Duty of importer to take action in respect of vessels placed on the market which are considered not to be in conformity _E102

25. —(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, and the competent national authorities of any other [^F223relevant state^F223] in which the importer made the vessel available on the market, 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.

^F63 Retention by importer of technical documentation and ... declaration of conformity _E16

26. 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) ^F64 a copy of the ... declaration of conformity (as referred to in regulation 43); and

(b) the technical documentation.

Retention by importer of technical documentation and EU declaration of conformity _E103

26. 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 EU declaration of conformity (as referred to in regulation 43); and

(b) the technical documentation.

Provision of information and cooperation

27. —(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.

Distributors

Duty to act with due care

28. 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.

Requirements which must be satisfied before a distributor makes available on the market a category A vessel _E17

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

(a) the vessel—

(i) bears the [^F65 UK ^F65] marking and the inscriptions; and

[^F66 (ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English; ^F66]

(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).

Requirements which must be satisfied before a distributor makes available on the market a category A vessel _E104

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

(a) the vessel—

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

(ii) is accompanied by the instructions and safety information in a language which can be easily understood by end-users in the [^F224relevant state^F224] in which the vessel is to be made available on the market;

(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).

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

30. —(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.

Requirements which must be satisfied before a distributor makes a category B vessel available on the market _E18

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

(a) the vessel—

(i) bears the inscriptions;

[^F67 (ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English; ^F67]

(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).

^F68 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements which must be satisfied before a distributor makes a category B vessel available on the market _E105

31. —(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 the instructions and safety information in a language which can be easily understood by end-users in the [^F225relevant state^F225] in which the vessel is to be made available on the market;

(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) Where the [^F226relevant state^F226] referred to in paragraph (1) is [^F227 Northern Ireland ^F227] , the language referred to in paragraph (1) must be English.

Storage and transport conditions

32. 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.

Duty for distributor to take action in respect of vessels made available on the market which are not in conformity _E19

33. —(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.

^F69 (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.

Duty for distributor to take action in respect of vessels made available on the market which are not in conformity _E106

33. —(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 and the competent national authorities of any other [^F228relevant state^F228] in which the distributor made the vessel available on the market, 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.

Provision of information and cooperation

34. —(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.

All economic operators

Cases in which obligations of manufacturers apply to importers and distributors

35. 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.

Translation of EU declaration of conformity _E20

^F7036. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Translation of EU declaration of conformity _E107

36. —(1) Before making a Category A vessel available on the market, an economic operator must ensure that the EU declaration of conformity is prepared in, or translated into, the language required by the [^F229relevant state^F229] in which it is to be made available on the market.

(2) Where the category A vessel is to be made available on the market in [^F230 Northern Ireland ^F230] , the language required is English.

Identification of economic operators

37. —(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.

Prohibition on improper use of [^F71 UK ^F71] marking _E21

38. —(1) An economic operator must not affix the [^F72 UK ^F72] 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 [^F72 UK ^F72] 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 [^F72 UK ^F72] marking.

(4) An economic operator must not affix to a vessel any other marking if the visibility, legibility and meaning of the [^F72 UK ^F72] marking would be impaired as a result.

Prohibition on improper use of CE marking _E108

38. —(1) An economic operator must not affix the CE 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 CE 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 CE marking.

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

[^F73 Obligations which are met by complying with obligations in the Directive

38A.—(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.

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

38B.—(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).

[^F74 Further use of the UK marking

38C.—(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). ^F74]

Qualifying Northern Ireland Goods

38D.—(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. ^F73]

PART 3 Conformity of Category A Vessels

Presumption of conformity of category A vessels _E22

^F7639. —(1) A category A vessel which is in conformity with a [^F75 designated ^F75] 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.

Presumption of conformity of category A vessels _E109

39. —(1) A category A vessel which is in conformity with a harmonised standard (or part of such a standard) the reference to which has been published in the Official Journal, 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.

Conformity assessment procedures prior to manufacture _E23

40. —(1) Prior to the manufacture of a category A vessel, [^F77 a Type ^F77] 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 [^F78 designated ^F78] 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 [^F79 designated ^F79] 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 [^F80 a Type ^F80] examination (Module B) and related matters.

Conformity assessment procedures prior to manufacture _E110

40. —(1) Prior to the manufacture of a category A vessel, an EU-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 harmonised 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 harmonised 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 an EU-type examination (Module B) and related matters.

Conformity assessment procedures prior to placing a vessel on the market

41. —(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.

Records and correspondence language requirements _E24

42. 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 [^F81 English ^F81] or in a language acceptable to [^F82 the approved body^F82] .

Records and correspondence language requirements _E111

42. 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 an official language of the [^F231relevant state^F231] in which the notified body is established or in a language acceptable to that body.

[^F83 Declaration ^F83] of conformity _E25

^F8443. 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.

EU declaration of conformity _E112

43. The EU 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.

Identification number _E26

44.[^F85—(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. ^F85]

(2) The identification number of the [^F86 approved ^F86] body must be affixed—

(a) by the [^F86 approved ^F86] body; or

(b) where instructed to do so by the [^F86 approved ^F86] body, by the manufacturer or the manufacturer's authorised representative.

Identification number _E113

44. —(1) The CE marking, affixed to the vessel or its data plate pursuant to regulation 6 (EU declaration of conformity, CE marking and inscriptions for category A vessels), must be followed by the identification number of the notified body involved in the relevant conformity assessment procedure pursuant to regulation 41(conformity assessment procedures prior to placing a vessel on the market).

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

(a) by the notified body; or

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

[^F87 UK(NI) indication

44A.—(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.

Register of notified bodies established in the United Kingdom

44B.—(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). ^F87]

[^F88 PART 4 Approval of Conformity Assessment Bodies

Approved bodies _E27

45.—(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 46 (approval of conformity assessment bodies); or

(b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 51(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 49 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“ notified body ” means a body—

“ approved body requirements ” means the requirements set out in Part 1 of Schedule 4.

Notified bodies _E114

45. —(1) A notified body is a conformity assessment body—

(a) which has been notified by the Secretary of State to the European Commission and to the other [^F232relevant states^F232] –

(i) under regulation 46 (notification); or

(ii) before the date these Regulations come into force, in accordance with Article 17 of the Directive; and

(b) in respect of which no objections [^F233 , other than an immaterial objection, ^F233] were raised by the European Commission or other [^F234relevant states^F234] –

(i) within 2 weeks of the date of notification, where the notification is accompanied by an accreditation certificate; or

(ii) within 2 months of the date of notification, where the notification is not accompanied by an accreditation[^F235 certificate; ^F235]

[^F236 (c) in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—

(i) the conformity assessment body is established in the United Kingdom; or

(ii) the accreditation certificate was issued by the United Kingdom Accreditation Service. ^F236]

(2) Paragraph (1) has effect subject to regulation 51 (changes to notifications).

Approval of conformity assessment bodies _E28

46.—(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a) a description of—

(i) the conformity assessment activities that the conformity assessment body intends to carry out;

(ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii) the category of vessels in respect of which the conformity assessment body claims to be competent; and

(b) either—

(i) an accreditation certificate; or

(ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6) When deciding whether to approve a conformity assessment body that 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.

(7) For the purposes of this regulation “ accreditation certificate ” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

Notification _E115

46. —(1) The Secretary of State may notify to the European Commission and the other [^F237relevant states^F237] only those conformity assessment bodies that qualify for notification.

(2) A conformity assessment body qualifies for notification if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become a notified body and the 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 module in respect of which the conformity assessment body claims to be competent;

(iii) the category of vessels in respect of which the conformity assessment body claims to be competent; and either

(b) an accreditation certificate; or

(c) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the notified body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the notified body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the notified body requirements.

(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission and the other [^F238relevant states^F238] , the Secretary of State may–

(a) have regard to any other matter which appears to the Secretary of State to be relevant; and

(b) set conditions that the conformity assessment body must meet.

(7) The Secretary of State must inform the European Commission of the United Kingdom's procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.

Presumption of conformity of approved bodies _E29

47.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

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

Presumption of conformity of notified bodies _E116

47. —(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such standard) the reference of which has been published in the Official Journal, the Secretary of State is to presume that the conformity assessment body meets the notified body requirements covered by that standard (or that part of that standard).

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

Monitoring _E30

48. The Secretary of State must monitor each approved body with a view to verifying that the body—

(a) continues to meet the approved body requirements;

(b) meets any conditions set—

(i) in accordance with regulation 46(6)(b); or

(ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 46(6)(b), as it applied immediately before IP completion day; and

(c) carries out its functions in accordance with these Regulations.

Contents of notification _E117

48. A notification under regulation 46 (notification) must include—

(a) details of—

(i) the conformity assessment activities in respect of which the conformity assessment body has made its application for notification;

(ii) the conformity assessment modules in respect of which the conformity assessment body has made its application for notification; and

(iii) the category of vessels in respect of which the conformity assessment body has made its application for notification; and either

(b) an accreditation certificate; or

(c) documentary evidence which attests to—

(i) the conformity assessment body's competence; and

(ii) the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to satisfy the notified body requirements.

Restriction, suspension or withdrawal of approval _E31

49.—(1) Where the Secretary of State determines that an approved body—

(a) no longer meets an approved body requirement, or

(b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 48(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 45 (approved bodies).

(2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 48(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 45.

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a) give notice in writing to the approved body of the proposed action and the reasons for it;

(b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c) consider any such representations made by the approved body.

(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created.

(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.

Monitoring _E118

49. —(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—

(a) continues to meet the notified body requirements;

(b) meets any conditions set in accordance with regulation 46(6)(b); and

(c) carries out its functions in accordance with these Regulations.

(2) The Secretary of State must inform the European Commission of the United Kingdom's procedures for the monitoring of notified bodies, and any changes to those procedures.

Operational matters in relation to approved bodies _E32

50.—(1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures—

(a) in respect of which the body's approval was given under regulation 46; or

(b) in respect of which the body's notification as a notified body was made.

(2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Part 2 of Schedule 4.

(3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body—

(a) to issue a Type examination certificate referred to in Schedule 2; or

(b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 44 (identification number).

United Kingdom Accreditation Service _E119

50. 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 notified body requirements; and

(b) monitoring notified bodies in accordance with regulation 49.

Subsidiaries and contractors _E33

51.—(1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation 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.

Changes to notifications

51. —(1) Where the Secretary of State determines that a notified body—

(a) no longer meets a notified body requirement, or

(b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 46(6)(b),

the Secretary of State must restrict, suspend or withdraw the body's status as a notified body under regulation 45 (notified bodies).

(2) Where the Secretary of State determines that a notified body no longer meets a condition referred to in regulation 46(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as a notified body under regulation 45.

(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 notified body of the proposed action and the reasons for it;

(b) give the notified body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c) consider any such representations made by the notified body.

(5) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the European Commission and the other [^F239relevant states^F239] .

(6) Where the Secretary of State has taken action in respect of a notified body under paragraph (1) or (2), or where a notified body has ceased its activity, the notified body must, at the request of the Secretary of State—

(a) transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the Secretary of State; or

(b) keep its files relating to the activities it has undertaken as a notified body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created.

Register of approved bodies _E34

52.—(1) The Secretary of State must—

(a) assign an approved body identification number to each approved body; and

(b) compile and maintain a register of—

(i) approved bodies;

(ii) their approved body 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.

Operational matters in relation to notified bodies _E121

52. —(1) Subject to the terms of its appointment and to paragraph (3), a notified body must carry out the conformity assessment activities and modules in respect of which the body's notification was made to the European Commission and to the other [^F240relevant states^F240] under regulation 46 (notification).

(2) Where a notified body carries out a conformity assessment procedure, it must do so in accordance with Part 2 of Schedule 4.

(3) A notified body must make provision for a manufacturer to be able to make an appeal against a refusal by the notified body—

(a) to issue an EU-type examination certificate referred to in Schedule 2; or

(b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 44 (identification number)

UK national accreditation body _E35

53. The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a) assessing whether a conformity assessment body meets the approved body requirements;

(b) monitoring approved bodies in accordance with regulation 48; and

(c) compiling and maintaining the register of approved bodies, in accordance with regulation 52. ^F88]

Subsidiaries and contractors _E122

53. —(1) A notified body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a) the body is satisfied that the subcontractor or subsidiary meets the notified body requirements;

(b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets 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 notified body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where a notified body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the notified body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation 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.

PART 5 Market surveillance and enforcement

Designation of market surveillance authority

54. —(1) In Great Britain, the market surveillance authority is—

(a) within its area, the weights and measures authority in relation to vessels for private use or consumption; and

(b) subject to paragraph (3), the HSE in relation to vessels for use in the workplace.

(2) In Northern Ireland, the market surveillance authority is—

(a) within its area, the district council in relation to vessels for private use or consumption; and

(b) the HSENI in relation to vessels for use in the workplace.

(3) In so far as these Regulations apply to vessels intended exclusively or primarily for use on relevant nuclear sites, the market surveillance authority is the Office for Nuclear Regulation.

(4) In paragraph (3), “ relevant nuclear site ” means a site which is–

(a) ^F89 a GB nuclear site (within the meaning given in section 68 of the Energy Act 2013 ;

(b) ^F90 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

55. —(1) Subject to paragraph (2), these Regulations and RAMS (in its application to vessels) 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 vessels).

(3) Before taking 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 prosecute offences under these Regulations.

Enforcement Powers

56. —(1) Schedule 5 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 6 has effect where the enforcing authority is the HSE or the Office for Nuclear Regulation.

(3) Schedule 7 has effect where the enforcing authority is the HSENI.

(4) In addition to the powers available to an enforcing authority under, as appropriate, paragraph (1), (2) or (3), the authority may use the powers set out in Schedule 8.

Exercise of enforcement powers _E36

57. When enforcing these Regulations or RAMS (in its application to vessels), the enforcing authority must exercise its powers in a manner which is consistent with—

(a) regulation 58 (evaluation of vessels presenting a risk);

(b) regulation 59 (enforcement action in respect of vessels which are not in conformity);

^F91 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) regulation 61 (enforcement action in respect of vessels which are in conformity but which present a risk);

(e) regulation 62 (enforcement action in respect of formal non-compliance); and

(f) regulation 63 (restrictive measures).

Exercise of enforcement powers _E123

57. When enforcing these Regulations or RAMS (in its application to vessels), the enforcing authority must exercise its powers in a manner which is consistent with—

(a) regulation 58 (evaluation of vessels presenting a risk);

(b) regulation 59 (enforcement action in respect of vessels which are not in conformity);

(c) regulation 60 (EU safeguard procedure);

(d) regulation 61 (enforcement action in respect of vessels which are in conformity but which present a risk);

(e) regulation 62 (enforcement action in respect of formal non-compliance); and

(f) regulation 63 (restrictive measures).

Evaluation of vessels presenting a risk

58. —(1) Where the market surveillance authority has sufficient reason to believe that a vessel presents a risk to the health or safety of persons, to domestic animals or to property, the market surveillance authority must carry out an evaluation in relation to the vessel covering the relevant requirements of Part 2 applying in respect of that vessel.

(2) Where an enforcing authority other than the market surveillance authority has sufficient reason to believe that a vessel presents a risk to the health or safety of persons, to domestic animals or to property, that enforcing authority may carry out an evaluation in relation to the vessel covering the relevant requirements of Part 2 applying in respect of that vessel.

Enforcement action in respect of vessels which are not in conformity _E37

59. —(1) Where, in the course of the evaluation referred to in regulation 58 (evaluation of vessels presenting a risk), an enforcing authority finds that the vessel is not in conformity with Part 2, it must, without delay, require a relevant economic operator to—

(a) take appropriate corrective actions to bring the vessel into compliance with those requirements within a prescribed period;

(b) withdraw the vessel from the market within a prescribed period; or

(c) recall the vessel within a prescribed period.

(2) The enforcing authority must inform the [^F92 approved ^F92] body which carried out the conformity assessment procedure in respect of the vessel of—

(a) the respects in which the vessel is not in conformity with Part 2; and

(b) the corrective actions which it requires the relevant economic operator to take.

(3) Where the enforcing authority is not the Secretary of State and it considers that the lack of conformity referred to in paragraph (1) is not restricted to the United Kingdom, it must notify the Secretary of State of—

(a) the results of the evaluation; and

(b) the corrective actions which it requires the relevant economic operator to take.

^F93 (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 vessel being made available on the market in the United Kingdom;

(b) withdraw the vessel from the United Kingdom market; or

(c) recall the vessel.

(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.

^F94 (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) The [^F95 notice in paragraph (6) ^F95] must include all available details and, in particular—

(a) the data necessary for the identification of the vessel;

(b) the origin of the vessel;

(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) the failure of the vessel to meet relevant requirements relating to the health or safety of persons, to the protection of domestic animals or to property; or

(ii) shortcomings in a [^F96 designated ^F96] standard referred to in regulation 39 (presumption of conformity of category A vessels) conferring a presumption of conformity.

(9) In this regulation, “ prescribed period ” means a period which is—

(a) prescribed by the enforcing authority; and is

(b) reasonable and commensurate with the nature of the risk presented by the vessel.

^F97 (10) An economic operator must ensure that it takes the action required by an enforcing authority under paragraph (1) of this regulation in respect of all the vessels that it has made available on the market ....

Enforcement action in respect of vessels which are not in conformity _E124

59. —(1) Where, in the course of the evaluation referred to in regulation 58 (evaluation of vessels presenting a risk), an enforcing authority finds that the vessel is not in conformity with Part 2, it must, without delay, require a relevant economic operator to—

(a) take appropriate corrective actions to bring the vessel into compliance with those requirements within a prescribed period;

(b) withdraw the vessel from the market within a prescribed period; or

(c) recall the vessel within a prescribed period.

(2) The enforcing authority must inform the notified body which carried out the conformity assessment procedure in respect of the vessel of—

(a) the respects in which the vessel is not in conformity with Part 2; and

(b) the corrective actions which it requires the relevant economic operator to take.

(3) Where the enforcing authority is not the Secretary of State and it considers that the lack of conformity referred to in paragraph (1) is not restricted to [^F241 Northern Ireland ^F241] , it must notify the Secretary of State of—

(a) the results of the evaluation; and

(b) the corrective actions which it requires the relevant economic operator to take.

(4)[^F242 Subject to paragraph (4A), ^F242] where the Secretary of State receives a notice under paragraph (3), or otherwise considers that the lack of conformity referred to in paragraph (1) is not restricted to [^F243 Northern Ireland ^F243] , the Secretary of State must inform the European Commission and other [^F244relevant states^F244] of—

(a) the results of the evaluation; and

(b) the actions which the enforcing authority requires the relevant economic operator to take.

[^F245 (4A) Paragraph (4) does not require the Secretary of State to inform the Commission or other relevant states where the lack of conformity extends only to any of England or Wales or Scotland. ^F245]

(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 vessel being made available on the market in [^F246 Northern Ireland ^F246] ;

(b) withdraw the vessel from [^F247 market in Northern Ireland ^F247] ; or

(c) recall the vessel.

(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) Where the Secretary of State receives a notice under paragraph (6), or takes measures under paragraph (5), the Secretary of State must notify the European Commission and the other [^F248relevant states^F248] of those measures without delay.

(8) The notices in paragraphs (6) and (7) must include all available details and, in particular—

(a) the data necessary for the identification of the vessel;

(b) the origin of the vessel;

(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) the failure of the vessel to meet relevant requirements relating to the health or safety of persons, to the protection of domestic animals or to property; or

(ii) shortcomings in a harmonised standard referred to in regulation 39 (presumption of conformity of category A vessels) conferring a presumption of conformity.

(9) In this regulation, “ prescribed period ” means a period which is—

(a) prescribed by the enforcing authority; and is

(b) reasonable and commensurate with the nature of the risk presented by the vessel.

^F249 (10) An economic operator must ensure that it takes the action required by an enforcing authority under paragraph (1) of this regulation in respect of all the vessels that it has made available on the market ....

EU safeguard procedure _E38

^F9860. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

EU safeguard procedure _E125

60. —(1) Where the market surveillance authorities of another [^F250relevant state^F250] have initiated the procedure under Article 35 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 vessel;

(b) any additional information which the enforcing authority has at its disposal relating to the lack of conformity of the vessel.

(2) Where the market surveillance authorities of another [^F251relevant state^F251] have initiated the procedure under Article 35 of the Directive (as amended from time to time), the Secretary of State must, without delay, inform the European Commission and the other [^F252relevant states^F252] of—

(a) any measures taken [^F253 in Northern Ireland ^F253] by an enforcing authority in respect of the vessel;

(b) ^F254 any additional information which an enforcing authority has at its disposal relating to the lack of conformity of the vessel; ...

^F254 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a measure taken by another [^F255relevant state^F255] in respect of a vessel is deemed justified under Article 35(7) of the Directive, the market surveillance authority must ensure that appropriate measures, such as withdrawal, are taken [^F256 in Northern Ireland ^F256] in respect of the vessel without delay.

(4) Where a measure taken by another [^F257relevant state^F257] under in respect of a vessel is considered by the European Commission to be justified pursuant to Article 36(1) of the Directive (as amended from time to time), the market surveillance authority must take all necessary measures to ensure that the vessel is withdrawn from [^F258 market in Northern Ireland ^F258] .

(5) Where the market surveillance authority is not the Secretary of State and it has taken action under paragraphs (3) or (4), it must notify the Secretary of State.

(6) Where the Secretary of State receives a notice under paragraph (5), or has taken action under paragraphs (3) or (4), the Secretary of State must inform the European Commission of the action taken [^F259 in respect of Northern Ireland ^F259] .

(7) If a measure taken by an enforcing authority pursuant to regulation 59 is considered unjustified by the European Commission under Article 36(1) of the Directive (as amended from time to time), the enforcing authority must withdraw that measure [^F260 in respect of Northern Ireland ^F260] .

Enforcement action in respect of vessels which are in conformity, but which present a risk _E39

61. —(1) Where, having carried out an evaluation under regulation 58 (evaluation of vessels presenting a risk), an enforcing authority finds that although a vessel is in conformity with Part 2, it presents a risk to the health or safety of persons, to domestic animals or to property, the enforcing authority must require a relevant economic operator to take all appropriate measures to—

(a) ensure that the vessel concerned, when placed on the market, no longer presents such a risk;

(b) withdraw the vessel within a prescribed period; or

(c) recall the vessel 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.

^F99 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The [^F100 notice referred to in paragraph (2) ^F100] must include all available details and, in particular—

(a) the data necessary for the identification of the vessel;

(b) the origin and the supply chain of the vessel;

(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—

(a) is prescribed by the enforcing authority; and

(b) is reasonable and commensurate with the nature of the risk presented by the vessel.

Enforcement action in respect of vessels which are in conformity, but which present a risk _E126

61. —(1) Where, having carried out an evaluation under regulation 58 (evaluation of vessels presenting a risk), an enforcing authority finds that although a vessel is in conformity with Part 2, it presents a risk to the health or safety of persons, to domestic animals or to property, the enforcing authority must require a relevant economic operator to take all appropriate measures to—

(a) ensure that the vessel concerned, when placed on the market, no longer presents such a risk;

(b) withdraw the vessel within a prescribed period; or

(c) recall the vessel 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)[^F261 Subject to paragraph (3A), ^F261] where the Secretary of State receives a notice under paragraph (2) or takes measures under paragraph (1), the Secretary of State must notify the European Commission and the other [^F262relevant states^F262] immediately.

[^F263 (3A) Paragraph (3) only applies to measures taken in Northern Ireland. ^F263]

(4) The notices referred to in paragraphs (2) and (3) must include all available details and, in particular—

(a) the data necessary for the identification of the vessel;

(b) the origin and the supply chain of the vessel;

(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—

(a) is prescribed by the enforcing authority; and

(b) is reasonable and commensurate with the nature of the risk presented by the vessel.

Enforcement action in respect of formal non-compliance _E40

62. —(1) Where an enforcing authority makes one of the following findings in relation to a vessel, it must require a relevant economic operator to remedy the non-compliance concerned within such reasonable period as the enforcing authority specifies—

(a) in relation to a category A vessel—

(i) no [^F101 UK ^F101] marking has been affixed;

(ii) ^F103 the [^F102 UK ^F102] marking has been affixed otherwise than in accordance with regulation 6 ( ... declaration of conformity, [^F102 UK ^F102] marking and inscriptions for category A vessels) or 38 (prohibition on improper use of [^F102 UK ^F102] marking);

(iii) where [^F104 an approved ^F104] body is involved in the production control phase for the vessel—

(aa) no identification number in respect of the [^F105 approved ^F105] body has been affixed; or

(bb) an identification number in respect of the [^F106 approved ^F106] body has been affixed otherwise than in accordance with regulation 44 (identification number);

(iv) ^{F107,F107,F107} the ... declaration of conformity has not been drawn up or has been drawn up otherwise than in accordance with regulations 6 ( ... declaration of conformity, [^F108 UK ^F108] marking and inscriptions for category A vessels) or 43 ( ... declaration of conformity);

(v) the technical documentation is unavailable or incomplete;

(b) in relation to a category A or a category B vessel—

(i) ^F109 an inscription has not been affixed or has been affixed otherwise than in accordance with regulation 6 ( ... declaration of conformity, [^F110 UK ^F110] marking and inscriptions for category A vessels) or 7 (inscriptions for category B vessels);

(ii) the information specified in regulation 11 (labelling of vessels) or 21 (information identifying importer) is absent, false or incomplete;

(iii) any other administrative requirement imposed on the manufacturer or importer under Part 2 has not been fulfilled.

(2) The enforcing authority must not take any enforcement action against the relevant economic operator under these Regulations in respect of the non-compliance concerned until the period referred to in paragraph (1) has elapsed.

(3) Where the non-compliance referred to in paragraph (1) persists, the enforcing authority must take all appropriate measures to—

(a) restrict or prohibit the vessel being made available on the market;

(b) ensure that the vessel is withdrawn; or

(c) ensure that the vessel is recalled.

^F111 (4) Nothing in this regulation is to prevent an enforcing authority from taking action under regulations 59 (enforcement action in respect of vessels which are not in conformity) ....

Enforcement action in respect of formal non-compliance _E127

62. —(1) Where an enforcing authority makes one of the following findings in relation to a vessel, it must require a relevant economic operator to remedy the non-compliance concerned within such reasonable period as the enforcing authority specifies—

(a) in relation to a category A vessel—

(i) no CE marking has been affixed;

(ii) the CE marking has been affixed otherwise than in accordance with regulation 6 (EU declaration of conformity, CE marking and inscriptions for category A vessels) or 38 (prohibition on improper use of CE marking);

(iii) where a notified body is involved in the production control phase for the vessel—

(aa) no identification number in respect of the notified body has been affixed; or

(bb) an identification number in respect of the notified body has been affixed otherwise than in accordance with regulation 44 (identification number);

(iv) the EU declaration of conformity has not been drawn up or has been drawn up otherwise than in accordance with regulations 6 (EU declaration of conformity, CE marking and inscriptions for category A vessels) or 43 (EU declaration of conformity);

(v) the technical documentation is unavailable or incomplete;

[^F264 (vi) the UK(NI) indication—

(aa) has not been affixed, in contravention of regulation 44A; or

(bb) has been affixed other than in accordance with regulation 44A; ^F264]

(b) in relation to a category A or a category B vessel—

(i) an inscription has not been affixed or has been affixed otherwise than in accordance with regulation 6 (EU declaration of conformity, CE marking and inscriptions for category A vessels) or 7 (inscriptions for category B vessels);

(ii) the information specified in regulation 11 (labelling of vessels) or 21 (information identifying importer) is absent, false or incomplete;

(iii) any other administrative requirement imposed on the manufacturer or importer under Part 2 has not been fulfilled.

(2) The enforcing authority must not take any enforcement action against the relevant economic operator under these Regulations in respect of the non-compliance concerned until the period referred to in paragraph (1) has elapsed.

(3) Where the non-compliance referred to in paragraph (1) persists, the enforcing authority must take all appropriate measures to—

(a) restrict or prohibit the vessel being made available on the market;

(b) ensure that the vessel is withdrawn; or

(c) ensure that the vessel is recalled.

(4) Nothing in this regulation is to prevent an enforcing authority from taking action under regulations 59 (enforcement action in respect of vessels which are not in conformity) or 60(3) (EU safeguard procedure).

Restrictive measures

63. 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 a vessel being made available on the market;

(b) withdraw a vessel; or

(c) recall a vessel.

Offences

64. —(1) It is an offence for a person to contravene or fail to comply with any requirement of regulations 4 to 13, 14(4), 16 to 26, 27(4), 28 to 33, 34(4) or 37 to 38.

(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 _E41

65. —(1) A person guilty of an offence under regulation 64 (offences) (other than an offence arising from a contravention of or failure to comply with a requirement of regulation 8 or regulation 26) 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, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding three months, or to both; and

(c) in 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.

(2) A person guilty of an offence arising from a contravention of or failure to comply with a requirement of regulation 8 or regulation 26 is liable on summary conviction—

(a) in England and Wales, to a fine;

(b) in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale.

Penalties _E128

65. —(1) A person guilty of an offence under regulation 64 (offences) (other than an offence arising from a contravention of or failure to comply with a requirement [^F265 to which paragraph (1A) applies ^F265] ) 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, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding three months, or to both; and

(c) in 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.

[^F266 (1A) This paragraph applies to an offence arising from a contravention or failure to comply with a requirement of—

(a) regulation 8;

(b) regulation 26; or

(c) a withdrawal or recall notice arising from a failure to affix the UK(NI) indication or a failure to affix the UK(NI) indication other than in accordance with regulation 44A. ^F266]

(2) A person guilty of an offence arising from a contravention of or failure to comply with a requirement [^F267 to which paragraph (1A) applies ^F267] is liable on summary conviction—

(a) in England and Wales, to a fine;

(b) in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale.

Defence of due diligence

66. —(1) Subject to paragraphs (2), (4) and (6), in proceedings for an offence under regulation 64 (offences), 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 referred to in paragraph (2) 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

67. —(1) Where the commission of an offence by one person (“A”) under regulation 64 (offences) is due to anything which another person (“B”) did or failed to do in the course of business, B is guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against A.

(2) Where a body corporate commits an offence, a relevant person is also guilty of the offence where the body corporate's offence was committed—

(a) with the consent or connivance of the relevant person; or

(b) as a result of the negligence of the relevant person.

(3) In paragraph (2), “ relevant person ” means—

(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;

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

Time limit for prosecution of offences

68. —(1) Subject to paragraph (4), in England and Wales an information relating to an offence under regulation 64 (offences) 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) Subject to paragraph (4), in Scotland—

(a) summary proceedings for an offence under regulation 64 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) ^F112section 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) Subject to paragraph (4), in Northern Ireland summary proceedings for an offence under regulation 64 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 paragraphs (1), (2) or (3) came to light, is conclusive evidence.

(6) This regulation has effect subject to paragraph 1(n) of Schedule 6 and paragraph 1(n) of Schedule 7.

Service of documents

69. —(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;

(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 address 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

70. —(1) This regulation applies where a person commits an offence under regulation 64 (offences).

(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

71. —(1) An enforcing authority may itself take action which an economic operator could have been required to take by a notice served under these Regulations where the conditions for serving such a notice are met and either—

(a) the 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 as a result of the condition in paragraph (1)(b) being met, 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) ^F113 in England and Wales by way of a complaint pursuant to section 58 of the Magistrates' Courts Act 1980 ;

(b) ^F114 in Northern Ireland in proceedings under article 62 of the Magistrates' Court (Northern Ireland) Order 1981 .

Appeals against notices

72. —(1) Any application for an order to vary or set aside the terms of a notice served under these Regulations 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 recallnotice by a person having an interest in the vessel 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 these Regulations if satisfied—

(a) that the requirements of these Regulations and RAMS (in its application to vessels) have been complied with in respect of the vessel to which the notice relates; or

(b) that the enforcing authority failed to comply with regulation 57 (exercise of enforcement powers) when serving the notice.

(4) On an application to vary the terms of a notice served under these Regulations, 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 73 (appropriate court for appeals against notices); and

(b) “ notice ” means—

(i) a prohibition notice served in accordance with Schedule 5;

(ii) a notice to warn served in accordance with Schedule 5;

(iii) a suspension notice served in accordance with Schedule 5;

(iv) a compliance notice served in accordance with Schedule 8;

(v) a withdrawal notice served in accordance with Schedule 8;

(vi) a recallnotice served in accordance with Schedule 8.

Appropriate court for appeals against notices

73. —(1) In England and Wales or Northern Ireland, the appropriate court for the purposes of regulation 72 (appeals against notices) is—

(a) the court in which proceedings have been brought in relation to the vessel for an offence under regulation 64 (offences);

(b) an employment tribunal seized of appeal proceedings against a notice which relates to the vessel and which has been served under or by virtue of paragraph 1 of Schedule 6;

(c) an industrial tribunal seized of appeal proceedings against a notice which relates to the vessel and which has been served under or by virtue of paragraph 1 of Schedule 7; or

(d) in any other case, a magistrates' court.

(2) In Scotland, the appropriate court for the purposes of regulation 72 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 the vessel and which has been served under or by virtue of paragraph 1 of Schedule 6.

(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 72, 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

74. —(1) Where an enforcing authority other than the HSE, [the HSENI or the Office for Nuclear Regulation] serves a relevant notice in respect of a vessel, that authority is liable to pay compensation to a person having an interest in the vessel 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 vessel in respect of which the relevant notice was served neither—

(i) presents a risk to the health and safety of persons, to domestic animals or to property; 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 72(5)(b).

PART 6 Miscellaneous

Review _E42

75. —(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 date these Regulations come into force.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Review _E129

75. —(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 [^F268relevant states^F268] .

(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 date these Regulations come into force.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Transitional provision _E43

76. —(1) A certificate issued by a United Kingdom approved body under regulations 10 (EC certificate of adequacy), 11 (EC type-examination certificate), 12(7) (EC verification) and 13 (EC certificate of conformity) of the 1991 Regulations, or under the corresponding provisions of [^F115 a ^F115] Member State's enactment implementing the 2009 Directive, is valid under these Regulations.

^F116 (2) In this regulation, “ 2009 Directive ” means Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels .

Transitional provision _E130

76. —(1) A certificate issued by a United Kingdom approved body under regulations 10 (EC certificate of adequacy), 11 (EC type-examination certificate), 12(7) (EC verification) and 13 (EC certificate of conformity) of the 1991 Regulations, or under the corresponding provisions of another [^F269relevant state’s ^F269] enactment implementing the 2009 Directive, is valid under these Regulations.

^F270 (2) In this regulation, “ 2009 Directive ” means Directive 2009/105/EC of the European Parliament and of the Council of 16 September 2009 relating to simple pressure vessels .

[^F117 Transitional provision in relation to EU Exit

76A.—(1) In this regulation—

“ pre-exit period ” means the period beginning with the commencement date and ending immediately before IP completion day;

“ product ” means a vessel to which these Regulations apply.

(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 21 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.

^F118 (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F118 (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F118 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ^F117]

Revocations and savings _E44

^F11977. —(1) Subject to paragraph (2), the 1991 Regulations and the Simple Pressure Vessels (Safety) (Amendment) Regulations 1994 are revoked.

(2) The Regulations referred to in paragraph (1) continue to apply, [^F120 subject to the modifications in paragraph (2A), ^F120] as if they had not been revoked, to a vessel placed on the market before the commencement date.

[^F121 (2A) The modifications referred to in paragraph (2) are as follows—

(a) in the 1991 Regulations—

(i) any reference to “the Community” is to be read as including the United Kingdom;

(ii) any reference to “member State” is to be read as including the United Kingdom;

(iii) in regulation 11 (EC type-examination certificate)—

(aa) in paragraph (6)(a), for “the Commission, any other approved body or any other member State” substitute “ or any other United Kingdom approved body ” ;

(bb) in paragraph (8), omit “, with a view to this information being passed by him to the Commission and the other member States”;

(iv) in regulation 17 (Functions of approved bodies in course of EC Surveillance)—

(aa) paragraph (2) is to be read as if “or elsewhere” were omitted;

(bb) paragraph (3) is to be read as if “, the Commission, any other approved body or any other member State” were omitted;

(v) paragraph 6 of Schedule 5 (enforcement), is to be read as if “, with a view to this information being passed by him to the Commission” were omitted;

(b) in the Simple Pressure Vessels (Safety) (Amendment) Regulations 1994, in regulation 5 (transitional provisions in respect of marking arrangements)—

(i) any reference to “the Community” is to be read as including the United Kingdom; and

(ii) paragraph (3) is to be read as if the following paragraph were substituted—

“ (3) In the event of such election, to demonstrate compliance with the marking arrangements in force on 31 December 1994, the manufacturer or his authorised representative established in the Community, shall apply the principal Regulations (as amended by these Regulations)—

(a) as if the amendments made by regulation 4(f) and (k) had not come into force; and

(b) read subject to the modifications made by regulation 77(2A)(a) of the Simple Pressure Vessels (Safety) Regulations 2016. ” ^F121]

(3) Accordingly, despite its repeal by regulation 78(7)(a), the entry in paragraph 10 of Schedule 5 to the Consumer Rights Act 2015 relating to the 1991 Regulations is to continue to have effect in relation to a vessel placed on the market before the commencement date.

Revocations and savings _E131

^F271 77. —(1) Subject to paragraph (2), the 1991 Regulations and the Simple Pressure Vessels (Safety) (Amendment) Regulations 1994 are revoked.

(2) The Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to a vessel placed on the market before the commencement date.

(3) Accordingly, despite its repeal by regulation 78(7)(a), the entry in paragraph 10 of Schedule 5 to the Consumer Rights Act 2015 relating to the 1991 Regulations is to continue to have effect in relation to a vessel placed on the market before the commencement date.

Consequential Amendments

^F12278. —(1) In Schedule 1 to the Provision and Use of Work Equipment Regulations 1998 omit the entry “The Simple Pressure Vessels (Safety) Regulations 1991” and in the appropriate place insert “ The Simple Pressure Vessels (Safety) Regulations 2016 ” .

^F123 (2) In Schedule 2 to the Provision and Use of Work Equipment Regulations (Northern Ireland) 1999 omit the entry “The Simple Pressure Vessels (Safety) Regulations 1999” and in the appropriate place insert “ The Simple Pressure Vessels (Safety) Regulations 2016 ” .

^F124 (3)The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Amendment and Specification) Order 2003 is amended as follows—

(a) in Schedule 3, omit the entry “Paragraph 3 of Schedule 5 to the Simple Pressure Vessels (Safety) Regulations 1991”, and after the last entry insert “ Regulation 55 of the Simple Pressure Vessels (Safety) Regulations 2016 (in so far as information comes to a public authority enforcing those regulations in respect of vessels for private use or consumption) ” ;

(b) in Schedule 4 omit the entry “paragraph 3 of Schedule 5 to the Simple Pressure Vessels (Safety) Regulations 1991”, and after the last entry insert “ Regulation 55 of the Simple Pressure Vessels (Safety) Regulations 2016 (in so far as information is disclosed to a public authority enforcing those regulations in respect of vessels for private use or consumption) ” ; and

(c) in Schedule 5, omit the entry in respect of the Simple Pressure Vessels (Safety) Regulations 1991.

^F125 (4)The Legislative and Regulatory Reform (Regulatory Functions) Order 2007 is amended as follows—

(a) in Part 3 of the Schedule, under the heading “Public health and safety”, omit the entry “Simple Pressure Vessels (Safety) Regulations 1991” and after the last entry insert “ Simple Pressure Vessels (Safety) Regulations 2016 ” ; and

(b) in Part 13 of the Schedule, omit the entry “Simple Pressure Vessels (Safety) Regulations 1991” and after the last entry insert “ Simple Pressure Vessels (Safety Regulations 2016 ” .

^F126 (5)The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009 is amended as follows—

(a) in Part 4 of Schedule 1, omit the entry “Simple Pressure Vessels (Safety) Regulations 1991” and after the last entry insert “ Simple Pressure Vessels (Safety) Regulations 2016 ” ; and

(b) in Part 2 of Schedule 2, omit the entry “Simple Pressure Vessels (Safety) Regulations 1991” and after the last entry insert “ Simple Pressure Vessels (Safety) Regulations 2016 ” .

^F127 (6) In the Energy Act 2013 (Office for Nuclear Regulation) (Consequential Amendments, Transitional Provisions and Savings) Order 2014 , omit paragraph 52 of Schedule 3.

^F128 (7) Subject to paragraph (3) of regulation 77, paragraph 10 of Schedule 5 to the Consumer Rights Act 2015 is amended as follows–

(a) omit the entry “paragraph 3(a) of Schedule 5 to the Simple Pressure Vessels (Safety) Regulations 1991(SI 1991/2749);”; and

(b) at the appropriate place insert—

“ regulation 55(1) or (2) of the Simple Pressure Vessels (Safety) Regulations 2016(SI 2016/1092); ” .

Regulation 4(1)

SCHEDULE 1 Essential Safety Requirements

PART 1 Materials

1. Materials used in the manufacture of a vessel must be selected according to the intended use of the vessel and in accordance with paragraphs 2 to 9.

Pressurised parts

2. The materials used for manufacturing the pressurised parts of the vessel must be—

(a) capable of being welded;

(b) ductile and tough, so that a rupture at minimum working temperature does not give rise to either fragmentation or brittle-type fracture;

(c) not adversely affected by ageing.

3. For steel vessels, the material must in addition meet the requirements set out in paragraph 5 and, for aluminium or aluminium alloy vessels, those set out in paragraph 6.

4. The materials must be accompanied by an inspection slip as defined in paragraph 21(b) of Schedule 2, drawn up by the producer of the materials.

Steel vessels

5. Non-alloy quality steels must meet the following requirements—

(a) they must be non-effervescent and supplied after normalisation treatment, or in an equivalent state;

(b) the content per product of carbon must be less than 0.25% and that of sulphur and phosphorous must each be less than 0.05%

(c) they must have the following mechanical properties per product—

(i) the maximum tensile strength _{Rm, max} must be less than 580 N/mm ^2;

(ii) the elongation after fracture must be:

if test pieces are taken parallel to the direction of rolling:

or, if test pieces are taken perpendicular to the direction of rolling:

(iii) the average bending rupture energy (KCV) for three longitudinal test pieces at minimum working temperature must not be less than 35 J/cm ² . Not more than one of the three figures may be less than 35 J/cm ² , with a minimum of 25 J/cm ² . In the case of steels intended to be used in the manufacture of vessels the minimum working temperature of which is lower than - 10°C and the wall thickness of which exceeds 5 mm, this property must be checked.

Aluminium vessels

6. —(1) Non-alloy aluminium must have an aluminium content of at least 99.5% and the alloys referred to in regulation 2(1)(b) (interpretation) must display adequate resistance to intercrystalline corrosion at maximum working temperature.

(2) Moreover, these materials must satisfy the following requirements—

(a) they must by supplied in an annealed state;

(b) they must have the following mechanical characteristics per product—

(i) the maximum tensile strength R _{m, max} must be no more than 350 N/mm ² ,

(ii) the elongation after fracture must be—

(aa) A ≥ 16% if the test piece is taken parallel to the direction of rolling;

(bb) A ≥ 14% if the test piece is taken perpendicular to the direction of rolling.

Welding materials

7. The welding materials used to manufacture the welds on or of the vessel must be appropriate to and compatible with the materials to be welded.

Accessories contributing to the strength of the vessel

8. —(1) Accessories contributing to the strength of the vessel (for example bolts and nuts) must be made—

(a) of a material specified in paragraphs 2 to 6; or

(b) of other kinds of steel, aluminium or an appropriate aluminium alloy compatible with materials used for the manufacture of pressurised parts.

(2) The materials referred to in sub-paragraph (1)(b) must, at minimum working temperature, have an appropriate elongation after fracture and bending rupture energy.

Non-pressurised parts

9. All unpressurised parts of welded vessels must be of materials which are compatible with that of the components to which they are welded.

Symbols

10. In this Part—

(a) “ A ” means elongation after fracture (

(b) “ A _{80 mm} ” means elongation after fracture (

(c) “ KCV ” means bending rupture energy in J/cm ²

(d) “ R _{m, max} ” means maximum tensile strength in N/mm ²

PART 2 Vessel Design

11. —(1) A manufacturer must, when designing a vessel, define the use to which it will be put, and select—

(a) the minimum working temperature T _min ;

(b) the maximum working temperature T _max ; and

(c) the maximum working pressure PS.

(2) Where a minimum working temperature exceeding - 10°C is selected, the qualities required of the materials must be satisfied at - 10°C.

12. A manufacturer must also take account of the following provisions—

(a) it must be possible to inspect the inside of vessels;

(b) it must be possible to drain the vessels;

(c) the mechanical qualities must be maintained throughout the period of use of the vessel for the intended purpose;

(d) the vessels must, bearing in mind their prescribed use, be adequately protected against corrosion.

13. A manufacturer must take account of the fact that under the conditions of use envisaged—

(a) the vessels must not be subjected to stress likely to impair their safety in use;

(b) internal pressure must not permanently exceed the maximum working pressure PS. However, it may momentarily do so by up to 10%.

14. Circumferential and longitudinal seams must be made using full penetration welds or welds of equivalent effectiveness and convex ends, other than hemispherical ones, must have a cylindrical edge.

Wall thickness

15. —(1) If the product of PS x V is not more than 3 000 bar.L, the manufacturer must select one of the methods described in paragraphs 16 (calculation method) and 17 (experimental method) for determining vessel wall thickness.

(2) If the product of PS x V is more than 3 000 bar.L, or if the maximum working temperature exceeds 100°C, such thickness must be determined by the method described in paragraph 16 (calculation method).

(3) The actual wall thickness of the cylindrical section and ends must, however, be not less than 2 mm in the case of steel vessels and not less than 3 mm in the case of aluminium or aluminium alloy vessels.

Calculation method

16. —(1) The minimum thickness of pressurised parts must be calculated having regard to the intensity of the stresses and to the following provisions—

(a) the calculation pressure to be taken into account must not be less than the maximum working pressure PS selected;

(b) the permissible general membrane stress must not exceed the lower of the values 0.6 R _eT or 0.3 R _m and the manufacturer must use the R _eT and R _m minimum values guaranteed by the producer of the material in order to determine the permissible stress.

(2) Where the cylindrical portion of the vessel has one or more longitudinal welds made using a non-automatic welding process, the thickness calculated as referred to in sub-paragraph (1) must be multiplied by the coefficient 1.15.

(3) In this paragraph—

(a) “ R _eT ” means the yield strength in N/mm ² , which is the value at the maximum working temperature T _max of any of the following—

(i) the upper yield point R _eH in N/mm ² , for a material with both a lower and an upper yield point;

(ii) the 0.2% proof strength R _p0.2 in N/mm ² ;

(iii) the 1.0% proof strength R _p1.0 in N/mm ² , in the case of non-alloy aluminium;

(b) “ R _m ” means tensile strength in N/mm ² .

Experimental method

17. Wall thickness must be so determined as to enable the vessels to resist at ambient temperature a pressure equal to at least five times the maximum working pressure, with a permanent circumferential deformation factor of no more than 1%.

PART 3 Manufacturing processes

18. Vessels must be constructed and subjected to production checks in accordance with Parts 2, 3 or 4 of Schedule 2.

Preparation of the component parts

19. Preparation of the component parts (for example forming and chamfering) must not give rise to surface defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the vessels.

Welds on pressurised parts

20. The characteristics of welds and adjacent zones must be similar to those of the welded materials and must be free of any surface or internal defects detrimental to the safety of the vessels.

_E45

21. —(1) Welds must be performed by qualified welders or operators possessing the appropriate level of competence, in accordance with approved welding processes.

(2) In sub-paragraph (1)—

(a) “ qualified ” means qualified by means of tests carried out by [^F129 an approved^F129] body; and

(b) “ approved ” means approved by [^F129 an approved^F129] body.

_E132

21. —(1) Welds must be performed by qualified welders or operators possessing the appropriate level of competence, in accordance with approved welding processes.

(2) In sub-paragraph (1)—

(a) “ qualified ” means qualified by means of tests carried out by a notified body; and

(b) “ approved ” means approved by a notified body.

22. The manufacturer must also, during manufacture, ensure consistent weld quality by conducting appropriate tests using adequate procedures. These tests must be the subject of a report.

Putting into service of the vessels

23. Vessels must be accompanied by the instructions and safety information.

Regulations 40 and 41

SCHEDULE 2 Conformity Assessment Procedures

PART 1 [^F130 EU- ^F130] Type Examination (Module B)

_E46

1. [^F131 Type ^F131] examination (Module B) is a conformity assessment procedure in which [^F132 an approved ^F132] body examines the technical design of a vessel and verifies and attests that the technical design of the vessel meets the applicable requirements of these Regulations that apply to it.

_E133

1. EU-type examination (Module B) is a conformity assessment procedure in which a notified body examines the technical design of a vessel and verifies and attests that the technical design of the vessel meets the applicable requirements of these Regulations that apply to it.

_E47

2. —(1) A manufacturer must lodge an application for [^F131 Type ^F131] examination (Module B) with a single [^F133 approved ^F133] body of the manufacturer's choice.

(2) The application must include—

(a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of the authorised representative;

(b) a written declaration that the same application has not been lodged with any other [^F133 approved ^F133] body;

(c) the technical documentation;

(d) where applicable, the prototype vessels (and any further prototype vessels requested by the [^F133 approved ^F133] body if needed for carrying out the test programme) representative of the production envisaged;

(e) the supporting evidence for the adequacy of the technical design solution; this supporting evidence must—

(i) mention any documents that have been used, in particular where the relevant [^F134 designated ^F134] standards have not been applied in full;

(ii) include, where necessary, the results of tests carried out in accordance with other technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under his responsibility.

_E134

2. —(1) A manufacturer must lodge an application for EU-type examination (Module B) with a single notified body of the manufacturer's choice.

(2) The application must include—

(a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of the authorised representative;

(b) a written declaration that the same application has not been lodged with any other notified body;

(c) the technical documentation;

(d) where applicable, the prototype vessels (and any further prototype vessels requested by the notified body if needed for carrying out the test programme) representative of the production envisaged;

(e) the supporting evidence for the adequacy of the technical design solution; this supporting evidence must—

(i) mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full;

(ii) include, where necessary, the results of tests carried out in accordance with other technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under his responsibility.

_E48

3. —(1) The technical documentation referred to in paragraph 2(2)(c) must—

(a) make it possible to assess the vessel's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of any risks;

(b) specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the vessel;

(c) contain, wherever applicable, at least the following elements—

(i) a general description of the vessel;

(ii) conceptual design and manufacturing drawings and schemes of components;

(iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel;

(iv) ^F136 a list of the [^F135 designated ^F135] standards applied in full or in part (where applicable specifying the parts which have been applied) ...;

(v) where [^F137 designated ^F137] standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements, including a list of other relevant technical specifications applied;

(vi) results of design calculations made and examinations carried out;

(vii) test reports;

(viii) the instructions and safety information;

(ix) A document describing—

(aa) the materials selected;

(bb) the welding processes selected;

(cc) the checks selected; and

(dd) any pertinent details as to the vessel design.

(2) Where a prototype vessel is examined, the technical documentation must also include—

(a) the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;

(b) the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel;

(c) a report on the examination and tests performed or a description of the proposed checks.

_E135

3. —(1) The technical documentation referred to in paragraph 2(2)(c) must—

(a) make it possible to assess the vessel's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of any risks;

(b) specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the vessel;

(c) contain, wherever applicable, at least the following elements—

(i) a general description of the vessel;

(ii) conceptual design and manufacturing drawings and schemes of components;

(iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel;

(iv) a list of the harmonised standards applied in full or in part (where applicable specifying the parts which have been applied), the references to which have been published in the Official Journal;

(v) where harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements, including a list of other relevant technical specifications applied;

(vi) results of design calculations made and examinations carried out;

(vii) test reports;

(viii) the instructions and safety information;

(ix) A document describing—

(aa) the materials selected;

(bb) the welding processes selected;

(cc) the checks selected; and

(dd) any pertinent details as to the vessel design.

(2) Where a prototype vessel is examined, the technical documentation must also include—

(a) the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;

(b) the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel;

(c) a report on the examination and tests performed or a description of the proposed checks.

_E49

4. —(1) The [^F133 approved ^F133] body must examine the technical documentation and supporting evidence in respect of a vessel and, if provided, the prototype representative of the production of the vessel, to assess the adequacy of the technical design of the vessel.

(2) Where a prototype vessel is examined, the [^F133 approved ^F133] body must—

(a) verify that a prototype vessel—

(i) has been manufactured in conformity with the technical documentation;

(ii) may safely be used under its intended working conditions;

(iii) identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(b) carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;

(c) carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations; and

(d) agree with the manufacturer on a location where the examinations and tests will be carried out.

_E136

4. —(1) The notified body must examine the technical documentation and supporting evidence in respect of a vessel and, if provided, the prototype representative of the production of the vessel, to assess the adequacy of the technical design of the vessel.

(2) Where a prototype vessel is examined, the notified body must—

(a) verify that a prototype vessel—

(i) has been manufactured in conformity with the technical documentation;

(ii) may safely be used under its intended working conditions;

(iii) identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

(b) carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;

(c) carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations; and

(d) agree with the manufacturer on a location where the examinations and tests will be carried out.

_E50

5. The [^F133 approved ^F133] body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes and, without prejudice to the notifying body's obligations vis-à-vis the Secretary of State, the [^F133 approved ^F133] body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer.

_E137

5. The notified body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes and, without prejudice to the notifying body's obligations vis-à-vis the Secretary of State, the notified body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer.

_E51

6. —(1) Where the type meets the requirements of these Regulations, the [^F133 approved ^F133] body must issue [^F138 a Type ^F138] examination certificate to the manufacturer, which must contain—

(a) the name and address of the manufacturer;

(b) the conclusions of the examination;

(c) the conditions (if any) for its validity;

(d) all relevant information to allow the conformity of manufactured vessels with the examined type to be evaluated and to allow for in-service control; and

(e) the necessary data for the identification of the approved type.

(2) The [^F131 Type ^F131] examination certificate referred to in sub-paragraph (1)—

(a) may have one or more annexes attached;

(b) must be accompanied by the descriptions and drawings necessary for identification of the approved type.

(3) Where the type does not satisfy the applicable requirements of these Regulations, the [^F133 approved ^F133] body must refuse to issue [^F139 a Type ^F139] certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

_E138

6. —(1) Where the type meets the requirements of these Regulations, the notified body must issue an EU-type examination certificate to the manufacturer, which must contain—

(a) the name and address of the manufacturer;

(b) the conclusions of the examination;

(c) the conditions (if any) for its validity;

(d) all relevant information to allow the conformity of manufactured vessels with the examined type to be evaluated and to allow for in-service control; and

(e) the necessary data for the identification of the approved type.

(2) The EU-type examination certificate referred to in sub-paragraph (1)—

(a) may have one or more annexes attached;

(b) must be accompanied by the descriptions and drawings necessary for identification of the approved type.

(3) Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue an EU-type certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

_E52

7. —(1)[^F140 An approved ^F140] body must keep itself appraised of any changes to the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation and, if so, the [^F133 approved ^F133] body must inform the manufacturer accordingly.

(2) A manufacturer must inform the [^F133 approved ^F133] body that holds the technical documentation relating to the [^F131 Type ^F131] examination certificate of all modifications to the approved type that may affect the conformity of the vessel with the essential safety requirements or the conditions for validity of the certificate; such modifications require additional approval in the form of an addition to the original [^F131 Type ^F131] examination certificate.

_E139

7. —(1) A notified body must keep itself appraised of any changes to the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation and, if so, the notified body must inform the manufacturer accordingly.

(2) A manufacturer must inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the vessel with the essential safety requirements or the conditions for validity of the certificate; such modifications require additional approval in the form of an addition to the original EU-type examination certificate.

_E53

8. —(1) Each [^F133 approved ^F133] body must inform the Secretary of State of all the [^F131 Type ^F131] examination certificates and any additions thereto which it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended, or otherwise restricted.

(2) Each [^F133 approved ^F133] body must inform the other [^F133 approved ^F133] bodies concerning the [^F131 Type ^F131] examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning such certificates and additions thereto which it has issued.

(3)[^F141 An approved ^F141] body must, on request, provide the [^F142 Secretary of State ^F142] and the other [^F133 approved ^F133] bodies, with a copy of the [^F131 Type ^F131] examination certificates and additions thereto which it has issued.

(4)[^F141 An approved ^F141] body must, on request, provide the [^F143 Secretary of State ^F143] with a copy of the technical documentation and the results of the examinations carried out by the [^F133 approved ^F133] body.

(5)[^F141 An approved ^F141] body must keep a copy of the [^F131 Type ^F131] examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

_E140

8. —(1) Each notified body must inform the Secretary of State of all the EU-type examination certificates and any additions thereto which it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended, or otherwise restricted.

(2) Each notified body must inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning such certificates and additions thereto which it has issued.

(3) A notified body must, on request, provide the Commission, the [^F272relevant states^F272] and the other notified bodies, with a copy of the EU-type examination certificates and additions thereto which it has issued.

(4) A notified body must, on request, provide the Commission and the [^F273relevant states^F273] with a copy of the technical documentation and the results of the examinations carried out by the notified body.

(5) A notified body must keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

_E54

9. A manufacturer must keep a copy of the [^F131 Type ^F131] examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authorities for a period of 10 years beginning on the day on which the vessel is placed on the market.

_E141

9. A manufacturer must keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authorities for a period of 10 years beginning on the day on which the vessel is placed on the market.

PART 2 Conformity to type based on internal production control plus supervised vessel testing (Module C1)

_E55

10. Conformity to type based on internal production control plus supervised vessel testing is a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 11 to 13 and it is the manufacturer's sole responsibility to ensure and declare that the vessels concerned are in conformity with the type described in the [^F131 Type ^F131] examination certificate and satisfy the applicable requirements of these Regulations.

_E142

10. Conformity to type based on internal production control plus supervised vessel testing is a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 11 to 13 and it is the manufacturer's sole responsibility to ensure and declare that the vessels concerned are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of these Regulations.

Manufacturing _E56

11. —(1) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the type described in the [^F131 Type ^F131] examination certificate and with the applicable requirements of these Regulations.

(2) Before commencing manufacture, a manufacturer must provide [^F144 an approved ^F144] body of the manufacturer's choice with all necessary information, and in particular—

(a) the technical documentation referred to in paragraph 2(2)(c), together with —

(i) the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;

(ii) the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel; and

(iii) a report on the examination and tests performed;

(b) the inspection document, describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures in respect thereof and the frequency with which they are to be performed; and

(c) the [^F131 Type ^F131] examination certificate.

Manufacturing _E143

11. —(1) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the type described in the EU-type examination certificate and with the applicable requirements of these Regulations.

(2) Before commencing manufacture, a manufacturer must provide a notified body of the manufacturer's choice with all necessary information, and in particular—

(a) the technical documentation referred to in paragraph 2(2)(c), together with —

(i) the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;

(ii) the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel; and

(iii) a report on the examination and tests performed;

(b) the inspection document, describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures in respect thereof and the frequency with which they are to be performed; and

(c) the EU-type examination certificate.

Vessel checks _E57

12. —(1) For each individual type of vessel manufactured, the [^F133 approved ^F133] body must carry out the appropriate examinations and tests in order to verify the conformity of the vessel with the type described in the [^F131 Type ^F131] examination certificate and with the corresponding requirements of these Regulations.

(2) The manufacturer must present the vessels in the form of uniform batches and must take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

(3) When a batch is examined, the [^F133 approved ^F133] body must ensure that the vessels have been manufactured and checked in accordance with the technical documentation, and must perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1.5 times the vessel's design pressure in order to check its strength; the pneumatic test must be subject to acceptance of the test safety procedures by the [^F145 Secretary of State ^F145] .

(4) In order to examine the weld quality, the [^F133 approved ^F133] body must carry out tests on test-pieces taken from, at the choice of the manufacturer, either a production test-piece or from a vessel. The tests must be carried out on longitudinal welds; however, where differing weld techniques are used for longitudinal and circumferential welds, the tests must be repeated on the circumferential welds.

(5) For the vessels subject to the experimental methods referred to in paragraph 17 (experimental method) of Schedule 1, these tests on test-pieces must be replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the essential safety requirements set out in that paragraph.

(6) In the case of accepted batches, the [^F133 approved ^F133] body must affix its identification number, or cause that number to be affixed, to each vessel and must draw up a written certificate of conformity relating to the tests carried out. All vessels in the batch may be placed on the market except for those which have not successfully undergone a hydrostatic test or a pneumatic test.

(7) If a batch is rejected, the [^F133 approved ^F133] body must take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches, the [^F133 approved ^F133] body may suspend the statistical verification.

(8) The manufacturer must be able to supply on request by the relevant authorities the [^F133 approved ^F133] body's certificates of conformity referred to in sub-paragraph (6).

^F146 (9) The [^F133 approved ^F133] body must supply the Secretary of State and, on request, other [^F133 approved ^F133] bodies, ... with a copy of the inspection report issued by it.

(10) The manufacturer must, under the responsibility of the [^F133 approved ^F133] body, affix the [^F133 approved ^F133] body's identification number during the manufacturing process.

(11) In this paragraph, a “batch” of vessels must consist of no more than 3,000 vessels of the model of the same type.

Vessel checks _E144

12. —(1) For each individual type of vessel manufactured, the notified body must carry out the appropriate examinations and tests in order to verify the conformity of the vessel with the type described in the EU-type examination certificate and with the corresponding requirements of these Regulations.

(2) The manufacturer must present the vessels in the form of uniform batches and must take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

(3) When a batch is examined, the notified body must ensure that the vessels have been manufactured and checked in accordance with the technical documentation, and must perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1.5 times the vessel's design pressure in order to check its strength; the pneumatic test must be subject to acceptance of the test safety procedures by the [^F274relevant state^F274] in which the test is performed.

(4) In order to examine the weld quality, the notified body must carry out tests on test-pieces taken from, at the choice of the manufacturer, either a production test-piece or from a vessel. The tests must be carried out on longitudinal welds; however, where differing weld techniques are used for longitudinal and circumferential welds, the tests must be repeated on the circumferential welds.

(5) For the vessels subject to the experimental methods referred to in paragraph 17 (experimental method) of Schedule 1, these tests on test-pieces must be replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the essential safety requirements set out in that paragraph.