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The Recreational Craft Regulations 2017

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Statutory Instruments

2017 No. 737

Consumer Protection

The Recreational Craft Regulations 2017

Made

11th July 2017

Laid before Parliament

12th July 2017

Coming into force

3rd August 2017

The Secretary of State is a Minister designated(1) for the purposes of section 2(2) of the European Communities Act 1972(2) in respect of measures relating to craft intended for recreational purposes.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of EU instruments to be construed as references to those provisions as amended from time to time.

The Secretary of State, in exercise of the powers conferred by section 2(2) of and paragraph 1A of Schedule 2(3) to the European Communities Act 1972, makes the following Regulations.

Modifications etc. (not altering text)

PART 1U.K.GENERAL

Citation and commencementU.K.

1.  These Regulations may be cited as the Recreational Craft Regulations 2017 and come into force on 3rd August 2017 (“the commencement date”).

Commencement Information

I1Reg. 1 in force at 3.8.2017, see reg. 1

InterpretationE+W+S

2.—(1) In these Regulations—

“the 1987 Act” means the Consumer Protection Act 1987(4);

F1...

F2...

“adaptor” means a person who adapts an engine for use in watercraft;

[F3“approved body” has the meaning given to it in regulation 55 (approved bodies);]

“authorised representative” means a person appointed in accordance with regulation 39;

F4...

“Commission” means the Commission of the European Union;

F5...

“components” means the components of watercraft listed in Schedule 2 when placed on the F6... market separately and when intended for installation in watercraft;

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

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

[F7“declaration of conformity” means the declaration required to be drawn up in accordance with regulation 10;

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

F8...

the “Directive” means Directive 2013/53/EU of the European Parliament and of the Council on recreational craft and personal watercraft repealing Directive 94/25/EC(6) [F9(as it had effect immediately before IP completion day)];

“distributor” means a person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

“district council” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972(7);

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

“enforcing authority” means any person enforcing these Regulations under regulation 66;

“engine family” means the manufacturer’s grouping of engines which, through their design, have similar exhaust or noise emission characteristics;

“essential requirements” means the requirements set out in regulation 6;

F10...

F11...

“hull length” means the length of the hull measured in accordance with the [F12designated] standard;

[F13 “importer” means a person who—

(a)

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

(b)

is established in Northern Ireland and places a product on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;]

“major craft conversion” means a conversion of a watercraft which—

(a)

changes the means of propulsion of the watercraft;

(b)

involves a major engine modification; or

(c)

alters the watercraft to such an extent that it may not meet the applicable essential requirements;

“major engine modification” means the modification of a propulsion engine which—

(a)

could potentially cause the engine to exceed the emissions limits set out in Part B of Schedule 1; or

(b)

increases the rated power of the engine by more than 15%;

“making available on the market” means any supply for distribution, consumption or use on the [F14market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge and related expressions must be construed accordingly;

“manufacturer” means a person who—

(a)

manufactures a product or has such a product designed or manufactured; and

(b)

markets that product under that person’s name or trademark;

“market surveillance authority” has the meaning set out in regulation 65 (designation of market surveillance authorities);

“means of propulsion” means the method by which the watercraft is propelled;

F15...

F16...

“personal watercraft” means a watercraft intended for sports and leisure purposes of less than 4 metres in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull;

“placing on the market” means the first making available of a product on the [F17market of Great Britain], and related expressions are to be construed accordingly;

[F18“private importer” means a person who—

(a)

is established in the United Kingdom; and

(b)

imports in the course of a non-commercial activity a watercraft from a country outside of the United Kingdom into the United Kingdom with the intention of putting it into service for the person's own use;]

“product” means a product to which these Regulations apply, in accordance with regulation 3;

“propulsion engine” means any spark or compression ignition internal combustion engine used directly or indirectly for propulsion purposes;

“putting into service” means the first use of a product in the [F19market of Great Britain] by its end-user and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93(9);

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

“recreational craft” means any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2.5 metres to 24 metres, regardless of the means of propulsion;

“relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 42 (applicable conformity assessment procedures);

“small or medium-sized enterprise” has the same meaning as in Commission Recommendation 2003/361/EC(10);

“technical documentation” has the meaning given in regulation 9 (technical documentation and conformity assessment);

[F20“technical specification” means a document that prescribes technical requirements to be fulfilled by a product;

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

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

“watercraft” means any recreational craft or personal watercraft;

“watercraft built for own use” means any watercraft predominantly built by its future user for that user’s own use; and

“withdrawal” means any measure aimed at preventing a watercraft in the supply chain from being made available on the market and related expressions must be construed accordingly.

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

(a)the product is in conformity with the essential requirements;

(b)each economic operator has complied with the obligations imposed on them by Part 2 of these Regulations which must be satisfied at or before the time at which the product is made available on the market.

(3) In these Regulations, except regulation 34 (monitoring) and Schedule 1, “risk” means a risk to—

(a)human health;

(b)the safety of consumers; or

(c)the environment.

F21(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F21(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I2Reg. 2 in force at 3.8.2017, see reg. 1

InterpretationN.I.

2.—(1) In these Regulations—

“the 1987 Act” means the Consumer Protection Act 1987(4);

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

“accreditation certificate” means a certificate, issued by the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) or a national accreditation body of another [F230relevant state], attesting that a conformity assessment body meets the notified body requirements;

“adaptor” means a person who adapts an engine for use in watercraft;

“authorised representative” means a person appointed in accordance with regulation 39;

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

“Commission” means the Commission of the European Union;

“competent national authority” means an authority having responsibility for enforcing the law of a [F231relevant state] which implements the Directive;

“components” means the components of watercraft listed in Schedule 2 when placed on the EU market separately and when intended for installation in watercraft;

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

“conformity assessment body” means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

“Decision 768/2008” means Decision No. 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products(5);

the “Directive” means Directive 2013/53/EU of the European Parliament and of the Council on recreational craft and personal watercraft repealing Directive 94/25/EC(6);

“distributor” means a person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

“district council” means a district council within the meaning of the Local Government Act (Northern Ireland) 1972(7);

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

“enforcing authority” means any person enforcing these Regulations under regulation 66;

“engine family” means the manufacturer’s grouping of engines which, through their design, have similar exhaust or noise emission characteristics;

“essential requirements” means the requirements set out in regulation 6;

“EU declaration of conformity” means the declaration required to be drawn up in accordance with regulation 10(1)(a) (EU declaration of conformity and CE marking);

“harmonised standard” has the meaning set out in paragraph (c) of Article 2(1) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council 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 1673/2006/EC of the European Parliament and of the Council(8) (as amended from time to time);

“hull length” means the length of the hull measured in accordance with the harmonised standard;

“importer” means a person who—

(a)

is established within the [F232relevant market], and

(b)

places a product from a [F233market outside of the relevant market on the relevant] market;

“major craft conversion” means a conversion of a watercraft which—

(a)

changes the means of propulsion of the watercraft;

(b)

involves a major engine modification; or

(c)

alters the watercraft to such an extent that it may not meet the applicable essential requirements;

“major engine modification” means the modification of a propulsion engine which—

(a)

could potentially cause the engine to exceed the emissions limits set out in Part B of Schedule 1; or

(b)

increases the rated power of the engine by more than 15%;

“making available on the market” means any supply for distribution, consumption or use on the [F234relevant] 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—

(a)

manufactures a product or has such a product designed or manufactured; and

(b)

markets that product under that person’s name or trademark;

“market surveillance authority” has the meaning set out in regulation 65 (designation of market surveillance authorities);

“means of propulsion” means the method by which the watercraft is propelled;

“national accreditation body” means national accreditation body as defined in point 11 of Article 2 of RAMS) (as amended from time to time);

[F235“NI Protocol obligation” means any obligation created or arising by or under the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement, whether or not an obligation to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies;]

“notified body requirements” means the requirements set out in Schedule 11;

“personal watercraft” means a watercraft intended for sports and leisure purposes of less than 4 metres in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull;

“placing on the market” means the first making available of a product on the [F236relevant] market, and related expressions are to be construed accordingly;

“private importer” means a person established within the [F237relevant market] who imports in the course of a non-commercial activity a watercraft from a [F238market outside of the relevant market into the relevant market] with the intention of putting it into service for that person’s own use;

“product” means a product to which these Regulations apply, in accordance with regulation 3;

“propulsion engine” means any spark or compression ignition internal combustion engine used directly or indirectly for propulsion purposes;

“putting into service” means the first use of a product in the [F239relevant] market by its end-user and related expressions are to be construed accordingly;

“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93(9);

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

“recreational craft” means any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2.5 metres to 24 metres, regardless of the means of propulsion;

“relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 42 (applicable conformity assessment procedures);

[F240“relevant market” means—

(a)

the market in Northern Ireland; and

(b)

the market of the EEA states;]

[F240“relevant state” means—

(a)

Northern Ireland; or

(b)

any EEA state;]

“small or medium-sized enterprise” has the same meaning as in Commission Recommendation 2003/361/EC(10);

“technical documentation” has the meaning given in regulation 9 (technical documentation and conformity assessment);

[F241“technical specification” means a document that prescribes the technical requirements to be fulfilled by a product;

“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;]

“watercraft” means any recreational craft or personal watercraft;

“watercraft built for own use” means any watercraft predominantly built by its future user for that user’s own use; and

“withdrawal” means any measure aimed at preventing a watercraft in the supply chain from being made available on the market and related expressions must be construed accordingly.

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

(a)the product is in conformity with the essential requirements;

(b)each economic operator has complied with the obligations imposed on them by Part 2 of these Regulations which must be satisfied at or before the time at which the product is made available on the market.

(3) In these Regulations, except regulation 34 (monitoring) and Schedule 1, “risk” means a risk to—

(a)human health;

(b)the safety of consumers; or

(c)the environment.

F242(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) In these Regulations (except in Part 4 (notification of conformity assessment bodies) and Schedule 11 (notified body requirements) and 12 (obligations of notified bodies)), “notified body” means—

(a)a notified body within the meaning set out in regulation 55 (notified body); or

(b)a notified body under the laws of any other [F243relevant state] which implement the Directive.

Extent Information

E52This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I142Reg. 2 in force at 3.8.2017, see reg. 1

[F22Designated standardE+W+S

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 [F23or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

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

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

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

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

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

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

(3) For the purposes of this regulation, a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[F24(3A) In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

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

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F25such] technical specifications adopted by the other recognised standardisation bodies [F26or by international standardising bodies as the Secretary of State considers to be relevant.].

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

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

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

(9) Regulations made under paragraph (8) are to be made by statutory instrument.

(10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

ScopeU.K.

3.—(1) Subject to regulation 4 (exclusions) these Regulations apply to the following products—

(a)recreational craft and partly completed recreational craft;

(b)personal watercraft and partly completed personal watercraft;

(c)components;

(d)propulsion engines which are installed or specifically intended for installation on or in watercraft;

(e)propulsion engines installed on or in watercraft that are subject to a major engine modification;

(f)watercraft that have been subject to major craft conversion.

(2) A watercraft that can also be used for charter or for sports and leisure training is covered by these Regulations when it is placed on the market for recreational purposes.

Commencement Information

I3Reg. 3 in force at 3.8.2017, see reg. 1

ExclusionsU.K.

4.—(1) The design and construction requirements set out in Part A of Schedule 1 do not apply to the following watercraft—

(a)watercraft intended solely for racing, including rowing racing boats and training boats, labelled as such by the manufacturer;

(b)canoes and kayaks designed to be propelled solely by human power, gondolas and pedalos;

(c)surfboards designed to be propelled by wind and to be operated by a person or persons standing;

(d)other surfboards;

(e)original historical watercraft and individual replicas thereof designed before 1950 built predominantly with the original materials and labelled as such by the manufacturer;

(f)experimental watercraft, unless they are placed on the market;

(g)watercraft built for own use, provided that such watercraft are not subsequently placed on the [F27EU] market for a period of five years beginning with the date on which the watercraft was put into service;

(h)watercraft specifically intended to be crewed and to carry passengers for commercial purposes, except when they fall within regulation 3(2), regardless of the number of passengers;

(i)submersibles;

(j)air cushion vehicles;

(k)hydrofoils;

(l)external combustion steam powered watercraft, fuelled by coal, coke, wood, oil or gas;

(m)amphibious vehicles, that is to say wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land.

(2) The exhaust emission requirements set out in Part B of Schedule 1 do not apply to the following—

(a)propulsion engines installed or specifically intended for installation in the following products—

(i)watercraft intended solely for racing and labelled as such by the manufacturer;

(ii)experimental watercraft, unless they are placed on the market;

(iii)watercraft specifically intended to be crewed and to carry passengers for commercial purposes, except when they fall within regulation 3(2) regardless of the number of passengers;

(iv)submersibles;

(v)air cushion vehicles;

(vi)hydrofoils;

(vii)amphibious vehicles, that is to say wheeled or track-laying motor vehicles, which are able to operate on water and on solid land;

(b)original historical propulsion engines and individual replicas thereof, which are based on a pre-1950 design, not produced in series and fitted on watercraft referred to in paragraph 4(1)(e) or paragraph 4(1)(h) above;

(c)propulsion engines built for own use provided that such engines are not subsequently placed on the market for a period of five years beginning with the date on which the watercraft was put into service.

(3) The noise emission requirements referred to in Part C of Schedule 1 do not apply to—

(a)any watercraft referred to in paragraph (2); and

(b)watercraft built for own use, provided that they are not placed on the market for a period of five years beginning with the date on which the watercraft was put into service.

Textual Amendments

Commencement Information

I4Reg. 4 in force at 3.8.2017, see reg. 1

Exhibition at trade fairsU.K.

5.  Nothing in these Regulations prevents the showing of a watercraft which does not comply with Part 2 of these Regulations at a trade fair, exhibition or demonstration, provided that a visible sign clearly indicates —

(a)that the product is not in conformity with Part 2 of these Regulations; and

(b)that the product will not be made available on the market or be put into service until it has been brought into conformity.

Commencement Information

I5Reg. 5 in force at 3.8.2017, see reg. 1

PART 2U.K.PLACING PRODUCTS ON THE MARKET

Essential requirementsU.K.

6.  A person may only make a product available on the market or put it into service if that product—

(a)complies with the requirements in Schedule 1; and

(b)does not endanger the health and safety of persons, property or the environment when correctly maintained and used in accordance with its intended purpose.

Commencement Information

I6Reg. 6 in force at 3.8.2017, see reg. 1

Making available and putting into serviceE+W+S

7.—(1) Nothing in these Regulations prevents a person making available in the United Kingdom or putting into service in the United Kingdom—

(a)any watercraft in conformity with Part 2;

(b)any component which is in conformity with Part 2 and which is intended to be incorporated into any watercraft in accordance with the declaration completed by a manufacturer or importer in accordance with Schedule 3;

(c)any of the following propulsion engines—

(i)engines, whether or not installed in watercraft, that are in conformity with Part 2;

F28(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)engines installed in watercraft and type-approved in accordance with Regulation (EC) No 595/2009(12) on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC complying with these Regulations, with the exclusion of the exhaust emission requirements set out in Part B of Schedule 1.

(2) Where an engine is adapted for installation in a watercraft, a person who so adapts that engine must—

(a)make a declaration, in accordance with Schedule 3, that the adapted engine will continue to meet the emission requirements of F29... Regulation 595/2009, when installed in accordance with the installation instructions the adaptor has provided; and

(b)take full account of the data and other information available from the manufacturer, so that, when the adapted engine is installed in accordance with the installation instructions the adaptor provides, the adapted engine continues to meet the exhaust emission requirements in F30... the Regulation referred to in paragraph (a), whichever is referred to in the declaration submitted in accordance with Schedule 3.

(3) Nothing in these Regulations prevents the making available in the United Kingdom of any partly completed watercraft where the manufacturer or the importer has declared, in accordance with Schedule 3, that the craft complies with the essential requirements at this stage in its construction and that the craft will be completed by others in full compliance with these Regulations.

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I7Reg. 7 in force at 3.8.2017, see reg. 1

Making available and putting into serviceN.I.

7.—(1) Nothing in these Regulations prevents a person making available in [F244Northern Ireland] or putting into service in [F244Northern Ireland]—

(a)any watercraft in conformity with Part 2;

(b)any component which is in conformity with Part 2 and which is intended to be incorporated into any watercraft in accordance with the declaration completed by a manufacturer or importer in accordance with Schedule 3;

(c)any of the following propulsion engines—

(i)engines, whether or not installed in watercraft, that are in conformity with Part 2;

(ii)engines installed in watercraft and type-approved in accordance with Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery(11), which comply with—

(aa)stage III A or stage III B or stage IV emission limits for C1 engines, used in other applications than the propulsion of inland waterway vessels, locomotives and railcars, as provided for in point 4.1.2 of Annex I of Directive 97/68/EC; and

(bb)these Regulations, with the exclusion of the exhaust emission requirements set out in Part B of Schedule 1;

(iii)engines installed in watercraft and type-approved in accordance with Regulation (EC) No 595/2009(12) on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC complying with these Regulations, with the exclusion of the exhaust emission requirements set out in Part B of Schedule 1.

(2) Where an engine is adapted for installation in a watercraft, a person who so adapts that engine must—

(a)make a declaration, in accordance with Schedule 3, that the adapted engine will continue to meet the emission requirements of either Directive 97/68/EC or Regulation 595/2009, when installed in accordance with the installation instructions the adaptor has provided; and

(b)take full account of the data and other information available from the manufacturer, so that, when the adapted engine is installed in accordance with the installation instructions the adaptor provides, the adapted engine continues to meet the exhaust emission requirements in either the Directive or the Regulation referred to in paragraph (a), whichever is referred to in the declaration submitted in accordance with Schedule 3.

(3) Nothing in these Regulations prevents the making available in [F244Northern Ireland] of any partly completed watercraft where the manufacturer or the importer has declared, in accordance with Schedule 3, that the craft complies with the essential requirements at this stage in its construction and that the craft will be completed by others in full compliance with these Regulations.

Extent Information

E53This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I143Reg. 7 in force at 3.8.2017, see reg. 1

MANUFACTURERSU.K.

Duty to ensure products comply with the essential requirementsU.K.

8.  Before placing a product on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Commencement Information

I8Reg. 8 in force at 3.8.2017, see reg. 1

Technical documentation and conformity assessmentU.K.

9.  Before placing a product on the market a manufacturer must—

(a)have a relevant conformity assessment procedure carried out; and

(b)draw up—

(i)the technical documentation referred to in Schedule 9; and

(ii)any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the product complies with the essential requirements.

Commencement Information

I9Reg. 9 in force at 3.8.2017, see reg. 1

[F31Declaration of conformity and UK markingE+W+S

10.—(1) Where the conformity of a product with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—

(a)draw up a declaration of conformity in accordance with regulation 53; and

(b)affix the UK marking in accordance with regulation 54.

(2) The declaration of conformity must follow the format set out in Schedule 4.

(3) But where a declaration of conformity relates to a partly-completed watercraft, the declaration must follow the format set out in Schedule 3.

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

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

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU declaration of conformity and CE markingN.I.

10.—(1) Where the conformity of a product with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—

(a)draw up the EU declaration of conformity in accordance with regulation 53 (EU declaration of conformity); and

(b)affix the CE marking to the product in accordance with regulation 54 (CE marking).

(2) The EU declaration of conformity must follow the format set out in Schedule 4 (EU Declaration of conformity), and be translated into a language required by the [F245relevant state] where the product will be made available or put into service, unless paragraph (3) applies.

(3) If an EU declaration of conformity relates to a partly completed watercraft, that declaration must follow the format set out in Schedule 3 and be translated into a language required by the [F245relevant state] where the partly completed watercraft will be made available or put into service.

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

(5) Where a product is subject to more than one [F246NI Protocol obligation] requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity, which—

(a)identifies all of the applicable EU instruments; and

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

Extent Information

E54This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I144Reg. 10 in force at 3.8.2017, see reg. 1

Duty of manufacturers to retain technical documentation and [F32EU] declaration of conformityU.K.

11.  A manufacturer must keep the technical documentation and the [F33EU] declaration of conformity drawn up in respect of a product for a period of 10 years beginning with the day on which the product is placed on the market.

Textual Amendments

Commencement Information

I10Reg. 11 in force at 3.8.2017, see reg. 1

Compliance procedures for series productionE+W+S

12.—(1) The manufacturer of a product which is manufactured by series production must ensure that, before placing the product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with the manufacturer’s obligations under Part 2.

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

(a)any changes in the design or characteristics of a product; and

(b)any changes in the [F34designated] standard or in another technical specification by reference to which the F35... declaration of conformity of the product was drawn up.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I11Reg. 12 in force at 3.8.2017, see reg. 1

Compliance procedures for series productionN.I.

12.—(1) The manufacturer of a product which is manufactured by series production must ensure that, before placing the product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with the manufacturer’s obligations under Part 2.

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

(a)any changes in the design or characteristics of a product; and

(b)any changes in the harmonised standard or in another technical specification by reference to which the EU declaration of conformity of the product was drawn up.

Extent Information

E55This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I145Reg. 12 in force at 3.8.2017, see reg. 1

Duty of manufacturers to ensure products are labelledU.K.

13.—(1) Before placing a product on the market, a manufacturer must indicate on the product—

(a)a type, batch or serial number; or

(b)another element which identifies the manufacturer as the manufacturer of the product;

(2) Where, in the case of a component, it is not possible to indicate the information on the component because of the size or nature of the component, the manufacturer must provide the information specified in paragraph (1)—

(a)on the packaging; or

(b)in a document accompanying the component.

Commencement Information

I12Reg. 13 in force at 3.8.2017, see reg. 1

Duty to provide informationU.K.

14.—(1) Before placing a product on the market, a manufacturer must ensure that the product is labelled with—

(a)the manufacturer’s name;

(b)their registered trade name or registered trade mark; and

(c)an address, which is the single point at which they can be contacted.

[F36(2) Where it is not possible to provide the information referred to in paragraph (1) on the product, the manufacturer must ensure that the information is provided—

(a)on the packaging; or

(b)in a document accompanying the product.]

Textual Amendments

Commencement Information

I13Reg. 14 in force at 3.8.2017, see reg. 1

Instructions and safety informationE+W+S

15.—(1) When placing a product on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in [F37English].

F38(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I14Reg. 15 in force at 3.8.2017, see reg. 1

Instructions and safety informationN.I.

15.—(1) When placing a product on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users in the [F247relevant state] in which the product is to be made available.

(2) When the product is being made available to consumers and other end-users in [F248Northern Ireland], that language which can be easily understood is English.

Extent Information

E56This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I146Reg. 15 in force at 3.8.2017, see reg. 1

Duty to take action in respect of product placed on the market which is considered not to be in conformityE+W+S

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

(a)bring the product into conformity;

(b)withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority F39... of the risk, giving details of—

(a)the reason why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I15Reg. 16 in force at 3.8.2017, see reg. 1

Duty to take action in respect of product placed on the market which is considered not to be in conformityN.I.

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

(a)bring the product into conformity;

(b)withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority and the competent national authorities in any [F249relevant state] in which the manufacturer has made the product available on the market of the risk, giving details of—

(a)the reason why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Extent Information

E57This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I147Reg. 16 in force at 3.8.2017, see reg. 1

Provision of information and co-operationU.K.

17.—(1) A manufacturer must, following a reasoned request from an enforcing authority, provide it with all of the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Part.

(2) The information and documentation referred to in paragraph (1) must be in a language that can be easily understood by the enforcing authority.

(3) The manufacturer must, at the request of the enforcing authority, co-operate with the authority on any action taken to eliminate the risks posed by a product that the manufacturer has placed on the market.

Commencement Information

I16Reg. 17 in force at 3.8.2017, see reg. 1

IMPORTERSU.K.

Prohibition on placing products on the marketU.K.

18.  An importer must not place a product on the market unless it complies with the essential requirements.

Commencement Information

I17Reg. 18 in force at 3.8.2017, see reg. 1

Requirements that must be satisfied before an importer places a product on the marketE+W+S

19.—(1) Before placing a product on the market an importer must ensure that—

(a)a relevant conformity assessment [F40procedure] has been carried out by the manufacturer;

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

(c)the product—

(i)bears the [F41UK] marking; and

(ii)is accompanied by the required documents; and;

(d)the manufacturer has complied with the requirements of regulations 13 (duty of manufacturers to ensure products are labelled) and 14 (duty to provide information).

(2) In paragraph (1)(c)(ii) “required documents” means—

(a)the F42... declaration of conformity; and

(b)the owner’s manual referred to in Schedule 1.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I18Reg. 19 in force at 3.8.2017, see reg. 1

Requirements that must be satisfied before an importer places a product on the marketN.I.

19.—(1) Before placing a product on the market an importer must ensure that—

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

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

(c)the product—

(i)bears the CE marking; and

(ii)is accompanied by the required documents; and;

(d)the manufacturer has complied with the requirements of regulations 13 (duty of manufacturers to ensure products are labelled) and 14 (duty to provide information).

(2) In paragraph (1)(c)(ii) “required documents” means—

(a)the EU declaration of conformity; and

(b)the owner’s manual referred to in Schedule 1.

Extent Information

E58This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I148Reg. 19 in force at 3.8.2017, see reg. 1

Duty not to place a product on the market where an importer suspects that it is not in conformityU.K.

20.—(1) Where an importer believes or has reason to believe that a product is not in conformity with the essential requirements, the importer must not place the product on the market.

(2) Where a product presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Commencement Information

I19Reg. 20 in force at 3.8.2017, see reg. 1

Duty of importer to ensure products are labelledE+W+S

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

(a)the importer’s name, registered trade name or registered trade mark; and

(b)the address at which they can be contacted.

[F43(2) Paragraph (1) does not apply where—

(a)either—

(i)in the case of a component, it is not possible to indicate the information specified in paragraph (1) on the component, or

(ii)the importer has imported the product from an EEA state and places it on the market within the period of [F44seven years] beginning with IP completion day, and

(b)before placing the product on the market, the importer indicates the information specified in paragraph (1)—

(i)in the case of component, in a document accompanying the product or on the packaging; or

(ii)in all other cases, in a document accompanying the product.]

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I20Reg. 21 in force at 3.8.2017, see reg. 1

Duty of importer to ensure products are labelledN.I.

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

(a)the importer’s name, registered trade name or registered trade mark; and

(b)the address at which they can be contacted.

(2) Where, in the case of components, it is not possible to indicate the information on the component, the importer must indicate the information specified in paragraph (1)—

(a)on the packaging; or

(b)in a document accompanying the component.

Extent Information

E59This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I149Reg. 21 in force at 3.8.2017, see reg. 1

Instructions and safety informationE+W+S

22.—(1) When placing a product on the market, an importer must ensure that it is accompanied by instructions and safety information in [F45English].

F46(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I21Reg. 22 in force at 3.8.2017, see reg. 1

Instructions and safety informationN.I.

22.—(1) When placing a product on the market, an importer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users in the [F250relevant state] in which the product is to be made available.

(2) When the product is being made available to consumers and other end-users in [F251Northern Ireland], the language which can be easily understood by consumers and other end-users is English.

Extent Information

E60This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I150Reg. 22 in force at 3.8.2017, see reg. 1

Storage and transportU.K.

23.  An importer must ensure that, while a product is the importer’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential requirements.

Commencement Information

I22Reg. 23 in force at 3.8.2017, see reg. 1

Duty to take action in respect of product placed on the market which is considered not to be in conformityE+W+S

24.—(1) An importer who considers or has reason to believe that a product 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 product into conformity;

(b)to withdraw the product from the market; or

(c)recall it, if appropriate.

(2) Where the product presents a risk, the importer must immediately inform the market surveillance authority F47... of the risk, giving details of—

(a)the reason or reasons why the product is not considered to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I23Reg. 24 in force at 3.8.2017, see reg. 1

Duty to take action in respect of product placed on the market which is considered not to be in conformityN.I.

24.—(1) An importer who considers or has reason to believe that a product 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 product into conformity;

(b)to withdraw the product from the market; or

(c)recall it, if appropriate.

(2) Where the product presents a risk, the importer must immediately inform the market surveillance authority and the competent national authorities of any other [F252relevant state] in which the importer has made the product available on the market of the risk, giving details of—

(a)the reason or reasons why the product is not considered to be in conformity with Part 2; and

(b)any corrective measures taken.

Extent Information

E61This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I151Reg. 24 in force at 3.8.2017, see reg. 1

Duty of importers to retain technical documentation and [F48EU] declaration of conformityU.K.

25.  An importer must, for the period of 10 years beginning on the day on which the product is placed on the market—

(a)keep a copy of the [F49EU] declaration of conformity at the disposal of the market surveillance authorities; and

(b)ensure that the technical documentation relating to that product can be made available to the market surveillance authorities upon request.

Textual Amendments

Commencement Information

I24Reg. 25 in force at 3.8.2017, see reg. 1

Provision of information and co-operationU.K.

26.—(1) An importer must, following a reasoned request from an enforcing authority, provide it with all of the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Part.

(2) The information and documentation referred to in paragraph (1) must be in a language that can be easily understood by the enforcing authority.

(3) The importer must, at the request of the enforcing authority, co-operate with that authority on any action taken to eliminate the risks posed by a product that the importer has placed on the market.

Commencement Information

I25Reg. 26 in force at 3.8.2017, see reg. 1

DISTRIBUTORSU.K.

Duty to act with due careU.K.

27.  When making a product available on the market, a distributor must act with due care to ensure the conformity of that product with Part 2.

Commencement Information

I26Reg. 27 in force at 3.8.2017, see reg. 1

Making available on the marketE+W+S

28.—(1) Before making a product available on the market, a distributor must verify that—

(a)the product—

(i)bears the [F50UK] marking;

(ii)is accompanied by the required documents;

(iii)is accompanied by the instructions and safety information in [F51English]; and

(b)the manufacturer has complied with the requirements of—

(i)regulation 13 (duty of manufacturers to ensure products are labelled); and

(ii)regulation 14 (duty to provide information); and

(c)the importer has complied with the requirements of regulation 21 (duty of importers to ensure products are labelled).

(2) For the purposes of this regulation “required documents” has the same meaning as in regulation 19(2) (requirements that must be satisfied before an importer places a product on the market).

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I27Reg. 28 in force at 3.8.2017, see reg. 1

Making available on the marketN.I.

28.—(1) Before making a product available on the market, a distributor must verify that—

(a)the product—

(i)bears the CE marking;

(ii)is accompanied by the required documents;

(iii)is accompanied by the instructions and safety information in a language that can be easily understood by consumers and other end-users in the [F253relevant state] in which the product is to be made available on the market; and

(b)the manufacturer has complied with the requirements of—

(i)regulation 13 (duty of manufacturers to ensure products are labelled); and

(ii)regulation 14 (duty to provide information); and

(c)the importer has complied with the requirements of regulation 21 (duty of importers to ensure products are labelled).

(2) For the purposes of this regulation “required documents” has the same meaning as in regulation 19(2) (requirements that must be satisfied before an importer places a product on the market).

Extent Information

E62This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I152Reg. 28 in force at 3.8.2017, see reg. 1

Duty not to [F52make a product available] on the market where a distributor suspects that it is not in conformityE+W+S

29.—(1) Where a distributor considers or has reason to believe that a product is not in conformity with the essential requirements, the distributor must not [F53make the product available] on the market.

(2) Where a product presents a risk, the distributor must inform the manufacturer or importer, and the market surveillance authority F54... of that risk.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I28Reg. 29 in force at 3.8.2017, see reg. 1

Duty not to [F254make a product available] on the market where a distributor suspects that it is not in conformityN.I.

29.—(1) Where a distributor considers or has reason to believe that a product is not in conformity with the essential requirements, the distributor must not [F255make the product available] on the market.

(2) Where a product presents a risk, the distributor must inform the manufacturer or importer, and the market surveillance authority and the competent national authorities of other [F256relevant states] in which the distributor has made the product available on the market of that risk.

Extent Information

E63This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I153Reg. 29 in force at 3.8.2017, see reg. 1

Storage and transportU.K.

30.  A distributor must ensure that, while a product is the distributor’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential requirements.

Commencement Information

I29Reg. 30 in force at 3.8.2017, see reg. 1

Duty to take action in respect of watercraft placed on the market which is considered not to be in conformityE+W+S

31.—(1) A distributor who considers or has reason to believe that a product that the distributor has made available on the market is not in conformity with Part 2 must ensure that corrective measures necessary are taken to—

(a)bring the product into conformity;

(b)to withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the distributor must immediately inform the market surveillance authority F55... of the risk, giving details of—

(a)the reason or reasons why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I30Reg. 31 in force at 3.8.2017, see reg. 1

Duty to take action in respect of watercraft placed on the market which is considered not to be in conformityN.I.

31.—(1) A distributor who considers or has reason to believe that a product that the distributor has made available on the market is not in conformity with Part 2 must ensure that corrective measures necessary are taken to—

(a)bring the product into conformity;

(b)to withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the distributor must immediately inform the market surveillance authority and the competent national authorities of any other [F257relevant state] in which the distributor has made the product available on the market of the risk, giving details of—

(a)the reason or reasons why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Extent Information

E64This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I154Reg. 31 in force at 3.8.2017, see reg. 1

Provision of information and co-operationU.K.

32.—(1) A distributor must, following a reasoned request from an enforcing authority, provide it with all of the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Part.

(2) The information and documentation referred to in paragraph (1) must be in a language that can be easily understood by the enforcing authority.

(3) The distributor must, at the request of the enforcing authority, co-operate with the authority on any action taken to eliminate the risks posed by a product that the distributor has made available F56... on the market.

Textual Amendments

Commencement Information

I31Reg. 32 in force at 3.8.2017, see reg. 1

IMPORTERS AND DISTRIBUTORSU.K.

Cases in which the obligations of manufacturers apply to importers and distributorsU.K.

33.  An importer or a distributor (“A”) who—

(a)places a product on the market under A’s own name or trademark; or

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

is to be treated as the manufacturer of that product for the purposes of these Regulations and must comply with the obligations of a manufacturer set out in this Part.

Commencement Information

I32Reg. 33 in force at 3.8.2017, see reg. 1

MANUFACTURERS AND IMPORTERSU.K.

MonitoringU.K.

34.—(1) Where appropriate with regard to the risks presented by the product to the health and safety of consumers the manufacturer or the importer must carry out monitoring to protect the health and safety of consumers by—

(a)carrying out sample testing of a product made available on the market;

(b)investigate any complaint that a product is not in conformity with Part 2; and

(c)keep a register of—

(i)complaints;

(ii)products that are not in conformity; and

(iii)the recall of any product.

(2) The manufacturer or the importer must keep distributors informed of monitoring carried out under this regulation.

(3) 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.

Commencement Information

I33Reg. 34 in force at 3.8.2017, see reg. 1

Translation of EU declaration of conformityN.I.

35.—[F57(1) For the purposes of regulation 10(2) and (3), where the product is to be made available on the market in [F58Northern Ireland], the language required is English.]

Textual Amendments

Commencement Information

I34Reg. 35 in force at 3.8.2017, see reg. 1

PRIVATE IMPORTERS AND ECONOMIC OPERATORSU.K.

Private importersE+W+S

36.—(1) If a manufacturer has not complied with the manufacturer’s obligations under this Part, a private importer must ensure, before putting a product into service, that—

(a)the product has been designed and manufactured in accordance with the essential requirements; and

(b)the obligations of the manufacturer under the following regulations have been met or carried out in relation to the product—

(i)regulation 9 (technical documentation and conformity assessment);

(ii)regulation 10 [F59(declaration of conformity and UK marking)];

(iii)regulation 11 (duty of manufacturers to retain technical documentation and F60... declaration of conformity); and

(iv)regulation 22 (instructions and safety information).

(2) A private importer must also carry out or have carried out any obligation to provide information and co-operation imposed on a manufacturer pursuant to regulation 17 (provision of information and co-operation).

(3) Where the technical documentation is not available from the manufacturer, a private importer must have this documentation drawn up using appropriate expertise.

(4) The private importer must ensure that the name and postal address of the [F61approved] body that carried out the relevant conformity assessment procedure in relation to the product under regulation 9(1)(a) is marked on the product.

Extent Information

E14This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I35Reg. 36 in force at 3.8.2017, see reg. 1

Private importersN.I.

36.—(1) If a manufacturer has not complied with the manufacturer’s obligations under this Part, a private importer must ensure, before putting a product into service, that—

(a)the product has been designed and manufactured in accordance with the essential requirements; and

(b)the obligations of the manufacturer under the following regulations have been met or carried out in relation to the product—

(i)regulation 9 (technical documentation and conformity assessment);

(ii)regulation 10 (EU declaration of conformity and CE marking);

(iii)regulation 11 (duty of manufacturers to retain technical documentation and EU declaration of conformity); and

(iv)regulation 22 (instructions and safety information).

(2) A private importer must also carry out or have carried out any obligation to provide information and co-operation imposed on a manufacturer pursuant to regulation 17 (provision of information and co-operation).

(3) Where the technical documentation is not available from the manufacturer, a private importer must have this documentation drawn up using appropriate expertise.

(4) The private importer must ensure that the name and postal address of the notified body that carried out the relevant conformity assessment procedure in relation to the product under regulation 9(1)(a) is marked on the product.

Extent Information

E65This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I155Reg. 36 in force at 3.8.2017, see reg. 1

Identification of economic operatorsU.K.

37.—(1) An economic operator (“E”) who receives a request 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 economic operator who has supplied E with a product; and

(b)any economic operator to whom E has supplied a product.

(2) The relevant period is—

(a)for information under paragraph (1)(a), a period of 10 years beginning on the day on which E was supplied with the product;

(b)for information under paragraph (1)(b) a period of 10 years beginning on the day on which E supplied the product.

Commencement Information

I36Reg. 37 in force at 3.8.2017, see reg. 1

Obligations on private importers to identify economic operatorsU.K.

38.—(1) A private importer who receives a request from the market surveillance authority before the end of the relevant period, must, within such period as the market surveillance authority may specify, identify to the market surveillance authority any economic operator which has supplied the private importer with a product.

(2) The relevant period is a period of 10 years beginning on the day on which the private importer was supplied with a product.

Commencement Information

I37Reg. 38 in force at 3.8.2017, see reg. 1

AUTHORISED REPRESENTATIVESU.K.

Authorised representativesE+W+S

39.—(1) A manufacturer may by written mandate, appoint a person established in the [F62United Kingdom] as their authorised representative to perform specified tasks on their 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 the task.

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

(a)keep a copy of—

(i)the F63... declaration of conformity; and

(ii)the technical documentation referred to in regulation 9 (technical documentation and conformity assessment)

at the disposal of the enforcing authority F64..., for a period of 10 years beginning on the day on which the product is placed on the market;

(b)provide, following a reasoned request from an enforcing authority, all of the information and documentation necessary to demonstrate the conformity of a the product with the essential requirements; and

(c)co-operate with the [F65enforcing authority], upon their request, on any action to eliminate the risks posed by a product covered by their mandate.

(4) The obligations in regulation 8 (duty to ensure watercraft comply with essential requirements) and regulation 9 (technical documentation and conformity assessment) must not form part of an authorised representative’s mandate.

(5) 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—

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

(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

Extent Information

E15This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I38Reg. 39 in force at 3.8.2017, see reg. 1

Authorised representativesN.I.

39.—(1) A manufacturer may by written mandate, appoint a person established in [F258a relevant state] as their authorised representative to perform specified tasks on their 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 the task.

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

(a)keep a copy of—

(i)the EU declaration of conformity; and

(ii)the technical documentation referred to in regulation 9 (technical documentation and conformity assessment)

at the disposal of the enforcing authority and competent national authorities, for a period of 10 years beginning on the day on which the product is placed on the market;

(b)provide, following a reasoned request from an enforcing authority, all of the information and documentation necessary to demonstrate the conformity of a the product with the essential requirements; and

(c)co-operate with the competent national authorities, upon their request, on any action to eliminate the risks posed by a product covered by their mandate.

(4) The obligations in regulation 8 (duty to ensure watercraft comply with essential requirements) and regulation 9 (technical documentation and conformity assessment) must not form part of an authorised representative’s mandate.

(5) 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—

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

(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

Extent Information

E66This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I156Reg. 39 in force at 3.8.2017, see reg. 1

MISCELLANEOUSU.K.

Prohibition on improper use of [F66UK] markingE+W+S

40.—(1) An economic operator must not affix the [F67UK] marking to a product unless—

(a)the economic operator is the manufacturer; and

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

(2) An economic operator must not affix to a product a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F67UK] marking.

(3) An economic operator must not affix to a product any other marking if the visibility, legibility and meaning of the [F67UK] marking would be impaired as a result.

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I39Reg. 40 in force at 3.8.2017, see reg. 1

Prohibition on improper use of CE markingN.I.

40.—(1) An economic operator must not affix the CE marking to a product unless—

(a)the economic operator is the manufacturer; and

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

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

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

Extent Information

E67This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I157Reg. 40 in force at 3.8.2017, see reg. 1

[F68Obligations that are met by complying with obligations in the DirectiveE+W+S

40A.—(1) In this regulation—

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

(b)“CE marking” has the meaning given in Article 3(28);

(c)“harmonised standard” has the meaning given in Article 3(20).

(2) For the purposes of this regulation, references to the requirements set out in Article 4(1) and Annex I are to be read as if they include a requirement that the owner's manuals referred to in point 2.5 of Part A of Annex I and point 4 of Part B of that Annex must be in English (instead of in a language or languages which can be easily understood by consumers and other end-users, as determined by the member State concerned).

(3) Where a product meets the requirements set out in Article 4(1) and Annex I—

(a)the requirements of regulation 6(a) and (b) are to be treated as being satisfied;

(b)regulation 2(2)(a) applies subject to the modification set out in paragraph (15)(c).

(4) Subject to paragraphs (8) and (9), paragraph (5) applies where, before placing a product on the market, the manufacturer—

(a)ensures that the product has been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I;

(b)draws up the technical documentation in accordance with Article 25;

(c)carries out the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 or has it carried out;

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

(e)affixes a CE marking to the product in accordance with Articles 16 to 18;

(f)draws up an EU declaration of conformity in accordance with Article 15; and

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

(5) Where this paragraph applies—

(a)the requirements of regulations 8, 9 and 10(1), (2), (3) and (5) are to be treated as being satisfied;

(b)regulations 10(4), 11, 12(2), 39(3) and 40 apply subject to the modifications set out in paragraph (15);

(c)Part 3 (except for regulations 43(2) and (3) and 48) does not apply;

(d)regulation 71 does not apply.

(6) Subject to paragraphs (8) and (9), paragraph (7) applies where, before placing a product on the market, the importer ensures that—

(a)the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 has been carried out;

(b)the manufacturer has drawn up the technical documentation in accordance with Article 25; and

(c)the product bears the CE marking in accordance with Articles 16 to 18.

(7) Where this paragraph applies—

(a)the requirements of regulation 19(1)(a), (b) and (c)(i) are to be treated as being satisfied;

(b)regulations 18, 19(2), 20, 23 and 25 apply subject to the modifications set out in paragraph (15).

(8) This paragraph applies where there is no designated standard or part of a designated standard that corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 14.

(9) Where paragraph (8) applies, paragraphs (4)(c) and (6)(a) of this regulation are to be read as requiring—

(a)in respect of products referred to in Article 20(1)(b)(i), one of the conformity assessment procedures (combination of procedures) referred to in the second indent of Article 20(1)(b)(i);

(b)in respect of exhaust emissions for products referred to in points (d) and (e) of Article 2(1), one of the conformity assessment procedures (or combinations of procedures) referred to in Article 21(b);

(c)in respect of noise emissions for products referred to in Article 22(1)—

(i)the conformity assessment procedure referred to in Article 22(1)(b); or

(ii)where applicable in accordance with Article 22(1)(c), one of the conformity assessment procedures referred to in Article 22(1)(c);

(d)in respect of noise emissions for products referred to in Article 22(2), the conformity assessment procedure referred to in Article 22(2)(b).

(10) Paragraph (11) applies where, before making a product available on the market, the distributor ensures that the product bears the CE marking in accordance with Articles 16 to 18.

(11) Where this paragraph applies—

(a)the requirement of regulation 28(1)(a)(i) is to be treated as being satisfied;

(b)regulations 19(2) (which contains the definition of “required documents” for the purposes of regulation 28), 29 and 30 apply subject to the modifications set out in paragraph (15).

(12) Paragraph (13) applies where the private importer—

(a)ensures before putting a product into service that the product has been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I; and

(b)ensures that the name and postal address of the notified body that carried out the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 is marked on the product.

(13) Where this paragraph applies, the requirements of regulation 36(1)(a) and 36(4) are to be treated as being satisfied.

(14) Where, before placing a product on the market or putting a product into service, a person applies the procedure referred to in Article 23 to the product, the requirements of regulation 43 are to be treated as being satisfied.

(15) The modifications referred to in paragraphs (3)(b), (5)(b), (7)(b) and (11)(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 “designated standard” is to be read as a reference to a harmonised standard;

(c)any reference to “essential requirements” is to be read as a reference to the requirements set out in Article 4(1) and Annex I (as modified by paragraph (2));

(d)any reference to “UK marking” is to be read as a reference to the CE marking;

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the product in accordance with Articles 19 to 22 and 24;

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Article 25.]

Textual Amendments

[F68Conformity assessment procedure obligation which is met by complying with the DirectiveE+W+S

40B.—(1) In this regulation any reference to an Article or an Annex is a reference to an Article of or Annex to the Directive.

(2) Paragraph (3) applies where—

(a)Articles 20 or 21 provide that the conformity assessment procedure referred to as Module B in those Articles may be carried out in relation to a product; and

(b)prior to the manufacture of a product, the manufacturer ensures that—

(i)the product has been designed in accordance with the essential requirements set out in Annex I to the Directive;

(ii)the conformity assessment procedure referred to as Module B in Articles 20 and 21 has been carried out in relation to that product, in accordance with those Articles and with Article 24(1).

(3) Where this paragraph applies—

(a)the requirement in regulation 42 to apply the conformity assessment procedure referred to in regulations 44 and 45 as Module B is to be treated as being satisfied in relation to that product;

(b)any reference to “relevant conformity assessment procedure” in regulations 9, 10(1), 19(1)(a), 36(4), 40(1)(b) and 53(b) is to be read as including the conformity assessment procedure referred to in Articles 20, 21 and 24 as Module B; and

(c)any reference to “technical documentation” in regulations 9(b), 11, 19(1)(b), 25(b) and 36(3) is to be read as including the technical documentation relating to the design of the product referred to in Article 25 of the Directive;

(d)the reference to “approved body” in regulation 36(4) is to be read as the body that undertook the conformity assessment procedure referred to as Module B in Articles 20 or 21.]

Textual Amendments

[F68 Expiry of regulations 40A and 40BE+W+S

40C.—(1) Subject to paragraph (2), regulation 40A ceases to have effect at the end of the period of [F69four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 40A—

(a)any product which was placed on the market pursuant to regulation 40A may continue to be made available on the market on or after the expiry of regulation 40A;

(b)any obligation to which a person was subject under regulation 40A in respect of a product placed on the market pursuant to regulation 40A continues to have effect after the expiry of regulation 40A, in respect of that product.

(3) Subject to paragraph (4), regulation 40B ceases to have effect at the end of the period of [F70four years] beginning with IP completion day.

(4) Where a conformity assessment procedure has been completed pursuant to regulation 40B in relation to a product prior to the expiry of regulation 40B, regulation 40B continues to apply in respect of that product where—

(a)the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body;

(b)the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and

(c)the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.

(5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after the conformity assessment procedure referred to as Module B in Articles 20 and 21 of the Directive has been carried out in relation to that product, in accordance with Article 24(1) of the Directive.]

Textual Amendments

[F68Qualifying Northern Ireland GoodsE+W+S

40D.—(1) Where paragraph (2) applies a product is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a)a product—

(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 product 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 product;

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

(iii)the product 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;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

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

Textual Amendments

PART 3U.K.CONFORMITY OF THE PRODUCT AND CONFORMITY ASSESSMENT PROCEDURES

Presumption of conformityE+W+S

41.—(1) A product which is in conformity with a [F71designated] standard (or part of such a standard) F72... is to be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).

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

Extent Information

E17This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I40Reg. 41 in force at 3.8.2017, see reg. 1

Presumption of conformityN.I.

41.—(1) A product 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 of the European Union is to be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).

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

Extent Information

E68This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I158Reg. 41 in force at 3.8.2017, see reg. 1

Applicable conformity assessment proceduresE+W+S

42.  Before placing a product on the market the manufacturer must apply the conformity assessment procedures set out in the modules set out in [F73Schedule 15] and referred to in regulations 44 (design and construction) to 47 (noise emissions: personal watercraft).

Extent Information

E18This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I41Reg. 42 in force at 3.8.2017, see reg. 1

Applicable conformity assessment proceduresN.I.

42.  Before placing a product on the market the manufacturer must apply the conformity assessment procedures set out in the modules set out in Annex II of Decision 768/2008 and referred to in regulations 44 (design and construction) to 47 (noise emissions: personal watercraft).

Extent Information

E69This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I159Reg. 42 in force at 3.8.2017, see reg. 1

Duty to carry out the post construction assessmentU.K.

43.—(1) Before putting a product into service a private importer must apply the procedure referred to in regulation 48 (requirements of the post-construction assessment) to that product if the manufacturer of the product has not already carried out the conformity assessment for the product concerned.

(2) Any person must, before placing or putting into service on the market—

(a)a propulsion engine or watercraft which has had a major engine modification or major craft conversion; or

(b)a watercraft which has had a change in its intended purpose so that it falls within scope of these Regulations

apply the procedure referred to in regulation 48 (requirements of the post-construction assessment).

(3) Any person placing on the market a watercraft built for own use before the end of the five-year period beginning on the day on which the watercraft was put into service, must apply the procedure referred to in regulation 48 before placing the watercraft on the market.

Commencement Information

I42Reg. 43 in force at 3.8.2017, see reg. 1

Design and constructionE+W+S

44.—(1) With regard to the design and construction of recreational craft, the following conformity assessment procedures set out in [F74Schedule 15] apply—

(a)for design categories A and B referred to in paragraph 1 of Part A of Schedule 1—

(i)for recreational craft of hull length from 2.5 metres to less than 12 metres, any of the following modules—

(aa)Module A1 (internal production control plus supervised product testing);

(bb)Module B [F75(type examination)] together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(cc)Module G (conformity based on unit verification);

(dd)Module H (conformity based on full quality assurance);

(ii)for recreational craft of hull length from 12 metres to less than 24 metres, any of the following modules—

(aa)Module B [F75(type examination)] together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(bb)Module G (conformity based on unit verification);

(cc)Module H (conformity based on full quality assurance);

(b)for design category C referred to in paragraph 1 of Part A of Schedule 1—

(i)for recreational craft of hull length from 2.5 metres to less than 12 metres where the [F76designated] standards relating to paragraphs 3.2 and 3.3 of Part A of Schedule 1 are complied with, any of the following modules—

(aa)Module A (internal production control);

(bb)Module A1 (internal production control plus supervised product testing);

(cc)Module B ([F77type examination] together with Module C (conformity to type based on internal production control)), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(dd)Module G (conformity based on unit verification);

(ee)Module H (conformity based on full quality assurance);

(ii)for recreational craft of hull length from 2.5 metres to less than 12 metres where the [F76designated] standards relating to paragraphs 3.2 and 3.3 of Part A of Schedule 1 are not complied with, any of the following modules—

(aa)Module A1 (internal production control plus supervised testing);

(bb)Module B ([F77type examination]) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification;

(cc)Module G (conformity based on unit verification);

(dd)Module H (conformity based on full quality assurance);

(iii)for recreational craft of hull length from 12 metres to 24 metres, any of the following modules—

(aa)Module B ([F77type examination]) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification;

(bb)Module G (conformity based on unit verification);

(cc)Module H (conformity based on full quality assurance);

(c)for design category D referred to in paragraph 1 of Part A of Schedule 1 for recreational craft of hull length of 2.5 metres to 24 metres, any of the following modules—

(i)Module A (internal production control);

(ii)Module A1 (internal production control plus supervised testing);

(iii)Module B ([F78type examination] together with Module C (conformity to type based on internal production control)), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(iv)Module G (conformity based on unit verification);

(v)Module H (conformity based on full quality assurance).

(2) With regard to the design and construction of personal watercraft, any of the following procedures set out in [F79Schedule 15] apply—

(a)Module A (internal production control);

(b)Module A1 (internal production control plus supervised testing);

(c)Module B ([F80type examination] together with Module C conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(d)Module G (conformity based on unit verification);

(e)Module H (conformity based on full quality assurance).

(3) With regard to the design and construction of components any of the following procedures set out in [F81Schedule 15] apply—

(a)Module B [F82(type examination)] together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

Extent Information

E19This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I43Reg. 44 in force at 3.8.2017, see reg. 1

Design and constructionN.I.

44.—(1) With regard to the design and construction of recreational craft, the following conformity assessment procedures set out in Annex II to Decision 768/2008/EC apply—

(a)for design categories A and B referred to in paragraph 1 of Part A of Schedule 1—

(i)for recreational craft of hull length from 2.5 metres to less than 12 metres, any of the following modules—

(aa)Module A1 (internal production control plus supervised product testing);

(bb)Module B (EU-type examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(cc)Module G (conformity based on unit verification);

(dd)Module H (conformity based on full quality assurance);

(ii)for recreational craft of hull length from 12 metres to less than 24 metres, any of the following modules—

(aa)Module B (EU-type examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(bb)Module G (conformity based on unit verification);

(cc)Module H (conformity based on full quality assurance);

(b)for design category C referred to in paragraph 1 of Part A of Schedule 1—

(i)for recreational craft of hull length from 2.5 metres to less than 12 metres where the harmonised standards relating to paragraphs 3.2 and 3.3 of Part A of Schedule 1 are complied with, any of the following modules—

(aa)Module A (internal production control);

(bb)Module A1 (internal production control plus supervised product testing);

(cc)Module B (EU type-examination together with Module C (conformity to type based on internal production control)), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(dd)Module G (conformity based on unit verification);

(ee)Module H (conformity based on full quality assurance);

(ii)for recreational craft of hull length from 2.5 metres to less than 12 metres where the harmonised standards relating to paragraphs 3.2 and 3.3 of Part A of Schedule 1 are not complied with, any of the following modules—

(aa)Module A1 (internal production control plus supervised testing);

(bb)Module B (EU type-examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification;

(cc)Module G (conformity based on unit verification);

(dd)Module H (conformity based on full quality assurance);

(iii)for recreational craft of hull length from 12 metres to 24 metres, any of the following modules—

(aa)Module B (EU type-examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification;

(bb)Module G (conformity based on unit verification);

(cc)Module H (conformity based on full quality assurance);

(c)for design category D referred to in paragraph 1 of Part A of Schedule 1 for recreational craft of hull length of 2.5 metres to 24 metres, any of the following modules—

(i)Module A (internal production control);

(ii)Module A1 (internal production control plus supervised testing);

(iii)Module B (EU- type examination together with Module C (conformity to type based on internal production control)), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(iv)Module G (conformity based on unit verification);

(v)Module H (conformity based on full quality assurance).

(2) With regard to the design and construction of personal watercraft, any of the following procedures set out in Annex II to Decision 768/2008/EC apply—

(a)Module A (internal production control);

(b)Module A1 (internal production control plus supervised testing);

(c)Module B (EU type-examination together with Module C conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(d)Module G (conformity based on unit verification);

(e)Module H (conformity based on full quality assurance).

(3) With regard to the design and construction of components any of the following procedures set out in Annex II to Decision 768/2008/EC apply—

(a)Module B (EU type-examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on quality product assurance) or Module F (conformity to type based on product verification);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

Extent Information

E70This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I160Reg. 44 in force at 3.8.2017, see reg. 1

Exhaust emissionsE+W+S

45.  With regard to exhaust emissions, for products referred to in regulation 3(1)(d) and (e), the engine manufacturer must apply the following procedures set out in [F83Schedule 15]—

(a)where the tests are conducted using the [F84designated] standard, any of the following modules—

(i)Module B [F85(type examination)] together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(ii)Module G (conformity based on unit verification);

(iii)Module H (conformity based on full quality assurance);

(b)where the tests are conducted without using the [F86designated] standard, either of the following modules—

(i)Module B [F87(type examination)] together with Module C1 (conformity to type based on internal production control plus supervised product testing);

(ii)Module G (conformity based on unit verification).

Extent Information

E20This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I44Reg. 45 in force at 3.8.2017, see reg. 1

Exhaust emissionsN.I.

45.  With regard to exhaust emissions, for products referred to in regulation 3(1)(d) and (e), the engine manufacturer must apply the following procedures set out in Annex II to Decision 768/2008/EC—

(a)where the tests are conducted using the harmonised standard, any of the following modules—

(i)Module B (EU-type examination) together with Module C (conformity to type based on internal production control), Module D (conformity to type based on quality assurance of the production process), Module E (conformity to type based on product quality assurance) or Module F (conformity to type based on product verification);

(ii)Module G (conformity based on unit verification);

(iii)Module H (conformity based on full quality assurance);

(b)where the tests are conducted without using the harmonised standard, either of the following modules—

(i)Module B (the EU- type examination) together with Module C1 (conformity to type based on internal production control plus supervised product testing);

(ii)Module G (conformity based on unit verification).

Extent Information

E71This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I161Reg. 45 in force at 3.8.2017, see reg. 1

Noise emissions: recreational craftE+W+S

46.—(1) The manufacturer must apply the relevant procedures in paragraphs (2) to (4) as set out in [F88Schedule 15] with regard to the noise emissions for recreational craft with—

(a)stern drive propulsion engines without integral exhausts or inboard propulsion engine installations; and

(b)stern drive propulsion engines without integral exhausts or inboard propulsion engine installations which are subject to major craft conversion and are subsequently placed on the market within the period of 5 years from the day on which that conversion was completed.

(2) Where tests are conducted using the [F89designated] standard for noise measurement, any of the following modules apply—

(a)Module A1 (internal production plus supervised product testing);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

(3) Where tests are conducted without using the [F90designated] standard for noise measurement, Module G (conformity based on unit verification) applies.

(4) Where the Froude number of power displacement ratio method is used for assessment, any of the following modules apply—

(a)Module A (internal production control);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

Extent Information

E21This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I45Reg. 46 in force at 3.8.2017, see reg. 1

Noise emissions: recreational craftN.I.

46.—(1) The manufacturer must apply the relevant procedures in paragraphs (2) to (4) as set out in Annex II to Decision 768/2008/EC with regard to the noise emissions for recreational craft with—

(a)stern drive propulsion engines without integral exhausts or inboard propulsion engine installations; and

(b)stern drive propulsion engines without integral exhausts or inboard propulsion engine installations which are subject to major craft conversion and are subsequently placed on the market within the period of 5 years from the day on which that conversion was completed.

(2) Where tests are conducted using the harmonised standard for noise measurement, any of the following modules apply—

(a)Module A1 (internal production plus supervised product testing);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

(3) Where tests are conducted without using the harmonised standard for noise measurement, Module G (conformity based on unit verification) applies.

(4) Where the Froude number of power displacement ratio method is used for assessment, any of the following modules apply—

(a)Module A (internal production control);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

Extent Information

E72This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I162Reg. 46 in force at 3.8.2017, see reg. 1

Noise emissions: personal watercraftE+W+S

47.—(1) The personal watercraft or engine manufacturer must apply the relevant procedure in paragraphs (2) or (3) as set out in [F91Schedule 15], with regard to noise emissions for—

(a)personal watercraft and outboard propulsion engines; and

(b)stern drive propulsion engines with integral exhausts intended for installation on recreational craft.

(2) Where the tests are conducted using the [F92designated] standard for noise measurement, any of the following modules apply—

(a)Module A1 (internal production control plus supervised product testing);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

(3) Where the tests are conducted without using the [F93designated] standard for noise measurement, Module G (conformity based on unit verification) applies.

Extent Information

E22This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I46Reg. 47 in force at 3.8.2017, see reg. 1

Noise emissions: personal watercraftN.I.

47.—(1) The personal watercraft or engine manufacturer must apply the relevant procedure in paragraphs (2) or (3) as set out in Annex II to Decision 768/2008/EC, with regard to noise emissions for—

(a)personal watercraft and outboard propulsion engines; and

(b)stern drive propulsion engines with integral exhausts intended for installation on recreational craft.

(2) Where the tests are conducted using the harmonised standard for noise measurement, any of the following modules apply—

(a)Module A1 (internal production control plus supervised product testing);

(b)Module G (conformity based on unit verification);

(c)Module H (conformity based on full quality assurance).

(3) Where the tests are conducted without using the harmonised standard for noise measurement, Module G (conformity based on unit verification) applies.

Extent Information

E73This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I163Reg. 47 in force at 3.8.2017, see reg. 1

Requirements of the post-construction assessmentU.K.

48.  A post-construction assessment must be carried out in accordance with the process set out in Schedule 5.

Commencement Information

I47Reg. 48 in force at 3.8.2017, see reg. 1

SUPPLEMENTARY REQUIREMENTS FOR CERTAIN CONFORMITY ASSESSMENTSU.K.

Conformity assessments carried out under Module B (EU-type examination)U.K.

49.—[F94(1) Where an economic operator has a conformity assessment carried out on a product under Module B (EU-type examination) of Annex II to Decision 768/2008/EC in relation to a product, the conformity assessment must be carried out in the manner set out in Schedule 10.

(2) A production type may cover several versions of the assessed product, if—

(a)the differences between the versions of the product do not affect the level of safety and the other requirements concerning the performance of the product; and

(b)the different versions of the product are referred to in the corresponding EU-type examination certificate, if necessary by means of amendments to the original certificate.

(3) For the purposes of this regulation—

“production type” means an examination of the adequacy of the technical design of the watercraft through examination of the technical documentation specified in paragraph 3 of Schedule 10 and a specimen watercraft that is representative of the completed watercraft that is to be or has been produced by the manufacturer.]

Textual Amendments

Commencement Information

I48Reg. 49 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module A1 (internal production control plus supervised product testing)E+W+S

50.—(1) Where an economic operator has a conformity assessment carried out on a product under Module A1 (internal production control plus supervised product testing) [F95as set out in Schedule 15]—

(a)the product checks must be carried out on at least one watercraft that is representative of the watercraft that is to be or has been produced by the manufacturer; and

(b)the requirements set out in Schedule 6 apply.

F96(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E23This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I49Reg. 50 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module A1 (internal production control plus supervised product testing)N.I.

50.—(1) Where an economic operator has a conformity assessment carried out on a product under Module A1 (internal production control plus supervised product testing) of Annex II to Decision 768/2008/EC—

(a)the product checks must be carried out on at least one watercraft that is representative of the watercraft that is to be or has been produced by the manufacturer; and

(b)the requirements set out in Schedule 6 apply.

(2) The possibility, referred to in Modules A1 and C1 of Annex II of Decision 768/2008, of using an accredited in-house body to perform a conformity assessment under those modules is not applicable in relation to watercraft.

Extent Information

E74This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I164Reg. 50 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module F (conformity to type based on product verification)E+W+S

51.  Where an economic operator has a conformity assessment carried out on a product under Module F (conformity to type based on product verification) [F97as set out in Schedule 15], the procedure set out in Schedule 7 applies.

Extent Information

E24This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I50Reg. 51 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module F (conformity to type based on product verification)N.I.

51.  Where an economic operator has a conformity assessment carried out on a product under Module F (conformity to type based on product verification) of Annex II to Decision 768/2008/EC, the procedure set out in Schedule 7 applies.

Extent Information

E75This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I165Reg. 51 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module C (conformity to type based on internal production control)E+W+S

52.—(1) This regulation applies where—

(a)an economic operator has a conformity assessment carried out on a watercraft under Module C (conformity to type based on internal production control) [F98set out in Schedule 15];

(b)Module C is used to assess the conformity of the product with the exhaust emission requirements of these Regulations; and

(c)the manufacturer is not working under a relevant quality system as described in Module H [F99set out in Schedule 15].

(2) [F100An approved] body chosen by the manufacturer must carry out product checks as required by Module C or have them carried out at random intervals to be determined by [F101the approved] body, in order to verify the quality of the internal checks on the product carried out under the manufacturer’s own checking measures.

(3) When the quality level appears unsatisfactory or when it seems necessary to verify the validity of the data presented by the manufacturer, the procedure set out in Schedule 8 applies.

Extent Information

E25This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I51Reg. 52 in force at 3.8.2017, see reg. 1

Conformity assessments carried out under Module C (conformity to type based on internal production control)N.I.

52.—(1) This regulation applies where—

(a)an economic operator has a conformity assessment carried out on a watercraft under Module C (conformity to type based on internal production control) of Annex II of Decision 768/2008/EC;

(b)Module C is used to assess the conformity of the product with the exhaust emission requirements of these Regulations; and

(c)the manufacturer is not working under a relevant quality system as described in Module H of Annex II to Decision 768/2008/EC.

(2) A notified body chosen by the manufacturer must carry out product checks as required by Module C or have them carried out at random intervals to be determined by the notified body, in order to verify the quality of the internal checks on the product carried out under the manufacturer’s own checking measures.

(3) When the quality level appears unsatisfactory or when it seems necessary to verify the validity of the data presented by the manufacturer, the procedure set out in Schedule 8 applies.

Extent Information

E76This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I166Reg. 52 in force at 3.8.2017, see reg. 1

[F102Declaration] of conformityE+W+S

53.  The F103... declaration of conformity for a product must—

(a)state that the product complies with the essential requirements;

(b)contain the elements specified in regulations 44 to 47 for the relevant conformity assessment [F104procedure] in respect of the product; and

(c)be set out in accordance with the model structure set out in Schedule 4.

Extent Information

E26This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I52Reg. 53 in force at 3.8.2017, see reg. 1

EU declaration of conformityN.I.

53.  The EU declaration of conformity for a product must—

(a)state that the product complies with the essential requirements;

(b)contain the elements specified in regulations 44 to 47 for the relevant conformity assessment in respect of the product; and

(c)be set out in accordance with the model structure set out in Schedule 4.

Extent Information

E77This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I167Reg. 53 in force at 3.8.2017, see reg. 1

[F105UK marking]E+W+S

54.—[F106(1) The UK marking must be affixed visibly, legibly and indelibly—

(a)to the product; or

(b)where paragraph (1A) applies, to—

(i)a label affixed to the product; or

(ii)a document accompanying the product.]

[F107(1A) For a period of [F108seven years] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the product; or

(b)a document accompanying the product.]

(2) Where [F109paragraph (1A) does not apply and] it is not possible or warranted, on account of the nature of a component to affix the [F110UK] marking in accordance with [F111paragraph (1)(a)], the [F110UK] marking must be affixed to—

(a)the packaging; and

(b)the accompanying documents.

(3) [F112Except where paragraph (3A) applies] where the product referred to in paragraph (1)—

(a)is a watercraft, the [F113UK] marking must be affixed to the watercraft builder’s plate and mounted separately from the watercraft identification number; or

(b)is a propulsion engine, the [F113UK] marking must be affixed on the engine.

[F114(3A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the watercraft or propulsion engine; or

(b)a document accompanying the watercraft or propulsion engine.]

(4) The [F115UK] marking must be followed by the identification number of the [F116approved] body where—

(a)that body is involved in the production control phase of the conformity assessment under Modules A (internal production control), A1 (internal production control plus supervised product testing) or C (conformity to type based on internal production control) set out in [F117Schedule 15]; or

(b)where a post construction assessment set out in Schedule 5 of these Regulations is being used.

(5) The identification number of the [F118approved] body must be affixed—

(a)by the [F118approved] body itself; or

(b)under the instructions of the [F118approved] body by the manufacturer.

Extent Information

E27This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I53Reg. 54 in force at 3.8.2017, see reg. 1

CE markingN.I.

54.—(1) The CE marking must be affixed visibly, legibly and indelibly to the product.

(2) Where it is not possible or warranted, on account of the nature of a component to affix the CE marking in accordance with paragraph (1), the CE marking must be affixed to—

(a)the packaging; and

(b)the accompanying documents.

(3) Where the product referred to in paragraph (1)—

(a)is a watercraft, the CE marking must be affixed to the watercraft builder’s plate and mounted separately from the watercraft identification number; or

(b)is a propulsion engine, the CE marking must be affixed on the engine.

(4) The CE marking must be followed by the identification number of the notified body where—

(a)that body is involved in the production control phase of the conformity assessment under Modules A (internal production control), A1 (internal production control plus supervised product testing) or C (conformity to type based on internal production control) set out in Annex II of Decision 768/2008; or

(b)where a post construction assessment set out in Schedule 5 of these Regulations is being used.

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

(a)by the notified body itself; or

(b)under the instructions of the notified body by the manufacturer.

Extent Information

E78This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I168Reg. 54 in force at 3.8.2017, see reg. 1

[F119UK(NI) indicationN.I.

54A.—(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 product, in accordance with this regulation.

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

(a)visibly, legibly and indelibly; and

(b)before a product 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 54.

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

(a)the manufacturer; or

(b)the manufacturer's authorised representative.

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

Textual Amendments

[F119Register of notified bodies established in the United KingdomN.I.

54B.—(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).]

Textual Amendments

PART 4E+W+S[F120NOTIFICATION OF CONFORMITY ASSESSMENT BODIES][F120APPROVAL OF CONFORMITY ASSESSMENT BODIES]

Textual Amendments

[F120Approved bodiesE+W+S

55.—(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 56 (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 61(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 59 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“notified body” means a body—

(a)

which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union in accordance with Article 26 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 55(b), as it had effect immediately before IP completion day;

“approved body requirements” means the requirements set out in Schedule 11.]

Extent Information

E28This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Notified bodiesN.I.

55.  For the purposes of this Part, 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 [F259relevant states]—

(i)under regulation 56 (notification); or

(ii)before the date these Regulations come into force, in accordance with Article 26 of the Directive; and

(b)in respect of which no objections [F260, other than an immaterial objection,] were raised by the European Commission or other [F261relevant states]—

(i)within 2 weeks of the date of notification, where 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 [F262certificate;]

[F263(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.]

Extent Information

E79This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I169Reg. 55 in force at 3.8.2017, see reg. 1

[F120Approval of conformity assessment bodiesE+W+S

56.—(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 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 relevant conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii)the product 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.

(8) 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.]

Extent Information

E29This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

NotificationN.I.

56.—(1) The Secretary of State may notify to the European Commission and the other [F264relevant states] 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 or modules in respect of which the conformity body claims to be competent; and

(iii)the product for 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 [F264relevant states], 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.

Extent Information

E80This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I170Reg. 56 in force at 3.8.2017, see reg. 1

[F120Presumption of conformity of approved bodiesE+W+S

57.—(1) Where a conformity assessment body demonstrates its conformity with the criteria set out 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 the standard).

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

Extent Information

E30This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Contents of notificationN.I.

57.  A notification under regulation 56 (notification) must include—

(a)the 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 module or modules in respect of which the conformity assessment body has made its application for notification;

(iii)the product 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.

Extent Information

E81This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I171Reg. 57 in force at 3.8.2017, see reg. 1

[F120Monitoring of approved bodiesE+W+S

58.  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 condition set—

(i)in accordance with regulation 56(6)(b); or

(ii)in the case of an approved body that was a notified body immediately before IP completion day, in accordance with regulation 56(6)(b) as it applied immediately before IP completion day; and

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

Extent Information

E31This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Presumption of conformity of notified bodiesN.I.

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

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

Extent Information

E82This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I172Reg. 58 in force at 3.8.2017, see reg. 1

[F120Restriction, suspension or withdrawal of approvalE+W+S

59.—(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 58(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 55 (approved bodies).

(2) With the consent of the approved body or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 58(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 55.

(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) 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 activities, the approved body must—

(a)at the request of the Secretary of State, 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)in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created.

(5) The activities undertaken as an approved body referred to in paragraph (4) include any activities that the body has undertaken as a notified body.]

Extent Information

E32This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Monitoring of notified bodiesN.I.

59.—(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)complies with any condition set in accordance with regulation 56(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.

Extent Information

E83This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I173Reg. 59 in force at 3.8.2017, see reg. 1

[F120Notice of proposed restriction, suspension or withdrawal of approvalE+W+S

60.—(1) Where the Secretary of State proposes to restrict, suspend or withdraw a body's status as an approved body in accordance with regulation 59 (restriction, suspension or withdrawal of approval), the Secretary of State must give notice in writing to the approved body that its approval will be restricted, suspended or withdrawn.

(2) A notice provided in accordance with paragraph (1) must—

(a)state the date on which the notice is issued;

(b)state the reasons why the approval is being restricted, suspended or withdrawn;

(c)state the date on which the restriction, suspension or withdrawal of the approval is to take effect;

(d)where an approval is being restricted or suspended, state what the effect of that restriction or suspension is on the approved body;

(e)inform the approved body of its right to make written representations to the Secretary of State against the proposal within 14 days of the date of the notice.

(3) Where an approved body submits written representations to the Secretary of State within 14 days of the notice in accordance with paragraph (2)(e), the Secretary of State must respond to the representations within 21 days of the date on which the representations are received, stating whether, having considered the representations, the notice issued under paragraph (1) will be modified or withdrawn.]

Extent Information

E33This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Authorisation of the United Kingdom Accreditation ServiceN.I.

60.  The Secretary of State may authorise the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) to carry out the following activities on behalf of the Secretary of State—

(a)assessing applications for designation as a notified body made under regulation 56 (application for designation as a notified body); and

(b)monitoring notified bodies required by regulation 59 (monitoring of notified bodies).

Extent Information

E84This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I174Reg. 60 in force at 3.8.2017, see reg. 1

[F120Operational requirements of approved bodiesE+W+S

61.  When an approved body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of approved bodies) has effect.]

Extent Information

E34This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Changes to notificationsN.I.

61.—(1) Where the Secretary of State determines that a notified body no longer meets a notified body requirements or that it is failing to fulfil its obligations under these Regulations other than a condition set in accordance with regulation 56(6)(b), the Secretary of State must restrict, suspend or withdraw the body’s status as a notified body under regulation 55.

(2) With the consent of the notified body, or where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 56(6)(b), the Secretary of State may restrict, suspend or withdraw the body’s status as a notified body under regulation 55.

(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) 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 [F265relevant states].

(5) Where the Secretary of State has taken action under paragraph (1) or (2), or where the notified body has ceased its activity, the notified body must—

(a)at the request of the Secretary of State, 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)in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as a notified body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created.

Extent Information

E85This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I175Reg. 61 in force at 3.8.2017, see reg. 1

[F120Subsidiaries and contractorsE+W+S

62.—(1) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are to be treated as having been carried out by an approved body for the purposes of regulations 44 to 47 only where the conditions in paragraphs (2) and (3) are satisfied.

(2) The approved body must—

(a)ensure that the subcontractor or subsidiary meets the approved body requirements; and

(b)inform the Secretary of State accordingly.

(3) The approved body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary.

(4) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the approved body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning—

(a)the assessment of the qualifications of the subcontractor or subsidiary; and

(b)the conformity assessment activities carried out by the subcontractor or subsidiary.

(5) When monitoring an approved body in accordance with regulation 58 (monitoring of approved bodies), the Secretary of State must treat the approved body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.

(6) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.]

Extent Information

E35This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Operational requirements of notified bodiesN.I.

62.  When a notified body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of notified bodies) has effect.

Extent Information

E86This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I176Reg. 62 in force at 3.8.2017, see reg. 1

[F120Register of approved bodiesE+W+S

63.—(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.]

Extent Information

E36This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Subsidiaries and contractorsN.I.

63.—(1) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are only to be treated as having been carried out by a notified body for the purposes of regulations 44 to 47 where the conditions in paragraphs (2) and (3) are satisfied.

(2) The notified body must—

(a)ensure that the subcontractor or subsidiary meets the notified body requirements; and

(b)inform the Secretary of State accordingly.

(3) The notified body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary.

(4) Where a notified body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the notified body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activities carried out by the subcontractor or subsidiary.

(5) When monitoring a notified body in accordance with regulation 59 (monitoring of notified bodies), the Secretary of State must treat the notified body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.

Extent Information

E87This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I177Reg. 63 in force at 3.8.2017, see reg. 1

[F120Authorisation of UK national accreditation bodyE+W+S

64.  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 58;

(c)compiling and maintaining the register of approved bodies in accordance with regulation 63.]

Extent Information

E37This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Appeal against a change to a notificationN.I.

64.—(1) Where the Secretary of State intends to restrict, suspend or withdraw a notification in accordance with regulation 61 (changes to notifications) the Secretary of State must give notice in writing to the notified body concerned that its notification will be restricted, suspended or withdrawn.

(2) A written notice provided in accordance with paragraph (1) must—

(a)state the date on which the notice is issued;

(b)state of the reasons why the notification is being restricted, suspended or withdrawn;

(c)state the date on which the restriction, suspension or withdrawal of the notification is to take effect;

(d)where a notification has been restricted or suspended, state what the effect of that restriction or suspension is upon the notified body;

(e)inform the notified body of its right to make representations to the Secretary of State, in writing, within 14 days of the date on the notice, against this decision.

(3) Where a notified body submits written representations to the Secretary of State, the Secretary of State must respond to those representations within 21 days of the date on which those representations are received, stating whether, having considered those representations, the notice issued under paragraph (1) will be modified or withdrawn.

Extent Information

E88This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I178Reg. 64 in force at 3.8.2017, see reg. 1

PART 5U.K.MARKET SURVEILLANCE AND ENFORCEMENT

Designation of market surveillance authoritiesU.K.

65.  The market surveillance authority is—

(a)within its area in Great Britain, the weights and measures authority; and

(b)in Northern Ireland, every district council.

Commencement Information

I54Reg. 65 in force at 3.8.2017, see reg. 1

EnforcementU.K.

66.—(1) The market surveillance authority must enforce these Regulations and RAMS (in its application to products covered by these Regulations).

(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 products covered by these Regulations).

(3) Before taking action under paragraph (2), the Secretary of State or the person appointed by the Secretary of State to act on the Secretary of State’s behalf, must notify the relevant market surveillance authority.

(4) In Scotland, only the Lord Advocate may prosecute an offence under these Regulations.

Commencement Information

I55Reg. 66 in force at 3.8.2017, see reg. 1

Enforcement powersU.K.

67.  Schedule 13 (enforcement and investigatory powers conferred on the market surveillance authority) and Schedule 14 (compliance, withdrawal and recall notices) of these Regulations have effect.

Commencement Information

I56Reg. 67 in force at 3.8.2017, see reg. 1

Evaluation of a product presenting a riskU.K.

68.—(1) Where the market surveillance authority has sufficient reason to believe that a product presents a risk, that authority must carry out an evaluation of that product in order to determine whether the product satisfies the requirements of Part 2 of these Regulations in respect of that product.

(2) Where an enforcing authority other than a market surveillance authority has sufficient reason to believe that a product presents a risk, that authority may carry out an evaluation of that product in order to determine whether the product satisfied the requirements of Part 2 of these Regulations in respect of that product.

Commencement Information

I57Reg. 68 in force at 3.8.2017, see reg. 1

Enforcement action in respect of products that are not in conformity and which present a riskE+W+S

69.—(1) Where in the course of the evaluation referred to in regulation 68 (evaluation of product presenting a risk), an enforcing authority finds that the product is not in conformity with Part 2 of these Regulations it must, without delay, require a relevant economic operator to—

(a)take the appropriate corrective action to bring the product into conformity with those requirements within a prescribed period;

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

(c)recall the product within a prescribed period.

(2) The enforcing authority must inform [F121any approved] body that carried out the conformity assessment in relation to the product of—

(a)the respect in which the product is not in conformity with Part 2 ; and

(b)the actions which the market surveillance authority requires the relevant economic operator to take to bring the product into conformity with Part 2.

(3) Where the enforcing authority is not the Secretary of State and it considers that the non-conformity referred to in paragraph (1) is not restricted to products that have been placed or made available on the market in the United Kingdom, it must notify the Secretary of State of—

(a)the results of the evaluation; and

(b)the actions which it has required the economic operator to take.

F122(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Where the relevant economic operator does not take adequate corrective action within the prescribed period, the enforcing authority must take appropriate measures to—

(a)prohibit or restrict the product being made available on the market in the United Kingdom;

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

(c)recall the product.

(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.

F123(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) The [F124notice referred to in paragraph (6)] must include details about the product and, in particular—

(a)the information necessary to identify the product that is not in conformity;

(b)the origin of the product;

(c)the nature of the alleged lack of conformity and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the economic operator; and

(f)whether the failure of the product to conform with the requirements of Part 2 is due to—

(i)the failure of the product to meet the requirements of that Part and Schedule 1 relating to risk; or

(ii)shortcomings in [F125a designated standard referred to in regulation 41 (presumption of conformity) which confers] a presumption of conformity.

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

(a)prescribed by the enforcing authority; and

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

Extent Information

E38This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I58Reg. 69 in force at 3.8.2017, see reg. 1

Enforcement action in respect of products that are not in conformity and which present a riskN.I.

69.—(1) Where in the course of the evaluation referred to in regulation 68 (evaluation of product presenting a risk), an enforcing authority finds that the product is not in conformity with Part 2 of these Regulations it must, without delay, require a relevant economic operator to—

(a)take the appropriate corrective action to bring the product into conformity with those requirements within a prescribed period;

(b)withdraw the product [F266from Northern Ireland] within a prescribed period; or

(c)recall the product [F267from Northern Ireland] within a prescribed period.

(2) The enforcing authority must inform the notified body that carried out the conformity assessment in relation to the product of—

(a)the respect in which the product is not in conformity with Part 2 ; and

(b)the actions which the market surveillance authority requires the relevant economic operator to take to bring the product into conformity with Part 2.

(3) Where the enforcing authority is not the Secretary of State and it considers that the non-conformity referred to in paragraph (1) is not restricted to products that have been placed or made available on the market in [F268Northern Ireland], it must notify the Secretary of State of—

(a)the results of the evaluation; and

(b)the actions which it has required the economic operator to take.

(4) [F269Subject to paragraph (4A),] where the Secretary of State receives notice from an enforcing authority under paragraph (3), or otherwise considers that the lack of conformity referred to in paragraph (1) is not restricted to [F270Northern Ireland], the Secretary of State must inform the European Commission and the other [F271relevant states] of—

(a)the results of the evaluation; and

(b)the actions which the enforcing authority has required the economic operator to take.

[F272(4A) Paragraph (4) does not require the Secretary of State to inform the Commission or the other relevant states where the lack of conformity extends only to any of England or Wales or Scotland.]

(5) Where the relevant economic operator does not take adequate corrective action within the prescribed period, the enforcing authority must take appropriate measures to—

(a)prohibit or restrict the product being made available on the market in [F273Northern Ireland];

(b)withdraw the product from the [F274market in Northern Ireland]; or

(c)recall the product.

(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 [F275relevant states] without delay.

(8) The notices referred to in paragraphs (6) and (7) must include details about the product and, in particular—

(a)the information necessary to identify the product that is not in conformity;

(b)the origin of the product;

(c)the nature of the alleged lack of conformity and the risk involved;

(d)the nature and duration of the measures taken;

(e)the arguments put forward by the economic operator; and

(f)whether the failure of the product to conform with the requirements of Part 2 is due to—

(i)the failure of the product to meet the requirements of that Part and Schedule 1 relating to risk; or

(ii)shortcomings in a harmonised standards referred to in regulation 41 (presumption of conformity) which confer a presumption of conformity.

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

(a)prescribed by the enforcing authority; and

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

Extent Information

E89This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I179Reg. 69 in force at 3.8.2017, see reg. 1

EU Safeguard procedureN.I.

70.—[F126(1) Where another [F127relevant state] has initiated the procedure under Article 44 of the Directive (as amended from time to time), the market surveillance authority must, without delay, inform the Secretary of State of—

(a)any measures taken by the market surveillance authority in respect of the product; and

(b)any additional information which the market surveillance authority has at its disposal relating to the lack of conformity of the product.

(2) Where another [F128relevant state] has initiated the procedure under Article 44 of the Directive (as amended from time to time), the Secretary of State must, without delay, inform the Commission and the other [F129relevant states] of—

(a)any measures taken by a market surveillance authority [F130in Northern Ireland] in respect of the product;

(b)any additional information which a market surveillance authority has at its disposal relating to the lack of conformity with the [F131product.]

F132(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a measure taken by another [F133relevant state] in respect of a product is considered justified under Article 45(2) of the Directive (as amended from time to time), the market surveillance authority must ensure that appropriate measures, such as withdrawal, are taken [F134in Northern Ireland] in respect of the product without delay.

(4) Where a measure taken by another [F135relevant state] in respect of a product is considered justified by the Commission under Article 45(2) of the Directive (as amended from time to time), the market surveillance authority must take the necessary measures to ensure that the product is withdrawn from the market in [F136in Northern Ireland].

(5) Where the market surveillance authority has taken action under paragraphs (3) or (4), it must inform the Secretary of State.

(6) Where the Secretary of State receives a notice under paragraph (5), the Secretary of State must inform the Commission of the action taken [F137in respect of Northern Ireland].

(7) If a measure taken by the market surveillance authority pursuant to regulation 69 is considered unjustified by the Commission under Article 44(1) of the Directive (as amended from time to time), the market surveillance authority must withdraw that measure [F138in respect of Northern Ireland].]

Textual Amendments

Commencement Information

I59Reg. 70 in force at 3.8.2017, see reg. 1

Enforcement action in respect of formal non-complianceE+W+S

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

(a)the [F139UK] marking—

(i)has not been affixed; or

(ii)has been affixed in violation of regulation 40 (prohibition on improper use of [F139UK] marking) or regulation 54 ([F139UK] marking);

(b)the F140... declaration of conformity or the declaration referred to in Schedule 3—

(i)has not been drawn up; or

(ii)has not been drawn up correctly;

(c)the technical documentation is either not available or is incomplete;

(d)the information set out in regulation 14 (duty to provide information) and regulation 21 (duty of importer to ensure products are labelled) is absent, false or incomplete;

(e)that there has been non-compliance with any other requirement referred to—

(i)in the case of the manufacturer or their authorised representative in regulations 8 to 17;

(ii)in the case of the importer in regulations 18 to 26;

(iii)in the case of a distributor in regulations 27 to 32; and

(iv)in the case of a private importer in regulations 36 to 38.

(2) The enforcing authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the relevant economic operator in respect of the non-compliance concerned 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 appropriate measures to—

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

(b)ensure that the product is recalled or withdrawn from the market; or

(c)in the case of a product imported by a private importer for their own use, that that product is prohibited or restricted.

(4) This regulation does not apply where the product presents a risk.

Extent Information

E39This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I60Reg. 71 in force at 3.8.2017, see reg. 1

Enforcement action in respect of formal non-complianceN.I.

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

(a)the CE marking—

(i)has not been affixed; or

(ii)has been affixed in violation of regulation 40 (prohibition on improper use of CE marking) or regulation 54 (CE marking);

[F276(aa)the UK(NI) indication—

(i)has not been affixed, in contravention of regulation 54A; or

(ii)has been affixed other than in accordance with regulation 54A;]

(b)the EU declaration of conformity or the declaration referred to in Schedule 3—

(i)has not been drawn up; or

(ii)has not been drawn up correctly;

(c)the technical documentation is either not available or is incomplete;

(d)the information set out in regulation 14 (duty to provide information) and regulation 21 (duty of importer to ensure products are labelled) is absent, false or incomplete;

(e)that there has been non-compliance with any other requirement referred to—

(i)in the case of the manufacturer or their authorised representative in regulations 8 to 17;

(ii)in the case of the importer in regulations 18 to 26;

(iii)in the case of a distributor in regulations 27 to 32; and

(iv)in the case of a private importer in regulations 36 to 38.

(2) The enforcing authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the relevant economic operator in respect of the non-compliance concerned 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 appropriate measures to—

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

(b)ensure that the product is recalled or withdrawn from the market; or

(c)in the case of a product imported by a private importer for their own use, that that product is prohibited or restricted.

(4) This regulation does not apply where the product presents a risk.

Extent Information

E90This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Commencement Information

I180Reg. 71 in force at 3.8.2017, see reg. 1

Restrictive measuresU.K.

72.  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 product from being made available on the market;

(b)withdraw a product from the market; or

(c)recall a product.

Commencement Information

I61Reg. 72 in force at 3.8.2017, see reg. 1

OffencesU.K.

73.—(1) It is an offence for a person to contravene or fail to comply with any requirement of—

(a)regulation 6;

(b)regulations 8 to 16;

(c)regulation 17(3);

[F141(d)regulations 18 to 25;]

(e)regulation 26(3);

(f)regulations 27 to 31;

(g)regulation 32(3);

(h)regulation 34;

(i)regulation 36 to 38; or

(j)regulation 40.

(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.

Textual Amendments

Commencement Information

I62Reg. 73 in force at 3.8.2017, see reg. 1

PenaltiesU.K.

74.  [F142Subject to regulation 74A,] any person who is guilty of an offence under regulation 73 (offences) is liable on summary conviction—

(a)in England and Wales—

(i)to imprisonment for a term not exceeding 3 months;

(ii)to a fine; or

(iii)to both.

(b)in Scotland and Northern Ireland—

(i)to imprisonment for a term not exceeding 3 months; or

(ii)to a fine not exceeding level 5 on the standard scale; or

(iii)to both.

Textual Amendments

Commencement Information

I63Reg. 74 in force at 3.8.2017, see reg. 1

[F143Penalty in relation to the UK(NI) indicationN.I.

74A.  A person guilty of an offence under regulation 73(2) insofar as the requirement relates to a UK(NI) indication is liable on summary conviction to a fine not exceeding level 5 on the standard scale.]

Textual Amendments

Defence of due diligenceU.K.

75.—(1) Subject to paragraphs (2) and (4), in proceedings for an offence under regulation 73 (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 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 7 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.

Commencement Information

I64Reg. 75 in force at 3.8.2017, see reg. 1

Liability of persons other than the principal offenderU.K.

76.—(1) Where the commission by one person (“X”) of an offence under these Regulations is due to anything which another person (“Y”) did or failed to do in the course of business, Y is guilty of an offence and may be proceeded against and punished, whether or not proceedings are taken against X.

(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; or

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

Commencement Information

I65Reg. 76 in force at 3.8.2017, see reg. 1

Service of documentsU.K.

77.—(1) Any document required or authorised by these Regulations to be served on a person may be served by—

(a)delivering it to that person in person;

(b)leaving it at that person’s proper address; or

(c)sending it by post or electronic means to that person’s proper address.

(2) In the case of a body corporate, a document may be served on a director of that body.

(3) In the case of a partnership, a document may be served on a partner or a person having control or management of the partnership business.

(4) For the purposes of this regulation, “proper address” means—

(a)in the case of a body corporate or its director—

(i)the registered or principal office of that body; or

(ii)the email address of the secretary or clerk of that body;

(b)in the case of a partnership, a partner or person having control or management of the partnership business—

(i)the principal office of the partnership; or

(ii)the email address of a partner or person having that control or management;

(c)in any other case, a person’s last known address, which includes 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.

Commencement Information

I66Reg. 77 in force at 3.8.2017, see reg. 1

Recovery of expenses of enforcementU.K.

78.—(1) This regulation applies where a person commits an offence under regulation 73 (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 authority has incurred in investigating the offence.

Commencement Information

I67Reg. 78 in force at 3.8.2017, see reg. 1

Action by enforcing authorityU.K.

79.—(1) An enforcing authority may 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 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 takes action as a result of the condition in paragraph (1)(b) being met, the authority may recover from the economic operator, as a civil debt, any costs or expenses reasonably incurred by the authority in taking the action.

(3) A civil debt recoverable under paragraph (2) may be recovered summarily—

(a)in England and Wales by way of a complaint pursuant to section 58 of the Magistrates’ Courts Act 1980(13);

(b)in Northern Ireland in proceedings under article 62 (debt proceedings) of the Magistrates Courts (Northern Ireland) Order 1981(14).

(4) In this regulation, “notice” means a notice served under Schedule 14.

Commencement Information

I68Reg. 79 in force at 3.8.2017, see reg. 1

Appeals against noticesU.K.

80.—(1) An 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)by a person having an interest in the product in respect of which the notice has been served, unless the notice is a recall notice.

(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 that the product to which the notice relates is in conformity with Part 2 and does not present a risk.

(4) On an application under paragraph (1) 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 81 (appropriate court for appeals against notices); and

(b)“notice” means any notice served under Schedule 14.

Commencement Information

I69Reg. 80 in force at 3.8.2017, see reg. 1

Appropriate court for appeals against noticesU.K.

81.—(1) In England and Wales or Northern Ireland, the appropriate court for the purposes of regulation 80 (appeals against notices) is—

(a)the court in which proceedings have been brought in relation to the product for an offence under regulation 73 (offences);

(b)in any other case, a magistrates’ court.

(2) In Scotland, the appropriate court for the purposes of regulation 80 is the sheriff of the sheriffdom in which the person making the appeal resides or has a registered principal office.

(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 80 (appeals against notices), 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.

Commencement Information

I70Reg. 81 in force at 3.8.2017, see reg. 1

Time limit for commencement of proceedingsU.K.

82.—(1) Subject to paragraph (4), in England and Wales, an information relating to an offence under regulation 73 (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 73 may be commenced before the end of 12 months after the date on which evidence sufficient in the Lord Advocate’s opinion to justify the proceedings came to the Lord Advocate’s knowledge; and

(b)section 136(3) of the Criminal Procedure (Scotland) Act 1995(15) (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 73 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 3 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.

Commencement Information

I71Reg. 82 in force at 3.8.2017, see reg. 1

CompensationU.K.

83.—(1) Where an enforcing authority serves a relevant notice in respect of a product, that authority is liable to pay compensation to a person having an interest in the product 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 product in respect of which the relevant notice was served neither—

(i)presents a risk; nor

(ii)contravenes any requirement of these Regulations; and

(b)the exercise of the power to serve the relevant notice was not attributable to neglect or default by a relevant economic operator.

(3) In this regulation, “relevant notice” means a notice served in accordance with Schedule 14.

Commencement Information

I72Reg. 83 in force at 3.8.2017, see reg. 1

[F144PART 5AE+W+SPOWERS OF THE SECRETARY OF STATE

Textual Amendments

Power to amend SchedulesE+W+S

83A.—(1) The Secretary of State may by regulations amend any of the provisions specified in paragraph (2) where the Secretary of State considers it necessary to do so in order to take into account technical progress and new scientific evidence.

(2) The provisions referred to in paragraph (1) are—

(a)in Schedule 1—

(i)points 2.3, 2.4, 2.5 and Section 3 of Part B;

(ii)Section 3 of Part C;

(b)Schedule 7;

(c)Schedule 9.

(3) The Secretary of State may by regulations amend Schedule 5 where the Secretary of State considers it necessary to do so in order to take into account technical progress, the adequacy of ensuring equivalent conformity and new scientific evidence.

(4) Regulations made under this regulation may—

(a)make different provisions for different cases; and

(b)make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Power to make provision for application of conformity assessments and of Schedule 1E+W+S

83B.—(1) Where one or both of the conditions in paragraph (2) is met, the Secretary of State may by regulations make provision about—

(a)detailed procedures for the operation of regulations 50 to 52 and paragraph 2 of Module B (as set out in Schedule 15), taking into account the specific conformity assessment needs of the products covered by these Regulations;

(b)the application of the watercraft design categories set out in point 1 of Part A of Schedule 1, including on the use of weather terminology and measurement scales used in those categories;

(c)the information on the builder's plate set out in point 2.2 of Part A of Schedule 1;

(d)the application of the Regulations on navigation lights set out in point 5.7 of Part A of Schedule 1;

(e)arrangements for discharge prevention, in particular as regards operation of holding tanks, set out in point 5.8 of Part A of Schedule 1;

(f)the installation and testing of gas appliances and permanently installed gas systems on watercraft, as referenced in point 5.5 of Part A of Schedule 1.

(2) The conditions referred to in paragraph (1) are that the Secretary of State considers it necessary to make such provision in order to—

(a)take into account the progress of technical knowledge; and

(b)ensure that these Regulations are applied in a uniform manner.

(3) Before making regulations under this regulation, the Secretary of State must consult such persons as the Secretary of State considers appropriate.

(4) Regulations made under this regulation may—

(a)make different provisions for different cases; and

(b)make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

PART 6U.K.MISCELLANEOUS

Amendment to the Consumer Rights Act 2015U.K.

84.  In paragraph 10 of Schedule 5 to the Consumer Rights Act 2015(16) at the appropriate place insert—

“regulation 66(1) or (2) of the Recreational Craft Regulations 2017 (S.I. 2017/737);”.

Commencement Information

I73Reg. 84 in force at 3.8.2017, see reg. 1

Amendment to the Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004U.K.

85.  The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004(17) Schedule 1 (specified subordinate legislation) is amended as follows—

(a)“The Recreational Craft Regulations 1996 insofar as not revoked by the Recreational Craft Regulations 2004” substitute “The Recreational Craft Regulations 2004 insofar as not revoked by the Recreational Craft Regulations 2017”; and

(b)omit the entry “The Recreational Craft Regulations 2004” and at the appropriate place insert “The Recreational Craft Regulations 2017”.

Commencement Information

I74Reg. 85 in force at 3.8.2017, see reg. 1

Amendment to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007U.K.

86.  The Legislative and Regulatory Reform (Regulatory Functions) Order 2007(18) is amended as follows—

(a)in Part 3 of the Schedule, under the heading “Public health and safety” omit the entry “The Recreational Craft Regulations 2004” and after the last entry insert “The Recreational Craft Regulations 2017”;

(b)in Part 8 of the Schedule, omit the entry “The Recreational Craft Regulations 2004” and after the last entry insert “The Recreational Craft Regulations 2017”; and

(c)in Part 13 of the Schedule, omit the entry “The Recreational Craft Regulations 2004” and after the last entry insert “The Recreational Craft Regulations 2017”.

Commencement Information

I75Reg. 86 in force at 3.8.2017, see reg. 1

Amendment to the Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009U.K.

87.  The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order(19) is amended as follows—

(a)in Part 4 of Schedule 1 omit the entry “The Recreational Craft Regulations 2004” ; and at the end insert “The Recreational Craft Regulations 2017”; and

(b)in Part 2 of Schedule 2 omit the entry “The Recreational Craft Regulations 2004” and at the end insert “The Recreational Craft Regulations 2017”.

Commencement Information

I76Reg. 87 in force at 3.8.2017, see reg. 1

ReviewE+W+S

88.—(1) The Secretary of State must from time to time—

(a)carry out a review of the regulatory provisions contained in these Regulations; and

(b)publish a report setting out the conclusions of the review.

(2) The first report must be published before the end of the period of 5 years beginning on the commencement date.

(3) Subsequent reports must be published at intervals not exceeding 5 years.

(4) Section 30(3) of the Small Business, Enterprise and Employment Act 2015(20) requires that a review carried out under this regulation must, so far as is reasonable, have regard to how the Directive is implemented in other member States.

(5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulations must, in particular—

(a)set out the objectives intended to be achieved by the regulatory provisions referred to in paragraph 1(a);

(b)assess the extent to which those objectives are achieved;

(c)assess whether those objectives remain appropriate; and

(d)if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act).

Commencement Information

I77Reg. 88 in force at 3.8.2017, see reg. 1

ReviewN.I.

88.—(1) The Secretary of State must from time to time—

(a)carry out a review of the regulatory provisions contained in these Regulations; and

(b)publish a report setting out the conclusions of the review.

(2) The first report must be published before the end of the period of 5 years beginning on the commencement date.

(3) Subsequent reports must be published at intervals not exceeding 5 years.

(4) Section 30(3) of the Small Business, Enterprise and Employment Act 2015(20) requires that a review carried out under this regulation must, so far as is reasonable, have regard to how the Directive is implemented in other [F277relevant states].

(5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulations must, in particular—

(a)set out the objectives intended to be achieved by the regulatory provisions referred to in paragraph 1(a);

(b)assess the extent to which those objectives are achieved;

(c)assess whether those objectives remain appropriate; and

(d)if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act).

Textual Amendments

Commencement Information

I181Reg. 88 in force at 3.8.2017, see reg. 1

Transitional provisionsU.K.

89.—(1) Nothing in these Regulations prevents the making available on the market of a product which—

(a)is in conformity with the requirements of Directive 94/25/EC on the approximation of laws, regulations and administrative provisions of the Member States relating to recreational craft(21); and

(b)was placed on the market before the commencement date.

(2) Nothing in these Regulations prevents the making available on the market or the putting into service of outboard SI (Spark Ignition) propulsion engines with power equal to less than 15kW which comply with the stage 1 exhaust emission limits laid down in point 2.1 of Part B of Annex 1 of the Directive which are—

(a)manufactured by small or medium-sized enterprises; and

(b)placed on the market before 18th January 2020.

Commencement Information

I78Reg. 89 in force at 3.8.2017, see reg. 1

[F145Transitional provisions in relation to EU ExitE+W+S

89A.—(1) In this regulation, “pre-exit period” means the period beginning on the commencement date and ending immediately before IP completion day.

(2) Subject to paragraph (3), where a product was made available on the market or put into service during the pre-exit period, despite the amendments made by Schedule 28 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 a member State of any matter; or

(b)any obligation to take action outside of the market in respect of the product.

(4) Where during the pre-exit period—

(a)a product has not been placed on the market; and

(b)the manufacturer has taken any action under regulation 42 or a person has taken action under regulation 43(2) or (3), as those provisions had effect immediately before IP completion day in relation to that product,

that action has effect as if it had been done under regulation 42 or 43 as they have effect on and after IP completion day.

(5) Where during the pre-exit period—

(a)a product has not been placed on the market or put into service; and

(b)the private importer or a person to whom regulation 43(2) applies, has taken any action under Schedule 5 as it had effect immediately before IP completion day in relation to that product,

that action has effect as if it had been done under Schedule 5 as it has effect on and after IP completion day.

[F146(6) Subject to paragraph (8), where before 11pm on 31st December 2024—

(a)a product has not been placed on the market; and

(b)a manufacturer has taken any action under the procedure that applies to that product in accordance with Articles 19 to 24 of the Directive

that action has effect as if it had been done under the applicable procedure referred to in regulation 42 or 43.

(7) Subject to paragraph (8), where before 11pm on 31st December 2024—

(a)a product has not been placed on the market or put into service; and

(b)a private importer or a person to whom regulation 43(2) applies has taken any action under the procedure that applies to that product in accordance with Article 23 of the Directive

that action has effect as if it had been done under the applicable procedure referred to in regulation 43.

(8) Paragraphs (6) and (7) do not apply—

(a)after the expiry of the validity of any certificate issued pursuant to the applicable procedure; and

(b)in any event, after 31st December 2027.]]

Textual Amendments

Revocations and savingsU.K.

90.—(1) The Recreational Craft Regulations 1996(22) are revoked save as regard their application to—

(a)any watercraft that was placed on the market or put into service prior to 1st January 2005; and

(b)the appointment or termination of appointment of any notified body for the purposes of those Regulations.

[F147(1A) For the purposes of paragraph (1), the Recreational Craft Regulations 1996 have effect with the following modifications—

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

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

(c)in Schedule 7 (EC type-examination (module B))—

(i)in paragraph 7 omit “and withdrawn”;

(ii)omit paragraph 8;

(d)in Schedules 9 (production quality assurance (module D)) and 12 (full quality assurance (module H))—

(i)in paragraph 5, for “national” substitute “ enforcement ”; and

(ii)in paragraph 6 omit “and withdrawn”;

(e)in Schedule 15 (enforcement), in paragraph 2 omit “with a view to this information being passed by the Secretary of State to the Commission”.]

(2) The Recreational Craft Regulations 2004(23) are revoked save as regards their application to—

(a)any watercraft that was placed on the market or put into service prior to the commencement date; and

(b)the appointment or termination of appointment of any notified body for the purposes of those Regulations.

[F148(3) “For the purposes of paragraph (2), the Recreational Craft Regulations 2004 have effect with the following modifications—

(a)any reference to “the Community” or “the European Union” is to be read as including the United Kingdom;

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

(c)in Schedule 7 (EC type-examination)—

(i)in paragraph 7 omit “and withdrawn”;

(ii)omit paragraph 8;

(d)in Schedules 9 (production quality assurance), 12 (full quality assurance) and 15 (product quality assurance (module E))—

(i)in paragraph 5, for “national” substitute “ enforcement ”; and

(ii)in paragraph 6 omit “and withdrawn;

(e)in Schedule 17 (enforcement), in paragraph 2 omit “with a view to this information being passed by the Secretary of State to the Commission”.]

Textual Amendments

Commencement Information

I79Reg. 90 in force at 3.8.2017, see reg. 1

Margot James

Parliamentary Under Secretary of State

Department for Business, Energy and Industrial Strategy

Regulation 2(1)

SCHEDULE 1U.K.(Annex I of the Directive)

Commencement Information

I80Sch. 1 in force at 3.8.2017, see reg. 1

A.Essential requirements for the design and construction of products referred to in Article 2(1)

1.WATERCRAFT DESIGN CATEGORIES

Design categoryWind force(Beaufort scale)Significant wave height(H ⅓, metres)
Aexceeding 8exceeding 4
Bup to, and including, 8up to, and including, 4
Cup to, and including, 6up to, and including, 2
Dup to, and including, 4up to, and including, 0,3

Explanatory notes:

A.

A recreational craft given design category A is considered to be designed for winds that may exceed wind force 8 (Beaufort scale) and significant wave height of 4 m and above but excluding abnormal conditions, such as storm, violent storm, hurricane, tornado and extreme sea conditions or rogue waves.

B.

A recreational craft given design category B is considered to be designed for a wind force up to, and including, 8 and significant wave height up to, and including, 4 m.

C.

A watercraft given design category C is considered to be designed for a wind force up to, and including, 6 and significant wave height up to, and including, 2 m.

D.

A watercraft given design category D is considered to be designed for a wind force up to, and including, 4 and significant wave height up to, and including, 0,3 m, with occasional waves of 0,5 m maximum height.

Watercraft in each design category must be designed and constructed to withstand the parameters in respect of stability, buoyancy, and other relevant essential requirements listed in this [F149Annex] [F149Schedule], and to have good handling characteristics.

Textual Amendments

2.GENERAL REQUIREMENTS

2.1.Watercraft identification

Each watercraft shall be marked with an identification number including the following information:

(1)

country code of the manufacturer,

(2)

unique code of the manufacturer assigned by [F150the national authority of the [F151relevant state]] [F150or on behalf of the Secretary of State],

(3)

unique serial number,

(4)

month and year of production,

(5)

model year.

Textual Amendments

Detailed requirements for the identification number referred to in the first paragraph are set out in the relevant [F152harmonised][F152designated] standard.

Textual Amendments

2.2.Watercraft builder’s plate

Each watercraft shall carry a permanently affixed plate mounted separately from the watercraft identification number, containing at least the following information:

(a)

manufacturer’s name, registered trade name or registered trade mark, as well as contact address;

(b)

[F153CE marking, as provided for in Article 18;]

[F153UK marking, as provided for in regulation 54;]

(c)

watercraft design category in accordance with Section 1;

(d)

manufacturer’s maximum recommended load derived from point 3.6 excluding the weight of the contents of the fixed tanks when full;

(e)

number of persons recommended by the manufacturer for which the watercraft was designed.

Textual Amendments

In the case of post-construction assessment, the contact details and the requirements referred to in point (a) shall include those of the [F154notified] [F154approved] body which has carried out the conformity assessment.

Textual Amendments

2.3.Protection from falling overboard and means of reboarding

Watercraft shall be designed to minimise the risks of falling overboard and to facilitate reboarding. Means of reboarding shall be accessible to or deployable by a person in the water unaided.

2.4.Visibility from the main steering position

For recreational craft, the main steering position shall give the operator, under normal conditions of use (speed and load), good all-round visibility.

2.5.Owner’s manual

Each product shall be provided with an owner’s manual [F155in accordance with Article 7(7) and Article 9(4)] [F155including the instructions and safety information referred to in regulations 15 and 22]. That manual shall provide all the information necessary for safe use of the product drawing particular attention to set up, maintenance, regular operation, prevention of risks and risk management.

Textual Amendments

3.INTEGRITY AND STRUCTURAL REQUIREMENTS

3.1.Structure

The choice and combination of materials and its construction shall ensure that the watercraft is strong enough in all respects. Special attention shall be paid to the design category in accordance with Section 1, and the manufacturer’s maximum recommended load in accordance with point 3.6.

3.2.Stability and freeboard

The watercraft shall have sufficient stability and freeboard considering its design category in accordance with Section 1 and the manufacturer’s maximum recommended load in accordance with point 3.6.

3.3.Buoyancy and flotation

The watercraft shall be constructed as to ensure that it has buoyancy characteristics appropriate to its design category in accordance with Section 1 and the manufacturer’s maximum recommended load in accordance with point 3.6. All habitable multihull recreational craft susceptible of inversion shall have sufficient buoyancy to remain afloat in the inverted position.

Watercraft of less than 6 metres in length that are susceptible to swamping when used in their design category shall be provided with appropriate means of flotation in the swamped condition.

3.4.Openings in hull, deck and superstructure

Openings in hull, deck(s) and superstructure shall not impair the structural integrity of the watercraft or its weather tight integrity when closed.

Windows, port lights, doors and hatch covers shall withstand the water pressure likely to be encountered in their specific position, as well as point loads applied by the weight of persons moving on deck.

Through hull fittings designed to allow water passage into the hull or out of the hull, below the waterline corresponding to the manufacturer’s maximum recommended load in accordance with point 3.6, shall be fitted with a means of shutoff which shall be readily accessible.

3.5.Flooding

All watercraft shall be designed so as to minimise the risk of sinking.

Where appropriate, particular attention shall be paid to:

(a)

cockpits and wells, which should be self-draining or have other means of keeping water out of the watercraft interior;

(b)

ventilation fittings;

(c)

removal of water by pumps or other means.

3.6.Manufacturer’s maximum recommended load

The manufacturer’s maximum recommended load (fuel, water, provisions, miscellaneous equipment and people (in kilograms)) for which the watercraft was designed, shall be determined in accordance with the design category (Section 1), stability and freeboard (point 3.2) and buoyancy and flotation (point 3.3).

3.7.Life raft stowage

All recreational craft of design categories A and B, and recreational craft of design categories C and D longer than 6 metres shall be provided with one or more stowage points for a life raft (life rafts) large enough to hold the number of persons the recreational craft was designed to carry as recommended by the manufacturer. Life raft stowage point(s) shall be readily accessible at all times.

3.8.Escape

All habitable multihull recreational craft susceptible of inversion shall be provided with viable means of escape in the event of inversion. Where there is a means of escape provided for use in the inverted position, it shall not compromise the structure (point 3.1), the stability (point 3.2) or buoyancy (point 3.3) whether the recreational craft is upright or inverted.

Every habitable recreational craft shall be provided with viable means of escape in the event of fire.

3.9.Anchoring, mooring and towing

All watercraft, taking into account their design category and their characteristics, shall be fitted with one or more strong points or other means capable of safely accepting anchoring, mooring and towing loads.

4.HANDLING CHARACTERISTICS

The manufacturer shall ensure that the handling characteristics of the watercraft are satisfactory with the most powerful propulsion engine for which the watercraft is designed and constructed. For all propulsion engines, the maximum rated engine power shall be declared in the owner’s manual.

5.INSTALLATION REQUIREMENTS

5.1.Engines and engine compartments
5.1.1.Inboard engine

All inboard mounted engines shall be placed within an enclosure separated from living quarters and installed so as to minimise the risk of fires or spread of fires as well as hazards from toxic fumes, heat, noise or vibrations in the living quarters.

Engine parts and accessories that require frequent inspection and/or servicing shall be readily accessible.

The insulating materials inside the engine compartment shall not sustain combustion.

5.1.2.Ventilation

The engine compartment shall be ventilated. The ingress of water into the engine compartment through openings must be minimised.

5.1.3.Exposed parts

Unless the engine is protected by a cover or its own enclosure, exposed moving or hot parts of the engine that could cause personal injury shall be effectively shielded.

5.1.4.Outboard propulsion engine starting

Every outboard propulsion engine fitted on any watercraft shall have a device to prevent the engine being started in gear, except:

(a)

when the engine produces less than 500 Newton’s (N) of static thrust;

(b)

when the engine has a throttle limiting device to limit thrust to 500 N at the time of starting the engine.

5.1.5.Personal watercraft running without driver

Personal watercraft shall be designed either with an automatic propulsion engine cut-off or with an automatic device to provide reduced speed, circular, forward movement when the driver dismounts deliberately or falls overboard.

5.1.6.Tiller-controlled outboard propulsion engines shall be equipped with an emergency stopping device which can be linked to the helmsman.
5.2.Fuel system
5.2.1.General

The filling, storage, venting and fuel-supply arrangements and installations shall be designed and installed so as to minimise the risk of fire and explosion.

5.2.2.Fuel tanks

Fuel tanks, lines and hoses shall be secured and separated or protected from any source of significant heat. The material the tanks are made of and their method of construction shall be in accordance with their capacity and the type of fuel.

Petrol fuel tank spaces shall be ventilated.

Petrol fuel tanks shall not form part of the hull and shall be:

(a)

protected against fire from any engine and from all other sources of ignition;

(b)

separated from living quarters.

Diesel fuel tanks may be integral with the hull.

5.3.Electrical system

Electrical systems shall be designed and installed so as to ensure proper operation of the watercraft under normal conditions of use and shall be such as to minimise risk of fire and electric shock.

All electrical circuits, except engine starting circuits supplied from batteries, shall remain safe when exposed to overload.

Electric propulsion circuits shall not interact with other circuits in such a way that either would fail to operate as intended.

Ventilation shall be provided to prevent the accumulation of explosive gases which might be emitted from batteries. Batteries shall be firmly secured and protected from ingress of water.

5.4.Steering system
5.4.1.General

Steering and propulsion control systems shall be designed, constructed and installed in order to allow the transmission of steering loads under foreseeable operating conditions.

5.4.2.Emergency arrangements

Every sailing recreational craft and single-propulsion engine non-sailing recreational craft with remote-controlled rudder steering systems shall be provided with emergency means of steering the recreational craft at reduced speed.

5.5.Gas system

Gas systems for domestic use shall be of the vapour-withdrawal type and shall be designed and installed so as to avoid leaks and the risk of explosion and be capable of being tested for leaks. Materials and components shall be suitable for the specific gas used to withstand the stresses and exposures found in the marine environment.

Each gas appliance intended by the manufacturer for the application for which it is used shall be so installed in accordance with the manufacturer’s instructions. Each gas-consuming appliance must be supplied by a separate branch of the distribution system, and each appliance must be controlled by a separate closing device. Adequate ventilation must be provided to prevent hazards from leaks and products of combustion.

All watercraft with a permanently installed gas system shall be fitted with an enclosure to contain all gas cylinders. The enclosure shall be separated from the living quarters, accessible only from the outside and ventilated to the outside so that any escaping gas drains overboard.

In particular, any permanently installed gas system shall be tested after installation.

5.6.Fire protection
5.6.1.General

The type of equipment installed and the layout of the watercraft shall take account of the risk and spread of fire. Special attention shall be paid to the surroundings of open flame devices, hot areas or engines and auxiliary machines, oil and fuel overflows, uncovered oil and fuel pipes and routing of electrical wiring in particular away from heat sources and hot areas.

5.6.2.Fire-fighting equipment

Recreational craft shall be supplied with fire-fighting equipment appropriate to the fire hazard, or the position and capacity of fire-fighting equipment appropriate to the fire hazard shall be indicated. The craft shall not be put into service until the appropriate fire-fighting equipment is in place. Petrol engine compartments shall be protected by a fire extinguishing system that avoids the need to open the compartment in the event of fire. Where fitted, portable fire extinguishers shall be readily accessible and one shall be so positioned that it can easily be reached from the main steering position of the recreational craft.

5.7.Navigation lights, shapes and sound signals

Where navigation lights, shapes and sound signals are fitted, they shall comply with the 1972 COLREG (The International Regulations for Preventing Collisions at Sea) or CEVNI (European Code for Interior Navigations for inland waterways) Regulations as appropriate.

5.8.Discharge prevention and installations facilitating the delivery ashore of waste

Watercraft shall be constructed so as to prevent the accidental discharge of pollutants (oil, fuel, etc.) overboard.

Any toilet fitted in a recreational craft shall be connected solely to a holding tank system or water treatment system.

Recreational craft with installed holding tanks shall be fitted with a standard discharge connection to enable pipes of reception facilities to be connected with the recreational craft discharge pipeline.

In addition, any through-the-hull pipes for human waste shall be fitted with valves which are capable of being secured in the closed position.

B.Essential requirements for exhaust emissions from propulsion engines

Propulsion engines shall comply with the essential requirements for exhaust emissions set out in this Part.

1.PROPULSION ENGINE IDENTIFICATION

1.1.Each engine shall be clearly marked with the following information:
(a)

engine manufacturer’s name, registered trade name or registered trade mark and contact address; and, if applicable, the name and contact address of the person adapting the engine;

(b)

engine type, engine family, if applicable;

(c)

a unique engine serial number;

(d)

[F156CE marking, as provided for in Article 18.]

[F156UK marking, as provided for in regulation 54.]

Textual Amendments

1.2.The marks referred to in point 1.1 must be durable for the normal life of the engine and must be clearly legible and indelible. If labels or plates are used, they must be attached in such a manner that the fixing is durable for the normal life of the engine, and the labels/plates cannot be removed without destroying or defacing them.
1.3.The marks must be secured to an engine part necessary for normal engine operation and not normally requiring replacement during the engine life.
1.4.The marks must be located so as to be readily visible after the engine has been assembled with all the components necessary for engine operation.

2.EXHAUST EMISSION REQUIREMENTS

Propulsion engines shall be designed, constructed and assembled so that when correctly installed and in normal use, emissions shall not exceed the limit values obtained from point 2.1, Table 1 and point 2.2, Tables 2 and 3:

2.1.Values applying for the purposes of Article 55(2) and Table 2 of point 2.2:
Table 1
(g/kWh)
TypeCarbon monoxideHydrocarbonsNitrogen oxidesNOxParticulatesPT
ABnABn
Two-stroke spark ignition150,0600,01,030,0100,00,7510,0Not applicable
Four-stroke spark ignition150,0600,01,06,050,00,7515,0Not applicable
Compression ignition5,0001,52,00,59,81,0

Where A, B and n are constants in accordance with the table, PN is the rated engine power in kW.

2.2.Values applying from 18 January 2016:
Table 2

Exhaust emission limits for compression ignition (CI) engines(20)

a
+

Alternatively, compression-ignition engines with rated engine power at or above 37 kW and below 75 kW and with a swept volume below 0,9 L/cyl shall not exceed a PT emission limit of 0,20 g/kWh and a combined emission limit of 5,8 g/kWh.

b
++

Any compression-ignition engine shall not exceed a Carbon monoxide (CO) emission limit of 5,0 g/kWh.

Swept VolumeSV(L/cyl)Rated Engine Power PN(kW)ParticulatesPT(g/kWh)Hydrocarbons + Nitrogen Oxides(g/kWh)
The values referred to in table 1
(19)0,34,7
0,155,8
0,145,8
0,125,8
0,125,8
0,115,8
Table 3

Exhaust emission limits for spark ignition (SI) engines

Type of engineRated EnginePower PN(kW)Carbon monoxideCO(g/kWh)Hydrocarbons + Nitrogen Oxides(g/kWh)
Stern-drive and inboard engines755
35016
35022
Outboard engines and PWC engines30
300
2.3.Test cycles:

Test cycles and weighting factors to be applied:

The following requirements of ISO standard 8178-4:2007 shall be used, taking into account the values set out in the table below.

For variable speed CI engines test cycle E1 or E5 shall be applied or alternatively, above 130 kW, test cycle E3 may be applied. For variable speed SI engines test cycle E4 shall be applied.

Cycle E1, Mode number12345
SpeedRated speedIntermediate speedLow-idle speed
Torque, %1007575500
Weighting factor0,080,110,190,320,3
SpeedRated speedIntermediate speedLow-idle speed
Cycle E3, Mode number1234
Speed, %100918063
Power, %100755025
Weighting factor0,20,50,150,15
Cycle E4, Mode number12345
Speed, %100806040Idle
Torque, %10071,646,525,30
Weighting factor0,060,140,150,250,4
Cycle E5, Mode number12345
Speed, %100918063Idle
Power, %1007550250
Weighting factor0,080,130,170,320,3

[F157Notified] [F157Approved] bodies may accept tests carried out on the basis of other tests cycles as specified in a [F158harmonised] [F158designated] standard and as applicable for the engine duty cycle.

Textual Amendments

2.4.Application of the propulsion engine family and choice of parent propulsion engine

The engine manufacturer shall be responsible for defining those engines from his range which are to be included in an engine family.

A parent engine shall be selected from an engine family in such a way that its emissions characteristics are representative for all engines in that engine family. The engine incorporating those features that are expected to result in the highest specific emissions (expressed in g/kWh), when measured on the applicable test cycle, should normally be selected as the parent engine of the family.

2.5.Test fuels

The test fuel used for exhaust emission testing shall meet the following characteristics:

Petrol Fuels
PropertyRF-02-99UnleadedRF-02-03Unleaded
minmaxminmax
Research Octane Number (RON)95—95—
Motor Octane Number (MON)85—85—
Density at 15 oC (kg/m3)748762740754
Initial boiling point (°C)24402440
Mass fraction of sulphur (mg/kg)—100—10
Lead content (mg/l)—5—5
Reid vapour pressure (kPa)5660——
Vapour pressure (DVPE) (kPa)——5660
Diesel Fuels
PropertyRF-06-99RF-06-03
minmaxminmax
Cetane number52545254
Density at 15 oC (kg/m3)833837833837
Final boiling point (°C)—370—370
Flash point (°C)55—55—
Mass fraction of sulphur (mg/kg)To be reported300 (50)—10
Mass fraction of ash (%)To be reported0,01—0,01

[F159Notified] [F159Approved] bodies may accept tests carried out on the basis of other tests fuel as specified in a [F160harmonised] [F160designated] standard.

Textual Amendments

3.DURABILITY

The manufacturer of the engine shall supply engine installation and maintenance instructions, which if applied should mean that the engine in normal use will continue to comply with the limits set out in points 2.1 and 2.2 throughout the normal life of the engine and under normal conditions of use.

This information shall be obtained by the engine manufacturer by use of prior endurance testing, based on normal operating cycles, and by calculation of component fatigue so that the necessary maintenance instructions may be prepared by the manufacturer and issued with all new engines when first placed on the market.

The normal life of the engine is as follows:

(a)

For CI engines: 480 hours of operation or 10 years, whichever occurs first;

(b)

For SI inboard or stern drive engines with or without integral exhaust:

(i)

for the engine category : 480 hours of operation or 10 years, whichever occurs first,

(ii)

for engines in the category : 150 hours of operation or three years, whichever occurs first,

(iii)

for the engine category : 50 hours of operation or one year, whichever occurs first;

(c)

personal watercraft engines: 350 hours of operation or five years, whichever occurs first;

(d)

outboard engines: 350 hours of operation or 10 years, whichever occurs first

4.OWNER’S MANUAL

Each engine shall be provided with an owner’s manual in [F161a language or languages which can be easily understood by consumers and other end-users, as determined by the [F162relevant state] in which the engine is to be marketed] [F161English].

Textual Amendments

The owner’s manual shall:

(a)

provide instructions for the installation, use and maintenance needed to assure the proper functioning of the engine to meet the requirements of Section 3 (Durability);

(b)

specify the power of the engine when measured in accordance with the [F163harmonised] [F163designated] standard.

Textual Amendments

C.Essential requirements for noise emissions

Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall comply with the essential requirements for noise emissions set out in this Part.

1.NOISE EMISSION LEVELS

1.1.Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall be designed, constructed and assembled so that noise emissions shall not exceed the limit values in the following table:
Rated Engine Power(single engine)In kWMaximum Sound Pressure Level = LpASmaxIn dB
67
72
75

where PN = rated engine power in kW of a single engine at rated speed and LpASmax = maximum sound pressure level in dB.

For twin-engine and multiple-engine units of all engine types an allowance of 3 dB may be applied.

1.2.As an alternative to sound measurement tests, recreational craft with inboard engine configuration or stern drive engine configuration, without integral exhaust, shall be deemed to comply with the noise requirements set out in point 1.1 if they have a Froude number of ≤ 1,1 and a Power to Displacement ratio of ≤ 40 and where the engine and exhaust system are installed in accordance with the engine manufacturer’s specifications.
1.3.‘Froude number’ Fn shall be calculated by dividing the maximum recreational craft speed V (m/s) by the square root of the waterline length lwl (m) multiplied by a given gravitational acceleration constant, g, of 9,8 m/s2.

‘Power to Displacement ratio’ shall be calculated by dividing the rated engine power PN (in kW) by the recreational craft’s displacement D (in tonnes)

2.OWNER’S MANUAL

For recreational craft with inboard engine or stern drive engines without integral exhaust and personal watercraft, the owner’s manual required under point 2.5 of Part A, shall include information necessary to maintain the recreational craft and exhaust system in a condition that, insofar as is practicable, will ensure compliance with the specified noise limit values when in normal use.

For outboard engines and stern drive engines with integral exhaust, the owner’s manual required under Section 4 of Part B shall provide the instructions necessary to maintain the engine in a condition, that insofar as is practicable, will ensure compliance with the specified noise limit values when in normal use.

3.DURABILITY

The provisions on the durability in Section 3 of Part B shall apply mutatis mutandis to the compliance with the requirements on noise emissions set out in Section 1 of this part.

Regulation 2(1)

SCHEDULE 2U.K.(Annex II of the Directive)COMPONENTS OF WATERCRAFT

Commencement Information

I81Sch. 2 in force at 3.8.2017, see reg. 1

(1)

Ignition-protected equipment for inboard and stern drive petrol engines and petrol tank spaces;

(2)

Start-in-gear protection devices for outboard engines;

(3)

Steering wheels, steering mechanisms and cable assemblies;

(4)

Fuel tanks intended for fixed installations and fuel hoses;

(5)

Prefabricated hatches, and port lights.

Regulation 7

SCHEDULE 3U.K.(Annex III of the Directive)DECLARATION BY THE MANUFACTURER OR THE IMPORTER OF THE PARTLY COMPLETED WATERCRAFT (ARTICLE 6(2))

Commencement Information

I82Sch. 3 in force at 3.8.2017, see reg. 1

The declaration by the manufacturer or the importer [F164established in the Union referred to in Article 6(2)] [F164established in the United Kingdom referred to in regulation 7(1)(b)] shall contain the following:

Textual Amendments

(a)

the name and address of the manufacturer;

(b)

the name and address of the representative of the manufacturer [F165established in the Union] [F165established in the United Kingdom] or, if appropriate, of the person responsible for the placing on the market;

(c)

a description of the partly completed watercraft;

(d)

a statement that the partly completed watercraft complies with the essential requirements that apply at this stage of construction; this shall include references to the relevant [F166harmonised] [F166designated] standards used, or references to the specifications in relation to which compliance is declared at this stage of construction; furthermore, it is intended to be completed by other legal or natural persons in full compliance with [F167this Directive] [F167these Regulations].

Textual Amendments

Regulation 10

SCHEDULE 4U.K.(Annex IV of the Directive)[F168EU] DECLARATION OF CONFORMITY No xxxxx

Textual Amendments

Commencement Information

I83Sch. 4 in force at 3.8.2017, see reg. 1

1.

No xxxxx (Product: product, batch, type, or serial number):

2.

Name and address of the manufacturer or his authorised representative [The authorised representative must also give the business name and address of the manufacturer] or the private importer.

3.

This declaration of conformity is issued under the sole responsibility of the manufacturer or the private importer or the person referred to in [F169Article 19(3) or (4) of Directive 2013/53/EU][F169regulation 43(2) or (3) of the Recreational Craft Regulations 2017 (S.I. 2017/737, “the Regulations”)].

4.

Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):

5.

The object of the declaration described in point 4 is in conformity with the relevant [F170Union harmonisation legislation] [F170statutory requirements]:

6.

References to the relevant [F171harmonised] [F171designated] standards used or references to the other technical specifications in relation to which conformity is declared:

7.

Where applicable, the [F172notified] [F172approved] body … (name, number) performed … (description of intervention) and issued the certificate:

8.

Identification of the person empowered to sign on behalf of the manufacturer or his authorised representative

9.

Additional information:

The [F173EU] declaration of conformity shall include a statement of the propulsion engine manufacturer and that of the person adapting an engine in accordance with [F174points (b) and (c) of Article 6(4)] [F174regulation 7(1)(c)(iii)] that:

(a)

when installed in a watercraft, in accordance with the installation instructions accompanying the engine, the engine will meet:

(i)

the exhaust emission requirements of [F175this Directive] [F175the Regulations];

(ii)

[F176the limits of Directive 97/68/EC as regards engines type-approved in accordance with Directive 97/68/EC which are in compliance with stage III A, stage III B or stage IV emission limits for CI engines used in other applications than propulsion of inland waterway vessels, locomotives and railcars, as provided for in point 4.1.2 of Annex I to that Directive;] or

(iii)

the limits of Regulation (EC) No 595/2009 as regards engines type-approved in accordance with that Regulation.

The engine must not be put into service until the watercraft into which it is to be installed has been declared in conformity, if so required, with the relevant provision of [F175this Directive] [F175the Regulations].

If the engine has been placed on the market during the additional transitional period provided for in [F177Article 55(2)] [F177regulation 89(2)], the [F173EU] declaration of conformity shall contain an indication thereof.

Signed for and on behalf of:

(place and date of issue)

(name, function) (signature)

Textual Amendments

Regulation 48

SCHEDULE 5U.K.(Annex V of the Directive)EQUIVALENT CONFORMITY BASED ON POST-CONSTRUCTION ASSESSMENT (MODULE PCA)

Commencement Information

I84Sch. 5 in force at 3.8.2017, see reg. 1

1.

Conformity based on post-construction assessment is the procedure to assess the equivalent conformity of a product for which the manufacturer has not assumed the responsibility for the product’s conformity with [F178this Directive] [F178these Regulations], and whereby a natural or legal person referred to in [F179Article 19(2), (3) or (4)] [F179regulation 43(1), (2) or (3)] who is placing the product on the market or putting it into service under his own responsibility is assuming the responsibility for the equivalent conformity of the product. This person shall fulfill the obligations laid down in points 2 and 4 and ensure and declare on his sole responsibility that the product concerned, which has been subject to the provisions of point 3, is in conformity with the applicable requirements of [F178this Directive] [F178these Regulations].

2.

The person who is placing the product on the market or putting it into service shall lodge an application for a post-construction assessment of the product with [F180a notified] [F180an approved] body and must provide [F181the notified] [F181the approved] body with the documents and technical file enabling [F181the notified] [F181the approved] body to assess the conformity of the product with the requirements of [F178this Directive] [F178these Regulations] and any available information on the use of the product after its first putting into service.

The person who is placing such a product on the market or putting it into service shall keep these documents and information at the disposal of the [F182relevant national authorities] [F182enforcing authority] for 10 years after the product has been assessed on its equivalent conformity in accordance with the post-construction assessment procedure.

3.

The [F183notified] [F183approved] body shall examine the individual product and carry out calculations, tests and other assessments, to the extent necessary to ensure that the equivalent conformity of the product with the relevant requirements of [F178this Directive] [F178these Regulations] is demonstrated.

The [F183notified] [F183approved] body shall draw up and issue a certificate and a related report of conformity concerning the assessment carried out and shall keep a copy of the certificate and related report of conformity at the disposal of the [F184national authorities] [F184enforcing authority] for 10 years after it has issued these documents.

The [F183notified] [F183approved] body shall affix its identification number next to the [F185CE] [F185UK] marking on the approved product or have it affixed under its responsibility.

In case the assessed product is a watercraft, the [F183notified] [F183approved] body shall also have affixed, under his responsibility, the watercraft identification number as referred to in point 2.1 of Part A of [F186Annex I] [F186Schedule 1], whereby the field for the country code of the manufacturer shall be used to indicate the country of establishment of the [F183notified] [F183approved] body and the fields for the unique code of the manufacturer assigned by [F187the national authority of the [F188relevant state]] [F187or on behalf of the Secretary of State] to indicate the post-construction assessment identification code assigned to the [F183notified] [F183approved] body, followed by the serial number of the post-construction assessment certificate. The fields in the watercraft identification number for the month and year of production and for the model year shall be used to indicate the month and year of the post-construction assessment.

4.

[F189CE marking and EU declaration of conformity][F189UK marking and declaration of conformity]

4.1.

The person who is placing the product on the market or putting it into service shall affix the [F190CE] [F190UK] marking and, under the responsibility of the [F191notified] [F191approved] body referred to in Section 3, the latter’s identification number to the product for which the [F191notified] [F191approved] body has assessed and certified its equivalent conformity with the relevant requirements of [F178this Directive] [F178these Regulations].

4.2.

The person who is placing the product on the market or putting it into service shall draw up [F192an EU] [F192a] declaration of conformity and keep it at the disposal of the [F193national authorities] [F193enforcing authority] for 10 years after the date the post-construction assessment certificate has been issued. The declaration of conformity shall identify the product for which it has been drawn up.

A copy of [F194the EU] [F194the] declaration of conformity shall be made available to the [F195relevant authorities] [F195enforcing authority] upon request.

4.3.

In the case the assessed product is a watercraft, the person who is placing the watercraft on the market or putting it into service shall affix to the watercraft the builder’s plate described in point 2.2 of Part A of [F196Annex I] [F196Schedule 1], which shall include the words ‘post-construction assessment’, and the watercraft identification number described in point 2.1 of Part A of [F196Annex I] [F196Schedule 1], in accordance with the provisions set out in Section 3.

5.

The [F197notified] [F197approved] body shall inform the person who is placing the product on the market or putting it into service of his obligations under this post-construction assessment procedure.

Textual Amendments

Regulation 50

SCHEDULE 6U.K.(Annex VI of the Directive)SUPPLEMENTARY REQUIREMENTS WHEN INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCTION TESTS SET OUT IN MODULE A1 IS USED (ARTICLE 24(2))

Commencement Information

I85Sch. 6 in force at 3.8.2017, see reg. 1

Design and construction

On one or several watercrafts representing the production of the manufacturer one or more of the following tests, equivalent calculation or control shall be carried out by the manufacturer or on his behalf:

(a)

test of stability in accordance with point 3.2 of Part A of [F198Annex I] [F198Schedule 1];

(b)

test of buoyancy characteristics in accordance with point 3.3 of Part A of [F198Annex I] [F198Schedule 1].

Textual Amendments

Noise emissions

For recreational craft fitted with inboard or stern drive engines without integral exhaust and for personal watercraft, on one or several watercraft representing the production of the watercraft manufacturer, the sound emission tests defined in Part C of [F198Annex I] [F198Schedule 1] shall be carried out by the watercraft manufacturer, or on his behalf, under the responsibility of [F199a notified] [F199an approved] body chosen by the manufacturer.

Textual Amendments

For outboard engines and stern drive engines with integral exhaust, on one or several engines of each engine family representing the production of the engine manufacturer, the sound emission tests defined in Part C of [F198Annex I] [F198Schedule 1] shall be carried out by the engine manufacturer, or on his behalf, under the responsibility of [F199a notified] [F199an approved] body chosen by the manufacturer.

Where more than one engine of an engine family is tested, the statistical method described in [F200Annex VII] [F200Schedule 7] shall be applied to ensure conformity of the sample.

Textual Amendments

Regulation 51

SCHEDULE 7U.K.(Annex VII of the Directive)CONFORMITY OF PRODUCTION ASSESSMENT FOR EXHAUST AND NOISE EMISSIONS

Commencement Information

I86Sch. 7 in force at 3.8.2017, see reg. 1

1.

For verifying the conformity of an engine family, a sample of engines shall be taken from the series. The manufacturer shall decide the size (n) of the sample, in agreement with the [F201notified] [F201approved] body.

2.

The arithmetical mean X of the results obtained from the sample shall be calculated for each regulated component of the exhaust and noise emission. The production of the series shall be deemed to conform to the requirements (‘pass decision’) if the following condition is met:

S is standard deviation, where:

X

=

the arithmetical mean of the results obtained from the sample

x

=

the individual results obtained from the sample

L

=

the appropriate limit value

n

=

the number of engines in the sample

k

=

statistical factor depending on n (see table below)

If n ≥ 20 then .

n2345678910111213141516171819
k0,9730,6130,4890,4210,3760,3420,3170,2960,2790,2650,2530,2420,2330,2240,2160,210,2030,198

Textual Amendments

Regulation 52

SCHEDULE 8U.K.(Annex VIII of the Directive)SUPPLEMENTARY PROCEDURE TO BE APPLIED UNDER CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)

Commencement Information

I87Sch. 8 in force at 3.8.2017, see reg. 1

In the cases referred to in [F202Article 24(5)] [F202regulation 52] when the quality level appears unsatisfactory, the following procedure shall apply:

Textual Amendments

An engine is taken from the series and subjected to the test described in Part B of [F203Annex I] [F203Schedule 1]. Test engines shall have been run in, partially or completely, in accordance with the manufacturer’s specifications. If the specific exhaust emissions of the engine taken from the series exceed the limit values in accordance with Part B of [F203Annex I] [F203Schedule 1], the manufacturer may ask for measurements to be done on a sample of engines taken from the series and including the engine originally taken. To ensure the conformity of the sample of engines with the requirements of [F204this Directive] [F204these Regulations], the statistical method described in [F205Annex VII] [F205Schedule 7] shall be applied.

Textual Amendments

Regulation 9

SCHEDULE 9U.K.(Annex IX of the Directive)TECHNICAL DOCUMENTATION

Commencement Information

I88Sch. 9 in force at 3.8.2017, see reg. 1

The technical documentation [F206referred to in Article 7(2) and Article 25] shall, as far as it is relevant for the assessment, contain the following:

(a)

A general description of the type;

(b)

Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data;

(c)

Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;

(d)

A list of the standards referred to in [F207Article 14] [F207regulation 41], applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in [F207Article 14] [F207regulation 41] have not been applied;

(e)

Results of design calculations made, examinations carried out and other relevant data;

(f)

Test reports, or calculations namely on stability in accordance with point 3.2 of Part A of [F208Annex I] [F208Schedule 1] and on buoyancy in accordance with point 3.3 of Part A of [F208Annex I] [F208Schedule 1];

(g)

Exhaust emissions test reports demonstrating compliance with Section 2 of Part B of [F208Annex I] [F208Schedule 1];

(h)

Sound emissions test reports demonstrating compliance with Section 1 of Part C of [F208Annex I] [F208Schedule 1].

Textual Amendments

Regulation 49

SCHEDULE 10U.K.EU-type examination

[F2091.  For the purposes of regulation 49, the conformity assessment carried out in accordance with Module B will be carried out in the manner set out in paragraphs 2, 3 and 4.U.K.

Textual Amendments

Commencement Information

I89Sch. 10 para. 1 in force at 3.8.2017, see reg. 1

2.  The conformity assessment must include an assessment of the adequacy of the technical design of the watercraft through examination of the technical documentation specified in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the watercraft (combination of production type and design type).U.K.

Textual Amendments

Commencement Information

I90Sch. 10 para. 2 in force at 3.8.2017, see reg. 1

3.  The conformity assessment must include an assessment of the adequacy of the following technical documentation—U.K.

(a)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc;

(b)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the watercraft;

(c)a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(d)results of design calculations made, examinations carried out, etc.;

(e)test reports; and

(f)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer’s behalf and under the manufacturer’s responsibility.

Textual Amendments

Commencement Information

I91Sch. 10 para. 3 in force at 3.8.2017, see reg. 1

4.  The technical documentation must include a general description of the watercraft.]U.K.

Textual Amendments

Commencement Information

I92Sch. 10 para. 4 in force at 3.8.2017, see reg. 1

Regulation 2(1)

SCHEDULE 11U.K.[F210Requirements of notified bodies][F210Requirements of approved bodies]

Textual Amendments

1.  A conformity assessment body must be established in the United Kingdom and have legal personality.U.K.

Commencement Information

I93Sch. 11 para. 1 in force at 3.8.2017, see reg. 1

2.  A conformity assessment body must be a third-party body independent of the organisation or the watercraft it assesses.U.K.

Commencement Information

I94Sch. 11 para. 2 in force at 3.8.2017, see reg. 1

3.  A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.U.K.

Commencement Information

I95Sch. 11 para. 3 in force at 3.8.2017, see reg. 1

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment must not be the—U.K.

(a)designer;

(b)manufacturer;

(c)supplier;

(d)installer;

(e)purchaser;

(f)owner;

(g)user; or

(h)maintainer

of the watercraft which the conformity assessment body assesses, nor the representative body of any of these persons.

Commencement Information

I96Sch. 11 para. 4 in force at 3.8.2017, see reg. 1

5.  Nothing in paragraph 4 of this Schedule will preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.U.K.

Commencement Information

I97Sch. 11 para. 5 in force at 3.8.2017, see reg. 1

6.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment must not be directly involved in the—U.K.

(a)design or manufacture;

(b)marketing;

(c)installation;

(d)use or maintenance

of the watercraft, or represent the persons engaged in those activities.

Commencement Information

I98Sch. 11 para. 6 in force at 3.8.2017, see reg. 1

7.  A conformity assessment body must not engage in any activity, including consultancy services, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are [F211approved].E+W+S

Extent Information

E40This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I99Sch. 11 para. 7 in force at 3.8.2017, see reg. 1

7.  A conformity assessment body must not engage in any activity, including consultancy services, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.N.I.

Extent Information

E91This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I182Sch. 11 para. 7 in force at 3.8.2017, see reg. 1

8.  Conformity assessment bodies must ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.U.K.

Commencement Information

I100Sch. 11 para. 8 in force at 3.8.2017, see reg. 1

9.  Conformity assessment bodies and their personnel must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.U.K.

Commencement Information

I101Sch. 11 para. 9 in force at 3.8.2017, see reg. 1

10.  A conformity assessment body must be capable of carrying out the conformity assessment tasks assigned to it by regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)) and in relation to which it has been [F211approved], whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.E+W+S

Extent Information

E41This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I102Sch. 11 para. 10 in force at 3.8.2017, see reg. 1

10.  A conformity assessment body must be capable of carrying out the conformity assessment tasks assigned to it by regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)) and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.N.I.

Extent Information

E92This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I183Sch. 11 para. 10 in force at 3.8.2017, see reg. 1

11.  At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been [F211approved], a conformity assessment body must have at its disposal, the necessary—E+W+S

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures;

(c)policies and procedures in place to distinguish between tasks that it carries out as [F212an approved] body and other activities;

(d)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the watercraft in question and the mass or serial nature of the production process; and

(e)means to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to all necessary equipment and facilities to perform these activities.

Extent Information

E42This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I103Sch. 11 para. 11 in force at 3.8.2017, see reg. 1

11.  At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body must have at its disposal, the necessary—N.I.

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures;

(c)policies and procedures in place to distinguish between tasks that it carries out as a notified body and other activities;

(d)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the watercraft in question and the mass or serial nature of the production process; and

(e)means to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to all necessary equipment and facilities to perform these activities.

Extent Information

E93This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I184Sch. 11 para. 11 in force at 3.8.2017, see reg. 1

12.  The personnel responsible for carrying out the conformity assessment activities must have—E+W+S

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [F211approved];

(b)satisfactory knowledge of the requirements of the assessments that they carry out and adequate authority to carry out those assessments.

Textual Amendments

Commencement Information

I104Sch. 11 para. 12 in force at 3.8.2017, see reg. 1

12.  The personnel responsible for carrying out the conformity assessment activities must have—N.I.

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments that they carry out and adequate authority to carry out those assessments.

Extent Information

E94This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I185Sch. 11 para. 12 in force at 3.8.2017, see reg. 1

Regulation 2(1)

SCHEDULE 12U.K.[F213Operational requirements of notified bodies] [F213Operational requirements of approved bodies]

Textual Amendments

1.  [F214Approved] bodies must carry out conformity assessments in accordance with the conformity assessment procedures provided for in regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)).E+W+S

Extent Information

E43This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I105Sch. 12 para. 1 in force at 3.8.2017, see reg. 1

1.  Notified bodies must carry out conformity assessments in accordance with the conformity assessment procedures provided for in regulations 42 (applicable conformity assessment procedures) to 52 (conformity assessments carried out under module C (conformity to type based on internal production control)).N.I.

Extent Information

E95This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I186Sch. 12 para. 1 in force at 3.8.2017, see reg. 1

2.  Conformity assessments must be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators and private importers. Conformity assessment bodies must perform their activities taking due account of the size of an undertaking the sector in which it operates, its structure, the degree of complexity of the watercraft technology in question and the mass or serial nature of the production process.U.K.

Commencement Information

I106Sch. 12 para. 2 in force at 3.8.2017, see reg. 1

3.  Conformity assessment bodies must respect the degree of rigour and level of protection required for the compliance of the watercraft with [F215these Regulations].E+W+S

Extent Information

E44This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I107Sch. 12 para. 3 in force at 3.8.2017, see reg. 1

3.  Conformity assessment bodies must respect the degree of rigour and level of protection required for the compliance of the watercraft with the Directive.N.I.

Extent Information

E96This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I187Sch. 12 para. 3 in force at 3.8.2017, see reg. 1

4.  Where [F216an approved] body finds that the requirements of regulation 6 (essential requirements) and Schedule 1 or the corresponding [F217designated] standards have not been met by the manufacturer or a private importer, that body must require that the manufacturer or private importer takes appropriate corrective measures and must not issue a conformity assessment certificate until the appropriate corrective measures have been taken.E+W+S

Extent Information

E45This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I108Sch. 12 para. 4 in force at 3.8.2017, see reg. 1

4.  Where a notified body finds that the requirements of regulation 6 (essential requirements) and Schedule 1 or the corresponding harmonised standards have not been met by the manufacturer or a private importer, that body must require that the manufacturer or private importer takes appropriate corrective measures and must not issue a conformity assessment certificate until the appropriate corrective measures have been taken.N.I.

Extent Information

E97This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I188Sch. 12 para. 4 in force at 3.8.2017, see reg. 1

5.  Where, in the course of the monitoring of the conformity of the watercraft following the issue of a conformity assessment certificate, [F218an approved] body finds that a watercraft is no longer in compliance, it will require the manufacturer to take appropriate corrective measures and must suspend or withdraw the conformity assessment certificate if necessary.E+W+S

Extent Information

E46This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I109Sch. 12 para. 5 in force at 3.8.2017, see reg. 1

5.  Where, in the course of the monitoring of the conformity of the watercraft following the issue of a conformity assessment certificate, a notified body finds that a watercraft is no longer in compliance, it will require the manufacturer to take appropriate corrective measures and must suspend or withdraw the conformity assessment certificate if necessary.N.I.

Extent Information

E98This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I189Sch. 12 para. 5 in force at 3.8.2017, see reg. 1

6.  Where corrective measures are not taken or do not have the required corrective effect, the [F219approved] body must restrict, suspend or withdraw any conformity assessment certificates as appropriate.E+W+S

Extent Information

E47This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I110Sch. 12 para. 6 in force at 3.8.2017, see reg. 1

6.  Where corrective measures are not taken or do not have the required corrective effect, the notified body must restrict, suspend or withdraw any conformity assessment certificates as appropriate.N.I.

Extent Information

E99This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I190Sch. 12 para. 6 in force at 3.8.2017, see reg. 1

7.—(1) [F220An approved] body must inform the Secretary of State in writing of—E+W+S

(a)any refusal, restriction, suspension or withdrawal of a conformity assessment certificate;

(b)any circumstances affecting the scope of and conditions for [F221approval]; and

(c)any request for information which [F222the approved] body has received from a market surveillance authority regarding conformity assessment activities.

(2) [F223An approved] body must, following a request from the Secretary of State, inform the Secretary of State in writing of any conformity assessment activities performed within the scope of its [F221approval] provided under regulation 56 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E48This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I111Sch. 12 para. 7 in force at 3.8.2017, see reg. 1

7.—(1) A notified body must inform the Secretary of State in writing of—N.I.

(a)any refusal, restriction, suspension or withdrawal of a conformity assessment certificate;

(b)any circumstances affecting the scope of and conditions for notification; and

(c)any request for information which the notified body has received from a market surveillance authority regarding conformity assessment activities.

(2) A notified body must, following a request from the Secretary of State, inform the Secretary of State in writing of any conformity assessment activities performed within the scope of its notification provided under regulation 56 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E100This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I191Sch. 12 para. 7 in force at 3.8.2017, see reg. 1

8.  [F224An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—E+W+S

(a)to refuse to issue a certificate of conformity or grant approval; and

(b)to restrict, suspend or withdraw a certificate of conformity or approval.

Extent Information

E49This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I112Sch. 12 para. 8 in force at 3.8.2017, see reg. 1

8.  A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—N.I.

(a)to refuse to issue a certificate of conformity or grant approval; and

(b)to restrict, suspend or withdraw a certificate of conformity or approval.

Extent Information

E101This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I192Sch. 12 para. 8 in force at 3.8.2017, see reg. 1

9.  [F225An approved] body must provide other bodies [F226approved] under these Regulations carrying on similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Extent Information

E50This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I113Sch. 12 para. 9 in force at 3.8.2017, see reg. 1

9.  A notified body must provide other bodies notified under these Regulations carrying on similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.N.I.

Extent Information

E102This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I193Sch. 12 para. 9 in force at 3.8.2017, see reg. 1

10.  [F227An approved] body must participate in the work of [F228any approved body coordination group established by the Secretary of State], directly or by means of its designated representatives.E+W+S

Extent Information

E51This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Commencement Information

I114Sch. 12 para. 10 in force at 3.8.2017, see reg. 1

10.  A notified body must participate in the work of any notified body coordination group established under the Directive, directly or by means of its designated representatives.N.I.

Extent Information

E103This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I194Sch. 12 para. 10 in force at 3.8.2017, see reg. 1

Regulation 67

SCHEDULE 13U.K.Enforcement and investigatory powers conferred on the market surveillance authority

Enforcement powers under the 1987 ActU.K.

1.  For the purposes of enforcing these Regulations, the following sections of the 1987 Act apply subject to the modifications in paragraph 2—

(a)section 13 (prohibition notices and notices to warn);

(b)section 14 (suspension notices);

(c)section 16 (forfeiture: England and Wales and Northern Ireland);

(d)section 17 (forfeiture: Scotland);

(e)section 18 (power to obtain information);

(f)section 19 (interpretation of Part II);

(g)section 29 (powers of search etc);

(h)section 30 (provisions supplemental to s 29);

(i)section 31 (powers of customs officer to detain goods);

(j)section 33 (appeals against detention of goods);

(k)section 34 (compensation for seizure and detention);

(l)section 35 (recovery of expenses of enforcement);

(m)section 37 (power of Commissioners for Revenue and Customs);

(n)section 42 (reports, etc.);

(o)section 45 (interpretation);

(p)section 46(1) (meaning of “supply”);

(q)Schedule 2 (prohibition notices and notices to warn).

Commencement Information

I115Sch. 13 para. 1 in force at 3.8.2017, see reg. 1

Modifications to the 1987 ActU.K.

2.  The sections of the 1987 Act referred to in paragraph 1 are to apply as if—

(a)in section 13—

(i)in subsection (1), for “unsafe” on each occasion that it appears, there were substituted “non-compliant”;

(ii)in subsection (1), “relevant” were omitted on each occasion that it appears;

(iii)in subsection (2), the words from “; and the Secretary of State may” to the end were omitted;

(iv)in subsection (4), the words “three months” were substituted for the words “six months;”

(v)subsections (5) to (7) were omitted;

(b)in section 14—

(i)in subsection (1), after “any safety provision has been contravened in relation to the goods”, there were inserted “or that such goods present a risk”;

(ii)in subsection (2)(b), after “a safety provision has been contravened in relation to the goods”, there were inserted “or that such goods present a risk”;

(iii)in subsection (2)(c), “under section 15 below” was omitted;

(iv)subsections (6) to (8) were omitted;

(c)in section 16—

(i)in subsection (1), after “a contravention in relation to the goods of a safety provision” there were inserted “or that such goods present a risk”;

(ii)in subsection (3), after “a contravention in relation to the goods of a safety provision” there were inserted “or that such goods present a risk”;

(iii)after subsection (4), there were inserted—

“(4A) A court may infer for the purposes of this section that any goods present a risk, if it is satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).”;

(d)in section 17—

(i)in subsection (1), after “a contravention of a safety provision”, there were inserted “or where the goods present a risk”;

(ii)in subsection (6), after “a contravention in relation to those goods of a safety provision” there were inserted “or that those goods present a risk”;

(iii)after subsection (7), there were inserted—

“(7A) The Sheriff may infer for the purposes of this section that any goods present a risk, if satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).”;

(e)in section 18, subsections (3) and (4) were omitted;

(f)in section 29—

(i)in subsection (4)(a), after “any contravention of any safety provision in relation to the goods” there were inserted “or whether the goods present a risk”;

(ii)in subsection (4)(b), after “any such contravention” there were inserted “or whether the goods present a risk”;

(g)in section 30—

(i)at the end of subsection (2)(a)(ii), for “and” there were substituted “or”;

(ii)after subsection (2)(a)(ii), there were inserted—

“(iii)that any goods which any officer has power to inspect under section 29 are on any premises and their inspection is likely to demonstrate that they present a risk; and”; and

(iii)subsections (5), (7) and (8) were omitted;

(h)in section 31(1), for “Part II of this Act”, there were substituted “the 2017 Regulations”;

(i)in section 34—

(i)omit the word “and” at the end of subsection (1)(a); and

(ii)after that subsection, insert—

“(aa)the goods do not present a risk; and”;

(j)in section 37(1), for “Part II of this Act”, there were substituted “the 2017 Regulations”;

(k)in section 42—

(i)subsections (1), (2) and (5) were omitted;

(ii)in subsection (3)—

(aa)the words from “and every person” to “section 27 above” were omitted; and

(bb)the words “under that section or by that person by virtue of any such regulations” were substituted by “under the 2017 Regulations”;

(l)in section 45(1)—

(i)the definitions of “conditional sale agreement”, “gas”, “motor vehicle”, “personal injury”, “subordinate legislation” and “substance” were omitted;

(ii)before the definition of “aircraft”, there were inserted—

““2017 Regulations” means the Recreational Craft Regulations 2017”;

(iii)for the definition of “enforcing authority” there were substituted—

““enforcing authority” has the same meaning as in regulation 2(1) of the 2017 Regulations;”;

(iv)for the definition of “goods” there were substituted—

““goods” means products or within the scope of the 2017 Regulations;”;

(v)after the definition of “modifications” there were inserted—

““non-compliant” in relation to any goods means that—

(a)

a safety provision has been contravened in relation to the goods; or

(b)

the goods present a risk;”;

(vi)after the definition of “premises”, there were inserted—

““present a risk” means present a risk within the meaning of “risk” set out in regulation 2(3) of the 2017 Regulations;”;

(vii)for the definition of “safety provision” there were substituted—

““safety provision” means any provision of the 2017 Regulations”; and

(viii)for the definition of “safety regulations” there were substituted—

““safety regulations” means the 2017 Regulations;”;

(m)in section 46(1), omit “and, in relation to gas or water, those references shall be construed as including references to providing the service by which the gas or water is made available for use”; and

(n)in Schedule 2—

(i)for “unsafe”, on each occasion that it appears, there were substituted “non-compliant”; and

(ii)for “safe”, on each occasion that it appears, there were substituted “not non-compliant”.

Commencement Information

I116Sch. 13 para. 2 in force at 3.8.2017, see reg. 1

Regulation 67

SCHEDULE 14U.K.Compliance notices, withdrawal notices and recall notices

Compliance noticeU.K.

1.  An enforcing authority may serve a compliance notice on a relevant economic operator in respect of a product if the authority has reasonable grounds for believing that there is non-compliance.

Commencement Information

I117Sch. 14 para. 1 in force at 3.8.2017, see reg. 1

2.  A compliance notice must—U.K.

(a)require the relevant economic operator on which it is served to—

(i)end the non-compliance within such period as may be specified in the notice; or

(ii)provide evidence, within such period as may be specified in the notice, demonstrating to the satisfaction of the market surveillance authority that the non-compliance has not in fact occurred; and

(b)warn the economic operator that, if the non-compliance persists or if satisfactory evidence has not been produced under sub-paragraph (a) within the period specified in the notice, further action may be taken in respect of the product or any product of the same type made available on the market by that relevant economic operator.

Commencement Information

I118Sch. 14 para. 2 in force at 3.8.2017, see reg. 1

3.  A compliance notice may include directions as to the measures to be taken by the economic operator to secure compliance, including different ways of securing compliance.U.K.

Commencement Information

I119Sch. 14 para. 3 in force at 3.8.2017, see reg. 1

4.  Subject to paragraph 5, an enforcing authority may revoke or vary a compliance notice by serving a notification on the economic operator.U.K.

Commencement Information

I120Sch. 14 para. 4 in force at 3.8.2017, see reg. 1

5.  An enforcing authority may not vary a compliance notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.U.K.

Commencement Information

I121Sch. 14 para. 5 in force at 3.8.2017, see reg. 1

Withdrawal noticeU.K.

6.  An enforcing authority may serve a withdrawal notice on a relevant economic operator in respect of product if the authority has reasonable grounds for believing that—

(a)the product has been made available on the market; and

(b)there is non-compliance.

Commencement Information

I122Sch. 14 para. 6 in force at 3.8.2017, see reg. 1

7.  A withdrawal notice must prohibit the relevant economic operator from making the product available on the market without the consent of the market surveillance authority.U.K.

Commencement Information

I123Sch. 14 para. 7 in force at 3.8.2017, see reg. 1

8.  A withdrawal notice may require the relevant economic operator to take action to alert end-users to any risk presented by the product.U.K.

Commencement Information

I124Sch. 14 para. 8 in force at 3.8.2017, see reg. 1

9.  A withdrawal notice may require the relevant economic operator to keep the enforcing authority informed of the whereabouts of any product referred to in the notice.U.K.

Commencement Information

I125Sch. 14 para. 9 in force at 3.8.2017, see reg. 1

10.  A consent given by the enforcing authority pursuant to a withdrawal notice may impose such conditions on the making available on the market of the product as the enforcing authority considers appropriate.U.K.

Commencement Information

I126Sch. 14 para. 10 in force at 3.8.2017, see reg. 1

11.  Subject to paragraph 7, an enforcing authority may revoke or vary a withdrawal notice by serving a notification on the economic operator.U.K.

Commencement Information

I127Sch. 14 para. 11 in force at 3.8.2017, see reg. 1

12.  An enforcing authority may not vary a withdrawal notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.U.K.

Commencement Information

I128Sch. 14 para. 12 in force at 3.8.2017, see reg. 1

Recall noticeU.K.

13.  The enforcing authority may serve a recall notice on a relevant economic operator in respect of a product if the authority has reasonable grounds for believing that—

(a)the product has been made available to end-users; and

(b)there is non-compliance.

Commencement Information

I129Sch. 14 para. 13 in force at 3.8.2017, see reg. 1

14.  A recall notice must require the relevant economic operator to use reasonable endeavours to organise the return of the product from end-users to the relevant economic operator or another person specified in the notice.U.K.

Commencement Information

I130Sch. 14 para. 14 in force at 3.8.2017, see reg. 1

15.  A recall notice may—U.K.

(a)require the recall to be effected in accordance with a code of practice;

(b)require the relevant economic operator to—

(i)contact end-users in order to inform them of the recall, to the extent that it is practicable to do so;

(ii)publish a notice in such form and such manner as is likely to bring to the attention of end-users any risk the product poses and the fact of the recall; or

(iii)make arrangements for the collection or return of the product from end-users or its disposal; or

(c)impose such additional requirements on the relevant economic operator as are reasonable and practicable with a view to achieving the return of the product.

Commencement Information

I131Sch. 14 para. 15 in force at 3.8.2017, see reg. 1

16.  In determining what requirements to include in a recall notice, the market surveillance authority must take into consideration the need to encourage distributors and end-users to contribute to its implementation.U.K.

Commencement Information

I132Sch. 14 para. 16 in force at 3.8.2017, see reg. 1

17.  A recall notice may only be issued by the market surveillance authority where—U.K.

(a)other action which it may require under these Regulations would not suffice to address the non-compliance;

(b)the action being undertaken by the relevant economic operator is unsatisfactory or insufficient to address the non-compliance;

(c)the market surveillance authority has given not less than 10 days’ notice to the relevant economic operator of its intention to serve such a notice; and

(d)the market surveillance authority has taken account of any advice obtained under paragraph 18.

Commencement Information

I133Sch. 14 para. 17 in force at 3.8.2017, see reg. 1

18.  A relevant economic operator which has received notice from the market surveillance authority of an intention to serve a recall notice may at any time prior to the service of the recall notice require the authority to seek the advice of such persons as the Institute determines on the questions of—U.K.

(a)whether there is non-compliance; and

(b)whether the issue of a recall notice would be proportionate.

Commencement Information

I134Sch. 14 para. 18 in force at 3.8.2017, see reg. 1

19.  Sub-paragraphs 17(b), (c) and (d) do not apply in the case of product presenting a serious risk requiring, in the view of the market surveillance authority, urgent action.U.K.

Commencement Information

I135Sch. 14 para. 19 in force at 3.8.2017, see reg. 1

20.  Where a relevant economic operator requires the enforcing authority to seek advice under paragraph 18, that relevant economic operator is to be responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute to advise the market surveillance authority.U.K.

Commencement Information

I136Sch. 14 para. 20 in force at 3.8.2017, see reg. 1

21.  In this Schedule, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.U.K.

Commencement Information

I137Sch. 14 para. 21 in force at 3.8.2017, see reg. 1

22.  A recall notice served by the market surveillance authority may require the relevant economic operator to keep the authority informed of the whereabouts of products to which the recall notice relates, so far as the relevant economic operator is able to do so.U.K.

Commencement Information

I138Sch. 14 para. 22 in force at 3.8.2017, see reg. 1

23.  Subject to paragraph 24, a market surveillance authority may revoke or vary a recall notice by serving a notification on the economic operator.U.K.

Commencement Information

I139Sch. 14 para. 23 in force at 3.8.2017, see reg. 1

24.  A market surveillance authority may not vary a recall notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.U.K.

Commencement Information

I140Sch. 14 para. 24 in force at 3.8.2017, see reg. 1

InterpretationU.K.

25.  In this Schedule, “non-compliance” means that a product—

(a)presents a risk; or

(b)is not in conformity with Part 2 or RAMS (in its application to the product).

Commencement Information

I141Sch. 14 para. 25 in force at 3.8.2017, see reg. 1

Regulations 42, 44 to 47, 50 to 52 and 54

[F229SCHEDULE 15E+W+SConformity assessment procedures

Textual Amendments

MODULE AE+W+SInternal production control

Internal production controlE+W+S

1.  Internal production control is the conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 to 4; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned meets the essential requirements that apply to it.

Technical documentationE+W+S

2.—(1) The manufacturer must draw up the technical documentation.

(2) The technical documentation must—

(a)make it possible to assess the product's conformity with the essential requirements that apply to it;

(b)include an adequate analysis and assessment of any risks;

(c)specify the essential requirements that apply to the product; and

(d)cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

(3) The technical documentation must contain, where applicable, at least the following—

(a)a general description of the product;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(d)a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(e)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

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

(g)test reports.

ManufacturingE+W+S

3.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured product with—

(a)the technical documentation referred to in paragraph 2; and

(b)the essential requirements that apply to it.

UK marking and declaration of conformityE+W+S

4.—(1) The manufacturer must affix the UK marking to each individual product that meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it together with the technical documentation at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

MODULE A1E+W+SInternal production control plus supervised product testing

Internal production control plus supervised product testingE+W+S

1.  Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 to 5; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned meets the essential requirements that apply to it.

Technical documentationE+W+S

2.—(1) The manufacturer must draw up the technical documentation.

(2) The technical documentation must—

(a)make it possible to assess the product's conformity with the essential requirements that apply to it;

(b)include an adequate analysis and assessment of any risks;

(c)specify the essential requirements that apply to the product; and

(d)cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

(3) The technical documentation must contain, where applicable, at least the following—

(a)a general description of the product;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(d)a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(e)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

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

(f)test reports.

ManufacturingE+W+S

3.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured product with—

(a)the technical documentation referred to in paragraph 2; and

(b)the essential requirements that apply to it.

Product checksE+W+S

4.—(1) For each individual product manufactured, one or more tests on one or more specific aspects of the product must be carried out on the manufacturer's behalf in order to verify the product's conformity with the essential requirements that apply to it.

(2) The tests must be carried out under the responsibility of an approved body chosen by the manufacturer.

(3) The manufacturer must, under the responsibility of the approved body, affix the approved body's identification number to the product during the manufacturing process.

UK marking and declaration of conformityE+W+S

5.—(1) The manufacturer must affix the UK marking to each individual product that meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it together with the technical documentation at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

MODULE BE+W+SType examination

Type examinationE+W+S

1.  Type examination is the part of a conformity assessment procedure in which an approved body—

(a)examines the technical design of a product; and

(b)verifies and attests that the technical design of the product meets the essential requirements that apply to it.

How type examination must be carried out, etc.E+W+S

2.—(1) The conformity assessment procedure must include an assessment of the adequacy of the technical design of the product through examination of the technical documentation and supporting evidence referred to in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type).

(2) The assessment referred to in sub-paragraph (1) may cover several versions of the product if—

(a)the differences between the versions of the product do not affect the level of safety and the other requirements concerning the performance of the product; and

(b)the different versions of the product are referred to in the corresponding type examination certificate, if necessary by means of amendments to the original certificate.

Application for type examinationE+W+S

3.—(1) The manufacturer must lodge an application for type examination with a single approved 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 declaration that the same application has not been lodged with any other approved body;

(c)the technical documentation;

(d)the specimens representative of the production envisaged; and

(e)the supporting evidence for the adequacy of the technical design solution.

(3) The manufacturer must, if requested by the approved body, provide further specimens if needed for carrying out the test programme.

(4) The technical documentation referred to in sub-paragraph (2)(c) must—

(a)make it possible to assess the product's conformity with the essential requirements that apply to it;

(b)include an adequate analysis and assessment of any risks;

(c)specify the essential requirements that apply to the product; and

(d)cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

(5) The technical documentation referred to in sub-paragraph (2)(c) must contain, where applicable, at least the following—

(a)a general description of the product;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(d)a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(e)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

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

(g)test reports.

(5) The supporting evidence for the adequacy of the technical design solution referred to in sub-paragraph (2)(e) must—

(a)mention any documents that have been used, in particular where the relevant designated standards or technical specifications have not been applied in full; and

(b)include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility.

Examination, etc. by approved bodyE+W+S

4.—(1) The approved body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product.

(2) The approved body must—

(a)verify that the specimen has been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards or technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards or specifications;

(b)carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards or technical specifications, these have been applied correctly;

(c)carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards or technical specifications have not been applied, the solutions adopted by the manufacturer meet the essential requirements covered by the standards or specifications; and

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

Evaluation reportE+W+S

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

Type examination certificateE+W+S

6.—(1) Where the type meets the essential requirements that apply to the product concerned, the approved body must issue a type examination certificate to the manufacturer.

(2) The certificate (which may have one or more annexes attached) 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)the necessary data for identification of the approved type; and

(e)all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.

(3) Where the type does not meet the essential requirements that apply to the product concerned, the approved body must refuse to issue a type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

ChangesE+W+S

7.—(1) The approved body must keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the essential requirements that apply to the product concerned and must determine whether such changes require further investigation. If so, the approved body must inform the manufacturer accordingly.

(2) The manufacturer must inform the approved body that holds the technical documentation relating to the type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements that apply to it or the conditions for validity of the certificate. Such modifications require additional approval in the form of an addition to the original type examination certificate.

Approved body's duties in respect of type examination certificatesE+W+S

8.—(1) The approved body must inform the Secretary of State about the 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 a list of certificates and any additions thereto refused, suspended or otherwise restricted.

(2) The approved body must inform the other approved bodies about the type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, about such certificates and additions thereto which it has issued.

(3) The approved body must, on request, provide the Secretary of State and other approved bodies with a copy of the type examination certificates and additions thereto which it has issued.

(4) The approved body must, on request, provide the Secretary of State with a copy of the technical documentation and the results of the examinations carried out by the approved body.

(5) The approved body must keep a copy of the 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 the certificate.

Manufacturer's duties in respect of type examination certificatesE+W+S

9.  The manufacturer must keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authority for 10 years after the product has been placed on the market.

MODULE CE+W+SConformity to type based on internal production control

Conformity to type based on internal production controlE+W+S

1.  Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 and 3; and

(b)ensures and declares that the product concerned is in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with—

(a)the approved type described in the type examination certificate; and

(b)the essential requirements that apply to it.

UK marking and declaration of conformityE+W+S

3.—(1) The manufacturer must affix the UK marking to each individual product thatis in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

MODULE C1E+W+SConformity to type based on internal production control plus supervised product testing

Conformity to type based on internal production control plus supervised product testingE+W+S

1.  Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 to 4; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned—

(i)is in conformity with the type described in the type examination certificate; and

(ii)meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with—

(a)the type described in the type examination certificate; and

(b)the essential requirements that apply to it.

Product checksE+W+S

3.—(1) For each individual product manufactured, one or more tests on one or more specific aspects of the product must be carried out on the manufacturer's behalf in order to verify the product's conformity with the essential requirements that apply to it.

(2) The tests must be carried out under the responsibility of an approved body chosen by the manufacturer.

(3) The manufacturer must, under the responsibility of the approved body, affix the approved body's identification number to the product during the manufacturing process.

UK marking and declaration of conformityE+W+S

4.—(1) The manufacturer must affix the UK marking to each individual product thatis in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

MODULE DE+W+SConformity to type based on quality assurance of the production process

Conformity to type based on quality assurance of the production processE+W+S

1.  Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 and 5; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned—

(i)is in conformity with the type described in the type examination certificate; and

(ii)meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer—

(a)must operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 3; and

(b)is subject to surveillance as specified in paragraph 4.

Quality systemE+W+S

3.—(1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the approved body of the manufacturer's choice for the products concerned.

(2) The application must include—

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

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

(c)all relevant information for the product category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the type examination certificate.

(3) The quality system must ensure that the products—

(a)are in conformity with the type described in the type examination certificate; and

(b)meet the essential requirements that apply to them.

(4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

(5) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, in particular, contain an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out;

(d)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

(6) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraph (3). The approved body must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard or technical specification.

(7) For the purpose of the assessment referred to in sub-paragraph (6), the approved body must ensure that—

(a)in addition to experience in quality management systems, the auditing team has at least one member with experience of evaluation in the relevant product field and product technology concerned and knowledge of the essential requirements that apply to the products;

(b)the audit includes an assessment visit to the manufacturer's premises; and

(c)the auditing team reviews the technical documentation referred to in sub-paragraph (2)(e) to verify the manufacturer's ability to identify the essential requirements that apply to the products and to carry out the necessary examinations with a view to ensuring compliance of the products with those requirements.

(8) The approved body must notify its decision on whether the quality system satisfies the requirements referred to in sub-paragraph (3) to the manufacturer. The notification must contain the conclusions of the audit and the approved body's reasoned assessment.

(9) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(10) The manufacturer must keep the approved body that approved the quality system informed of any intended change to the quality system, and if so informed, the approved body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (3) or whether a reassessment is necessary.

(11) The approved body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the approved body's reasoned assessment.

Surveillance under the responsibility of the approved bodyE+W+S

4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records, such as inspection reports and test data, calibration data, and qualification reports on the personnel concerned.

(3) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.

(4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking and declaration of conformityE+W+S

5.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3(1), the approved body's identification number to each individual product that is in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

Manufacturer's duty to keep application, etc.E+W+S

6.  The manufacturer must, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the enforcing authority—

(a)a copy of the application referred to in paragraph 3(1) including the information and documentation referred to in paragraph 3(2);

(b)documents relating to any change to the quality system referred to in paragraph 3(10), as approved by the approved body;

(c)the decisions and reports of the approved body referred to in paragraphs 3(11) and 4(3) and (4).

Approved body's duties in respect of quality system approvalsE+W+S

7.—(1) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State a list of quality system approvals refused, suspended or otherwise restricted.

(2) Each approved body must inform the other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

MODULE EE+W+SConformity to type based on product quality assurance

Conformity to type based on product quality assuranceE+W+S

1.  Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 and 5; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned—

(i)is in conformity with the type described in the type examination certificate; and

(ii)meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer—

(a)must operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 3; and

(b)is subject to surveillance as specified in paragraph 4.

Quality systemE+W+S

3.—(1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the approved body of the manufacturer's choice for the products concerned.

(2) The application must include—

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

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

(c)all relevant information for the product category envisaged;

(d)the documentation concerning the quality system; and

(e)the technical documentation of the approved type and a copy of the type examination certificate.

(3) The quality system must ensure that the products—

(a)are in conformity with the type described in the type examination certificate; and

(b)meet the essential requirements that apply to them.

(4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

(5) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, in particular, contain an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the examinations and tests that will be carried out after manufacture;

(c)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and

(d)the means of monitoring the effective operation of the quality system.

(6) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraph (3). The approved body must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard or technical specification.

(7) For the purpose of the assessment referred to in sub-paragraph (6), the approved body must ensure that—

(a)in addition to experience in quality management systems, the auditing team has at least one member with experience of evaluation in the relevant product field and product technology concerned and knowledge of the essential requirements that apply to the products;

(b)the audit includes an assessment visit to the manufacturer's premises; and

(c)the auditing team reviews the technical documentation referred to in sub-paragraph (2)(e) to verify the manufacturer's ability to identify the essential requirements that apply to the products and to carry out the necessary examinations with a view to ensuring compliance of the products with those requirements.

(8) The approved body must notify its decision on whether the quality system satisfies the requirements referred to in sub-paragraph (3) to the manufacturer. The notification must contain the conclusions of the audit and the approved body's reasoned assessment.

(9) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(10) The manufacturer must keep the approved body that approved the quality system informed of any intended change to the quality system, and if so informed, the approved body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (3) or whether a reassessment is necessary.

(11) The approved body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the approved body's reasoned assessment.

Surveillance under the responsibility of the approved bodyE+W+S

4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.

(3) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.

(4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking and declaration of conformityE+W+S

5.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3(1), the approved body's identification number to each individual product that is in conformity with the type described in the type examination certificate and meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

Manufacturer's duty to keep application, etc.E+W+S

6.  The manufacturer must, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the enforcing authority—

(a)a copy of the application referred to in paragraph 3(1) including the information and documentation referred to in paragraph 3(2);

(b)documents relating to any change to the quality system referred to in paragraph 3(10), as approved by the approved body;

(c)the decisions and reports of the approved body referred to in paragraphs 3(11) and 4(3) and (4).

Approved body's duties in respect of quality system approvalsE+W+S

7.—(1) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

(2) Each approved body must inform the other approved bodies of quality system approvals which it has refused, suspended or withdrawn and, upon request, of quality system approvals which it has issued.

MODULE FE+W+SConformity to type based on product verification

Conformity to type based on product verificationE+W+S

1.  Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2, 5(1) and 6; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned, which has been subject to the provisions of paragraph 3—

(i)is in conformity with the type described in the type examination certificate; and

(ii)meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with—

(a)the approved type described in the type examination certificate; and

(b)the essential requirements that apply to it.

VerificationE+W+S

3.—(1) An approved body chosen by the manufacturer must carry out appropriate examinations and tests in order to check the conformity of the product with—

(a)the approved type described in the type examination certificate; and

(b)the essential requirements that apply to it.

(2) The examinations and tests to check the conformity of the products with the essential requirements that apply to it must be carried out, at the choice of the manufacturer, either by—

(a)examination and testing of every product as specified in paragraph 4; or

(b)examination and testing of the products on a statistical basis as specified in paragraph 5.

Verification of conformity by examination and testing of every productE+W+S

4.—(1) All products must be individually examined, and appropriate tests set out in the relevant designated standard or technical specifications or equivalent tests must be carried out in order to verify conformity with the approved type described in the type examination certificate and with the essential requirements that apply to it. In the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out.

(2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility.

(3) The manufacturer must keep the certificates of conformity at the disposal of the enforcing authority for 10 years after the product has been placed on the market.

Statistical verification of conformityE+W+S

5.—(1) The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced and must present the manufacturer's products for verification in the form of homogeneous lots.

(2) A random sample must be taken from each lot by the approved body. All products in a sample must be individually examined, and appropriate tests set out in the relevant designated standard or technical specification or equivalent tests must be carried out in order to ensure their conformity with the essential requirements that apply to them and to determine whether the lot is to be accepted or rejected. In the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out.

(3) If a lot is accepted, all products of the lot must be considered approved, except for those products from the sample that have been found not to satisfy the tests.

(4) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility.

(5) The manufacturer must keep the certificates of conformity at the disposal of the enforcing authority for 10 years after the product has been placed on the market.

(6) If a lot is rejected, the approved body or, if the approved body fails to do so, the Secretary of State must take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots, the approved body may suspend the statistical verification and take appropriate measures.

UK marking and declaration of conformityE+W+S

6.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3, the approved body's identification number to each individual product that is in conformity with the approved type described in the type examination certificate and meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

(4) If the approved body referred to in paragraph 3 agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the product.

Affixing of approved body's identification number during manufacturing processE+W+S

7.  If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the product during the manufacturing process.

Authorised representativeE+W+S

8.  Where the manufacturer appoints an authorised representative (see regulation 39), the obligations in paragraphs 2 and 5(1) must not form part of the authorised representative's mandate.

MODULE GE+W+SConformity based on unit verification

Conformity based on unit verificationE+W+S

1.  Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2, 3 and 5; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned, which has been subject to the provisions of paragraph 4, meets the essential requirements that apply to it.

Technical documentationE+W+S

2.—(1) The manufacturer must draw up the technical documentation and make it available to the approved body referred to in paragraph 4.

(2) The technical documentation must—

(a)make it possible to assess the product's conformity with the essential requirements that apply to it;

(b)include an adequate analysis and assessment of the risks;

(c)specify the essential requirements that apply to the product; and

(d)cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

(3) The technical documentation must contain, where applicable, at least the following—

(a)a general description of the product;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(d)a list of the designated standards and other relevant technical specifications, applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(e)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

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

(g)test reports.

(4) The manufacturer must keep the technical documentation at the disposal of the enforcing authority for 10 years after the product has been placed on the market.

ManufacturingE+W+S

3.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the essential requirements that apply to it.

VerificationE+W+S

4.—(1) An approved body chosen by the manufacturer must carry out appropriate examinations and tests, set out in the relevant designated standard or technical specification or equivalent tests, to check the conformity of the product with the essential requirements that apply to it or have them carried out. In the absence of such a designated standard or technical specification the approved body concerned must decide on the appropriate tests to be carried out.

(2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to the approved product or have it affixed under its responsibility.

(3) The manufacturer must keep the certificates of conformity at the disposal of the enforcing authority for 10 years after the product has been placed on the market.

UK marking and declaration of conformityE+W+S

5.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 4, the approved body's identification number to each product that meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

MODULE HE+W+SConformity based on full quality assurance

Conformity based on full quality assuranceE+W+S

1.  Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer—

(a)fulfils the obligations set out in paragraphs 2 and 5; and

(b)ensures and declares on the manufacturer's sole responsibility that the product concerned meets the essential requirements that apply to it.

ManufacturingE+W+S

2.  The manufacturer—

(a)must operate an approved quality system for design, manufacture and final product inspection and testing of the product concerned as specified in paragraph 3; and

(b)is subject to surveillance as specified in paragraph 4.

Quality systemE+W+S

3.—(1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the approved body of the manufacturer's choice for the product concerned.

(2) The application must include—

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

(b)the technical documentation for one model of each category of products intended to be manufactured, which must contain, where applicable, at least the following—

(i)a general description of the product;

(ii)conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits;

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

(iv)a list of the designated standards and other relevant technical specifications applied in full or in part (and where designated standards have been applied in part, the technical documentation must specify the parts which have been applied);

(v)where designated standards have not been applied, descriptions of the solutions adopted to meet the essential requirements;

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

(vii)test reports;

(c)the documentation concerning the quality system; and

(d)a declaration that the same application has not been lodged with any other approved body.

(3) The quality system must ensure that the products meet the essential requirements that apply to them.

(4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

(5) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, in particular, contain an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

(b)the technical design specifications, including standards, that will be applied and, where the relevant designated standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements that apply to the products will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered;

(d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned;

(g)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

(6) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraph (3). The approved body must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard or technical specification.

(7) For the purpose of the assessment referred to in sub-paragraph (6), the approved body must ensure that—

(a)in addition to experience in quality management systems, the auditing team has at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the essential requirements that apply to the products;

(b)the audit includes an assessment visit to the manufacturer's premises; and

(c)the auditing team reviews the technical documentation referred to sub-paragraph (2)(b) to verify the manufacturer's ability to identify the essential requirements that apply to the products and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(8) The approved body must notify the manufacturer or the manufacturer's authorised representative of its decision on whether the quality system satisfies the requirements referred to in sub-paragraph (3). The notification must contain the conclusions of the audit and the approved body's reasoned assessment.

(9) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(10) The manufacturer must keep the approved body that approved the quality system informed of any intended change to the quality system, and if so informed, the approved body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (3) or whether a reassessment is necessary.

(11) The approved body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the approved body's reasoned assessment.

Surveillance under the responsibility of the approved bodyE+W+S

4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer must, for assessment purposes, allow the approved body access to the design, manufacture, inspection, testing and storage sites and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations and tests; and

(c)the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.

(3) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.

(4) In addition, the approved body may pay unexpected visits to the manufacturer. During such visits, the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking and declaration of conformityE+W+S

5.—(1) The manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 3(1), the approved body's identification number to each individual product that meets the essential requirements that apply to it.

(2) The manufacturer must draw up a declaration of conformity for each product model and keep it at the disposal of the enforcing authority for 10 years after the product has been placed on the market. The declaration of conformity must identify the product model for which it has been drawn up.

(3) The manufacturer must make a copy of the declaration of conformity available to the enforcing authority upon request.

Manufacturer's duty to keep application, etc.E+W+S

6.  The manufacturer must, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the enforcing authority—

(a)the technical documentation referred to in paragraph 3(2)(b);

(b)the documentation concerning the quality system referred to in paragraph 3(2)(c);

(c)documents relating to any change to the quality system referred to in paragraph 3(10), as approved by the approved body;

(d)the decisions and reports of the approved body referred to in paragraphs 3(11) and 4(3) and (4).

Approved body's duties in respect of quality system approvalsE+W+S

7.—(1) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

(2) Each approved body must inform the other approved bodies of quality system approvals which it has refused, suspended or withdrawn and, upon request, of quality system approvals which it has issued.]

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations transpose Directive 2013/53/EU of the European Parliament and of the Council of 20th November 2013 on recreational watercraft and personal watercraft (OJ No L 354, 28.12.2013 p.90) (“the Directive”).The Directive repeals and replaces Directive 1994/25/EC as amended by Directive 2003/44/EC which was implemented in the United Kingdom by the Recreational Craft Regulations 1996 (S.I. 1996/1353) (as amended by S.I. 1998/116). These Regulations revoke and replace S.I. 1996/1353.

Regulation 3 sets out the application of the Regulations to watercraft and personal watercraft and components subject to the exemptions set out in regulation 4.

Part 2 sets out the obligations of persons placing a watercraft on the market. Regulation 6 provides that any person who places a watercraft on the market or puts it into service must ensure that it complies with the essential requirements set out in Schedule 1 to these Regulations and includes the requirement that a product must not endanger the health and safety of persons, property or the environment.

Regulations 8 to 17 set out the obligations that are specific to manufacturers. Manufacturers must ensure that watercraft have been designed and manufactured to comply with the essential requirements. The Regulations impose obligations on manufactures to carry out conformity assessments; draw up technical documentation, draw up declarations of conformity and affix the CE marking, label the equipment and ensure it is accompanied by instructions and safety information. Manufacturers must also monitor compliance. Regulation 16 places a duty on manufacturers to immediately take corrective action where the manufacturer considers or has reason to believe that a watercraft placed on the market may not conform. The obligations imposed on the manufacturer’s authorised representative are set out in regulation 39.

Regulations 18 to 26 set out the obligations that are specific to importers. These obligations include ensuring that they are not placing on the market watercraft which are not in conformity with the essential requirements, checking that the manufacturer has carried out a relevant conformity assessment procedure and labelled the craft correctly. Regulation 23 requires importers to ensure that storage and transport conditions do not jeopardise conformity with the essential requirements. Regulation 24 places a duty on importers to immediately take corrective action where they consider or have reason to believe that a watercraft placed on the market may not conform.

Regulations 27 to 32 set out the obligations that are specific to distributors. These obligations include ensuring that they are not placing on the market watercraft which are not in conformity with the essential requirements and that storage and transport conditions do not jeopardise conformity with the essential requirements.

Regulations 33 provides that an importer or distributor who places a watercraft on the market under their own trade mark or who modifies a watercraft such that it may affect conformity is to be treated as the manufacturer for the purposes of these Regulations.

Regulation 36 imposes obligations on a private importer where the manufacturer of a watercraft has not complied with the obligations on manufacturer.

Regulations 37 and 38 set out obligations on economic operators and private importers to identify the economic operator who supplied the watercraft.

Regulation 40 prohibits the improper use of the CE mark.

Part 3 sets out the product and conformity assessment procedures.

Part 4 sets out provisions concerning notification and monitoring of the bodies which carry out conformity assessment procedures in the UK.

Part 5 sets out provisions for market surveillance and enforcement of these Regulations. Regulation 65 identifies the market surveillance authorities which have an obligation to enforce the Regulations. Regulation 67 and Schedules 13 and 14 provide for the enforcement powers which the enforcing authorities are to have. Regulation 73 provides for the contravention of certain provisions of these Regulations to be an offence. Regulation 74 sets out the penalties that are to apply for offences under these Regulations. Regulation 80 sets out provision for appeals against notices served under these Regulations.

Part 6 deals with the power of a notified body to charge a fee and sets out a review provision, transitional provisions, and revocations.

A transposition note and full impact assessment of the impact that these Regulations will have on the costs of business, the voluntary sector and the public sector are available from the Single Market Product Safety Team, Department for Business, Energy and Industrial Strategy, 1 Victoria Street, London SW1H 0ET and are also published with the Explanatory Memorandum alongside these Regulations on www.legislation.gov.uk.

(2)

1972 c. 68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 (c. 51), section 27(1) and the European Union (Amendment) Act 2008 (c.7), Schedule, Part 1.

(3)

Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 and amended by Part 1 of the Schedule to the European Union (Amendment) Act 2008.

(5)

OJ L 218, 13, 8, 2008, p.82.

(6)

OJ No L 354, 28.12.2013, p.90.

(8)

OJ No L 316, 14.11.2012, p.12.

(9)

OJ No L 218, 13.8.2008, p.30.

(10)

OJ No L 124, 20.5.2003, p.36.

(11)

OJ No L 59. 27.2.1998, p.1.

(12)

OJ No L 188, 18.7.2009, p.1.

(13)

1980 c.43; section 58 was amended by the Crime and Courts Act 2013 (c.22), Schedule 10 paragraph 40.

(15)

1995 c.46.

(16)

2015 c.15.

(17)

S.I. 2004/693. Regulation 3(a) inserts a reference to the Recreational Craft Regulations 2004 into the Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004.

(21)

OJ No L 164, 30.6.1994, p.15.

(22)

S.I. 1996/1353; these Regulations were revoked with savings in respect of certain limited exceptions, by S.I. 2004/1464, regulation 1(4).

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