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

I1Reg. 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;

F1(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)engines installed in watercraft and type-approved in accordance with Regulation (EC) No 595/2009(2) 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 F2... 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 F3... 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

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. 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 [F44Northern Ireland] or putting into service in [F44Northern 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(1), 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(2) 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 [F44Northern 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

E16This 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

I35Reg. 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

I3Reg. 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

I4Reg. 9 in force at 3.8.2017, see reg. 1

[F4Declaration 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

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

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 [F45relevant 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 [F45relevant 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 [F46NI 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

E17This 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

I36Reg. 10 in force at 3.8.2017, see reg. 1

Duty of manufacturers to retain technical documentation and [F5EU] declaration of conformityU.K.

11.  A manufacturer must keep the technical documentation and the [F6EU] 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

I5Reg. 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 [F7designated] standard or in another technical specification by reference to which the F8... declaration of conformity of the product was drawn up.

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

Commencement Information

I6Reg. 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

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

Commencement Information

I37Reg. 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

I7Reg. 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.

[F9(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

I8Reg. 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 [F10English].

F11(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

I9Reg. 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 [F47relevant 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 [F48Northern Ireland], that language which can be easily understood is English.

Extent Information

E19This 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

I38Reg. 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 F12... 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

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

I10Reg. 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 [F49relevant 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

E20This 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

I39Reg. 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

I11Reg. 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

I12Reg. 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 [F13procedure] has been carried out by the manufacturer;

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

(c)the product—

(i)bears the [F14UK] 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 F15... declaration of conformity; and

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

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

I13Reg. 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

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

Commencement Information

I40Reg. 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

I14Reg. 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.

[F16(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 [F17seven 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

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

I15Reg. 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

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

Commencement Information

I41Reg. 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 [F18English].

F19(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

I16Reg. 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 [F50relevant 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 [F51Northern Ireland], the language which can be easily understood by consumers and other end-users is English.

Extent Information

E23This 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

I42Reg. 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

I17Reg. 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 F20... 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

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

I18Reg. 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 [F52relevant 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

E24This 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

I43Reg. 24 in force at 3.8.2017, see reg. 1

Duty of importers to retain technical documentation and [F21EU] 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 [F22EU] 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

I19Reg. 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

I20Reg. 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

I21Reg. 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 [F23UK] marking;

(ii)is accompanied by the required documents;

(iii)is accompanied by the instructions and safety information in [F24English]; 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

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

I22Reg. 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 [F53relevant 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

E25This 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

I44Reg. 28 in force at 3.8.2017, see reg. 1

Duty not to [F25make 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 [F26make 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 F27... of that risk.

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

I23Reg. 29 in force at 3.8.2017, see reg. 1

Duty not to [F54make 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 [F55make 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 [F56relevant states] in which the distributor has made the product available on the market of that risk.

Extent Information

E26This 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

I45Reg. 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

I24Reg. 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 F28... 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

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

I25Reg. 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 [F57relevant 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

E27This 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

I46Reg. 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 F29... on the market.

Textual Amendments

Commencement Information

I26Reg. 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

I27Reg. 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

I28Reg. 34 in force at 3.8.2017, see reg. 1

Translation of EU declaration of conformityN.I.

35.—[F30(1) For the purposes of regulation 10(2) and (3), where the product is to be made available on the market in [F31Northern Ireland], the language required is English.]

Textual Amendments

Commencement Information

I29Reg. 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 [F32(declaration of conformity and UK marking)];

(iii)regulation 11 (duty of manufacturers to retain technical documentation and F33... 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 [F34approved] 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

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. 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

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I47Reg. 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

I31Reg. 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

I32Reg. 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 [F35United 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 F36... 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 F37..., 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 [F38enforcing 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

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

I33Reg. 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 [F58a 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

E29This 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

I48Reg. 39 in force at 3.8.2017, see reg. 1

MISCELLANEOUSU.K.

Prohibition on improper use of [F39UK] markingE+W+S

40.—(1) An economic operator must not affix the [F40UK] 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 [F40UK] marking.

(3) An economic operator must not affix to a product any other marking if the visibility, legibility and meaning of the [F40UK] marking would be impaired as a result.

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

I34Reg. 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

E30This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Commencement Information

I49Reg. 40 in force at 3.8.2017, see reg. 1

[F41Obligations 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

[F41Conformity 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

[F41 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 [F42four 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 [F43four 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

[F41Qualifying 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

(1)

OJ No L 59. 27.2.1998, p.1.

(2)

OJ No L 188, 18.7.2009, p.1.