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.
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;
(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 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.
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.
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.
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 Member 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 Member 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 EU instrument 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
11. A manufacturer must keep the technical documentation and the EU 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.
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.
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.
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.
(2) Where it is not possible to provide the information referred to in paragraph (1) on the product that information must be provided—
(a)on the packaging;
(b)or in a document accompanying the product.
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 Member 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 the United Kingdom, that language which can be easily understood is English.
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 Member 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.
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.
18. An importer must not place a product on the market unless it complies with the essential requirements.
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.
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.
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.
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 Member 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 the United Kingdom, the language which can be easily understood by consumers and other end-users is English.
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.
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 Member 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.
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 EU 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.
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.
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.
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 Member 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).
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 place the product 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 Member States in which the distributor has made the product available on the market of that risk.
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.
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 Member 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.
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 placed on the market.
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.
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.
35.—(1) For the purposes of regulation 10(2) and (3), where the product is to be made available on the market in the United Kingdom, the language required is English.
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.
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.
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.
39.—(1) A manufacturer may by written mandate, appoint a person established in the EU 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.
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.
OJ No L 59. 27.2.1998, p.1.
OJ No L 188, 18.7.2009, p.1.