S.I. No. 65/2017 - European Union (Recreational Craft and Personal Watercraft) Regulations 2017
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
2 amending acts · 2023-06-09, S.I. No. 288/2023 - European Union (Recreational Craft and Personal Watercraft) (Amendmen…
CONTENTS
Regulations
PART 1 General Provisions
1.
Citation
2.
Interpretation
3.
Application
4.
Making available on the market, putting into service and essential requirements
5.
Free movement
6.
Market surveillance authority and competent authority
PART 2 Obligations of Economic Operators and Private Importers
7.
Obligations of manufacturers
8.
Authorised representatives
9.
Obligations of importers
10.
Obligations of distributors
11.
Cases in which obligations of manufacturers apply to importers and distributors
12.
Obligations of private importers
13.
Identification of economic operators
PART 3 Conformity of Products
14.
Presumption of conformity of products
15.
EU declaration of conformity and declaration in accordance with Annex III
16.
General principles of CE marking
17.
Products subject to CE marking
18.
Rules and conditions for affixing CE marking and other markings
PART 4 Conformity Assessment Procedures
19.
Applicable conformity assessment procedures
20.
Design and construction
21.
Exhaust emissions
22.
Noise emissions
23.
Post construction assessment
24.
Supplementary requirements
25.
Technical documentation
PART 5 Notification of Conformity Assessment Bodies
26.
Notifying authority
27.
Notification
28.
Application for notification
29.
Presumption of conformity
30.
Restriction, suspension or withdrawal of notification
31.
Operational obligations of notified bodies
32.
Appeal from decision of notified body
33.
Information obligations of notified bodies
34.
Fees
PART 6 Union Market Surveillance, Control of Products Entering Union Market and Safeguard Procedure
35.
Union market surveillance and control of products entering Union market
36.
Procedure for dealing with products presenting risk at national level
37.
Products presenting serious risk
38.
Formal non-compliance
PART 7 Inspections and Surveillance
39.
Inspections and surveillance
40.
Appointment of authorised officers
41.
Powers of authorised officers
42.
Compliance notice
43.
Procedures for prohibition notices and restriction measures
44.
Publication of information relating to prohibition notices and restriction measures
45.
Right of appeal against prohibition notice and restriction measures
46.
Giving of documents
47.
Offences and penalties
48.
Forgery
49.
Offence by body corporate
50.
Forfeiture and seizure
51.
Costs of prosecutions
52.
Prosecution of offences
PART 8 Miscellaneous and Transitional Provisions
53.
Transitional provisions
54.
Continuance of Regulations of 1998
55.
Revocations
SCHEDULE Minimum Criteria for Notification as a Notified Body in the State
S.I. No. 65 of 2017
EUROPEAN UNION (RECREATIONAL CRAFT AND PERSONAL WATERCRAFT) REGULATIONS 2017
Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of 10th March, 2017.
I, SHANE ROSS, T.D., Minister for Transport, Tourism and Sport, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive No. 2013/53/EU of 20 November 20131 and of giving further effect to Regulation (EC) No. 765/2008 of 9 July 20082 , hereby make the following regulations:
PART 1 General Provisions
Citation
These Regulations may be cited as the European Union (Recreational Craft and Personal Watercraft) Regulations 2017.
Interpretation
(1) In these Regulations—
“accreditation” has the meaning assigned to it by Article 2(10) of Regulation (EC) No. 765/20082;
“Accreditation Board” means the Irish National Accreditation Board being a committee of the Health and Safety Authority referred to in section 56A (inserted by section 32 of the Industrial Development (Forfás Dissolution) Act 2014 (No. 13 of 2014)) of the Safety, Health and Welfare at Work Act 2005 (No. 10 of 2005);
“Annex” means an Annex to the Directive;
“authorised officer” means a person appointed under Regulation 40;
“authorised representative” means a person established within the Union who has received a written mandate from a manufacturer to act on behalf of the manufacturer in relation to specified tasks;
“CE marking” means a marking by which a manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
“CI engine” means a compression ignition engine;
“competent authority” means the Marine Survey Office;
“compliance notice” has the meaning given to it by Regulation 42;
“component” means any of the components specified in Annex II when placed separately on the Union market;
“conformity assessment” means the process demonstrating whether the requirements of these Regulations relating to a product have been fulfilled;
“conformity assessment body” means a person who performs conformity assessment activities including calibration, testing, certification and inspection;
“Decision” means Decision No. 768/2008/EC of 9 July 20083 ;
“Directive” means Directive No. 2013/53/EU of 20 November 20131;
“Directive No. 97/68/EC” means Directive No. 97/68/EC of 16 December 19974 , as amended by—
- (a) Commission Directive No. 2001/63/EC of 17 August 20015 ,
- (b) the Act concerning the conditions of Accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the Adjustments to the Treaties on which the European Union is founded6 ,
- (c) Directive No. 2002/88/EC of 9 December 20027 ,
- (d) Directive No. 2004/26/EC of 21 April 20048 ,
- (e) Council Directive No. 2006/105/EC of 20 November 20069 ,
- (f) Regulation (EC) No. 596/2009 of 18 June 200910 ,
- (g) Commission Directive No. 2010/26/EU of 31 March 201011 ,
- (h) Directive No. 2011/88/EU of 16 November 201112 , and
- (i) Commission Directive No. 2012/46/EU of 6 December 201213 ;
“distributor” means a person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
“economic operator” means a manufacturer, an authorised representative, an importer or a distributor;
“engine family” means a manufacturer’s grouping of engines which, through their design, have similar exhaust or noise emission characteristics;
“harmonised standard” means harmonised standard within the meaning of Article 2(1)(c) of Regulation (EU) No. 1025/2012 of 25 October 201214 ;
“hull length” means the length of the hull measured in accordance with the harmonised standard;
“importer” means a person established within the Union who places a product from a third country on the Union 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 safety and environmental requirements specified in these Regulations;
“major engine modification” means the modification of a propulsion engine which—
- (a) could potentially cause the engine to exceed the emission limits set out in Part B of Annex I, or
- (b) increases the rated power of the engine by more than 15 per cent;
“making available on the market” means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
“manufacturer” means a person who manufactures a product or has such a product designed or manufactured and markets that product under the manufacturer’s name or trademark;
“Marine Survey Office” means that part of the Department of Transport, Tourism and Sport which is known by that name;
“market” means the Union market;
“market surveillance” means the activities carried out and measures taken by the market surveillance authority to ensure that products comply with the applicable requirements set out in Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;
“market surveillance authority” means the Marine Survey Office;
“means of propulsion” means the method by which the watercraft is propelled;
“Minister” means Minister for Transport, Tourism and Sport;
“notified body” means a conformity assessment body notified to the Commission to carry out conformity assessment procedures that has been granted notification—
- (a) under Regulation 27, or
- (b) by another Member State, and whose appointment has been notified to the Commission under Article 26 of the Directive;
“notifying authority” means the Minister;
“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 Union market;
“private importer” means a person established within the Union who imports, in the course of a non-commercial activity, a product from a third country into the Union with the intention of putting it into service for the person’s own use;
“product” shall be construed in accordance with Regulation 3(1);
“prohibition notice” means a notice given to a person under Regulation 36, 37 or 38(4), as the case may be;
“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 to which these Regulations apply in the Union by its end-user;
“recall” means any measure aimed at achieving the return of a product that has already been made available to the end-user;
“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;
“Regulation (EC) No. 595/2009” means Regulation (EC) No. 595/2009 of 18 June 200915 as amended by Commission Regulation (EU) No. 582/2011 of 25 May 201116 and Commission Regulation (EU) No. 133/2014 of 31 January 201417 ;
“Regulation (EC) No. 765/2008” means Regulation (EC) No. 765/2008 of 9 July 20082;
“Regulations of 1998” means the European Communities (Recreational Craft) Regulations 1998 ( S.I. No. 40 of 1998 ) (as amended by the European Communities (Recreational Craft) (Amendment) Regulations 2004 ( S.I. No. 422 of 2004 ));
“SI engine” means a spark ignition engine;
“small or medium-sized enterprise” means a small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation No. 2003/361/EC of 6 May 200318 ;
“Union” means the European Union;
“Union harmonisation legislation” means any Union legislation harmonising the conditions for the marketing of products;
“watercraft” means any recreational craft or personal watercraft;
“watercraft built for own use” means a watercraft predominantly built by its future user for that person’s own use;
“withdrawal” means any measure aimed at preventing a product in the supply chain from being made available on the market.
- (2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.
Application
(1) Subject to paragraph (2), 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 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 are subject to major craft conversion.
- (2) These Regulations do not apply to the following products:
- (a) with regard to the design and construction requirements specified in Part A of Annex I:
- (i) watercraft intended solely for racing, including rowing racing boats and training rowing boats, labelled as such by the manufacturer;
- (ii) canoes and kayaks designed to be propelled solely by human power, gondolas and pedalos;
- (iii) surfboards designed solely to be propelled by wind and to be operated by a person or persons standing;
- (iv) surfboards;
- (v) original historical watercraft and individual replicas of such watercraft designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer;
- (vi) experimental watercraft, provided that the watercraft is not placed on the Union market;
- (vii) watercraft built for own use, provided that the watercraft is not subsequently placed on the Union market during a period of 5 years from the date it is put into service;
- (viii) watercraft specifically intended to be crewed and to carry passengers for commercial purposes, regardless of the number of passengers, but without prejudice to paragraph (3);
- (ix) submersibles;
- (x) air cushion vehicles;
- (xi) hydrofoils;
- (xii) external combustion steam powered watercraft, fuelled by coal, coke, wood, oil or gas;
- (xiii) amphibious vehicles, such as wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land;
- (b) with regard to exhaust emission requirements specified in Part B of Annex I:
- (i) propulsion engines installed or specifically intended for installation on the following products:
- (I) watercraft intended solely for racing and labelled as such by the manufacturer;
- (II) experimental watercraft, provided that the watercraft is not placed on the Union market;
- (III) watercraft specifically intended to be crewed and to carry passengers for commercial purposes, regardless of the number of passengers, but without prejudice to paragraph (3);
- (IV) submersibles;
- (V) air cushion vehicles;
- (VI) hydrofoils;
- (VII) amphibious vehicles, such as wheeled or track-laying motor vehicles, which are able to operate both on water and on land;
- (ii) original and individual replicas of historical propulsion engines, which are based on a pre-1950 design, not produced in series and fitted on watercraft referred to in clause (v) or (vii) of subparagraph (a);
- (iii) propulsion engines built for own use provided that such engines are not subsequently placed on the Union market during a period of 5 years from the date the watercraft in which the engines are installed are put into service;
- (c) with regard to noise emission requirements referred to in Part C of Annex I:
- (i) all watercraft referred to in subparagraph (b);
- (ii) watercraft built for own use, provided that the watercraft is not subsequently placed on the Union market during a period of 5 years from the date it is put into service.
- (3) Notwithstanding subparagraph (a)(viii), (b)(i)(III) or (c)(i) of paragraph (2), these Regulations apply to watercraft which may be used for charter or for sports and leisure training when placed on the Union market for recreational purposes.
Making available on the market, putting into service and essential requirements
(1) A product to which these Regulations apply may be made available on the market or put into service only if—
- (a) the product does not endanger the health and safety of persons, property or the environment, when correctly maintained and used in accordance with its intended purpose, and
- (b) the product meets the essential requirements specified in Annex I applicable to that product.
- (2) A person who makes available on the market a product to which these Regulations apply in contravention of paragraph (1) shall be guilty of an offence.
- (3) Each of the following persons who put into service a product to which these Regulations apply in contravention of paragraph (1) shall be guilty of an offence:
- (a) a private importer;
- (b) a person referred to in Regulation 5(4) who has adapted an engine referred to in subparagraph (b) or (c) of Regulation 5(3);
- (c) a person who has carried out a major engine modification referred to in subparagraph (a) of Regulation 19(3) or a major craft conversion referred to in subparagraph (b) of Regulation 19(3);
- (d) a person referred to in Regulation 19(4).
Free movement
(1) Nothing in these Regulations shall impede the making available on the market of a partly completed watercraft in respect of which the manufacturer or the importer, as the case may be, has drawn up a declaration in accordance with Annex III that such watercraft is intended to be completed by another person.
- (2) Nothing in these Regulations shall impede the making available on the market or the putting into service of a component—
- (a) that complies with these Regulations,
- (b) that is intended to be incorporated into watercraft, and
- (c) in respect of which the appropriate declaration referred to in Regulation 15 has been drawn up by the manufacturer or importer, as the case may be.
- (3) Nothing in these Regulations shall impede the making available on the market or the putting into service of a propulsion engine—
- (a) that complies with these Regulations, whether or not installed in a watercraft,
- (b) that—
- (i) is installed in a watercraft,
- (ii) is type-approved in accordance with Directive No. 97/68/EC and is in compliance with emission limits for CI engines as provided for in point 4.1.2 of Annex I to that Directive and specified for—
- (I) stage III A,
- (II) stage III B, or
- (III) stage IV,
and used in other applications than propulsion of inland waterway vessels, locomotives or railcars, and
- (iii) complies with these Regulations, other than the exhaust emission requirements applicable to propulsion engines specified in Part B of Annex I,
or
- (c) that—
- (i) is installed in a watercraft,
- (ii) is type-approved in accordance with Regulation (EC) No. 595/2009, and
- (iii) complies with these Regulations, other than the exhaust emission requirements applicable to propulsion engines specified in Part B of Annex I.
- (4) Notwithstanding paragraph (3), in respect of a propulsion engine referred to in paragraph (b) or (c) of that paragraph, the person undertaking the adaptation of such an engine shall—
- (a) ensure that, when installed in a watercraft in accordance with that person’s installation instructions and taking full account of the information and data available from the engine manufacturer, the propulsion engine will continue to comply with the exhaust emission requirements of either—
- (i) Directive No. 97/68/EC, or
- (ii) Regulation (EC) No. 595/2009,
applicable to that propulsion engine, as declared by the engine manufacturer, and
- (b) draw up an EU declaration of conformity referred to in Regulation 15 that the propulsion engine will continue to meet the exhaust emission requirements of either—
- (i) Directive No. 97/68/EC, or
- (ii) Regulation (EC) No. 595/2009,
applicable to that propulsion engine, when installed in accordance with the installation instructions supplied by that person.
- (5) Nothing in these Regulations shall impede the showing of products to which these Regulations apply that do not comply with these Regulations at trade fairs, exhibitions and demonstrations provided that a clearly visible sign is displayed at any such trade fair, exhibition or demonstration indicating that the products concerned—
- (a) do not comply with these Regulations, and
- (b) shall not be made available on the market or put into service until they so comply.
Market surveillance authority and competent authority
For the purposes of these Regulations, the Marine Survey Office is the market surveillance authority and the competent authority in the State.
PART 2 Obligations of Economic Operators and Private Importers
Obligations of manufacturers
(1) A manufacturer shall ensure that a product placed on the market by that manufacturer has been designed and manufactured in accordance with the requirements of Regulation 4(1) and the essential requirements specified in Annex I applicable to the product.
- (2) Before placing a product on the market, the manufacturer of the product shall—
- (a) draw up the technical documentation in accordance with Regulation 25,
- (b) either—
- (i) carry out the conformity assessment procedure applicable to the product, or
- (ii) have the conformity assessment procedure carried out,
in accordance with Regulations 19, 20, 21, 22 and 24,
- (c) where the compliance of the product with the applicable requirements set out in Annex I has been demonstrated by the conformity assessment procedure, draw up the appropriate declaration referred to in Regulation 15 in accordance with that Regulation,
- (d) affix a CE marking to a product in accordance with Regulations 17 and 18,
- (e) ensure that the product bears a type, batch or serial number or other element allowing its identification or in the case of a component, where because of its size or nature that is not possible, on its packaging or in the document accompanying the component,
- (f) ensure that procedures are in place for series production to remain in conformity with the requirements of these Regulations, having regard to any changes in product design or characteristics and changes in the harmonised standards by reference to which conformity of a product is declared,
- (g) indicate on the product or, where that is not possible, on its packaging or a document accompanying the product—
- (i) the manufacturer’s name, registered trade name or registered trade mark, and
- (ii) the postal address which shall indicate a single point at which the manufacturer can be contacted,
and
- (h) ensure that the product is accompanied by instructions and safety information in an owner’s manual in both the Irish and English languages or in the English language only.
- (3) A manufacturer of a product which the manufacturer has placed on the market shall—
- (a) retain the technical documentation and a copy of the appropriate declaration referred to in Regulation 15 for 10 years after the product has been placed on the market,
- (b) carry out, as required, when deemed appropriate with regard to a risk presented by a product, to protect the health and safety of consumers, sample testing of the product which has been made available on the market,
- (c) investigate and, if necessary, keep a register of complaints, non-conforming products and product recalls,
- (d) keep distributors informed of any such monitoring referred to in subparagraphs (b) and (c),
- (e) in respect of a product which the manufacturer considers or has reason to believe is not in conformity with the requirements of these Regulations—
- (i) immediately take any corrective measures necessary to bring the product into conformity including withdrawing it, or recalling it, if appropriate, and
- (ii) where the product presents a risk, immediately inform the competent authority and the competent authorities of the other Member States in which the product has been made available, to that effect, giving details of—
- (I) the non-compliance, and
- (II) any corrective measures taken,
- (f) further to a reasoned request from the competent authority, provide it with all the information and documentation, in the Irish or English language, necessary to demonstrate the conformity of the product, and
- (g) cooperate with the competent authority, at its request, on any action taken to eliminate a risk posed by a product which the manufacturer has placed on the market.
- (4) Where a manufacturer affixes, or has affixed on its behalf, a CE marking to a product, the manufacturer indicates that it takes responsibility for the conformity of the product with all the applicable requirements set out in the relevant Union harmonisation legislation which provides for the affixing of the CE marking to the product.
- (5) This Regulation applies to importers and distributors in the circumstances referred to in Regulation 11 and, accordingly, in this Regulation a reference to a manufacturer includes a reference to an importer or a distributor, as the case may be.
Authorised representatives
(1) A manufacturer may, by written mandate, appoint an authorised representative.
- (2) Subject to paragraph (3), an authorised representative shall perform the tasks specified in the mandate received from the manufacturer.
- (3) The tasks referred to in paragraph (2) shall not include—
- (a) the obligations referred to in Regulation 7(1), and
- (b) the drawing up of the technical documentation referred to in Regulation 25.
- (4) The mandate shall permit the authorised representative to perform the following tasks in respect of a product which shall include, but are not limited to:
- (a) retaining a copy of the appropriate declaration referred to in Regulation 15 at the disposal of the market surveillance authority for 10 years after a product has been placed on the market;
- (b) retaining a copy of the technical documentation referred to in Regulation 25 at the disposal of the market surveillance authority for 10 years after a product has been placed on the market;
- (c) further to a reasoned request from the competent authority, providing it with all the information and documentation necessary to demonstrate the conformity of a product;
- (d) cooperate with the competent authority, at its request, on any action taken to eliminate a risk posed by a product covered by its mandate.
Obligations of importers
(1) An importer shall not place a product on the market unless that product complies with these Regulations.
- (2) Before placing a product on the market an importer shall ensure that—
- (a) the appropriate conformity assessment procedure has been carried out by the manufacturer,
- (b) the manufacturer has drawn up the technical documentation in accordance with Regulation 25, and containing the relevant documents specified in Annex IX,
- (c) the product bears a CE marking in accordance with Regulation 17,
- (d) the product is accompanied by the appropriate declaration referred to in Regulation 15,
- (e) the product is accompanied by an owner’s manual—
- (i) specified in point 2.5 of Part A of Annex I, and
- (ii) in the case of—
- (I) a product referred to in Part B of Annex I, an owner’s manual specified in point 4 of that Part;
- (II) a product referred to in Part C of Annex I, containing the information or instructions, as the case may be, referred to in point 2 of that Part,
- (f) the manufacturer has complied with the requirements specified in subparagraphs (e) and (g) of Regulation 7(2),
- (g) the product is accompanied by instructions and safety information in an owner’s manual in both the Irish and English languages or in the English language only, and
- (h) the importer’s name, registered trade name or registered trade mark and the postal address at which the importer can be contacted is indicated on the product, or, in the case of a component where that is not possible, on the packaging or in a document accompanying the product.
- (3) Before placing a product on the market, where an importer considers or has reason to believe that a product is not in conformity with the requirements specified in Regulation 4(1) and Annex I, the importer—
- (a) shall not place the product on the market until the product has been brought into conformity, and
- (b) where the product presents a risk, shall inform the manufacturer and the market surveillance authority of the risk.
- (4) Before placing a product on the market, an importer shall ensure that, while the product is under the responsibility of the importer, the storage of the product or the conditions under which it is transported do not jeopardise its compliance with the requirements specified in Regulation 4(1) and Annex I.
- (5) An importer of a product which the importer has placed on the market shall, for 10 years after the product has been placed on the market—
- (a) retain a copy of the appropriate declaration referred to in Regulation 15 at the disposal of the market surveillance authority, and
- (b) ensure that the technical documentation drawn up in accordance with Regulation 25 is made available to the market surveillance authority, upon request.
- (6) An importer shall—
- (a) carry out, as required, when deemed appropriate with regard to a risk presented by a product, to protect the health and safety of consumers, sample testing of any such product made available on the market,
- (b) investigate and, if necessary, keep a register of complaints, non-conforming products and product recalls, and
- (c) keep distributors informed of any such monitoring referred to in subparagraphs (a) and (b).
- (7) 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 the requirements of these Regulations—
- (a) shall immediately take any corrective measures necessary to bring that product into conformity, including withdrawing or recalling it, if appropriate, and
- (b) where the product presents a risk, shall immediately inform the competent authority and the competent authorities of the other Member States in which the importer made the product available, to that effect, giving details of—
- (i) the non-compliance, and
- (ii) any corrective measures taken.
- (8) An importer shall—
- (a) further to a reasoned request from the competent authority, provide it with all the information and documentation, in the Irish or the English language, necessary to demonstrate the conformity of a product, and
- (b) cooperate with the competent authority, at its request, on any action taken to eliminate a risk posed by a product which the importer has placed on the market.
Obligations of distributors
(1) A distributor shall not make a product available on the market without acting with due care in relation to the requirements of these Regulations.
- (2) Before making a product available on the market, a distributor shall verify that—
- (a) the product bears the CE marking in accordance with Regulation 17,
- (b) the product is accompanied by an owner’s manual—
- (i) specified in point 2.5 of Part A of Annex I, and
- (ii) in the case of—
- (I) a product referred to in Part B of Annex I, an owner’s manual specified in point 4 of that Part;
- (II) a product referred to in Part C of Annex I, containing the information or instructions, as the case may be, referred to in point 2 of that Part,
- (c) the product is accompanied by the appropriate declaration referred to in Regulation 15,
- (d) the product is accompanied by instructions and safety information in an owner’s manual in both the Irish and English languages or in the English language only,
- (e) the manufacturer has complied with the requirements specified in subparagraphs (e) and (g) of Regulation 7(2), and
- (f) the importer has complied with the requirements specified in Regulation 9(2)(h).
- (3) Before making a product available on the market, where a distributor considers, or has reason to believe, that a product is not in conformity with the requirements specified in Regulation 4(1) and Annex I, the distributor—
- (a) shall not make the product available on the market until the product has been brought into conformity with those requirements, and
- (b) where the product presents a risk, shall inform the manufacturer or the importer, as the case may be, and the market surveillance authority of the risk.
- (4) A distributor shall ensure that, while a product is under the responsibility of the distributor, the storage of the product or the conditions under which it is transported do not jeopardise its compliance with the requirements specified in Regulation 4(1) and Annex I.
- (5) A distributor who considers, or has reason to believe, that a product which the distributor has made available on the market is not in conformity with the requirements of these Regulations—
- (a) shall ensure that the necessary corrective measures, as appropriate, are taken to bring that product into conformity, or to withdraw or recall the product, and
- (b) where the product presents a risk, shall immediately inform the competent authority and the competent authorities of the other Member States in which the distributor made the product available on the market to that effect, giving details of—
- (i) the non-compliance, and
- (ii) any corrective measures taken.
- (6) A distributor shall—
- (a) further to a reasoned request from the competent authority, provide it with all the information and documentation which is necessary to demonstrate the conformity of a product, and
- (b) cooperate with the competent authority, at its request, on any action taken to eliminate a risk posed by a product which the distributor has made available on the market.
Cases in which obligations of manufacturers apply to importers and distributors
An importer or a distributor shall be considered a manufacturer for the purposes of these Regulations and shall fulfil the obligations of the manufacturer under Regulation 7 where any of the following circumstances apply:
- (a) the importer places a product on the market under the importer’s name or trademark;
- (b) the distributor places a product on the market under the distributor’s name or trademark;
- (c) the importer or distributor modifies a product already placed on the market in such a way that compliance with the requirements of these Regulations may be affected.
Obligations of private importers
Where a manufacturer does not fulfil the obligations to ensure the conformity of a product with these Regulations, a private importer shall, before putting a product into service—
- (a) ensure that it was designed and manufactured in accordance with the requirements of Regulation 4(1) and Annex I,
- (b) carry out, or have carried out, the obligations of the manufacturer under subparagraphs (a) to (d) and (h) of paragraph (2) and subparagraphs (a), (f) and (g) of paragraph (3) of Regulation 7,
- (c) draw up, or have drawn up by a person with an appropriate level of qualifications and technical expertise and competence, the technical documentation required under Regulation 7(2)(a), where the manufacturer has not already done so, and
- (d) ensure that the name and address of the notified body which has carried out the conformity assessment of the product is marked on the product.
Identification of economic operators
(1) An economic operator (“the first-mentioned economic operator”) shall, on request, identify to the market surveillance authority any other economic operator—
- (a) who has supplied the first-mentioned economic operator with a product, or
- (b) to whom the first-mentioned economic operator has supplied a product.
- (2) An economic operator shall be able to present the information referred to in paragraph (1) to the market surveillance authority for a period of 10 years after the economic operator has supplied, or been supplied with, the product.
- (3) A private importer shall, on request, identify to the market surveillance authority the economic operator who has supplied the private importer with a product.
- (4) A private importer shall be able to present the information referred to in paragraph (3) to the market surveillance authority for a period of 10 years after the private importer has been supplied with the product.
PART 3 Conformity of Products
Presumption of conformity of products
A product which is in conformity with harmonised standards (or parts of such standards), references to which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards (or parts of those standards) specified in Regulation 4(1) and Annex I.
EU declaration of conformity and declaration in accordance with Annex III
(1) A person required by these Regulations to draw up an EU declaration of conformity in respect of a product to which these Regulations apply shall ensure that the declaration—
- (a) states that the fulfilment of the following requirements applicable to the product have been demonstrated in respect of that product:
- (i) the requirements specified in Regulation 4(1) and Annex I, or
- (ii) the requirements specified in subparagraph (b) or (c) of Regulation 5(3) and in Regulation 5(4),
- (b) has the model structure set out in Annex IV,
- (c) contains the elements specified in the relevant modules—
- (i) in Annex II to the Decision for the relevant conformity assessment procedure applicable to, and followed in respect of, a product, and
- (ii) in Annex V for equivalent conformity based on post-construction assessment applicable to, and followed in respect of, a product,
and
- (d) when the product is made available on the market or put into service in the State, is translated into—
- (i) both the Irish and English languages, or
- (ii) the English language only.
- (2) A person who has drawn up an EU declaration of conformity in accordance with paragraph (1) shall ensure that the declaration is continuously updated.
- (3) A manufacturer, a private importer or a person referred to in Regulation 5(4) who has adapted an engine referred to in subparagraph (b) or (c) of Regulation 5(3), who has drawn up an EU declaration of conformity in accordance with paragraph (1), shall be responsible for compliance of the product with these Regulations.
- (4) A manufacturer, a private importer, or a person referred to in Regulation 5(4) who has adapted an engine referred to in subparagraph (b) or (c) of Regulation 5(3), who has drawn up an EU declaration of conformity in accordance with paragraph (1), shall ensure that the declaration shall accompany—
- (a) watercraft,
- (b) components, when placed on the market separately, and
- (c) propulsion engines,
when made available on the market or put into service.
- (5) A manufacturer or an importer of a partly completed watercraft specified in Regulation 5(1) shall, when the partly completed watercraft is made available on the market in the State—
- (a) draw up a declaration containing the elements specified in Annex III,
- (b) ensure the declaration shall accompany the partly completed watercraft, and
- (c) translate the declaration into—
- (i) both the Irish and English languages, or
- (ii) the English language only.
General principles of CE marking
(1) The CE marking shall be affixed to a product only in accordance with the requirements of these Regulations.
- (2) The CE marking shall be the only marking which attests to the conformity of a product with all the applicable requirements of the relevant Union harmonisation legislation which provides for the affixing of the CE marking to the product.
- (3) The following persons, as the case may require, shall ensure that this Regulation is complied with in relation to a product:
- (a) the manufacturer of the product;
- (b) the authorised representative concerned, where the requirement to affix the CE marking to a product in accordance with Regulations 17 and 18 is specified in the mandate received by the authorised representative from the manufacturer;
- (c) the importer of the product, in the circumstances referred to in paragraph (a) or (c) of Regulation 11;
- (d) a distributor of the product, in the circumstances referred to in paragraph (b) or (c) of Regulation 11;
- (e) a private importer of the product, in a case where Regulation 12(b) applies;
- (f) a person referred to in Regulation 5(4) who has adapted an engine referred to in subparagraph (b) or (c) of Regulation 5(3);
- (g) a person who has carried out a major engine modification referred to in subparagraph (a) of Regulation 19(3) or a major craft conversion referred to in subparagraph (b) of Regulation 19(3);
- (h) a person referred to in Regulation 19(4);
- (i) a person referred to in Regulation 19(5).
Products subject to CE marking
(1) The following products are subject to CE marking when made available on the market or put into service:
- (a) watercraft;
- (b) components;
- (c) propulsion engines.
- (2) A product referred to in paragraph (1) which bears the CE marking shall be presumed to comply with these Regulations.
Rules and conditions for affixing CE marking and other markings
(1) A person shall not make available on the market or put into service a product referred to in Regulation 17(1), unless the CE marking, specified in Annex II to Regulation (EC) No. 765/2008, is affixed to the product, in accordance with paragraphs (2) to (6), before it is so made available or put into service.
- (2) The CE marking shall be affixed visibly, legibly and indelibly to the product concerned.
- (3) In the case of a component, where it is not possible or warranted, because of the nature or size of that product, to affix the CE marking in accordance with paragraph (1), the CE marking shall be affixed to the packaging and the accompanying documents.
- (4) In the case of a watercraft, the CE marking shall be affixed on the watercraft builder’s plate which is mounted separately from the watercraft identification number.
- (5) In the case of a propulsion engine, the CE marking shall be affixed on the engine.
- (6) The CE marking shall be affixed to the product before it is placed on the market or put into service.
- (7) The CE marking shall be followed by the identification number of the notified body, where that body is involved in the production control phase or the post-construction assessment.
- (8) The identification number of the notified body shall be affixed—
- (a) by the notified body itself, or
- (b) where instructed to do so by the notified body, by—
- (i) the manufacturer,
- (ii) the authorised representative of the manufacturer,
- (iii) the private importer,
- (iv) the person who has carried out a major engine modification referred to in subparagraph (a) of Regulation 19(3) or a major craft conversion referred to in subparagraph (b) of Regulation 19(3),
- (v) the person referred to in Regulation 19(4), or
- (vi) the person referred to in Regulation 19(5).
- (9) The CE marking and, where applicable, the identification number of the notified body referred to in paragraph (7), may be followed by a pictogram or any other mark indicating a special risk or use.
- (10) A person shall not affix a sign, marking or inscription to a product which is likely to mislead third parties as to the meaning or form of the CE marking.
- (11) A person shall not affix a marking to a product if it is likely to impair the visibility, legibility or meaning of the CE marking.
- (12) A person shall not affix a CE marking, in a manner which contravenes this Regulation, to a product which is otherwise in conformity with the requirements of these Regulations.
- (13) A person who affixes a CE marking to a product which is not in conformity with the requirements of these Regulations shall be guilty of an offence.
PART 4 Conformity Assessment Procedures
Applicable conformity assessment procedures
(1) A manufacturer of a product to which these Regulations apply shall apply the conformity assessment procedures specified in Regulations 20, 21 and 22 before placing the product on the market.
- (2) A private importer of a product to which these Regulations apply shall apply the conformity assessment procedure specified in Regulation 23 before putting the product into service where the manufacturer has not carried out the conformity assessment for the product concerned.
- (3) A person shall apply the conformity assessment procedure specified in Regulation 23 before placing on the market or putting into service—
- (a) a propulsion engine following the carrying out of a major engine modification, or
- (b) a watercraft following the carrying out of a major craft conversion.
- (4) A person who intends—
- (a) to place on the market or put into service a watercraft to which these Regulations do not apply, and
- (b) to change the purpose of the watercraft in such a manner that these Regulations shall apply to the watercraft following such change,
shall apply the conformity assessment procedure specified in Regulation 23 before placing the watercraft on the market or putting it into service.
- (5) A person who intends to place on the market a watercraft referred to in subparagraph (a)(vii) of Regulation 3(2) before the end of a period of 5 years from the date the watercraft was put into service, shall apply the conformity assessment procedure specified in Regulation 23 before placing the watercraft on the market.
Design and construction
(1) The conformity assessment procedures specified in Annex II to the Decision and set out in this Regulation shall apply with regard to design and construction of recreational craft, personal watercraft and components.
- (2) The conformity assessment procedures to be applied in respect of recreational craft of hull length from 2.5 metres to less than 12 metres of design categories A and B referred to in point 1 of Part A of Annex I shall be—
- (a) Module A1,
(b)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (c) Module G, or
- (d) Module H.
- (3) The conformity assessment procedures to be applied in respect of recreational craft of hull length from 12 metres to 24 metres of design categories A and B referred to in point 1 of Part A of Annex I shall be—
(a)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (b) Module G, or
- (c) Module H.
- (4) The conformity assessment procedures to be applied in respect of recreational craft of hull length from 2.5 metres to less than 12 metres of design category C referred to in point 1 of Part A of Annex I shall be—
- (a) where the harmonised standards relating to points 3.2 and 3.3 of Part A of Annex I are complied with—
- (i) Module A,
- (ii) Module A1,
(iii)(I) Module B, and
- (II) any one of the following modules:
- (A) Module C;
- (B) Module D;
- (C) Module E;
- (D) Module F,
- (iv) Module G, or
- (v) Module H,
or
- (b) where the harmonised standards relating to points 3.2 and 3.3 of Part A of Annex I are not complied with—
- (i) Module A1,
(ii)(I) Module B, and
- (II) any one of the following modules:
- (A) Module C;
- (B) Module D;
- (C) Module E;
- (D) Module F,
- (iii) Module G, or
- (iv) Module H.
- (5) The conformity assessment procedures to be applied in respect of recreational craft of hull length from 12 metres to 24 metres of design category C referred to in point 1 of Part A of Annex I shall be—
(a)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (b) Module G, or
- (c) Module H.
- (6) The conformity assessment procedures to be applied in respect of recreational craft of hull length from 2.5 metres to 24 metres of design category D referred to in point 1 of Part A of Annex I shall be—
- (a) Module A,
- (b) Module A1,
(c)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (d) Module G, or
- (e) Module H.
- (7) The conformity assessment procedures specified in Annex II to the Decision to be applied in respect of the design and construction of personal watercraft shall be—
- (a) Module A,
- (b) Module A1,
(c)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (d) Module G, or
- (e) Module H.
- (8) The conformity assessment procedures specified in Annex II to the Decision to be applied in respect of the design and construction of components shall be—
(a)(i) Module B, and
- (ii) any one of the following modules:
- (I) Module C;
- (II) Module D;
- (III) Module E;
- (IV) Module F,
- (b) Module G, or
- (c) Module H.
Exhaust emissions
The manufacturer of a propulsion engine referred to in subparagraph (d) or (e) of Regulation 3(1) shall apply the following conformity assessment procedures specified in Annex II to the Decision in respect of exhaust emissions of such a propulsion engine:
- (a) where tests are conducted using the harmonised standard for exhaust emission measurement—
(i)(I) Module B, and
- (II) any one of the following modules:
- (A) Module C;
- (B) Module D;
- (C) Module E;
- (D) Module F,
- (ii) Module G, or
- (iii) Module H;
- (b) where tests are conducted without using the harmonised standard for exhaust emission measurement—
- (i) Module B and Module C1, or
- (ii) Module G.
Noise emissions
(1) A manufacturer shall apply the conformity assessment procedures specified in Annex II to the Decision in respect of noise emissions to—
- (a) recreational craft with stern drive propulsion engines without integral exhausts,
- (b) recreational craft with inboard propulsion engine installations,
- (c) recreational craft with stern drive propulsion engines without integral exhausts subject to major craft conversion and subsequently placed on the market within 5 years of the conversion, and
- (d) recreational craft with inboard propulsion engine installations subject to major craft conversion and subsequently placed on the market within 5 years of the conversion.
- (2) The conformity assessment procedures to be applied in respect of the recreational craft specified in paragraph (1) shall be—
- (a) where tests are conducted using the harmonised standard for noise measurement—
- (i) Module A1,
- (ii) Module G, or
- (iii) Module H,
- (b) where tests are conducted without using the harmonised standard for noise measurement, Module G, or
- (c) where the Froude number and power displacement ratio method is used for assessment—
- (i) Module A,
- (ii) Module G, or
- (iii) Module H.
- (3) A manufacturer of a personal watercraft or a propulsion engine shall apply the conformity assessment procedures specified in Annex II to the Decision in respect of noise emissions to—
- (a) personal watercraft,
- (b) outboard propulsion engines intended for installation on recreational craft, and
- (c) stern drive propulsion engines with integral exhausts intended for installation on recreational craft.
- (4) The conformity assessment procedures to be applied in respect of a personal watercraft or a propulsion engine specified in paragraph (3) shall be—
- (a) where tests are conducted using the harmonised standard for noise measurement—
- (i) Module A1,
- (ii) Module G, or
- (iii) Module H,
or
- (b) where tests are conducted without using the harmonised standard for noise measurement, Module G.
Post construction assessment
For the purposes of paragraphs (2), (3), (4) and (5) of Regulation 19, the post construction conformity assessment procedure shall be carried out in accordance with Annex V.
Supplementary requirements
(1) Where the procedure specified in Module B of Annex II to the Decision is used to conduct the assessments specified for the purposes of Regulation 20, 21 or 22, the EU type examination shall be carried out in the manner specified in the second indent of point 2 of Module B.
- (2) A production type as referred to in Module B of Annex II to the Decision used by a notified body to carry out conformity assessment may apply to several versions of the same product, provided that—
- (a) any difference between the versions of the product does not affect the level of safety and other requirements in relation to the performance of the product, and
- (b) other versions of the product are referred to in the corresponding EU type examination certificate and, if necessary, by amendments to the original certificate.
- (3) Where the procedure specified in Module A1 of Annex II to the Decision is used to conduct the assessments specified for the purposes of Regulation 20, 21 or 22, the product checks shall be carried out on one or more watercraft representing the production of the manufacturer, and the supplementary requirements specified in Annex VI shall apply.
- (4) The product checks referred to in Module A1 or C1 of Annex II to the Decision shall not be carried out by accredited in-house bodies referred to in those modules.
- (5) Where the procedure specified in Module F of Annex II to the Decision is used to conduct the assessments specified for the purposes of Regulation 21, Annex VII shall apply to the assessment of conformity with the exhaust emission requirements.
- (6) Where the procedure specified in Module C of Annex II to the Decision is used to conduct the assessments specified for the purposes of Regulation 21, and if the manufacturer is not operating an approved quality system specified in Module H of Annex II to the Decision, a notified body, chosen by the manufacturer to carry out the product checks or to have them carried out at random intervals determined by the notified body, shall carry out such checks in order to verify the quality of the internal checks on the product.
- (7) If, in respect of the procedures referred to in paragraph (6), the notified body is of the opinion that—
- (a) the quality level may be unsatisfactory, or
- (b) it may be necessary to verify the validity of the data presented by the manufacturer,
the procedure specified in Annex VIII shall apply.
Technical documentation
(1) The technical documentation referred to in Regulation 7(2)(a) shall contain—
- (a) all relevant data and details of the means used by the manufacturer to ensure that a product complies with the requirements of Regulation 4(1) and Annex I, and
- (b) the relevant documents specified in Annex IX.
- (2) The technical documentation shall ensure that the design, construction, operation and assessment of conformity of the product shall be clear and intelligible.
PART 5
Notification of Conformity assessment Bodies
Notifying authority
(1) The Minister is designated as the notifying authority in the State for the purposes of Article 27 of the Directive and these Regulations.
- (2) The Accreditation Board shall carry out the following activities on behalf of the notifying authority—
- (a) the setting up and carrying out of the necessary procedures for the assessment and accreditation of conformity assessment bodies, and
- (b) the monitoring of notified bodies, including compliance with the requirements of paragraphs 16, 17, 18, and 19 of the Schedule.
Notification
(1) A conformity assessment body shall meet the requirements of and fulfil the obligations specified in the Schedule for the purposes of notification.
- (2) An application for notification by a conformity assessment body shall be in accordance with Regulation 28.
- (3) The notifying authority may, where—
- (a) a conformity assessment body has made an application in accordance with Regulation 28, and
- (b) the notifying authority is satisfied that the conformity assessment body meets the requirements of and fulfils the obligations specified in the Schedule,
grant notification to the conformity assessment body.
- (4) The grant of notification may be made subject to such conditions as the notifying authority may determine, and such conditions may include conditions which apply upon or during, or following the termination of, the grant of notification.
- (5) Subject to paragraph (6), the duration of the grant of notification shall be at the discretion of the notifying authority which may renew or withdraw the grant as appropriate.
- (6) A grant of notification shall be withdrawn—
- (a) upon the expiry of the period of the grant,
- (b) upon the expiry of 90 days notice in writing given by a notified body to the notifying authority,
- (c) upon determination by the notifying authority, or by an appeal panel on appeal under Regulation 30, that the notified body no longer meets the requirements of and fulfils the obligations specified in the Schedule, or
- (d) upon determination by the notifying authority that the notified body does not comply with, or has ceased to comply with, the conditions attached to such grant.
- (7) A person shall not hold himself or herself out, or represent himself or herself, as being a notified body where the person has not been granted a notification under paragraph (3) or by the notifying authority of another Member State in accordance with Article 26 of the Directive.
Application for notification
(1) A conformity assessment body shall submit an application for notification as a notified body under these Regulations to the notifying authority.
- (2) The application referred to in paragraph (1) shall be accompanied—
- (a) by a description of the conformity assessment activities,
- (b) by—
- (i) the conformity assessment module or modules, and
- (ii) the product or, if applicable, more than one of the products to which these Regulations apply,
in relation to which the conformity assessment body claims to have the competence to perform conformity assessment in accordance with the requirements of these Regulations and relevant harmonised standards,
and
- (c) by such other information and documentation as the notifying authority may require to satisfy itself that the conformity assessment body meets the requirements of, and fulfils the obligations specified in, the Schedule for the purposes of notification as a notified body.
- (3) The application referred to in paragraph (1) shall be accompanied by a certificate of accreditation issued by the Accreditation Board attesting that the conformity assessment body meets the requirements specified in paragraphs 1 to 15 of the Schedule.
Presumption of conformity
Where a conformity assessment body demonstrates conformity with the criteria laid down in the relevant harmonised standards (or part of such standards), the references to which have been published in the Official Journal of the European Union, the body shall be presumed to comply with the requirements specified in paragraphs 1 to 15 of the Schedule, in so far as the applicable harmonised standards (or part of such standards) apply to those requirements.
Restriction, suspension or withdrawal of notification
(1) Where the notifying authority has ascertained or has been informed that a notified body no longer meets the requirements specified in paragraphs 1 to 15 of the Schedule or that it is failing to fulfil its obligations under this Part, the notifying authority shall restrict, suspend or withdraw notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.
- (2) The notifying authority shall inform the notified body concerned of its decision and allow the body an opportunity to make representations to it.
- (3) Where a notified body is aggrieved by a decision of the notifying authority to restrict, suspend or withdraw its notification, the notified body may, within 21 days of the date of the decision, appeal the decision to an appeal panel established by the notifying authority for the purpose of hearing the appeal and stating the grounds on which the appeal is made.
- (4) An appeal panel referred to in paragraph (3) shall consist of such number of independent and suitably qualified persons as the notifying authority decides.
- (5) An appeal panel may affirm, set aside or modify the decision of the notifying authority.
- (6) The decision of an appeal panel is final other than on a point of law on which an appeal lies to the High Court.
Operational obligations of notified bodies
(1) A notified body shall carry out a conformity assessment in accordance with the conformity assessment procedures specified in Regulations 19 to 24 and Article 38(2) of the Directive.
- (2) Where a notified body finds that the requirements specified in Regulation 4(1) and Annex I or corresponding harmonised standards have not been met by a manufacturer or a private importer, it shall require that manufacturer or private importer, as the case may be, to take appropriate corrective measures and it shall not issue a conformity certificate.
- (3) Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product is no longer in compliance, it shall, by notification, require the manufacturer of the product to take appropriate corrective measures and shall suspend or withdraw the certificate, if necessary.
- (4) Where corrective measures referred to in paragraph (3) are not taken or do not have the required effect, the notified body concerned shall, having considered any representations made to it by the manufacturer or the private importer, as the case may be, restrict, suspend or withdraw any certificate, as appropriate.
Appeal from decision of notified body
(1) A manufacturer or a private importer, as the case may be, may, within 21 days of the date of a refusal to issue a certificate under paragraph (2) of Regulation 31, or the restriction, suspension or withdrawal of a certificate under paragraph (3) or (4) of Regulation 31, appeal the decision of the notified body to the notifying authority, stating the grounds on which the appeal is made.
- (2) The notifying authority shall establish an appeal panel for the purpose of hearing an appeal under paragraph (1).
- (3) An appeal panel shall comprise such number of independent and suitably qualified persons as the notifying authority decides.
- (4) An appeal panel may affirm, set aside or modify the decision of the notified body.
- (5) The decision of an appeal panel is final other than on a point of law which lies to the High Court.
Information obligations on notified bodies
(1) A notified body shall inform the notifying authority of—
- (a) any refusal, restriction, suspension or withdrawal of a certificate,
- (b) any circumstances affecting the scope of or conditions for notification,
- (c) any request for information which it has received from the market surveillance authority or the market surveillance authorities of other Member States regarding conformity assessment activities, and
- (d) conformity assessment activities performed within the scope of its notification and any other conformity assessment activity performed, including cross-border activities and subcontracting, on request from the notifying authority.
- (2) A notified body shall provide other notified bodies which perform conformity assessment activities of a similar nature in respect of the same products with relevant information on matters relating to negative and, on request, positive, conformity assessment results.
Fees
(1) A notified body may charge fees in connection with or incidental to carrying out conformity assessment procedures under these Regulations.
- (2) The fees charged under paragraph (1) shall not exceed the sum of the following:
- (a) the costs incurred or to be incurred by the notified body in carrying out conformity assessment procedures;
- (b) an amount of profit which is reasonable in the circumstances, having regard to the character and extent of the work done by the body on behalf of the person who has submitted the product for the assessment of conformity, and the commercial rate normally charged on account of profit for that work or similar work.
- (3) The power in paragraph (1) includes the power to require the payment of fees in advance of carrying out the conformity assessment procedures requested.
- (4) The fees charged under paragraph (1) shall be recoverable, from the person by whom the fee is payable, as a simple contract debt in any court of competent jurisdiction.
PART 6 Union Market Surveillance, Control of Products Entering Union Market and Safeguard Procedure
Union market surveillance and control of products entering Union market
(1) A person shall not place a product on the market unless, when used in accordance with its intended purpose or under conditions which may reasonably be foreseen and when properly installed and maintained, it does not endanger the health or safety of persons.
- (2) A person who fails to comply with paragraph (1) shall be guilty of an offence.
- (3) Articles 15(3) and 16 to 29 of Regulation (EC) No. 765/2008 apply to the products to which these Regulations apply.
Procedure for dealing with products presenting risk at national level
(1) Where the market surveillance authority has reason to believe that a product presents a risk to the health or safety of persons, to property or to the environment, it shall carry out an evaluation in relation to the product concerned in respect of all relevant requirements specified in these Regulations.
- (2) The relevant economic operator or the private importer, as the case may be, shall cooperate as necessary with the market surveillance authority in carrying out an evaluation under paragraph (1).
- (3) Where, in the course of carrying out an evaluation under paragraph (1), the market surveillance authority finds that the product does not comply with the requirements specified in these Regulations, it shall notify its finding without delay to the relevant economic operator concerned, or the private importer, as the case may be.
- (4) Where the market surveillance authority has reason to believe that action is required to prevent a risk to the health and safety of persons, to property or to the environment it may decide to give a prohibition notice stating that opinion, having regard to the nature of the risk referred to in paragraph (1), to—
- (a) the economic operator or operators concerned, requiring the economic operator, within a reasonable period stated in the prohibition notice, to—
- (i) take all appropriate corrective action to bring the product into compliance with the requirements of these Regulations,
- (ii) withdraw the product from the market, or
- (iii) recall the product,
or
- (b) the private importer concerned, specifying the appropriate corrective action to be taken by the private importer to—
- (i) bring the product into compliance with the requirements of these Regulations,
- (ii) refrain from putting the product into service, or
- (iii) where the product has been put into service, to refrain from use of the product.
- (5) The market surveillance authority shall take all appropriate provisional measures it considers necessary where the relevant economic operator or private importer, as the case may be, does not take adequate corrective action as required by, and within the period referred to in, the prohibition notice given under paragraph (4).
- (6) The provisional measures which the market surveillance authority may take under paragraph (5) are as follows:
- (a) in respect of the relevant economic operator—
- (i) the prohibition or restriction of the product from being made available on the market in the State,
- (ii) the withdrawal of the product from the market in the State, or
- (iii) the recall of the product from the market in the State;
- (b) in respect of a private importer—
- (i) the prohibition of the putting into service of the product in the State, or
- (ii) the prohibition or restriction of the use of the product which has been put into service in the State.
- (7) Where the market surveillance authority decides to withdraw a product manufactured in another Member State, it shall inform the economic operator concerned at the address indicated on the product or in the documentation accompanying the product.
- (8) The market surveillance authority shall inform the notified body which carried out the conformity assessment of the product of the giving of a prohibition notice under paragraph (4).
- (9) Where the market surveillance authority considers that the non-compliance is not restricted to the State, it shall inform the Commission and the other Member States of the results of the evaluation referred to in paragraph (1) and of the actions it has required the relevant economic operator to take.
- (10) Regulations 43, 44 and 45 apply to a prohibition notice given under paragraph (4) and to any measures taken by the market surveillance authority under paragraph (5).
Products presenting serious risk
(1) Where, in the course of carrying out an evaluation under Regulation 36(1) or where it has otherwise ascertained or been informed, the market surveillance authority is of the opinion that a product may present a serious risk to the health or safety of persons, to property or to the environment and that immediate action is required to prevent such harm, it shall undertake such evaluation and assessment as seem to it to be appropriate, including a risk assessment, if necessary.
- (2) An evaluation or assessment referred to in paragraph (1), including any risk assessment, shall take into account, but shall not be limited to, an assessment of the nature of the hazard and the likelihood of its occurrence.
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