Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal WatercraftIssued pursuant
to [1 November 2016] 1. General Provisions1. This Regulation prescribes: 1.1. the requirements for the design, manufacture and conformity assessment of recreational craft and personal watercraft, and also engines thereof (hereinafter - the products), the product market surveillance authority, and the procedures for performing market surveillance of the products; 1.2. the procedures for assigning the unique code of the manufacturer to a natural or legal person which manufactures recreational crafts or personal watercrafts in the Republic of Latvia. [1 November 2016] 2. Within the meaning of this Regulation: 2.1. recreational craft - a watercraft of any type (excluding personal watercraft) intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion; 2.2. recall - any measure aimed at achieving the return of the products that have already been made available to the end user; 2.3. major engine modification - the modification of a propulsion engine which: 2.3.1. could potentially cause the engine to exceed the emission limit referred to in Part B of Annex 1 to this Regulation; 2.3.2. increases the rated power of the engine by more than 15 %; 2.4. major craft conversion - a conversion of a watercraft which: 2.4.1.changes the means of propulsion of the watercraft; 2.4.2. involves a major engine modification; 2.4.3. alters the watercraft to such an extent that it may not meet the applicable essential safety and environmental requirements referred to in this Regulation; 2.5. CE marking - a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in European Union harmonisation legislation providing for its affixing; 2.6. engine family - the manufacturer's grouping of engines which, through their design, have similar exhaust or noise emission characteristics; 2.7. European Union harmonisation legislation - any European Union legislation harmonising the conditions for the marketing of products; 2.8. importer - any natural or legal person established in the European Union who places products from the third countries on the market; 2.9. withdrawal from the market - any measure aimed at preventing a product in the supply chain from being made available on the market; 2.10. distributor - any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes the products available on the market; 2.11. hull length - the length of the hull measured in accordance with the requirements of the harmonised standard; 2.12. watercraft - any recreational craft or personal watercraft; 2.13. placing on the market - the first making available of the product on the market; 2.14. putting into service - the first use of the product in the European Union by its end user; 2.15. notified body - a product conformity assessment authority notified to the European Commission in accordance with the laws and regulations regarding the procedures for establishing the notifying committee, and also the procedures for taking a decision and notifying the European Commission by the committee regarding the conformity assessment authorities which perform conformity assessment in the regulated area, or other product conformity assessment authority notified by European Union Member States or the European Economic Area states; 2.16. watercraft built for own use - a watercraft built by a private individual predominately for his own use; 2.17. making available on the market - any supply of the products for distribution or use on the European Union market in the course of an economic activity, whether in return for payment or free of charge; 2.18. propulsion engine - any spark or compression ignition, internal combustion engine used directly or indirectly for propulsion purposes; 2.19. means of propulsion - the method by which the watercraft is propelled; 2.20. authorised representative - any natural or legal person established in the European Union who has received a written mandate from the manufacturer to act on his behalf in relation to specified tasks; 2.21. private importer - any natural or legal person established in the European Union who imports in the course of a non-commercial activity a product from a third country for his own use; 2.22. manufacturer - any natural or legal person who manufactures the products or has such products designed or manufactured, and markets such products under his name or trademark; 2.23. market surveillance - surveillance in conformity with the definition laid down in Article 2(17) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (hereinafter - Regulation (EC) No 765/2008); 2.24. economic operators - the manufacturer, the authorised representative, the importer and the distributor; 2.25. personal watercraft - a watercraft intended for sports and leisure purposes of less than 4 m 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 (persons) sitting, standing or kneeling on, rather than within the confines of a hull. 3. This Regulation shall apply to: 3.1. recreational craft and partly completed recreational craft; 3.2. personal watercraft and partly completed personal watercraft; 3.3. components referred to in Paragraph 7 of this Regulation when placed on the European Union market separately (hereinafter - the product components); 3.4. propulsion engines which are installed or specifically intended for installation on or in watercraft; 3.5. propulsion engines installed on or in watercraft that are subject to a major engine modification; 3.6. watercraft that are subject to major craft conversion. 4. The products referred to in Paragraph 3 of this Regulation and their components may be made available or put into service only if they do not endanger the health and safety of persons, property or the environment when correctly maintained and used according to their intended purpose, and only provided that they meet the requirements referred to in Annex 1 to this Regulation. 5. This Regulation shall not apply: 5.1. with regard to the design and construction requirements laid down in Part A of Annex 1 to this Regulation: 5.1.1. to watercraft intended solely for racing, including rowing racing boats and training rowing boats, labelled as such by the manufacturer; 5.1.2. to canoes and kayaks designed to be propelled solely by human power, and also gondolas and pedalos; 5.1.3. to surfboards designed solely to be propelled by wind and to be operated by a person (persons) standing; 5.1.4. to surfboards; 5.1.5. to the original historical watercraft (and individual replicas thereof) designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer; 5.1.6. to experimental watercraft, provided that they are not placed on the European Union market; 5.1.7. to watercraft built for own use, provided that they are not subsequently placed on the European Union market during a time period of five years from the putting into service of the watercraft; 5.1.8. to watercraft specifically intended to be crewed and to carry passengers for commercial purposes; 5.1.9. to submersibles; 5.1.10. to air cushion vehicles; 5.1.11. to hydrofoils; 5.1.12. to external combustion steam powered watercraft, fuelled by coal, coke, wood, oil or gas; 5.1.13. to amphibious vehicles, i.e. wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land; 5.2. with regard to exhaust emission requirements laid down in Part B of Annex 1 to this Regulation: 5.2.1. to propulsion engines installed or intended for installation on: 5.2.1.1. watercraft intended solely for racing and labelled as such by the manufacturer; 5.2.1.2. experimental watercraft (provided that they are not yet placed on the European Union market); 5.2.1.3. watercraft specifically intended to be crewed and to carry passengers for commercial purposes; 5.2.1.4. submersibles; 5.2.1.5. air cushion vehicles; 5.2.1.6. hydrofoils; 5.2.1.7. amphibious vehicles, i.e. wheeled or track-laying motor vehicles, which are able to operate both on water and on solid land; 5.2.2. to original historical propulsion engines (and their individual replicas) which are based on a pre-1950 design, not produced in series and fitted on the watercraft referred to in Sub-paragraphs 5.1.5 and 5.1.7 of this Regulation; 5.2.3. to propulsion engines built for own use provided that they are not subsequently placed on the European Union market during a time period of five years from the putting into service of the watercraft; 5.3. with regard to the noise emission requirements referred to in Part C of Annex 1 to this Regulation: 5.3.1. to all watercraft referred to in Sub-paragraph 5.2 of this Regulation; 5.3.2. to watercraft built for own use, provided that they are not subsequently placed on the European Union market during a time period of five years from the putting into service of the watercraft. 6. The fact that the same watercraft could also be used for charter or for sports and leisure training shall not prevent it being covered by the requirements of this Regulation when it is placed on the European Union market for recreational purposes. 7. The product components are as follows: 7.1. ignition-protected equipment - for all inboard engines, engines with a Z-drive thruster and outboard engines; 7.2. start-in-gear protection devices - for all outboard engines; 7.3. steering wheels, steering mechanisms and cable assemblies; 7.4. fuel tanks intended for fixed installations and fuel hoses. 8. The Ministry of Transport shall, upon a recommendation of the State stock company "Maritime Administration of Latvia", inform the national standardisation authority regarding the applicable standards published in the Official Journal of the European Union which have been adopted in the status of the national standards (hereinafter - the applicable standards). 9. The national standardisation authority shall publish the list of the applicable standards on its official website. 2. Making Products Available on the Market10. The making available on the market and putting into service of watercraft conforming to the requirements of this Regulation shall be permitted in Latvia. 11. The making available on the market of partly-completed watercraft where the manufacturer or the importer declares, in accordance with Paragraph 55 of this Regulation, that they are intended to be completed by others, shall be permitted in Latvia. 12. The making available on the market of the product components referred to in Paragraph 7 of this Regulation if they conform to the requirements of this Regulation and they are intended to be incorporated into watercraft according to the declaration of the manufacturer or the importer, as referred to in Paragraph 55 of this Regulation, shall be permitted in Latvia. 13. The making available on the market or putting into service of any of the following propulsion engines shall be permitted in Latvia: 13.1. engines, whether or not installed in watercraft, conforming to the requirements of this Regulation; 13.2. engines installed in watercraft and type-approved in accordance with the regulatory enactment regarding the emission of pollutants from internal combustion engines to be installed in non-road mobile machinery and which are in conformity with stage III A, stage III B or stage IV emission limits for CI engines used in other applications than propulsion of inland waterway vessels, locomotives and railcars, as provided for in the abovementioned regulatory enactment, and conforming to the requirements of this Regulation (excluding the exhaust emission requirements referred to in Part B of Annex 1 to this Regulation); 13.3. engines installed in watercraft and type-approved in accordance with Regulation (EC) No 595/2009 of 18 June 2009 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 (hereinafter - Regulation (EC) No 595/2009), and conforming to the requirements of this Regulation (excluding the exhaust emission requirements referred to in Part B of Annex 1 to this Regulation). 14. Sub-paragraphs 13.2 and 13.3 of this Regulation shall apply provided that where an engine is adapted for installation in a watercraft, the person undertaking the adaptation shall ensure that full account is taken of the data and other information available from the engine manufacturer in order to ensure that, when installed according to the installation instructions provided by the person adapting the engine, the engine will continue to meet the exhaust emission requirements laid down in the laws and regulations regarding the emission of pollutants from internal combustion engines to be installed in non-road mobile machinery or Regulation (EC) No 595/2009, as declared by the engine manufacturer. The person adapting the engine shall declare, as referred to in Paragraph 53 of this Regulation, that the engine, when installed according to the installation instructions provided by the person adapting the engine, will continue to meet the exhaust emission requirements laid down in the laws and regulations regarding the emission of pollutants from internal combustion engines to be installed in non-road mobile machinery or Regulation (EC) No 595/2009, as declared by the engine manufacturer. 15. It shall be permitted to demonstrate the products referred to in Paragraph 3 of this Regulation and their components at exhibitions, trade fairs and other similar events, provided that a visible sign clearly indicates that such products may be made available or put into service only after ensuring their conformity in accordance with this Regulation. 3. Obligations of Economic Operators and Private Importers3.1. Obligations of Manufacturers16. When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements referred to in Paragraph 4 of this Regulation. 17. Manufacturers shall draw up the technical documentation in accordance with Paragraph 85 of this Regulation and carry out any of the conformity assessment procedures referred to in Annex 2 to this Regulation in conformity with the requirements referred to in Chapter 5 of this Regulation. 18. Where conformity of a product with the requirements of this Regulation has been proven by the conformity assessment procedure, manufacturers shall draw up the declaration referred to in Paragraph 52 of this Regulation and mark and affix the CE marking thereto in accordance with Paragraphs 56, 57, and 58 of this Regulation. 19. Manufacturers shall keep the technical documentation and a copy of the declaration referred to in Paragraph 52 of this Regulation for 10 years after the product has been placed on the market. 20. Manufacturers shall ensure that procedures are in place for series production to remain in constant conformity, taking into account changes in the product design or characteristics and changes in the applicable standards by reference to which conformity of the product has been declared. 21. When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring. 22. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the components does not allow it, that the required information is provided on the packaging or in a document accompanying the product. 23. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the relevant product or, where that is not possible, the abovementioned information shall be indicated on its packaging or in a document accompanying the product. 24. Manufacturers shall ensure that the product is accompanied by instructions and safety information in the owner's manual in a language or languages which can be easily understood by consumers and other end users. 25. Manufacturers who consider or have reason to believe that the product which they have placed on the market is not in conformity with the requirements of this Regulation shall immediately take the necessary measures to bring the abovementioned product into conformity, to withdraw it or recall it from the market, if appropriate. Where the product presents a risk, manufacturers shall immediately inform the market surveillance authority thereof by giving details of the non-compliance and of any measures taken to eliminate the risk caused by the product. 26. Manufacturers shall, upon reasoned request from the market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Regulation. The abovementioned information and documents shall be provided in the official language. Manufacturer shall, upon request from the market surveillance authority, cooperate with that authority on any action taken to eliminate the risks posed by the products which they have placed on the market. 3.2. Authorised Representatives27. A manufacturer may, by a written mandate, appoint an authorised representative. The authorised representative shall perform at least the following tasks: 27.1. keep a copy of the declaration referred to in Paragraph 52 of this Regulation and the technical documentation for 10 years after the product has been placed on the market by ensuring accessibility thereof for the market surveillance authority; 27.2. upon reasoned request from the market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Regulation; 27.3. upon request from the market surveillance authority, cooperate with it on any action taken to eliminate the risks posed by the products covered by the issued mandate. 28. The obligations referred to in Paragraph 16 of this Regulation and the development of technical documentation shall not form part of tasks of the authorised representative. 3.3. Obligations of Importers29. Importers shall only place on the European Union market the products conforming to the requirements of this Regulation. 30. Before placing the product on the market, importers shall ensure that the conformity assessment procedure has been carried out by the manufacturer. Importers shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the CE marking in accordance with Paragraph 56 of this Regulation, and the product is accompanied by the documents required in accordance with Paragraph 54 or 55 of this Regulation, Part A, Sub-paragraph 2.5 of Annex 1, Part B, Paragraph 4 of Annex 1 and Part C, Paragraph 2 of Annex 1 to this Regulation and that the manufacturer has complied with the requirements laid down Paragraphs 22 and 23 of this Regulation. 31. Where an importer considers or has reason to believe that a product is not in conformity with the requirements referred to in Paragraph 4 of this Regulation, he shall not place the product on the market until it has been brought into conformity. Where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authority to that effect. 32. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the relevant product or, where that is not possible, the abovementioned information shall be indicated on its packaging or in a document accompanying the product. 33. Importers shall ensure that the product is accompanied by instructions and safety information in the owner's manual in a language or languages which can be easily understood by consumers and other end users. 34. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the requirements referred to in Paragraph 4 of this Regulation. 35. When deemed appropriate with regard to the risks presented by the product, importers shall ensure meeting the requirements laid down for manufacturers referred to in Paragraph 21 of this Regulation. 36. Importers who consider or have reason to believe that the product which they have placed on the market is not in conformity with the requirements of this Regulation, shall ensure meeting the requirements laid down for manufacturers referred to in Paragraph 25 of this Regulation. 37. Importers shall, for a time period of 10 years after the product has been placed on the market, keep a copy of the declaration referred to in Paragraph 52 of this Regulation at the disposal of the market surveillance authority and upon request of the market surveillance authority ensure that the technical documentation can be made available to it. 38. Importers shall, upon reasoned request from the market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Regulation. The abovementioned information and documents shall be provided in the official language of the market surveillance authority. Importers shall, upon request from the market surveillance authority, cooperate with that authority on any action taken to eliminate the risks posed by the products which they have placed on the market. 3.4. Obligations of Distributors39. When making the product available on the market distributors shall comply with the requirements of this Regulation. 40. Before making the product available on the market distributors shall verify that the product bears the CE marking in accordance with Paragraph 56 of this Regulation, that it is accompanied by the documents referred to in Paragraph 24, 52 or 55 of this Regulation, Part A, Sub-paragraph 2.5 of Annex 1, Part B, Paragraph 4 of Annex 1 and Part C, Paragraph 2 of Annex 1 to this Regulation and by instructions and safety information in a language (or languages) which can be easily understood by consumers and other end users in the Member State in which the product is made available on the market, and that the manufacturer and the importer have complied with the requirements referred to in Paragraphs 22 and 23 or Paragraphs 32 and 33 of this Regulation accordingly. 41. Where a distributor considers or has reason to believe that the product is not in conformity with the requirements referred to in Paragraph 4 of this Regulation, he shall not make the product available on the market until it has been brought into conformity. Where the product presents a risk, the distributor shall inform the manufacturer or the importer, as well as the market surveillance authorities, to that effect. 42. Distributors shall ensure that, while the product is under their responsibility, storage or transport conditions do not jeopardise its conformity with the requirements referred to in Paragraph 4 of this Regulation. 43. Distributors who consider or have reason to believe that the product which they have made available on the market is not in conformity with this the requirements of this Regulation, shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Where the product presents a risk, distributors shall immediately inform the relevant State surveillance and control authorities of the states in which they have made the product available on the market to that effect, giving detailed information of the non-conformity and of any measures taken to eliminate the risk caused by the product. 44. Distributors shall, upon reasoned request from the market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Regulation. The abovementioned information and documents shall be provided in the official language of the market surveillance authority. Distributors shall, upon request from the market surveillance authority, cooperate with that authority on any action taken to eliminate the risks posed by the products which they have made available on the market. 45. An importer or distributor shall be considered a manufacturer and he shall be subject to the same obligations as the manufacturer under Sub-chapter 3.1 of this Regulation, if he places the product on the market under his name or trademark or modifies the product already placed on the market in such a way that conformity with the requirements of this Regulation may be affected. 3.5. Obligations of Private Importers46. If the manufacturer does not fulfil the obligation for the conformity of the product with the requirements of this Regulation, a private importer, before putting the product into service, shall ensure that it has been designed and manufactured in accordance with the requirements referred to in Paragraph 4 of this Regulation and carry out or has carried out the obligations of the manufacturer referred to in Paragraphs 17, 18, 19, 24 and 26 of this Regulation. 47. If the required technical documentation is not available from the manufacturer, the private importer shall have it drawn up using appropriate expertise. 48. The private importer shall 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. 3.6. Identification of Economic Operators49. Economic operators shall, upon request from the market surveillance authority, be able to present the information regarding an economic operator to whom they have supplied the product for a time period of 10 years after they have been supplied with the product and for a time period of 10 years after they have supplied the product. 50. Private importers shall, upon request from the market surveillance authority, be able to present the information regarding the economic operator who has supplied them with the product for a time period of 10 years after they have been supplied with the product. 4. Conformity of the Product51. Products which are in conformity with the applicable standards or parts thereof the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the safety requirements covered by those standards or parts thereof, referred to in this Regulation. 52. The European Union declaration of conformity (hereinafter - the declaration of conformity) shall state the fulfilment of the requirements referred to in Paragraph 4 or Sub-paragraphs 13.2 and 13.3 of this Regulation which has been drawn up according to the model structure included in Annex 3 to this Regulation and contains the elements specified in the relevant modules included in Sub-chapter 5.5 and Annex 2 to this Regulation, and which shall be continuously updated. The declaration of conformity shall be translated into the language (languages) laid down by the European Union Member State on whose market the product is made available or put into service. 53. By drawing up the declaration of conformity, the manufacturer, private importer or the person adapting the engine referred to in Paragraph 14 of this Regulation shall assume responsibility for the conformity of the product. 54. The declaration of conformity shall accompany the following products when they are made available on the market or put into service: 54.1. watercraft; 54.2. components when placed on the market separately; 54.3. propulsion engines. 55. The manufacturer or the importer shall append a declaration to the watercraft referred to in Paragraph 11 of this Regulation which is translated into the language (languages) required by the European Union Member State on whose market the product is made available and contains the following information: 55.1. the name and address of the manufacturer; 55.2. the given name and surname or name and address of the representative of the manufacturer established in the European Union or, if appropriate, of the person responsible for the placing on the market; 55.3. a description of the partly completed watercraft; 55.4. a statement that the partly completed watercraft conforms to the essential requirements that apply at this stage of construction; this shall include references to the relevant applicable standards used, or references to the specifications in relation to which conformity is declared at this stage of construction; furthermore, it is intended to be completed by other legal or natural persons in full conformity with this Regulation. 56. The following products are subject to CE marking in conformity with the general principles laid down in Article 30 of Regulation (EC) No 765/2008 when they are made available on the market or put into service: 56.1. watercraft; 56.2. components; 56.3. propulsion engines. 57. The CE marking shall be affixed to the products referred to in Paragraph 56 of this Regulation thus certifying the conformity of the abovementioned products with the requirements of this Regulation. In case of components, where that is not possible or not warranted on account of the size or nature of that product, CE marking shall be affixed to the packaging and to the accompanying documents. In the case of watercraft, the CE marking shall be affixed on the watercraft builder's plate mounted separately from the watercraft identification number. In the case of a propulsion engine, the CE marking shall be affixed on the engine. 58. CE marking shall be visible, legible and indelible. 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 in the post-construction assessment. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative, or by the person referred to in Paragraph 60, 61 or 62 of this Regulation. The CE marking and the identification number may be followed by a pictogram or any other mark indicating a special risk or use. 5. Conformity Assessment5.1. Applicable Procedures59. The manufacturer shall apply the conformity assessment procedures referred to in Sub-chapters 5.2, 5.3 and 5.4 of this Regulation before placing on the market the products referred to in Paragraph 3 of this Regulation. 60. The private importers shall apply the procedure referred to in Sub-chapter 5.5 of this Regulation before putting into service the products referred to in Paragraph 3 of this Regulation, if the manufacturer has not carried out the conformity assessment for the product concerned. 61. Any person placing on the market or putting into service a propulsion engine or a watercraft after a major modification or conversion thereof, or any person changing the intended purpose of a watercraft not covered by this Regulation in a way that it falls under its scope, shall apply the procedure referred to in Sub-chapter 5.5 of this Regulation before placing the product on the market or putting it into service. 62. Any person placing on the market a watercraft built for own use before the end of the five-year period referred to in Sub-paragraph 5.1.7 of this Regulation shall apply the procedure referred to in Sub-chapter 5.5 of this Regulation before placing the product on the market. 5.2. Design and Construction of Recreational Craft63. For recreational craft design categories A and B referred to in Part A, Paragraph 1 of Annex 1 to this Regulation: 63.1. if hull length is from 2,5 m to less than 12 m, any of the following procedures shall be applied (modules and descriptions thereof are indicated in Annex 2 to this Regulation): 63.1.1. internal production control and supervised product testing (Module A1); 63.1.2. European Union type (hereinafter - the EU type) examination (Module B) together with conformity to type examination based on internal production control (Module C), or conformity to type examination based on quality assurance in production process (Module D), or conformity to type examination based on the product quality assurance (Module E), or conformity to type examination based on the product verification (Module F); 63.1.3. conformity examination based on unit verification (Module G); 63.1.4. conformity examination based on full quality assurance (Module H); 63.2. if hull length from 12 m to 24 m, any of the following modules shall be applied: B + C, B + D, B + E, B + F, G, H. 64. For design category C referred to in Part A, Paragraph 1 of Annex 1 to this Regulation, if hull length is from 2,5 m to less than 12 m and: 64.1. the applicable standards are fulfilled in respect of Part A, Sub-paragraphs 3.2 and 3.3 of Annex 1 to this Regulation, any of the following modules shall apply: internal production control (Module A), A1, B + C, B + D, B + E, B + F, G, H; 64.2. the applicable standards are not fulfilled in respect of Part A, Sub-paragraphs 3.2 and 3.3. of Annex 1 to this Regulation, any of the following modules shall apply: A1, B + C, B + D, B + E, B + F, G, H. 65. For design category D referred to in Part A, Paragraph 1 of Annex 1 to this Regulation, if hull length is from 2,5 m to less than 24 m, any of the following modules shall apply: A, A1, B + C, B + D, B + E, B + F, G, H. 5.3. Design and Construction of Personal Watercraft and Components66. With regard to design and construction of personal watercraft any of the following modules shall apply: A, A1, B + C, B + D, B + E, B + F, G, H. 67. With regard to design and construction of components any of the following modules shall apply: B + C, B + D, B + E, B + F, G, H. 5.4. Exhaust and Noise Emissions68. With regard to exhaust emissions, for the products referred to in Sub-paragraphs 3.4 and 3.5 of this Regulation, the engine manufacturer shall apply the following procedures: 68.1. where examination is conducted using the applicable standards, any of the following modules shall apply: B + C, B + D, B + E, B + F, G, H; 68.2. where examination is conducted without using the applicable standards, Module B shall apply together with conformity to type examination based on internal production control and supervised product testing (Module C 1), or Module G. 69. With regard to noise emissions for recreational craft with stern drive propulsion engines without integral exhausts or inboard propulsion engine installations and for recreational craft with stern drive propulsion engines without integral exhausts or with inboard propulsion engine installations which are subject to major craft conversion and subsequently placed on the market within five years following conversion, the manufacturer shall apply the following procedures: 69.1. Module A1, G or H where tests are conducted by using the applicable standards for noise measurements; 69.2. Module G where tests are conducted without using the applicable standards for noise measurements; 69.3. Module A, G or H where power/displacement ratio method and the Froude number are used for assessment:
ϑ - craft speed; g - gravitational acceleration constant; L - craft length. 70. With regard to noise emissions for personal watercraft and outboard propulsion engines and stern drive propulsion engines with integral exhausts intended for installation on recreational craft, the personal watercraft or engine manufacturer shall apply the following procedures: 70.1. Module A1 or Module G, or Module H where tests are conducted by using the applicable standards for noise measurements; 70.2. Module G where tests are conducted without using the applicable standards for noise measurements. 5.5. Post-construction Assessment Procedure (Module PCA)71. Conformity based on post-construction assessment is the procedure for assessment of equivalent conformity of a product for which the manufacturer has not assumed the responsibility in relation to the conformity of the product with this Regulation, and whereby the natural or legal person referred to in Paragraph 60, 61 or 62 of this Regulation who is placing the product on the market or putting it into service under his own responsibility is assuming the responsibility for equivalent conformity of the product. The abovementioned person shall fulfil the obligations laid down in Paragraphs 60 and 62 of this Regulation and ensure and declare that the product concerned to which Paragraph 61 of this Regulation applies, is in conformity with the requirements of this Regulation. 72. The person who is placing the product on the market or putting it into service shall submit an application for a post-construction assessment of the product with the notified body, as well as shall provide the notified body with the documents and technical file enabling the notified body to assess the conformity of the product with the requirements of this Regulation and any available information on the use of the product after its first putting into service. 73. The person who is placing such a product on the market or putting it into service shall keep these documents and information at the disposal of the relevant State institutions for 10 years after the product has been assessed on its equivalent conformity. 74. The notified body shall examine the individual product and carry out calculations, tests and other assessments, to the extent necessary to ensure that the equivalent conformity of the product with the relevant requirements of this Regulation is demonstrated. After conducting examination the notified body shall develop an assessment report. If the examined product conforms to the requirements of this Regulation, the notified body shall draw up and issue a certificate and a related report of conformity, and also ensure that a copy of the certificate and of the related report of conformity is available to State institutions for 10 years after issuance of the abovementioned documents. 75. The notified body shall affix its identification number next to the CE marking on the approved product (or have it affixed under its responsibility). In case the assessed product is a watercraft, the notified body shall also have affixed, under his responsibility, the watercraft identification number in accordance with Part A, Sub-paragraph 2.1 of Annex 1 to this Regulation, whereby the field for the country code of the manufacturer shall be used to indicate the country of establishment of the notified body and the fields for the unique code of the manufacturer assigned by the national authority of the European Union Member State to indicate the post-construction assessment identification code assigned to the notified body, followed by the serial number of the post-construction assessment certificate. The fields in the watercraft identification number for the month and year of production and for the model year shall be used to indicate the month and year of the post-construction assessment. 76. The person who is placing the product on the market or putting it into service shall affix the CE marking and the identification number of the notified body to the product for which the notified body has assessed and certified its equivalent conformity with the relevant requirements of this Regulation. 77. The person who is placing the product on the market or putting it into service shall draw up a declaration of conformity and ensure its availability to the relevant State institutions for 10 years after the date the post-construction assessment certificate has been issued. The declaration of conformity shall identify the product for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant State institutions upon request. 78. In case the assessed product is a watercraft, the person who is placing the watercraft on the market or putting it into service shall affix to the watercraft the builder's plate referred to in Part A, Sub-paragraph 2.2 of Annex 1 to this Regulation which shall include the words "post-construction assessment", and the watercraft identification number referred to in Part A, Sub-paragraph 2.1 of Annex 1 to this Regulation, in accordance with Paragraph 75 of this Regulation. 79. The notified body shall inform the person who is placing the product on the market or putting it into service of his obligations under the post-construction assessment procedure referred to in this Regulation. 5.6. Supplementary Requirements80. When Module B is used, the technical design of the product shall be assessed through examination of the technical documentation and supporting evidence that approve the conformity of the technical design (any documents that have been used, in particular where the relevant applicable standards and (or) technical specifications have not been applied in full; where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility shall be included). The production type referred to in Module B may cover several versions of the product provided that the following conditions are conformed to: 80.1. the differences between the versions do not affect the level of safety and the other requirements concerning the performance of the product; 80.2. versions of the product are referred to in the corresponding EU-type examination certificate, if necessary through amendments to the original certificate. 81. When Module A1 is used, the product checks shall be carried out on one or several watercraft representing the production of the manufacturer, and the supplementary requirements referred to in Annex 4 to this Regulation shall apply. 82. When Modules A1 and C1 are used, the product may not be tested by the accredited in-house bodies referred to in these Modules. 83. When Module F is used, the procedure referred to in Annex 5 to this Regulation shall be carried out for assessment of conformity with the exhaust emission requirements. 84. When Module C is used, with regard to assessment of conformity with the exhaust emission requirements of this Regulation, if the manufacturer is not working under an approved quality assurance system as referred to in Module H, the notified body chosen by the manufacturer shall carry out product checks or have them carried out at random intervals determined by that body, in order to verify the quality of the internal checks on the product. When the quality level appears unsatisfactory or when it seems necessary to verify the validity of the data presented by the manufacturer, the procedure referred to in Annex 6 to this Regulation shall be applied. 5.7. Technical Documentation85. The technical documentation referred to in Paragraph 17 of this Regulation shall contain all the relevant data and details of the means used by the manufacturer to ensure that the product conforms to the requirements referred to in Paragraph 4 of this Regulation. The technical documentation shall include: 85.1. a general description of the type of the product; 85.2. conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; 85.3. a list of the applicable standards, applied in full or in part, and descriptions of the solutions adopted to fulfil the requirements of this Regulation,if the applicable standards are not applied; 85.4. results of design calculations made, examinations carried out and other relevant data; 85.5. test reports, or calculations in relation to stability in accordance with the conditions referred to in Part A, Sub-paragraph 3.2 of Annex 1 to this Regulation and on buoyancy in accordance with the conditions referred to in Part A, Sub-paragraph 3.3 of Annex 1 to this Regulation; 85.6. exhaust emissions test reports demonstrating conformity with the requirements referred to in Part B, Chapter 2 of Annex 1 of this Regulation; 85.7. noise emissions test reports demonstrating conformity with the requirements referred to in Part C, Chapter 1 of Annex 1 to this Regulation. 86. The technical documentation shall ensure that the design, construction, operation and assessment of conformity of the product may be clearly understood. 6. Notified Bodies87. The notified bodies shall conform to the requirements laid down in the laws and regulations regarding assessment, accreditation and supervision of conformity assessment authorities, and their officials and the personnel responsible for carrying out the conformity assessment tasks shall not be the designers, manufacturers, suppliers, installers, purchasers, owners, users or maintainers of the products which they assess, nor the representatives of the abovementioned parties. It shall not preclude the use of the assessed products that are necessary for the operation of the conformity assessment body or the use of such products for personal purposes. 88. Officials and employees of the notified body responsible for carrying out the conformity assessment tasks shall not be directly involved in the design or manufacture, the marketing, installation, use or maintenance of the abovementioned products, and shall not represent the parties engaged in the abovementioned activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities in relation to which the body is notified (especially - in respect to consultancy services). 89. The notified body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of the conformity assessment activities of the notified body. 90. Employees of the notified body shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements (particularly - financial) which might influence their judgement or the results of their conformity assessment activities (especially - as regards persons or groups of persons with an interest in the results of the abovementioned activities). 91. The notified body shall be capable of carrying out the conformity assessment procedures assigned to it in accordance with the requirements referred to in Chapter 5 of this Regulation and be responsible for the conformity assessment carried out regardless of whether the abovementioned procedures are carried out by the notified body itself or on its behalf. 92. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, the notified body shall have at its disposal: 92.1. the necessary personnel with technical knowledge and sufficient and appropriate experience for performance of the conformity assessment tasks; 92.2. a description of the procedures according to which conformity assessment is carried out, ensuring the transparency and ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as the notified body and other activities; 92.3. the procedures for the performance of activities which take due account of the size of an entrepreneur, the sector in which it operates, its structure, the degree of complexity of the manufacturing technology of the product in question and the mass or serial nature of the production process; 92.4. the necessary means for the performance of the technical and administrative tasks in relation to the conformity assessment activities in an appropriate manner, and access to all the necessary equipment or facilities. 93. The personnel responsible for carrying out the conformity assessment activities shall have the following: 93.1. sound technical and vocational training carried out and covering all the conformity assessment activities in relation to which the notified body has been notified; 93.2. knowledge of the requirements in relation to the assessments to be carried out and adequate authority to carry out the abovementioned assessments; 93.3. knowledge and understanding of the essential requirements, the applicable standards, the relevant European Union legal acts and the national laws and regulations; 93.4. the ability to draw up certificates, protocols and reports demonstrating that an assessment has been carried out. 94. The notified body shall guarantee objectivity of the inspection personnel. Remuneration of the personnel shall not depend on the number of tests carried out or test results. 95. The notified body shall insure its civil legal liability. 96. The duty of the personnel of the notified body is not to disclose the commercial information obtained through professional activity (except the cases referred to in this Regulation in relationship with State institutions). Property rights are protected. 97. The notified body shall ensure that its employees are informed regarding the standardisation processes and participate in the sectoral working groups of notified bodies of the European Union. 98. If the notified body enters into sub-contracts regarding performance of specific tasks in relation to conformity assessment or uses the branch, it shall make sure that the sub-contractor or branch meets the requirements of this Regulation, and inform the notifying committee accordingly. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 99. The notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established. 100. The notified body shall keep the documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them in order to present them to the notifying committee. 101. The European Commission shall assign an identification number to each notified body. The notified body that has obtained a permit to carry out the post-construction conformity assessment shall have an identification code granted in the country of accreditation. 102. The notified body shall carry out the conformity assessment procedures referred to in Chapter 5 of this Regulation in a proportionate manner, avoiding unnecessary burdens for economic operators and private importers. The notified body shall perform its activities, taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process, however, in so doing it shall nevertheless respect the degree of rigour and the level of protection required for the conformity of the product with the requirements of this Regulation. 103. If the notified body finds that requirements laid down in Paragraph 4 of this Regulation or in the applicable standards have not been met by a manufacturer or a private importer, it shall require the abovementioned manufacturer or private importer to take appropriate corrective measures and shall not issue a conformity certificate. 104. If, in the course of monitoring the conformity after issue of a certificate, the notified body finds that the product is no longer in conformity, it shall require the manufacturer to take appropriate corrective measures and, if necessary, suspend or withdraw the certificate. If the relevant measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate. 105. The notified bodies shall inform the notifying committee of the following: 105.1. any refusal, restriction, suspension or withdrawal of a certificate; 105.2. any circumstances affecting the conditions for notification; 105.3. any request for information which they have received from the market surveillance authorities regarding conformity assessment activities; 105.4. the conformity assessment activities performed within the scope of their notification and any other activities performed (including cross-border activities and subcontracting). 106. The notified bodies shall mutually cooperate in providing information on issues relating to negative and, upon request, positive conformity assessment results. 7. Market Surveillance107. The functions of the market surveillance authority for the products to which this Regulation applies, shall be fulfilled by the Consumer Rights Protection Centre. The Consumer Rights Protection Centre shall take the measures laid down in the laws and regulations regarding safety of goods and services in order not to allow distribution of the products non-conforming to the requirements of this Regulation on the market. 108. When carrying out market surveillance, the officials of the Consumer Rights Protection Centre are entitled: 108.1. to control and supervise the conformity of the products to be made available on the market with the requirements of this Regulation by visiting trade, storage and production sites; 108.2. to provide instructions to economic operators regarding the necessary actions for prevention of non-conformities after carrying out the product checks; 108.3. to request and receive information free of charge that is necessary for the performance of supervision in conformity with the requirements referred to in this Regulation; 108.4. to request the notified body to provide information regarding certificates which it has granted, withdrawn or refused (including to request to provide test reports and technical documentation). 109. If the Consumer Rights Protection Centre detects any of the following non-conformities, it shall request that the relevant economic operator or private importer rectifies the non-conformity detected: 109.1. CE marking is affixed infringing the requirements referred to in Paragraph 56, 57 or 58 of this Regulation; 109.2. the CE marking referred to in Paragraph 56 of this Regulation has not been affixed; 109.3. the declaration of conformity or the declaration referred to in Paragraph 55 of this Regulation has not been drawn up; 109.4. the declaration of conformity or the declaration referred to in Paragraph 55 of this Regulation has been drawn up incorrectly; 109.5. the technical documentation is not available or is incomplete; 109.6. the information referred to in Paragraph 23 or 32 of this Regulation is absent or it is false or incomplete; 109.7. any other requirements referred to in Sub-chapter 3.1 or 3.3 of this Regulation are not fulfilled. 110. If the non-conformity referred to in Paragraph 109 of this Regulation persists, the Consumer Rights Protection Centre shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market. 111. If the non-conformity referred to in Paragraph 109 of this Regulation is detected in the case of the product imported by a private importer for his own use, registration and use of the product concerned is prohibited until prevention of the non-conformity detected in accordance with the laws and regulations regarding ship registration with the Latvian Ship Register, the procedures for registration of watercraft with the Road Traffic Safety Directorate, and the laws and regulations regarding safety of recreational craft. 7.1 Granting a Unique Code of the Manufacturer[1 November 2016] 111.1 In the Republic of Latvia a unique code of the manufacturer shall be granted by the Navigation Safety Inspection of the State stock company "Maritime Administration of Latvia" (hereinafter - the Inspection). 111.2 The unique code of the manufacturer shall consist of three capital letters of the Latin alphabet in different combinations, and it shall be selected by the manufacturer, complying with the condition that it is different for each manufacturer. 111.3 In order to obtain the unique code of the manufacturer, the manufacturer shall submit a submission to the Inspection, indicating his contact information and desirable unique code of the manufacturer, and the declaration of conformity drawn up in conformity with Paragraph 52 of this Regulation or its copy, a copy of the intended CE marking (hereinafter - the documents), and also a declaration that the production unit is located in the territory of the Republic of Latvia (indicate the specific address of the production site). 111.4 The Inspection shall, within five working days, examine the conformity of the documents with the requirements of this Regulation. If the result of examination is positive, the Inspection shall take a decision to grant the unique code of the manufacturer and notify the manufacturer thereof. 111.5 The Inspection shall enter the unique code of the manufacturer granted in accordance with Paragraph 111.4 of this Regulation in the electronic internal information exchange database managed by the European Commission (hereinafter - the database) where it shall be available for the market supervisory authorities of the European Union and European Economic Area states, and also shall publish it together with the information on the manufacturer on the website of the State stock company "Maritime Administration of Latvia" http://www.lja.lv/ (hereinafter - the website). 111.6 The manufacturer shall immediately inform the Inspection regarding any changes in the documents or declaration and, if necessary, submit new documents and declaration to the Inspection. 111.7 The manufacturer shall submit the documents and declaration repeatedly to the Inspection every three years for updating of the unique code of the manufacturer on the database and website. If the declaration and documents are not submitted or they do not meet the requirements of this Regulation, the Inspection shall annul the unique code of the manufacturer granted to the manufacturer and delete it from the database and website. 111.8 The manufacturer may contest the decision to refuse to grant the unique code of the manufacturer or to annul it in accordance with the procedures laid down in the Maritime Administration and Marine Safety Law. 8. Closing Provisions112. Cabinet Regulation No. 647 of 30 August 2005, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft (Latvijas Vēstnesis, 2005, No. 152), is repealed. 113. The making available on the market or putting into service of the products which are in conformity with the requirements of Cabinet Regulation No. 647 of 30 August 2005, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft, and which were placed on the market before 18 January 2017, is permitted in Latvia. 114. The making available on the market or putting into service of such outboard spark-ignition propulsion engines with power equal to or less than 15 kW which conform to the stage I exhaust emission limits laid down in Part B, Sub-paragraph 2.1 of Annex 1 to this Regulation and which were manufactured by small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC (14) and placed on the market before 18 January 2020, is permitted in Latvia. Informative Reference to the European Union DirectiveThe Regulation contains legal norms arising from Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC. Prime Minister Laimdota Straujuma Acting for the Minister of
Transport,
Annex 1 Applicable RequirementsA. Essential requirements for the design and construction of the products referred to in Sub-paragraph 3.1 of this Regulation 1. Watercraft design categories Table 1
Watercraft in each design category must be designed and constructed to withstand the parameters in respect of stability, buoyancy, and other relevant essential requirements listed in this Annex, and to have good handling characteristics. 2. General Requirements 2.1. Watercraft identification Each watercraft shall be marked with an identification number including the following information: 2.1.1. country code of the manufacturer; 2.1.2. unique code of the manufacturer assigned to the manufacturer by the State stock company "Maritime Administration of Latvia" in the Republic of Latvia; 2.1.3. unique serial number; 2.1.4. month and year of production; 2.1.5. model year. Detailed requirements for the identification number are set out in the relevant applicable standard. 2.2. Watercraft builder's plate Each watercraft shall carry a permanently affixed plate mounted separately from the watercraft identification number, containing at least the following information: 2.2.1. manufacturer's name, registered trade name or registered trade mark, as well as contact address; 2.2.2. CE marking in accordance with Paragraph 56 of this Regulation; 2.2.3. watercraft design category in conformity with Part A, Chapter 1 of this Annex; 2.2.4. manufacturer's maximum recommended load derived in accordance with Part A, Sub-paragraph 3.6 of this Annex (excluding the weight of the contents of the fixed tanks when full); 2.2.5. number of persons recommended by the manufacturer for which the watercraft was designed. In case of post-construction assessment, the contact details and the requirements referred to in Part A, Sub-paragraph 2.2.1 of this Annex shall include those of the notified body which carried out the conformity assessment. 2.3. Protection from falling overboard and means of reboarding Watercraft shall be designed to minimise the risks of falling overboard and to facilitate reboarding. Means of reboarding shall be accessible to or deployable by a person in the water unaided. 2.4. Visibility from the main steering position For recreational craft, the main steering position shall give the operator, under normal conditions of use (speed and load), good all-round visibility. 2.5. Owner's manual Each product shall be provided with an owner's manual in accordance with Paragraphs 18 and 26 of this Regulation. That manual shall provide all the information necessary for safe use of the product drawing particular attention to set up, maintenance, regular operation, prevention of risks and risk management. 3. Integrity and structural requirements 3.1. Structure The choice and combination of materials and its construction shall ensure that the watercraft is strong enough in all respects. Special attention shall be paid to the design category (Part A, Chapter 1 of this Annex), and the manufacturer's maximum recommended load (Part A, Sub-paragraph 3.6 of this Annex). 3.2. Stability and freeboard The watercraft shall have sufficient stability and freeboard considering its design category (Part A, Chapter 1 of this Annex) and the manufacturer's maximum recommended load (Part A, Sub-paragraph 3.6 of this Annex). 3.3. Buoyancy and flotation The watercraft shall be constructed as to ensure that it has buoyancy characteristics appropriate to its design category (Part A, Chapter 1 of this Annex) and the manufacturer's maximum recommended load (Part A, Sub-paragraph 3.6 of this Annex). All habitable multihull recreational craft susceptible of inversion shall have sufficient buoyancy to remain afloat in the inverted position. Watercraft of less than 6 metres in length that are susceptible to swamping when used in their design category shall be provided with appropriate means of flotation in the swamped condition. 3.4. Openings in hull, deck and superstructure Openings in hull, deck(s) and superstructure shall not impair the structural integrity of the watercraft or its weather tight integrity when closed. Windows, port lights, doors and hatch covers shall withstand the water pressure likely to be encountered in their specific position, as well as point loads applied by the weight of persons moving on deck. Through hull fittings designed to allow water passage into the hull or out of the hull, below the waterline corresponding to the manufacturer's maximum recommended load (Part A, Sub-paragraph 3.6 of this Annex), shall be fitted with a means of shutoff which shall be readily accessible. 3.5. Flooding risk All watercraft shall be designed so as to minimise the risk of sinking. Where appropriate, particular attention shall be paid to: 3.5.1. cockpits and wells, which should be self-draining or have other equipment (means) of keeping water out of the watercraft interior; 3.5.2. ventilation fittings; 3.5.3. removal of water by pumps or other equipment. 3.6. Manufacturer's maximum recommended load The manufacturer's maximum recommended load (fuel, water, provisions, miscellaneous equipment and people (in kilograms)) for which the watercraft was designed, shall be determined according to the design category (Part A, Chapter 1 of this Annex), stability and freeboard (Part A, Sub-paragraph 3.2 of this Annex)) and buoyancy and flotation (Part A, Sub-paragraph 3.3 of this Annex). 3.7. Life raft stowage All recreational craft of design categories A and B, and recreational craft of design categories C and D longer than 6 metres shall be provided with one or more stowage points for a life raft (life rafts) large enough to hold the number of persons the recreational craft was designed to carry as recommended by the manufacturer. Life raft stowage point(s) shall be readily accessible at all times. 3.8. Escape All habitable multihull recreational craft susceptible of inversion shall be provided with viable means of escape in the event of inversion. Where there is a means of escape provided for use in the inverted position, it shall not compromise the structure (Part A, Sub-paragraph 3.1 of this Annex), the stability (Part A, Sub-paragraph 3.2 of this Annex) or buoyancy (Part A, Sub-paragraph 3.3 of this Annex) whether the recreational craft is upright or inverted. Every habitable recreational craft shall be provided with viable means of escape in the event of fire. 3.9. Anchoring, mooring and towing All watercraft, taking into account their design category and their characteristics, shall be fitted with one or more strong points or other means capable of safely accepting anchoring, mooring and towing loads. 4. Handling characteristics The manufacturer shall ensure that the handling characteristics of the watercraft are satisfactory with the most powerful propulsion engine for which the watercraft is designed and constructed. For all propulsion engines, the maximum rated engine power shall be declared in the owner's manual. 5. Installation requirements 5.1. Engines and engine compartments 5.1.1. Inboard engines All inboard mounted engines shall be placed within an enclosure separated from living quarters and installed so as to minimise the risk of fires or spread of fires as well as hazards from toxic fumes, heat, noise or vibrations in the living quarters. Engine parts and accessories that require frequent inspection and (or) servicing shall be readily accessible. The insulating materials inside the engine compartment shall not sustain combustion. 5.1.2. Ventilation The engine compartment shall be ventilated. The ingress of water into the engine compartment through openings must be minimised. 5.1.3. Exposed parts Unless the engine is protected by a cover or its own enclosure, exposed moving or hot parts of the engine that could cause personal injury shall be effectively shielded. 5.1.4. Outboard propulsion engine starting Every outboard propulsion engine fitted on any watercraft shall have a device to prevent the engine being started in gear, except: 5.1.4.1. when the engine produces less than 500 N of static thrust; 5.1.4.2. when the engine has a throttle limiting device to limit thrust to 500 N at the time of starting the engine. 5.1.5. Personal watercraft running without driver Personal watercraft shall be designed either with an automatic propulsion engine cut-off or with an automatic device to provide reduced speed, circular, forward movement when the driver dismounts deliberately or falls overboard. 5.1.6. Tiller-controlled outboard propulsion engines Tiller-controlled outboard propulsion engines shall be equipped with an emergency stopping device which can be linked to the helmsman. 5.2. Fuel system 5.2.1. General Requirements The filling, storage, venting and fuel-supply arrangements and installations shall be designed and installed so as to minimise the risk of fire and explosion. 5.2.2. Fuel tanks Fuel tanks, lines and hoses shall be secured and separated or protected from any source of significant heat. The material the tanks are made of and their method of construction shall be according to their capacity and the type of fuel. Petrol fuel tank spaces shall be ventilated. Petrol fuel tanks shall not form part of the hull and shall be: 5.2.2.1. protected against fire from any engine and from all other sources of ignition; 5.2.2.2. separated from living quarters. Diesel fuel tanks may be integral with the hull. 5.3. Electrical system Electrical systems shall be designed and installed so as to ensure proper operation of the watercraft under normal conditions of use and shall be such as to minimise risk of fire and electric shock. All electrical circuits, except engine starting circuits supplied from batteries, shall remain safe when exposed to overload. Electric propulsion circuits shall not interact with other circuits in such a way that either would fail to operate as intended. Ventilation shall be provided to prevent the accumulation of explosive gases which might be emitted from batteries. Batteries shall be firmly secured and protected from ingress of water. 5.4. Steering system 5.4.1. General requirements Steering and propulsion control systems shall be designed, constructed and installed in order to allow the transmission of steering loads under foreseeable operating conditions. 5.4.2. Emergency arrangements Every sailing recreational craft and single-propulsion engine non-sailing recreational craft with remote-controlled rudder steering systems shall be provided with emergency means of steering the recreational craft at reduced speed. 5.5. Gas system Gas systems for domestic use shall be of the vapour-withdrawal type. They shall be designed and installed so as to avoid leaks in the hull and the risk of explosion and be capable of being tested for leaks. Materials and components shall be suitable for the specific gas used to withstand the stresses and exposures found in the marine environment. Each gas appliance intended by the manufacturer for the application for which it is used shall be so installed according to the manufacturer's instructions. Each gas-consuming appliance must be supplied by a separate branch of the distribution system, and each appliance must be controlled by a separate closing device. Adequate ventilation must be provided to prevent hazards from leaks and products of combustion. All watercraft with a permanently installed gas system shall be fitted with an enclosure to contain all gas cylinders. The enclosure shall be separated from the living quarters, accessible only from the outside and ventilated to the outside so that any escaping gas drains overboard. In particular, any permanently installed gas system shall be tested after installation. 5.6. Fire protection 5.6.1. General requirements The type of equipment installed and the layout of the watercraft shall take account of the risk and spread of fire. Special attention shall be paid to the surroundings of open flame devices, hot areas or engines and auxiliary machines, oil and fuel overflows, uncovered oil and fuel pipes and routing of electrical wiring in particular away from heat sources and hot areas. 5.6.2. Fire-fighting equipment Recreational craft shall be supplied with fire-fighting equipment appropriate to the fire hazard, or the position and capacity of fire-fighting equipment appropriate to the fire hazard shall be indicated. The craft shall not be put into service until the appropriate fire-fighting equipment is in place. Petrol engine compartments shall be protected by a fire extinguishing system that avoids the need to open the compartment in the event of fire. Where fitted, portable fire extinguishers shall be readily accessible and one shall be so positioned that it can easily be reached from the main steering position of the recreational craft. 5.7. Navigation lights, shapes and sound signals Where navigation lights, shapes and sound signals are fitted, they shall conform to the 1972 the International Regulations for Preventing Collisions at Sea (CORLEG) or CEVNI (European Code for Interior Navigations for inland waterways) Regulations as appropriate. 5.8. Discharge prevention and installations facilitating the delivery ashore of waste Watercraft shall be constructed so as to prevent the accidental discharge of pollutants (oil, fuel, etc.) overboard. Any toilet fitted in a recreational craft shall be connected solely to a holding tank system or water treatment system. Recreational craft with installed holding tanks shall be fitted with a standard discharge connection to enable pipes of reception facilities to be connected with the recreational craft discharge pipeline. Any through-the-hull pipes for human waste shall be fitted with valves which are capable of being secured in the closed position. B. Essential requirements for exhaust emissions from propulsion engines Propulsion engines shall conform to the essential requirements for exhaust emissions set out in this Part. 1. Propulsion engine identification 1.1. Each engine shall be clearly marked with the following information: 1.1.1. engine manufacturer's name, registered trade name or registered trade mark and contact address; and, if applicable, the given name, surname and contact address of the person adapting the engine; 1.1.2. engine type, engine family, if applicable; 1.1.3. a unique engine serial number; 1.1.4. CE marking in accordance with Paragraph 56 of this Regulation. 1.2. The marks referred to in Part B, Sub-paragraph 1.1 of this Annex must be durable for the normal life of the engine and must be clearly legible and indelible. If labels or plates are used, they must be attached in such a manner that the fixing is durable for the normal life of the engine, and the labels (plates) cannot be removed without destroying or defacing them. 1.3. The marks must be secured to an engine part necessary for normal engine operation and not normally requiring replacement during the engine life. 1.4. The marks must be located so as to be readily visible after the engine has been assembled with all the components necessary for engine operation. 2. Exhaust emission requirements Propulsion engines shall be designed, constructed and assembled so that when correctly installed and in normal use, emissions shall not exceed the limit values indicated in Tables 2, 3 and 4 of this Annex. 2.1. Values applying for the purposes of Paragraph 115 of this Regulation and Table 3 of this Annex: Table 2
Explanatory notes. A, B and n - constants according to Table 2; PN - the rated engine power in kW. 2.2. Values applying from 18 January 2016: Table 3 Exhaust emission limits for compression ignition engines(2)
Notes. (1) Alternatively, compression-ignition engines with rated engine power at or above 37 kW and below 75 kW and with a swept volume below 0,9 L/cyl shall not exceed a PT emission limit of 0,20 g/kWh and a combined HC + NOx emission limit of 5,8 g/kWh. (2) Any compression-ignition engine shall not exceed a Carbon monoxide (CO) emission limit of 5,0 g/kWh. Table 4 Exhaust emission limits for spark ignition engines
2.3. Test cycles and weighting factors to be applied The following requirements of ISO standard 8178-4:2007 shall be used, taking into account the values set out in the Table below. For variable speed CI engines test cycle E1 or E5 shall be applied or alternatively, above 130 kW, test cycle E3 may be applied. For variable speed SI engines test cycle E4 shall be applied. Table 5
Notified bodies may accept tests carried out on the basis of other tests cycles as specified in an applicable standard and as applicable for the engine duty cycle. 2.4. Application of the propulsion engine family and choice of parent propulsion engine The engine manufacturer shall be responsible for defining those engines from his range which are to be included in an engine family. A parent engine shall be selected from an engine family in such a way that its emissions characteristics are representative for all engines in that engine family. The engine incorporating those features that are expected to result in the highest specific emissions (expressed in g/kWh), when measured on the applicable test cycle, should normally be selected as the parent engine of the family. 2.5. Test fuels The test fuel used for exhaust emission testing shall meet the following characteristics set out in Tables 6 and 7 of this Annex: Table 6 Petrol Fuels
Table 7 Diesel Fuels
Notified bodies may accept tests carried out on the basis of other tests fuel as indicated in an applicable standard. 3. Durability The manufacturer of the engine shall supply engine installation and maintenance instructions, which if applied should mean that the engine in normal use will continue to conform to the limits referred to in Part B, Sub-paragraphs 2.1 and 2.2 of this Annex throughout the normal life of the engine and under normal conditions of use. This information shall be obtained by the engine manufacturer by use of prior endurance testing, based on normal operating cycles, and by calculation of component fatigue so that the necessary maintenance instructions may be prepared by the manufacturer and issued with all new engines when first placed on the market. The normal life of the engine is as follows: 3.1. for CI engines: 480 hours of operation or 10 years (whichever occurs first); 3.2. for SI inboard or stern drive engines with or without integral exhaust: 3.2.1. for the engine category PN ≤ 373kW - 480 hours of operation or 10 years (whichever occurs first); 3.2.2. for the engine category 373 < PN ≤ 485kW - 150 hours of operation or 3 years (whichever occurs first); 3.2.3. for the engine category PN > 485kW - 50 hours of operation or 1 year (whichever occurs first); 3.3. personal watercraft engines - 350 hours of operation or 5 years (whichever occurs first); 3.4. outboard engines - 350 hours of operation or 10 years (whichever occurs first). 4. Owner's manual Each engine shall be provided with an owner's manual in a language (languages) which can be easily understood by consumers and other end-users and as determined by the EU Member State in which the engine is to be marketed. The owner's manual shall: 4.1. provide instructions for the installation, use and maintenance of the engine needed to assure the proper functioning of the engine in accordance with the requirements referred to in Part B, Chapter 3 of this Annex; 4.2. specify the power of the engine when measured in accordance with the applicable standards. C. Essential requirements for noise emissions Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall conform to the essential requirements for noise emissions provided for in this Part. 1. Noise emission levels 1.1. Recreational craft with inboard or stern drive engines without integral exhaust, personal watercraft and outboard engines and stern drive engines with integral exhaust shall be designed, constructed and assembled so that noise emissions shall not exceed the limit values indicated in Table 8 of this Annex: Table 8
Explanatory notes. PN - rated engine power in kW of a single engine at rated speed; LpASmax - maximum sound pressure level in dB. For twin-engine and multiple-engine units of all engine types an allowance of 3 dB may be applied. 1.2. As an alternative to sound measurement tests, recreational craft with inboard engine configuration or stern drive engine configuration, without integral exhaust, shall be deemed to conform to the noise requirements referred to in Part C, Sub-paragraph 1.1 of this Annex if they have a Froude number of ≤ 1,1 and a Power to Displacement ratio of ≤ 40 and where the engine and exhaust system are installed according to the engine manufacturer's specifications. 1.3. Froude number Fn shall be calculated by dividing the maximum recreational craft speed V (m/s) by the square root of the waterline length lwl (m) multiplied by a given gravitational acceleration constant, (g = 9,8 m/s2):
Power to Displacement ratio shall be calculated by dividing the rated engine power PN by the recreational craft's displacement D (in t): Power to Displacement ratio = PN / D 2. Owner's manual For recreational craft with inboard engine or stern drive engines without integral exhaust and personal watercraft, the owner's manual referred to in Part A, Sub-paragraph 2.5 of this Annex, shall include information necessary to maintain the recreational craft and exhaust system in a condition that, insofar as is practicable, will ensure conformity with the specified noise limit values when in normal use. For outboard engines and stern drive engines with integral exhaust, the owner's manual referred to in Part B, Chapter 4 of this Annex shall provide the instructions necessary to maintain the engine in a condition, that insofar as is practicable, will ensure conformity with the specified noise limit values when in normal use. 3. Durability The provisions on the durability referred to in Part B, Chapter 3 of this Annex shall apply mutatis mutandis to the conformity with the requirements on noise emissions referred to in Part C, Chapter 1 of this Annex. Acting for the Minister of
Transport,
Annex 2 Conformity Assessment Procedures and Descriptions ThereofI. Internal
production control 1. Internal production control is a conformity assessment procedure by which the manufacturer fulfils the obligations referred to in Paragraphs 2, 3 and 4 of this Chapter and ensures and declares that the relevant products are in conformity with the requirements of that regulatory enactment which applies to them. 2. Technical documentation A manufacturer shall develop technical documentation. The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the product. The technical documentation, where possible, shall contain at least the following elements: - a general description of the product; - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; - descriptions and explanations necessary for the understanding of the abovementioned drawings and schemes and the operation of the product; - a list of the standards, applied in full or in part, and (or) relevant technical specifications, and descriptions of the solutions adopted to fulfil the essential requirements of this Regulation when the applicable standards have not been applied. If the abovementioned standards are applied partially, the technical documentation shall specify the parts of the standards which have been applied; - results of design calculations made, examinations carried out and other relevant data; - test reports. 3. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the technical documentation referred to in Paragraph 2 of this Chapter and with the requirements of the laws and regulations that apply to them. 4. Conformity marking and declaration of conformity 4.1. The manufacturer shall affix the required conformity marking set out in this Regulation to each individual product that satisfies the requirements of the applicable regulatory enactment. 4.2. The manufacturer shall draw up a declaration of conformity for a product model and keep it at the disposal of the State institutions for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 5. Authorised representative The manufacturer's obligations referred to in Paragraph 4 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. II. Internal
production control and supervised production tests 1. Internal production control and supervised production tests are a conformity assessment procedure by which the manufacturer fulfils the obligations referred to in Paragraphs 2, 3, 4 and 5 of this Chapter and ensure and declare that the relevant products are in conformity with the requirements of that regulatory enactment which applies to them. 2. Technical documentation A manufacturer shall develop technical documentation. The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the product. The technical documentation, where possible, shall contain at least the following elements: - a general description of the product; - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; - descriptions and explanations necessary for the understanding of the abovementioned drawings and schemes and the operation of the product; - a list of the standards, applied in full or in part, and (or) relevant technical specifications, and descriptions of the solutions adopted to fulfil the essential requirements of this Regulation when the applicable standards have not been applied. If the abovementioned standards are applied partially, the technical documentation shall specify the parts of the standards which have been applied; - results of design calculations made, examinations carried out and other relevant data; - test reports. 3. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the technical documentation referred to in Paragraph 2 of this Chapter and with the requirements of the laws and regulations that apply to them. 4. Product checks A manufacturer or other person acting on behalf of the manufacturer shall subject one or several particular aspects of each product manufactured separately to one or several tests in order to ascertain regarding conformity with the relevant requirements laid down in the regulatory enactment. According to the choice of the manufacturer the tests shall be carried out either by an accredited in-house body or they are carried out under the responsibility of the notified body chosen by the manufacturer. Where the tests are carried out by the notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. 5. Conformity marking and declaration of conformity 5.1. In conformity with this Regulation the manufacturer shall affix the necessary conformity marking to each product which conforms to the requirements of the applicable regulation. 5.2. The manufacturer shall draw up a declaration of conformity for a product model and keep it at the disposal of the State institutions for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 6. Authorised representative The manufacturer's obligations referred to in Paragraph 5 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. III. EU type
examination 1. EU-type examination is the part of a conformity assessment procedure by which the notified body examines the technical design of the product, and also verifies and attests that the technical design of the product meets the requirements of this Regulation. 2. EU-type examination shall be carried out in one of the following ways: - examine finished product (production type), which is the specimen representative of the production envisaged; - assess conformity of the technical design of the product by examining the technical documentation and evidence referred to in Paragraph 3 of this Chapter, and also one or several critical parts of the product - the specimen representative of the production envisaged (combination of production type and design type); - assess conformity of the technical design of the product by examining the technical documentation and evidence referred to in Paragraph 3 of this Chapter, however without examination of a specimen (design type). 3. The manufacturer shall submit an application for EU-type examination with the notified body of his choice. The application shall include: - the manufacturer's given name, surname (name) and address, and if the application is submitted by an authorised representative - also the given name, surname (name) and address of the representative; - a written certification that the same application has not been submitted with any other notified body; - technical documentation. The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the product. The technical documentation, where possible, shall contain at least the following elements: - - a general description of the product; - - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; - - descriptions and explanations necessary for the understanding of the abovementioned drawings and schemes and the operation of the product; - - a list of the standards, applied in full or in part, and (or) relevant technical specifications, and descriptions of the solutions adopted to fulfil the essential requirements of this Regulation when the applicable standards have not been applied. If the abovementioned standards are applied partially, the technical documentation shall specify the parts of the standards which have been applied; - - results of design calculations made, examinations carried out and other relevant data; - - test reports; - the specimens representative of the production envisaged. The notified body may request additional samples, where necessary, in order to carry out test programme; - evidence which approve conformity of the technical design. This supporting evidence shall mention any documents that have been used, in particular - where the relevant applicable standards and (or) technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. 4. The notified body shall: 4.1. for the product - examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product; 4.2. for the specimen(s) - verify that the specimen(s) have been manufactured in conformity with the abovementioned technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant applicable standards and (or) technical specifications, as well as the elements which have been designed without applying the relevant provisions of those standards; 4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards and (or) technical specifications, these have been applied correctly; 4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards and (or) technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of this Regulation; 4.5. agree with the manufacturer on a location where the examinations referred to in this Paragraph will be carried out. 5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with Paragraph 4 of this Chapter and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. 6. Where the type meets the requirements of this Regulation that apply to the product concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached. The certificate and its annexes shall contain all the relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. 7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer conform to the requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. 8. Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and (or) any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and (or) any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and (or) any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and (or) additions thereto which it has issued. The European Commission, the Member States and the other notified bodies may, upon request, obtain a copy of the EU-type examination certificates and (or) additions thereto. Upon request, the European Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file (including the documentation submitted by the manufacturer) until expiry of the validity of the certificate. 9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the State institutions for 10 years after the product has been placed on the market. 10. The manufacturer's authorised representative may submit the application referred to in Paragraph 3 of this Chapter and fulfil the obligations referred to Paragraphs 7 and 9 of this Chapter, provided that they are specified in the mandate. IV. Conformity
to type examination based on internal production control 1. Conformity to type examination based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraphs 2 and 3 of this Chapter, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the regulatory enactment that applies to them. 2. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation. 3. Conformity marking and declaration of conformity 3.1. The manufacturer shall affix the required conformity marking in conformity with this Regulation to each individual product that is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Regulation. 3.2. The manufacturer shall draw up a declaration of conformity for a product model and keep it at the disposal of the State institutions for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 4. Authorised representative The manufacturer's obligations referred to in Paragraph 3 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. Conformity to
type examination based on internal production control and
supervised product testing 1. Conformity to type examination based on internal production control and supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraphs 2, 3 and 4 of this Chapter, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation. 2. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation. 3. Product checks A manufacturer or other person acting on behalf of the manufacturer shall subject one or several particular aspects of each product manufactured separately to one or several tests in order to ascertain regarding conformity with the requirements of this Regulation. According to the choice of the manufacturer the tests shall be carried out either by an accredited in-house body or they are carried out under the responsibility of the notified body chosen by the manufacturer. Where the tests are carried out by the notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process. 4. Conformity marking and declaration of conformity 4.1. The manufacturer shall affix the required conformity marking in conformity with this Regulation to each individual product that is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Regulation. 4.2. The manufacturer shall draw up a declaration of conformity for a product model and keep it at the disposal of the State institutions for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 5. Authorised representative The manufacturer's obligations referred to in Paragraph 4 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. VI. Conformity
to type examination based on quality assurance of the production
process 1. Conformity to type examination based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in Paragraphs 2 and 5 of this Chapter, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation. 2. Manufacturing The manufacturer shall operate an approved quality assurance system for production, final product inspection and testing of the products concerned as specified in Paragraph 3 of this Chapter, and shall be subject to surveillance as specified in Paragraph 4 of this Chapter. 3. Quality assurance system 3.1. The manufacturer shall submit an application to the chosen notified body to assess the quality assurance system of the relevant products. The application shall include: - the manufacturer's given name, surname (name) and address, and if the application is submitted by an authorised representative - also the given name, surname (name) and address of the representative; - a written certification that the same application has not been submitted with any other notified body; - all relevant information for the product category envisaged; - the documentation of the quality assurance system; - the technical documentation of the approved type and a copy of the EU-type examination certificate. 3.2. The quality assurance system shall ensure that the products are in conformity with the type described in the EU-type examination certificate and this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written processes, procedures and instructions. The quality assurance system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: - the quality assurance objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; - the corresponding manufacturing, quality control and quality assurance techniques, processes, and also other systematic measures to be taken; - the examinations and tests to be carried out before and after manufacture, and also during it, and the frequency thereof; - the records related to quality (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned); - the means of monitoring the achievement of the required design and product quality and the effective operation of the quality assurance system. 3.3. The notified body shall assess the quality assurance system to determine whether it satisfies the requirements referred to in Sub-paragraph 3.2 of this Chapter. The notified body shall presume conformity with those requirements in respect of the elements of the quality assurance system that conform to the corresponding specifications of the national standard that implements the relevant applicable standard and (or) technical specifications. In addition to experience in quality assurance systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the requirements of the applicable regulatory enactment. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in Sub-paragraph 3.1 of this Chapter to verify the manufacturer's ability to identify the relevant requirements of the regulatory enactment and to carry out the necessary examinations with a view to ensuring conformity of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality assurance system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality assurance system informed of any intended changes to the quality assurance system. The notified body shall evaluate any proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in Sub-paragraph 3.2 of this Chapter or whether a reassessment is necessary. The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising of the approved quality assurance system. 4.2. The manufacturer shall, for assessment purposes, allow the representatives of the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: - the documentation of the quality assurance system; - the quality records (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned). 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality assurance system and shall provide the manufacturer with an audit report. 4.4. The representatives of the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality assurance system. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out - also with a test report. 5. Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the required conformity marking in conformity with this Regulation, and - under the responsibility of the notified body referred to in Sub-paragraph 3.1 of this Chapter - the identification number of such authority to each individual product that satisfies the type described in the EU-type examination certificate and the requirements of this Regulation. 5.2. The manufacturer shall draw up in writing the declaration of conformity of each model of the product and keep it for the needs of State institutions together with the technical documents for at least 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 6. The manufacturer shall, for a time period ending at least 10 years after the product has been placed on the market, keep at the disposal of the State institutions: - the documentation referred to in Sub-paragraph 3.1 of this Chapter; - the information regarding the changes referred to in Sub-paragraph 3.5 of this Chapter, as approved; - the decisions and reports of the notified body referred to in Sub-paragraphs 3.5, 4.3 and 4.4 of this Chapter. 7. Each notified body shall inform its notifying authorities of quality assurance system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality assurance system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality assurance system approvals which it has refused, withdrawn, suspended or otherwise restricted, and, upon request - also concerning the quality assurance system approvals which it has issued. 8. Authorised representative The manufacturer's obligations referred to in Sub-paragraphs 3.1, 3.5 and Paragraphs 5 and 6 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. VII. Conformity
to type examination based on product quality assurance 1. Conformity to type examination based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraphs 2 and 5 of this Chapter, and ensures and declares that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of the regulatory enactment that applies to them. 2. Manufacturing The manufacturer shall operate an approved quality assurance system for final product inspection and testing of the products concerned as specified in Paragraph 3 of this Chapter, and shall be subject to surveillance as specified in Paragraph 4 of this Chapter. 3. Quality assurance system 3.1. The manufacturer shall submit an application to the chosen notified body to assess the quality assurance system of the relevant products. The application shall include: - the manufacturer's given name, surname (name) and address, and if the application is submitted by an authorised representative - also the given name, surname (name) and address of the representative; - a written certification that the same application has not been submitted with any other notified body; - all relevant information for the product category envisaged; - the documentation of the quality assurance system; - the technical documentation of the approved type and a copy of the EU-type examination certificate. 3.2. The quality assurance system shall ensure conformity of the products with the type described in the EU-type examination certificate and with the requirements of this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality assurance system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: - the quality assurance objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; - the examinations and tests that will be carried out after manufacture; - the records related to quality (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned); - the means of monitoring enabling to control the effective operation of the quality assurance system. 3.3. The notified body shall assess the quality assurance system to determine whether it satisfies the requirements referred to in Sub-paragraph 3.2 of this Chapter. The notified body shall presume conformity with those requirements in respect of the elements of the quality assurance system that conform to the corresponding specifications of the national standard that implements the relevant applicable standard and (or) technical specification. In addition to experience in quality assurance systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the requirements of the applicable regulatory enactment. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in Sub-paragraph 3.1 of this Chapter to verify the manufacturer's ability to identify the relevant requirements of the regulatory enactment and to carry out the necessary examinations with a view to ensuring conformity of the product with those requirements. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising of the quality assurance system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality assurance system informed of any intended changes to the quality assurance system. The notified body shall evaluate any proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in Sub-paragraph 3.2 of this Chapter or whether a reassessment is necessary. The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising of the approved quality assurance system. 4.2. The manufacturer shall, for assessment purposes, allow the representatives of the notified body access to the inspection, testing and storage sites and shall provide it with all necessary information, in particular: - the documentation of the quality assurance system; - the quality records (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned). 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality assurance system and shall provide the manufacturer with an audit report. 4.4. The representatives of the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality assurance system. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out - also with a test report. 5. Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the required conformity marking in conformity with this Regulation, and - under the responsibility of the notified body referred to in Sub-paragraph 3.1 of this Chapter - the identification number of such authority to each individual product that satisfies the type described in the EU-type examination certificate and the requirements of this Regulation. 5.2. The manufacturer shall draw up in writing the declaration of conformity of each model of the product and keep it for the needs of State institutions together with the technical documents for at least 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 6. The manufacturer shall, for a time period ending at least 10 years after the product has been placed on the market, keep at the disposal of the State institutions: - the documentation referred to in Sub-paragraph 3.1 of this Chapter; - the information regarding the changes referred to in Sub-paragraph 3.5 of this Chapter, as approved; - the decisions and reports of the notified body referred to in Sub-paragraphs 3.5, 4.3 and 4.4 of this Chapter. 7. Each notified body shall inform its notifying authorities of quality assurance system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality assurance system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality assurance system approvals which it has refused, withdrawn, suspended, and, upon request - also concerning the quality assurance system approvals which it has issued. 8. Authorised representative The manufacturer's obligations referred to in Sub-paragraphs 3.1, 3.5 and Paragraphs 5 and 6 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. VIII. Conformity
to type examination based on product verification 1. Conformity to type examination based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraph 2, Sub-paragraph 5.1 and Paragraph 6 of this Chapter, and ensures and declares that the products concerned, which have been subject to the provisions of Paragraph 3 of this Chapter, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation. 2. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation. 3. Verification The notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation. The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer either by examination and testing of every product as specified in Paragraph 4 of this Chapter or by examination and testing of the products on a statistical basis as specified in Paragraph 5 of this Chapter. 4. Verification of conformity by examination and testing of every product 4.1. All products shall be individually examined and appropriate tests referred to in the relevant applicable standard(s) and(or) technical specifications, or equivalent tests, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the requirements of the regulatory enactment. In the absence of such an applicable standard, the notified body concerned shall decide on the appropriate tests to be carried out. 4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the State institutions for 10 years after the product has been placed on the market. 5. Statistical verification of conformity 5.1. The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots. 5.2. A random sample shall be taken from each lot according to the requirements of the regulatory enactment. All products in a sample shall be individually examined and appropriate tests set out in the relevant applicable standard(s) and(or) technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with the requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such an applicable standard, the notified body concerned shall decide on the appropriate tests to be carried out. 5.3. If a lot of the products is accepted, all products of the lot shall be considered approved, except those products from the sample that have been found not to satisfy the tests. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the State institutions for 10 years after the product has been placed on the market. 5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot is being placed on the market. In the event of frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures. 6. Conformity marking and declaration of conformity 6.1. The manufacturer shall affix the required conformity marking and - under the responsibility of the notified body referred to in Paragraph 3 of this Chapter - the identification number of such authority to each individual product that is in conformity with the approved type described in the EU-type examination certificate and satisfies the requirements of this Regulation. 6.2. The manufacturer shall draw up in writing the declaration of conformity of each model of the product and keep it for the needs of State institutions together with the technical documents for at least 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. If the notified body referred to in Paragraph 3 of this Chapter agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products. 7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the products during the manufacturing process. 8. Authorised representative The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations referred to in Paragraph 2 and Sub-paragraph 5.1 of this Chapter. IX. Conformity
examination based on unit verification 1. Conformity examination based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraphs 2, 3 and 5 of this Chapter, and also ensures and declares that the products, which have been subject to the provisions of Paragraph 4, are in conformity with the requirements of the regulatory enactment that applies to it. 2. Technical documentation The manufacturer shall develop technical documentation and make it available to the notified body referred to in Paragraph 4 of this Chapter. The documentation shall make it possible to assess the product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and use of the product. The technical documentation, where possible, shall contain at least the following elements: - a general description of the product; - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; - descriptions and explanations necessary for the understanding of the abovementioned drawings and schemes and the operation of the product; - a list of the standards, applied in full or in part, and (or) relevant technical specifications, and descriptions of the solutions adopted to fulfil the essential requirements of Directive when the applicable standards have not been applied. If the abovementioned standards are applied partially, the technical documentation shall specify the parts of the standards which have been applied; - results of design calculations made, examinations carried out and other relevant data; - test reports. The manufacturer shall keep the technical documentation at the disposal of the State institutions for 10 years after the product has been placed on the market. 3. Manufacturing The manufacturer shall take all the measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the regulatory enactment. 4. Verification The notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant applicable standards and (or) technical specifications, or equivalent tests, to check the conformity of the product with the requirements of the this Regulation, or have them carried out. In the absence of such an applicable standard and (or) technical specification the notified body concerned shall decide on the appropriate tests to be carried out. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the State institutions for 10 years after the product has been placed on the market. 5. Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the required conformity marking and - under the responsibility of the notified body referred to in Paragraph 4 of this Chapter - the identification number of such authority to each product that satisfies the requirements of this Regulation. 5.2. The manufacturer shall draw up in writing the declaration of conformity of each model of the product and keep it for the needs of State institutions together with the technical documents for at least 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 6. Authorised representative The manufacturer's obligations referred to in Paragraphs 2 and 5 of this Chapter may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. X. Conformity
examination based on full quality assurance 1. Conformity examination based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations referred to in Paragraphs 2 and 5 of this Chapter, and also ensures and declares on his sole responsibility that the products satisfy the requirements of the regulatory enactment that applies to them. 2. Manufacturing The manufacturer shall operate an approved quality assurance system for design, manufacture and final product inspection and testing of the products concerned in conformity with Paragraph 3 of this Chapter and shall be subject to surveillance in conformity with Paragraph 4 of this Chapter. 3. Quality assurance system 3.1. The manufacturer shall submit an application to the chosen notified body to assess the quality assurance system of the relevant products. The application shall include: - the manufacturer's given name, surname (name) and address, and if the application is submitted by an authorised representative - also the given name, surname (name) and address of the representative; - the technical documentation for one model of each category of the products intended for production. The technical documentation, where possible, shall contain at least the following elements: - - a general description of the product; - - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data; - - descriptions and explanations necessary for the understanding of the abovementioned drawings and schemes and the operation of the product; - - a list of the standards, applied in full or in part, and (or) relevant technical specifications, and descriptions of the solutions adopted to fulfil the essential requirements of Directive when the applicable standards have not been applied. If the abovementioned standards are applied partially, the technical documentation shall specify the parts of the standards which have been applied; - - results of design calculations made, examinations carried out and other relevant data; - - test reports; - the documentation of the quality assurance system; - a written declaration that the same application has not been submitted to any other notified body. 3.2. The quality assurance system shall ensure conformity of the products with the requirements of the regulatory enactment that applies to them. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality assurance system documentation shall permit a consistent interpretation of the quality assurance programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: - the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; - the technical design specifications, including standards, that will be applied and, where the relevant applicable standards and (or) technical specifications will not be applied in full, the means that will be used to ensure that the essential requirements of the legislative instrument that apply to the products will be met; - the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered; - the corresponding manufacturing, quality control and quality assurance techniques, processes, and also other systematic measures to be taken; - the examinations and tests to be carried out before and after manufacture, and also during it, and the frequency thereof; - the records related to quality (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned); - the means of monitoring the achievement of the required design and product quality and the effective operation of the quality assurance system. 3.3. The notified body shall assess the quality assurance system to determine whether it satisfies the requirements referred to in Sub-paragraph 3.2 of this Chapter. The notified body shall presume conformity with those requirements in respect of the elements of the quality assurance system that conform to the corresponding specifications of the national standard that implements the relevant applicable standard and (or) technical specification. In addition to experience in quality assurance systems, the auditing team shall have at least one member experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in Sub-paragraph 3.1 of this Chapter to verify the manufacturer's ability to identify the relevant requirements of the regulatory enactment and to carry out the necessary examinations with a view to ensuring conformity of the product with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising of the quality assurance system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality assurance system informed of any intended changes to the quality assurance system. The notified body shall evaluate any proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in Sub-paragraph 3.2 of this Chapter or whether a reassessment is necessary. The notified body shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. 4. Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising of the approved quality assurance system. 4.2. The manufacturer shall, for assessment purposes, allow the representatives of the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: - the documentation of the quality assurance system; - the quality examination records (such as results of analyses, calculations, tests, etc.) according to the design quality assurance system; - the quality records (such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.) according to the manufacturing quality assurance system. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality assurance system and shall provide the manufacturer with an audit report. 4.4. The representatives of the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality assurance system. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out - also with a test report. 5. Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the required conformity marking and - under the responsibility of the notified body referred to in Paragraph 1 of this Chapter - the identification number of such authority to each product that satisfies the requirements of this Regulation. 5.2. The manufacturer shall draw up in writing the declaration of conformity of each model of the product and keep it for the needs of State institutions together with the technical documents for at least 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. A copy of the declaration of conformity shall be available for all the relevant institutions upon their request. 6. The manufacturer shall, for a time period ending at least 10 years after the product has been placed on the market, keep at the disposal of the State institutions: - the technical documentation referred to in Sub-paragraph 3.1 of this Chapter; - the documentation concerning the quality assurance system referred to in Sub-paragraph 3.1 of this Chapter; - the information regarding the changes referred to in Sub-paragraph 3.5 of this Chapter, as approved; - the decisions and reports of the notified body referred to in Sub-paragraphs 3.5, 4.3 and 4.4 of this Chapter. 7. Each notified body shall inform its notifying authorities of quality assurance system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality assurance system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality assurance system approvals which it has refused, withdrawn, suspended, and, upon request - also concerning the quality assurance system approvals which it has issued. 8. Authorised representative The manufacturer's obligations referred to in Sub-paragraphs 3.1, 3.5 and Paragraphs 5 and 6 of this Chapter may be fulfilled by his authorised representative, on his behalf, provided that they are specified in the mandate. Acting for the Minister of
Transport,
Annex 3 EU DECLARATION OF CONFORMITY No. xxxxx*
3. This declaration of conformity is issued under the sole responsibility of the manufacturer, the private importer or the person referred to in Paragraph 60 or 61 of Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft.
9. Additional information: The EU declaration of conformity shall include a statement of the propulsion engine manufacturer and that of the person adapting an engine in accordance with Sub-paragraphs 13.2 and 13.3 of Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft, that, when installed in a watercraft, according to the installation instructions accompanying the engine, the engine will meet: 1) the requirements referred to in Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft, in respect of exhaust emission; 2) the limits laid down in the regulatory enactment regarding the emission of pollutants from internal combustion engines to be installed in non-road mobile machinery as regards engines type-approved in accordance with the abovementioned regulatory enactment and which are in conformity with stage III A, stage III B or stage IV emission limits for CI engines used in other applications than propulsion of inland waterway vessels, locomotives and railcars, as provided for in the abovementioned regulatory enactment; or 3) the limits of Regulation (EC) No 595/2009 as regards engines type-approved in accordance with the abovementioned Regulation. The engine must not be put into service until the watercraft into which it is to be installed has been declared in conformity (if so required) with the requirements referred to in Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft. If the engine has been placed on the market before 18 January 2020, the EU declaration of conformity shall contain an indication thereof. The declaration of conformity has been signed for and on behalf of:
* It is optional to assign a number to the declaration of conformity. Acting for the Minister of
Transport,
Annex 4 Supplementary Requirements when Using Module A1 - Internal Production Control and Supervised Production Tests(Paragraph 81 of Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft) I. Design and construction 1. On one or several watercrafts representing the production of the manufacturer one or more of the following tests, equivalent calculation or control shall be carried out by the manufacturer or on his behalf: 1.1. test of stability in accordance with Part A, Sub-paragraph 3.2 of Annex 1 to Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft (hereinafter - the Regulation); 1.2. test of buoyancy characteristics in accordance with Part A, Sub-paragraph 3.3 of Annex 1 to the Regulation. II. Noise emission 2. For recreational craft fitted with inboard or stern drive engines without integral exhaust and for personal watercraft - on one or several watercraft representing the production of the watercraft manufacturer, the sound emission tests defined in Part C of Annex 1 to the Regulation shall be carried out by the watercraft manufacturer (or on his behalf, under the responsibility of the notified body chosen by the manufacturer). 3. For outboard engines and stern drive engines without integral exhaust, on one or several engines of each engine family representing the production of the engine manufacturer, the sound emission tests defined in Part C of Annex 1 to the Regulation shall be carried out by the engine manufacturer (or on his behalf, under the responsibility of the notified body chosen by the manufacturer). 4. Where more than one engine of an engine family is tested, the statistical method referred to in Annex 5 to the Regulation shall be applied to ensure conformity of the sample. Acting for the Minister of
Transport,
Annex 5 Conformity of Production Assessment for Exhaust and Noise EmissionsFor verifying the conformity of an engine family, a sample of engines shall be taken from the series. The manufacturer shall decide the size (n) of the sample, in agreement with the notified body. The arithmetical mean X of the results obtained from the sample shall be calculated for each regulated component of the exhaust and noise emission. The production of the series shall be deemed to conform to the requirements ("pass decision") if the following condition is met: X + k.S ≤ L S is standard deviation, where S2 = ∑(x - X)2 / (n - 1), where X - the arithmetical mean of the results obtained from the sample; x - the individual results obtained from the sample; L - the appropriate limit value; n - the number of engines in the sample; k - statistical factor depending on n (see table).
Acting for the Minister of
Transport,
Annex 6 Supplementary Procedure to be Applied under Conformity to Type Based on Internal Production Control (Module C)In the cases referred to in Paragraph 84 of Cabinet Regulation No. 27 of 12 January 2016, Regulations Regarding Building, Conformity Assessment and Making Available on the Market of Recreational Craft and Personal Watercraft, when the quality level appears unsatisfactory, the following procedure shall apply: an engine is taken from the series and subjected to the test referred to in Part B of Annex 1 to the Regulation. Test engines shall have been run in, partially or completely, according to the manufacturer's specifications. If the specific exhaust emissions of the engine taken from the series exceed the limit values in accordance with Part B of Annex 1 to the Regulation, the manufacturer may ask for measurements to be done on a sample of engines taken from the series and including the engine originally taken. To ensure the conformity of the sample of engines with the requirements of the Regulation, the statistical method referred to in Annex 5 to the Regulation shall be applied. Acting for the Minister of
Transport,
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Title: Noteikumi par atpūtas kuģu un ūdens motociklu būvniecību, atbilstības novērtēšanu un piedāvāšanu ..
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