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Product Safety Act (Act No. V Of 2001) Recreational Craft Regulations, 2003. (L.N. 254 Of 2003 )

PRODUCT SAFETY ACT (ACT NO. V OF 2001)Recreational Craft Regulations, 2003

IN exercise of the powers conferred by articles 38 to 40 of the Product Safety Act, 2001, the Minister of Finance and Economic Affairs, on the advice of the Malta Standards Authority, has made the following regulations:-
1.1. The title of these regulations is the Recreational Craft
Regulations, 2003.
1.2. These regulations shall come into force on the date of publication in the Gazette.
1.2.1. Provided that the requirement to provide information to the Commission referred to in regulation 7.4 of these regulations shall come into force on the 1st May 2004 or on such earlier date as the Minister responsible for consumer affairs, after consultation with the Malta Standards Authority, may prescribe.
2.1. These regulations shall apply to recreational craft, partly completed boats and components referred to in Annex II of the Directive, set out in Schedule II to these regulations, when separate and when installed;
2.2. The following are excluded from the scope of these regulations:-
(a) craft intended solely for racing, including rowing racing boats and training rowing boats labelled as such by the manufacturer;
(b) canoes and kayaks, gondolas and pedalos; (c) sailing surfboards;
(d) powered surfboards, personal watercraft and other similar powered craft;
(e) original, and individual replicas of, historical craft designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer;

Citation and commencement.

Scope.

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Definitions.

(f) experimental craft, provided that they are not subsequently placed on the market;
(g) craft built for own use, provided that they are not subsequently placed on the market during a period of five years;
(h) craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to regulation 3.1.1, in particular those defined in Council Directive
82/714/EEC of the 4th October, 1982 laying down technical requirements for inland waterway vessels1, regardless of the number
of passengers;
(i) submersibles;
(j) air cushion vehicles; (k) hydrofoils.
3.1. For the purposes of these regulations, the following definitions shall apply:
3.1.1. “authorized representative” means any person (or organisation) established in the Community or Malta who has been appointed by the manufacturer to act on his behalf in carrying out certain tasks required by these regulations;
3.1.2. “CE marking” means the CE conformity marking consisting of the symbol ‘CE’ as set out in Annex IV of the Directive, which is set out in Schedule IV to these regulations;
3.1.3. “Commission” means the European Commission;
3.1.4. “Community” means the European Community;
3.1.5. “essential safety, health, environment protection and consumer protection requirements” means the requirements in Annex I of the Directive, which is set out in Schedule I to these regulations;
3.1.6. “Harmonised Standard” means a technical specification adopted by the European Committee for Standardisation (CEN) or the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), upon a remit from the European Commission in accordance with Directive 98/34/ EC2 of the European Parliament and of the Council laying down a

1 OJ No. L301, 28-10-82, P.1.

2 OJ No. L204, 21-07-98, P.37.

procedure for the provision of information in the field of technical standards and regulations as amended by Directive 98/48/EC3 of the European Parliament and of the Council, the reference of which has been published in the OJEU;
3.1.7. “importer” means any person who places on the Community or Maltese market and puts into service the product that is covered by these regulations and imported from a third country;
3.1.8. “Manufacturer” means the person:
3.1.8.1. who is primarily responsible for the design and construction of the product covered by these regulations with a view to placing it on the Community or Maltese market on his/their behalf;
3.1.8.2. who is responsible for “re-building” or modifying an existing boat or product falling under these regaulations, and who in so doing is creating an “as-new” product, with a view to placing it on the Community or Maltese market on his/their behalf;
3.1.8.3. who takes responsibility for the appraisal of the design, construction and any necessary modification of used imported products from third countries;
3.1.9. “National Standard transposing the Harmonised Standard” means a Standard issued by one of the members of CEN/ CENELEC/ETSI which is declared and noted to be identical to the Harmonised Standard originally issued by CEN/CENELEC/ ETSI, the reference of which has been published in the OJEU;
3.1.10. “notified body” means a body which has been appointed by a Member State and notified to the Commission and the other Member States, pursuant to Article 9 of the Directive, to carry out one or more of the conformity assessment procedures mentioned and referred to in regulation 6 of these regulations;
3.1.10.1. Maltese notified bodies wishing to operate within the scope of these regulations shall follow the procedure listed in L.N. 136 of 2003

: Method for Designating Conformity Assessment Bodies Regulations, 20034;
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3 OJ No. L217, 05-08-98, P.18.

4 Published in the Government Gazette No: 14,433 of 24th June 2003, by virtue of the Product Safety Act Cap. 427.

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Applicability.

General requirements.

3.1.11. “OJEU” means the Official Journal of the European
Union;
3.1.12. “placing on the market” means the initial action of making available a product for the first time on the Community or Maltese market, with a view to distribution or use on the Community or Malta;
3.1.12.1. “making available” means the transfer of the product, irrespective of the legal act on which the transfer is based (sale, loan, hire, lease, gift or any other type of legal instrument);
3.1.13. “putting into service” means the first use of a product covered by these regulations in the Community or Maltese territory by its end user;
3.1.14. “recreational craft” shall mean any boat of any type, regardless of the means of propulsion, from 2.5 to 24 m hull length, measured according to the appropriate harmonised standards intended for sports and leisure purposes;
3.1.14.1. The fact that the same boat could be used for charter or for recreational boating training shall not prevent it being covered by these regulations when it is placed on the market for recreational purposes;
3.1.15. “the Directive” means Council Directive 94/25/EC5 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft.
4.1. The provisions of these regulations are applicable to all imported products falling under these regulations as well as to those manufactured for the local market.
4.1.1. No person may construct, import, place on the market or put into service any product which does not comply with the provisions of these regulations.
5.1. All necessary measures shall be taken to ensure that the products referred to in regulation 2.1 of these regulations may be placed on the market and put into service for use in accordance with their intended purpose only if they do not endanger the safety and health of persons, property or the environment when correctly constructed and maintained.

5 OJ No. L164, 30-06-94, P.15.

5.1.1. The provisions of these regulations shall not prevent competent authorities from adopting, in compliance with the Treaty, provisions concerning navigation on certain waters for the purpose of protection of the environment, the fabric of waterways, and ensuring safety of waterways, providing that this does not require modification to craft conforming to these regulations.
5.2. The products referred to in regulations 2.1 of these regulations shall meet the essential safety, health, environmental protection and consumer protection requirements set out in Annex I of the Directive, which are set out in Schedule I hereto.
5.3. The placing on the market and putting into service in Maltese territory of the products referred to in regulation 2.1 of these regulations bearing the CE marking referred to in Annex IV of the Directive, as set out in Schedule IV hereto, which indicates their conformity with all provisions of these regulations, including the conformity procedures set out in Chapter II of the Directive and regulation 6 of these regulations, shall not be prohibited, restricted or impeded.
5.4. The placing on the market of partly-completed boats, where the builder or his authorized representative or the person responsible for the placing on the market declares, in accordance with Annex III (a) of the Directive, as set out in Schedule III (a) hereto, that they are intended to be completed by others, shall not be prohibited, restricted or impeded.
5.5. The placing on the market and putting into service of components referred to in Annex II of the Directive, as set out in Schedule II hereto, and bearing the CE marking referred to in Annex IV of the Directive, as set out in Schedule IV hereto, which indicates their conformity with the relevant essential requirements where these components are intended to be incorporated into recreational craft, in accordance with the declaration, referred to in Annex III (b) of the Directive, as set out in Schedule III(b) hereto, of the manufacturer, his authorized representative or, in the case of imports from third country, of any person who places those components on the Community or Maltese market, shall not be prohibited, restricted or impeded.
5.6. At trade fairs, exhibitions, demonstrations, no obstacles shall be created to the showing of the products referred to in regulation 2.1 of these regulations which do not comply with these regulations, provided that a visible sign clearly indicates that such products may not be marketed or put into service until they have been made to comply.
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Conformity assessment procedures.

5.7. Compliance with the essential requirements, referred to in regulation 5.2 of these regulations, of products referred to in regulation
2.1 of these regulations shall be presumed if they meet the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the OJEU.
6.1. Before producing and placing on the market products referred to in regulation 2.1 of these regulations, the manufacturer or his authorized representative shall apply the following procedures for boat design categories A, B, C and D as referred to in Section 1 of Annex I of the Directive, set out in Schedule I hereto:-
6.1.1. for categories A and B —
(a) for boats of less than 12 metres hull length, the internal production control plus tests (module Aa) referred to in Annex VI of the Directive, set out in Schedule VI to these regulations;
(b) for boats from 12 metres to 24 metres hull length, the EC type-examination (module B) referred to in Annex VII of the Directive, set out in Schedule VII to these regulations, supplemented by type conformity (module C) referred to in Annex VIII of the Directive, set out in Schedule VIII to these regulations, or any of the following modules: B plus D, or B plus F, or G or H;
6.1.2. for category C —
(a) for boats from 2.5 metres to 12 metres hull length—
(i) where the harmonised standards relating to sections
3.2 and 3.3 of Annex I of the Directive, set out in Schedule I to these regulations are complied with, the internal production control (module A), referred to in Annex V of the Directive, set out in Schedule V to these regulations,
(ii) where the harmonised standards relating to sections
3.2 and 3.3 of Annex I of the Directive, set out in Schedule I to these regulations are not complied with, the internal production control plus tests (module Aa) referred to in Annex VI of the Directive, set out in Schedule VI to these regulations;
(b) for boats from 12 metres to 24 metres hull length, the EC type-examination (module B) referred to in Annex VII of the Directive, set out in Schedule VII to these regulations, followed by type conformity (module C) referred to in Annex VIII of the
Directive, set out in Schedule VIII to these regulations, or any of the following modules: B plus D, or B plus F, or G or H;
6.1.3. for category D
—for boats from 2.5 metres to 24 metres hull length, the internal production control (module A) referred to in Annex V of the Directive, set out in Schedule V to these regulations; and
6.1.4. for components referred to in Annex II of the Directive, set out in Schedule II hereto, any of the following modules: B plus C, or B plus D, or B plus F, or G or H.
7.1. Where it is ascertained that recreational craft or components referred to in Annex II of the Directive, set out in Schedule II to these regulations and bearing the CE marking referred to in Annex IV of the Directive, set out in Schedule IV to these regulations when correctly constructed, installed, maintained and used in accordance with their intended purpose may endanger the safety and health of persons, property or the environment, the Director of Consumer Affairs shall take all appropriate interim measures to withdraw them from the market or prohibit or restrict their being placed on the market or put into service.
7.1.1. The Consumer and Industrial Goods Directorate6 of the Malta Standards Authority shall be immediately informed of any such measures taken under regulation 7.1 and 7.2 of these regulations, indicating the reasons for such decision and, in particular, whether non-conformity is the result of:
(a) failure to comply with the essential requirements referred to in regulation 5.2 of these regulations;
(b) incorrect application of the standards referred to in regulation 5.7 of these regulations, in so far as it is claimed that those standards have been applied;
(c) shortcomings in the standards referred to in regulation
5.7 of these regulations themselves.
7.2. Where a non-complying component referred to in Annex II of the Directive, set out in Schedule II to these regulations, or craft bears the CE marking, the Director of Consumer Affairs shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Consumer and Industrial Goods Directorate of the Malta Standards Authority.
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Withdrawal and prohibition from market.

6 L.N. 213 of 2000

– Malta Standards Authority (Establishment of Directorates) Order, 2000, published in the Government

Gazette No. 17,002 of 20th October, 2000

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CE Marking.

7.3. Any decision taken pursuant to these regulations which restricts the placing on the market and putting into service of products shall state the exact grounds on which it is based.
7.3.1. Such a decision shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in Malta and of the time limits to which such remedies are subject.
7.4. The Consumer and Industrial Goods Directorate of the Malta Standards Authority shall immediately inform the Commission of any measures taken in pursuance of regulations 7.1, 7.1.1, 7.2, 7.3 and 7.3.1 of these regulations.
8.1. The CE conformity marking shall consist of the initials ‘CE’.
8.1.1. The form of the marking to be used is shown in Annex
IV of the Directive, set out in Schedule IV to these regulations.
8.2. Recreational craft and components referred to in Annex II of the Directive, set out in Schedule II hereto, which are regarded as meeting the essential requirements referred to in regulation 5.2 of these regulations must bear the CE marking of conformity when they are placed on the market.
8.3. The affixing of markings on the appliances which are likely to deceive third parties as to the meanign and form of the CE marking shall be prohibited. Any other marking may be affixed to the appliance or to the data plate provided that the visivility and legivility of the CE marking is not hereby reduced.
8.3.1. The CE markign shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes VI, IX, X, XI and XII of the Directive, set out in Schedules VI, IX, X, XI and XII hereto.
8.4. Subject to regulation 8.5 below, where any recreational craft or component is subject to any other directive or directives, as the case may be, in addition to the Directive which also provides for the affixing of the CE marking, the CE marking shall indicate that the recreational craft or component, as the case may be, also fulfils the provisions of that other directive or those directives.
8.5. Where one or more of the other directives referred to in regulation 8.4 allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the recreational craft or component in question fulfils the provisions
only of the directive or directives applied by the manufacturer; and, in this case, particulars of the directives applied, as published in the OJEU, must be given in the documents, notices or instructions required by those directives and accompanying the recreational craft or component in question.
8.6 The affixing of markings or inscriptions on the craft which are likely to mislead third parties with regard to the meaning or the form of the CE marking shall be prohibited. Any other markings may be affixed to the recreatonal craft and components as referred to in Annex II of the Directive, set out in Schedule II hereto and, or on their packaging, provided that the visibility and legibility of the CE marking is not thereby reduced.
8.7 Without prejudice to regulation 7 of these regulations:
(a) where it is established that the CE marking has been affixed wrongly, the manufacturer or his authorized representative shall be obliged to end the infringement under conditions laid down by the Director of Consumer Affairs;
(b) where non-compliance continues, the Director of Consumer Affairs shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure laid down in regulation 7 of these regulations.
9.1. The Recreational Craft Regulations, 2001 are hereby being revoked.
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Revokes L.N. 231 of 2001

.

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Definitions:

A. OCEAN: Designed for extended voyages where conditions may exceed wind force 8 (Beaufort scale) and significant wave heights of 4 m and above, and vessels largely self-sufficient.
B. OFFSHORE: Designed for offshore voyages where conditions up to, and including, wind force 8 and significant wave heights up to, and including, 4 m may be experienced.
C. INSHORE: Designed for voyages in coastal waters, large bays, estuaries, lakes and rivers where conditions up to, and including, wind force 6 and significant wave heights up to, and including, 2 m may be experienced.
D. SHELTERED WATERS: Designed for voyages on small lakes, rivers, and canals where conditions up to, and including, wind force 4 and significant wave heights up to, and including, 0.5 m may be experienced.
Boats in each Category must be designed and constructed to withstand these parameters in respect of stability, buoyancy, and other relevant essential requirements listed in Annex I of the Directive, set out in Schedule I to these regulations, and to have good handling characteristics.
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Recreational craft and components as referred to in Annex II of the Directive, set out in Schedule II to these regulations, shall comply with the essential requirements in so far as they apply to them.

Each craft shall be marked with a hull identification number including the following information:
- manufacturer’s code,
- country of manufacture,
- unique serial number,
- year of production,
- model year.
The relevant harmonized standard gives details of these requirements.

Each craft shall carry a permanently affixed plate mounted separately from the boat hull identification number, containing the following information:
- manufacturer’s name,
- CE marking (see Annex IV of the Directive, set out in Schedule IV to these regulations),
- boat design category according to section 1,
- manufacturer’s maximum recommended load according to section 3.6 of this
Schedule,
- number of persons recommended by the manufacturer for which the boat was designed to carry when under way.

Depending on the design category, craft shall be designed to minimize the risks of falling overboard and to facilitate reboarding.
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For motor boats, the main steering position shall give the operator, under normal conditions of use (speed and load), good all-round visibility.

Each craft shall be provided with an owner’s manual drawn up in Maltese or in any other language of the Community acceptable to the Maltese authorities. This manual should draw particular attention to risks of fire and flooding and shall contain the information listed in sections 2.2, 3.6 and 4 of this Schedule as well as the unladen weight of the craft in kilograms.

The choice and combination of materials and its construction shall ensure that the craft is strong enough in all respects. Special attention shall be paid to the design category according to section 1 of this Schedule, and the manufacturer’s maximum recommended load in accordance with section 3.6 of this Schedule.

The craft shall have sufficient stability and freeboard considering its design category according to section 1 and the manufacturer’s maximum recommended load according to section 3.6 of this Schedule.

The craft shall be constructed to ensure that it has buoyancy characteristics appropriate to its design category according to section 1.1, and the manufacturer’s maximum recommended load according to section 3.6. All habitable multihull craft shall be so designed as to have sufficient buoyancy to remain afloat in the inverted position.
Boats of less than six 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.

Openings in hull, deck(s) and superstructure shall not impair the structural integrity of the craft or its weathertight integrity when closed.
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Windows, portlights, doors and hatchcovers shall withstand the water pressure likely to be encountered in their specific position, as well as pointloads 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 according to section 3.6 of this Schedule, shall be fitted with shutoff means which shall be readily accessible.

All craft shall be designed so as to minimize the risk of sinking. Particular attention should be paid where appropriate to:
- cockpits and wells, which should be self-draining or have other means of keeping water out of the boat interior,
- ventilation fittings,
- removal of water by pumps or other means.

The manufacturer’s maximum recommended load (fuel, water, provisions, miscellaneous equipment and people (in kilograms)) for which the boat was designed, as marked on the builder’s plate, shall be determined according to the design category (section 1of this Schedule), stability and freeboard (section 3.2 of this Schedule) and buoyancy and flotation (section 3.3 of this Schedule).

All craft of categories A and B, and craft of categories C and D longer than six metres shall be provided with one or more stowage points for a liferaft (liferafts) large enough to hold the number of persons the boat was designed to carry as recommended by the manufacturer. This (these) stowage point(s) shall be readily accessible at all times.

All habitable multihull craft over 12 metres long shall be provided with viable means of escape in the event of inversion.
fire.
All habitable craft shall be provided with viable means of escape in the event of
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All craft, 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.

The manufacturer shall ensure that the handling characteristics of the craft are satisfactory with the most powerful engine for which the boat is designed and constructed. For all recreational marine engines, the maximum rated engine power
shall be declared in the owner’s manual in accordance with the harmonized standard.

5.1.1. Inboard engine

All inboard mounted engines shall be placed within an enclosure separated from living quarters and installed so as to minimize 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 engine spaces shall be non-combustible.

5.1.2. Ventilation

The engine compartment shall be ventilated. The dangerous ingress of water into the engine compartment through all inlets must be prevented.

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 engines starting

All boats with outboard engines shall have a device to prevent starting the engine in gear, except:
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(a) when the engine produces less than 500 newtons (N) of static thrust;
(b) when the engine has a throttle limiting device to limit thrust to 500 N at the time of starting the engine.

5.2.1. General

The filling, storage, venting and fuel-supply arrangements and installations shall be designed and installed so as to minimize 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. All tank spaces shall be ventilated.
Liquid fuel with a flash point below 550 C shall be kept in tanks which do not form part of the hull and are:
(a) insulated from the engine compartment and from all other source of ignition; (b) separated from living quarters.
Liquid fuel with a flash point equal to or above 550 C may be kept in tanks that are integral with the hull.

Electrical systems shall be designed and installed so as to ensure proper operation of the craft under normal conditions of use and shall be such as to minimize risk of fire and electric shock.
Attention shall be paid to the provision of overload and short-circuit protection of all circuits, except engine starting circuits, supplied from batteries.
Ventilation shall be provided to prevent the accumulation of gases which might be emitted from batteries. Batteries shall be firmly secured and protected from
ingress of water.

5.4.1. General

Steering systems shall be designed, constructed and installed in order to allow the transmission of steering loads under foreseeable operating conditions.
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5.4.2. Emergency arrangements

Sailboat and single-engined inboard powered motor boats with remote-controlled rudder steering systems shall be provided with emergency means of steering the
craft at reduced speed.

Gas systems for domestic use shall be of the vapour-withdrawal type and shall be designed and installed so as to avoid leaks and the risk of explosion and be capable
of being tested for leaks. Materials and components shall be suitable for the specific gas used to withstand the stresses and exposures found in the marine environment.
Each appliance shall be equipped with a flame failure device effective on all burners. 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 craft 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. Any permanent gas system shall be tested after installation.

5.6.1. General

The type of equipment installed and the layout of the craft 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 avoiding electrical wiring above hot areas of machines.

5.6.2. Fire-fighting equipment

Craft shall be supplied with fire-fighting equipment appropriate to the fire hazard. Petrol engine enclosures shall be protected by a fire extinguishing system that avoids the need to open the enclosure 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 craft.

Where navigation lights are fitted, they shall comply with the 1972 Colreg or
CEVNI regulations, as appropriate.

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Craft shall be constructed so as to prevent the accidental discharge of pollutants
(oil, fuel, etc.) overboard.
Craft fitted with toilets shall have either: (a) holding tanks; or
(b) provision to fit holding tanks on a temporary basis in areas of use where the discharge of human waste is restricted.
In addition, any through-the-hull pipes for human waste shall be fitted with valves which are capable of being sealed shut.
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1. Ignition-protected equipment for inboard and stern drive engines.
2. Start-in-gear protection devices for outboard engines.
3. Steering wheels, steering mechanisms and cable assemblies.
4. Fuel tanks and fuel hoses.
5. Prefabricated hatches and portlights.

B 3101

(Regulation 5.4 and 5.5 of these regulations and Article 4 (2) and (3) of the

Directive)

(a) The declaration by the builder or his authorized representative referred to in regulation 5.4 of these regulations and Article 4 (2) of the Directive (partly completed craft) shall contain the following:
- the name and address of the builder,
- the name and address of the representative of the builder or, if appropriate, of the person responsible for the placing on the market,
- a description of the partly completed craft,
- a statement that the partly completed craft is intended to be completed by others and that it complies with the essential requirements that apply at this stage of construction.
(b) The declaration by the builder, his authorized representative or the person responsible for placing on the market referred to in regulation 5.5 of these regulations and Article 4 (3) of the Directive (components) shall contain the following:
- the name and address of the builder,
- the name and address of the representative of the builder or, if appropriate, of the person responsible for the placing on the market,
- a description of the component,
- a statement that the component complies with the relevant essential requirements.
B 3102

The CE conformity marking shall consist of the initials ‘CE’ taking the following form:
<.. image removed ..>

For the avoidance of doubt, it is hereby declared that the grid providing the background in the above graduated drawing is not part of the CE marking.

— if the CE marking is reduced or enlarged the proportions given in the above drawing must be respected,
— the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm,
— the CE marking is followed by the identification number of the notified body if it intervenes in the control of production.

B 3103
1. The manufacturer or his authorized representative, who carries out the obligations laid down in point 2 of this Schedule, ensures and declares that the products concerned satisfy the requirements of the regulations that apply to them. The manufacturer or his authorized representative shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations).
2. The manufacturer shall establish the technical documentation described in point 3 and he or his authorized representative shall keep it for a period ending at least
10 years after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes.
Where neither the manufacturer nor his authorized representative is established within the Community or Malta, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the market.
3. Technical documentation shall enable the conformity of the products with the requirements of the regulations to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the product (see Annex XIII of the Directive, set out in Schedule XIII to these regulations).
4. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity with the technical documentation.
5. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure compliance of the manufactured products with the technical documentation referred to in point 2 of this Schedule and with the requirements of the regulations that apply to them.
B 3104

This module consists of module A, as referred to in Annex V of the Directive, set out in Schedule V to these regulations, plus the following supplementary requirements:
On one or several boats 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:
- test of stability according to point 3.2 of the Essential Requirements (Schedule
I to these regulations),
- test of buoyancy characteristics according to point 3.3 of the Essential
Requirements (Schedule I to these regulations) Provisions common to both variations
These tests or calculations or control shall be carried out on the responsibility of a notified body chosen by the manufacturer. On the responsibility of the notified body, the manufacturer shall affix the former ’s distinguishing number during the manufacturing process.

B 3105
1. A notified body ascertains and attests that a specimen, representative of the production envisaged, meets the provisions of the regulations that apply to it.
2. The application for the EC type-examination shall be lodged by the manufacturer or his authorized representative with a notified body of his choice.
The application shall include:
- the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address in addition,
- a written declaration that the same application has not been lodged with any other notified body,
- the technical documentation, as described in point 3 of this Schedule.
The applicant shall place at the disposal of the notified body a specimen, representative of the production envisaged and hereinafter called ‘type’7.
The notified body may request further specimens if needed for carrying out the test programme.
3. The technical documentation shall enable the conformity of the product with the requirements of the regulations to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture and functioning of the product (see Annex XIII of the Directive, set out in Schedule XIII to these regulations).
4. The notified body shall:
4.1. examine the technical documentation, verify that the type has been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in regulation 5.7 of these regulations and Article 5 of the Directive, as well as the components which have been designed without applying the relevant provisions of those standards;

7 A type may cover several versions of the product provided that the differences between the versions do not affect the level of safety and the other requirements concerning the performance of the product.

B 3106
4.2. perform or have performed the appropriate examinations and necessary tests to check whether, where the standards referred to in regulation 5.7 of these regulations and Article 5 of the Directive have not been applied, the solutions adopted by the manufacturer meet the Essential Requirements of the Directive (Schedule I to these regulations);
4.3. perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;
4.4. agree with the applicant the location where the examinations and necessary tests shall be carried out.
5. Where the type meets the provisions of the regulations, the notified body shall issue an EC type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the examination, conditions for its validity and the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
If the manufacturer is denied a type certification, the notified body shall provide detailed reasons for such denial.
6. The applicant shall inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved product which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original EC type-examination certificate.
7. Each notified body shall communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued
and withdrawn.
8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative shall keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least 10 years after the last product has been manufactured.
Where neither the manufacturer nor his authorized representative is established the Community or Malta, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community or Maltese market.

1. The manufacturer or his authorized representative ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the regulations that apply to them. The manufacturer shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations).
2. The manufacturer shall take all measures necessary to ensure that the manufacturing process assures compliance of the manufactured products with the type as described in the EC type-examination certificate and with the requirements of the regulations that apply to them.
3. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last product has been manufactured.
Where neither the manufacturer nor his authorized representative is established within the Community or Malta, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community or Maltese market (see Annex XIII of the Directive, set out in Schedule XIII to these regulations).
B 3107
B 3108

1. The manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of the regulations that apply to them.
The manufacturer or his authorized representative shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations). The CE marking shall be accompanied by the distinguishing number of the notified body responsible for the monitoring as specified in point 4 of this Schedule.
2. The manufacturer shall operate an approved quality system for production, final product inspection and testing as specified in point 3 of this Schedule and shall be subject to monitoring as specified in point 4 of this Schedule.

3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body of his choice, for the products concerned.
The application shall include:
- all relevant information for the product category envisaged,
- the documentation concerning the quality system,
- where appropriate, the technical documentation of the approved type (see Annex XIII of the Directive, set out in Schedule XIII to these regulations) and a copy of the EC type-examination certificate.
3.2. The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the regulations that apply 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. The quality system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records.
B 3109
It shall contain in particular an adequate description of:
- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality,
- the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
- the means to monitor the achievement of the required product quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2 of this Schedule. It shall presume conformity with these requirements in respect of quality systems that implement the relevant harmonized standard.
The auditing team shall have at least one member with experience of evaluation in the product technology concerned. The evaluation procedure shall include an inspection visit to the manufacturer’s premises.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.
The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.
The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 of this Schedule or whether a reassessment is required.
It shall notify its decisions to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

B 3110
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and shall provide it with all necessary information, in particular:
- the quality system documentation,
- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit
report to the manufacturer.
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.
5. The manufacturer shall, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
-the documentation referred to in the second indent of the second subparagraph of point 3.1 of this Schedule,
- the updating referred to in the second subparagraph of point 3.4 of this Schedule,
- the decision and reports from the notified body which are referred to in the final subparagraph of point 3.4, point 4.3 and point 4.4 all of this Schedule.
6. Each notified body shall give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

B 3111
1. This module describes the procedure whereby a manufacturer or his authorized representative checks and attests that the products subject to the provisions of
point 3 of this Schedule are in conformity with the type as described in the EC type-
examination certificate and satisfy the requirements of the regulations that apply to them.
2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products with the type as described in the EC type-examination certificate and with the requirements of the regulations that apply to them. The manufacturer or his authorized representative shall affix the CE marking to each product and shall draw up a declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations).
3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product with the requirements of the regulations either by examination and testing of every product as specified in point 4 of this Schedule or by examination and testing of products on a statistical basis, as specified in point 5 of this Schedule, at the choice of the manufacturer.
3.1. The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last product
has been manufactured.

4.1. All products shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in regulation 5.7 of these regulations and Article
5 of the Directive or equivalent tests shall be carried out in order to verify their
conformity with the type as described in the EC type-examination certificate and the requirements of the regulations that apply to them.
4.2. The notified body shall affix, or cause to be affixed, its distinguishing number to each approved product and draw up a written certificate of conformity relating to the tests carried out.
4.3. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.

lots and shall take all measures necessary in order that the manufacturing process ensures
the homogeneity of each lot produced.
5.2. All products shall be available for verification in the form of homogeneous lots. A random sample shall be drawn from each lot. Products in a sample shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in regulation 5.7 of these regulations and Article 5 of the Directive, or equivalent tests, shall be carried out to ensure their conformity with the requirements of the regulations which apply to them and to determine whether the lot is accepted or rejected.
5.3. The statistical procedure shall use the following elements:
- the statistical method to be applied,
- the sampling plan with its operational characteristics.
5.4. In the case of accepted lots, the notified body shall affix, or cause to be affixed, its distinguishing number to each product and shall draw up a written certificate of conformity relating to the tests carried out. All products in the lot may be put on the market except those products from the sample which were found not to be in conformity.
If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent the putting on the market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified body, affix the latter’s distinguishing number during the manufacturing process.
5.5. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.

B 3113
1. This module describes the procedure whereby the manufacturer ensures and declares that the product concerned, which has been issued with the certificate referred to in point 2 of this Schedule, conforms to the requirements of the regulations that apply to it. The manufacturer or his authorized representative shall affix the CE marking to the product and draw up a declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations).
2. The notified body shall examine the individual product and carry out the appropriate tests as set out in the relevant standard(s) referred to in regulation 5.7 of these regulations and Article 5 of the Directive, or equivalent tests, to ensure its conformity with the relevant requirements of the regulations.
The notified body shall affix, or cause to be affixed, its distinguishing number on the approved product and shall draw up a certificate of conformity concerning the tests carried out.
3. The aim of the technical documentation is to enable conformity with the requirements of the regulations to be assessed and the design, manufacture and
operation of the product to be understood (see Annex XIII of the Directive, set out in
Schedule XIII to these regulations).
B 3114

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of point 2 of this Schedule ensures and declares that the products concerned satisfy the requirements of the regulations that apply to them. The manufacturer or his authorized representative shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV of the Directive, set out in Schedule XV to these regulations). The CE marking shall be accompanied by the distinguishing number of the notified body responsible for the surveillance as specified in point 4 of this Schedule.
2. The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 of this Schedule and shall be subject to surveillance as specified in point 4 of this Schedule.

3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified body.
The application shall include:
- all relevant information for the product cagetory envisaged,
- the quality system’s documentation.
3.2. The quality system shall ensure compliance of the products with the requirements of the regulations that apply 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. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
It shall contain in particular an adequate description of:
- the quality objectives and the organizational structure, responsibilities and powers of the management with regard to design and product quality,
B 3115
- the technical design specifications, including standards, that will be applied and, where the standards referred to in regulation 5.7 of these regulations and Article 5 of the Directive will not be applied in full, the means that will be used to ensure that the essential requirements of the regulations 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 systematic actions that will be used,
- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
- the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2 of this Schedule. It shall presume compliance with these requirements in respect of quality systems that implement the relevant harmonized standard (MSA EN ISO 9000).
The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure shall include an assessment visit to the manufacturer’s premises.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.
The manufacturer or his authorized representative shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.
The notified body shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 of this Schedule or whether a reassessment is required.
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in particular:
- the quality system documentation,
- the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
- the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit
report to the manufacturer.
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
5. The manufacturer shall, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
- the documentation referred to in the second indent of the second subparagraph of point 3.1 of this Schedule,
- the updating referred to in the second subparagraph of point 3.4 of this Schedule,
- the decisions and reports from the notified body which are referred to in the final subparagraph of point 3.4, point 4.3 and point 4.4 of this Schedule.
6. Each notified body shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.

The technical documentation referred to in Annexes V, VII, VIII, IX and XI of the Directive, set out in Schedules V, VII, VIII, IX and XI to these regulations must comprise all relevant data or means used by the manufacturer to ensure that components or craft comply with the essential requirements relating to them.
The technical documentation shall enable understanding of the design, manufacture and operation of the product, and shall enable assessment of conformity with the requirements of these regulations and the Directive.
The documentation shall contain so far as relevant for assessment:
- a general description of the type,
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
- a list of the standards referred to in regulation 5.7 of these regulations and Article 5 of the Directive, applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in regulation 5.7 of these regulations and Article 5 of the Directive have not been applied,
- results of design calculations made, examinations carried out, etc.,
- test reports, or calculations namely on stability according to point
3.2 of the Essential Requirements and on buoyancy according to point
3.3 of the Essential Requirements, listed in Schedule I to these regulations.
B 3117
B 3118

1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of boat or components which they inspect, nor the authorized representative of any of these parties. They shall not become either involved directly or as authorized representatives in the design, construction, marketing or maintenance of the said products. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.
2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the result of the inspection, especially from persons or groups of persons with an interest in the result of verifications.
3. The body shall have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the administrative and technical tasks connected with verification; it shall also have access to the equipment required for special verification.
4. The staff responsible for inspection shall have:
- sound technical and professional training,
- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,
- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.
5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.
6. The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.
7. The staff of the body shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State in which its activities are carried out) under the regulations or any provision of national law giving effect to it.

B 3119
1. The written declaration of conformity to the provisions of these regulations and the Directive must always accompany:
- the recreational craft and be joined to the owner’s manual (Annex I, point 2.5, of the Directive, set out in Schedule I, point 2.5 to these regulations),
- the components as referred to in Annex II of the Directive, set out as Schedule II
to these regulations.
2. The written declaration of conformity shall include the following8:
- name and address of the manufacturer or his authorized representative9,
- description of the recreational craft10 or of the component9,
- references to the relevant harmonized standards used, or references to the specifications in relation to which conformity is declared,
- where appropriate, reference to the EC type-examination certificate issued by a notified body,
- where appropriate, the name and address of the notified body,
- identification of the person empowered to sign on behalf of the manufacturer or his authorized representative.

8 and be drawn up in the language as foreseen under point 2.5 of Annex I of the Directive, set out in point 2.5 of Schedule I to these regulations.

9 business name and full address; authorized representative must also give the business name and address of the manufacturer.

10 description of the product make, type, serial number, where appropriate.